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| VOLUME 82 No. 1 


| 


2006 Maryland Leadership Elections 
Statements of the Candidates and 
Official Ballot 


| Recognizing Pharmacy Excellence 
MPha 2006 Awards Nomination Form 


Continuing Education 
“Recommendations for Prevention 
and Control of Influenze: 2005-06 
Flu Season” 


° 
: =i 
MARYLAND_PHARMACISTS ASSOCIATION | JAN./FE! 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 
410-727-0746 
www.marylandpharmacist.org 


MPhA Officers 2005 — 2006 


Matt Shimoda, Pharm.D., President 

Ginger Apyar, P.D., First-Vice President 
Joe Marrocco, P.D., Second-Vice President 
Walter Abel, P.D., Treasurer 

George Voxakis, Pharm, D., Honorary President 


House Officers 


Mary Kremzner, Pharm.D., Speaker 
Barry Poole, R.Ph., Vice-Speaker 


MPhA Staff 


Howard Schiff, P.D., Executive Director 
Elsie Prince, Office Manager 
Nancy Ruskey, Administrative Assistant 


MPhA Trustees 


Cynthia Boyle, Pharm.D., Chairperson 
Michelle Andoll, P.D. ,J.D................ 2008 
Doug:Campbell?}R: Rive. een eee 2006 
Kathryn: Fader, R.Ph 222 ee 2006 
Butch Henderson, R.Ph 

Neil:Letkach}P.Disaiae > ce ee 2007 
Magaly Rodriguez deBittner, Pharm.D. . .2007 
David RUSSO#R. Pie tee ee 2008 
Carol Stevenson, Pharm.D. ............ 2007 
Doris: Voight, Pharm. Dee 22 eee 2008 
Stephen Wienner, P:Dsi 0 a ae ee 2006 
Lisa Clayville, President ASP 


Ex-Officio Members 
David Knapp, Ph.D., Dean - 
UMB School of Pharmacy 
Jeffrey Brewer - MSHP Representative 


Maryland State Board of Pharmacy 


John Balch, P.D., President 
Mark Levi, P.D., Treasurer 
Jeanne Furman, P.D., Secretary 
Margie A. Bonnett 

Joseph A. DeMino, P.D. 

David R. Chason, R.Ph. 


Mayer Handelman, P_D. 
Mike Souranis, P.D. 
Donald Taylor, P.D. 
Rodney Taylor, Pharm. D. 
Donald Yee, P.D. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


President S|GLECLIN base. tere pene eeimeme we? Prete Hn Eee a oe tt wee 5 
aera DCULICALIY SPEAKING... gmrerne ciemennc stenrn. PUNINE, Wet pt oycytie gre es tapes sw sts ie = 6 
“New Therapeutic Options for Patients with Diabetes” 

Statements Ontne: Candidates sae tS ee Se Seer ee 9 
POOOMVarviandiLeCadersnipseleCUlONSmemtn water. ccc ccs tcc te ete eee 11 
“Official Ballot” 

Maly du GslaninidCiStSinsSOCIAliONe wm . mete, wid. s Peete ss cs ec ese es ibs) 


“Constitution and Bylaws” 


ReECOOMIZINoinaliidaCVeEXGClGlCG eis thir tis wit els fem eie es wc ces vie a we a lele s 16 
“The 2006 MPhA Awards” 


aeeclatelidge be) .. APRA yao cos tne on 20 cee ee enone ee eee PM 
“Minors & Prescriptions: Where does HIPAA Fit In?” (Part 2 of 2) 


AONE NT AYE ECO LTC Aa cee ceca y eich O oC ee en 23 
“Recommendations for Prevention and Control of Influenza: 2005-06 Flue Season” 


Advertiser’s Index 


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Stcaalic LIA ACCULICG Smee tierce cormc termes ee meets se SLES SS ERI. Ny 19 
MeEGiCdiS tai CANCUWOLK AIL C teeter Ses ec ee ee eee ee ee 4 
PhannaclStsivil LUG COM Dalle Sametime MCE tole. cues ncntndn sec edecghes tye <i=;e,008 28 


Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 
650 West Lombard Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals 
postage paid at Baltimore, MD and at additional mailing office. Articles and editorials that appear do not necessarily reflect 
the official positions of the Maryland Pharmacists Association and may contain views and opinions for which the authors 
hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West Lombard Street, 
Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


BT-Rated 


Not Substitutable 


NOC 67425-403-50 


ISTA 


Pere iet woh 


loa 


@ www.istavision.com 


| § TA z 2005 ISTA Pharmaceuticals®, Inc. All rights reserved 
Pharmaceuticals ISTALOL® is a registered trademark of ISTA Pharmaceuticals®, Inc. 1SL241-8/05 


GENT 


Important information for pharmacists treating patients with glaucoma 


FDA: Generic Substitution for BT-Rated Meds Carries Risk 
The Legal Necessity of Ensuring Bioequivalence 


The FDA grants BT ratings only to drugs with no recognized bioequivalent. 


Bioequivalent drugs, according to the Orange Book, “can be expected to have 
the same clinical effect and safety profile when administered to patients 
under the conditions specified in the labeling.” The Orange Book remains the 
definitive authority on drug bioequivalence. 


Pharmacists may be unaware that ophthalmic beta-blocker Istalol® 
(timolol maleate ophthalmic solution) 0.5% carries a BT rating.* No drug is 
bioequivalent to Istalol®. /t may be 
illegal in your state to substitute 
BT-rated products. Check pharmacy 
laws in your state. Such substitutions 
have the potential to place a pharmacist’s 
professional license and personal assets at 
risk. Moreover, a pharmacist who substitutes a drug that is not bioequivalent may be 
negligent and, should that negligence result in injury to a patient, a legal cause of action may 
be established against that pharmacist. 


“Istalol® carries a BT 
rating. No drug is 
bioequivalent to Istalol®.” 


How can pharmacists ensure they are selecting bioequivalent medications, thereby protecting 
themselves and their patients? Pharmacists should refer to the FDA authoritative source, the 
Orange Book. In many states, the Orange Book is the only official reference for bioequivalence. 
Caution must be used when employing pharmacy software programs that only list generic 
equivalents and do not indicate whether a drug has a BT rating. 


As clearly indicated by the FDA BT rating, no other product, including generic timolol, is therapeutically 
equivalent to Istalol®, and therefore cannot be substituted for it. To do so may be a violation in your state. 


*FDA Orange Book 2005. fon www.istavision.com 


ISTA Ph ticals®. | | § IA © 2005 ISTA Pharmaceuticals®, Inc. All rights reserved. 
armaceuticals’, Inc. Pharmaceu ticals’ ISTALOL” is a registered trademark of ISTA Pharmaceuticals®, Inc. ISL241-8/05 


Greetings! 


Well we are into the first Quarter of 2006! I hope that everyone rested before the 
New Year because it has been a rather “busy” time since. We have seen the 
implementation of Medicare Part D and the issues that it brought. The program 
had its many and might I say well documented problems, but with any new 
program as sweeping as Medicare Part D we knew that it would not be a smooth 
transition. Despite all the agony we and our patients endured through this 
process we as a profession became stronger. Pharmacy in most instances was 
seen as the steady face for our patients, trying to work through the system (many 
times for hours on end), making sure that our patients continued with their 
medications in spite of uncertainty for re-imbursement or confusion about the 
patients coverage (or lack there of). I personally want to THANK YOU for 
showing the country that we do care and I believe we have found new respect 
from many quarters. As I said before we are the “go to” experts that Pharmacists 
have been for many years and will continue to be for the years ahead. 


Our Mid-Year meeting in January was a success as well as filled with timely topics. Thanks to Howard, Elsie, Nancy, and 
especially Convention Committee Chair and soon to be President Ginger Apyar. Without your help these meetings would 
never get off the ground and be as successful as they are. 


February the 16" brought our sixth annual Legislative day in Annapolis. The Maryland Pharmacy Collation with its 
member organizations spearheaded this important task; we at MPhA want especially thank Murhl Flowers for his 
guidance and time. We face many issues in the current session both locally and nationally. The Technician bill, Pseudo- 
ephedrine monitoring, tracking of CDS prescriptions, difficult issues with a potential conscious clause, and many others. 
Legislative Day is just the beginning; we must be active on these many legislative issues on a continual basis. Call or 
better yet meet with your local political representatives and let them know how these issues affect you and your 
profession. I would be remise not to mention the bills that affect us professionally but just as importantly economically! 
Please keep in touch with the ever changing political landscape and give our organization feed-back and questions should 
they arise. Howard is very busy with these efforts and needs our help; you can call or utilize our website at 


www.marylandpharmcist.org. 


Our committees are busy working on many tasks. The Communication Committee headed by Doris Voight is trying to 
put a new face on our newsletter as well as help our web-master upgrade and improve our website. The membership 
committee is sending applications to the over 5,000 Pharmacists residing or practicing Pharmacy in Maryland as we 
speak. It is imperative that we increase our membership to keep this a viable organization. The Professional programs 
committee has been working diligently. We are currently busy with Immunization training, Medication Management 
Therapy (MTM) partnering with Outcomes, and many other projects that will be “grabbing” your attention shortly. I have 
already mentioned the Convention Committee and believe it or not the Annual Convention June 10"-13" in Ocean City is 
just around the corner. We are soliciting resolutions for the House of Delegates to consider, Speaker of the House Mary 
Kremzner would be happy to hear from you even if the resolution is just and idea, she will work with you to put the idea 
into the form of a resolution (you can e-mail the Association to her attention). 


As you can see there is a lot going on and we want all of our members to feel welcome and share their views and ideas 
with the Association. 


Thank You Again! 


Matthew Shimoda, Pharm.D. 
President 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 Page 6 


“Therapeutically Speaking...” 


“New Therapeutic Options for Patients with Diabetes” 
Kellie Monzillo, Pharm.D. Candidate 2006 


Adult patients with diabetes gained new adjunctive treatment options with the introduction of two new 
classes of antihyperglycemic drugs in the spring of 2005. In April, Amylin Pharmaceuticals along with Eli Lilly 
and Company received FDA approval of exenatide (Byetta) for type 2 diabetes just one month after Amylin had 
received approval of pramlintide (Symlin) for type 1 and type 2 diabetes. Both products are only available as 
subcutaneous injections and have been shown to improve glycemic control without the unwanted side effect of 
weight gain that has been a limitation of several other available hypoglycemic agents. 


Exenatide (Byetta) 


Exenatide is the first in a new class of 
antidiabetic medications referred to as incretin 
mimetics. Exenatide is indicated as adjunctive 
therapy to improve glycemic control in adult patients 
with type 2 diabetes who are taking oral antidiabetic 
medications (metformin, sulfonylurea, or a 
combination of metformin and a sulfonylurea) who 
have not attained adequate glycemic control on these 
oral medications alone.’ 

Incretin hormones contribute to glycemic 
control by several mechanisms including enhanced 
glucose-dependent insulin synthesis and release, 
decreased glucagon secretion, and slowed gastric 
emptying.’ Glucagon-like peptide-1 (GLP-1) is 
responsible for 70-80% of the incretin effects in 
normal individuals and its release is impaired in 
patients with type 2 diabetes.’ Exenatide is a GLP-1 
receptor agonist and mimics its antidiabetic effects. 
Following exenatide administration, insulin 
secretion is enhanced in response to increases in 
glucose concentration and inappropriate glucagon 
secretion is inhibited, decreasing hepatic glucose 
production.” Additionally, exenatide slows gastric 
emptying resulting in slowed glucose absorption and 
overall decreased food intake.” The combined effects 
result in reductions in postprandial and fasting 
glucose concentrations, glycated hemoglobin 
(referred to as Alc), and body weight. 

In three randomized controlled trials, patients 
taking metformin, sulfonylurea, or combined 
metformin and sulfonylurea therapy were 
randomized to receive exenatide 5 mcg, 10 mcg or 
placebo twice daily for 30 weeks in addition to their 
existing antidiabetic agent. In all three trials, patients 
taking exenatide showed dose dependent decreases 
in Alc (approximately 0.8%), fasting and 
postprandial glucose, and decreased body weight as 
compared to placebo groups.” 


The recommended starting dose is 5 mcg 
injected subcutaneously twice daily at any time 
within the 60 minute period before the morning and 
evening meals. Exenatide should not be 
administered after a meal.’ If necessary, following 
one month of therapy the dose may be increased to a 
maintenance dose of 10 mcg twice daily before 
meals.' Exenatide is supplied as a 250 mcg/ml 
solution in either 1.2 ml or 2.4 ml prefilled pens. 
Subcutaneous injection with the pen may be 
administered in the abdomen, thigh, or upper arm. 

Exenatide is not indicated for use in patients 
with type 1 diabetes and is not a substitute for 
insulin in insulin-requiring patients with type 2 
diabetes. Exenatide is extensively eliminated by the 
kidney and therefore patients with severe renal 
impairment (CrCl< 30ml/min) should not use 
exenatide. Safety in children has not been 
established and exenatide is not indicated for 
pediatric use. ' 

The most common adverse effects of exenatide 
are nausea and vomiting. Nausea is experienced by 
up to 44% of patients initiated on exenatide, 
although this dose-related effect may be minimized 
by gradual dosage titration.’ The occurrence of 
nausea is more pronounced early on in therapy and 
usually subsides with continued use.’ Other adverse 
effects can include diarrhea, dizziness, headache, 
and nervousness. 

When given adjunctively with metformin, the 
incidence of hypoglycemia is no different from 
placebo. However, when exenatide is administered 
with medications that may induce hypoglycemia 
(such as a sulfonylurea agent) the incidence of 
hypoglycemia increases. Hypoglycemia is dose 
dependent based on doses of both exenatide and the 
sulfonylurea.’ Dose reduction of the sulfonylurea 
should be considered when adding exenatide to 
reduce the risk of hypoglycemia.” 


Page 7 Maryland Pharmacist + Jan./Feb./Mar. 2006 


Because exenatide slows gastric emptying, it 
may reduce the rate and extent of co-administered 
oral medications. For example, exenatide has been 
shown to decrease the bioavailability of lovastatin 
and acetaminophen.’ Medications such as antibiotics 
and oral contraceptives that require threshold 
concentrations for efficacy should be administered at 
least one hour before administering exenatide.” The 
effect of exenatide on the clinical effectiveness of 
oral contraceptive therapy has not been studied. 

Exenatide should be considered as 
adjunctive therapy in patients with type 2 diabetes 
who are currently maximized on metformin, a 
sulfonylurea, or a combination of metformin plus 
sulfonylurea who are not reaching their glycemic 
goals and for whom weight control is a 
consideration. Some patients may be fearful or 
reluctant to begin a medication that requires 
subcutaneous injection, and will require education 
from the pharmacist. Monitoring for patients on 
exenatide should include routine monitoring of 
blood glucose, Alc, and weight as well as signs and 
symptoms of hypoglycemia.’ 


Pramlintide (Symlin) 


Pramlintide, the first in a new class of 
antihyperglycemic medications known as 
amylinomimetics, is indicated for use with insulin in 
adults with type 1 or type 2 diabetes who are unable 
to achieve adequate glycemic control despite 
intensive insulin therapy.* 

Amylin is an endogenous neuroendocrine 
hormone that is co-secreted with insulin from 
pancreatic beta cells in response to increases in 
blood glucose. Amylin exerts its effects on blood 
glucose by slowing gastric emptying, regulating 
food intake by reducing appetite, and by decreasing 
hepatic glucose production through inhibition of 
postprandial glucagon secretion.® The release of 
amylin and insulin is significantly reduced in 
patients with type 1 and insulin-requiring type 2 
diabetes following food intake.” 

Pramlintide, a synthetic analog of human 
amylin, mimics the effects of endogenous amylin. 
Results of pramlintide clinical trials demonstrate 
efficacy in decreasing postprandial glucose 
concentration, reducing glucose fluctuation and 
decreasing food intake.*® Studies in patients with type 
| and type 2 diabetes show a decrease in Alc by 
approximately 0.4% and patients were able to 
slightly reduce their total daily dose of insulin. 

During clinical trials, the most commonly 


Page 8 


reported adverse effects were nausea, headache, 
anorexia, vomiting, abdominal pain, and inflicted 
injury. Nausea, the most common side effect, is 
seen when therapy is initiated and is minimized with 
slow dosage titration and lessens over time with 
continued therapy.’ Pramlintide alone does not cause 
hypoglycemia, but when added adjunctively to 
insulin therapy, it increases the risk of insulin- 
induced hypoglycemia.® 

Patients should be considered for pramlintide 
therapy if they have been unable to achieve glycemic 
goals with individualized insulin regimens alone and 
only if their diabetes is closely managed by a 
healthcare professional. Contraindications for 
pramlintide use are hypoglycemic unawareness or a 
confirmed diagnosis of gastroparesis. Also, 
pramlintide therapy should not be considered if 
patients have an Alc > 9%, show poor adherence to 
insulin therapy or self-blood glucose monitoring, 
have recurrent episodes of severe hypoglycemia, or 
require drugs that alter gastrointestinal motility.* 
Pramlintide’s safety and efficacy has not been 
established in pediatric patients and therefore is not 
indicated for use in this population. 

Dosing of pramlintide differs between patients 
with type 1 and type 2 diabetes. For type 1 diabetes, 
the recommended starting dose of pramlintide is 15 
mcg subcutaneously (SC) before major meals 
(defined as > 250 kcal or > 30 grams carbohydrate). 
The dose of preprandial, rapid-acting, or short-acting 
insulin dosages, including fixed-mix insulins (e.g., 
70/30) should be reduced by 50% when initiating 
pramlintide. The dose of pramlintide may be 
increased in 15 mcg increments when no clinically 
significant nausea has been present for at least three 
days.” In patients with type 2 diabetes, the 
recommended starting dose is 60 mcg SC before 
major meals and should be titrated to 120 mcg 
before major meals as tolerated.* The same 
precautions apply to patients with type 2 diabetes 
regarding insulin dosage reduction when initiating 
pramlinitide, and only increasing pramlintide dose 
with nausea resolution. For all patients the insulin 
regimen should be adjusted once the final 
pramlintide dose is established. 

Pramlintide is supplied in 5 ml vials containing 
0.6 mg/ml pramlintide acetate. To administer 
pramlintide from vials, the patient should be 
instructed to use a U-100 insulin syringe (0.3 ml 
size) using the conversion table shown (Table 1). 
(Continued on page 20) 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


Statements of the Candidates 


Treasurer 


Walter Abel, R.Ph. 
I, Walter Abel, with respect and appreciation, accept the Board’s nomination for a second term 
as Treasurer of the Maryland Pharmacists Association. 

Pharmacy has always been my profession and it is in the interest of promoting the 
profession that I want to continue to be part of the Board meetings and participate as an 
interested member. I am thankful for being given the opportunity to serve as Treasurer during 
the past year and promise to continue to conscientiously and prudently watch over the 
organization’s finances. Thank you for the nomination and your continued support. 

Walter H. Abel 


Trustee Seat # 1 


Doug Campbell, R.Ph. 

I have been a member of the MPhA Board of Trustees for the past few years, and serve as 
volunteer Curator of the B. Olive Cole Pharmacy Museum at Kelly Memorial Building— 
MPhA’s headquarters. I would be honored to continue to serve on the Board to further improve 
and develop the Profession of Pharmacy here in Maryland, and to continue to serve in the 
development of The Maryland Pharmacists Association. 


Mary E. Kremzner, Pharm.D., 

CDR United States Public Health Service (PHS) 
Deputy Director, Division of Drug Information 
Office of Training and Communication 

Center for Drug Evaluation and Research (CDER) 
Food and Drug Administration (FDA) 


My practicing pharmacy experience has been with chain pharmacy, independent community 
pharmacy and my current position in federal government. Throughout my 19-year career, I have 
continuously worked in a community pharmacy position and currently maintain my skills as a 
practicing pharmacist by working part-time for Watermont pharmacy. 


At this time, I serve full-time as the deputy director in the FDA’s Division of Drug Information. 
In this capacity, I supervise a staff of 20 that consists mainly of Pharm.D.s. The Division is 
charged with the responsibility of responding to inquiries from a broad range of sources, 
including regulated industry, academia, health care professionals, consumers, and others. I joined 
the agency in 1996 and have served in various capacities as a pharmacist. (Continued on page! 2) 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 Page 9 


(Continued from page 11) 

Having served as the Vice Speaker in 2005 and now Speaker of the House in 2006, I see how 
important a role MPhA plays for all Maryland pharmacists. The MPhA must remain an active 
and vital part of the Maryland pharmacist community and this can be done by reaching out to all 
who practice the profession. Promotion of the MPhA, what it does and what it can do for all 
pharmacists in Maryland, is of paramount importance to the future well being of the our 
profession. As I have been privileged to work various fields of pharmacy, I would consider 
serving as a Trustee in the MPhA an even greater privilege. 


I am a graduate of the University of Maryland, School of Pharmacy with a Bachelor of Science 
Degree in Pharmacy in 1987 and a Pharm.D. in 1998. 


Trustee Seat #2 


Butch Henderson, P.D. 

After graduating from University of Maryland School of Pharmacy in 1988, I began working as a 
pharmacist for Klein’s Family Markets in Harford County. In 1992, I became the pharmacy 
director and now oversee 7 stores in Harford and Baltimore Counties. I have been privileged to 
serve MPhA as a trustee since 2000 and am honored to be nominated again. I believe that we are 
in the midst of an amazing opportunity to show the public what we do and just how 
knowledgeable and valuable we are as pharmacists. Many people think of recent events as 
obstacles: Y2K, HIPAA, Medicare Drug Plans; but we must be forward thinking and look for the 
opportunities in these events. Pharmacists must step up and show the public what we can do, 
and in most cases these are things you are already doing, now—show them, tell them, and bill 
them! Yes, with MTM you can be paid for things that you already are doing! Contrary to what 
some public and government heads think, pharmacy is more than the cost of a drug. The value 
of pharmacy is in services, drugs, education, therapy management. Now is the time to show this 
and share this. We must defend our profession and show the value of our services. 

Organizations like MPhA are working to promote pharmacy, the profession, not just a segment: 
“retail”, “independent”, “institutional”, ... but pharmacy as a whole. With the coordinated 
efforts of organizations and pharmacists we can continue to be strong, and maybe we will 
encourage our kids to be pharmacists after all. Thank you for your consideration. 


John VanWie, P.D. 

It is an honor and delight to be nominated for Trustee of the MPhA. Asa 1984 graduate of 
University of Maryland my entire career has been in retail pharmacy. Trained with Peoples Drug 
Store, pre-CVS, since 1985 I have been with Safeway in various management positions with my 
concentration of recent years in business development. As an MPhA member since graduation 
and more recently holding positions of Vice Speaker (2003) and Speaker of the House (2004- 
2005), it is my strong belief we need to make a contribution to the profession by sharing what we 
have learned throughout our careers. MPhA is one group that enables us make this contribution 
and it would a privilege to be your Trustee. Thank you for your consideration. 


Page 10 Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


2006 Maryland Leadership Elections 
Official Ballot 


A a a I ES EE a EET ET EE ED OEY LSA RE AE SS SS a eh EE 
Please select the candidate you believe will best fulfill the duties of the office by checking the box 
appearing beside their name. 


Maryland Pharmacists Association Officers 


Treasurer 


O Walter Abel, R.Ph. 


Please select the candidate you believe will best represent you as a member on the Board of Trustees 
by checking the box appearing beside their name. 


Maryland Pharmacists Association Board of Trustees 
Trustee Seat # 1 
O Doug Campbell, R.Ph. O Mary E. Kremzner, Pharm.D. 


Trustee Seat # 2 


O Butch Henderson, P.D. O John VanWie, P.D. 


When completed, seal and return your self-mail ballot to the Maryland Pharmacists Association, 
received by Friday, May 5, 2006. For questions, please call MPhA at 800-833-7587. 


Fold 


2006 Maryland Leadership Elections 
Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201-1572 


Fold 


Maryland Pharmacists Association 
Constitution and Bylaws 


Constitution 

Article I. Name 

This Association shall be known as the Maryland Pharmacists Association and 
shall be abbreviated "MPhA". 

Article II. Mission 

The mission of MPhA is to promote excellence in pharmacy practice, 
strengthen the profession of pharmacy, and advocate for all Maryland 
Pharmacists. 

Article III. Purpose 

The purpose of MPhA is to promote: 

- The health and well-being of Maryland citizens. 

- Safe and effective use of medications and health care devices. 

- Collaboration among health care professionals and organizations. 

- Professional competence. 

- Leadership development. 

- Responsible legislation and regulation. 

- The history and tradition of Maryland Pharmacy. 

Article 1V. Membership 

A. Active Membership 

Any pharmacist in good professional standing who has a valid license to 
practice pharmacy in any state is eligible to become an active member. 

B. Other Categories of Membership 

The Board of Trustees shall establish other categories of membership as it 
deems appropriate. 

Article V. Governing Body 

The Governing Body of the MPhA shall be the Board of Trustees. 

The Board of Trustees shall provide supervision, control, and direction of the 
affairs of the Association; shall implement policies established by the House of 
Delegates, making changes if necessary within the limits of the Bylaws; shall 
actively pursue the purposes of the Association; and shall have the final 
discretion in the disbursement of its funds. It may adopt procedures for the 
conduct of its business, and may, in the execution of the powers granted, 
appoint such agents as it may consider necessary. 

The Board of Trustees must approve all contracts entered into on behalf of the 
Association by the President or Executive Director. 

The Board of Trustees shall ratify the slate of At-Large and Independent 
nominees for appointment to the Board of Pharmacy. 

Article VI. Officers 

The Officers of the MPhA shall be active members of the Association and 
consist of the President, Vice President (who shall be the President-elect), 
Treasurer, and the Immediate Past President (who shall serve as Chairman of 
the Board of Trustees). 

Article VII. Executive Committee 

The Chairman of the Board of Trustees, the President, Vice President, 
Treasurer, Speaker of the House of Delegates, and the Executive Director (in 
an ex-officio capacity) shall constitute the Executive Committee. The 
Executive Committee may exercise the powers of the Board of Trustees for 
emergency business when the Board of Trustees is not in session, reporting to 
the Board of Trustees any action taken. Three (3) members shall constitute a 
quorum for the transaction of business. A meeting may be called by the 
Chairman of the Board of Trustees or the President. 

Simultaneous with the preparation of the proposed yearly budget by the Budget 
and Finance Committee, the Executive Committee shall conduct a performance 
review of the Executive Director and if appropriate negotiate changes in the 
Executive Director's compensation and benefits. Any changes in compensation 
and benefits shall be shared with the Budget and Finance Committee and 
presented to the Board of Trustees for approval. 

Article VIII. Legislative Body 

The Legislative Body of the MPhA shall be the House of Delegates. 

The House of Delegates shall be charged with the following duties and 
responsibilities: serve as the policy making body of the Association; consider 
and implement by resolution, action, or other manner all appropriate proposals 
emanating from the membership; receive reports of Association Officers and 
Committees; adopt rules for the conduct of business; ratify the slate of Officers 
and trustees for election; and approve all proposed constitution and Bylaws 
changes prior to a vote of the Association members. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


Article IX. Parliamentary Authority 

The Rules of Order of the Board of Trustees shall be the version of "Robert's 
Rules of Order" approved by the Board of Trustees. 

The Rules of Order of the House of Delegates shall be the version of "Robert's 
Rules of Order" approved by the House of Delegates. 

Article X. Amendment of Constitution 

Every proposal to amend this Constitution must be submitted in writing to the 
Constitution and Bylaws Committee. After prudent consideration the 
committee shall present its recommended changes to the Board of Trustees. 
The proposed changes shall be presented to the membership at a regular or 
special meeting of the House of Delegates. Upon the affirmative vote of at 
least two-thirds of the delegates present at this meeting, a vote of the 
Association members shall be conducted. 

A proposed amendment shall then become part of the Constitution with an 
affirmative vote of at least two-thirds of the responders. 


Bylaws 

Article I. Membership 

A. Dues 

The annual dues for each category of membership of the Association shall be 
determined by the Board of Trustees. Members who fail to pay their dues 
within a period specified for each category of membership by the Board of 
Trustees shall be notified by the Executive Director. If payment is not made 
within a grace period specified by the Board of Trustees, without further notice 
and without hearing, the delinquent members shall be dropped from the 
Association rolls and thereupon forfeit all rights and privileges of membership 
including but not limited to the right to hold office, the right to vote in 
elections, the right to serve as a Delegate, privileges of member discounts, and 
eligibility for member only promotions. The Board of Trustees may establish 
procedures for extending the time for payment of dues and continuation of 
membership privileges upon request of a member showing good cause. 

B. Meetings 

The Association shall meet at least two times during the year at times set by the 
Board of Trustees. One meeting shall be know as the Annual Meeting and one 
shall be known as the Mid Year Meeting. 

Article II. Board of Trustees 

A. Composition 

The Board of Trustees shall be composed of thirteen (13) members which shall 
include the following Officers: Immediate Past President, who shall serve as 
Chairman; President; Vice President, who shall be the President-elect; 
Treasurer; Speaker of the House of Delegates; Vice Speaker of the House of 
Delegates, who shall be the Speaker-elect; six(6) elected Trustees; and one(1) 
Trustee who is the President or designee of the Academy of Student 
Pharmacists of the University of Maryland School of Pharmacy. 

Ex-officio members of the Board of Trustees shall include the Executive 
Director of the Maryland Pharmacists Association, the Dean of the University 
of Maryland School of Pharmacy, and the President or designee from each of 
the following organizations: the Maryland Society of Health System 
Pharmacists, the Maryland Chapter of the American Society of Consultant 
Pharmacists, and the Maryland Pharmaceutical Society. No ex-officio member 
shall have voting privileges. 

B. Terms of Office 

Elected Trustees shall serve for staggered three (3) year terms, two (2) elected 
each year. Any Trustee shall be eligible for reelection up to a maximum of 
three (3) consecutive terms. A vote by the Association members to elect the 
Trustees shall be initiated within sixty (60) days after nominations have been 
certified by the House of Delegates. The results of the election shall be 
reported to the Board of Trustees by a Canvassing Committee appointed by the 
President. Newly elected Trustees, upon installation, immediately enter upon 
the performance of their duties and shall continue in office until their 
successors are elected and installed, or unless they resign, are removed, or are 
otherwise unable to fulfill an unexpired term. 

C. Meetings of the Board of Trustees 

The Board of Trustees shall have regular meetings throughout the year, 
including a meeting at the time and place of the Annual Meeting. The Board 
shall meet upon call of the Chairman of the Board, or President at such times 


Page 13 


and places that may be designated, and shall be called to meet upon demand of 
a majority of the Board. Notice of all meetings of the Board of Trustees shall 
be transmitted to the last recorded address of the Board member at least ten 
(10) days in advance of such meetings. With the exception of executive 
sessions, where confidential issues are discussed, all regular meetings of the 
Board of Trustees are open to the general membership. 

D. Quorum 

A majority of the whole Board shall constitute a quorum at any meeting of the 
Board. 

E. Absences 

If a member of the Board of Trustees is absent from three (3) consecutive 
meetings for reasons which the Board has declared to be insufficient by a two- 
thirds majority vote of the entire Board of Trustees, and if the Trustee is given 
reasonable prior notice of the potential removal, resignation shall be deemed to 
have been tendered and accepted. 

F. Compensation 

Trustees shall not receive compensation for their services as Trustees, but the 
Board may, by resolution, authorize reimbursement of expenses incurred in the 
performance of their duties. Nothing herein shall preclude a Trustee from 
serving the Association in any other capacity and receiving compensation for 
such services. 

G. Resignation or removal 

Any Trustee may resign at any time by giving written notice to the President, 
the Executive Director or to the Board of Trustees. Such resignation shall take 
effect at the time specified therein, or if no time is specified, at the time of 
acceptance thereof as determined by the Chairman of the Board. Any Trustee 
may be removed by a two-thirds majority vote of the entire Board of 
Trustees. The Trustee shall be given reasonable prior notice of the potential 
removal and the reasons for removal. 

H. Vacancies 

Any Trustee vacancy that may occur on the Board by reason of death, 
resignation, or removal shall be filled by a majority vote of all remaining 
members of the Board for the unexpired term. 

I. Indemnification 

As used in this Article, any word or words defined in section §2 -418 of the 
Corporations and Associations Article of the Annotated Code of Maryland, as 
amended from time to time, (the "Indemnification Section") shall have the 
same meaning as provided in the Indemnification Section. 

This Association shall indemnify and advance expenses to a Trustee or Officer 
of the Association in connection with a proceeding to the fullest extent 
permitted by and in accordance with this Indemnification Section. With 
respect to an employee or agent, other than a Trustee or Officer of the 
Association, the Association may, as determined by the Board of Trustees of 
the Association, indemnify and advance expenses to such employees or agent 
in connection with proceedings to the extent permitted by and in accordance 
with the Indemnification Section. 

Article III. Officers 

A. Terms of Office and Elections 

The President shall be a non-elected position. The Vice President (who will be 
the President-elect) shall be elected annually and the Treasurer shall be elected 
biannually by a vote of the Association members initiated within sixty (60) 
days after nominations have been approved by the House of Delegates. The 
results shall be reported to the Board of Trustees by a Canvassing Committee 
appointed by the President. 

B. Installation 

Each officer shall take office upon installation and shall assume the duties of 
his or her office and shall serve for the stated term of office or until the 
successor is duly elected and installed. 

C. Vacancies 

Except for vacancies in the position of President, which shall be filled by the 
Vice President, and Speaker of the House of Delegates, which shall be filled by 
the Vice Speaker, vacancies in all other offices shall be filled for the balance of 
the term thereof by an individual elected by a majority vote of the entire Board 
of Trustees. 

D. President 

The President shall be the principal officer of the organization and shall preside 
at membership meetings of the Association. In the absence of the Chairman of 
the Board of Trustees, the President shall preside at meetings of the Board of 
Trustees and of the Executive Committee. The President shall be an ex-officio 
member of all committees with right to vote. The President shall submit a 
report at the Annual Meeting of the Association. 

E. Vice President (who shall be the President-elect) 

The Vice President shall be the President-elect, and in the event of the 
temporary disability or absence of the President and with the approval of the 


Page 14 


Board of Trustees, shall assume and perform the duties of President until the 
President is able to resume such duties. 

The Vice President shall have such duties as the President and the Board of 
Trustees may assign. The Vice President shall be an ex-officio member of all 
committees with right to vote. The Vice President shall chair the Nominating 
Committee and present a report of the Committee at the Mid-Year Meeting. 
Upon completion of his/her term of office, the Vice President shall 
automatically assume the office of the President. 

F. Treasurer 

The Treasurer shall ensure the maintenance of an account of all monies 
received, invested, and expended by the Association; shall oversee 
disbursements authorized by the Board of Trustees; and shall make a report at 
the Annual Meeting or when called upon by the President. All sums received 
shall be deposited in institutions approved by the Board of Trustees. Funds 
may be drawn only upon the signature of the Treasurer and one of the 
individuals approved by the Board of Trustees. The funds, books, and 
vouchers and the Treasurer's control shall be at all times subject to the 
verification and inspection by the Board of Trustees. The Treasurer shall 
ensure that an audit of the books by an accounting firm approved by the Board 
of Trustees be performed on an annual basis and also upon a significant change 
of Association staff. The Treasurer shall ensure that all required tax returns 
and other governmental requirements be performed in a timely manner. The 
Treasurer shall chair the Budget and Finance Committee, which is responsible 
for drafting an annual budget to present to the Board of Trustees. 

G. Bonding 

A fidelity bond may be purchased for any officer, Trustee, or employee of the 
Association and in such an amount as the Board of Trustees shall establish. 
Article IV. Election Process 

A. Nominations 

The Nominating Committee shall be responsible for the selection and 
submission to the Board of Trustees the names of candidates for the offices of 
the Association as set forth in Article III, section 1 and Article IV, section 1 of 
these Bylaws. 

B. Slate Approval 

After presentation to the Board of Trustees, the slate of candidates shall be 
presented to the House of Delegates for final approval. Further nominations for 
each office may be made by the House of Delegates. 

C. Voting 

A vote of the Association members shall be initiated within 60 days after the 
nominations have been approved by the House of Delegates. The nominee for 
each position receiving the highest vote, as certified by a Canvassing 
Committee, shall be declared duly elected. In the event of a tie vote, a 
supplemental mail ballot election shall be held. 

Article V. Executive Director and Staff 

A, Executive Director 

The administration and management of the Association shall be conducted by 
an Executive Director, employed or appointed by, and directly responsible to 
the Board of Trustees. 

The Executive Director shall be the chief executive and operating officer of the 
Association, with responsibility for the management and direction of all 
operations, programs, activities, and affairs of the Association within the 
framework of the policies and directives determined by the Board of Trustees. 
The Executive Director shall be responsible for the employment, annual 
performance evaluation, and the termination of employment of Association 
office personnel. The Executive Director shall: serve as the Secretary to the 
House of Delegates, give notice of and attend all meetings of the Association, 
keep a record of all proceedings, and have other such duties as may be 
established by the Board of Trustees. 

B. Office Staff 

The Association shall employ an office staff to perform and conduct the daily 
activities of the Association. The staff shall be supervised, directed by and 
answer to the Executive Director within the framework of accepted office 
practices and policies established by the Board of Trustees. 

Article VI. House of Delegates (House) 

A. Composition 

The House of Delegates shall consist of the officers of the House of Delegates 
and any member in good standing upon petition to the Speaker of the House 
and certification by the Secretary. Prospective delegates must petition the 
Speaker by a time designated by the Secretary. 

B. Ex-Officio Delegates 

The Officers, trustees, past presidents of the Maryland Pharmacists 
Association, and the Officers of the House shall be eligible to serve as Ex- 
Officio Delegates with vote in the House of Delegates. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


C. Officers of the House of Delegates 

The Officers of the House of Delegates shall consist of the Speaker, Vice 
Speaker (who shall be the Speaker-elect), and the Secretary. The Executive 
Director of the Maryland Pharmacists Association shall serve as Secretary but 
shall not be entitled to a vote. 

D. General Duties of the House Officers 

The Officers of the House of Delegates shall arrange the programs for all 
meetings of the House of Delegates. The Officers shall represent the House of 
Delegates to the Board of Trustees and Association Committees to ensure the 
dissemination of information and implementation of policies adopted by the 
House. 

E. Duties of the Speaker of the House 

The Speaker of the House shall preside at all meetings of the House of 
Delegates, unless unavailable at which time the Vice Speaker shall preside. In 
the event that both the Speaker and the Vice Speaker are unable to preside, the 
Secretary of the House shall conduct an election for a temporary Speaker for 
the corresponding meeting of the House of Delegates. The Speaker shall 
appoint a parliamentarian to serve as an advisor on procedures and rulings. 
The Speaker shall appoint a House Nominating Committee, a Resolutions 
Committee, a Constitution and Bylaws Committee (as necessary) and other 
committees of the House as may be necessary. The Speaker shall present an 
annual report to the House of Delegates to include action taken on the previous 
year’s resolutions. The term of office for the Speaker is one year. 

F. Duties of the Vice Speaker of the House 

The Vice Speaker shall be the Speaker-elect, and preside at meetings of the 
House of Delegates when the Speaker is unavailable, and assume the duties of 
the Speaker in the event that the Speaker cannot fulfill the duties of that office. 
The Vice Speaker shall serve as chair of the Resolutions Committee. The term 
of office for the Vice Speaker is one year. Upon completion of his/her term of 
office, the Vice Speaker shall automatically assume the office of Speaker of the 
House. 

G. Duties of the Secretary of the House 

The Secretary of the House shall read all relevant communications to the 
House. The Secretary shall conduct and record voting in the House of 
Delegates when requested by the Speaker. The Secretary shall notify members 
of the House of Delegates of their appointment and shall report and certify the 
credentials of all delegates for House of Delegates sessions. The Secretary 
shall be responsible for the publication and maintenance of proceedings of the 
House of Delegates and shall distribute relevant reports to the Delegates. 

H. Meetings of the House 

The House of Delegates shall meet at least twice yearly: once at the Annual 
Meeting and once at the Mid-Year Meeting. Special meetings of the House 
may be called at the discretion of the Speaker or upon written request of 10% 
of the membership of the Association. Each Delegate shall be entitled to one 
vote. No Delegate shall act as a proxy for another Delegate. All Association 
members may attend any session of the House of Delegates and shall be 
granted the privileges of the floor, but only certified delegates may vote. 

I. Quorum 

A quorum for purposes of conducting the business of the House shall be at least 
twenty-five (25) Delegates. 

J. Resolutions Committee 

Resolutions may be submitted to the Resolutions Committee any time prior to 
the last meeting of the Committee which precedes the Annual Meeting. In 
addition, resolutions bearing the signature of two active members may be 
presented to the Speaker or the Secretary of the House of Delegates at least 24 
hours prior to consideration by the House. 

The Resolutions Committee shall be appointed by the Speaker of the House of 
Delegates at least ninety (90) days prior to the Annual Meeting of the 
Association. In the absence or incapacity of the Vice Speaker, a member 
appointed by the Speaker of the House shall serve as chair of the Resolutions 
Committee. 

The Resolutions Committee shall submit all resolutions to the Board of 
Trustees at the meeting scheduled in the month prior to the Annual Meeting. 
The Board of Trustees shall review each resolution and make a 
recommendation that the House of Delegates adopt, defeat, or refer to a 
committee. 

K. Election of the Speaker and Vice Speaker of the House 

The House Nominating Committee shall be responsible for the nomination of 
candidates for the office of Vice Speaker of the House of Delegates. The office 
of Speaker of the House of Delegates is automatically filled by the current Vice 
Speaker. In the event that the Vice Speaker is unable to serve as Speaker, the 
House Nominating Committee shall be responsible for nomination of 
candidates for the office of Speaker of the House of Delegates. 

The House Nominating Committee will present a slate of at least two 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


candidates (if possible) for each position to a session of the House of Delegates 
at the Annual Meeting. The House Nominating Committee shall consider 
experience and demonstrated leadership abilities. Members of the House 
Nominating Committee may not be nominated for any position. 

If approved by the House, an election shall be held at the final session of the 
House of Delegates at which time the new Officers of the House of Delegates 
shall be installed. 

Article VII. Committees 

A. Presidential Appointments 

The President shall annually appoint the chair of each committee as may be 
required by the Constitution or Bylaws or as the President may find necessary. 
B. Nominating Committee 

The Vice President shall serve as chair of the Nominating Committee. The 
Nominating Committee shall nominate at least two (2) individuals (if possible) 
for each forthcoming available seat on the Board of Trustees and the office of 
Vice President, and Treasurer (on alternate years). The Nominating Committee 
shall consider geographic diversity, practice specialty, and experience in 
making its nominations. Nominees for the offices of Vice President and 
Treasurer shall have a minimum of 2 years MPhA Board of Trustees 
experience. The slate of candidates shall be presented to the House of 
Delegates at the Mid-Year meeting. 

Members of the Nominating Committee may not be nominated for any 
position. 

C. Budget and Finance Committee 

The Treasurer shall serve as the chair of the Budget and Finance Committee. A 
proposed annual budget of the Association shall be prepared by the Budget and 
Finance Committee and presented to the Board of Trustees for its approval at 
least two (2) months prior to the beginning of the fiscal year. 

D. Past Presidents’ Council 

The Past Presidents' Council shall be comprised of all past presidents who are 
current members. The Past Presidents' Council shall be responsible for the 
selection of the Honorary President as well as the recipients of all MPhA 
awards. Selection shall be by a majority vote of at least a minimum of 50% of 
the Past Presidents responding within 30 days to a notice for a meeting of the 
Past Presidents’ Council. The President may designate additional 
responsibilities to the Past Presidents' Council as directed by the Board of 
Trustees. The Past Presidents’ Council shall be chaired by the most recent past 
president not currently serving on the Board of Trustees. 

Article VIII. Non-Discrimination Policy 

It is the policy of the Maryland Pharmacists Association to prohibit 
discrimination among individuals on the basis of sex, race, religion, national 
origin, sexual orientation, age, or physical or mental disability. 

Article IX. Amendment of Bylaws 

Every proposal to amend these Bylaws must be submitted in writing to the 
Constitution and Bylaws Committee. After prudent consideration, the 
committee shall present its recommended changes to the Board of Trustees. 
The proposed changes shall be presented to the membership at a regular or 
special meeting of the House of Delegates. Upon the affirmative vote of at 
least two-thirds of the delegates present at this meeting, a vote of the 
Association members shall be conducted. 

A proposed amendment shall then become part of the Bylaws with an 
affirmative vote of at least two-thirds of the responders. 


Revised 11-17-05 


Page 15 


Recognizing Pharmacy Excellence 
The 2006 MPhA Awards 


Each year, the Maryland Pharmacists Association recognizes professional excellence through a series of awards. To 
nominate a pharmacist for one of the awards described below, complete the Official Award Nomination Form. The forms 
should be submitted to: Award Nominations, c/o Maryland Pharmacists Association, 650 West Lombard Street, Baltimore, 
Maryland 21201-1572. 


All nominations will be reviewed by the Past Presidents Council who is responsible for selecting the award 
recipients. The decision of the Council is final. Award recipients will be notified in advance of the award’s presentation at 
the 124th Annual MPhA Convention. 


For consideration, all nominations must be received no later than Friday, April 7, 2006. 


a Pharmacists Mutual Distinguished Young Pharmacist Award 
Awarded to a pharmacist who graduated within the past ten years and has made a significant contribution to the 
profession through service to a local, state or national pharmacy organization. Who is Eligible: Any MPhA 
pharmacist member who graduated from pharmacy school in 1996 or after. 


a Maryland Pharmacists Association Honorary President 
An honorary position on the Board of Trustees given to a person, not necessarily a pharmacist, who has worked for 
the MPhA or Maryland Pharmacy over a long period of time. Who is Eligible: Any long standing contributor to the 
profession or the Association. 


me MPhA Mentor Award 
This award recognizes individuals who encourage pharmacists, technicians, and/or student pharmacists in the pursuit 
of excellence in education, pharmacy practice, service, and/or advocacy. Who is Eligible: Any MPhA pharmacist 
member who meets the criteria of the Award. 


mi Seidman Distinguished Achievement Award 
Created to honor the major impact on the pharmacy profession by Henry Seidman, this award is presented for 
outstanding service by a Maryland pharmacist to the pharmacy profession during either the past year or over a period 
of years. Who is Eligible: Any MPhA pharmacist member who meets the criteria of the award. 


& Wyeth-Ayerst Bowl of Hygeia Award 
The Bowl of Hygeia recognizes a pharmacist who has performed outstanding services to the community in any area, 
with a particular emphasis on non-pharmacy contributions. Who is Eligible: Any MPhA member pharmacist who 
has not already received the Bowl of Hygeia. 


w Elan Innovative Practice Award 
Established in 1993, this award aims to recognize forward-thinking pharmacists who have expanded their practices 
into new areas. Any practicing pharmacist member within the geographic area who has demonstrated innovative 
pharmacy practice resulting in improved patient care. Who is Eligible: Any MPhA pharmacist member who meets 
the criteria of the award. 


Page 16 Maryland Pharmacist ¢® Jan./Feb./Mar. 2006 


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2006 Awards Nominations 
Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201-1572 


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Page 20 


(Continued from page 8) 
Pramlintide and insulin should be administered in 
separate injections and never mixed together, or 
injected at the same site. Recommended injection 
sites for pramlintide are the abdomen or thigh; 
administration in the arm is not recommended due to 
variable absorption.* Because pramlintide slows 
gastric emptying, absorption of oral medications 
may be delayed therefore medications intended for 
rapid onset should be administered at least one hour 
before or two hours after injecting pramlintide.* 
Patients taking pramlintide should be 
encouraged to check their blood glucose several 


times a day (before and after meals, and at bedtime) 
and whenever they experience signs or symptoms of 
hypoglycemia. A healthcare professional should 
closely monitor blood glucose levels as well as 
adverse effects to determine the need for dose 
adjustments of both pramlintide and insulin until the 
optimal therapeutic regimen is achieved.” 

The availability of two new therapeutic options 
to treat diabetes mellitus are very welcome, and 
provide additional opportunities for pharmacists to 
educate patients about diabetes management. 


' Byetta package insert. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2005, Apr. 
* Mosby’s Drug Consult [Database on the internet]. St. Louis, Missouri: Elsevier Inc. c2005 — [cited 12/14/05]. Available 


from: http://www.mdconsult.com/das/drug. 


* Uwaifo GI, Ratner RE. Novel Pharmacologic Agents for Type 2 Diabetes. Endocrinol Metab Clin N Am. 2005;34:155-197. 
* DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control 
and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care; 2005 May; 28(5):1092-1100. 

° Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 
30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care; 2004 Nov; 27(11):2628-2635. 

° Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on 
glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care; 


2005 May; 28(5):1083-1091. 


” Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. 


Available at: http://www.thomsonhc.com (cited: 12/14/05). 


* Symlin package insert. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2005, Jun. 


...edited by Mary Lynn McPherson, Pharm.D., BCPS, CDE 
Professor, University of Maryland School of Pharmacy 


Maryland Pharmacist * Jan./Feb./Mar. 2006 


PHARMACY MARKETING GROUP, INC 


AND THE LAW 


By Rachel Jackson 
And Karen E. Peterson, R.Ph., J.D. 


This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your 
State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing 
quality products and services to the pharmacy community. 


MINORS AND PRESCRIPTIONS: 
WHERE DOES HIPAA FIT IN? 


(Part 2 of 2) 


Remember Kate, the pharmacist at 
Hometown Pharmacy? She was faced with 
the difficult question of whether or not to give 
Mrs. Johnson information regarding a 
prescription her daughter Jenny may have 
gotten filled recently. Is a minor protected by 
HIPAA? 

State and other applicable laws 
present three situations when dealing with 
prescriptions (or any health information) for a 
minor: 

1) When the health care provider 
must treat the personal 
representative as the primary 
decision maker 

2) When the health care provider 
must treat the minor individual 
as the primary decision maker 
(the personal representative 
does not have an absolute 
right to the information) 

3) When the health care provider 
may treat either the minor or 
the personal representative as 
the primary decision maker. 

Recall that the first situation happens 
all the time, when parents are taking care of 
their baby, toddler, or young child. The third 
situation is common as the child grows up. 
Many state pharmacy laws say the ‘patient or 
patient's caregiver should receive counseling, 
but do not make the distinction as to when a 
pharmacist should deal with one over the over. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


The second situation is the trickiest, 
and laws vary from state to state. When is a 
minor the treatment decision maker? All state 
laws give minors the power to consent to 
sexually transmitted infection (“ST1”) services, 
although some states add conditions. Some 
states, such as Massachusetts, also allow a 
minor to consent to contraceptive services. 
Since the minor is the one to give consent, he 
or she is considered the decision maker for 
this particular treatment; thus any information 
pertaining to this treatment is considered 
confidential and the health care provider is not 
allowed to share it with others, including 
parents. In this case, HIPAA grants the minor 
distinct rights that should be respected. 

That means the pharmacist should do 
everything in his or her power to see that the 
use of certain medications in adolescents are 
kept confidential. If 15-year-old Sara comes to 
Hometown Pharmacy with a prescription for 
Acyclovir 200 mg 5x daily for 10 days, Kate 
should not discuss it with Sara’s mom at the 
soccer game that weekend. Sara was granted 
consent by state law, so speaking about it with 
her mom may be a violation of Sara’s rights. 

It’s true that a minor’s confidential 
information is more prone to ‘slip through the 
cracks’ when the information must be shared 
for payment purposes. Sara could have 
received confidential STI testing, but the 
information may show up on her parents’ 
insurance company’s Explanation of Benefits 


Page 21 


form. Kate shouldn’t be the reason Sara’s 
parents find out. 

Quite a few studies have shown that 
minors would not seek STI or contraceptive 
care if their parents would find out. This is why 
it is important to know what the laws are in 
your state, and use your professional judgment 
when handling prescriptions in these matters. 
Do your best to keep the information 
confidential — this will foster a great 
relationship between you and the patient. 

In order to best provide confidentiality 
to your adolescent patients, there are several 
things you can do. 

e Know your state’s laws so you 
understand when a minor has 
the right to confidentiality. 

e Encourage your minor patients 
to read all privacy notices to be 
aware of the rights they may 
have as an individual. 

e If aminor comes in with a new 
prescription for birth control 
pills, ask questions during 
counseling such as, “Upon 
refill, if your mom is in the store 
Shall | have her pick this up for 
you?” Then document it! 

e Inform the minor that if they 
use their parents’ insurance to 
cover the cost of the 
medication, it may show up on 
a report from the insurance 
company. 

e Ask minor patients if they 
would like to use an alternate 
form of communication, such 
as Calling a cell phone or 
mailing to a friend’s house. 
Then document it! 

e Mark confidential prescriptions, 
using such things as 
clothespins, stickers, or 
brightly colored paper. 

How should Kate answer Mrs. 
Johnson's question about Jenny’s recent 
prescription? If it was for acne medication, 
Mrs. Johnson has a right to know and Kate 
should answer truthfully; Jenny does not have 
a right to privacy. If the prescription is for STI 
treatment, the information is confidential no 
matter what the state and Kate cannot answer 
Mrs. Johnson. If the prescription was for birth 
control, the answer depends on the state. If 
Hometown Pharmacy is in Massachusetts, 
Kate should answer that the information is 
confidential and she can’t be of any 


Page 22 


assistance. However, in Indiana a minor 
cannot give consent for contraceptive services 
unless she is married, thus state law would not 
protect Jenny's information. If Hometown 
Pharmacy is in Indiana and Jenny managed to 
get care behind her mother’s back, Kate would 
have to tell Mrs. Johnson the truth unless she 
suspects the information would endanger 
Jenny. 

Be aware of these three situations. 
Know your state laws, use your professional 
judgment, and remember that HIPAA can also 
apply to minors. 


©Rachel Jackson and Karen Peterson. Rachel 
Jackson is a student at the lowa College of 
Pharmacy in lowa City, lowa. Karen E. 
Peterson, R.Ph., J.D. is a Professional Liability 
Claims Attorney at Pharmacists Mutual 
Insurance Company. 


This article discusses general principles of law and 
risk management. It is not intended as legal advice. 
Pharmacists should consult their own attorneys and 
insurance companies for specific advice. 
Pharmacists should be familiar with policies and 
procedures of their employers and insurance 
companies, and act accordingly. 


For more information, see: 

Boonstra H and Nash E. Minors and the right to consent to health 
care, The Guttmacher Report on Public Policy, 2000, 
3(4):4-8. 
http://www.guttmacher.org/pubs/tgr/03/4/gr030404. pdf. 

HIPAA Regulations. http://aspe.hhs.gov/admnsimp/pl104191 .htm. 

OCR Guidance Explaining Significant Aspects of the Privacy Rule 
— 4 Dec 2002. 
http://www.hhs.gov/ocr/hipaa/guidelines/personalrepre 
sentatives.pdf. 


Rebecca Gudeman. Adolescent Confidentiality and Privacy 
Under the Health Insurance Portability and 


Accountability Act. Youth Law News: Journal of the 
National Center of Youth Law. Jul-Sept 2003. 
http://www. youthlaw.org/downloads/adolescnt_confiden 
tiality.pdf. 

The American Bar Association. Facts about Children and the Law. 
28 Dec 2000. 
http://www. abanet.org/media/factbooks/childlaw.pdf. 

The Guttmacher Institute. Minors’ Access to STD Services. State 
Policies in Brief. 1 Sept 2005. 
http://www.guttmacher.org/statecenter/spibs/spib_ MAS 
S.pdf. 

The Guttmacher Institute. Minors’ Access to Contraceptive Services. 
State Policies in Brief. 1 Sept 2005. 
http://www. guttmacher.org/statecenter/spibs/spib_ MACS.pd 
f. 


Maryland Pharmacist * Jan./Feb./Mar. 2006 


Continuing Education — 
for Pharmacists _- 


Recommendations for 
Prevention and 
Control of Influenza: 
2005-06 Flu Season 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 

Ohio Northern University 
Ada, Ohio 


and 


J. Richard Wuest, R.Ph., 
Pharm.D. 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


Goals. The goal of this lesson is to 
examine updated recommendations 
for the prevention and control of 
influenza for the 2005-06 flu season. 
The focus is on inactivated influ- 
enza vaccine. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. identify etiologic and patho- 
physiologic characteristics of the 
influenza viruses; 

2. describe the major strategy 
for prevention of influenza infection; 

3. recognize primary changes 
and updates from previous recom- 
mendations for prevention and 
control of influenza; and 

4. recommend sources of 
information regarding availability 
and other immunization product 
issues relative to influenza vaccine 
for the 2005-06 flu season. 


Epidemics of influenza cause 
approximately 36,000 deaths each 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


are highest among children; rates of 
serious illness and death are 
greatest among persons aged >65 
years, children less than two years, 
and individuals of any age who 
suffer from medical conditions that 
place them at increased risk for 
complications from influenza. 

The Advisory Committee on 
Immunization Practices (ACIP) of 
the Centers for Disease Control and 
Prevention (CDC) has updated its 
annual recommendations for the use 
of influenza vaccine during the 
2005-06 flu season (MMWR 2005; 
54:1-40) Four points of interest to 
pharmacists at the community level 
include: 

e persons with any condition (e.g., 
cognitive dysfunction, spinal cord 
injuries, seizure disorders, or other 
neuromuscular disorders) that can 
compromise respiratory function or 
the handling of respiratory secre- 
tions or that can increase the risk 
for aspiration should be vaccinated 
against influenza; 

e all healthcare workers should be 
vaccinated against influenza 
annually, and facilities that employ 
healthcare workers should be 
strongly encouraged to provide 
vaccine to workers by using ap- 
proaches that maximize immuniza- 
tion rates; 

e use of both available vaccines 
(inactivated; and live, attenuated 


Volume XXIII, No. 9 


influenza vaccine [LAIV]) is encour- 
aged for eligible persons every 
influenza season, especially persons 
in recommended target groups. 
During periods when inactivated 
vaccine is in short supply, use of 
LAIV is especially encouraged when 
feasible for eligible persons (includ- 
ing healthcare workers) because 
this might considerably increase the 
availability of inactivated vaccine 
for persons in groups at high risk; 
and 

e CDC and other agencies will 
assess the vaccine supply through- 
out the manufacturing period and 
will make recommendations preced- 
ing the 2005-06 influenza season 
regarding the need for tiered timing 
of vaccination of different risk 
groups. In addition, CDC will 
publish ACIP recommendations 
regarding inactivated vaccine 
subprioritization (tiering) on a later 
date in MMWR. 


Influenza Viruses 
Influenza viruses are the most 
important pathogens that cause 
acute respiratory disease, largely 
because of the enormous number of 
persons affected each year. During 
the influenza epidemic in the winter 
of 1962-63, an estimated 80 million 
persons were affected in the U.S., 
and deaths from influenza and 
pneumonia increased by about 
70,000. The most severe influenza 
pandemic (worldwide epidemic) 
occurred in 1917-18, when up to 20 
million persons died. 
Epidemiology. Affected 
persons are the only important 
source of influenza virus. The virus 
can be detected in respiratory 
secretions during the first few days 
of illness, but is rarely found beyond 
the first week. Persistent carriers 


Page 23 


SE ST LY RE SR EE LL ED ES ET SE PE CSTR SE SS TE ES LTE a ES TT RT ET ATA Ss 5ST TE TTT TE 


Is it a Cold or Influenza? 


chest discomfort, cough 


hacking cough 
complications 
earache 


mild to moderate, 


sinus congestion, 


Influenza 

characteristic high, 102-104°F 
sudden onset, lasts 3-4 days 
prominent 

usual, often severe 

extreme, can last 2-3 weeks 
early and prominent 
sometimes 

sometimes 

sometimes 

common, can become severe 


Table 1 
Symptom Cold 
fever rare 
headache rare 
| general aches & pains shght 
| fatigue & weakness mild 
prostration never 
runny, stuffy nose common 
sneezing usual 
sore throat common 


bronchitis, pneumonia; can be 
life threatening 


have not been identified, although 
there is convincing evidence that 
mild infections are more common 
than clinical disease. The viruses 
may, therefore, persist in a popula- 
tion by causing sporadic mild illness 
that resembles the common cold. 

The antigenic composition of 
influenza virus vaccine from year to 
year is determined prior to the 
beginning of the season by the 
predominant circulating strains 
worldwide and may change ona 
yearly basis. Since 1977, influenza 
A (H1N1) viruses, influenza A 
(H3N2) viruses, and influenza B 
viruses have been in global circula- 
tion. In 2001, influenza A (H1N2) 
viruses emerged. 

At any given time, a single 
subtype of influenza virus A pre- 
dominates throughout the world. 
The virus is subject to mutation by 
a phenomenon known as antigenic 
drift (i.e., single-base mutations 
leading to single amino acid substi- 
tutions) and antigenic shift (i.e., a 
major change in the viral hemag- 
glutinin to a completely new type), 
resulting in formation of different 
influenza strains. Influenza B is less 
likely to mutate. 

Type A influenza strains are 
responsible for major influenza 
epidemics. Nearly all epidemics 
reach their peak during the winter, 
with January and February report- 
ing the greatest number of cases in 
the northern hemisphere. Type B 
influenza virus infects children 


Page 24 


primarily, and is often localized 
to schools and other closed 
populations. Type B influenza 
virus typically causes less severe 
epidemics and occurs in four-to 
six-year cycles. 

Epidemics in any single 
locality tend to persist for only six 
to eight weeks. The short, 
explosive nature of the epidemics 
is accounted for by the short 
incubation period (two to three 
days), ease of transmission, 
widespread seeding of the virus 
prior to the outbreak, and the 
high attack rates. 

Clinical Presentation. 
The clinical manifestations of 
influenza may range from symp- 
toms of mild upper respiratory 
illness to severe pneumonia with 
involvement of numerous organs. 
It is often difficult to distinguish 
the illness of isolated cases from 
that caused by other common 
upper respiratory tract pathogens 
such as the common cold (Table 
1). Oftentimes, a characteristic 
pattern is readily discernible 
when groups of affected individu- 
als are encountered (e.g., an 
epidemic). 

Following an incubation 
period of two to three days, the 
patient presents with the charac- 
teristic syndrome of sudden onset 
of prostration (i.e., extreme 
exhaustion), myalgia (muscle 
pain), headache, and pain behind 
the eyes. Fever of 103° to 104° F 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


may occur within a few hours. Brady- 
cardia is the norm, but tachycardia is 
characteristic of the most severely ill. 
The face appears flushed and hot, and 
the skin feels dry. 

The first 24 to 48 hours of illness 
are characterized by systemic symp- 
toms. Respiratory involvement be- 
comes more prominent as the systemic 
symptoms subside. Pharyngitis alone 
is unusual, but associations with 
runny nose, conjunctivitis, naso- 
pharyngitis, and inflamed trachea and 
bronchi are common. Mucosal edema 
is always present and may progress to 
hemorrhagic necrosis of the tracheo- 
bronchial mucosa. Rales (abnormal 
respiratory sounds; “gurgling” noise on 
breathing) in the lungs are present in 
up to a third of uncomplicated cases. A 
dry, hacking cough and burning 
across the sternum are often the most 
distressing components of the illness. 
Gastrointestinal manifestations are 
rare. 

Secondary bacterial infections of 
the ears, sinus, bronchi, and lungs 
may appear during the late stages of 
illness, and are noted by a sudden 
return of high fever and extreme 
exhaustion or shortness of breath. 
Bacterial pneumonia is responsible for 
the majority of fatalities. Bacterial 
infections that manifest on day three 
to five of influenza are especially 
problematic in patients with conges- 
tive heart failure, rheumatic heart 
disease, or chronic pulmonary disease, 
and in pregnant women. The disease 
tends to be more severe in such 
patients. 

Patients usually recover in a few 
days to, at most, a week. Those 
convalescing longer may exhibit 
persistent cough, easy fatigability, 
muscle aching, or malaise. Symptoms 
persisting beyond three weeks can 
often be associated with depression. 


Controlling Influenza 

The primary option for controlling 
influenza is immunoprophylaxis with 
vaccine. Inactivated (i.e., killed virus) 
influenza vaccine and live, attenuated 
influenza vaccine (LAIV) are available 
for use in the U.S. Annual vaccination 
of persons at high risk for complica- 
tions and their contacts is the most 


effective means for reducing influ- 
enza morbidity. Increased vaccina- 
tion rates among persons residing or 
working in closed settings (e.g., 
nursing homes, dormitories) can 
reduce the onset of outbreaks. 
Vaccination of healthcare workers 
and others in close contact with 
persons at increased risk for severe 
influenza illness can also reduce 
transmission of influenza virus and 
subsequent influenza-related 
complications. Antiviral drugs used 
for chemoprophylaxis or treatment 
of influenza are important adjuncts 
to the vaccine; however, they are 
not a substitute for vaccination. 

Target Groups for Vaccina- 
tion. Vaccination with inactivated 
influenza vaccine is recommended 
for the following persons who are at 
increased risk for complications 
from influenza: 

e persons aged >65 years; 

e residents of nursing homes 
and other chronic-care facilities that 
house persons of any age who have 
chronic medical conditions; 

e adults and children who have 
required regular medical follow-up 
or hospitalization during the pre- 
ceding year because of chronic 
metabolic diseases (including 
diabetes mellitus), renal dysfunc- 
tion, hemoglobinopathies, or immu- 
nosuppression (including immuno- 
suppression caused by medications 
or by human immunodeficiency 
virus); 

e adults and children who have 
any condition (e.g., cognitive 
dysfunction, spinal cord injuries, 
seizure disorders, or other neuro- 
muscular disorders) that can 
compromise respiratory function or 
the handling of respiratory secre- 
tions or that can increase the risk 
for aspiration; 

e children and adolescents (aged 
six months to 18 years) who are 
receiving long-term aspirin therapy 
and, therefore, might be at risk for 
experiencing Reye syndrome after 
influenza infection; 

e women who will be pregnant 
during the influenza season; and 

e children aged six to 23 
months. 


Table 2 
Influenza Vaccine Comparisons 


Factor 
route of administration 


type of vaccine 
number of strains 


immunosuppressed not re- 
quiring protected environment 


immunosuppressed requiring 
protected environment 


persons at high risk, but not 
severely immunosuppressed 


with other vaccines 
of another live vaccine 


of inactivated vaccine 


**No data available on safety or efficacy 


Inactivated Vaccine 
IM injection 
killed virus 


3 (2 Influenza A and 
1 Influenza B) 


administered to close contacts of | yes 


administered to close contacts of yes 


administered simultaneously yes 
administered within 4 weeks yes 


administered within 4 weeks yes 


Live, Attenuated 
Vaccine (LAIV) 
intranasal spray 
live virus 

same as inactivated 


strains updated annually same as inactivated 

administration frequency annually same as inactivated 

approved age and risk groups >6 months healthy persons 5-49 
years 

administered to close contacts of — yes yes 


inactivated vaccine 
preferred 


yes 


yes** 


best to space 4 weeks 
apart 
yes 


*Inactivated influenza vaccine coadministration has been evaluated systematically only 
among adults with pneumococcal polysaccharide vaccine. 


Vaccination is also recom- 
mended for: 

e persons aged 50 to 64 years 
because this group has an increased 
prevalence of high-risk conditions 
(as identified above); 

e persons who can transmit 
influenza to those at high risk (e.g., 
employees of assisted living and 
other residences for persons in 
groups at high risk); 

e healthcare workers; and 

e travelers to the tropics or 
those who travel with organized 
tourist groups at any time of year, 
or persons who travel to the South- 
ern Hemisphere between April and 
September. 

In addition to groups cited above 
for which annual influenza vaccina- 
tion is recommended, influenza 
vaccine should be administered to 
any person who wishes to reduce the 
likelihood of becoming ill with 
influenza or transmitting the 
infection to others should they 
become infected. Individuals in 
essential community service roles 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


(e.g., firemen, police) should be 
considered for vaccination to mini- 
mize disruption of these activities 
during influenza outbreaks. 
Comparison of Live, Attenu- 
ated Influenza Vaccine with 
Inactivated Influenza Vaccine. 
Both inactivated influenza vaccine 
and LAIV can reduce the risk for 
influenza infection and illness. The 
vaccines are compared in Table 2. 
Similarities. Both forms of 
vaccine contain strains of influenza 
viruses that are antigenically 
equivalent to the recommended 
strains each year: one influenza A 
(H3N2) virus, one influenza A 
(H1N1) virus, and one influenza B 
virus. One or more virus strains 
may be altered each year based on 
the results of global surveillance for 
influenza viruses and emergence 
and spread of new strains. Viruses 
for both vaccines are grown in 
fertilized chicken eggs, thus both 
vaccines may contain limited 
amounts of residual egg protein. 
Both vaccines are administered 


Page 25 


FluMist™ (MedImmune, Inc.) 


| 0.5 mL/dose. 


: Table 3 
Approved Influenza Vaccines by Age Groups - U.S. 
Vaccine 6 mo-3 yrs 4yrs 5-49 yrs >50 yrs 
FluZone® X* X X X 
(Sanofi Pasteur, Inc.) 
| Fluvirin™ (Chiron) X X X 


X 


*Children 6-35 months should receive 0.25 mL/dose. Persons >35 months should receive 


annually to provide optimal protec- 
tion against influenza infections. 

Differences. Inactivated | 
influenza vaccine contains killed 
viruses, whereas LAIV contains 
live, attenuated viruses that remain 
capable of replication. Inactivated 
influenza vaccine is administered 
intramuscularly by injection. LAIV 
is administered intranasally by 
sprayer. LAIV is more expensive 
than inactivated influenza vaccine, 
although the price differential has 
decreased substantially over the 
past year. Inactivated influenza 
vaccine is approved for use in 
persons aged >6 months, including 
those who are healthy and those 
with chronic medical conditions, 
whereas LAIV is approved for use 
among healthy persons aged five to 
49 years. 

Recommended Vaccines and 
Doses for Different Age Groups. 
When vaccinating children aged six 
months to three years, only inacti- 
vated influenza vaccine that has 
been approved by FDA for this age 
group should be used (Table 3). 
Inactivated influenza vaccine from 
Sanofi Pasteur, Inc. (FluZone® ) is 
approved for use among children 
aged >6 months. Inactivated influ- 
enza vaccine from Chiron 
(Fluvirin™) is labeled in the U.S. 
for use in children aged >4 years 
because data to demonstrate efficacy 
in younger persons have not been 
provided to FDA. LAIV from 
MedImmune (FluMist™) is ap- 
proved for use in healthy individuals 
aged five to 49 years. 

Timing of Annual Influenza 
Vaccination. Individuals at high 
risk for serious complications should 
be vaccinated beginning in Septem- 


Page 26 


ber if vaccine is available. In 
facilities housing elderly residents 
(e.g., nursing homes), vaccination 
before October should generally be 
avoided because antibody levels in 
such persons can begin to decrease 
soon after vaccination, thus leading 
to insufficient immunity. Children 
nine years of age and under who 
have not been previously vaccinated 
require two doses spaced at least one 
month apart. They can receive their 
first dose in September so that both 
doses of vaccine can be administered 
before the onset of flu season. 
Children who have been previously 
vaccinated require only one dose to 
provide optimal protection against 
influenza. 

In the U.S., October to Novem- 
ber is the optimal time to vaccinate. 
It is recommended that vaccination 
be provided in October and earlier 
primarily in individuals aged >50 
years, persons <50 years who are at 
increased risk for influenza-related 
complications (including children 
aged six to 23 months), household 
contacts of children aged 0 to 23 
months), and healthcare workers. 
Vaccination of all other persons 
should be deferred until November, 
ideally, unless vaccine supplies 
dictate otherwise. 

Many individuals who should or 
wish to receive influenza vaccine 
remain unvaccinated after Novem- 
ber. Influenza vaccine should 
continue to be offered in December, 
and throughout the influenza 
season, as long as vaccine supplies 
remain available, even after influ- 
enza activity has been documented 
in the community. Seasonal influ- 
enza activity in the United States 
can begin to increase as early as 
October or November, but influenza 


activity has not reached peak levels 
in the majority of recent seasons 
until late December-early March. 
Although the timing of influenza 
activity can vary by region, vaccine 
administered after November is still 
likely to offer benefit in the majority 
of influenza seasons. Adults develop 
peak antibody protection against 
influenza infection two weeks after 
vaccination. 

Sources of Information 
Regarding Influenza and Its 
Surveillance. Information regard- 
ing influenza surveillance, preven- 
tion, detection, and control is 
available at www.cdc.gov/flu/ 
weekly/fluactivity.htm. Periodic 
updates regarding influenza are 
published in the Morbidity and 
Mortality Weekly Report (MMWR) 


(www.cdc.gov/mmwr). 


A Note on Bird Flu 

Popularized by the press during the 
past year, bird flu (Avian Influenza) 
is a highly infectious disease of birds 
caused by the H5N1 subtype of 
influenza A virus. This virus 
circulates among birds worldwide 
and can be deadly to them. A few 
human deaths have been reported 
worldwide. The World Health 
Organization is continuing to 
monitor antigenic and genetic 
changes in circulating H5N1 
viruses, especially in humans. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


Continuing Education Quiz 


This month’s questions are taken from the article on “Recommendations for Prevention and Control of Influenza: 2005-06 Flu Season”. Circle 
your answers to the following questions and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 21201- 
1572. There is no charge for this quiz for MPhA members (non-members $ 10.00). The completed quiz for this issue must be received by 
9/15/08. A continuing education certificate for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to eight weeks. 


Please type or print clearly. ACPE# 129-144-05-009-HO1. 


Name 

Address 
City, State, Zip 
Daytime Phone 


Date Completed 
(Required) 


1. The letter “L” in LAIV refers to which of the 


following? 
a. Lasting c. Live 
b. Latent d. Lymphatic 


2. The most severe influenza pandemic, when up to 
20 million people died, occurred in: 

a. 1897 to 1898. c. 1962 to 1963. 

b. 1917 to 1918. d. 1992 to 1993. 


3. In persons affected by the influenza virus, the 
virus is most likely to be detected in respiratory 
secretions during: 

a. the first few days. c. days 7 to 9. 

b. days 4to6. . d. days 11 to 14. 


4. From Table 1, the symptom more likely to be 
present with influenza infection than the common 
cold is: 

a. sneezing. c. sore throat. 

b. runny, stuffy nose. d. high fever. 


5. When the influenza virus mutates by undergoing 
a single-based mutation leading to a single amino 
acid substitution in its DNA strand, it is referred to 
as an: 

a. antibody shift. c. antigenic shift. 

b. antibody drift. d. antigenic drift. 


6. The form of influenza virus that is LESS hkely to 
mutate is: 


a. Influenza A. 
b. Influenza B. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2006 


The Maryland Pharmacy Continuing 
Education Coordinating Council is 
accredited by the Accreditation Council for 


Pharmacy Education as a provider of 
continuing education for pharmacists. 


7. Which of the following is responsible for the 
majority of fatalities in patients with influenza? 
a. Bacterial pneumonia 
b. Heart failure 
c. Hypertensive crisis 
d. Pulmonary edema 


8. Both forms of influenza vaccine contain strains of 
viruses in which of the following ratios? 

a. One influenza A virus and one influenza B virus 

b. One influenza A virus and two influenza B 
viruses 

c. Two influenza A viruses and one influenza B 
virus 

d. Two influenza A viruses and two influenza B 
viruses 


9. Inactivated influenza vaccine (FluZone® ) is 
approved for use among children as young as: 
a. one month. 
b. three months. 
c. six months. 


10. The optimal time for an annual influenza vaccine 
1s: 

a. August. c. December. 

b. October. d. February. 


Page 27 


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TPIT) An 


VOLUME 82 No. 2 


From The President 
“Matthew Shimoda, Pharm.D.” 


MPhA 124th Annual Convention 


“In Pictures” 


Therapeutically Speaking... 
“Chemotherapy Update: Oral Tyrosine 
Kinase Inhibitors” 


Continuing Education 
“Natural Products: Calcium to 
Capsicum” 


MARYLAND PHARMACISTS ASSOCIATION 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 
410-727-0746 
www.marylandpharmacist.org 


MPhA Officers 2005 - 2006 MPhA Trustees 


Matt Shimoda, Pharm.D., President Cynthia Boyle, Pharm.D., Chairperson 
Ginger Apyar, P.D., First-Vice President Michelle Andol, P-D. J.D... 2008 
Joe Marrocco, P.D., Second-Vice President Doug Campbell, R.Ph. 
Walter Abel, P.D., Treasurer Kathryn Fader, R.Ph. 
George Voxakis, Pharm.D., Honorary President Butch Henderson, R.Ph. 
Neil Leikach, P.D. 
Magaly Rodriguez deBittner, Pharm.D. .... 
House Officers David Russo, R.Ph 
Carol Stevenson, Pharm.D. 
Mary Kremzner, Pharm.D., Speaker Doris; Vogl PhatnD 2... 2 2 2008 


Barry Poole, R.Ph., Vice-Speaker Stephen Wienner, P.D. ................ 2006 
Lisa Clayville, President ASP 


MPhA Staff Ex-Officio Members 
David Knapp, Ph.D., Dean - 
Howard Schiff, P.D., Executive Director UMB School of Pharmacy 
Elsie Prince, Office Manager 


Jeffrey B , Pharm.D. - MSHP. R tati 
Nancy Ruskey, Administrative Assistant Mca ie eM seas ue EGIL Ss epresentative 


Maryland State Board of Pharmacy 


John Balch, P.D., President Mayer Handelman, P.D. 
Mark Levi, P.D., Treasurer Mike Souranis, P.D. 
Jeanne Furman, P.D., Secretary Donald Taylor, P.D. 
Margie A. Bonnett Rodney Taylor, Pharm.D. 
Joseph A. DeMino, P.D. Donald Yee, P.D. 

David R. Chason, R.Ph. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


eT eyagi UMAe? led cevoile (a) ae -e Behe eee CE ee CORE ic tear ere: Crna ay ee oe 5 
Matthew Shimoda, Pharm.D. 


mera DCuluiGallViSDGakill Oncetsrenete-tivtars cotuiciets © crabs te othe see te vce vre'e o's = 10 
“Chemotherapy Update: Oral Tyrosine Kinase Inhibitors” 


Rous eehidale? LE one eR Bato ac oso oo en 6 6578 6 Oo oe eee ibs 
“Collaborative Practice: Risks and Rewards” 


NEMWodaterrwer seers: Ain od Gobo bono GCC ERO 0.0 eee ills) 
NCPDP Prepares to Enumerate Authorizing Pharmacies 


CONUDUINELEGUCAt Ol memamiettt seer ecviei Mae ietet st Mee «far e's sPeNe, we ee oe este ses 23 
“Natural Products: Calcium to Capsicum” 


Advertiser’s Index 


ErIendly PharmacGyalitcr aC meee, ee ee ee 16 
Medical StaffingiNGtwWOckall|Gmpermerrre te ov ce te ee ee ee es 14 
MerckiHumanilealiniDiviSiolamentten teeter i clears a ove tsiser eis ccavens efeteye See 24 
Nutramax LaboralonlessinCwesenetnr tes. . cw eee ec ne ess 23 
PharmaciStS MULUGIECOM Dall CS mm mmrrnrrenemt iano aon iere oo niopnie ni eis ss een 4 


Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 
650 West Lombard Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals 
postage paid at Baltimore, MD and at additional mailing office. Articles and editorials that appear do not necessarily reflect 
the official positions of the Maryland Pharmacists Association and may contain views and opinions for which the authors 
hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West Lombard Street, 
Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


What does this mean for you? 


It means Pharmacists Mutual Insurance 
Company promises "To help our 
customers attain financial peace of mind." 


It means our employees stand behind 
that promise each and every day. 


It means our President, our 
pharmacist/attorneys, our home office 
staff, and our sales representatives are 
focused on helping you achieve financial 
security. 


It means we are the only insurance 
company devoted to pharmacists. 


It means value that we believe you can't 
get anywhere else. 


Call us at 800-247-5930 or visit 


Pp har macists www.phmic.com today to see what it 


means to have our people stand 


Mutudlonpanis 


One Pharmacists Way, Highway 18 West Pharmacists Mutual Insurance Company Dave Geoghegan 

P.O. Box 370 « Algona, IA 50511-0370 Pharmacists Life Insurance Company P.O. Box 177 
Pharmacists National® Insurance Corporation Kingsville, MD 21087 
Pro Advantage Services, Inc. 410-592-9856 


PMC Quality Commitment, Inc. dave.geoghegan@phmic.com 


Pharmacists Mutual is endorsed by the Maryland Pharmacists Association (compensated endorsement). 


From the President 
Matthew Shimoda, Pharm.D. 


First and foremost I would like to personally thank the Officers, Board of 
Trustees, Executive Director Howard Schiff, and especially our office staff Elsie 
and Nancy. Without this infrastructure this organization would not be able to 
function for the good of our current and future members. 


This has been a trying yet productive year for the profession of Pharmacy. We 
have endured national catastrophic disasters that showed the country that 
Pharmacists can and will do “what ever it takes” to care for our patients. Many 
of our members were at the forefront in this effort and for that I Thank You. I 
know that I have talked about the beginning, and continuing process that our 
Profession faced with regards to Medicare Part D and we are all probably tired 
about hearing about it again, but this has truly been an historic event for 
Pharmacy. We all suffered through the confusion and pain that this program brought to our practices, but in the end we as 
Pharmacists are the “Heroes” that made this program even come close to being a success. I can’t pick-up any one of the 
Journals dealing with Pharmacy and see the same pained expressions and complaints about the Medicare Modernization 
Act of 2003, yet we have made a difference for millions of recipients in our state as well as the country for that we should 
feel proud. 


This year has been as equally busy for MPhA on the Legislative front. Many important issues affecting our daily 
practices came before and were debated in the United States Congress as well as our own State Legislation. The 
Technician issue, Pseudoephedrine mandates, Electronic Prescribing, budgetary issues concerning the building of the 
Pharmacy School addition (once and for all!), Prescription drug monitoring programs, establishment of a clear 
contraception dispensing program authorizing Pharmacists to dispense without a prescription, the “day after pill” and how 
this will affect individual Pharmacists and Pharmacies. These are only some of the issues the Profession faces. Our 
association has been active in keeping our membership informed and in many cases able to testify about these important 
issues to our elected officials. This is in many ways is thanks to the Maryland Pharmacy Coalition, Howard, and 
especially Muhl Flowers who will be sorely missed as the liaison and Chair of our Legislative Committee. Thank you for 
your dedication and hard work over these many years. As you can see the MPhA is busy with the ongoing issues 
effecting Pharmacy and we will continue to be the “watch dog” with these and I am sure many more issues to come. 


This April, I had the privilege to attend the Annual APhA Convention in San Francisco with Cynthia, Howard, and 
Ginger. It was exciting to see many old friends of Pharmacy and hear about the current state of affairs facing all of us. I 
will tell you that we in Maryland are not alone in the daunting task of running a Pharmacists Association! I had the 
opportunity to network and glean ideas from our fellow colleagues across the country. Soon to be President Ginger Apyar 
has been very active in attending Leadership conferences, meetings, and having the enthusiasm to want to make MPhA a 
more efficient and effective conduit for our profession. Thank You Ginger for going that extra mile for everyone. 


When Cynthia Boyle became President of the Association she set forth worthy goals that would lead us forward. These 
goals were not meant to be accomplished in a day, or in her term as President. The goals she set forth have been and will 
continue to evolve and as an Association we need to see that the basic premise of these goals is not lost. 


I want to thank the members of all our committees for their hard and more importantly innovative ideas. I thought that it 


was important to focus on all of the goals yet concentrate on a few at a time to allow for more continuity as a group. I will 
list some of the committees as well as goals to give some clarity for the future. 


Maryland Pharmacist ¢ April/May/June 2006 Page 5 


Membership 

e This is one of the toughest challenges we face. This is certainly not unique to our Association and as a matter of 
fact we are doing much better than many of our counterparts. 

e Adding a Technician category was a priority of mine especially with upcoming regulatory issues. We have many 
Technicians that have joined and many more inquires. 

e At the suggestion of the committee and Elsie we have sent out mass mailings to Pharmacists that may have just 
forgotten to renew or even better see THE VALUE of joining our organization, this was a success with many 
additions. 

e We have stressed the value of personal contact with our fellow Pharmacists/Technicians to encourage them to 
join. 

e We have accomplished our goal of enrolling all facets of practice settings with the help of our diverse Board. 


Communications 

The Web site has been greatly enhanced, but we still need to allow for more individual member sites. 

We now have a new Logo (looks great-thanks Butch). 

Electronic payment has been activated. 

We still need to explore the possibility of e-communities with members being allowed to explore the many 
questions that we all face in our daily practices. 

e We need to consider our monthly newsletter being sent via e-mail. 


Convention/Meetings 
e As with this year’s Annual Convention the theme “All Shook-up” will be the case. We are trying new formats just 
like other State and National Pharmacy organizations. 
e We will see how this new format works and possibly look to other formats in the future. 
e It has been a difficult year finding funding for the CE’s as grant money must be used and it MUST be requested 
as early as possible to allow the Association time to ascertain new topics and speakers. 
e The Association has been fortunate to provide quality CE’s due to the hard work of the committee and staff. 


MPhA Foundation 
e We need a clear and concise definition of what the Foundation needs from the Association 
e As discussed by the Executive Committee we need some guidance as to an updated goal. 


There are many more goals and needs for the Association and with the continued hard work of everyone we can achieve 
an Association that people want to be a part of. 


Many more Thanks need to go out. Thank You Mark Sanford for your help with the new Constitution and Bylaws 
committee and the tedious job in having one ready to be voted on and passed. To our ASP Board member Lisa Clayville 
you always added solid comments from the students as their advocate. You will be sorely missed. Dean Knapp, Thank 
you for giving so much assistance from the UMB School of Pharmacy and your wisdom to our Board. 


It has been a great year and I know in my heart it will be even better next year. I will still put in my plea that with the help 
of many no task seems as big. 


Once again, many thanks to the Association and its members. 2006-2007 will bring bigger and better things for all of our 
members. 


Thanks to all, 

Matthew Shimoda, PharmD 
President 2005 - 2006 

Maryland Pharmacists Association 


Page 6 Maryland Pharmacist « April/May/June 2006 


MPhA 124" Annual Convention In Pictures 
Ocean City, Maryland 
June 10 - 13, 2006 


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Bia 
Board of Trustees 


Mentor of the Year Award Incoming President 
Doris Voigt Ginger Apyar 


a a __| 
Bowl of Hygeia Award 
Mary Kremzner Jerry Herpel 


Maryland Pharmacist ¢ April/May/June 2006 Page 7 


Page 8 


Beh 48 ft oS a 
Seidman Award Distinguished Young Pharmacist Aw 
Mark Sanford Tom Garguilo 


Innovative Practice Award Outgoing Presidents Awar 
Stephen Wienner Matthew Shimoda 


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Crab Feast 
Jerry and Daughter Grace 


Crab Feast 


John and Carol Brian and Wife 
Hoai and Hoai An 


Maryland Pharmacist ¢ April/May/June 2006 


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Maryland Pharmacist ¢ April/May/June 2006 Page 9 


Therapeutically Speaking... 


Chemotherapy Update: Oral Tyrosine Kinase Inhibitors 


Deborah M. McNutt, Pharm.D and James A. Trovato, Pharm.D. BCOP 


Over the past ten years, the treatment of cancer has evolved tremendously. Greater understanding cancer 
cell biology has led to the development of a new generation of chemotherapeutic agents such as monoclonal 
antibodies and kinase inhibitors.” ? Although the majority of these targeted chemotherapeutic agents are 
administered intravenously, recently approved tyrosine kinase inhibitors are oral medications. This update 
will focus on the mechanism of action, indications, pharmacokinetics, adverse effects, and key patient 
counseling information for the newer oral tyrosine kinase inhibitors erlotinib (Tarceva), sorafenib (Nexavar), 
and sunitinib (Sutent). Additionally, safety issues regarding the storage, handling, and dispensing of these 


agents will be discussed. 


Oral Tyrosine Kinase Inhibitors 

The oral tyrosine kinase inhibitors are a 
growing class of chemotherapeutic agents that 
community pharmacists will increasingly 
encounter. The mechanism of action of these 
agents may be responsible for their tolerable and 
unique side effect profile. Simply stated, the 
tyrosine kinase inhibitors, erlotinib, sorafenib, 
and sunitinib act intracellularly by binding to the 
tyrosine kinase domain of the growth factor 
receptor. This in turn prevents the activation of 
many signaling pathways within the cancer cell 
responsible for promoting tumor growth, 
metastasis, and angiogenesis (new blood vessel 
formation). Erlotinib is an inhibitor of the 
human epidermal growth factor receptor type 1 
tyrosine kinase, whereas sorafenib and sunitinib 
inhibit multiple receptor kinases including the 
vascular endothelial growth factor (VEGF) 
tyrosine kinase. 

Erlotinib (Tarceva®) is FDA approved as 
monotherapy for the treatment of patients with 
locally advanced or metastatic non-small cell 
lung cancer (NSCLC) who have failed at least 
one chemotherapy regimen. It is also indicated 
in combination therapy with gemcitabine for the 
first-line treatment of locally advanced, 
unresectable or metastatic pancreatic cancer.’ 
The recommended daily dose of erlotinib is 150 
mg daily, which is approximately 60% absorbed 
without food and increases to almost 100% with 
food.’ Despite the greater bioavailability with 
food, it is recommended to take erlotinib one 
hour before or two hours after meals. There is no 
data on dosage adjustment for liver dysfunction 
or renal impairment. 


Maryland Pharmacist eApril/May/June 2006 


Erlotinib is 93% protein bound and primarily 
metabolized by the CYP3A4 enzyme system. Strong 
CYP3A4 enzyme inducers such as phenytoin, 
carbamazepine, phenobarbital, and herbal 
supplements (St. John’s Wort) will decrease the 
concentration of erlotinib. Known CYP3A4 enzyme 
inhibitors, such as antifungal agents (e.g., 
ketoconazole, itraconazole), and antiretrovirals (e.g., 
ritonivir, nelfinavir) and will significantly increase 
erlotinib concentration, necessitating dosage 
adjustment.’ In addition, patients taking warfarin 
should be monitored for bleeding. 

The most common adverse events associated 
with therapy are an acne-like rash, dry skin, 
diarrhea, conjunctivitis, and dry eyes, which can be 
symptomatically managed.” ° Rash is best described 
as a pustular/papular eruption with an acne-like 
distribution. Systemic and topical retinoids used to 
treat acne vulgaris are not recommended; 
clindamycin 1% gel or clindamycin 1% with 
benzoyl peroxide 5% gel have been shown to be 
effective. Dry skin can be treated with emollients 
such as Eucerin or Aquaphor. Although rare, 
interstitial lung disease has been reported and the 
onset has ranged from 6 days to 9 months after the 
initiation of therapy.” 

Patient counseling points include taking erlotinib 
on an empty stomach, and self-monitoring for 
adverse effects (e.g., acne-like rash, dry skin, dry 
eyes). Should these effects, persistent diarrhea, 
nausea, vomiting, eye irritation, unexplained 
shortness of breath or cough occur, the patient 
should contact their physician immediately. Patients 
who are taking warfarin concurrently should self- 
monitor for bleeding or unexplained bruising, and 
contact their prescriber if such occurs. 


Page 10 


Sunitinib (Sutent®) is FDA approved for 
the treatment of gastrointestinal stromal tumor 
after disease progression and for the treatment of 
advanced renal cell carcinoma® The daily- 
recommended dose is 50 mg for four weeks, 
then two weeks off. ° Food has no effect on the 
bioavailability of sunitinib and it is 90% — 95% 
protein bound. Like erlotinib, the CYP3A4 
enzymes are the primary metabolizers of 
sunitinib, and co-administration with known 
CYP3A4 inducers and inhibitors may necessitate 
dosage adjustment.° Grapefruit juice may 
increase plasma concentrations of sunitinib.° 

There is no data on dosage adjustment for 
liver dysfunction or renal impairment. 

The most common are adverse events 
associated with sunitinib are fatigue, 
gastrointestinal complaints (nausea, vomiting, 
diarrhea, constipation, abdominal pain), 
mucositis/stomatitis, bleeding, neutropenia, 
muscle pain, and anorexia.” In addition, 
adverse events that may affect the patient 
psychosocially are rash, skin and hair 
discoloration, and hand-foot syndrome.” 

Patient counseling points include 
administration without regard to food, common 
adverse effects (e.g., diarrhea, nausea, mouth 
pain/irritation, dyspepsia, vomiting, dysgeusia, 
fatigue and hypertension), and possible need for 
supportive care (e.g., anti-emetic or anti- 
diarrheal medication). Patients should be told to 
self-monitor for yellow skin discoloration that 
may occur after a week of therapy, and 
depigmentation of hair (e.g., gray color). Other 
dermatologic effects include dryness, thickening 
or cracking of skin, and blister or rash formation 
on palms of hand and soles of feet. 

Sorafenib (Nexavar®) is FDA approved for 
the treatment of patients with advanced renal 
cell carcinoma (RCC).'° In a Phase III trial 
sorafenib significantly prolonged the 
progression-free survival compared with placebo 
in patients with previously treated advanced 
RCC." In addition, 74% of sorafenib patients 
had tumor shrinkage as compared to 20% of 
placebo patients. 

The oral bioavailability of sorafenib is 38- 
49% and this is substantially reduced when 
taken with a high-fat meal; sorafenib should be 
taken on an empty stomach.’® The recommended 
daily dose of sorafenib is 400 mg (2 x 200 mg 
tablets) taken twice daily. If patients experience 


Maryland Pharmacist eApril/May/June 2006 


intolerable side effects then the drug should be 
stopped and/or dose reduced. When dose reduction 
is necessary, reduce to 400 mg once daily or every 
other day if necessary. 

Sorafenib is metabolized primarily in the liver, 
although dosage adjustment is not necessary with 
mild to moderate hepatic or renal impairment.'° 
Sorafinib has not been evaluated in patients with 
severe hepatic or renal impairment. Co- 
administration with ketoconazole did not result in 
increased sorafenib serum concentrations, therefore 
sorafenib metabolism is unlikely to be altered by 
CYP3A4 inhibitors.'° Although there is no clinical 
information on the effect of CYP3A4 inducers on 
the pharmacokinetics of sorafenib, inducers of 
CYP3A4 activity are expected to increase 
metabolism of sorafenib.'° The most common 
adverse effects associated with sorafenib are rash, 
diarrhea, hand-foot skin reaction, fatigue, and 
hypertension. '! 

Patient counseling points include informing 
female patients that sorafenib may cause birth 
defects or fetal loss, and pregnancy should be 
avoided during treatment and for at least 2 weeks 
after topping therapy. In fact, both men and women 
should be counseled to use effective birth control, 
and breast-feeding should be avoided. Patients 
should be counseled about potential hand-foot skin 
irritation (e.g., ulceration, blistering or severe pain) 
and rash; contact prescriber should such occur. 
Blood pressure should be routinely monitored during 
therapy, especially during the first six weeks of 
therapy due to risk of hypertension. 


Safe Handling of Oral Chemotherapy 

Proper storage recommendations for all oral 
chemotherapeutic agents include using shelves and 
storage areas that bear clear and distinctive labeling 
identifying them as hazardous drugs.'* Oral 
chemotherapy should be segregated from all other 
inventory drugs to reduce potential errors and to 
ensure the safety of personnel.” The risk of handling 
oral chemotherapy without the use of gloves is 
unknown, but the American Society of Health- 
System Pharmacists (ASHP) has put forth 
recommendations for the compounding and handling 
of, and reducing exposure to hazardous drugs to help 
ensure the safety of all pharmacy personnel.'’ The 
following is an abbreviated list of these ASHP 
recommendations that pertain to the community 
pharmacist. 


Page 11 


Page 12 


Hazardous drugs should be labeled or 
otherwise identified as such to prevent 
improper handling. 

Tablet and capsule forms of hazardous drugs 
should not be placed in automated counting 
machines, which subject them to stress and 
may introduce powdered contaminants into 
the work area. 

Workers should be aware that tablets or 
capsules might be coated with a dust of 
residual hazardous drug that could be 
inhaled, absorbed through the skin, ingested, 
or spread to other locations, and that liquid 
formulations may be aerosolized or spilled. 
During routine handling of oral hazardous 
drugs and contaminated equipment, workers 
should wear two pairs of gloves that meet 
the ASTM chemotherapy glove standard. 
Wash hands thoroughly after removing 
gloves. 

Counting and pouring of hazardous drugs 
should be done carefully, and clean 
equipment should be dedicated for use with 
these drugs. 

Hazardous drugs should be dispensed in the 
final dose and form whenever possible. 
Disposal of unused or unusable oral dosage 
forms of hazardous drugs should be 
performed in the same manner as for 
hazardous injectable forms and waste. 


References: 


1. Schoffski P, Dumez H, Clement P, 
Hoeben A, Prenen H, Wolter P, et al. 
Emerging role of tyrosine kinase 
inhibitors in the treatment of advanced 
renal cell cancer: a review. Ann Oncol. 
2006; 2: [Epub ahead of print] 

2. Krause DS, Van Etten RA. Tyrosine 
kinases as targets for cancer therapy. N 
Engl J Med. 2005; 353(2):172-86. 

3. Tarceva (package insert). Melville, NY: 
OSI Pharmaceuticals, Inc; 2005. 

4. Johnson JR, Cohen M, Sridhara R, Chen 
YF, Williams GM, Duan J, et al. 
Approval summary for erlotinib for 
treatment of patients with locally 
advanced or metastatic non-small cell 
lung cancer after failure of a least one 
prior chemotherapy regimen. Clin 
Cancer Res. 2005; 11(18):6414-21. 


10. 


11. 


12) 


13: 


Shepherd FA, Pereira JR, Ciuleanu T, Tan 
EH, Hirsh V, Thongprasert S, et al. Erlotinib 
in previously treated non-small-cell lung 
cancer. N Engl J Med. 2005; 353(2):123-32. 
Sutent (package insert). New York, NY: 
Pfizer, Inc; 2006. 

Motzer RJ, Michaelson MD, Redman BG, 
Hudes GR, Wilding G, Figlin RA, et al. 
Activity of SU11248, a  multitargeted 
inhibitor of vascular endothelial growth 
factor receptor and platelet-derived growth 
factor receptor, in patients with metastatic 
renal cell carcinoma. J Clin Oncolo. 2006; 
24(1):16-24. 

Faivre S, Delbaldo C, Vera K, Robert C, 
Lozahic S, Lassau N, et al. Safety, 
pharmacokinetic, and antitumor activity of 
SU11248, a novel oral multitarget tyrosine 
kinase inhibitor, in patients with cancer. J 
Clin Oncolo. 2006; 24(1):25-35. 

Robert C, Saria JC, Spatz A, Le Cesne A, 
Malka D, Pautier P, et al. Cutaneous side- 
effects of kinase inhibitors and blocking 
antibodies. Lancet Oncol. 2005 Jul;6(7):491- 
500. 

Nexavar (package insert). Emeryville, CA: 
Onyx Pharmaceuticals, Inc; 2005. 

B. Escudier, C. Szczylik, T. Eisen, et al. 
Randomized Phase III trial of the Raf kinase 
and VEGFR inhibitor sorafenib (BAY 43- 
9006) in patients with advanced renal cell 
carcinoma (RCC). Proc Am Soc Clin Onc. 
2005. Abstract 4510. 

Griffin E. Safety considerations and safe 
handling of oral chemotherapy agents. Clin J 
Oncol Nursing. 2003; 7(6):25-29 supp. 
Power LA, Harrison BR, Connar TH, Mead 
KR, Polovich M, McDiarmid MA, et al. 
ASHP guidelines on handling hazardous 
drugs — prepublication copy. 
http://www.ashp.org/bestpractices/new/HD- 
Prepub-final.pdf. Accessed 4/12/06 


Edited by.... 


Mary Lynn McPherson, Pharm.D., BCPS 
Professor, University of Maryland, School of 
Pharmacy 


Maryland Pharmacist *April/May/June 2006 


PHARMACY MARKETING GROUP, INC 


AND THE LAW 


By Dena Kroska and Karen E. Peterson, R.Ph, J.D. 


This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State 
Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality 


products and services to the pharmacy community. 


COLLABORATIVE PRACTICE: 
RISKS AND REWARDS 


Increasingly, pharmacists are becoming more 
involved as decision-makers in patient care 
through collaborative practice agreements with 
physicians and other practitioners with 
prescriptive authority. A collaborative practice 
agreement is defined as a voluntary agreement 
between a prescriber and pharmacist 
establishing cooperative practice procedures 
under defined conditions. The term 
“collaborative practice” is often used 
interchangeably with the term “collaborative 
drug therapy management”, which refers to the 
practice where prescribers authorize 
pharmacists to engage in specific activities, 
such as the initiation, adjustment or evaluation 
of drug therapy. 


These collaborative arrangements between 
prescribers and pharmacists offer many 
benefits for patients, such as increased access 
to healthcare through a pharmacist, a reduction 
in the number drug-related complications due to 
optimal management of drug therapy, and a 
decrease in costs. In addition, benefits to 
prescribers include reduced costs of care, as 
well as fewer chronic care patient visits, which 
allows more time to care for acute care patients. 
Finally, these arrangements allow pharmacists 


Maryland Pharmacist ¢ April/May/June 2006 


to focus on the patient instead of the product, 
so they are able to apply their specialized 
knowledge of drug therapy to improve patient 
outcomes. 

As with any practice opportunity, it is necessary 
to evaluate the risks, as well as the benefits, 
before deciding to become involved. However, 
one factor that makes the risk of engaging in a 
collaborative practice arrangement difficult to 
evaluate is that it is difficult to tell what, if any, 
authority is granted to a pharmacist by a state 
board of pharmacy to enter into these 
arrangements. An informal survey of state 
boards of pharmacy revealed wide variances 
from state to state, as well as scope of practice 
rules that are not always easy to interpret. 
Pharmacists practicing in states where 
collaborative practice arrangements are neither 
explicitly allowed, nor explicitly prohibited may 
consider seeking further clarification from the 
state board before entering in to such 
arrangements. 


Pharmacists practicing in states where 
collaborative arrangements are explicitly 
allowed must be cautious to strictly adhere to 
the rules and regulations governing the 
arrangements. Regulations may determine 


Page 13 


minimum qualifications of parties to 
collaborative agreements, set limitations on 
activities or classes of drugs that are the subject 
of agreements, or set forth the necessary 
structure or components of the agreement. 


By assuming responsibility of the initiation of 
drug therapy according to a collaborative 
arrangement with a prescriber, a pharmacist 
may assume a greater risk of liability if there is 
an adverse event. When considering an 
opportunity to enter in to a collaborative 
arrangement with a prescriber, it is crucial that 
both parties thoroughly review the proposed 
agreement. The agreement will set forth the 
rights and responsibilities of both parties. It is 
particularly important that the parties 
understand how responsibility for adverse 
outcomes is apportioned. It is wise for both 
parties to confirm that their activities under such 
an arrangement are covered by their respective 
professional liability insurance carriers and for 
each party to obtain proof of the other's 
coverage. 


Collaborative practice arrangements present 
some very exciting opportunities for 
pharmacists to tangibly impact patient care ina 
positive manner. They may also allow a 
pharmacist to grow his or her business in a new 
direction. The opportunities are abundant, but 
so are the risks. A thorough understanding of 
both will allow a pharmacist to make wise 
decisions about his or her role in this evolving 
area. 


References: 


©Dena Kroska and Karen Peterson. Dena 
Kroska is a Pharm. D Candidate at Drake 
University in Des Moines, lowa.. Karen E. 
Peterson, R.Ph., J.D. is a Professional Liability 
Claims Attorney at Pharmacists Mutual 
Insurance Company. 


Page 14 


This article discusses general principles of law 
and risk management. It is not intended as 
legal advice. Pharmacists should consult their 
own attorneys and insurance companies for 
specific advice. Pharmacists should be familiar 
with policies and procedures of their employers 
and insurance companies, and act accordingly. 


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Maryland Pharmacist ¢ April/May/June 2006 


NPI Update: NCPDP Prepares to Enumerate Authorizing Pharmacies 


With the recent CMS publication of their requirements of Electronic File Interchange Organizations (EFIOs) on their web 
site http://www.cms.hhs.gov/NationalProvidentStand/ NCPDP continues to move forward with their enumeration plans for 
pharmacies. CMS has targeted “late spring” to go live with bulk enumeration for EFIOs and NCPDP is poised to begin 

enumeration when CMS is ready. NCPDP was selected as a beta test site by CMS and conducted testing with CMS during 


February 2006. 


What is EFI? 


Electronic File Interchange (EFI), also referred to as 
“bulk enumeration”, is a process by which a health care 
provider (e.g. pharmacy) or group of providers 
(pharmacies) can have a particular organization (the 
“EFIO”) apply for National Provider Identifiers (NPI) on 
their behalf. In other words, rather than a pharmacy or 
group of pharmacies submitting a paper or web NPI 
application, the EFIO obtains an NPI for them. 


How Did NCPDP Decide to Become an 
EFIO? 

Pharmacies are currently the only providers that have a 
single identifier, the NCPDP Provider (pharmacy) ID, 
formerly known as the NABP number. The 
administrative simplification provisions of the Health 
Insurance Portability and Accountability Act (HIPAA) 
of 1996 (P.L. 104-191) required the Secretary of HHS to 
adopt a unique identifier for all health care providers, 
including pharmacies, for use in the nationwide health 
care system. Between now and May 23, 2007, our 
industry must move away from using the NCPDP 
Provider ID on claims and other HIPAA standard 
transactions to using the pharmacy’s new NPI. 


For over two decades, NCPDP has been enumerating 
pharmacies with NCPDP Provider IDs. NCPDP 
maintains a database of all pharmacies that includes 
other information on pharmacy demographics and hours of 
operation, pharmacy payment center information, state 
license numbers and other affiliations. Industry uses this 
database for claims processing, direct mailings of product 
recalls and publications, network development, health plan 
directories and rebate information. When asked if 
pharmacies would prefer for NCPDP to bulk enumerate 
pharmacies and obtain their NPIs, virtually every 
pharmacy chain supported the idea. 


Recent EFIO Activities 


As aresult, NCPDP enhanced the current database to 
include information required by CMS when enumerating 
providers as well as other information not maintained by 
CMS but important for proper reimbursement. The 


Maryland Pharmacist ¢ April/May/June 2006 


database is currently in production and the additional 
data is being added from pharmacies submitting 
NCPDP’s paper application/update forms available at 
http://www.ncpdp.org/PDF/Provider_number_app.pdf. 
Also, a standard Excel file format is available to those 
pharmacy chains that wish to electronically submit 
information to NCPDP. To obtain the Excel format, 
please contact Jeannine Deese at jdeese@ncpdp.org. It 
will also be published on the web site soon. 


NCPDP is encouraging pharmacies to cleanse their 
internal data and update their pharmacy information with 
NCPDP between now and May so that when CMS is 
ready to go live with the EFI submission/bulk 
enumeration in late spring, pharmacy data on the 
NCPDP database is clean and ready to submit on behalf 
of those pharmacies that have authorized NCPDP to do 
so. 


What if a Pharmacy has Already 
Obtained an NPI? 


If a pharmacy or pharmacies have already obtained their 
NPI(s), it is important that the number(s) are 
communicated to NCPDP so that the number(s) can be 
added to the NCPDP Pharmacy Database. Adding NPIs 
to the Pharmacy Database is a vital method of 
dissemination of new NPIs by pharmacies and will aid in 
avoiding possible payment disruptions — already 
identified by the health care industry as a major potential 
issue when transitioning from old numbers to the NPI. 
Many payers intend on continuing to use “legacy” or 
“proprietary” identifiers in their claims processing 
systems and therefore intend on “cross walking” the new 
NPI to the legacy number (e.g. the NCPDP Provider 
pharmacy ID). The NCPDP Pharmacy Database 
provides this cross walk to subscribers of the database. 


What Must NCPDP Do Next? 


NCPDP will take several steps when CMS has 
completed testing. NCPDP must register as an EFIO 
with CMS and an authorized official of NCPDP must 
complete and sign a certification statement and mail it to 


Page 15 


the CMS Enumerator, Fox Systems, Inc. NCPDP cannot 
submit live files until this has been completed. 


As stated earlier, NCPDP 1s collecting all of the relevant 
data from those pharmacies on whose behalf NCPDP 
will act. NCPDP will enter it into NCPDP Pharmacy 
Database. According to CMS, NCPDP must certify that 
data submitted is not greater than twelve (12) months 
old. This is why NCPDP is requesting that pharmacies 
update their data with NCPDP, even if they believe 
nothing has recently changed. 


Once CMS is ready to enumerate, NCPDP will create 
the XML file required by CMS for submission to 
NPPES and upload (transmit) the file(s) electronically to 
NPPES. NCPDP will then receive two emails from 
NPPES. The first contains the NPPES-generated file 
name. The second indicates whether the file upload was 
successful. 


Once a file is submitted to NPPES, it is placed in a 
“queue”. This means that the file is held until the 
Enumerator is ready to have NPPES review it. Once the 
file is removed from the queue, its contents — including 
each pharmacy’s record — will be run against NPPES 
and its edits. Typically, no later than six business days 
after the file is released from the queue, NCPDP will 


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receive an email from NPPES stating that the file has 
been processed and can be downloaded by NCPDP. 


For records that successfully pass all edits and 
validations, NPIs are assigned for each pharmacy. NPIs 
will be included in a return file that NCPDP can 
download. NCPDP will then notify a pharmacy or 
pharmacy chain of its NPI(s). Some records may require 
Enumerator intervention, especially if the pharmacy is 
requesting an additional NPI(s). NPPES will make 
available to NCPDP a return file that will contain codes 
that indicate the status of each record pending with the 
Enumerator. In this scenario, the Enumerator may 
contact NCPDP for assistance in resolving discrepancies 
involving certain records. 


Pharmacy chain data will likely be submitted to NPPES 
in distinct batches to simplify the administrative 
activities surrounding enumeration and resubmission of 
rejected or pended records for the Enumerator, NCPDP 
and the chain’s contact person. 


Where Can I Find More Information? 


For more information on the pharmacy NPI, NCPDP’s 
role as an EFIO or the pharmacy industry’s timeline on 
converting to the NPI, visit the NCPDP web site at 


http://www.ncpdp.org/frame_news_npi-info.htm 


Page 16 


Continuing Education 
for Pharmacists 


Natural Products: 
Calcium to Capsicum 


J. Richard Wuest, R.Ph., 
Pharm.D. 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


and 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 

Ohio Northern University 

Ada, Ohio 


Goals. The goals of this lesson are 
to present information on the 
claims, mechanisms of action, 
typical dosages used and other 
items of interest on natural 
products and nutraceuticals 
alphabetically from calcium to 
capsicum, and to provide 
background information for 
assisting others on their proper 
selection and use. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. identify claims, mechanisms 
of action, and typical dosages for 
natural products and nutraceuticals 
presented; 

2. select from a list, the 
synonyms for these products; and 

3. describe popular uses of the 
products discussed. 


This lesson is part of a series that 
presents an overview of the common 
uses, proposed mechanisms of 
action, typical dosage regimens and 
other information of interest on 
natural products and nutraceu- 
ticals. 


Maryland Pharmacist ¢ April/May/June 2006 


Gossel 


The paramount difference 
between drugs and natural products 
was explained in the first lesson in 
this series. However, since natural 
products are a controversial topic for 
some people, the authors restate 
that the information presented is 
neither a promotion of nora 
condemnation against their use. It 
is merely an overview of what has 
been reported in both the public and 
scientific literature, and certainly 
not an in-depth treatise. 


Calcium (available as calcium 
acetate, calcium ascorbate, calcium 
aspartate, calcium carbonate, 
calcium chelate, calcium chloride, 
calcium citrate, calcium gluconate, 
calcium lactate, calcium lacto- 
gluconate, calcium phosphate, 
dicalcium phosphate, hydroxy- 
apatite, oyster shell calcium and 
tricalcium phosphate) is the most 
abundant cation in the body and 
the fifth most abundant element 
(after oxygen, nitrogen, sulfur and 
hydrogen). 

The average adult human body 
contains 21 to 25 grams of calcium 
per kilogram of fat-free tissue for a 
total of more than one kilogram of 
calcium per total body weight. Over 
90 percent of calcium is in skeletal 
tissue and teeth which serve asa 
reservoir of calcium for its continual 
function throughout the body. The 


Volume XXIII, No. 1 


remaining 10 percent is distributed 
almost equally between intracellular 
and extracellular fluids. Normal 
calcium serum values are 4.5 to 5 
mEq/liter (~10mg/dL). Of this total, 
50 percent is present as calcium ion, 
another 5 percent is complexed with 
phosphate, citrate and other anions, 
while the remaining 45 percent is 
protein-bound, awaiting use 
wherever needed. 

Vitamin D and parathyroid 
hormone are required for proper 
absorption and excretion of calcium. 
There is an intricate mechanism 
within the parathyroid gland 
whereby the body measures the 
serum calcium content. When this 
concentration is too high, it exerts a 
negative feedback control via 
calcium-sensing receptors within 
the gland, which then decreases the 
amount of calcium absorbed from 
the dietary intake. 

In addition to Vitamin D, 
phosphate ions and magnesium 
reduce the fluctuation of calcium 
from its normal concentration. 
From person to person, there are 
wide variations in calcium intake 
and excretion during a 24-hour 
period. In spite of this, in healthy 
individuals, parathyroid hormone, 
vitamin D, magnesium and 
inorganic phosphate salts assure 
that the body has enough, but not 
too much, ionized calcium available 
in the blood for its many different 
functions. 

Calcium plays many vital roles 
in a variety of physiological and 
biochemical processes within the 
human body. In addition to being 
the principle component of skeletal 
tissue and imparting the structural 
integrity of bone and teeth, calcium 
is involved in the function of nearly 
every type of cell and tissue in the 


Page 17 


Table 1 
Functions of Calcium 
in the Body 


‘blood coagulation 


-cell membrane and capillary 
permeability 


-cellular adhesiveness 


-contraction of heart, smooth and 
skeletal muscle 


‘enzyme activity 


*nervous, muscular and skeletal 
tissue function 


*renal function 
‘respiration 


-storage and release of hormones 
and neurotransmitters 


*uptake and binding of amino acids 
in cells 


body. It is essential for proper 
maintenance and functioning of the 
cardiovascular, renal, endocrine, 
central nervous, pulmonary and 
metabolic systems. Functions of 
calcium in the body are summarized 
in Table 1. 

The major food source for 
calcium is milk and other dairy 
products. Other foods with relatively 
high calcium content include 
apricots, bok choi, broccoli, cabbage, 
mustard greens, salmon, sardines 
and tofu. 

Calcium must be in a soluble 
form to be absorbed. Gastric acidity 
increases solubility, as does vitamin 
C and some amino acids. The lac- 
tose in milk forms a soluble complex 
with calcium, thus enhancing the 
value of dairy products as a food 
source. Additionally, milk is fortified 
with vitamin D which also enhances 
calcium absorption. 

A deficiency of blood calcium 
levels (hypocalcemia) is rarely due 
to an insufficient amount being 
present in dietary intake. Rather, it 
is generally caused by either 
inadequate parathyroid hormone 
production or decreased intestinal 


Page 18 


absorption of calcium. The latter is 
due to vitamin D deficiency or a 
malabsorption disease such as celiac 
disease, chronic biliary obstruction, 
chronic pancreatitis, cystic fibrosis, 
diverticulitis, enteritis or sprue. 

The most prominent symptom of 
hypocalcemia is increased neuro- 
muscular activity. This will 
eventually lead to tetany, which 
begins with numbness and tingling 
in the hands and feet followed by 
muscle spasms. These are often 
exhibited as twitching of facial 
muscles and can continue on to 
epileptic-like convulsions. With 
hypocalcemia, there are progres- 
sively worsening abnormal EKG 
readings. 

Regardless of the cause, acute 
hypocalcemia must be treated with 
intravenous infusion of calcium 
gluconate, since there is generally a 
problem with absorption that has 
resulted in the deficiency. Calcium 
chloride is rarely used for this, since 
it can be very irritating to veins 
when injected. 

Other skeletal diseases 
associated with calcium deficiency 
are rickets, osteomalacia and 
osteoporosis. Rickets is a vitamin D 
deficiency that causes a variety of 
bone deformities in children. Rickets 
in adults is called osteomalacia. The 
more common disorder in adults, 
osteoporosis, leads to easy fracturing 
of bones. 

Injectable Calcium Salts. The 
FDA-approved indications for 
calcium-containing injectables 
follow. 

1. FDA has approved calcium- 
containing injectables for treatment 
of hypocalcemia due to rapid fetal 
growth during pregnancy and in 
those conditions which require a 
prompt increase in blood plasma 
calcium levels, such as neonatal 
tetany and tetany due to para- 
thyroid deficiency, vitamin D 
deficiency and alkalosis. Other 
therapy, such as parathyroid 
hormone or vitamin D may be 
indicated according to the etiology of 
the tetany. It is also important to 
institute oral calcium therapy as 
soon as possible. 


2. They are approved for the 
treatment of magnesium 
intoxication or depression due to 
overdosage of magnesium sulfate. 

3. They are also approved to 
combat the deleterious effects of 
hyperkalemia as measured by 
electrocardiogram, pending 
correction of the increased 
potassium level in the extracellular 
fluid. 

Calcium injection may also be 
used in cardiac resuscitation when 
epinephrine injection has failed to 
strengthen myocardial contractions. 

Calcium injection has reportedly 
also been used as adjunctive therapy 
for severe insect bites or stings, to 
decrease capillary permeability in 
sensitivity reactions, to treat 
nonthrombocytopenic purpura and 
exudative dermatoses (such as 
dermatitis herpetiformis), and for 
severe itching around drug-induced 
eruptions of the skin. Calcium salts 
(usually calcium gluconate 
injection) are used as an electrolyte 
supplement in total parenteral 
nutrition (TPN) infusions. 

There are a few unapproved, but 
nonetheless medically acceptable 
(i.e., off-label), uses for injectable 
calcium including calcitriol- 
resistant rickets, rhabdomyolysis, 
cardiopulmonary bypass, hypo- 
calcemia associated with acute 
pancreatitis, and calcium channel 
blocker overdose. 

Oral calcium supplements 
are prescribed for glucocorticoid- 
induced osteoporosis, for leg cramps 
associated with pregnancy, to lower 
LDL levels in patients with 
hypercholesterolemia, to prevent the 
development of hypertension, to 
treat osteomalacia and to prevent 
and treat osteoporosis. Calcium 
carbonate is an FDA-approved OTC 
antacid, and calcium carbonate and 
calcium acetate are used as 
phosphate binders in patients with 
renal failure. 

Claims are made that oral 
calcium is useful in reducing the 
risk of colorectal cancer, treating 
diarrhea, reducing excess fluoride in 
children and treating premenstrual 
syndrome. 


Maryland Pharmacist ¢ April/May/June 2006 


Cn neers eennre eee eens eaccec ec es cca renee eeeee eee sce ee ere SE AE TEE 2 PSS 2 LSS ASAE SE ET A ST ORNL NE 


Table 2 
Daily Dietary Reference Intake 
of Elemental Calcium 


Age Dietary Intake 
1to3 500 mg 
4to8 800 mg 
9 to 18 1300 mg 
19 to 50 1000 mg 
over 50 1200 mg 
pregnant 

or lactating 

women 

under 19 1300 mg 
pregnant 

or lactating 

women 


19 andolder 1000 mg 


From a legal standpoint, oral 
calcium supplements are natural 
products for dietary supplementa- 
tion. They are not “drugs.” The 
labels for calcium-containing 
nutritional supplements are not 
controlled by FDA in the same 
manner as are nonprescription 
drugs. Manufacturers of oral 
calcium supplements, therefore, 
cannot make direct therapeutic 
claims on the label. If a therapeutic 
claim is made, by law the product is 
a drug, and requires an FDA- 
approved NDA, just like injectable 
drug products. 

Many manufacturers/ 
distributors of calcium supplements 
avoid problems by making claims in 
other media rather than on the 
actual product label. The latter will 
contain “weasel words” such as 
“clinically proven to ...;” “helps 
promote or maintain ...;” “assists 
the body in ...;” “a natural way to 
enhance ...;” “to support a healthy 
.... etc. The disclaimer “These 
statements have not been evaluated 
by the Food and Drug Administra- 
tion. This product is not intended to 
diagnose, treat, cure or prevent any 
disease.” is printed on the label and 
any promotional materials. 

The typical doses of calcium 
(measured as elemental calcium) 
used in clinical studies to prove 
effectiveness in reducing bone loss 
range from 500 to 1600 mg, divided 
into three or four doses daily. 


Maryland Pharmacist « April/May/June 2006 


The daily Dietary Reference Intake 
(DRI) amounts of elemental calcium 
are listed in Table 2. 

The two major salts used for 
calcium supplementation are the 
carbonate and citrate forms. Cal- 
cium carbonate consists of approx- 
imately 40 percent elemental cal- 
cium, which means a 1 gram dose 
contains 400 mg of elemental cal- 
cium. Calcium citrate consists of 
approximately 21 percent of elemen- 
tal calcium. This means a 1 gram 
dose of calcium citrate contains 210 
mg of elemental calcium. 

To determine a proper amount of 
either salt to obtain the DRI of 
elemental calcium, the following 
ratios can be used to calculate the 
dose: 

Calcium carbonate: 2500 mg = 
1000 mg of elemental calcium. 

Calcium citrate: 4700 mg = 
1000 mg of elemental calcium. 


Calendula (Calendula officinalis), 
also known as garden marigold, gold 
bloom, holligold, marigold, marybud 
and pot marigold, is thought to have 
originated in Egypt many centuries 
ago. It is now grown in most fertile 
parts of the planet. Legend has it 
that the plant was given its name 
because it has a tendency to bloom 
in harmony with the lunar 
calendar, every month during the 
new moon phase in the southern 
Mediterranean region. 

There are a wide variety of 
plants in the marigold family. All 
have a pungent odor and some are 
used as seasoning in food. A ref- 
erence point for familiarity of what 
calendula looks like is the yellow- 
orange round marigold flowers 
people plant in their gardens. It is 
believed that the pungent odor is an 
effective pesticide which repels 
insects. 

The flowers of calendula are used 
orally as an antispasmodic, to ini- 
tiate menses and reduce dysmenor- 
rhea, treat cancer and heal gastric 
and duodenal ulcers. It is also used 
as a gargle to treat inflammation of 
the mouth and pharynx. Topically it 
is used to promote healing of 
wounds and leg ulcers. 


Claims are made that there is 
some clinical evidence that calen- 
dula has antibacterial, antiviral and 
antitumor activity in vitro, and 
that it stimulates granulation tissue 
in wounds. In this country, these 
claims are not accepted by FDA. 

On the adverse side of the story, 
calendula can cause an allergic 
reaction in persons sensitive to 
chrysanthemums, daisies, mari- 
golds, ragweed and many other 
plants and herbs. 

When used orally, a typical dose 
for calendula is one cup of tea, three 
times a day. The tea is prepared by 
steeping 1 to 2 grams of dried flower 
in 150 mL of boiling water for five to 
10 minutes. The resulting solution 
is strained before drinking. The 
tincture (1:5 ratio in 90 percent 
alcohol) is usually taken as a 0.3 to 
1.2 mL dose three times a day. 

Calendula tea is used as a 
mouthwash. It is also applied 
topically after soaking an absorbent 
cloth in the tea and then applied as 
a poultice to the inflamed or 
wounded skin. When the tincture is 
used topically, typically 2 to 4mLis 
diluted with 0.25 to 0.5 liter of 
water. 


Capsicum (Capsicum annuum; C. 
frutescens), is also known as 
African chilies, capsaicin, cayenne 
pepper, chili pepper, goat’s pod, 
green pepper, hot pepper, 
Hungarian pepper, Louisiana sport 
pepper, Mexican pepper, paprika, 
pimento, red pepper, sweet pepper 
and tabasco pepper. The plant isa 
spreading annual shrub indigenous 
to tropical America that was 
initially described to Europeans bya 
physician who accompanied 
Christopher Columbus on one of his 
voyages to the West Indies in the 
late 1400s. The name was derived 
from the Latin word “capsa”, or box, 
which referred to the partially 
hollow, box-like shape of its fruit. 
There are several species and 
many hybrids of the group of plants 
referred to as peppers that are used 
as spices. There are two other 
familiar pepper-based species. Piper 
nigrum is the source of black and 


Page 19 


ee eee a SE ST a TS TT AS A SE LE SRP eS SS SSE? SGA I SS SO IE EC SS 


white pepper that accompanies salt 
on the dining table. Bell peppers 
(green, orange, red and yellow) 
constitute the species used in salads 
and to spice up meals. These three 
types of peppers are the most widely 
consumed spices in the world. 

This section focuses on 
capsicum, preparations of which 
have been used for centuries. Native 
Americans, calling the plant 
cayenne, ingested it for antispas- 
modic, aphrodisiac, carminative, 
digestive aid and purgative (bowel 
cleansing) properties. They also 
used it topically as a counterirritant 
to relieve itching and muscle pain. 

Today in folk medicine, people 
take capsicum orally as an anti- 
flatulent; for colic, cramps, and 
diarrhea; to reduce blood cholesterol 
and clotting; to increase peripheral 
circulation; to treat motion sick- 
ness, alcoholism, and fever; and to 
prevent arteriosclerosis and heart 
disease. 

Capsaicin, a component of 
capsicum oleoresin, has attained 
FDA approval as a safe and effective 
drug for nonprescription use. It has 
a chemical structure similar to 
eugenol, which is the active prin- 
ciple of oil of cloves, and has proven 
local analgesic activity. In the U.S., 
topical creams, gels and lotions 
contain capsaicin in strengths of 
0.025 and 0.075 percent. They are 
approved for OTC sale for temporary 
relief of pain from rheumatoid 
arthritis and relief of neuralgias 
such as pain following shingles 
(herpes zoster) or painful diabetic 
neuropathies. They are also used for 
HIV-associated peripheral neuro- 
pathies, post-herpetic flareups and 
for trigeminal neuropathies. Capsin, 
Pain-X and Zostrix are among the 
commercially available products. 

In homeopathic medicine, 
capsicum is used for inflammation 
of the urinary tract, gastrointestinal 
tract, mouth and throat. It is also 
used for middle ear infections. 

The mechanism of action for 
capsaicin is proposed to be stimu- 
lation of release of substance P (a 
mediator of pain) in nerve endings 
to eventual depletion. When 


Page 20 


adjoining neurons take in this 
substance, they fire and transmit 
impulses along the CNS to the brain 
which perceives the sensation as 
itching in low levels of stimulation 
and pain in higher levels. 

When first applied, capsaicin 
produces sensations ranging from 
warming to burning. However, after 
repeated application, substance P is 
depleted in that area. This reduces 
the ability of the affected neurons to 
transmit impulses, thus alleviating 
pain and itching. It may take as 
long as three days for full 
therapeutic effects to occur. 

Proof of therapeutic effects for 
capsicum or any of its components 
when taken orally is lacking at this 
point in time. However, its irritant 
effects are the basis for its use in 
many of the self-defense products 
(pepper sprays) on the market. 

Capsicum can induce adverse 
reactions when taken orally. It can 
cause gastric irritation, sweating 
and flushing of the face and neck, 
and increased tearing and runny 
nose. Excessive ingestion of 
capsicum has reportedly resulted in 
gastrointestinal, liver and kidney 
damage. 

The most well-known adverse 
effect of capsicum is undoubtedly 
the intolerable burning sensation 
that follows contact with mucous 
membranes. In fact, this is the 
reasoning behind its use in self- 
defense products. When sprayed into 
the eyes, it causes immediate 
blindness and irritation that can 
last up to 30 minutes, without 
permanent damage. 

On the self-medication side of the 
picture, it is imperative that those 
who apply capsaicin-containing 
products wash and dry their hands 
thoroughly after each application. 
They must avoid accidental 
touching of their own eyes, mouth, 
nasal passages and other mucous 
membranes and transitional skin 
(i.e., ips, nipples, external genitals), 
as well as those of other persons. 

If such contact does occur, the 
area should be thoroughly flushed 
with lots of water. There are 
anecdotal, but not scientifically 


proven, reports that the use of milk 
to flush the irritated mucous 
membranes is beneficial. 

Allergic reaction to capsicum 
and its components has been 
reported in persons sensitive to 
anise, avocados, bananas, bell 
peppers, birch pollen, black and 
green peppercorns, celery, 
chestnuts, coriander, cumin, fennel 
and kiwi. 

In folk medicine, typical oral 
doses of capsicum are 30 to 120 mg 
of dried capsicum fruit, 0.6 to 2 mg 
of capsicum oleoresin or 0.3 to 1 mL 
of capsicum tincture. The usual 
frequency of these doses is three 
times a day. 

For topical use, the approved 
labeling of capsaicin-containing 
OTC products (0.025 and 0.075 
percent) states that they can be 
applied to affected areas a 
maximum of three to four times a 
day. 


Maryland Pharmacist ¢ April/May/June 2006 


Continuing Education Quiz 


This month’s questions are taken from the article on “Natural Products: Calcium to Capsicum”. Circle your answers to the following questions 
and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 21201-1572. There is no charge for this quiz for 
MPhA members (non-members $ 10.00). The completed quiz for this issue must be received by 1/15/08. A continuing education certificate 
for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to eight weeks. Please type or print clearly. 


ACPE# 129-144-05-001-H01. 


Name 

Address 

City, State, Zip 
Daytime Phone 


Date Completed 
(Required) 


1. Which of the following is the most abundant 


cation in the body? 
a. Calcium c. Potassium 
b. Iron d. Sodium 


2. Which of the following vitamins is required for 
proper absorption and excretion of calcium? 

a. Vitamin A c. Vitamin C 

b. Vitamin B d. Vitamin D 


3. Which of the following hormones assures that the 
body has sufficient ionized calcium available in the 
blood? 

a. Cortisol 

b. Insulin 

c. Parathyroid 

d. Somatropin 


4. The most prominent symptom of hypocalcemia is: 


a. decreased neuromuscular activity. 
b. increased neuromuscular activity. 


5. The calcium salt that is usually used as an 
electrolyte supplement in total parenteral nutrition 
(TPN) infusions is: 

a. calcium acetate. 

b. calcium citrate. 

c. calcium gluconate. 

d. calcium lactate. 


6. The calcium salt that contains the highest 
percentage of elemental calcium per 1 gram dose is: 
a. calcium carbonate. 
b. calcium citrate. 


Maryland Pharmacist ¢ April/May/June 2006 


The Maryland Pharmacy Continuing 
Education Coordinating Council is 
accredited by the Accreditation Council for 


Pharmacy Education as a provider of 
continuing education for pharmacists. 


7. Calendula is a member of which of the following 
families of plants. 

a. Carnation 

b. Hollyhock 

GC, Lally 

d. Marigold 


8. The flowers of calendula are used for all of the 
following EXCEPT: 

a. as an antispasmodic. 

b. to alleviate acne vulgaris. 

c. to reduce dysmenorrhea. 

d. to treat inflammation of the mouth. 


9. Capsicum is also known by all of the following 
names EXCEPT: 

a. bell pepper. 

b. cayenne pepper. 

c. paprika. 

d. pimento. 


10. Which of the following has attained FDA ap- 
proval as a safe and effective drug for nonprescrip- 
tion use? 

a. Calendula 

b. Calcium lactate 

c. Capsaicin 


Page 21 


Maryland Pharmacists 
Duty to Report 


Code of Maryland regulations 
10.34.10.05. Duty to Report. 
A. Except when the conduct in question includes drug or alcohol 
abuse or dependency, a pharmacist shall report to the Board: 
(1) Conduct which violates a statute or regulation pertaining to the 


practice of pharmacy; 

(2) Conduct by a pharmacist that deceives, defrauds, or harms the 
public; and 

(3) The unauthorized practice of pharmacy. 

B. A pharmacist shall report to the pharmacist rehabilitation 
committee, as defined in Health Occupations Article, § 12-317, 
Annotated Code of Maryland, conduct by a pharmacist that 
involves drug or alcohol abuse or dependency. 


Practically speaking this means: 


1) If you are aware of a fellow pharmacist who is impaired by drugs or 
alcohol you have a legal obligation to report it, 

2) The mechanism for reporting is the Pharmacists’ Education and 
Assistance Committee (PEAC), 

3) The Board of Pharmacy can sanction you if they become aware that 
you could have but did not report such a case. 


Simply, you have an easy, anonymous way to protect yourself, your fellow 
pharmacist and the public by making a referral to PEAC. Failure to report 
such a case violates Maryland Pharmacy Regulations and could adversely 
affect your own ability to practice pharmacy. 


To make a referral or to learn how PEAC provides 

confidential help to an impaired pharmacist contact: 

Pharmacists’ Education and Assistance Committee 

Phone (410) 983-0302 or (410) 706-7513 armacists 
E-mail PEAC@direcway.com Asabatance 
Website www.peacmaryland.org ie iis 


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Maryland Pharmacist ¢ April/May/June 2006 Page 23 


Merck Pharmacist Achievement Award 


features a bronze medallion depicting a replica 
of the actual mortar and pestle thought to 
have been used by Charles E. Dohme 
while he was serving his apprenticeship. 


Paula Bailey Hinson, DPh 

Tennessee Pharmacists Association 
A.D. “Sonny” Borja-Barton, PharmD, MBA 
Hawaii Pharmacists Association 

Cynthia J. Boyle, PharmD 

Maryland Pharmacists Association 
Glenn R. Boyles, RPh 

Florida Pharmacy Association 

Randall Brooks, RPh 

Louisiana Pharmacists Association 
Donna Marie Cestone, RPh 

New Jersey Pharmacists Association 
Andrew J. Charter, RPh 

Oregon State Pharmacy Association 
Gail Deyle, RPh 

Nebraska Pharmacists Association 
Maria Diaz-Olmo, RPh 

Colegio e Farmaceuticos de Puerto Rico 
Michel B. Disco, RPh 

New Mexico Pharmaceutical Association 
Mark Dodson, DPh 

Oklahoma Pharmacists Association 
Michael J. Donohue, RPh, FACA 
Washington State Pharmacy Association 
Dale E. English Il, RPh 

Ohio Society of Health-System Pharmacists 
Jeanne R. Ezell, DPh, MS 

Tennessee Society of Hospital Pharmacists 
Debra Farver, PharmD 

South Dakota Society of Health-System 
Pharmacists 


Recognizing 
Excellence 


Each day, a handful of pharmacists give of their time and expertise 


in service to their colleagues and their professional associations. 


For almost 20 years, Merck & Co., Inc., has helped to say “thank 


you” for that commitment and leadership through the Merck 


Pharmacist Achievement Award. 


In 2005, these outstanding pharmacists were recognized for their 


significant professional achievements by their peers. 


William J. Fitzgerald, RPh, Dean 
Montana Pharmacy Association 

Billy D. Gammel, PD 

Arkansas Pharmacists Association 
Christopher R. Gauthier, RPh 

Maine Pharmacy Association 

Steven Gray, PharmD, JD 

California Pharmacists Association 
Benjamin J. Gruda, RPh 

Pharmacists Society of the State of New York 
Matt Hartwig, RPh 

Missouri Pharmacy Association 

Eddie Klein, RPh 

Texas Pharmacy Association 

Eric M. Lambert, RPh 

West Virginia Pharmacists Association 
Heather A. Larch, RPh 

Rhode Island Pharmacists Association 
Kathleen T. Lebeau, RPh 

Minnesota Pharmacists Association 
William X. Malloy, PharmD 

Indiana Pharmacists Alliance 
Jonathan G. Marquess, PharmD, CDE, CDM 
Georgia Pharmacy Association 

Sophie Mcintyre, PharmD 
Massachusetts Pharmacists Association 
Julie Meintsma, RPh 

South Dakota Pharmacists Association 
Mark Munger, PharmD 

Utah Pharmaceutical Association 
Matthew Osterhaus, RPh 

lowa Pharmacy Association 


€} MERCK © 2006 Merck & Co., Inc. All rights reserved. 20650319(1)-PHA 


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Robert Pickle, Jr, RPh 

Mississippi Pharmacists Association 
Kerry A. Prickett, RPh 

Alabama Pharmacy Association 
Timothy W. Robertson, RPh 

Virginia Pharmacists Association 
Michae! J. Sanborn, RPh 

Michigan Pharmacists Association 
Bruce S. Sigman, RPh 
Pennsylvania Pharmacists Association 
Marilyn Silcock, PharmD 

Idaho State Board of Pharmacy 
Marc Sweeney, RPh, PharmD 

Ohio Pharmacists Association 

Joel C. Thornbury, RPh 

Kentucky Pharmacists Association 
Davie Waggett, RPh 

North Carolina Association of Pharmacists 
Dean Winsch, PharmD 

Wyoming Pharmacy Association 
Jerome W. Wohleb, PharmD 
Arizona Pharmacy Alliance 

Mark A. Zwaska, RPh, MS 
Pharmacy Society of Wisconsin 


merck.com 


[ 


VOLUME 82 No. 3 


President’s Address iilerui ebay Ae 


“Virginia Apyar, PD.” 


a apnitaslas 
© Siepteestt) . ; 


The Maryland P3 Project 


“The Program” 


Therapeutically Speaking... 
“Lyrica®: Just Another “Me Too” for 
Neuropathic Pain” 


Continuing Education 
“A New Era in the Management of 
Diabetes: Inhaled Insulin” 


AA DWI AAIPAY DLIADAAA COICO TC A CaSKRCLA TICAVAL__. 


Phot nealseniy 3 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 
410-727-0746 
www.marylandpharmacist.org 


MPhA Officers 2006 - 2007 MPhA Trustees 


Ginger Apyar, P.D., Pharm.D., President Matthew Shimoda, Pharm.D., Chairperson 
Joe Marrocco, P.D., First-Vice President Michelle Andoll? P:D.2 J D222 ss) eee 
Walter Abel, P.D., Treasurer Butch Henderson. ik ie.) eee eee 
Joe Fine, R.Ph., Honorary President Mary Kremzner, Pharm.D. 
Neil Leikach Pi Ditet = ay ee 
Magaly Rodriguez deBittner, Pharm.D. ... 


House Officers David Russo, R.Ph 
Carol Stevenson, Pharm.D. 


Barry Poole, R.Ph., Speaker Doris Voigt; Bnarmi Dewees eens 2008 
Ruth Blatt, P.D., Vice-Speaker Walter Fasch, President ASP 


Ex-Officio Members 
MPhA Staff David Knapp, Ph.D., Dean - 


UMB School of Pharmacy 


Howard Schiff, P.D., Executive Director Larry Siegel, Pharm.D. - MSHP Representative 


Elsie Prince, Office Manager 
Nancy Ruskey, Administrative Assistant 


Maryland State Board of Pharmacy 


John Balch, P.D., President Mayer Handelman, P.D. 

Mark Levi, P.D., Treasurer Mike Souranis, P.D. 

Jeanne Furman, P.D., Secretary Donald Taylor, P.D. 

Margie A. Bonnett Rodney Taylor, Pharm.D. 
Joseph A. DeMino, P.D. Cynthia Anderson, M.S., R.Ph. 
David R. Chason, R.Ph. 

Alland Leandre, M.S., M.B.A. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


presi ChieStACClGSSmmemeinrs: itera) can eeEs yet me 2 eM oe Be teas ts e) 
Virginia Apyar, P.D. 


TREKS RSH RULE Tah TPAST LPAMG) (S101 8 cee Ree Pee ean” Aig ee ena ee te eek or ere Cee 6 
The Program 


Boe TGBULL Cal cl W Me mean rete ce ees ee od nn ea eee alas ee er dee 9 
“Combat Methamphetamine Epidemic Act:: What this Act Means for your Retail Setting” 


iherapeuticallyspeakinge ay eae eee. Oe Pe. eee ee teeter: Ast 
“Lyrica®: Just Another “Me Too” for Neuropathic Pain?” 


TONEY eG A ET PL en en ins a; 14 
“Camphor' 
OUeINUINPAROUGGLION Mcnt enone oe ge, ink i ah 15 


“A New Era in the Management of Diabetes: Inhaled Insulin” 


Advertiser’s Index 


VIBO Gato L OC eNeLWOLK ALC samme nenmnen rere MN Pe ek a cyte are 13 
VieKeSSOn meine hartsctaes 6 og hel ak Boren werte ne ene. Mth iy eek 4 
EMUUNAGVAVVAlILCC Ett lets eee eee ii ses te «ee MI ell) 8 
Bieta cists MuULUd| GOMIDANICS@. Maki awe AMROMEEOT oe 4 


Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 
650 West Lombard Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals 
postage paid at Baltimore, MD and at additional mailing office. Articles and editorials that appear do not necessarily reflect 
the official positions of the Maryland Pharmacists Association and may contain views and opinions for which the authors 
hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West Lombard Street, 
Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


Is your pharmacy running you? 


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to win in the marketplace. 


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personal and business goals with: 


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we can help you run your business better. Call today! 
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MCKESSON 


Empowering Healthcare 


President’s Address 


As I assume the duties as your 122" President of the Maryland 
Pharmacists Association, I think back on how I became involved in 
MPhA. I was the pharmacist-in-charge for a chain that had a store on 
94” St. at the Ocean Plaza Mall in Ocean City. The Roche salesman 
came in one day to introduce himself and I asked him about the state 
association. He was a wealth of information. Soon after that I was 
invited to an Eastern Shore Pharmaceutical Society meeting and then 
became a member of MPhA. That was back in 1985. 


In preparation for my year as 
president our Executive Director 
had me attend the Sanofi-Aventis 
Pharmaceuticals Pharmacy 
Leadership Conference in Denver, 
CO. There I was able to meet 
president-elects from other states 
and found out that we share the 
same challenges and problems. 
What amazed me was, while the 
challenges and problems were 
mutual, MPhA was in a much 
better situation to over come and 
work through the problems facing 
the practice of pharmacy. 
Pharmacy always seems to be in 
an environment that is in a 
constant state of flux. Currently, 
we can see forward movement 
with medication therapy 
management services as a 
defining goal. Howard and I 
attended the 36th Annual 
Southeastern Pharmacy Officers 
Conference held in Charleston, 
SC. The topics that were 
discussed at the conference table 
were not all limited to 
reimbursement issues. Quality 
and medication errors, 
compounding, conscience clause, 
importation, DOD mandatory 
mail, the federal government 
regulating pharmacy thus 
eliminating the need for boards, 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 


the national cost of dispensing 
study to mention a few. 


Our Past-Presidents and Board 

of Trustees over the last few 
years have revamped our 
Association through By-Laws 
changes and our Board structure. 
The changes they have 
implemented are too many to list, 
from a new logo to the strength of 
the Maryland Pharmacy 
Coalition. All of these endeavors 
have advanced our association. 
By doing such a terrific job in the 
past this year we can fully 
concentrate on the legislative 
issues coming to the General 
Assembly and the P-3 Project. 
Success of the P-3 Project will 
define the practice of pharmacy in 
Maryland. 


A colleague phoned me to 
congratulate me on my new 
office. He said he used to be a 
member of MPhA. When I asked 
him why he let his membership 
lapse he said he didn’t get 
anything out of being a member. 
My response was, the return on 
your investment as a member 
depends on the energy you put 
forth. Our Newsletter gets rave 
reviews on keeping the 
membership informed. To some, 


Virginia Apyar, P.D., President 


that is the value for them in 
membership. To truly experience 
the value of an association at 
some point in time participation at 
our two yearly meetings, being 
involved on a committee or 
attending the Board of Trustees 
meeting makes one a major 
stakeholder in the momentum of 
the Association. In my first 
candidate statement when I ran for 
a Trustee seat, I closed saying if 
elected I hoped to exceed the 
member’s expectations of the 
Association. | still feel the same, 
and with our Chairman of the 
Board Matthew Shimoda and 
Vice-President Joseph Marrocco, I 
know MPhA will continue to 
grow and exceed the member’s 
expectations. It is an honor and 
privilege to serve as your 
President. 


Yours truly, 


Ginger 


Page 5 


The Maryland P3 Program 


PATIENTS 
PHARMACISTS 
PARTNERSHIPS 


Program Description 

The Maryland P3 Program (Patients, Pharmacists, Partnerships) is designed to apply a proven 
healthcare model that improves the quality of care and reduces overall health care costs. The first 
target group consists of patients with diabetes in Allegany County, Maryland. With success, the program 
will expand throughout Maryland. 


The Maryland P3 Program replicates the highly successful Asheville Project. This program provides 
participating employers with the support and tools to link employees, retirees, and their dependents, as 
well as Maryland Medical Assistance patients enrolled in Maryland Physicians Care with community 
pharmacists to help them manage their diabetes. Regular patient visits and active communication with 
the participant’s physician and other health care providers assures good outcomes. A distinctive 
program component is a diabetes credential that the patient can earn through program participation 
that acknowledges the participant is capable of self-managing their condition. 


Success of the Model 


The model that will be utilized in this program APhA Foundation’s Patient Self-Management 
aligns incentives that encourage collaboration Program has resulted in’: 

among health care stakeholders to provide e A savings of approximately $918 per 
patients with a service that will teach them how employee in total health care costs for 
to better self-manage their diabetes and improve the initial year, with an even greater 
their overall health, which in return reduces savings in subsequent years 

overall medical costs. Aligned economic e Return on investment (ROJ) of at least 
incentives begin with the employer or public 4:1 beginning in the second year 
payer who provides an incentive to patients, e A 50% reduction in absenteeism and 
such as waived co-payments for diabetes-related fewer worker compensation claims 
medications or gift certificates. The program e High employee satisfaction — 95% 
also provides payment to the pharmacists for approval for pharmacist care — and 
providing education and diabetes care improved quality of life 


management. The employer or public payer 
will receive a return on investment as a result of 
healthier workers, decreased absenteeism and a 
decrease in overall health care costs. 


e Employees savings an of average $400- 
$600 per year through incentives 


Page 6 Maryland Pharmacist ¢ July/Aug./Sept. 2006 


Patient Self-Management ProgramS™ 
for Diabetes: First Year Cost Savings 


Average Cost Per Patient 


$10,000 
$8,000 
$6,000 
$4,000 
$2,000 : Average 
$0 : - Cost 
Savings 
mm MTMS OMY) |: Gee Pepper! 4 SOM a WTS ARCS x] er) A7rty Pes (S351 6 WW CORE |) Per 
lmMedication| == 83,128 CT C‘S7ZCCCCC*C*“‘é#z‘L WRPpatienntt 
jmimedical! | Wt w iw itt se2senw Siw it ef Tw SN saraoe TT) ggag 


Align the Incentives, Empower the Patient, Control the Costss” 


Collaborating Partners 
The Maryland Pharmacists Association will 


serve as the coordinator of the network of 
participating pharmacists. The University 
Maryland School of Pharmacy will provide 
educational program development, pharmacist 
training, and analysis of outcome data. The 
Department of Health and Mental Hygiene will 
also receive data for program evaluation. 
Maryland Physicians Care and self-insured 
employers in Allegany County will make the 
program available on a voluntary basis to their 
beneficiaries with diabetes. Technical advice 
and implementation materials will be provided 
by the American Pharmacist Association 
Foundation, which is a non-profit organization 
whose mission is to improve the quality of 
patient health outcomes that can be affected by 
pharmacy. This program is a result of a 
collaboration of the Maryland General 
Assembly, Department of Health and Mental 
Hygiene, University of Maryland, School of 
Pharmacy, Maryland Pharmacists Association, 
and Maryland Pharmacists. 


If you would like more information about the 
Maryland P3 Program please contact Dr. 
Christine Lee by email at 


clee@rx.umaryland.edu. 


'Cranor CW, Bunting BA, Christensen DB. The 
Asheville Project: Long-Term Clinical and 
Economic Outcomes of a Community Pharmacy 
Diabetes Care Program. J Am Pharm Assoc. 
2003; 43:173-84 

*Garrett DG, Blum] BM. Patient Self- 
Management Program for Diabetes: First-Year 
Clinical, Humanistic, and Economic Outcomes. 
J Am Pharm Assoc. 2005; 45:130-137 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 Page 7 


Pharmacy Wanted 


Excellent Ooportunity * High Income Potential 
Rated To Be A Golden Opportunity 


Pharmacy to be located within an established Retail Business 
looking to satisty the needs of their customers ey adding a 
Pharmacy to their establishment. The customer base Is a mix 
of upscale, aging empty nesters and young families looking 
to establish themselves. 


« Strong, Friendly Personality A Must 
' Old Fashioned Charm & Common Sense Required | 


Sublease space from existing business. 
Rent Is negotiable down to zero. 


Please E-mail your interest or resume to: 
pharmacywanted@hotmail.com 


Serious inquires only please 


PHARMACY MARKETING GROUP, INC 


AND THE LAW 


By Kerianne M. Hanson & Don R. McGuire, Jr., R.Ph., J.D. 


This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and 
your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to 
providing quality products and services to the pharmacy community. 


COMBAT METHAMPHETAMINE EPIDEMIC ACT: 
WHAT THIS ACT MEANS FOR YOUR RETAIL SETTING 


On March 9", 2006, President Bush signed the 
Patriot Act, which includes a portion known as 
the Combat Methamphetamine Epidemic Act of 
2005.' In light of this law, the sale of 
pseudoephedrine-containing products across the 
nation is set up for big changes, and the 
responsibility of enforcing these changes has 
landed on the shoulders of licensed pharmacists 
in retail settings. 


Pseudoephedrine is a decongestant found in 
multiple products used to treat symptoms 
associated with the common cold and seasonal 
allergies.” It is also the primary ingredient 
needed to manufacture methamphetamine, an 
illicit drug that has rapidly gained popularity in 
the U.S. over the past few years. The new 
regulations regarding the sale of 
pseudoephedrine are intended to curb the 
manufacturing of methamphetamine by making 
it more difficult to accumulate large amounts of 
pseudoephedrine and by keeping a record of all 
pseudoephedrine purchases. 


" Legal Requirements for the Sale and Purchase of Drug 
Products Containing Pseudoephedrine, Ephedrine, and 
Phenylpropanolamine. U.S. Food and Drug Administration. 
Accessed May 24, 2006. 
www.fda.gov/cder/news/methamphetamine.htm. 


* Lexi-Comp’s Drug Information Handbook. 13" ed. 
Hudson, OH: APhA; 2005:1275-76. 


The Combat Methamphetamine Epidemic Act 
categorizes pseudoephedrine as a controlled 
substances and regulates, among other factors, 
the amount of pseudoephedrine sold to 
individuals. Although some states, particularly 
in the Midwest, have been regulating the sale of 
pseudoephedrine for over a year now, the 
Combat Methamphetamine Epidemic Act makes 
the regulations federal law. Beginning 
September 30, 2006, patients everywhere in the 
nation will need to visit a pharmacy in order to 
purchase pseudoephedrine-containing products. 


It is important to keep in mind that some of the 
specific regulations, such as who in the 
pharmacy is allowed to sell the products (i.e. 
pharmacists only, technicians, interns, etc.) and 
the number of boxes which can be sold in a 
single transaction, have been left up to the 
individual states. Pharmacists should check 
with their State Board of Pharmacy to ensure 
they are aware of state-specific regulations and 
train their pharmacy staff accordingly. 


Some of the federal regulations regarding the 
sale of pseudoephedrine-containing products 
according to the Combat Methamphetamine 
Epidemic Act are summarized below: 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 Page 9 


e All pseudoephedrine-containing 
products must be kept behind the 
counter. 

e An individual may purchase no 
more than 3.6 grams of 
pseudoephedrine in one day. 

e An individual may purchase no 
more than 7.5 grams of 
pseudoephedrine in any 30-day 
period. 

e The purchaser must present a State 
or Federal Government issued photo 
identification card at the time of 
purchase. 

e Either a written or electronic 
logbook of all pseudoephedrine 
transactions must be kept by the 
pharmacy for a period not less than 
two years from the date of purchase. 

e For each sale, information including 
the name and address of the 
purchaser, the name of the product, 
the quantity purchased, and the date 
and time of the transaction must be 
collected and entered into the 
logbook. Many states will also 
require additional information be 
collected, such as the purchaser’s 
birthday or a driver’s license 
number. 

e Products packaged for individual 
sale that contain less than 60 
milligrams of pseudoephedrine are 
exempt from the logbook 
requirements but must also be kept 
behind the counter. 

e The pharmacist must confirm the 
information provided by the 
purchaser matches that provided on 
the identification card. 

e The purchaser must provide a 
signature verifying the information 
provided is correct. 


* The Library of Congress. Title Vil: Combat 
Methamphetamine Epidemic Act of 2005. House Report 
109-333. Accessed May 24, 2006. 
http://thomas.loc.gov/cgi- 


bin/cpquery/?&dbname=cp109&sid=cp109djs6R&refer= 


&r_n=hr333.109&item=&sel=TOC 358801&> 


Page 10 


In response to the new regulations, and in an 
effort to further hinder methamphetamine 
production, many product manufacturers have 
voluntarily re-formulated their products to 
contain alternative decongestants such as 
Phenylephrine. These products, commonly 
identified by the letters PE (ex. Sudafed” PE), 
may offer alternatives to patients who need 
decongestant products on a daily basis. It is also 
important to recognize that the majority of the 
regulations established by the Combat 
Methamphetamine Epidemic Act do not apply to 
prescription products containing 
pseudoephedrine, but these products will be 
classified as controlled substances, and 
regulations set forth by the Controlled 
Substance Act 1970 are now applicable. 


Complete information regarding the Combat 
Methamphetamine Epidemic Act and the 
regulations it sets forth are available on the 
Food and Drug Administration’s website 
(www.fda.gov) and from each individual state’s 
Board of Pharmacy. 


© Kerianne M. Hanson and Don R. McGuire. 
Kerrianne M. Hanson is a Pharm.D/MBA 
Candidate at the Drake University College of 
Pharmacy in Des Moines, Iowa. Don R. 
McGuire Jr., R.Ph., J.D. is Assistant General 
Counsel, at Pharmacists Mutual Insurance 
Company. 


This article discusses general principles of law 
and risk management. It is not intended as legal 
advice. Pharmacists should consult their own 
attorneys and insurance companies for specific 
advice. Pharmacists should be familiar with 
policies and procedures of their employers and 
insurance companies, and act accordingly. 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 


Therapeutically Speaking... 


Lyrica”: Just Another “Me Too” for Neuropathic Pain? 


Laura Scarpaci, Pharm.D. 


Palliative Care Resident, University of Maryland School of Pharmacy 
Edited by Mary Lynn McPherson, Pharm.D., BCPS, Professor, University of Maryland School of Pharmacy 


Approved in 2005 by the FDA, Lyrica® (pregabalin) is one of several agents recently added to our analgesic 


armamentarium. In addition to being approved as adjunctive therapy for patients with partial onset seizures, it is also 


indicated to treat painful diabetic peripheral neuropathy and postherpetic neuralgia.’ Pregabalin has been described as 


being just another “me too” drug or “son of gabapentin.” It is true that pregabalin and gabapentin share a number of 


similarities including chemical structure, mechanism of action, and therapeutic utility, but are there any distinctions that 


warrant recommending pregabalin over gabapentin? 


Neuropathic pain may be experienced by patients 
with a variety of disease states, including diabetes 
mellitus, herpes zoster or shingles, HIV, and cancer 
among others. Of the 14 million people diagnosed with 
diabetes in the United States, between 20-24% suffer 
from peripheral neuropathy.” Furthermore, between 15- 
48% of patients with a herpes zoster outbreak develop 
neuropathic pain with higher prevalence in older adults.° 
Patients with neuropathic pain incur on average three 
times greater annual health care costs than those without 
neuropathic pain. Additionally, painful neuropathy has 
been associated with decreased quality of life due to 
fatigue, depression, interference with interpersonal 
relationships and activities of daily living.’ 

Neuropathic pain is a consequence of nerve 
damage; patients typically describe such pain as electric, 
tingling, shooting, or burning in quality. Patients 
suffering from neuropathic pain may also complain of a 
pain in response to a normally non-noxious stimulus 
such as the touch from a bed sheet (allodynia) or an 
exaggerated painful response to a normally noxious 
stimulus, such as a hot shower feeling like scalding 
water (hyperalgesia). Medications such as the tricyclic 
antidepressants, anticonvulsants, opioids, capsaicin, and 
lidocaine have been traditionally employed to manage 
neuropathic pain. Recently two new medications have 
been approved for the management of neuropathic pain: 
Cymbalta® (duloxetine), the first non-tricyclic 
antidepressant with an indication for neuropathic pain, 
and Lyrica® (pregabalin). 

Pregabalin is classified as a gamma-aminobutyric 
acid (GABA) analog, similar to gabapentin 
(Neurontin®). Although its exact mechanism of action is 
still unknown, pregabalin, like gabapentin, appears to 
bind selectively with high affinity to the alpha,-delta 
subunit of voltage-gated calcium channels in central 
nervous system tissues.’ Jn vitro studies suggest binding 
at this site reduces calcium influx into hyperexcited 
neuron terminals, which subsequently lowers the release 


of several neurotransmitters (i.e. glutamate, 
norepinephrine, and substance P). It does not seem to 
have direct GABA-mimetic effects nor bind directly to 
GABA or benzodiazepine receptors. 

In a study by Sabatowski et al. examining post 
herpetic neuralgia (PHN), 238 patients were randomized 
in a multi-center, double-blind, placebo controlled trial 
and received either 150 mg/day (n = 81) or 300 mg / day 
(n = 76) of pregabalin, or placebo (n = 81).° Exclusion 
criteria included failure to respond to previous treatment 
for PHN with gabapentin > 1200 mg/day. Significant 
improvement in mean pain scores was noted in the 150 
mg and 300 mg/day pregabalin groups in comparison to 
placebo (-1.20, p<0.0002; -1.57, p<0.0001, 
respectively). Improvement in comparison to placebo 
occurred as early as | week and remained significant 
throughout the study for both treatment groups. There 
were more responders among the intent to treat 
population in the 150 (26%, p=0.006) and 300 mg/day 
(28%, p=0.003) pregabalin groups than in the placebo 
group (10%). Pregabalin also significantly improved 
mean sleep-interference score among the intent to treat 
population. 

A study by Rosenstock et al. enrolled 146 patients 
in a multi-center, double-blind, placebo-controlled, 
parallel group, 8 week trial examining the efficacy of 
pregabalin in the treatment of painful diabetic peripheral 
neuropathy.” Patients were randomized to receive 
pregabalin 300mg/day (n=76) or placebo (n=70). 
Exclusion criteria included failure to respond to 
treatment with gabapentin = 1200 mg/day. The mean 
pain score decreased significantly for pregabalin 300 
mg/day (baseline, 6.5; endpoint 4.0) in comparison to 
placebo (baseline 6.1; endpoint, 5.3; P=0.0001), 
beginning during the first week and continuing through 
week 8. Pregabalin also demonstrated a statistically 
significant improvement in the mean sleep interference 
score in comparison to placebo. 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 Page 11 


So what allows pregabalin to stand apart from 
gabapentin? There are some fine pharmacological 
differences between the two agents. The oral 
bioavailability of pregabalin and time to onset of 
decreased pain is better in comparison to gabapentin 
(table 1). Unfortunately, at this time, there are no direct 
head-to-head trials comparing pregabalin to gabapentin 
in the treatment of neuropathic pain conditions. 

There are no significant drug interactions associated 
with pregabalin use, however, concurrent administration 
of opioids, benzodiazepines, or ethanol may increase the 
risk of somnolence and dizziness.’ Pregabalin is not 
protein bound, undergoes negligible metabolism, and is 
eliminated primarily unchanged by renal excretion, with 
an elimination half-life of 6.3 hours. Pregabalin 
clearance is decreased in patients with renal impairment 
and hemodialysis removes pregabalin from the serum, 
necessitating dosage adjustments. The pharmacokinetics 
of pregabalin has not been adequately studied in 
pediatric patients. 

Pregabalin is contraindicated in patients with 
known hypersensitivity to pregabalin or any of its 
components.’ If it is to be discontinued, pregabalin 
should be withdrawn gradually over a minimum of | 
week to minimize the potential of increased seizure 
frequency in patients with seizure disorders. The most 
common adverse effects associated with pregabalin 
include dizziness, somnolence, dry mouth, edema, 
blurred vision, weight gain, and “thinking abnormal.” 


Table 1 — Comparison of Pregabalin and Gabapentin 
Pregabalin 


Indications peripheral neuropathy (DPN) and post- 
herpetic neuralgia (PHN) 

Pharmacokinetic profile Linear 
Plasma concentration is proportional to 
dose 

Oral bioavailability >90% of dose 


(No food effect and dose proportional) 


Time to effective dose (PHN) 1 day 


Effective starting dose of 150 mg/d 


~ Neuropathic pain associated with diabetic 


Dosing for neuropathic pain associated with 
diabetic peripheral neuropathy and post-herpetic 
neuralgia is as follows: initial dose 50 mg three times a 
day (150 mg/day) in patients with creatinine clearance > 
60 mL/min. Dose may be increased to 100 mg three 
times a day (300 mg/day) within 1 week based on 
efficacy and tolerability. No evidence supports increased 
efficacy above dosages of 300 mg/day in patients with 
peripheral diabetic neuropathy, however patients with 
post-herpetic neuralgia may be increased to 600 mg/day 
if they are tolerating pregabalin and remain symptomatic 
after 2-4 weeks of treatment. Table 2 describes the 
necessary dosage adjustment for patients with renal 
impairment or who are receiving hemodialysis.’ 

In conclusion, is pregabalin just another “me too” 


drug? Pregabalin has several advantages in comparison 
to gabapentin, including linear pharmacokinetics, 
improved oral bioavailability, and time to effective dose, 
however there is a paucity of head-to-head data 
comparing pregabalin to other agents. Pregabalin is 
clearly efficacious in the management of neuropathic 
pain associated with postherpetic neuralgia and diabetic 
peripheral neuropathy, however, it remains to be seen 
whether this medication is superior to gabapentin or 
other agents, such as tricyclic antidepressants or other 
anticonvulsants. 


Gabapentin 


‘Neuropathic pain associated with post herpetic neuralgia 


Nonlinear 
Plasma concentration increases disproportionately to the dose 


60% 900 mg/day 

47% 1200 mg/day 

34% 2400 mg/day 

33% 3600 mg/day 

9 or more days 

Titrate to effective dose of 1800 mg/d 


Table 2 — Pregabalin Dosing in Patients with Renal Impairment 


Creatinine Clearance (CLer) Total Pregabalin Daily Dose (mg/day)" Nein ae ire es 1 
: mL/min : 


I me CI ee res wines 6 BID Or-lID . 
REN, ELS WE a ee) ee BID or TID 


. 15-30 25-50 OD or BID 
2 iad) LE STS | 
. Suppl d following hemodialysi 


P 


Patients on the 25-50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg 
Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 m 


Page 12 Maryland Pharmacist ¢ July/Aug./Sept. 2006 


TID = three divided doses; BID = two divided doses; QD = single daily dose 
“ Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose. 
’ Supplementary dose is a single additional dose. 


' Lyrica® (pregabalin) Capsules CV [package insert]. New York, NY: Pfizer, Inc; 2005. 

* Schmader KE. Epidemiology and Impact on Quality of Life of Postherpetic Neuralgia and Painful Diabetic Neuropathy. 
The Clinical Journal of Pain. 2002; 18:350-354. 

* Taylor RS. Epidemiology of Refractory Neuropathic Pain. Pain Practice. 2006. 6(1):22-26. 

* Warner G, Figgitt DP. Pregabalin: as adjunctive treatment of partial seizures. CNS Drugs. 2005; 19(3):265-272. 

* Sabatowski R, Galvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, Versavel M. Pregabalin reduces pain and 
improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomized, placebo- 
controlled trial. 


° Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic neuropathy: a 
double-blind, placebo-controlled trial. Pain. 2004;110:628-638. 


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Maryland Pharmacist ¢ July/Aug./Sept. 2006 Page 13 


ie UC 1G. 5 eS 900-222-1222 


the maryland poison center’s monthly update. news. advances. information. 
July/August 2006 


Camphor 


Approximately 10,000 exposures to camphor-containing products are reported to poison centers in the United States 
each year. Approximately 80% of cases involve children less than 6 years old. Most poisonings are unintentional or due to 
misuse of a product. Camphor-containing products include cold sore ointments and liquids, muscle liniments, 
rubefacients and camphor spirits. Some common brand names include Campho-phenique (10.8% camphor), 
Mentholatum Ointment (9% camphor), Vicks VapoSteam (6.2% camphor), and Vicks VapoRub (4.7% camphor). Prior to 
1983, most fatalities due to camphor ingestions were associated with camphorated oil (20% camphor) being mistaken 
for castor oil. An FDA ruling in 1983 limits the concentration of camphor in non-prescription products to not greater than 
11%. Fatalities are now rare, but serious poisonings still occur. Non-FDA approved ethnic remedies can be found in the 
U.S. that contain greater than 11% camphor. Recently, patches containing camphor intended for topical use on children 
were voluntarily withdrawn. Triaminic Vapor Patch (4.7% camphor) and WellPatch Cough & Cold Soothing Vapor Pads (5% 
camphor) were removed from the market in June and July 2006 due to the possibility of small children removing them 
and ingesting them. 


One gram of camphor in small children has been fatal. This amounts to as little as 2 teaspoonfuls of an OTC product 
containing 10% camphor! Ingested amounts of less than 30mg/kg are unlikely to produce severe toxicity. Exposure to 
camphor is often detected because of it’s characteristic odor. Camphor-containing liquids are absorbed rapidly from the 
gastrointestinal tract. Dermal and mucous membrane absorption also occurs; however, serious toxicity with topical 
exposure is rare. Camphor’s mechanism of toxicity is unknown, but it possesses both excitatory and depressant activity. 
Agitation, delirium and seizures may occur within 520 minutes. Severe symptoms may be preceded by oral irritation, 
nausea and vomiting, but often occur without warning. Lethargy and coma may follow. Death is secondary to respiratory 
failure or seizures. 


Most ingestions in children warrant immediate referral to an emergency department for an observation period of at least 
2-4 hours. There is no evidence that activated charcoal is beneficial. Camphor-induced seizures are treated with 
benzodiazepines. 


DID YOU KNOW THAT... mothballs used to contain camphor? 


Years ago, mothballs were made of camphor. Most, if not all, of the mothballs sold in the United States today contain 
paradichlorobenzene or naphthalene instead. A characteristic odor similar to camphor is evident with these products. The toxicities 
associated with the ingestion of naphthalene and paradichlorobenzene are very different from that of camphor. Call the Maryland 

Poison Center at 800-222-1222 for help in diagnosing and treating all mothball and camphor-containing product ingestions. 


+ —% A Oe ry 
a a Ve ES ad 


Maryland Poison Center 
Post and share this edition of toxtidbits with your colleagues. Send any comments University of Maryland School of Pharmacy 
or questions to: toxtidbits, 410.706.7184 (fax) or Lbooze@rx.umaryland.edu. 


Continuing Education 
for Pharmacists 


A New Era in the 
Management of 
Diabetes: Inhaled 
Insulin 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 

Ohio Northern University 

Ada, Ohio 


and 


J. Richard Wuest, R.Ph., 
Pharm.D. 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


Goals. The goal of this lesson is to 
discuss the use of inhaled insulin in 
management of type 1 and type 2 
diabetes mellitus. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. describe key points relative to 
diabetes, and patient reactions to 
the use of injectable versus inhaled 
insulin; 

2. identify physical and chemi- 
cal characteristics that define the 
overall action of inhaled insulin; 

3. explain the physiologic and 
pharmacologic principles that define 


This continuing education activity 
is Supported by 
an educational grant from 
GlaxoSmithKline. 


& 
ck 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 


Gossel 


Wuest 


the therapeutic usefulness of 
inhaled insulin; and 

4. select, from a list, important 
points to pass along to patients 
relative to correct use of inhaled 
insulin. 


FDA has approved the first-ever 
inhaled insulin (Exubera), which is 
a new alternative to injectable 
insulin for the more than five 
million Americans who use insulin. 
Exubera is the first new insulin 
delivery option introduced since 
insulin was first used more than 80 
years ago. It is a powder form of 
recombinant (rDNA) human insulin 
for the treatment of adult patients 
with type 1 and type 2 diabetes 
mellitus (Table 1). 


Background on Insulin 

The therapeutic insulin era began 
January 11,1922, with the first 
clinical use of insulin following its 
discovery by Banting and Best. In 
the ensuing 80 years, scientists 
discovered the basic pathophysiology 
of diabetes, elucidated insulin’s 
structure, and directed their atten- 
tion to developing improved insulin 
formulations (e.g., NPH, Lente). 
These advancements led to develop- 
ment and availability of rapid-acting 
(e.g., aspart, glulisine, lispro) and 
basal insulin (e.g., glargine) ana- 
logs, which have resulted in routine 


Volume XXIV, No. 4 


Table 1 
Diabetes Facts ‘ 


e 20.8 million people in the U.S. 

(7 percent of the population) have 
diabetes. 

e An estimated 14.6 million people 
(of the 20.8 million) have been 
diagnosed with diabetes; unfortu- 
nately, 6.2 million (nearly one-third 
of the total) are unaware they have 
the disease. 

e There are 41 million Americans 
with pre-diabetes, in addition to 
the 20.8 million. 

e To differentiate between pre- 
diabetes and diabetes, a Fasting 
Plasma Glucose Test (FPG) or an 
Oral Glucose Tolerance Test 
(OGTT) can be done. The American 
Diabetes Association recommends 
the FPG because it is easier, faster, 
and less expensive to perform. 

e With an FPG test, a fasting blood 
glucose value between 100 and 125 
mg/dL signals pre-diabetes. A level 
of 126 mg/dL or higher defines 
diabetes. 

e For the OGTT test, if the 2-hour 
blood glucose level is between 140- 
199 mg/dL, the person is pre- 
diabetic. A value of 200 mg/dL or 
higher means the person tested has 
diabetes. 

e Persons with pre-diabetes do not 
automatically progress to diabetes. 
Those who lose weight and increase 
their physical exercise can often 
prevent or delay the disease. 

e Among adults with diagnosed 
diabetes, 16 percent take insulin 
only, 12 percent take both insulin 
and oral hypoglycemics, 57 percent 
take oral hypoglycemics only, and 
15 percent take neither insulin nor 
oral hypoglycemics. 


use of insulin regimens that closely 

approach physiological conditions. 
Because insulin is essential in 

controlling type 1 diabetes, a 


Page 15 


ee ee a SS a SR TT a SS AS SS SS SSE SS SSP SS SSSR SPS SSS PSR SSS SS 


noninvasive delivery system isa 
more convenient alternative. The 
progressive decline in beta-cell 
function that is the hallmark in 
pathogenesis of type 2 diabetes 
means that many patients will 
eventually fail on oral antidiabetic 
therapy and require insulin at some 
point. 

Numerous long-term prospec- 
tive clinical trials have demon- 
strated the benefits of tight glycemic 
control in reducing the risk of 
secondary complications in persons 
with type 1 and type 2 diabetes. 
Other studies have shown that 
despite the benefits of tight glycemic 
control, which ultimately may only 
be achieved with insulin in type 2 
diabetic patients, there is reluctance 
on the part of many patients, and 
oftentimes their physicians, to 
initiate insulin therapy. This 
reluctance may be due to the social 
stigma of diabetes, lifestyle restric- 
tion, sense of guilt or failure, weight 
gain, perception of worsening 
pathology, physical limitations to 
drawing up insulin, or needle 
anxiety. Physicians, therefore, often 
prescribe a simple regimen initially 
in order to assure maximum patient 
compliance. 

It should be stressed that many 
individuals with type 2 diabetes 
have a positive regard for injectable 
insulin in terms of efficacy, preven- 
tion of complications, and improved 
overall health. For various reasons, 
insulin use may be reserved as a 
last resort for therapy after the 
stepwise approach of diet, exercise, 
and oral antidiabetic agents have 
failed to produce and maintain 
adequate glycemic control. However, 
many (some reports say most) 
patients eventually require exog- 
enous insulin to attain glycemic 
control targets. 


Diabetes: The Disease 

Despite therapeutic advances, the 
incidence of both type 1 and type 2 
diabetes continues to increase in the 
U.S. with type 2 at epidemic propor- 
tions. Type 1 disease typically 
develops when the body’s immune 
system destroys the pancreatic beta 


Page 16 


cells. Risk factors may be autoim- 
mune, genetic, or environmental. 
There is presently no way to prevent 
type 1 diabetes. 

Type 2 diabetes is associated 
with decreased sensitivity to insulin 
in muscle, liver, and adipose (i.e., 
fat) cells, as well as progressive 
decline in pancreatic insulin produc- 
tion. The precise causes of insulin 
resistance with eventual beta-cell 
failure remain unclear; however, it 
appears that both genetic predispo- 
sition and environmental factors 
interact. Obesity and sedentary 
lifestyle are closely linked to both 
onset and progression of type 2 
diabetes; weight loss, exercise, and 
selective medications can often delay 
or prevent its onset. 

The leading cause of morbidity 
and mortality in patients with 
diabetes is cardiovascular disease. A 
marker of insulin resistance, 
hyperinsulinemia, is an independent 
risk factor for cardiovascular 
disease. Diabetes treatments that 
decrease hyperinsulinemia and/or 
insulin resistance seem to protect 
against cardiovascular events more 
than treatments that do not impact 
these factors. Moreover, aggressive 
treatment of dyslipidemia is critical 
to effectively manage the complica- 
tions of diabetes. 

However, despite the more 
favorable time-action profiles of 
modern insulin analogs, which can 
help optimize glycemic control, 
many patients remain suboptimally 
controlled. Even in teaching institu- 
tions throughout the U.S., Ameri- 
can Diabetes Association treatment 
goals are only infrequently attained. 
For these reasons, the development 
of a novel, noninvasive, dry-powder 
insulin delivery system for inhala- 
tion use shows promise for adults 
with type 1 and type 2 diabetes. 


Exubera 

Exubera is an inhaled dry powder 
formulation of recombinant (rDNA) 
human insulin with a particle 
diameter of 1-5 um. The powder is 
contained in blister packs and used 
in combination with an inhaler 


device. There are two dosage 
strengths: each blister contains 

1 mg or 3 mg of insulin brought up 
to a total weight of 5 mg with 
mannitol, glycine, sodium citrate, 
and sodium hydroxide. The inhala- 
tion system is designed to deliver a 
fine dry-powder formulation of 
regular human insulin deeply into 
the lung in a reproducible and 
efficient manner. 

A blister pack is inserted into 
the inhalation device (similar to a 
nebulizer). A pneumatic mechanism 
is activated by a lever, which 
punctures the blister. The powder is 
dispersed in a discrete cloud into the 
air chamber. The insulin cloud is 
inhaled slowly, at the beginning of a 
deep breath. With a bioavailability 
of 10 to 15 percent and dose equiva- 
lence about three times greater than 
that of injected insulin, each admin- 
istration delivers the equivalent of 
approximately 3 IU or 9 IU of 
subcutaneous (SC) insulin, respec- 
tively. 

Early studies have shown 
promising results. Onset of action of 
inhaled insulin is faster than that of 
regular human insulin, more closely 
resembling onset of rapid-acting 
insulin analogs. Exogenously 
administered insulin by SC injection 
has several disadvantages when 
used in controlling prandial (meal- 
time) glycemia. Physiologic insulin 
secretion peaks 30 to 45 minutes 
after meals and then decreases to 
basal levels over the next two to 
three hours. Subcutaneous injection 
of regular human insulin causes 
plasma insulin to increase slowly 
with a peak level achieved 90 to 120 
minutes following the injection, and 
then a slow decline to baseline 
approximately eight hours after 
injection. This leads to postprandial 
hyperglycemia followed by 
hyperinsulinemia and increased 
risk of hypoglycemia before the next 
meal. Although the rapid-acting 
insulin analogs have reduced some 
of these difficulties, another problem 
associated with SC insulin injec- 
tions is the frequent inter- and 
intra-individual absorption varia- 
tion. This appears more often in the 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 


older, type 2 diabetes population, in 
whom absorption of rapid-acting 
insulin from SC sites has been 
shown to be slower than in patients 
with type 1 diabetes. Inhaled insulin 
is a viable alternative to prandial 
injectable insulin administration in 
patients with diabetes because of its 
more favorable pharmacokinetic 
profile and less invasive route of 
administration. In type 1 diabetes, 
inhaled insulin is used in combina- 
tion with a longer-acting injectable 
insulin. In type 2 diabetes, inhaled 
insulin can be used as monotherapy, 
or in combination with longer-acting 
insulins or oral hypoglycemics. 

Clinical Trials. Two 12-week 
clinical trials evaluated the effect of 
inhaled insulin in patients with type 
1 or type 2 diabetes. These studies 
demonstrated that patient satisfac- 
tion is increased with inhaled 
insulin compared with injectable 
insulin. The data showed that 
improved patient satisfaction is 
consistently correlated with im- 
provements in glycemic control. 

The two 12-week trials were 
then extended to one year. Patient 
satisfaction and preference, along 
with effects on HbA1C levels with 
inhaled insulin, were compared with 
an SC insulin regimen both in 
patients with type 1 or type 2 
diabetes. In the 12-week parent 
studies, patients were randomized to 
inhaled insulin or SC insulin 
regimen. In the one-year extension 
studies, patients were permitted to 
select their treatment regimen of 
choice. Patient satisfaction was 
recorded at baseline (beginning of 
parent studies), week 12 (end of 
parent studies), and one-year 
(extension studies). 

Of the 60 patients who received 
inhaled insulin during the 12-week 
trials, 85 percent (n = 51) chose to 
continue treatment, 3.3 percent (n = 
8) switched to SC insulin, and 1.7 
percent (n = 1) did not continue in 
the trial. Of the 61 patients who 
received SC insulin in the 12-week 
studies, 21.3 percent (n = 13) chose 
to continue treatment, 75.4 percent 
(n = 46) switched to inhaled insulin, 
and 3.3 percent (n = 2) did not 


Maryland Pharmacist ° July/Aug./Sept. 2006 


continue. From baseline to one year, 
reductions in HbA1C of 0.8 percent 
were maintained, and greater 
improvements were noted in the 
subjects using inhaled insulin 
versus those in the SC insulin 
group, with overall satisfaction of 
37.9 percent versus 3.1 percent, 
respectively. ; 

The Lung as a Site for 
Insulin Delivery. The lung is an 
excellent site for drug delivery. The 
alveolar-capillary network, witha 
surface area of 140 m?, is the body’s 
largest microvascular organ and 
receives the entire cardiac output. 
Because the lung provides a large 
surface area for drug absorption, 
inhaled insulin rapidly attains peak 
plasma level and metabolic effect. 
The primary mechanism of insulin 
absorption across the alveolar 
capillary and epithelial cells re- 
mains unknown, but is believed to 
be transcytosis (i.e., “across the 
cells”) and formation of insulin 
vesicles. In this process, insulin 
molecules are taken up in vesicles 
by the alveolar epithelial cells. 
These insulin-containing vesicles 
are released between epithelial cells 
and the alveolar capillary endothe- 
lial cells. Insulin molecules are then 
taken up within vesicles by endothe- 
lial cells, transported across them, 
and released into the alveolar 
capillary blood. 

Pulmonary Delivery of 
Insulin. Following inhalation, 
pulmonary delivery of insulin 
results in peak insulin levels within 
15 to 20 minutes, with return to 
baseline 40 to 60 minutes later. If 
inhaled insulin is not administered 
correctly, a large portion of the dose 
will deposit in the upper airways 
and subsequently be removed from 
the lung via mucociliary clearance. 
In order to be absorbed systemically, 
insulin must be deposited deep 
within the lung. Two major factors 
affect its optimal deep-lung deposi- 
tion: particle size and particle 
velocity. The optimal particle size 
for delivery to the alveoli is 1 to 
3 um in aerodynamic diameter. 
Larger particles will likely be 
deposited in the oropharynx and 


upper airways, whereas smaller 
particles will be lost on exhalation. 
Independent of particle size, particle 
velocity also has a major effect on 
absorption. Inhaled insulin particles 
must have a low velocity for optimal 
deposition and absorption. 

Safety. The safety of injected 
insulin is well documented. There is 
less data to support the safety of 
inhaled insulin, although in gen- 
eral, studies have confirmed that its 
safety is comparable with SC 
insulin. The incidence of hypoglyce- 
mia is similar. In animal studies 
with rats and monkeys, daily 
inhalation was well tolerated with 
no evidence of airway or pulmonary 
lesions. 

The American Conference of 
Governmental Industrial Hygienists 
has determined that the threshold 
limit value for inhalation of in- 
soluble “nuisance dust” into the 
lung is 30 mg/day. Inhaled insulin 
is rapidly absorbed from the epithe- 
lial surface of the lung and therefore 
will only deposit up to an average of 
10 mg of insulin into the lung each 
day. This means that therapeutic 
daily doses of inhaled insulin would 
not be expected to adversely affect 
pulmonary function. In general, 
pulmonary function has been stable 
in patients with type 1 and type 2 
diabetes who have been treated with 
inhaled insulin, and no clinically 
significant differences in common 
measures of pulmonary function 
(spirometry, lung volume, diffusion, 
capacity or oxygen saturation) have 
been noted. 

An increase in the incidence of 
mild-to-moderate cough has been 
reported, which should be expected 
with inhalation devices. Cough 
tended to occur within seconds to 
minutes after insulin inhalation, 
and lessened with continued use. 

Increased antibody formation 
has been reported with insulin 
analogs in general. The clinical 
impact, if any, of such increases has 
yet to be determined. Pooled data 
from Phase II and III (three- and 
six-month) studies of inhaled insulin 
in patients with type 1 and type 2 
diabetes have demonstrated that 


Page 17 


a 


Table 2 
Patient Advice for Exubera 


e Read the Medication Guide 
provided by the manufacturer 
before you start using Exubera, and 
each time you get your prescription 
filled. 
e This medicine should not be used 
if you smoke or have stopped 
smoking within the past six 
months. If you decide to start 
smoking, contact your doctor for a 
different treatment for your 
diabetes. 
e Tell your doctor if you have 
unstable or poorly controlled lung 
disease, or are using any other 
inhaled medicine. 
e This medicine is to be placed in 
the Exubera inhaler device and 
inhaled through your mouth into 
your lungs as directed. The manu- 
facturer states that mealtime 
doses should be taken 10 minutes 
before a meal. 
¢ Do not open the blister. The 
inhaler device will open it auto- 
matically. Do not swallow the 
powder or breathe into the inhaler. 
e Follow your doctor’s advice on 
diet, exercise, sleep, personal 
hygiene, and how to monitor your 
blood sugar. 
e Tell your doctor about all other 
prescription and OTC medicines, 
vitamin/mineral supplements, 
natural products and herbal 
remedies you are taking. Some 
OTC medicines (decongestants, 
aspirin) have a warning on their 
label advising persons with 
diabetes not to take them unless 
directed by a doctor. If you see such 
a warning on the label of an OTC 
product, ask your doctor or phar- 
macist if it is okay for you to take 
the OTC product. 
¢ Unopened blisters should be 
stored at room temperature, 
protected from moisture. Do not 
refrigerate, freeze or use them after 
the expiration date on the label. 
e After opening the foil overwrap, 
follow the storage instructions in 
the Medication Guide and use this 
medicine within three months. 
e The inhaler device can be used for 
up to one year from first use. The 
release unit should be changed 
every two weeks. 


Page 18 


switching from SC insulin to 
inhaled insulin is associated with 
increased antibody levels. However, 
these increased antibody levels have 
not caused a need for increased 
insulin doses or allergic reactions. 


Factors that Affect Inhaled 
Insulin Activity 

Smoking. Smoking is reported 
to be as common in persons with 
diabetes as in the general popula- 
tion, and is known to increase the 
permeability of the alveolar-capil- 
lary barrier in humans. Smoking 
may therefore increase absorption of 
inhaled insulin such that its dose 
requirements may be lower in 
smokers. In comparison, SC insulin 
absorption is decreased in smokers, 
necessitating larger SC doses. 
Exubera is contraindicated in 
patients who smoke or who have 
discontinued smoking less than six 
months prior to starting therapy. 

Lung Disease. In persons 
with underlying lung disease such 
as asthma, COPD, or upper respira- 
tory infections (URI), delivery of 
inhaled insulin to the blood may be 
affected by the overall efficiency of 
pulmonary function. For example, a 
study showed that subjects with 
chronic asthma absorb less insulin 
after inhalation than healthy 
subjects, resulting in less action to 
reduce blood glucose levels. The 
decreased insulin absorption is 
believed to be caused by a difference 
in the airway caliber or pulmonary 
vasculature as a result of chronic 
lung disease. The patient’s physi- 
cian may suggest that inhaled 
insulin not be used during intermit- 
tent URIs. 


Counseling Patients on 
Inhaled Insulin. A comprehensive 
Medication Guide is provided with 
Exubera. Patients should under- 
stand all the information before 
beginning therapy. A summary of 
these points, which pharmacists 
may use in their counseling, is 
provided in Table 2. 


Overview and Summary 

The benefits of intensive insulin 
therapy have been demonstrated in 
large clinical trials. Despite such 
advantages, intensive insulin 
therapy is not widely accepted 
because of real or imagined barriers 
to invasive insulin. Inhaled insulin 
is anon-invasive method of supply- 
ing insulin that should alleviate 
some of the problems and/or fears 
associated with insulin injections. It 
has demonstrated efficacy in terms 
of achieving significant attainment 
of HbAIC targets in both type 1 and 
type 2 disease. Inhaled insulin is, 
therefore, a suitable alternative to 
injectable insulin to promote 
achievement of good glycemic 
control, and therefore help to 
prevent the microvascular, 
macrovascular, and neuropathic 
complications of diabetes and 
decrease the risk of premature 
death. 

Once inhaled insulin is made 
available, it may be of particular 
benefit in patients who are unrecep- 
tive to multiple daily insulin injec- 
tions. It represents a promising and 
novel diabetes therapy that offers 
the benefit of noninvasive adminis- 
tration, along with a time-action 
profile that combines the advan- 
tages of both rapid-acting insulin 
analogs and regular human insulin. 


Maryland Pharmacist « July/Aug./Sept. 2006 


Continuing Education Quiz 


This month's questions are taken from the article on “A New Era in the Management of Diabetes: Inhaled Insulin”. Circle your answers to the 
following questions and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 21201-1572. There is no 
charge for this quiz for MPhA members (non-members $ 10.00). The completed quiz for this issue must be received by 4/15/09. A 
continuing education certificate for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to eight weeks. Please type 


or print clearly. ACPE# 129-144-06-004-H01. 


Name 
Address 
City, State, Zip 
Daytime Phone 


Date Completed 
(Required) 


1. All of the following are rapid-acting insulin 


analogs EXCEPT: 
a. aspart. c. glulisine. 
b. glargine. d. lispro. 


2. With a fasting plasma glucose (FPG) test, the 
lowest level that defines diabetes is: 

a. 26 mg/dL. c. 126 mg/dL. 

b. 99 mg/dL. d. 199 mg/dL. 


3. Which of the following is a marker of insulin 


resistance and an independent risk factor for cardio- 


vascular disease? 
a. Hyperinsulinemia 
b. Hypoinsulinemia 
c. Hyperglycemia 
d. Hypoglycemia 


4. All ofthe following statements about Exubera are 
true EXCEPT: 

a. itis a dry powder formulation. 

b. it is recombinant (rDNA) human insulin. 


c. it comes in a blister pack to be used in combina- 


tion with an inhaler device. 
d. it comes in five dosage strengths. 


5. Compared to injectable insulin, the dose equiva- 
lence of Exubera is about: 

a. three times greater than that of injectable 
insulin. 

b. three times less than that of injectable insulin. 


6. The onset of action of Exubera is: 
a. faster than that of regular human insulin. 
b. slower than that of regular human insulin. 


The Maryland Pharmacy Continuing 
Education Coordinating Council is 
accredited by the Accreditation Council for 


Pharmacy Education as a provider of 
continuing education for pharmacists. 


7. The primary mechanism of insulin absorption 
across the alveolar capillary and epithelial cells is: 
a. active transport.  c. passive diffusion. 
b. iontophoresis. d. unknown. 


8. Following inhalation, pulmonary delivery of 
insulin results in peak insulin levels within: 

a. 1 to 5 minutes. 

b. 15 to 20 minutes. 

c. 30 to 35 minutes. 

d. 40 to 45 minutes. 


9. Which of the following OTC medicines has a 
warning on its label advising persons with diabetes 
not to take them unless directed by a doctor? 

a. Antihistamines 

b. Decongestants 

c. Expectorants 

d. Laxatives 


10. Unopened blisters of Exubera should be stored: 
a. in the freezer. 
b. in the refrigerator. 
c. atroom temperature. 


Maryland Pharmacist ¢ July/Aug./Sept. 2006 Page 19 


What does this mean for you? 


It means Pharmacists Mutual Insurance 
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It means our employees stand behind 
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Pro Advantage Services, Inc. 410-592-9856 


PMC Quality Commitment, Inc. dave.geoghegan@phmic.com 


Pharmacists Mutual is endorsed by the Maryland Pharmacists Association (compensated endorsement). 


( lida 


VOLUME 83 No. 1 


President’s Commentary 
“Off to a Great Start for 2007” 


Candidate Statements 
“Official Ballot” 


Recognizing Pharmacy Excellence 
“The 2007 MPhA Awards” 


Continuing Education 
“Acute Viral Hepatitis: 
Prevelance, Prognosis, and Prevention” 


ARYLAND PHARMACISTS ASSOCIATION | 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 


410-727-0746 


www.marylandpharmacist.org 


MPhA Officers 2006 - 2007 


Ginger Apyar, P.D., President 

Joe Marrocco, P.D., First-Vice President 
Walter Abel, P.D., Treasurer 

Joe Fine, R.Ph., Honorary President 


House Officers 


Barry Poole, R.Ph., Speaker 
Ruth Blatt, P.D., Vice-Speaker 


MPhA Staff 


Howard Schiff, P.D., Executive Director 
Elsie Prince, Office Manager 
Nancy Ruskey, Administrative Assistant 


MPhA Trustees 


Matthew Shimoda, Pharm.D., Chairperson 
Mishelle Andoll, P.D:, J:Doc eS. 2008 
Butch: Henderson: RiPhs 2 2009 
Mary Kremzner, Pharm.D. 

Neil Leikach, PiD. 2.222. 
Magaly Rodriguez deBittner, Pharm.D. ... 

David Russo, R.Ph 

Carol Stevenson, Pharm.D. 

Doris Voigt, PharmD...) a 2008 
Walter Fasch, President ASP 


Ex-Officio Members 
David Knapp, Ph.D., Dean - 

UMB School of Pharmacy 
Jennifer Thomas, Pharm.D. - MSHP 
Representative 


Maryland State Board of Pharmacy 


Mark Levi, P.D., President 
Jeanne Furman, P.D., Treasurer 
Donald Taylor, P.D., Secretary 
Margie A. Bonnett 

Joseph A. DeMino, P.D. 

David R. Chason, R.Ph. 


Alland Leandre, M.S., M.B.A. 
Mayer Handelman, P.D. 

Mike Souranis, P.D. 

Harry Finke, Jr., P.D. 

Rodney Taylor, Pharm.D. 
Cynthia Anderson, M.S., R.Ph. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


PRSIgentsm @OMMCNtAnVe ices eee tite te «canon gs: 5 
Virginia Apyar, P.D. 


Candidates tateMmentserrngreccn rt ie eee. ere te wy i Mie ol Pap leg 
“Official Ballot” 


RecoomZzinesianmacyalxcellencemt. 22 rr tts eee. ..... Seeemenes eee... 12 
“Award Nomination Form” 


Screening and Intervening on Medication Related Problems of Older Russian Americans 
IB altimore Git yane et te Pees eee re Tc. a, ri. ieee. ba oece le. 15 


Licrapentically,speakingencer eer. 10m ele... ss of eie ha tareec elses oe 17 
“Counterfeit Drug Products: Problems and Solutions”’ 


1Y.¢ AC ELLEN conobovtn [6 640050 c0DUb UC DN URC DG BREED es ote aaa aan. | 
“Combat Methamphetamine Epidemic Act: What this Act Means for your Retail Setting” 


Continuing Education |. Seeperre etter 93 
“Acute Viral Hepatitis: Prevalence, Prognosis, and Prevention”’ 


Advertiser’s Index 


Dicdical Stating Networks Cm eee ww ow wie ese ciee DD 
MIGISCSSOTrerr-titet.(.1. eee te et ee eee fe ob intneed oe aesee 28 
Pharmacistsaylutual Compamiesmire cert  . os. cel de es cl tellvkees (4 


Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 650 West Lombard 
Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals postage paid at Baltimore, MD and at additional 
mailing office. Articles and editorials that appear do not necessarily reflect the official positions of the Maryland Pharmacists Association and may 
contain views and opinions for which the authors hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West 
Lombard Street, Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


What does this mean for you? 


It means Pharmacists Mutual Insurance 
Company promises "To help our 
customers attain financial peace of mind." 


It means our employees stand behind 
that promise each and every day. 


It means our President, our 
pharmacist/attorneys, our home office 
staff, and our sales representatives are 
focused on helping you achieve financial 
security. 


It means we are the only insurance 
company devoted to pharmacists. 


It means value that we believe you can't 
get anywhere else. 


$ Call us at 800-247-5930 orvisit 
Pharmacists |tateamseseos 
: hind you. 
Mutual (Companies fii 


One Pharmacists Way, Highway 18 West Pharmacists Mutual Insurance Company Dave Geoghegan 

P.O. Box 370 « Algona, IA 50511-0370 Pharmacists Life Insurance Company : P.O. Box 177 
Pharmacists National® Insurance Corporation Kingsville, MD 21087 
Pro Advantage Services, Inc. 410-592-9856 


PMC Quality Commitment, Inc. dave.geoghegan@phmic.com 


Pharmacists Mutual is endorsed by the Maryland Pharmacists Association (Compensated endorsement). 


ifaberns see, Pal < 


P a 9 G f+ teeehemiy if . 
residents’ Commentary veiloadl” 

biectecett|, Fe 
The Maryland Pharmacists Association is off to a great start for 2007. a 
On Sunday, January 28, 2007 the Mid-year Meeting was held at the 
Sheraton Hotel in Columbia. There was a dramatic increase in 
attendance compared to years past .The thought was we might even have 
to find a larger meeting space in the future. Thanks to the undaunted 
efforts of Howard, Elsie and Nancy, the day was flawless. What made the 
Mid-year so great was the line-up of speakers that our Chairperson, 
Doris Voigt, arranged. Thank you Doris! Doris also served as the 
meetings official photographer. Her work can be seen on the website 
click on snapshots. The networking the day provided was evident when 
Howard tried to get the attendees back into the meeting room after 
scheduled breaks and lunch. He did manage to keep the day on schedule. 


- 
. 
Belo) 


pie 


Our corporate sponsors were visible in the exhibit area. As you walked ; aa 
along the mini trade show, you noticed someone was missing. That Virginia Apyar, President 


pictured in 
someone was BIG PHARMA. The days of the large drug companies the lower level of the B. Olive Cole 
being association sponsors are sadly over. While we can still apply on- Pharmacy Museum 


line to get an educational grants, that is also getting more difficult. While 

all state associations struggled when big pharma no longer was able to provide speakers for CE programs, MPhA was ina 
unique position and we were able to adapt. What made of transition easier—our relationship with the University of 
Maryland, School of Pharmacy and its faculty. When a faculty member presents, either at the mid-year or convention, 
they are always a draw that fills the room. This year we reached out to the U.S. Public Health Service to present and no 
one was disappointed. We hope they will continue to be a part of the mid-year and the convention. 


More good news is the success of Legislative Day 2007. On February 07, 2007 the Maryland Pharmacy Coalition 
(MPC), which MPhA is a member, had its first dinner CE on current legislative issues. The goal of this CE program was 
to educate pharmacists on the current issues and how to present them to their legislators in Annapolis. The response 
again was overwhelming. Over eighty pharmacists attended. Pharmacists are now a voice to be heard in Annapolis. I 
hope more MPhA members will be in Annapolis in 2008! 


One of the best opportunities to come from being president of the association was an invitation to represent pharmacy on 
the Governor’s Workforce Investment Board (GWIB), Healthcare Industry Initiative. I am the only pharmacist on this 
board. The steering committee I am serving on has been charged with defining healthcare in Maryland. This includes 
occupations in the healthcare industry and the available workforce that is in the state. The pharmacist shortage is high on 
the list for the GWIB to focus on. The first healthcare initiative the GWIB focused on was the nursing shortage in 
Maryland. Industry uses a code system for occupations. This code system from the U.S. Census Bureau is referred to as 
NAICS (North American Industry Classifications System). I was surprised to learn that pharmacists are not listed 
separately as were doctors, nurses and dentists. But that we were classified as “other healthcare professionals”. I think 
that is a problem for our profession. At the GWIB we looked at another coding of occupations. The Maryland State 
Department of Education has created 10 career clusters to help students focus on a career path thus eliminating workforce 
shortages. Pharmacy is listed separately in career cluster 6 which is titled health and biosciences. Career clusters are 
used to enhance economic development by providing students a full range of career opportunities to meet the workforce 
demand thus having an educated, qualified workforce for the state’s healthcare industry. Our report should be printed by 
the end of the year. Solving the pharmacists’ shortage won’t happen as quickly as we would hope. The efforts of this 
group will ease the shortage perhaps with a new definition of healthcare which will include wellness care, self care and 
the careers available. 


I am looking forward to seeing everyone at the 125" Convention at the Clarion Resort Fontainebleau Hotel in Ocean 
City June 16-19, 2007 


Ginger 
Page 5 


Candidate Statements 


Viee President 


Candidate Magaly Rodrigues de Bittner, Pharm.D., BCPS, FAPhA 
MPhA Trustee- 2000-2007 

Chair, Department of Pharmacy Practice and Science 

University of Maryland, School of Pharmacy 

PharmD- 1983 University of Maryland 

BS in Pharmacy- 1979 University of Puerto Rico 


It is difficult for me to believe that I have been serving MPhA as a trustee for the past 6 years. As the Chair of the 
Professional Development Committee, I have been able to promote the development of opportunities for pharmacists to be 
reimbursed for professional services (the Maryland P3 project is one of the examples of such programs). We have 
published collaborative practice protocols in the MPhA website, facilitated the delivery of training programs in diabetes 
and immunization, and provided programming in MPhA meetings for dissemination of opportunities available to 
Maryland pharmacists. We have been able to advocate and provide leadership on many significant changes in Maryland 
pharmacy practice that affect pharmacists in all fields of pharmacy. Pharmacists in Maryland have been able to endure 
(and survive) Medicare Reform and welcome the opportunity that Medication Therapy Management (MTM) has brought 
to pharmacy. We saw the approval of legislation on collaborative practice and immunization, and most recently the birth 
of the Maryland P3 project. All of these opportunities have brought pharmacy practice to the forefront and have increased 
the ability of the pharmacists to impact the health care of Maryland citizens. I have seen our organization grow 
significantly and become an important voice for pharmacy in Maryland. Together we can continue to grow our 
professional organization to higher levels. 


I am sure that you agree with me that we have come a long way but a lot of work still needs to be done. We must promote 
business models to help all Maryland pharmacists take advantage of these opportunities. We must deal with the pressures 
of increased prescription volume, shrinking profit margins, and a shortage of pharmacists. We must become a proactive 
organization that seeks to create change and provide members with the resources necessary to maximize their 
contributions to the health care team. 


I believe that the Maryland Pharmacists Association is in a great position to continue to address the issues facing 
pharmacy in the state. I would be honored to serve you, my colleagues, as the president of this organization and contribute 
to advancing pharmacy practice in Maryland. I will dedicate my time and energy to assure that MPhA continues to be an 
agent of change and represents the needs of the Maryland pharmacists and pharmacy technicians. I am, in fact, honored to 
be a pharmacist and would be even more honored to earn your vote to become MPhA president. Let’s work together for 
our profession, pharmacy. Thank you for your support! 


Candidate Carol Stevenson, Pharm.D. 

I am honored to be nominated for the position of vice president of MPhA. I ama 1970 graduate of the University of 
Kansas and a 2003 graduate of the University of Maryland Non-Traditional Pharm.D. program. During my career, I have 
had the opportunity to practice in military hospitals in Maryland and overseas; in civilian hospitals, and in the retail 
setting at Medicine Shoppe and at Metro Food Markets. I am presently the manager of NeighborCare Pharmacy at 
Oakcrest Retirement Community. Being a trustee of the Maryland Pharmacist’s Association for the past term has been a 
privilege for me. I have found the organization to be a great advocate for the entire profession of pharmacy. I believe that 
the Maryland Pharmacist’s Association is one of the best organizations to enable pharmacists to contribute to their 
profession and to those they serve. MPhA honors the past with our wonderful building and museum; looks to the future 
by developing student involvement and leadership; embraces technicians as vital colleagues; encourages new initiatives 
such as the P3 project and Medication Therapy Management; supports the Maryland Pharmacy Coalition; and provides 


Page 6 Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


excellent educational opportunities for both members and non-members. I would be most honored to serve MPhA as 
vice president. 


Trustee Seat i 


Candidate Kristen Fink, Pharm.D. 

Since I joined MPhA I have had the great opportunity to participate not only in the professional development committee 
but in the heart of Maryland pharmacy. It is my sincere desire to serve on the Board of Trustees and work to strengthen 
and promote the profession of pharmacy as well as further the growth and potential of all pharmacists in the state of 
Maryland. 


As a clinical pharmacy specialist for Kaiser Permanente I have a strong background in disease state management, 
Medicare Part D Medication Therapy Management, and drug use optimization. A graduate of Duquesne University, I am 
now a student preceptor for six pharmacy schools and make it my top priority to show students the wide array of 
opportunities available to them. One of my passions is patient safety; I have designed several projects that have been 
successful in reducing medication errors both in the Pittsburgh hospital where I interned and in the managed care setting. 
As the daughter of an independent pharmacist here in Baltimore, I have worked in the retail setting since age 16 and have 
an in depth knowledge of the great potential and challenges that retail pharmacy faces everyday. 


I believe that the emerging opportunities in collaborative practice and medication therapy management are changing 
pharmacy as we know it. Not only are we recognized by our peers and patients for our ability to help manage their health, 
we now have the potential to be reimbursed for the knowledge we have to offer. I am proud to say that I have just 
submitted my application to become the first independent pharmacist in the state of Maryland to implement a 
collaborative practice agreement, partnering with a local physician. This collaborative practice model is already a success 
in my current practice at Kaiser Permanente and my goal is to use my knowledge and experience to help make this model 
a reality for every interested pharmacist. I believe that my varied background and knowledge base will allow me to 
contribute a great deal to the Board of Trustees for MPhA as well as the pharmacy profession as a whole. I hope that you 
will give me the opportunity to contribute my enthusiasm and drive to the MPhA Board of Trustees. 


Candidate Brian Hose, PharmD 

I am honored to be nominated for my first elected position within MPhA and am excited to continue my service to the 
organization. I have worked in Community Pharmacy for the past 3 years and specifically for Independent Epic 
Pharmacies since 2005. Iam a 2006 graduate of the University of Maryland School of Pharmacy and since graduation 
have been employed as a Staff Pharmacist at Boonsboro and Sharpsburg Pharmacies, located in Western Maryland. I am 
also a member of the P3 Pharmacist Network and currently work in the Cumberland pilot program counseling diabetic 
patients. 


For 2006-2007, I was selected as MPhA’s appointee to the Maryland Pharmacy Coalition (MPC). This appointment has 
allowed me to stay involved in an organization that I feel is becoming increasingly important to our profession as we learn 
the value of Pharmacy’s voice in the legislative process. I served as the MPC Chairman in 2005-2006 where I helped 
develop our Pharmacy Month supplement published in the Baltimore Sun and our Legislative Initiatives in Annapolis. 
This year I took on the responsibility of chairing MPhA’s Legislative Committee and at the time of this statement am busy 
preparing for another successful year lobbying our legislative leaders. I continue to be involved with the School of 
Pharmacy and have been active in the Alumni Association since graduation. 


I am dedicated to protecting the viability of our profession whether through lobbying efforts in Annapolis and Washington 


or new and innovative pharmacy practice initiatives. Thank you for your consideration and I look forward to my 
continued service to MPhA and our profession. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 Page 7 


Trustee Seat 2 


Candidate Neil Leikach, RPh 


I have been a trustee for 1 term and would like to be reelected to the board for another term. I graduated from Maryland 
in 1992 and have been active in MPhA, NCPA and the alumni association since then. As an owner of 3 

independent pharmacies in the Baltimore area, I have seen how state and federal legislation has change the way we 
practice community pharmacy. As a group,MPhA, can help steer pharmacy in the right direction and continue to show 


Marylander's what our profession is all about. Thank you for your consideration. 


Candidate Scott Vehovic, R.Ph. 


As a 1996 graduate of Duquesne University, I’m currently the district pharmacy supervisor for the Walgreen Company in 
Baltimore and have practiced the profession of retail pharmacy here in Maryland solely for almost eleven (11) years. The 
obstacles to our profession have changed since then, however our role as providers has not. The education, knowledge, 
and skills we possess make our jobs as pharmacists vital to the future of healthcare and pharmacy. The strength of the 
MPhA is dependent on the sharing of information we have gained through our experiences. I am honored to be 
nominated as a Trustee and as a current MPhA member, my primary goal has always been to use my knowledge and 
experience to improve patients’ lives while at the same time reduce the costs of healthcare in Maryland. In the future we 
will play a more proactive role, ensuring patients use their medications correctly through MTM and other clinically based 
programs. It is this synergy between patients and pharmacists that makes the practice of pharmacy a total healthcare 
package versus a commodity. I appreciate the opportunity to represent all Maryland pharmacists practicing in this 


endeavor. 


a 


A basic philosophy of Dr. John C. Krantz Jr. was “...knowledge of the 
history of a science is essential to an intelligent understanding of it.” 


A basic philosophy of Dr. John C. Krantz Jr. was “...knowledge of the history of a science is essential to an intelligent 
understanding of it.” Close friends and colleagues of Dr. Krantz have stated that he had an encyclopedic knowledge that 
covered a wide field of experimental and clinical medicine. He served thirty-three years as professor of pharmacology at 
the University of Maryland, School of Medicine. The son of a Maryland pharmacist, Dr. Krantz graduated from the 
University of Maryland, School of Pharmacy in 1919. He had the privilege of attending the pharmacy school while Dr. E. 
F. Kelly was dean. With all his scientific contributions too numerous to list, some important ones still used today include 
isosorbide dinitrate and theophylline. At the time Dr. Krantz wrote his book Historical Medical Classics Involving New 
Drugs (1974), very few oral agents were available to treat diabetes mellitus. An important concept one can take from the 
book, and from the developments since its print, is that medical science is always changing and evolving. 


The treatment of diabetes 
mellitus is starkly different today 
then the treatment of the 1960’s. 
A striking example is the limited 
choice of oral diabetic agents over 
four decades ago. Only two 
different classes of oral diabetic 
agents were available compared to 
the six classes today. Tolbutamide 
(Orinase®), chlorpropamide 
(Diabinese®), tolazamide 
(Tolinase®), acetohexamide 


Page 8 


(Dymelor®), all sulfonylureas, and 
phenformin (DBJ), a biguanide, 
completed the list of oral diabetic 
agents in the 1960’s. Phenformin 
was eventually taken off the 
market in 1977 due to cases of 
fatal lactic acidosis. First- 
generation sulfonylurea use has 
since declined due to the 
introduction of second-generation 
sulfonylureas that includes 
glyburide (Diabeta ®, 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


Micronase®), glipizide 
(Glucotrol®), and glimepiride 
(Amaryl®). Glyburide and 
glipizide were first introduced in 
1984, followed by glimepiride in 
1996. 


(Continued on page 11) 


2007 Maryland Leadership Elections 
Official Ballot 


Please select the candidate you believe will best fulfill the duties of the office by checking the box 
appearing beside their name. 


Maryland Pharmacists Association Officers 


Vice President 


O Magaly Rodrigues de Bittner, Pharm.D. 0 Carol Stevenson, Pharm.D. 


Please select the candidate you believe will best represent you as a member on the Board of Trustees 
by checking the box appearing beside their name. 


Maryland Pharmacists Association Board of Trustees 
Trustee Seat # 1 
O Kristen Fink, Pharm.D. O Brian Hose, Pharm.D. 


Trustee Seat # 2 


O Neil Leikach, R.Ph. 0 Scott Vehovic, R.Ph. 


When completed, seal and return your self-mail ballot to the Maryland Pharmacists Association, 
received by Friday, May 4, 2007. For questions, please call MPhA at 800-833-7587. 


Fold 


2007 Maryland Leadership Elections 
Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201-1572 


Fold 


The introduction of second- 
generation sulfonylureas 
represented advancement in the 
treatment of type 2 diabetes 
mellitus (T2DM). The newer 
compounds were approximately 
100 times more potent and 
effective at lower doses. Second- 
generations were less likely to 
produce side effects/and or drug 
interactions, and thus their use is 
preferred over first-generations. ° 
Sulfonylureas work to lower 
fasting plasma glucose (FPG) by 
increasing the release of insulin 
from functioning pancreatic B- 
cells. The major adverse effects 
include hypoglycemia and weight 
gain. Hypoglycemia was more 
prevalent with first-generations 
due to their relatively long half- 
lives. 

The 1990’s saw marked 
advances and changes in the 
treatment of T2DM. Three new 
classes of drugs were introduced 
and a new biguanide, metformin, 
was made available. Metformin, 
although in clinical use for over 
four decades, was not available in 
the U.S. until 1995. Its primary 
mechanism is to decrease hepatic 
gluconeogenesis. The incidence of 
lactic acidosis is minimal, 0.03 per 
1000 patient-years, and since it 
does not affect insulin secretion, 
metformin does not cause 
hypoglycemia. Added benefits of 
metformin include a small 
reduction in LDL and modest 
weight reduction. The new classes 
of drugs included a-glucosidase 
inhibitors (AGI), 
thiazolidinediones (TZD), and 
nonsulfonylurea secretagogues. 

AGIs became available in 
1996 and include acarbose 
(Precose®) and miglitol (Glyset®). 
AGIs work by reducing 
postprandial glucose levels by 


slowing intestinal absorption of 
carbohydrates. For this reason, 
acarbose and miglitol should be 
taken with meals. Like metformin, 
AGIs do not produce 
hypoglycemia, but have no affect 
on LDL levels. GI disturbances 
(abdominal pain, diarrhea, 
flatulence) are the most common 
adverse affects which can be 
minimized by slowly titrating 
doses. TZDs, troglitazone 
(Resulin®), rosiglitazone 
(Avandia®), and pioglitazone 
(Actos®), were first marketed in 
1997. TZDs work by improving 
insulin sensitivity in muscle and 
adipose tissue and secondarily by 
decreasing hepatic glucose 
production. This class requires the 
presence of insulin to work. Along 
with the intended benefits of new 
drugs, there are also unwanted 
adverse effects. Troglitazone was 
removed from the market by the 
FDA in March 2000 due to 
hepatotoxicity. Rosiglitazone and 
pioglitazone do not share this same 
hepatotoxicity profile, but caution 
should be taken in hepatic 
impairment. Common side effects 
include edema and weight gain and 
there is no risk of hypoglycemia. 
In 1998, the nonsulfonylurea 
secretagogues were introduced. 
They include repaglinide 
(Prandlin®) and nateglinide 
(Starlix®). When glucose is 
present, these agents stimulate 
insulin release from functioning 
pancreatic B-cells. Due to short 
half-lives, stimulation of insulin 
release is short, which reduces the 
risk of hypoglycemia and weight 
gain. These drugs are dosed prior 
to meals and are useful in patients 
with high postprandial glucose 
levels. Proving that medical 
science is always changing, 
another new class of drugs for 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


(Continued from page 8) 


treating T2DM was introduced in 
late 2006. Sitagliptin (Januvia®) 
was the first dipeptidyl peptidase 4 
inhibitor (DPP-4) to be marketed. 
It protects endogenous incretin 
hormones. Simply speaking, 
sitagliptin enhances the body’s 
own ability to lower blood glucose 
when it is elevated. Headache, 
upper respiratory infections, and 
nasopharyngitis were common side 
effects and hypoglycemia was seen 
in 1.2% of patients. This is 
comparable to placebo. 

So, what’s next? Mitaglinide, a 
nonsulfonylurea secretagogue, is in 
phase II trials. Novartis is expected 
to release its DPP-4 inhibitor 
vildagliptin (Galvus®) in early 
2007. Another new class is 
currently in clinical trials for 
treating T2DM, the glucokinase 
(GK) activators. GK is found in 
the liver and controls hepatic 
glucose metabolism and influences 
glucose uptake and production. It 
appears the evolutionary trend of 
treating T2DM will continue. 


Koski RR. Practical Review of 
Oral Antihyperglycemic Agents 
for Type 2 Diabetes Mellitus. The 
Diabetes Educator. 
2006;32(6):869-76. 


Skaer TL, Sclar DA, Robison LM. 
Trends in the Prescribing of Oral 
Agents for the Management of 
Type 2 Diabetes Mellitus in the 
United States, 1990-2001. The 
Diabetes Educator. 20 


Page 11 


Recognizing Pharmacy Excellence 
The 2007 MPhA Awards 


Each year, the Maryland Pharmacists Association recognizes professional excellence through a series of awards. To 
nominate a pharmacist for one of the awards described below, complete the Official Award Nomination Form. The forms 
should be submitted to: Award Nominations, c/o Maryland Pharmacists Association, 650 West Lombard Street, Baltimore, 
Maryland 21201-1572. 


All nominations will be reviewed by the Past Presidents Council who is responsible for selecting the award 
recipients. The decision of the Council is final. Award recipients will be notified in advance of the award’s presentation at 
the 125th Annual MPhA Convention. 


For consideration, all nominations must be received no later than Friday, April 6, 2007. 


wi Pharmacists Mutual Distinguished Young Pharmacist Award 
Awarded to a pharmacist who graduated within the past ten years and has made a significant contribution to the 
profession through service to a local, state or national pharmacy organization. Who is Eligible: Any MPhA 
pharmacist member who graduated from pharmacy school in 1997 or after. 


a Maryland Pharmacists Association Honorary President 
An honorary position on the Board of Trustees given to a person, not necessarily a pharmacist, who has worked for 
the MPhA or Maryland Pharmacy over a long period of time. Who is Eligible: Any long standing contributor to the 
profession or the Association. 


Fi MPhA Mentor Award 
This award recognizes individuals who encourage pharmacists, technicians, and/or student pharmacists in the pursuit 
of excellence in education, pharmacy practice, service, and/or advocacy. Who is Eligible: Any MPhA pharmacist 
member who meets the criteria of the Award. 


m Seidman Distinguished Achievement Award 
Created to honor the major impact on the pharmacy profession by Henry Seidman, this award is presented for 
outstanding service by a Maryland pharmacist to the pharmacy profession during either the past year or over a period 
of years. Who is Eligible: Any MPhA pharmacist member who meets the criteria of the award. 


& Wyeth-Ayerst Bowl of Hygeia Award 
The Bowl of Hygeia recognizes a pharmacist who has performed outstanding services to the community in any area, 
with a particular emphasis on non-pharmacy contributions. Who is Eligible: Any MPhA member pharmacist who 
has not already received the Bowl of Hygeia. 


a Elan Innovative Practice Award 
Established in 1993, this award aims to recognize forward-thinking pharmacists who have expanded their practices 
into new areas. Any practicing pharmacist member within the geographic area who has demonstrated innovative 
pharmacy practice resulting in improved patient care. Who is Eligible: Any MPhA pharmacist member who meets 
the criteria of the award. 


Page 12 Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


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2007 Awards Nominations 
Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201-1572 


Fold 


 — 


Screening and Intervening on Medication Related Problems of 
Older Russian Americans in Baltimore City 


Tatiana N. Kondrakhina Pharm.D. Candidate 


During the summers of 2005 and 2006, I was involved in a geriatrics focused project with Dr. Brandt, Associate 
Professor, Geriatric Pharmacotherapy and Dr. Julie Caler, Geriatric Pharmacotherapy resident. The project involved 
screening and intervening on medication related problems of older Russian Americans in Baltimore City. The results of 
this effort hopefully will have positive impact on understanding and improving pharmaceutical care for the population of 


older adults who cannot speak English. 


Patients were screened for identification of medication 
related problems utilizing the medication risk 
questionnaire that was translated into Russian. The 
survey was performed during the home visit with a 
Senior Friendly community health nurse, Miriam 
Rossman. During the summer of 2005, the project was 
paired with the Vial of Life program, which was 
designed to assist emergency rescue teams in medical 
treatment in the event that a patient is unable to 
communicate. During the summer of 2006, the project 
was paired with project LIGHT at Levindale Hebrew 
Geriatric Center and Hospital, coordinator Veronica 
Poklemba, APRN-PMH. The goal of LIGHT was to 
screen the Russian speaking elderly patients for 
depression. 

There were 64 patients screened during the Vials of 
Life Session with 64% of the participants taking five or 
more medications and 72 % had three or more medical 
problems. Even though only 16% of patients 
acknowledged having difficulty following their 
medication regimen, many patients had expired 
medications at home and could not recall how often they 
take their medications. The patients who had difficulty 
following their medication regimen were living alone, 
were older than 70 and had evidence of cognitive 
impairment. Interestingly, only one patient out of seven 
was willing to have her/his medications reviewed by a 
pharmacist. The language barrier, poor condition of 
health, and a distant relationship with medical 
professionals may explain this phenomenon. Consults 
were developed and shared with the patients and if 
applicable their respective healthcare professionals. 
There were follow-up appointments with patients to 
evaluate the implementation of the consults. 

The translation of medical information into Russian 
and explanation of the goal of Vial of Life program was 
performed parallel with the medication related problems 
survey. The form with important medical information 
was placed in a small prescription vial, which was stored 
in the refrigerator. Red stickers on the entry door and 


Maryland Pharmacist « Jan./Feb./Mar. 2007 


the refrigerator were placed to help the paramedics to 
quickly find the critical details necessary to help the 
patient. This program is crucial for the Russian speaking 
elderly population who cannot communicate with 
emergency rescue teams in English and are at a high risk 
for health-related emergency situations. 

The translation for the screening interview to 
identify patients with depression was performed during 
the LIGHT project. There were a total of 27 patients 
screened using the Geriatric Depression Scale translated 
to Russian. Six patients with signs of depression were 
identified. All identified patients agreed to start 
counseling and were scheduled to see a psychiatrist at 
Sinai Hospital. 


Conclusions: 
As a student pharmacist, I learned quite a few things 
during this experiential course. All in all I felt that: 


e Personal contact was much better than 
telephone: patients were more open to answer 
questions, and more willing to meet again. 

e The patients may in reality take more . 
medications than they report during a survey. 
During a home visit, they showed more 
medications than they mentioned in the 
questionnaire. 

e The parallel participation in Vial of Life 
program was very helpful for filling out the 
Medication Risk Questionnaire because the 
senior citizens perceived that they were 
receiving a benefit in exchange for their time. 

e All screened patients with depression live alone 
or have a sick spouse at home. Some patients 
had poorly controlled symptoms such as pain or 
high blood pressure. 

e Many patients with signs of depression had been 
taking antidepressants in the past, but only when 
they felt extremely depressed. The patients 


Page 15 


reported stopping medications due to a having to 
take multiple medications. 

e Most of the patients felt uncomfortable 
discussing their mental health problems due to 
stigma related to seeking professional help. 

e Many patients utilize traditional herbal and 
supplemental products, the contents of which 
may be unknown to the primary health care 
provider. 

e The process of impairment of memory and 
mental abilities may be troubling for an older 
adult with a good level of education and a highly 
intellectual job in the past. They may refuse to 
take medications or use assistive devices 
because they do not want to feel old and 
helpless. 

e Many Russian speaking patients were 
dismissing their health problems as an inevitable 
part of aging that did not warrant medical 
attention. Some patients with poorly controlled 
symptoms were unwilling to share their 
problems with their physicians. They did not 
want “to waste the doctor’s time” with concerns 
they think their doctor will consider 
unimportant. 


It is extremely important especially for older Russian 
American individuals to see their health provider 
regularly and bring all of their medications to the 
doctor’s office for review. In addition, it is vital that 
pharmacists assist with medication lists that should 
accompany the patient at all times. The results of this 
project demonstrate the many factors and challenges that 
can complicate the provision of pharmaceutical care to 
elderly patients of different cultures and languages. 


Page 16 Maryland Pharmacist - Jan./Feb./Mar. 2007 


“Therapeutically Speaking..." 
Counterfeit Drug Products: Problem and Solutions 


Mrs. Harrity is a long-time patient who arrives for her bi-monthly refills of hydrochlorothiazide and glyburide. “Do you 
know if there has been a problem with fake Lipitor?” she asks. In speaking with her, you learn that she has been 
obtaining Lipitor from what she describes as an on-line Canadian pharmacy, to treat hypercholesterolemia. She states, 
“The tablets have not looked the same and now my cholesterol is up 70 points from 190 to 260”. 


(era drugs are any brand 
name or generic product sold 
under a product name without proper 
authorization.’ While this definition 
includes product that has been 
relabeled or repackaged without 
authorization, most important to 
patient health are counterfeits that 
contain incorrect drug, no drug, 
improper dose, and/or contaminants. 
Risks involved with taking a 
counterfeit drug include unexpected 
side effects, allergic reactions, and 
the worsening of their medical 
condition. 

Counterfeit drug products 
within the U.S. drug supply chain are 
a potentially serious public health 
concern, although the scope of this 
problem is not known. In the U.S, the 
prevalence of counterfeit drugs from 
community pharmacies 1s thought to 
be less than 1%. Estimates of the 
prevalence of counterfeit medicines 
worldwide range from 5-10% 
generally, and up to 50% in select 
countries.” FDA investigations 
suggest that the number of 
counterfeit drugs within the U.S. is 
increasing. Through the 1990’s, the 
FDA investigated an average of five 
counterfeit drug cases per year. This 
number has sharply increased to over 
20 cases per year since 2000, 
prompting the FDA to issue a report 
in 2004.° The FDA more recently 
reported the initiation of 58 
counterfeit drug cases, representing 


Maryland Pharmacist -Jan./Feb./Mar. 2007 


an almost doubling of cases since 
2003. However, this increase may be 
due to increased vigilance by and 
coordination among manufacturers, 
distributors, re-packagers, 
pharmacies, patients, and regulators. 


Multi-Pronged Approach 

The FDA has outlined a multi- 
pronged approach to limit 
counterfeiting and has provided 
comment on progress to date.** The 
seven areas of improvement are: a) 
securing the actual drug product and 
its packaging, b) securing the 
movement of the product as it travels 
through the U.S. drug distribution 
chain, c) enhancing regulatory 
oversight and enforcement, d) 
increasing penalties for 
counterfeiters, e) implementing 
secure business practices, f) 
heightening vigilance and awareness 
of counterfeit drugs, and g) 
increasing international 
collaboration. While internet 
pharmacies located outside the U.S. 
are a potential source for introducing 
unapproved and counterfeit drugs 
into the U.S., the FDA report does 
not address international internet 
pharmacies or the illegal re- 
importation of medicines into the 
U.S., since these avenues are 
formally not part of the U.S. drug 
supply chain. 

Technology is playing a central 
role in the efforts to secure product, 


packaging, and movement through 
the supply chain, via a combination 
of track and trace technologies and 
product authentication technologies. 
The FDA encourages the use of one 
or more authentication technologies 
for drug products, especially 
products with greater potential to be 
counterfeited. Authentication 
technologies include color-shifting 
inks, holograms, taggants, and 
chemical markers that can be 
imbedded in a drug or its label. In 
addition, these technologies also 
have the ability to detect “gray 
market” products. “Gray market” 
products are those that are sold by a 
manufacturer at a relative discount to 
a buyer (e.g. hospital), but which is 
subsequently sold to a third party 
who would not receive the same 
discount from the manufacturer. The 
gray market stems from preferential 
product pricing for some customers, 
compared to other customers. 

Since individual states license 
distributors and pharmacies, state 
boards of pharmacy can play a 
critical role in implementing 
increased regulatory oversight. The 
Healthcare Distribution Management 
Association (HDMA) has suggested 
strengthening licensing procedures to 
consider that a legitimate drug 
wholesaler is structured as a “going 
concern,” demonstrates financial 
responsibility, and possesses robust 
operational standards and 


Page 17 


demonstrable compliance histories. It 
has also been suggested that 
manufacturers and distributors only 
sell to authorized distributors and 
licensed providers, and that 
authorized distributors only purchase 
from manufacturers or other 
authorized distributors. It has been 
further suggested that manufacturers 
assume greater responsibility for 
product integrity in the supply chain. 


Authentication Technologies 
for Packaging 

Radio frequency identification 
(RFID) is one of the leading package 
authentication technologies. RFID is 
the technology in Maryland’s EZ- 
Pass highway toll collection system, 
allowing drivers to save time when 
driving over the Chesapeake Bay 
Bridge. The FDA has indicated that 
RFID is the most promising track 
and trace technology. Track and trace 
would yield an accurate drug 
"pedigree" to document that the drug 
was manufactured and distributed 
under secure conditions. The 
Pharmaceutical Research and 
Manufacturers of America (PhRMA) 
White Paper supports electronic 
technologies, such as two- 
dimensional bar codes and RFID 
tags, allowing real-time 
authentication at the dispensing 
location. 

A misunderstanding of RFID is 
the notion that anybody can read an 
RFID tag, such that anyone could 
figure out what prescriptions a 
patient is carrying with them as they 
leave the pharmacy. As provocative 
as this scenario sounds, this scenario 
would not be the case with RFID, or 
at least highly unlikely. Does anyone 
worry about their EZ-Pass tag being 
read by a would-be-thief, while their 
car is parked at work ? No, and 
patients would not have to worry 
about RFID broadcasting what 
medicines they are taking. First, a 
drug RFID tag on a bottle of 100 
tablets would be separated from the 
dispensed tablets. Second, an RFID 
tag for a drug only encodes for a 


Page 18 


series of numbers and letters, and 
would only have meaning if 
connected to product identity, which 
would be a challenge. 


Product Authentication 

A disadvantage of 
authentication technologies for 
packaging, such as RFID, is that they 
only provide information about the 
packaging, which may not be 
indicative of what is actually inside 
the package. Yes, authentication of 
packaging is probably the best that 
can be achieved by wholesalers, who 
operate at low financial margins and 
practically never open packages. 
However, as an “end of the line” 
check, product authentication by 
pharmacists has great potential for 
being a final confirmation of product 
identity. Product authentication 
technology also holds promise to 
minimize dispensing errors. 

One promising technology is 
near infrared (NIR) spectroscopy, or 
simply NIR. NIR has been 
demonstrated to rapidly, in real time, 
identify medicines, without 
destroying or harming the medicine. 
Analytical Spectral Devices, Inc. has 
developed the RxSpec® technology 
which utilizes NIR to directly check 
the prescription drug while in the 
dispensing vial. This real time 
measurement is sensitive to chemical 
composition, color, and dosage level. 
The measured “chemical fingerprint” 
is compared to a known database, 
thereby providing 100% assurance 
that the dispensed drug is correct in 
both type and dose/concentration. 
Currently, the system is used in 
central-fill and mail-order 
pharmacies. Prescription vials that 
are filled, but uncapped move within 
an RFID-tagged carrier that pauses 
under the RxSpec® NIR camera. The 
RxSpec® system then collects an 
NIR image, as well as reads the 
RFID tag in the vial's carrier. The 
system queries a database for the 
NIR image of the drug that should be 
in the vial. A pass/fail result is 
recorded and later displayed to the 


pharmacist at the final inspection 
station. 

Professor Stephen Hoag and I at 
the University of Maryland are 
developing NIR technology that 
would allow pharmaceutical 
manufactures to encode each lot 
batch of medicines. Each batch of 
product, such as Lipitor, would be 
made unique by incorporating slight 
tablet formulation changes, 
compared to the previous batches. 
The unique formulation would 
provide for a “spectral signature” 
that is invisible to the naked eye, but 
readable by an NIR camera. 


View of Tomorrow 

The primary barriers of 
implementing anti-counterfeit 
technology are not technological in 
nature, but lie in the fact that 
manufactures, distributors, and 
pharmacists must work together to 
protect the entire drug distribution 
system. Pharmacists have of course 
always played a leading role in 
assuring that the right patient gets the 
right drug at the right time. However, 
the different and sometimes 
conflicting interests of manufactures, 
distributors, and pharmacists does 
create significant barriers to the 
implementation of new technologies. 
These barriers won’t be overcome 
without significant effort and 
participation of all these different 
groups. At this point, it appears that 
counterfeit drug products are a small 
but growing problem in the US, but 
that it is in everyone’s best interest to 
continue to work together to secure 
an even better drug distribution 
system. 

Back to Mrs. Harrity’s question, 
her cholesterol increase may in fact 
be due to taking a counterfeit form of 
Lipitor. She should consider having 
this prescription filled along with her 
hydrochlorothiazide and glyburide at 
her local pharmacy. 


Maryland Pharmacist -Jan./Feb./Mar. 2007 


References 

1. Federal Food Drug and Cosmetic Act. http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm. Accessed December 5, 2006. 

2. Counterfeit Drugs Questions and Answers. http://www. fda.gov/oc/initiatives/counterfeit/qa.html. Accessed December 5, 2006. 
3. Combating Counterfeit Drugs: A Report of the Food and Drug Administration. February 2004. 

http://www. fda.gov/oc/initiatives/counterfeit/report02_04.html. Accessed December 5, 2006. 

4. Combating Counterfeit Drugs: A Report of the Food and Drug Administration. May 2005. http://www.fda.gov/oc/initiatives/ 
counterfeit/update2005.html. Accessed December 5, 2006. 


James E. Polli, RPh, PhD 
Associate Professor, University of Maryland School of Pharmacy 


jpolli@rx.umaryland.edu 


Column Editor: 
Mary Lynn McPherson, Pharm.D., BCPS 
Professor, University of Maryland School of Pharmacy 


mmcphers@rx.umaryland.edu 


Maryland Pharmacist -Jan./Feb./Mar. 2007 Page 19 


PHARMACY MARKETING GROUP, INC 


AND THE LAW 


By Kerianne M. Hanson & Don R. McGuire, Jr., R.Ph., J.D. 


This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy 
Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to 
the pharmacy community. 


COMBAT METHAMPHETAMINE EPIDEMIC ACT: 
WHAT THIS ACT MEANS FOR YOUR RETAIL SETTING 


On March 9"", 2006, President Bush signed the Beginning September 30, 2006, patients 

Patriot Act, which includes a portion known as the everywhere in the nation will need to visit a 

Combat Methamphetamine Epidemic Act of 2005’. pharmacy or other regulated seller in order to 

In light of this decision, the sale of purchase pseudoephedrine-containing products. 

pseudoephedrine-containing products across the 

nation is set up for big changes, and the It is important to keep in mind that some of the 

responsibility of enforcing these changes has specific regulations, such as who in the pharmacy is 

landed on the shoulders of licensed pharmacists in allowed to sell the products (i.e. pharmacists only, 

retail settings. technicians, interns, etc.) has been left up to the 
individual states. States may also implement more 

Pseudoephedrine is a decongestant found in stringent requirements for the purchase limitations. 

multiple products used to treat symptoms Pharmacists should check with their State Board of 

associated with the common cold and seasonal Pharmacy to ensure they are aware of state- 

allergies* It is also the primary ingredient needed specific regulations and train their pharmacy staff 

to manufacture methamphetamine, an illicit drug accordingly. 

that has rapidly gained popularity in the U.S. over 

the past few years. The new regulations regarding Some of the federal regulations regarding the sale 

the sale of pseudoephedrine are intended to curb of pseudoephedrine-containing products according 

the manufacturing of methamphetamine by making to the Combat Methamphetamine Epidemic Act are 

it more difficult to accumulate large amounts of summarized below’: 

pseudoephedrine and by keeping a record of all 

pseudoephedrine purchases. e All pseudoephedrine-containing 

products must be kept behind the 

The Combat Methamphetamine Epidemic Act counter. 

categorizes pseudoephedrine as a controlled e An individual may purchase no more 

substance and regulates, among other factors, the than 3.6 grams of pseudoephedrine in 

amount of pseudoephedrine sold to individuals. one day. 

Although some states, particularly in the Midwest, 

have been following pseudoephedrine regulations e An individual may purchase no more 

for over a year now, the Combat Methamphetamine than 9 grams of pseudoephedrine in any 


Epidemic Act makes the regulations federal law. 


3 The Library of Congress. Title Vil: Combat Methamphetamine 


1 Legal Requirements for the Sale and Purchase of Drug Products Epidemic Act of 2005. House Report 109-333. Accessed May 24 


Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. : 

oe : 2006. http://thomas.loc.gov/cqgi- 
Sanyo a, piesa Aaa ek gta 24, 2006. bin/cpquery/?&dbname=cp 1098&sid=cp 109djs6R&refer=&r_n=hr333.10 
www ida .govicder/news/menampheamine mm. 9&item=&sel=TOC 358801&> 


2 Lexi-Comp’s Drug Information Handbook. 13" ed. Hudson, OH: 
APhA; 2005:1275-76. 


Page 20 Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


30-day period (however, only 7.5 grams In response to the new regulations, and in an effort 


if the seller is a mobile retail vendor). to further hinder methamphetamine production, 
The purchaser must present a State or many product manufacturers have voluntarily re- 
Federal Government issued photo formulated their products to contain alternative 
identification card at the time of decongestants such as Phenylephrine. These 
purchase. products, commonly identified by the letters PE (ex. 
Either a written or electronic logbook of Sudafed® PE), may offer alternatives to patients 

all pseudoephedrine transactions must who need decongestant products on a daily basis. 
be kept by the pharmacy for a period not It is also important to recognize that the majority of 
less than two years from the date of the regulations established by the Combat 
purchase. Methamphetamine Epidemic Act do not apply to 
For each sale, information including the prescription products containing pseudoephedrine, 
name and address of the purchaser, the but these products will be classified as controlled 
name of the product, the quantity substances, and regulations set forth by the 
purchased, and the date and time of the Controlled Substance Act 1970 are now applicable. 
transaction must be collected and 

entered into the logbook. Many states Complete information regarding the Combat 

will also require additional information be Methamphetamine Epidemic Act and the 
collected, such as the purchaser’s regulations it sets forth are available on the Food 
birthday or a driver’s license number. and Drug Administration’s website (www.fda.gov) 
Products packaged for individual sale and from each individual state’s Board of 

that contain less than 60 milligrams of Pharmacy. 


pseudoephedrine are exempt from the : 


logbook requirements but must also be 
kept behind the counter. © Kerianne M. Hanson and Don R. McGuire. Kerrianne 
M. Hanson is a Pharm.D/MBA Candidate at the Drake 


mesibbelpacist ust conto mule University College of Pharmacy in Des Moines, lowa. 


LU aa aie iy oe etic ag Don R. McGuire Jr., R.Ph., J.D. is Assistant General 

AMENS Nom EUS AACS UA: Counsel, at Pharmacists Mutual Insurance Company. 

identification card. 

The purchaser must provide a signature This article discusses general principles of law and risk management. 

verifyi ng the information provided is It is not intended as legal advice. Pharmacists should consult their own 
t attorneys and insurance companies for specific advice. Pharmacists 

correct. should be familiar with policies and procedures of their employers and 


insurance companies, and act accordingly. 


Combat Methamphetamine Epidemic Act: 
What This Act Means For Your Retail Setting 


This a Clarification of Rx and the Law article entitled 
Combat Methamphetamine Epidemic Act: What This Act 
Means For Your Retail Setting. The law does not restrict 
sales to only pharmacies. Sales are restricted to 
retailers who have undertaken the control and training 
requirements of the Act. States are also allowed to 
enact more stringent requirements than the Federal 
sales limitations. The 30 day sales limitation should 
have said that individuals are restricted to purchasing no 
more than 9 grams of pseudoephedrine in a 30 day 
period. The 7.5 gram limitation applies to sales by 
mobile retail vendors. We apologize for the 
inaccuracies. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 Page 21 


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Page 22 Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


Continuing Education 
for Pharmacists 


Acute Viral Hepatitis: 
Prevalence, 
Prognosis, and 
Prevention 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 


Ohio Northern University 
Ada, Ohio 


and 


J. Richard Wuest, R.Ph., 
Pharm.D. 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


Goals. The goals of this lesson are 
to discuss acute viral hepatitis with 
emphasis on the biological charac- 
teristics of and physical responses 
to hepatitis viruses A, B, and C. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. summarize key points 
relative to the biological character- 
istics of hepatitis A, B, and C 
viruses; 

2. identify the pathological 
responses to infection by hepatitis 
A, B, and C viruses; and 

3. select from a list important 
points to convey to patients relative 
to acute viral hepatitis. 


This continuing education activity 
is supported by 
an educational grant from 
GlaxoSmithKline. 


& 
os 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


i 


Gossel 


Acute viral hepatitis is a systemic 
infection of the liver predominantly. 
Most clinical cases are caused by 
one of five viruses: hepatitis A virus 
(HAV), hepatitis B virus (HBV), 
hepatitis C virus (HCV), hepatitis D 
virus (HDV), and hepatitis E virus 
(HEV). Together, they infect nearly 
5 million people in the U.S., and 
according to a World Health Organi- 
zation estimate, more than 500 
million people worldwide. 

All human hepatitis viruses are 
RNA viruses with the exception of 
HBV, which is a DNA virus. All 
hepatitis viruses produce clinically 
similar illnesses ranging from 
asymptomatic disease to rapidly 
progressive and chronic liver disease 
that can lead to cirrhosis and 
hepatocellular carcinoma. The three 
viruses that cause most human 
cases of hepatitis in the U.S. are 
compared in Table 1. 


Epidemiology 
Viral hepatitis was formerly labeled 
either as “infectious” or “serum” 
hepatitis for HAV and HBV, respec- 
tively. Distinguishing between the 
various viral types cannot be 
accomplished solely on the basis of 
clinical or epidemiologic features. 
Today, classification involves 
specific serologic testing. 

Hepatitis A. HAV is a highly 


contagious virus that causes 


Volume XXIV, No. 7 


widespread human infection world- 
wide, particularly in developing 
countries. There are also areas in 
the U.S., which because of poor 
sanitation practices, have high HAV 
infection rates. 

The course of hepatitis A 
infection is extremely variable. The 
majority of infections in children are 
asymptomatic, whereas most adult 
infections are symptomatic. Approx- 
imately 100 people in the U.S. die 
each year as a result of HAV. 

HAV is transmitted almost 
exclusively by the fecal-oral route. 
Unlike HBV and HCV, the hepatitis 
A virus remains stable when 
hepatocytes secrete it into the bile, 
which passes into the digestive 
tract. Fecal matter from an infected 
person, therefore, contains a high 
concentration of the virus, and it 
can survive on a hand or other 
surface for three to four hours at 
normal room temperatures. The 
virus can also be transmitted via a 
contaminated eating utensil. 

Person-to-person transmission 
of HAV is accelerated by poor 
hygiene and overcrowding. Large 
outbreaks have been traced to 
contaminated food, water, milk, and 
raw shellfish. Spread within fami- 
hes, children and employees in 
daycare facilities through diaper 
changing, and persons within 
institutions including the military 
and prisons is also common. Kissing 
on the mouth and anal sex are 
confirmed routes of transmission. 
Contaminated needles and/or 
syringes used for injecting illicit 
drugs is a route of transmission. It 
is not known how infection occurs in 
about 40 percent of reported cases. 
The Centers for Disease Control and 
Prevention (CDC) lists household or 
sexual contacts, daycare attendance 


Page 23 


rr , 


Table 1 
Comparison of Hepatitis A, B and C 
Hepatitis A Hepatitis B Hepatitis C 
Cause Hepatitis A virus (HAV) Hepatitis B virus (HBV) Hepatitis C virus (HCV) 
Detection Feces of persons with HAV Blood and certain body fluids of Blood and certain body fluids of 
persons with HBV persons with HCV 
Spread Close personal contact Exposure to body fluid from person Exposure to body fluid from 
(including sex or sharing a infected with HBV; unprotected sex; person infected with HCV; 
household); food or water sharing needles; needlestick; sharing needles; needlestick; 
contaminated with HAV mother-infant transmission at birth mother-infant transmission at birth; 
unprotected sex (rare) 
Incubation 15 to 50 days (20 average) 45 to 160 days (120 average) 14 to 180 days (45 average) 
Onset Acute Insidious or acute Insidious 
Severity Mild Occasionally severe Moderate 
Risk Household contacts or sex Sex partners of infected persons or Injecting drug users; clotting factor 
partners of infected persons; those with multiple sex partners; recipients before 1987; hemodialysis 
children in US high-rate areas men who have sex with men; injecting | patients; blood and solid organ 
during 1987-97; travelers to drug users; household contacts of transplant recipients prior to 1992; 
countries with increased rates'; | chronically ill persons; infants of infants of infected mothers; sex 
men who have sex with men; infected mothers; infants/children from| partners of infected persons or those 
injecting and non-injecting drug | countries with high HBV rates’; with multiple sex partners (rare, 
users workers exposed to blood; chronic but may increase risk of infection) 
hemodialysis patients 
Infection Not chronic; once infected, HAV | Chronic for 90% infected at birth, 30% Chronic for 75-85% of those infected; 
cannot recur; 15% have pro- infected at age 1-5 years, 2-6% infected| chronic liver disease for 70%; 8000 
longed illness or relapsing after age 5 years; 5000 die annually in | to10,000 die annually in US; high- 
symptoms over 6-9 months US; higher risk of liver cancer or er risk of liver cancer or cirrhosis; 
cirrhosis leading indication for liver 
transplant 
Treatment None available; alcohol Interferon, pegylated interferon, lami- | Interferon, pegylated interferon, 
worsens prognosis vudine, adefovir, entecavir approved ribavirin; combination therapy can 
for chronic HBV; liver transplant; eliminate virus in approx. 50%; 
alcohol worsens prognosis; liver alcohol worsens prognosis; liver 
function testing every 6-12 months function testing every 6-12 months 
Prevention Hepatitis A vaccine; hand Hepatitis B vaccine; safe sex; avoiding | No available vaccine; safe sex; 
washing around food prep- tattoos, shared needles/syringes; per- avoiding tattoos, shared needles/ 
aration, diaper changes and sons with HBV should avoid donating | syringes; persons with HCV should 
toilet use blood, organs, or tissues; get avoid donating blood, organs or 
vaccinated against hepatitis A tissues; get vaccinated against 
hepatitis A and B 
‘Excluding Canada, Western Europe, Japan, Australia, New Zealand 
Including Asia, Africa, Pacific Islands, Eastern Europe, Middle East, Amazon basin 


or employment, and international 
travel as the major risk factors for 
transmission of HAV. 

There seems to be a predilection 
for hepatitis A outbreaks in late fall 
and early winter. The incidence of 
hepatitis A in developed countries 
has been declining in recent years, 


However, other fluids, such as semen, 
vaginal secretions, and saliva are also 
infectious. HBV can remain contagious 
in the environment for at least seven 
days. It can also be inactivated by 
disinfectants such as 1:10 dilutions of 
household bleach. 

The mode of transmission may be 
by contact with contaminated body 


most likely as a function of 
improved sanitation. 

Hepatitis B. HBV belongs 
to a family of genetically related 
animal viruses that are 
hepatotropic (i.e., have a high 
affinity for the liver). The 
highest concentrations of infec- 
tious HBV are found in blood. 


Page 24 Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


secretions, percutaneously usually 
through accidental needlesticks or 
by sharing needles and/or syringes 
with infected persons, or by mater- 
nal-neonatal transmission. Trans- 
mission of HBV can also occur 
during close contact with an in- 
fected person. HBV infection via 
blood transfusion is now rare in the 
U.S. as a result of screening of blood 
donors. The means of transmission 
in 30 to 40 percent of cases remains 
unknown. Perinatal transmission is 
uncommon in the U.S.; most 
infections occur during delivery and 
are not related to breast feeding. 
Oral ingestion is a potential, but 
inefficient, route of exposure. There 
is ahuman reservoir of persistently 
infected persons nearly worldwide. 

CDC estimates that more than 
1.25 million individuals in the U.S. 
and 350 million people worldwide 
are HBV carriers. They constitute 
the primary reservoir of hepatitis B 
in humans. Approximately 90 
percent of infants and 6 to 10 
percent of adults in the U.S. who 
are infected with HBV will become 
carriers. Approximately 50,000 HBV 
cases are reported in the U.S. each 
year; the number of unreported 
cases may be 10 times greater. High 
rates of HBV infection occur in 
spouses of acutely infected persons, 
sexually promiscuous persons 
(especially men who have sex with 
men), health care workers exposed 
to blood, persons who require 
repeated transfusions especially 
with pooled blood product concen- 
trates, residents and staff of custo- 
dial institutions for the developmen- 
tally handicapped, prisoners, and to 
lesser extent, family members of 
chronically infected patients. 

Hepatitis C. Hepatitis C virus 
is acommon chronic bloodborne 
infection in the U.S., accounting for 
an estimated 8000 to 10,000 deaths 
annually. Approximately four 
million persons in the U.S. have 
been infected; three million have 
chronic HCV infection. 

Routine screening of blood 
donors for HBV, along with elimina- 
tion of commercial blood sources in 
the early 1970s, reduced the fre- 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


quency of transfusion-associated 
hepatitis. Voluntary self-exclusion of 
blood donors at risk for AIDS in the 
1980s, along with introduction of 
donor screening for HIV, further 
reduced the probability of acquiring 
HCV via transfusion. 

Individuals who encounter 
infected blood or instruments or 
needles, such as illicit drug users, 
health care workers or public safety 
workers, are at risk of acquiring 
hepatitis C infection. Other poten- 
tial risks include intranasal cocaine 
use, tattooing and body piercing. 
People who live with HCV infected 
individuals should not share per- 
sonal items such as razors, tooth- 
brushes, and nail clippers. Women 
with hepatitis C infection do not 
need to avoid pregnancy or breast 
feeding. Approximately 5 percent of 
infants born to HCV infected 
females may be infected. HCV- 
positive mothers should abstain 
from breast-feeding if their nipples 
are cracked or bleeding. 

Chronic hepatitis C appears to 
be aslowly progressive disease that 
may gradually advance over two to 
four decades. Newly acquired cases 
of hepatitis C that are diagnosed in 
an otherwise healthy person can 
often be traced back to the 
individual’s brief period of illicit 
injection drug use or promiscuous 
sexual encounters two to four 
decades earlier. 


Pathogenesis 

The hepatitis viruses do not directly 
cause damage to hepatocytes; 
rather, the clinical manifestations 
and outcomes following acute 
hepatic damage associated with 
viral hepatitis are determined by 
the immunologic response of the 
host. The pathogenesis of hepatitis 
B has been studied to greatest 
extent. Persons with defective 
cellular immune competence are 
more likely to remain chronically 
infected rather than to clear the 
virus from the body. 


Signs And Symptoms 

Following an incubation period that 
varies widely according to the 
responsible agent (see Table 1), 


signs and symptoms of acute viral 
hepatitis appear. Prodromal symp- 
toms of acute viral hepatitis are 
systemic and variable. Constitu- 
tional symptoms include anorexia, 
nausea, and vomiting; cough, runny 
nose, and sore throat; fatigue; 
malaise; arthralgias, myalgias, 
headache; and photophobia that 
may precede onset of jaundice by 
one to two weeks. Gastrointestinal 
symptoms are often associated with 
alterations in smell and taste. A 
low-grade fever of 100-102° Fis 
usually more common in hepatitis A 
than in hepatitis B or C, except 
when hepatitis B occurs with the 
serum sickness-like syndrome. A 
fever of 103-104° F may accompany 
the symptoms, but this is rare. A 
dark urine and clay-colored stools 
one to five days before onset of 
clinical jaundice may be noted. 

Weight loss of five to 10 pounds 
is common and may continue 
throughout the entire icteric (i.e., 
pertaining to jaundice) phase. The 
liver enlarges and may be tender, 
with pain and discomfort in the 
right upper quadrant. Ten to 20 
percent of patients with acute 
hepatitis develop splenomegaly and 
cervical adenopathy. 

Constitutional symptoms abate 
during recovery, but some liver 
enlargement and abnormalities in 
liver function tests remain. The 
duration of the posticteric phase 
may range from two to 12 weeks, 
and is usually more prolonged in 
acute hepatitis B and C. Complete 
recovery from hepatitis A occurs 
within one to two months, and in 
three to four months in 75 percent 
of persons with uncomplicated 
hepatitis B or C. 


Prognosis 

In general, hepatitis A is a self- 
limiting disease. Most previously 
healthy patients infected with HAV 
recover completely from their illness 
within weeks to six months without 
clinical complications. Recovery is 
generally complete, and followed by 
protection against future HAV 
infection. Illness may be prolonged. 
Relapse of clinical illness occurring 


Page 25 


a 


weeks to months after apparent 
recovery has been described. 
Cholestatic hepatitis, noted by 
protracted cholestatic jaundice with 
itching is another unusual variant 
of acute hepatitis A. Approximately 
20 percent of adults with hepatitis A 
require hospitalization. 

Ninety-five to 99 percent of 
otherwise healthy adults with acute 
HBV infection recover completely. 
Elderly patients and those with 
serious underlying medical disor- 
ders may have a prolonged recovery, 
and are more likely to develop 
severe hepatitis. The presence of 
ascites, peripheral edema, and 
hepatic encephalopathy suggest a 
poor prognosis. A low serum albu- 
min and high serum bilirubin 
values, and hypoglycemia suggest 
severe hepatocellular pathology. The 
fatality rate in hepatitis A and Bis 
low, but increased by old age and 
underlying debilitating disorders. 

Hepatitis C causes signs and 
symptoms that are less severe than 
hepatitis B during the acute phase. 
Jaundice is less likely to occur. 
Fatalities are rare; the precise 
fatality rate is unknown. HCV 
ranks with alcohol as a major cause 
of chronic liver disease and cirrhosis 
in the U.S. Infection with this virus 
causes inflammation and low-grade 
damage to the liver that, over 
several decades, can lead to cirrho- 
sis and hepatocellular carcinoma. 
HCV is the most frequent indication 
for liver transplantation. 

Fulminant hepatitis (occurring 
suddenly and with great intensity) 
is the most feared complication of 
viral hepatitis. Fortunately, this 
massive hepatic necrosis is rare. It 
occurs in persons with both hepati- 
tis B and D infections, but rare 
fulminant cases of hepatitis A also 
occur in older adults and others 
with underlying chronic liver 
disease, including chronic hepatitis 
B and C. More than half of all 
severe hepatitis cases are caused by 
HBV, a significant number of which 
are associated with HDV infection, 
and another portion with underlying 
chronic hepatitis C. Fulminant 


Page 26 


hepatitis is rare in persons with 
HCV alone. 

A late complication of acute 
hepatitis B is chronic hepatitis B 
that occurs in a small number of 
patients with acute disease. Acute 
hepatitis is more apt to advance to 
chronic hepatitis when there is 
incomplete resolution of clinical 
symptoms of loss of appetite, weight 
loss, and fatigue and persistence of 
hepatomegaly; signs of multilobular 
(widespread) hepatic necrosis on 
liver biopsy during protracted, 
severe acute viral hepatitis; and 
failure of aminotransferase, biliru- 
bin, and albumin serum levels to 
return to normal within six to 12 
months following acute illness. 
Pancreatitis, myocarditis, atypical 
pneumonia (pulmonary virus 
disease with symptoms resembling 
those of pneumonia), aplastic 
anemia, and peripheral neuropathy 
are rare complications of viral 
hepatitis. 


Prophylaxis 
Knowledge of the natural history of 
hepatitis infections has steadily 
evolved over the past several de- 
cades. Emphasis is upon prevention 
through immunization of viral 
hepatitis since antiviral therapy is 
effective in only a small number of 
patients. Prophylaxis differs for 
each type of viral hepatitis. 

Hepatitis A and B. The first 
plasma-derived HBV vaccine was 
licensed in the U.S. in 1982. It is no 
longer available in this country. A 
recombinant HBV vaccine was 
licensed in the U.S. in 1986 
(Engerix-B), followed closely by 
another vaccine in 1989 
(Recombivax HB). The first HAV 
vaccine was licensed in the U.S. in 
1995 (Havrix), followed by approval 
of a second vaccine in 1996 (Vaqta). 
Both vaccines are inactivated whole- 
virus vaccines that have demon- 
strated safety and efficacy in 
preventing HAV infection. A com- 
bined HAV/HBV vaccine (Twinrix) 
was approved for use in the U.S. in 
2001. 

Hepatitis C and D. Hepatitis 
D infection can be prevented by 


vaccinating high-risk persons with 
hepatitis B vaccine. There is no 
vaccine to prevent HDV specifically. 


‘Likewise, there is no vaccine to 


immunize against HCV. Prevention 
of infection is best achieved by 
screening donor blood, excluding 
blood donors in high-risk situations, 
and use of highly sensitive serologic 
screening tests for HCV infection. 
There are no recommendations for 
babies born to mothers with hepati- 
tis C and no restrictions for their 
breast feeding. 


Patient Advice 

It is imperative that patients who 
are at risk or plan to travel to areas 
where the viruses are found speak 
with their physician about preven- 
tive measures for hepatitis immuni- 
zation. Vaccines for HAV and HBV 
are safe and effective for prophylaxis 
against their respective viruses. 


Overview and Summary 
Hepatitis is acommon infection 
caused by one or more contagious 
viruses. There are safe and effective 
vaccines that protect against 
hepatitis A and B. There is no 
vaccine for hepatitis C or D. Indi- 
viduals at risk for hepatitis should 
seek immunization and avoid 
practices and conditions that 
increase their susceptibility. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


Continuing Education Quiz 


This month’s questions are taken from the article on “Acute Viral Hepatitis: Prevalence, Prognosis, and Prevention”. Circle your answers to 
the following questions and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 21201-1572. There is 
no charge for this quiz for MPhA members (non-members $ 10.00). The completed quiz for this issue must be received by 10/15/08. A 

continuing education certificate for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to eight weeks. Please type 


or print clearly. ACPE# 129-144-06-007-H01. 


Name 
Address 

City, State, Zip 
Daytime Phone 


Date Completed 
(Required) 


1. All human hepatitis viruses are RNA viruses 
EXCEPT: 

a. HAV. c. HGV. 

b. HBV. d. HDV. 


2. In which of the following age groups are the 
majority of hepatitis A infections asymptomatic? 
a. Children 
b. Adults 


c. Geriatrics 


3. The Centers for Disease Control and Prevention 


lists all of the following as major risks for transmis- 


sion of HAV EXCEPT: 
a. daycare attendance. 
b. international travel. 
c. playing with pets. 
d. sexual contact. 


4. HBV belongs to a family of genetically related 
animal viruses that are: 

a. hepatoblastic. c. hepatomegalic. 

b. hepatoenteric. d. hepatotropic. 


5. The mode of transmission of hepatitis B virus 
includes all of the following EXCEPT: 
a. accidental needlesticks. 
b. fecal/oral route. 
c. needle/syringe sharing by infected individuals. 
d. maternal/neonatal transmission. 


Maryland Pharmacist ¢ Jan./Feb./Mar. 2007 


The Maryland Pharmacy Continuing 
Education Coordinating Council is 
accredited by the Accreditation Council for 


Pharmacy Education as a provider of 
continuing education for pharmacists. 


6. Hepatitis viruses: 
a. directly cause damage to hepatocytes. 
b. do not directly cause damage to hepatocytes. 


7. When comparing HAV, HBV, and HCV, which 
has the shortest average incubation period? 

a. HAV 

b. HBV 

c. HCV 


8. Which of the following types of hepatitis viruses is 
most likely to cause a low-grade fever of 100-102°F? 
a. HAV 
b. HBV 
Cali 


9. The first hepatitis virus vaccine was licensed in 
the U.S. in: 

Bh sys. c. 1972. 

b. 1962. d. 1982. 


10. At the present time, there is no vaccine for: 
a. HAV. 
b. HBV. 
¢) HCV: 


Page 27 


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- VOLUME 83 No. 2 


_President’s Commentary 
‘All Good Things Must Come to an End” 


125" Annual Convention 


“In Pictures” 


Therapeutically Speaking 
“MTMS is More Than MythS” 


Continuing Education 
“Varicella-zoster Virus Infection: 
the Diseases and Vaccines for 
Prevention” 


Crab Feast — Berlin Fire Hall 


MARYLAND PHARMACISTS ASSOCIATION 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 


410-727-0746 


www.marylandpharmacist.org 


MPhA Officers 2006 - 2007 


Ginger Apyar, P.D., President 

Joe Marrocco, P.D., First-Vice President 
Walter Abel, P.D., Treasurer 

Joe Fine, R.Ph., Honorary President 


House Officers 


Barry Poole, R.Ph., Speaker 
Ruth Blatt, P.D., Vice-Speaker 


MPhA Staff 


Howard Schiff, P.D., Executive Director 
Elsie Prince, Office Manager 
Nancy Ruskey, Administrative Assistant 


MPhA Trustees 


Matthew Shimoda, Pharm.D., Chairperson 
Michelle Andoll, P.D., J.Do. 2... eee. 2008 
Butch Henderson, R.Ph. ..........---- 

Mary Kremzner, Pharm.D. 

Neil teikach, PDs 36. ee ee 
Magaly Rodriguez deBittner, Pharm.D. ... 

David RUSSO, R.PN. 32. ee 2008 
Carol Stevenson, Pharm.D. 2007 
Doris Voigt, Pharm.D. .........--055.: 2008 
Walter Fasch, President ASP 


Ex-Officio Members 
David Knapp, Ph.D., Dean - 

UMB School of Pharmacy 
Jennifer Thomas, Pharm.D. - MSHP 
Representative 


Maryland State Board of Pharmacy 


Mark Levi, P.D., President 
Jeanne Furman, P.D., Treasurer 
Donald Taylor, P.D., Secretary 
Margie A. Bonnett 

Joseph A. DeMino, P.D. 

David R. Chason, R.Ph. 


Alland Leandre, M.S., M.B.A. 
Mayer Handelman, P.D. 

Mike Souranis, P.D. 

Harry Finke, Jr., P.D. 

Rodney Taylor, Pharm.D. 
Cynthia Anderson, M.S., R.Ph. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


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Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 650 West Lombard 
Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals postage paid at Baltimore, MD and at additional 
mailing office. Articles and editorials that appear do not necessarily reflect the official positions of the Maryland Pharmacists Association and may 
contain views and opinions for which the authors hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West 
Lombard Street, Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


ofober eee 


Presidents’ Commentary Sanbably 


'/ 
| : pi cecstiles 
| bieiteeetlh 


All good things must come to an end and so does my term as 
President of the Maryland Pharmacists Association. I am confident 
that our Association will continue to advance the profession of 
pharmacy. My confidence comes from the tremendous support I had 
over the past year from our membership. The transition from this 
president to Joe Morocco will be seamless. Joe's outstanding 
leadership has been evident this past year and it was greatly 
appreciated. 


a-n.cihaA 


Working together with my Chairmen, the Board of Trustees and our 
Executive Director and staff has made my job an easy one. I have 
had the good fortune to have Matt Shimoda as my Chairman of the 
Board and Joe Morrocco as Vice-President. I had an enviable 
position with these 2 officers, one on my left, the other on my right. ‘ Pk 
Both were dedicated, to assisting this officer. I couldn’t have done Virginia Apyar, President pictured in 
it without you! Hats off to our treasurer, Walter Abel who kept us in the lower level of the B. Olive Cole 
check with our finances. A huge thank-you to my Chairman: Pharmacy Museum 
Michelle Andoll-Comminucations, Doris Voigt-Mid-year and 

Convention, Brian Hose-Legislation, Professional Developement-Hoai An Truong, Membership-Mary Kremzer, 
and Speaker of the House-Barry Poole, and Vice-Speaker-Ruth Blatt, and ASP-Walter Fasch. 


In March, the Building and Property Chairman, Doug Campbell, spent a Saturday at the Flag House being part 
of a program on 1812 era pharmacy and medicine. Doug was able to display some artifacts from the B. Olive 
Cole Museum Collection at the Star-Spangled Banner Museum. It was a great opportunity to be involved in the 
community and spread the word about pharmacy. Thank-you Doug, for your enthusiasm and introducing B. 
Olive Cole to those in attendance. 


While attending the American Pharmacists Association convention in Atlanta this past March, I learned about 
the renovation and expansion of the headquarters building at 2215 Constitution Ave, N. W.,Washington, DC. 
The campaign is known as, Bringing your Medicines to Life. How fortunate that pharmacy has such a 
prominent address in our nation’s capital! This historic national landmark is the only privately owned building 
on the National Mall. It was designed by John Russell Pope whose work included the National Archives, the 
Jefferson Memorial and DAR Constitution Hall. To support this campaign, pavers are being offered through a 
pledge. The pavers will be located on the East Terrace of the building. The Ohio Pharmacists Association has 
issued a challenge to the other state associations to make a pledge of $5,000 each to have a paver on the East 
Terrace. I hope the membership will be involved and Maryland will be represented. With this great symbol of 
pharmacy in our own backyard we have a unique opportunity to show our support. Already, many Maryland 
pharmacists have made a pledge for their own personal paver. 


It has been an honor and a pleasure to serve as your President this past year. I am certain that our past successes 
combined with the efforts of the membership will build future ones. I feel very optimistic! I have had the most 
wonderful opportunity and I have worked with an outstanding leadership team. But, I couldn’t say good-bye 
without recognizing the dedication and good work of Elsie, Nancy and Howard. Thank you for your support 
and encouragement! 


All the best! 
Ginger 


Page 4 Maryland Pharmacist ¢ April/May/June 2007 


MPhA 125° Annual Convention In Pictures 
Ocean City, Maryland 
June 16 - 19, 2007 


ntor of the Year Award 
Ellen Yankellow 


oa 


Outgoing Speaker—Barry Poole 
Incoming Speaker—Ruth Blatt 


Incoming President 
Joe Marrocco 


& EY a 
Bowl of Hygeia Award 
John Balch 


Maryland Pharmacist ¢ April/May/June 2007 Page 5 


Seidman Award Distinguished Young Pharmacist Award 
Paul Holly Brian Hose 


Outgoing Presidents Award 
Ray Love Ginger Apyar 


Murhl’s Dress Code—Strictly Casual Trade Show 


Matt Loses the Tie Christine Lee P3 


Crab Feast Craresccane 
John VanWie Pharmacists Mutua] 


Page 6 Maryland Pharmacist « April/May/June 2007 


PHARMACY MARKETING GROUP, INC 


AND THE LAW 


By Don McGuire, R.Ph., J.D. 


This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy 
Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the 


pharmacy community. 


NOBODY EVER READS THOSE THINGS 


Steve was busy at work in his pharmacy. He 
was filling a prescription for one of his patient’s 
HRT orders. Steve was very annoyed at the 
stack of leaflets provided with the stock bottle. 
He decided to simplify his life and threw the 
leaflets away. 


Joan was at work across town in her pharmacy. 
Joan had ordered a motorized wheelchair for 
one of her patients. The chair had arrived with a 
multi-page instruction booklet prominently 
marked — “Give This Instruction Booklet to the 
Ultimate User”. Joan decided that she could tell 
Mr. Jones everything that he would need to 
know to operate the chair and threw the booklet 
away. 


Later that year, Steve was served with a lawsuit 
by Ms. Smith alleging that he didn’t warn her 
about the dangers of HRT. Joan was also served 
with a lawsuit. Mr. Jones was injured when he 
tumbled out of the chair while maneuvering on 
an incline. He alleged that he was not properly 
instructed on the use of the chair. 


When interviewed by their defense attorneys, 
both Steve and Joan had the same response, 
‘Nobody ever reads those things, so I don’t 
bother providing them.” While this may be true 
for some patients, it is a poor risk management 
decision. It is a poor decision for two reasons. 


First, the provision of these information leaflets 
may be required by law (as in the case of 
estrogens and other products) or by the 
manufacturer (as in the case of the motorized 
wheelchair). It can be difficult to present a 
credible defense to these allegations when it is 
clear that the information wasn’t provided. 
Failure to follow these requirements and provide 
this information can be seen as a breach of duty 
and lead to a finding of negligence or negligence 
per se. 


In legal terms, negligence is defined as the 
failure to use the degree of care that would have 
been used by a reasonable, prudent person in the 
same or similar circumstances. For Steve and 
Joan, this means measuring their actions against 
what a reasonable pharmacist would have done 
in their situations. The plaintiff-patient will 
prevail if they can prove that the pharmacist 
failed to meet the standard of care and that they 
were injured as a result of the pharmacist’s 
actions. 


However, in the case of negligence per se, the 
failure to follow the requirements of a statute or 
regulation is taken as proof of negligence. In 
the majority of states, the plaintiff-patient has 
only to prove that their injury resulted from this 
violation. This makes the likelihood of a 
plaintiff's verdict much higher. 


Maryland Pharmacist eApril/May/June 2007 Page 7 


The second reason that this kind of behavior is 
not good risk management is that it deprives 
some patients of needed information. Even if 
most patients won’t read the booklets, the 
remaining patients don’t even get the 
opportunity to read them. Think about the 
owner’s manual for a new automobile. They 
can be hundreds of pages long and most people 
haven’t read theirs from cover to cover. But, if 
they have a question, the manual ‘is there for 
them to consult. The same thing applies to our 
patients. Maybe they won’t go home and read it 
right away, but it is there to consult. 


In a practical sense, it is much easier to defend a 
case where the patient was fully informed, but 
chose to ignore the information, rather than a 
case where the patient never received the 


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information. We. will never know which of 
those patients would be able to say, “I would 
have read it if they had given it to me.” Steve or 
Joan’s response to their defense attorneys 
doesn’t sound very persuasive when contrasted 
with this statement. It is better for you and your 
patients to let them decide whether they will 
read this type of information. 


ee LEE EEE EEE EERE 


© Don McGuire, R.Ph., J.D., is Assistant General 
Counsel at Pharmacists Mutual Insurance Company. 


This article discusses general principles of law and risk 
management. It is not intended as legal advice. 
Pharmacists should consult their own attorneys and 
insurance companies for specific advice. Pharmacists 
should be familiar with policies and procedures of their 
employers and insurance companies, and act accordingly. 


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Page 8 Maryland Pharmacist eApril/May/June 2007 


A Brief History of the Pharmacists Education and Assistance Committee 


Tony Tommasello, Pharmacist, Ph.D. 


The Pharmacists’ Education and Assistance Committee (PEAC) was created in 1983 as the “Pharmacists Rehabilitation 
Committee.” PEAC is a 501(c)3 not-for-profit corporation with the mission to preserve professional health and public 
safety through advocacy and education. PEAC offers support and services to pharmacists in need of treatment and 
rehabilitation for alcoholism, drug abuse, chemical dependence or other physical, emotional, or mental condition. PEAC 
is authorized under Health Occupations 12-317 as the pharmacist rehabilitation committee for the State of Maryland. 


Table 1 offers a synopsis of the PEAC lifespan in 5 
year increments from its inception in 1983 to the current 
year. From the outset the founding members recognized 
that the mission of the committee was to offer assistance 
to ailing or impaired pharmacists and not to protect 
criminals. The committee had no funding, no anticipated 
funding stream, and no promise of state support. Among 
the founding members was the late Bunky Lachman who 
was then a member of the Board of Pharmacy. Before 
accepting any cases PEAC developed a treatment contract 
that listed the behaviors expected of pharmacists in return 
for the committee’s advocacy and support. The contract 
required a thorough assessment, treatment as determined 
by the assessment process, strict abstinence from all mood 
altering chemicals, random urine monitoring, participation 
in a 12-step support group, cessation of pharmacy practice 
under certain conditions, regular contact with a PEAC 
monitor, and an acknowledgement that failure to adhere to 
the contract stipulations would result in referral of his or 
her case to the Board for immediate disciplinary action as 
warranted. 

As the committee began accepting cases it became 
evident that pharmacists who became impaired by alcohol 
and especially substance abuse often ran afoul of the 
pharmacy practice act. Many of these cases eventually 
came under Board scrutiny as a result of their infractions 
and subsequently were sanctioned by the Board through a 
disciplinary action that resulted in a license suspension or 
revocation. Other pharmacists entered into PEAC 
monitored recovery completely unknown to the Board. 
Some of these failed to achieve stable sobriety and put the 
public safety at risk. Such cases were reported to the 
Board for immediate disciplinary action. If a pharmacist 
was both under a Board disciplinary order and engaged in 
a PEAC treatment contract PEAC provided monitoring 
reports to the Board’s disciplinary committee through the 
Board’s compliance officer. 

As the burden of reporting grew PEAC argued that 
these reports had become unfunded mandates and pleaded 
to the Board for financial support. However, without 
legislation recognizing a pharmacists’ rehabilitation 
committee no state funding could be awarded. The Board 
crafted legislation defining a “pharmacists’ rehabilitation 


Maryland Pharmacist ¢ April/May/June 2007 


committee” in the law, enabling funding of its efforts, and 
providing liability protection for committee members 
when acting in good faith. Under Executive Director 
Rosyln Sheer the Board partnered with the School of 
Pharmacy and PEAC and held an art auction that raised 
funds to support PEAC activities while waiting for the 
enabling legislation to take effect. 

In subsequent years the Board provided growing 
financial support for PEAC. The committee hired a part- 
time program coordinator to secure documentation from 
PEAC monitors, pharmacist employers, and therapists for 
PEAC clients. These documents formed the basis for the 
quarterly reports to the Board’s disciplinary committee. 
The Board began writing language into its consent orders 
that required pharmacists impaired by alcohol or 
substance abuse to enter into a PEAC contract. The 
committee incorporated as a 501(c)3 not-for-profit entity 
in order to establish the distinction between the Board’s 
disciplinary processes and PEAC’s mission of 
rehabilitative intent. The balance between the Board’s 
disciplinary authority and PEAC’s offer of rehabilitative 
support provided the means to encourage voluntary 
treatment participation by substance impaired pharmacists 
but simultaneously ensured public safety through rapid 
disciplinary board action in the event of failed treatment. 
PEAC created ACPE approved continuing education 
programming in order to disseminate the message of 
confidential PEAC supported and directed clinical 
interventions for substance dependence without 
jeopardizing one’s pharmacy career. 

The Board’s budget for PEAC activities grew 
simultaneously with the expanded mission and scope of 
PEAC. In an effort to promote increased referrals to 
PEAC of pharmacists impaired by alcohol or substance 
abuse the Board passed legislation requiring pharmacists 
to report to the Board violations of the pharmacy practice 
act that they observe except when those infractions are 
caused by alcohol or substance abuse in which case the 
report is to be made to the pharmacists’ rehabilitation 
committee. This “Duty-to-Report” legislation was crafted 
under the leadership of Board President Stanton Ades 
with cooperation from PEAC. 


Page 9 


Throughout this evolution PEAC struggled to secure 
funding separate from the Board. Some support was 
secured through contributions from MPhA and MSHP 
collected as voluntary additions to membership dues. 
Additional dollars were contributed to the Moskowitz 
fund established to provide financial assistance to 
recovering pharmacists. Although well paid, pharmacists 
entering substance abuse treatment are often young, 
married and struggling to make ends meet. The double 
whammy of facing expensive treatment costs and reduced 
income (due to a period of under- or unemployment) 
creates a counter therapeutic focus on income generation 
that sparks distraction from treatment priorities. 
Moskowitz funds recipients are carefully screened and 
support, when granted, is provided in the form of a low 
interest loan paid directly to creditors (mortgage holders, 
utility companies) and never as cash awards to 
individuals. Despite these contributions the vision of 
shared and equal funding by the pharmacy community and 
the Board of Pharmacy was never realized. 

PEAC proposed a bold and ambitious initiative that 
called for a larger budget to support a part-time executive 
director who would energize a campaign to broadly 
disseminate the committee’s mission to “preserve 
professional health and public safety through advocacy 
and education” and to improve the reports from PEAC to 
the Board’s disciplinary committee. The dissemination 


Table 1: Hallmark events in PEAC evolution 


operation 


1989 — 1993 5-10 


1994 — 1998 10-15 


2004 — 2008 20—25 


Page 10 


Creation of PEAC (originally the “Pharmacists’ Rehabilitation 
no funding, no paid positions 
Board recognizes value of PEAC and helps with fundraising but provides 
no state support. BOP introduces enabling legislation to provide future 
funding, defines a “pharmacist rehabilitation committee” and provides legal 
protection to PEAC members and those making reports of impaired 
pharmacists to PEAC. 

Board provides some funding to cover part time coordinator and some 
operating expenses. PEAC incorporates as a 501(c)3 not-for-profit 
corporation and establishes the Moskowitz fund to provide financial 
support for recovering pharmacists. PEAC creates ACPE approved 
continuing education programming on the topics of substance abuse and 
pharmacy practice focusing on the issue of pharmacists impaired by alcohol 
or substance abuse or dependence. 

PEAC budget expands, coordinator position %FTE increases, PEAC 


1999 — 2003 15-20 
provides quarterly reports to BOP on board referred cases. “Duty-to- 
Report” added to pharmacy practice act. 


PEAC mission expands, executive director hired, breakdown between 
PEAC and BOP, Board votes for use of in-house staff to monitor 
pharmacists with substance abuse or mental health problems who are under 
a BOP disciplinary order. PEAC must adjust to reduced funding and the 
new era of relations between PEAC and BOP. 


campaign would incorporate the new “Duty-to-Report” 
law and emphasize the desirability of engaging in 
confidential assistance through PEAC before substance 
abuse led to serious dysfunction and Board disciplinary 
action. The reports were to be increased from quarterly to 
monthly and were to provide additional detail with respect 
to treatment participation. In addition, PEAC initiated site 
visits to recovering pharmacists at their places of 
employment. 

PEAC’s performance fell short of expectations under 
this initiative. PEAC met with the Board to listen to its 
criticism of PEAC. Subsequent to this meeting significant 
changes were made in PEAC staffing, the contractual 
arrangement was altered, and reporting to the disciplinary 
committee was corrected in accordance with the needs 
expressed by the committee members. Despite these 
changes the Board voted to hire a new staff member to 
monitor pharmacists under disciplinary action (suspension 
or revocation) for their compliance with the terms of the 
disciplinary order. Under this new arrangement PEAC 
continues to be the state’s “pharmacist rehabilitation 
committee” of record as defined in HO 12-317 but is 
supported by the Board for only those cases that are not 
under a disciplinary order of the Board. This puts 
significant strains on the committee’s financial health and 
creates new challenges for the committee to address in the 
year 2007 and beyond. 


Hallmark events 


Maryland Pharmacist « April/May/June 2007 


“Therapeutically Speaking... MTMS is More Than MythS” 


Jennifer A. James, Pharm.D. 


In partnership with MPhA and Outcomes Pharmaceutical Healthcare, LLC the author has provided training to 
pharmacists on the documentation and billing for Medication Therapy Management Services provided to covered 
beneficiaries of Medi-CareFirst. For more information about how you can participate go to www.getoutcomes.com The 
following article describes the process of MTMS and uses a case example to demonstrate the benefit of performing 
comprehensive medication reviews in detecting drug related problems related to patient adherence. 


Historically, many pharmacists have offered 
“Brown Bag” sessions for patients to bring in their 
medications for review once a year, but a limited number 
of highly motivated patients take the initiative to 
participate. Of course, the prospective drug utilization 
review conducted as part of prescription processing has 
and will continue to prevent medication related problems 
in community pharmacies every day. However, many 
drug-related problems will only be detected when 
additional patient information is gathered. The current 
practice environment has expanded opportunities to use 
the pharmacist medication expertise with individual 
patients, in particular with the high risk elderly 
population taking multiple medications. The well 
known concept of pharmaceutical care has been reborn 
under the new banner of Medication Therapy 
Management Services (MTMS). 

According to our eleven national pharmacy 
organizations “MTMS is a distinct service or group of 
services that optimize therapeutic outcomes for 
individual patients. MTMS are independent of, but can 
occur in conjunction with, the provision of a medication 
product.” The core elements of MTMS in community 
pharmacy established by APhA and NACDS include a 
medication therapy review, a personal medication 
record, a medication action plan, intervention and 
referral, then documentation and follow up. The purpose 
of MTMS is to detect adverse events, increase 
appropriate medication use and create collaboration 
between pharmacists and prescribers. Certainly, 
pharmacists can also offer more complex disease state 
management services or participate in collaborative drug 
therapy management protocols for nicotine cessation, 
metabolic syndrome, anticoagulation or other conditions. 


More than three hundred Maryland community 
pharmacies have contracted to provide MTMS and each 
site may have multiple pharmacists providing services. 

Both independent and corporate owners are 
supportive of this initiative. In order to provide MTMS, 
an appropriate private or semi-private area where 
consultations can occur is needed; a nominal investment 
can create one. The interpersonal skills and motivation 


Maryland Pharmacist ¢ April/May/June 2007 


of pharmacists to provide MTMS is likely the 
determining factor in success. Effective communication 
with the patient, caregiver and prescriber are the heart of 
MTMS. Additionally, written documentation is required 
for continuity of care as well as compensation for 
services. 

Marketing is necessary to establish patient 
demand and perceived value for MTMS. Since the 
number of patients who have access to MTMS as a 
covered benefit is relatively small, targeted direct phone 
calls may be implemented. The following script may be 
used to initiate the conversation. “Hi, this is Jen, your 
pharmacist calling, how are you today? ... Iam calling 
to schedule an appointment to go over your medications. 
Your insurance will cover the cost of this service. We 
will sit down together and review your medications one 
by one to help you get the most you can from them and 
understand what to watch for. I will type up a list with 
each of your medications, directions and purpose that 
you can take with you. Are you interested?” 

The best situation for a comprehensive 
medication review to occur is a private face to face 
encounter during a scheduled appointment time. The 
initial visit is usually about one hour per patient. The 
pharmacist collects a database including not only the 
medication use history, but a complete past medical 
history, family history, social history and focused review 
of systems to aid assessment of medication 
appropriateness. Medication related problems include 
interactions with conditions / drugs / foods, need for 
additional therapy, under or over-utilization, and adverse 
events. Failure to take medications due to administration 
technique or adherence behavior may be the easiest 
interventions for pharmacists to initiate directly with the 
patient. 

Adherence is a complex and multi-factorial 
challenge pharmacists face daily with their patients. 
Access, age, cost, frequency, mental status, number of 
doses, knowledge, and support systems all play a role.” 
In our current busy practice environment over-utilization 
may most frequently be identified when adjudication 
fails because a refill is requested too soon. The following 
case was selected from practice to highlight the 


Page 11 


interventions pharmacists can make to improve 
medication adherence. 

The case is a 76 year old African American 
woman who has no specific complaint. She agreed to 
schedule when offered a MTMS appointment by phone 
and presented to the pharmacy alone, using a walker to 
ambulate. Her past medical history is significant for 
asthma, diabetes, hypertension, anxiety, resolved back 
pain, hip dislocation in 2000, and colon cancer in 2001. 
Family history includes a father with hypertension who 
died at 49 years old from a stroke, and a mother with 
diabetes who died at age 63 years of age of heart failure. 
Social history is negative for smoking, alcohol and illicit 
drugs; she lives with husband and has 3 biological and 3 
adopted children. Her 12 year old daughter is keenly 
interested in her health, helps set up her medications and 
usually administers her insulin. Her medication list is: 
albuterol inhaler 2 puffs twice daily as needed, Azmacort 
2 puffs twice daily, Humalog sliding scale < 8 units four 
times daily, Lantus 42 units at 9pm daily, propranolol 
40mg twice daily, lisinopril 10mg daily, 
hydrochlorothiazide 25mg daily, fluoxetine 20mg daily, 
clonazepam 1mg as needed, and vitamin D 400 IU daily. 


Table 1 — Sample Documentation of Interventions 


Visit #1 Albuterol/Azmacort 
Administration / 
Technique 


Patient acce 


Administration / 
Technique 


14 days after 
Visit #1 


Medication 

Review 
Patient was contacted last week to invite for medication review appointment, presented in pharmacy today. Symptom 
management is priority. Patient has four chronic conditions, managed with nine prescription and one nonprescription 
medication. Handwritten master medication list prepared for 


Patient Altered 
Consultation Administration / 
Technique 


Patient knowledge deficit: patient was not shaking inhalers, actuated two puffs in the same breath. Patient did not know to 
use albulterol MDI prior to steroid. Patient was confused about rinsing after steroid (was rinsing after albuterol instead.) 
pted corrections to technique, restated and demonstrated appro 
Follow-Up Call | Propranolol Patient 
Consultation 


patient. 


The patient reports excellent blood pressure and 
blood glucose control, but does not have blood glucose 
log or meter to review. Therefore, full assessment of 
medical conditions will require additional monitoring 
beyond the scope of her medication review visit and will 
not be addressed here. During the visit the patient 
demonstrated use of her metered dose inhaler; problems 
related to her technique and knowledge regarding the 
medications were detected. When inquiring about her 
actual medication use behavior, the patient described an 
overly complex medication schedule including dosing 
five times a day; breakfast, lunch, 2pm, dinner and 
bedtime. Both of these medication related problems 
were addressed during the visit. 

Before leaving, the patient was provided with a 
neatly written list of her medications including the name, 
directions and purpose for use. An appointment for 
telephone follow up was scheduled for two weeks later. 
Her medication action plan in table 1 details the 
interventions and follow up performed. The reason, 
action, result coding is utilized by most documentation 
systems. 


#0, [Sele Datel 19. See ee Reason NT Action. «.ity|ew Me Result meet feuenae Prescriberaoeeoee 
Pharmacy Care Note 


Complex Drug Therapy Comprehensive 


CMR with Primary Care Provider 
Encounter 


Primary Care Provider 


priate technique. 
Altered Primary Care Provider 
Administration / 

Technique. 


Patient believed inpatient schedule of 7 am and 2 pm dosing of propranolol was medically necessary. Suggested dosing at 
morning and evening meal, approximately 12 hours apart. Upon telephone follow-up two weeks later, patient had not 


missed any doses of propranolol, vs. previously missing 1-2 doses per week. 


After the five steps of the patient care process is 
complete, billing can be submitted. Pharmacists in 
primary care settings have billed for education and drug 
therapy management services under the auspices of a 
supervising physician for many years. Recently, 
pharmacist-specific CPT codes were established (Table 
2). The “T” suffix indicates codes are temporary, though 
permanent status is sought. Similar to other CPT codes, 


Page 12 


different levels are established for new versus 
established patients. Uniquely, the codes are submitted 
in direct correlation to time spent providing care. 
Additionally, a place of service code (01) was approved 
for the pharmacy setting. In order to submit to claims a 
National Provider Identification (NPI) number must be 
obtained, applications are available online at 
https://nppes.cms.hhs.gov. 


Maryland Pharmacist ¢ April/May/June 2007 


Table 2 - Billing Codes for Pharmacists 


Add-on each 15 minutes for both new and follow up 


Currently, Maryland pharmacists may Fortunately, the practice environment is growing to 
participate in four Medicare Part D plans which include include MTMS and compensation. Excellent resources 
compensation for MTMS, or they may charge patients from our national professional organizations establish a 
directly. Member Health, United Health Care, Humana straightforward framework for provision of services 
and Medi-CareFirst vary widely in determining supported by many employers. Maryland pharmacists 
eligibility and compensation for services. Most offer have unique opportunities to provide care to Medicare 
MTMS only to the highest risk patients as defined by the Part D beneficiaries... Let’s get started! 
number of medications, annual spending above $4000, 
and the number of chronic conditions. Plans often start 1. Medication Therapy Management in 
by contacting the patient by mail or phone and only a Community Pharmacy Practice — Core Elements 
select set of patients are eligible for an annual face to of an MTM Service. Version 1.0 APhA and 
face visit with their community pharmacist. Medi- NACDS Foundation. J Am Pharm Assoc. 2005; 
CareFirst is a standout in that all beneficiaries are 45: 573-579. 
eligible for face to face MTMS and compensation is 2. Krueger KP et al. Improving Adherence and 
provided on a fee for service basis. Covered services Persistence: A Review and Assessment of 
include patient counseling on new prescription, changes Interventions and Description of Steps Toward a 
and selection of OTC self care items, consultations National Adherence Initiative. J Am Pharm 
regarding drug therapy problems, cost — efficacy Assoc. 2003; 43: 668-79. 


formulary switches and patient adherence as well as 
comprehensive medication reviews. 


Edited by Mary Lynn McPherson, Pharm.D., Professor, University of Maryland, School of Pharmacy 


2007 Corporate Sponsors 


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Maryland Pharmacist ¢ April/May/June 2007 Page 13 


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Sexual Side Effects Associated with SSRIs 


Introduction 

Selective-serotonin reuptake inhibitors (SSRIs) were haled as promising treatments for depression upon their release 
on the market in the 1990’s. They demonstrated similar efficacy compared to monoamine oxidase inhibitors (MAOIs) 
and the tricyclic antidepressants (TCAs), while having a much more favorable adverse effect profile. 

The prominent adverse effects associated with SSRIs are GI effects, headaches, and activation or sedation 
(depending upon the agent). Sexual dysfunction was originally thought to be nominal among the SSRIs, especially 
compared to MAOIs and TCAs. Even postmarketing surveillance data of 2,487 patients taking fluoxetine demonstrated 
that only 0.64% of patients reported orgasmic dysfunction, and only 1.2% reported libido difficulties.’? Time and further 
clinical study, however, elucidated a much greater incidence of sexual dysfunction among the SSRIs, ranging from 20 up 
to approximately 60% of patients.*” 

Such high incidence of sexual dysfunction is particularly concerning because it may warrant a change in therapy, or 
promote non-adherence. Ina study of over 1,000 patients taking antidepressants, 40% of respondents who experienced 
sexual difficulties while on medications, stated that the dysfunction was sufficient enough to warrant discontinuation.° 
Pharmacists who are well-educated regarding antidepressant-induced sexual dysfunction are therefore poised to 
significantly improve patient adherence to medication and quality of life. 


Sexual Side Effects Associated with SSRIs tends to be more common among men taking SSRIs, it 


From a treatment standpoint, it is preferable to 
consider medication-induced sexual effects based upon 
specific phases in the sexual cycle. The sexual response 
cycle is divided into the following phases: desire, 
excitement (or arousal), plateau, orgasm, and resolution. 

SSRIs can have significant effects in the desire, 
excitement, and orgasmic phases. While dysfunction 


can occur in both genders, with men typically 
experiencing delayed ejaculation and anorgasmia, and 
women experiencing decreased libido and anorgasmia. 
Impotence and priapism have been noted in men as well, 
but to a lesser extent.’ 


Figure 1. Sexual response cycle, and the SSRI-induced sexual dysfunction associated with each stage 
These effects are thought to be mediated by several factors, including CNS effects (serotonin and dopamine 
neurotransmission, or sedative effects), hormonal effects (especially prolactin influences), and peripheral effects (alpha 


blockade and nitric oxide synthetase inhibition).'°*"" 


Resolution 
phase 


Orgasmic phase: 


Desire phase: 
Decreased libido 


Orgasmic dysfunction Excitement/ 
(anorgasmia, delayed, J intensity) A oh ; 
Ejaculatory dysfunction rousa! phase: 
(premature, painful Impotence _ 
| Vaginal lubrication 
Priapism 
Plateau 
phase 


Maryland Pharmacist ¢ April/May/June 2007 Page 15 


The incidence of dysfunction seems to be equal overall among SSRIs, though there has been some evidence to 
suggest that paroxetine may be a slightly worse offender, but this has not been born out in all studies.'"!”"? 


Treatment of SSRI-Induced Sexual Dysfunction 

The first step to dealing with patient complaints of sexual dysfunction is to determine whether or not the problem 
is medication-induced. Several other factors can affect sexual functioning, including mental illnesses (depression itself 
has effects on sexual functioning, as does bipolar disorder and substance abuse), psychosocial factors (stress, divorce, 
relational difficulties, etc.), medical conditions (cardiovascular disease, diabetes, hormonal deficiencies, and others), and 
medications (several medications can cause depression, and indirectly affect sexual functioning such as antihypertensives 
and steroids). If SSRIs are the likely cause, then practitioners must consider all available treatment options. 

Copious amounts of literature exist addressing treatments for SSRI-induced sexual dysfunction, the majority of 
which are anecdotal case reports — though there are several clinical trials of specific treatments. 

There are 5 general treatment approaches: waiting for tolerance to develop, drug holidays, dosage reduction, 
medication substitution, and medication augmentation (i.e., antidotes).'” Table 1 summarizes the evidenced-based 
efficacy of these approaches. 


Table 1. Efficacy of treatment strategies for SSRI-induced sexual dysfunction 


. : Tolerance is rare (remission in ~6%, moderate 
Tolerance Likely : Q 1B 
improvement in ~ 12%) after 6 months 


N/A 
Not effective for patients on fluoxetine 
Drug Holiday N/A Likely 


- May encourage non-adherence 
Possibly 


oo te uo ee bcteetes =e 


Yes 
Substitution : 
Nefazodone (400mg/d)'* - Availability may be limited as brand name is no 
8 longer manufactured . 
Yes 
Oo 


Study did not specify individual drug-dose decrease, 
and generalized | of 50% may not be feasible in 
many pts’ 

- May cause re-emergence of depression 


Dosage Reduction 


Bupropion 
(300mg/d) 


- May only be effective for problems with arousal 

- Have only shown efficacy in men” 

- Possible efficacy as seen in case reports, but clinical 
trials have demonstrated a placebo effect”? ** 


Sildenafil (SOmg) 


Buspirone 
(20-60mg/d), Amantadine 
(100mg), Granisetron 
(1-2mg), Yohimbine 
(various doses; 5.4- 


Augmentation 
(Antidotes) 


N 


- Shown to have placebo effect in 2 trials with low 
dose (150mg/d), but efficacy in subscale of sexual 
desire/frequency in another’? ”! 

- May only be effective for problems with libido 

Possibly (frequency/desire) 
- May only be effective in women 


Possible efficacy as seen in case reports, but no 
29-32 


Stimulants (e.g., 
methylphenidate), 
Cyproheptadine 


clinical trials have reported efficacy to date 


Unlikely 


Page 16 Maryland Pharmacist ¢ April/May/June 2007 


A “watchful waiting” approach to treatment may be warranted, but is unlikely to work for most patients. The 
only study analyzing this effect demonstrated that more than 80% of patients had no change in sexual dysfunction after 6 
months." 

Others have postulated a “drug holiday”, where patients do not take their medication during the weekend, for 
example. While this method may be effective for some, it has multiple problems, not the least of which is encouraging 
patients to improperly adhere to medications. Espousing this method may insinuate that patients can take medications 
when they want to, and discontinue them at their discretion, without the aid of a healthcare professional. Also, this 
method has shown to be ineffective with fluoxetine due to its long half-life." 

Still others have reasoned that a dosage reduction may be helpful, however the study analyzing this effect offered 
no suggestion on individual medications, or acceptable dosage reductions (patients had their antidepressant reduced by 
50% in the study). The obvious drawback to such a strategy would be a recurrence of depression, and would be 
particularly dangerous in patients with a history of severe depression or suicidality. 

For most patients, substituting the offending agent with bupropion, mirtazapine, or nefazodone would likely be 
the best option, as clinical trials have demonstrated efficacy with few adverse sequelae.'”'* Patients should be assessed on 
an individual basis as to which of these medications would be best, based upon comorbidities, patient and family history 
of response, and patient preference. Bear in mind that availability is an issue with nefazodone since the brand version 
(Serzone®) is no longer manufactured (in large part due to its potential for hepatotoxicity). 

If it is clinically inappropriate to switch a patient from an antidepressant that has been particularly helpful, then 
approaching treatment from a more phase-specific standpoint would be advisable. For a patient with primarily libido 
complaints, a trial of bupropion might prove effective (doses of at least 300mg/d are warranted, as lower doses have 
shown to be ineffective).'”*' The clinical trial supporting this treatment included mostly women, however, so the results 
cannot necessarily be generalized to men.”! 

For patients with arousal complaints, a trial of sildenafil (or other phosphodiesterase inhibitors) would be 
warranted, though clinical trials have only included men, so effects on women are uknown.” 

Several other so-called “antidotes” have anecdotally been reported to treat SSRI-induced sexual dysfunction, 
including buspirone, amantadine, yohimbine, granisetron, cyproheptadine, and stimulants (a list that’s not exhaustive), but 
these have either not been tested in clinical trials, or have been shown to have a placebo effect when tested, and should 
therefore be considered as last line therapy in patients receiving SSRIs.” 


Counseling Tips 

Choosing an appropriate therapy is only half the picture in treating sexual dysfunction, especially if the dysfunction 
is never assessed by a healthcare professional in the first place. Many patients never consult anyone before discontinuing 
their medications. Pharmacists, therefore, play a vital role in helping patients to understand the adverse sexual effects 
associated with SSRI’s and other antidepressants, and can significantly lessen the stigma attached to such effects. With 
proper counseling, pharmacists can serve as liaisons to help patients maintain contact and good communication with 
prescribers. 

As such, there are several counseling tips pharmacists ought to keep in mind regarding sexual dysfunction with 
SSRIs: 

1. Be comfortable discussing sexuality with patients! Patients will generally mirror your confidence, or your 
shyness in regards to discussing sexual dysfunction. 

2. Don’t fear the power of suggestion! When a patient picks up an SSRI prescription for the first time, counseling 
them about sexual dysfunction will not cause them to have an adverse sexual side effect. 

3. Initially, be general in your approach (i.e., say “This medication may cause changes in your sexual functioning, so 
be sure to let me or your physician know if that occurs so that we can properly manage these effects”). This 
establishes a proper rapport with the patient, and offers them an open line of communication so they are not 
embarrassed to discuss their concerns with you.” 

4. Be prepared to be more specific if the patient requests more information about sexual dysfunction (i.e., say “With 
this type of antidepressant, men may experience difficulty achieving an erection, or orgasm (delayed ejaculation), 
and women may experience difficulty with sexual desire (libido) or achieving orgasm’). 

5. Don’t be afraid to ask patients about any difficulty with sexual functioning when they come in for refills. Patients 
may be too shy to volunteer this information. Remember that the goal is to improve adherence and quality of life, 
so ask! 


Maryland Pharmacist ¢ April/May/June 2007 Page 17 


References 


I. 
ae 


bt 
4. 


32. 
EF 


Rosen RC, Lane RM, Menza M. Effects of SSRIs on sexual function: A critical review. J Clin Psychopharmacol 1999;19:67-85. 

Fisher S, Bryant SG, Kent TA. Post-marketing surveillance by patient self-monitoring: trazodone versus fluoxetine. J Clin 
Psychopharmacol 1993;13:235-42. 

Clayton A, Keller A, McGarvey EL. Burden of phase-specific sexual dysfunction with SSRIs. J Affective Disorders 2006;91:27-32. 
Clayton AH, Pradko JF, Croft HA, Montano CB, Leadbetter RA, Bolden-Watson C, et al. Prevalence of sexual dysfunction among newer 
antidepressants. J Clin Psychiatry 2002;63:357-366. 

Kennedy SH, Eisfeld BS, Dickens SE, Bacchiochi JR, Bagby RM. Antidepressant-induced sexual dysfunction during treatment with 
moclobemide, paroxetine, sertraline, and venlafaxine. J Clin Psychiatry 2000;61:276-81. 

Montejo AL, Llorca G, Izquierdo JA, Rico-Villademoros F. Incidence of sexual dysfunction associated with antidepressant agents: A 
prospective multicenter study of 1022 outpatients. J Clin Psychiatry 2001;62(Supp 3):10-21. 

Young LY, Koda-Kimble MA, editors. Applied therapeutics: The clinical use of drugs, 8" Ed. Vancouver, WA: Applied Therapeutics, 
Inc.; 2004. 

Stahl SM. The psychopharmacology of sex, part 2: Effects of drugs and disease on the 3 phases of human sexual response. J Clin 
Psychiatry 2001;62:147-8 

Gitlin MJ. Effects of depression and antidepressants on sexual functioning. Bulletin of the Menninger Clinic 1995;59:232-48. 

Bishop JR, Moline J, Ellingrod VL, Schultz S, Clayton AH. Serotonin 2A-1438 G/A and G-protein Beta3 subunit C825T polymorphisms 
in patients with depression and SSRI-associated sexual side effects. Neuropsychopharmacol 2006;31:2281-8. 


_ Finkel MS, Laghrissi-Thode F, Pollock BG, Rong J. Paroxetine is a novel nitric oxide synthetase inhibitor. Psychopharmacol Bulletin 


1996;32:653-8. 

Price JS, Waller P, Wood S. Comparison of he post marketing safety of four selective serotonin re-uptake inhibitors including the 
investigation of symptoms occurring on withdrawal. Br J Clin Pharmacol 1996;42:757-63. 

Montejo-Gonzales AL, Llorca G, Izquierdo JA, Ledesma A, Bousono M, Calcedo A, et al. SSRI-induces sexual dysfunction: fluoxetine, 
paroxetine, sertraline, and fluvoxamine in a prospective, multicenter, and descriptive clinical study of 344 patients. J Sex Marital Ther 
1997;23:176-94. 

Rothschild AJ. Selective serotonin reuptake inhibitor-induced sexual dysfunction: Efficacy of a drug holiday. Am J Psychiatry 
1995;152:1514-6. 

Clayton AH, McGarvey EL, Abouesh AI, Pinkerton RC. Substitution of an SSRI with bupriopion sustained release following SSRI- 
induced sexual dysfunction. J Clin Psychiatry 2001 ;62:185-190. 

Walker PW, Cole JO, Gardner EA, Hughes Ar, Johnston JA, Batey SR, et al. Improvement in fluoxetine-associated sexual dysfunction in 
patients switched to bupropion. J Clin Psychiatry 1993;54:459-65. 


. Gelenberg AJ, Laukes C, McGahuey C, Okayli G, Moreno F, Zentner L, et al. Mirtazapine substitution in SSRI-induced sexual 


dysfunction. J Clin Psychiatry 2000;61:356-60. 
Ferguson JM, Shrivastava RK, Stahl SM, Hartford JT, Borian F, Ieni J, et al. Reemergence of sexual dysfunction in patients with major 
depressive disorder: Double-blind comparison of nefazodone and sertraline. J Clin Psychiatry 2001 362:24-29. 


_ Masand PS, Ashton Ak, Gupta S, Frank B. Sustained-release bupropion for selective serotonin reuptake inhibitor-induced sexual 


dysfunction: A randomized, double-blind, placebo-controlled, parallel-group study. Am J Psychiatry 2001;158:805-7. 
DeBattista C, Solvasaon B, Poirier J, Kendrick E, Loraas E. A placebo-controlled, randomized, double-blind study of adjunctive 
bupropion sustained release in the treatment of SSRI-induced sexual dysfunction 


. Clayton AH, Warnock JK, Kornstein SG, Pinkerton R, Sheldon-Keller A, McGarvey EL. A placebo-controlled trial of bupropion SR as an 


antidote for selective serotonin reuptake inhibitor-induced sexual dysfunction. J Clin Psychiatry 2004; 65:62-7. 


. Nurnberg HG, Hensley PL, Gelenberg AJ, Fava M, Lauriello J, Paine S. Treatment of antidepressant-associated sexual dysfunction with 


sildenafil: A randomized controlled trial. JAMA 2003;289:56-64. 


_ Landen M, Eriksson E, Agren H, Fahlen T. Effect of buspirone on sexual dysfunction in depressed patients treated with selective serotonin 


reuptake inhibitors. J Clin Psychopharmacol 1999;19:268-71. 
Balon R. Intermittent amantadine for fluoxetine-induced anorgasmia. J Sex Marital Ther 1996;22:290-2. 


. Michelson D, Kociban K, Tamura R, Morrison MF. Mirtazapine, yohimbine, or olanzapine augmentation therapy for serotonin reuptake- 


associated female sexual dysfunction: A randomized, placebo controlled trial. J Psychiatric Res 2002:36:147-52. 


_ Hollander E, McCarley A. Yohimbine treatment of sexual side effects induced by serotonin reuptake blockers. J Clin Psychiatry 


1992;53:207-9. 


_ Jacobsen FM. Fluoxetine-induced sexual dysfunction and an open trial of yohimbine. J Clin Psychiatry 1992;53:119-22. 
. Nelson EB, Shah VN, Welge JA, Keck PE Jr. A placebo-controlled, crossover trial of granisetron, in SRI-induced sexual dysfunction. J 


Clin Psychiatry 2001 ;62:469-73. 


. Bartlik BD, Kaplan P, Kaplan HS. Psychostimulants apparently reverse sexual dysfunction secondary to selective serotonin re-uptake 


inhibitors. J Sex Marital Ther 1995;21:264-71. 
Aizenberg D, Zemishlany Z, Weizman A. Cyproheptadine treatment of sexual dysfunction induced by serotonin reuptake inhibitors. Clin 
Neuropsychopharmacol 1995;18:320-4. 


_ McCormick S, Olin J, Brotman AW. Reversal of fluoxetine-induced anorgasmia by cyproheptadine in two patients. J Clin Psychiatry 


1990;51:383-4. 
Lauerma H. Successful treatment of citalopram-induced anorgasmia by cyproheptadine. Acta Psychiatr Scand 1996; 93:69-70. 
Stimmel GL, Gutierrez MA. Counseling patients about sexual issues. Pharmacother 2006;26:1608-15. 


Darren Jay Freeman, Pharm.D. 
University of Maryland School of Pharmacy 
Psychiatric Pharmacy Practice Resident 


Page 18 Maryland Pharmacist « April/May/June 2007 


Continuing Education 
for Pharmacists 


Varicella-zoster Virus 
Infection: the 
Diseases and 
Vaccines for 
Prevention 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 

Ohio Northern University 
Ada, Ohio 


and 


J. Richard Wuest, R.Ph., 
PharmD 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


Goals. The goals of this lesson are 
to discuss chickenpox and shingles, 
and describe the vaccines used to 
prevent them. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. identify the pathological 
responses to infection by the Vari- 
cella zoster virus; 

2. choose key points relative to 
the etiology, pathogenesis, and 
clinical features of chickenpox and 
shingles; 

3. recognize the vaccines for 
prevention of Varicella zoster 
infection in terms of their physio- 
logical and clinical characteristics; 
and 

4. select important points to 
convey to patients relative to 
varicella infection and its preven- 
tion. 


Maryland Pharmacist ¢ April/May/June 2007 


Gosse 


Introduction 

Varicella zoster virus (VZV) causes 
two distinct clinical entities: vari- 
cella (chickenpox) and herpes zoster 
(shingles). Chickenpox is a wide- 
spread and extremely contagious 
infection of childhood. Latent VZV 
may reactivate later as shingles. 


Etiology, Pathogenesis and 
Pathology 

The association between chickenpox 
and shingles has been known for 
nearly 100 years. Viral isolates 
obtained from patients with 
chickenpox and shingles produce 
similar changes in tissue culture, 
suggesting that the viruses are 
biologically similar. VZV isa 
member of the family Herpes- 
viridae. 

Primary Infection. VZV 
enters the host via the respiratory 
route and conjunctiva. The virus is 
believed to replicate within the 
nasopharynx and regional lymph 
nodes, which results in infiltration 
of the reticuloendothelial system 
with eventual appearance in the 
blood and development of primary 
viremia. The virus is then dissemi- 
nated to other tissues including the 
liver, spleen, and sensory ganglia. 
Further replication occurs in the 
viscera, followed by viral infection of 
the skin. Viremia in patients with 
chickenpox manifests as diffuse and 
scattered lesions involving the 


Volume XXIV, No. 12 


dermis and epidermis. The vesicles, 
which contain infectious virus, 
ultimately rupture and release fluid, 
or will be reabsorbed slowly. 

Recurrent Infection. Once 
the primary (initial) outbreak has 
subsided, the virus presumably 
retreats into the dorsal root ganglia 
where it can remain dormant for 
years until some excitatory factor 
reactivates it. The mechanism of 
reactivation that results in herpes 
zoster remains unknown. Examina- 
tion of representative dorsal root 
ganglia during active herpes zoster 
reveals hemorrhage, edema, and 
lymphocytic infiltration. 

In the immunocompetent host, 
active replication of VZV in other 
organs, such as the lung or brain, 
can occur during either chickenpox 
or herpes zoster, but is uncommon. 
Pulmonary involvement is charac- 
terized by interstitial pneumonitis 
and pulmonary hemorrhage. 
Central nervous system involve- 
ment results in histopathologic 
changes in the brain similar to 
those encountered in measles and 
other virus-induced inflammatory 
responses. Hemorrhagic necrosis of 
the brain, as is typical with herpes 
simplex virus encephalitis, is 
uncommon in VZV infection. 


Epidemiology and Clinical 
Manifestations 

Chickenpox. Humans are the 
only host for VZV. With an attack 
rate of 90 percent or more of suscep- 
tible individuals, chickenpox is 
highly contagious. Males and 
females of all races are infected 
equally. Normally endemic in the 
population at large, the virus 
becomes epidemic in susceptible 
individuals during seasonal peaks 
(late winter and early spring in 


Page 19 


EE 


temperate climates). In the U.S., 
the incidence is highest between 
March and May, and lowest between 
September and November. Children 
between ages five and nine years are 
most commonly affected, and 
account for half of all infections. The 
majority of other cases involve 
young people one to four years and 
10 to 14 years of age. Since intro- 
duction of the varicella vaccine for 
children, varicella cases have been 
reduced by 90 percent. 

The incubation period for 
varicella ranges from 10 to 21 days; 
the usual period is 14 to 16 days. 
Secondary attack rates between 70 
and 90 percent are reported in 
susceptible siblings within a house- 
hold. Infected persons remain 
infectious for approximately 48 
hours prior to onset of the vesicular 
rash, throughout the period of 
vesicle formation (usually four to 
five days), and until all vesicles 
become crusted. Once all skin 
lesions have crusted, an individual 
no longer transmits VZV. Indirect 
transmission via an immunized 
third person is not believed to occur. 

The patient with chickenpox 
may have a mild prodrome (warning 
signs) of low-grade fever and mal- 
aise occurring one to two days before 
onset of rash. Oftentimes in chil- 
dren, the rash is the first sign of 
disease. Inmunocompetent patients 
usually develop a benign illness that 
is associated with weakness and 
exhaustion, and temperatures of 
100° to 103° F that last three to five 
days. Skin lesions, which are the 
hallmark of infection, usually 
appear first on the face and scalp, 
then on the trunk, and then on the 
extremities. The rash is generalized 
and causes itching. It progresses 
rapidly from discolored spots of skin 
that are not elevated (macules) to 
small circumscribed, solid eleva- 
tions of skin (papules) to vesicular 
lesions before crusting. A typical 
case includes each form of lesion 
and scabs, all in various stages of 
progression. Most lesions are small 
(5 to 10 mm), havea red base, and 
appear over two to four days. 
Lesions can also appear on the 


Page 20 


mucous membranes of the orophar- 
ynx, respiratory tract, vagina, 
conjunctiva, and cornea. Healthy 
children usually have 200 to 500 
lesions. Recovery by an immuno- 
competent person usually results in 
lifetime immunity from another 
attack of chickenpox. A repeat 
infection of chickenpox may occur in 
immunocompromised persons. As is 
also true of other viral infections, 
re-exposure to natural varicella may 
lead to reinfection that, fortunately, 
boosts the person’s antibody titres 
without causing clinical illness. 

Complications of Chicken- 
pox. Secondary bacterial infection of 
skin lesions can follow, usually 
caused by Streptococcus pyogenes 
or Staphylococcus aureus, and is 
the most common infectious compli- 
cation of varicella. Secondary 
infection is the most frequent cause 
of hospitalization and outpatient 
medical visits. Viral shedding from 
skin lesions after scratching may 
result in infection. Varicella pneu- 
monia is the most serious complica- 
tion in chickenpox, appearing more 
often in adults (up to 20 percent of 
all cases) than in children. The 
complication usually begins three to 
five days into the illness. Patients 
experience rapid respirations 
(tachypnea), cough, dyspnea, and 
fever most frequently; and cyanosis, 
pleuritic chest pain, and expectora- 
tion of blood or blood-stained sputum 
(hemoptysis) less frequently. 
Pneumonia following chicken pox is 
usually viral but may be bacterial. 
Secondary bacterial pneumonia is 
more likely to occur in children 
under the age of one, rather than in 
older children. About 12,000 people 
are hospitalized with chickenpox 
each year in the U.S., with about 
100 deaths reported. 

Herpes Zoster. Herpes zoster 
is more commonly called shingles, 
from the Latin cingulum, meaning 
“oirdle.” Similarly, the descriptor 
zoster is derived from the classical 
Greek, referring to a “belt-like 
binding” (i.e., a zoster) used by 
warriors to secure their armor. 

Herpes zoster is a sporadic 
disease. It is the reactivated form of 


the VZV from the dorsal root 
ganglia; most patients who develop 
shingles have not had a recent 
exposure to another individual with 
VZV infection. It is estimated that 
500,000 to 1 million people in the 
U.S. experience an outbreak of 
shingles each year. A recently 
released FDA report stated that 
shingles is estimated to affect two in 
every 10 people in their lifetime. 
Unlike chickenpox, shingles occurs 
throughout the year. Herpes zoster 
is contagious to those who have not 
had varicella, or have not received 
the varicella vaccine. Individuals 
can contract chickenpox from close 
contact with a person who has 
shingles. However, a person cannot 
catch shingles from someone else. 

More than 90 percent of patients 
with shingles have serological 
evidence of a previous VZV infection. 
It is not possible to predict who will 
develop the condition or what 
triggers its reactivation. It may 
occur at any age, but its incidence is 
greatest during the sixth decade of 
life and beyond, and in those witha 
compromised immune system. 

The classic presentation of 
shingles begins as a prodrome of 
fever, tiredness, and headaches that 
may precede eruption of vesicles by 
several days. Lesions are usually 
localized to a single dermatome (the 
area of skin supplied with afferent 
nerve fibers by a single posterior 
spinal root). Mild-to-moderate 
burning or tingling occurs within 
the affected dermatome. Der- 
matomes from T3 to L3 are most 
commonly involved and often 
associated with severe pain that 
may be misdiagnosed as myocardial 
infarction or renal colic. Zoster 
ophthalmicus is a form of herpes 
zoster involving the ophthalmic 
ganglion of the trigeminal nerve. It 
results in painful eye inflammation 
with impaired vision. Without 
treatment, it can lead to blindness. 
Zoster ophthalmicus accounts for 
approximately 10 to 25 percent of 
herpes zoster cases. 

As stated earlier, the factors 
that lead to the reactivation of VZV 
are not well understood. Known 


Maryland Pharmacist ¢ April/May/June 2007 


a ee 


physiologic factors include increas- 
ing age, immunosuppression, intra- 
uterine exposure to varicella, and 
outbreak of varicella at younger 
than 18 months of age. Reactivation 
is usually benign in children. Often 
preceding the appearance of lesions 
by 48 to 72 hours, a red maculo- 
papular (lesions with a flat base 
surrounding a solid elevation in the 
center) rash forms unilaterally 
along the dermatome, and changes 
rapidly into vesicular lesions 
reminiscent of the original 
chickenpox outbreak. Lesions may 
cover more than one dermatome and 
occasionally cross the midline to the 
other side of the body. They may 
remain few in number and continue 
to form for up to three to five days. 
The lesions usually begin to dry and 
scab three to five days after appear- 
ance. The vesicular fluid becomes 
cloudy with pus. The duration of 
illness generally lasts seven to 10 
days, but it may take two to four 
weeks before the skin returns to 
normal. The rash may leave scar- 
ring and changes in pigmentation. 
Seronegative individuals (persons 
without antibodies to an earlier 
varicella infection) may become 
infected with chickenpox. On rare 
occasion, pain localized to a der- 
matome will be felt in the absence of 
skin lesions. When branches of the 
trigeminal nerve are involved, 
lesions may appear on the face, in 
the eyes, or in the mouth or on the 
tongue. 

Herpes Zoster Complica- 
tions. Pain associated with acute 
neuritis that leads to development of 
postherpetic neuralgia (PHN) is the 
most debilitating complication of 
herpes zoster, in both the normal 
and immunocompromised host. 
PHN is a condition where pain 
accompanying the rash persists long 
after the lesions have disappeared, 
commonly more than 30 days after 
the lesions have healed. It is best 
characterized as unrelenting sharp, 
burning, and stabbing pain that 
makes daily activities such as 
dressing and bathing almost 
unbearable. PHN is rare in young 
patients. At least half of patients 


Maryland Pharmacist ¢ April/May/June 2007 


over age 50 with shingles report 
pain of some extent months after 
the cutaneous manifestations have 
resolved. Altered sensation in the 
dermatome, resulting in abnormally 
reduced or greater sensitivity to 
touch is common. Other complica- 
tions include inflammation of the 
brain or spinal cord, and paralysis 
of peripheral nerves. 

Symptoms of shingles will be 
more severe in the immunocompro- 
mised host. Lesions continue to 
appear for over a week, and scab 
formation is usually incomplete 
until three weeks into the illness. 
Cutaneous dissemination develops 
in approximately 40 percent of 
patients with Hodgkin’s disease and 
non-Hodgkin’s lymphoma. In these 
patients, the risk of pneumonitis, 
meningoencephalitis, hepatitis, and 
other serious complications in- 
crease. Even in immunocompro- 
mised patients, however, dissemi- 
nated zoster is rarely fatal. 


Prevention 

Chickenpox. Varicella vaccine 
(Varivax) is a live, attenuated viral 
vaccine (Table 1). Isolated in the 
early 1970s from vesicular fluid 
obtained from an otherwise healthy 
child with varicella disease, vari- 
cella vaccine was licensed in the 
U.S. in 1995. 

The vaccine is estimated to be 
70 to 90 percent effective against 
infection, and 85 to 95 percent 
effective against moderate or severe 
disease. More than 90 percent of 
vaccine responders will maintain 
antibody levels for at least six years. 
Among healthy adolescents and 


adults, 78 percent of vaccine recipi- 
ents develop antibodies after one 
dose, with 99 percent developing 


- them after a second dose adminis- 


tered four to eight weeks later. 

Immunity appears to be long- 
lasting and is probably permanent 
in the majority of recipients. Break- 
through infection (i.e., varicella 
disease in a vaccinated person) will 
be significantly milder, with fewer 
lesions, many of which will be 
maculopapular rather than vesicu- 
lar; most patients will not have 
fever. 

Most clinical investigations 
have not identified time since 
vaccination as a risk factor for 
breakthrough varicella. The pres- 
ence of asthma, use of steroids, and 
younger age (1.e., younger than 15 
months) have been suggested as 
being risk factors for breakthrough 
varicella. 

Varivax is recommended for all 
children without contraindications 
at 12 to 18 months of age. It may be 
given regardless of prior history of 
varicella; however, vaccination is 
not necessary for children with a 
reliable history of chickenpox. The 
vaccine is also recommended for all 
children without evidence of vari- 
cella immunity by their thirteenth 
birthday. Children who have not 
been vaccinated previously and who 
do not have a reliable history of 
chickenpox are considered to be 
susceptible for chickenpox. Efforts 
should be made to ensure varicella 
immunity by this age, because 
varicella disease is more severe, 
complications more frequent, and 
two doses of vaccine are required 


Table 1 
Comparison of Vaccines 


(Zostavax)” varicella-zoster 


Vaccination against 
chickenpox in persons 
12 months of age & 


Vaccine Contents Use 
Varicella Live, attenuated 
(Varivax)" vaccine 

older 
Zoster Live, attenuated 


Prevention of shingles 
in persons 60 years of 
virus age and older 


Administration 

12 mo-12 yr: 0.5 ml 
sc; >13 yr: 0.5 mL sc 
with second dose 4-8 
weeks later 


>60 yr: single dose 
administered sc 


*For more information visit: www.Varivax.com or www.Zostavax.com 


Page 21 


eee en 


Table 2 
Patient Advice for the 
Zoster Vaccine | 


e This vaccine is to be used for adults 
60 years of age and older to prevent 
shingles (also known as zoster). Only 
your healthcare provider can decide 
if the vaccine is right for you. 

e This vaccine works by helping your 
immune system protect you from 
getting shingles and the pain and 
other complications that come with 
shingles. If you do get shingles even 
though you have been vaccinated, the 
vaccine may help prevent the severe 
nerve pain that can follow shingles. 

e As with any vaccine, this one may 
not protect everyone who receives it. 
e This vaccine should not be used to 
treat shingles once you have it. If you 
do get shingles, contact your health- 
care provider within the first few 
days of getting the rash. 

e You should not receive the vaccine 
if you: 1) are allergic to any of its 
ingredients, including allergies to 
gelatin or neomycin; 2) havea 
weakened immune system; 3) have 
active tuberculosis that is not being 
treated; or 4) are pregnant or may be 
pregnant. 

e Be sure to tell your healthcare 
provider before receiving the vaccine 
if you: 1) have or have had any medi- 
cal problems; 2) are taking any medi- 
cations, including those that might 
weaken your immune system; 3) are 
breastfeeding; 4) have had shingles 
in the past; or 5) may be in close 
contact with someone who may be 
pregnant and has not had chickenpox 
or been vaccinated against chicken- 
pox, or someone who has problems 
with their immune system. 

e Contact your healthcare provider 
right away if any medical condition 
you have gets worse or you develop 
any new or unusual symptoms after 
you receive this vaccine. 


after 13 years of age. The Advisory 
Committee on Immunization 
Practices has provisionally recom- 
mended two doses for individuals 
under 13 years of age. This change 
in vaccine schedule is expected to be 
adopted in January of 2007. (http:// 
www.cde.gov/nip/publications/acip- 
list. htm) 

The vaccine should be adminis- 
tered subcutaneously in the deltoid 
muscle. It is safe and effective in 


Page 22 


children when administered con- 
comitantly with measles-mumps- 
rubella (MMR) vaccine at different 
sites with separate syringes. A 
combined live attenuated measles- 
mumps-rubella-varicella (MMRV) 
vaccine (ProQuad?) is licensed for 
persons 12 months to 12 years of 
age. 

Shingles. Zostavax is a 
recently licensed (May 2006) product 
that reduces the risk of acquiring 
shingles in persons 60 years of age 
and older (Table 1). It is the only 
vaccine licensed in the U.S. that 
reduces the risk of reactivation of 
the varicella zoster virus. It should 
not be used to treat established 
shingles. The vaccine is not a 
substitute for varicella virus 
vaccine, and should not be used to 
immunize children against 
chickenpox. Likewise, Varivax is 
not a substitute for Zostavax. 
Potency of Varivax is considerably 
lower than that of Zostavax. The 
higher dose of the zoster vaccine 
seems to be necessary to overcome 
the immunosenescence (i.e., reduced 
response of the immune system) 
associated with aging. For this 
reason, the vaccine intended to 
protect against chickenpox is not to 
be used for shingles prevention 1n 
adults. 

Prevention of shingles with the 
zoster vaccine should eventually 
result in fewer cases of shingles 
along with the multiple health 
benefits that will follow. A double- 
blind, placebo-controlled pre-market- 
ing study of the vaccine was con- 
ducted in approximately 38,000 
individuals. Overall, the vaccine 
reduced the occurrence of shingles 
by 64 percent in persons aged 60 to 
69 years. Effectiveness declined with 
increasing age: 41 percent for the 70 
to 79 age group; 18 percent for those 
80 years of age and older. Addition- 
ally, duration of pain following onset 
of shingles was reduced slightly in 
those who developed shingles despite 
being vaccinated. Specifically, pain 
in the vaccine group lasted an 
average of 20 days, versus 22 days 
in the placebo group. Pain severity 
did not differ among the two groups. 


In this study, serious adverse 
events in persons receiving the 
vaccine were noted in 1.9 percent of 
recipients, verses 1.3 percent of 
persons who received placebo. The 
number of deaths in both groups 
was equal. FDA concluded that the 
study results were inconclusive; the 
manufacturer continues to investi- 
gate safety. 

The most common adverse 
reactions in persons who received 
the vaccine included redness, pain, 
itching, tenderness, and swelling at 
the injection site. Headache was 
also reported. 

Zostavax should be adminis- 
tered subcutaneously in the upper 
arm (deltoid muscle). The entire 
contents of a vial should be given. 
Advice to convey to persons vacci- 
nated with Zostavax or their 
caregivers is provided in Table 2. 


Overview and Summary 
Chickenpox and shingles are both 
caused by Varicella zoster. Whereas 
chickenpox results from acute 
infection, shingles follows when the 
dormant virus is reactivated. 
Vaccination of individuals >12 
months of age with the varicella 
vaccine effectively prevents 
chickenpox; vaccination of adults 
>60 years with the zoster vaccine 
may prevent shingles outbreaks. 
The two vaccines are not inter- 
changeable and should only be used 
for their approved indication. 


Maryland Pharmacist ¢ April/May/June 2007 


Continuing Education Quiz 


This month’s questions are taken from the article on “Varicella-zoster Virus Infection: the Diseases and Vaccines for Prevention”. Circle your 
answers to the following questions and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 21201-1572. 
There is no charge for this quiz for MPhA members (non-members $ 10.00). The completed quiz for this issue must be received by 

12/15/09. A continuing education certificate for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to eight weeks. 


Please type or print clearly. ACPE# 129-144-06-012-H01. 


Name 

Address 

City, State, Zip 
Daytime Phone 


Date Completed 
(Required) 


1. Once the primary outbreak of Varicella zoster 
infection has subsided, the virus presumably retreats 
to the: 

a. posterior root ganglia. 

b. anterior root ganglia. 

c. proximal root ganglia. 

d. dorsal root ganglia. 


2. Central nervous system involvement in a VZV 
infection results in histopathologic changes similar 
to: 

a. measles. c. mumps. 

b. smallpox. d. influenza. 


3. Inthe U.S., the incidence of chickenpox is highest 
from: 

a. December to February. 

b. March to May. 

c. June to August. 

d. September to November. 


4. For varicella, persons remain infectious from how 
long prior to onset of the vesicular rash until the 
time all vesicles have crusted? 

a. 12 hours c. 48 hours 

b. 24 hours d. 96 hours 


5. Secondary bacterial infections of chickenpox 
lesions are usually caused by: 

a. E. coli. c. P. aeruginosa. 

b. H. influenzae. d. S. aureus. 


Maryland Pharmacist ¢ April/May/June 2007 


The Maryland Pharmacy Continuing 
Education Coordinating Council is 
accredited by the Accreditation Council for 


Pharmacy Education as a provider of 
continuing education for pharmacists. 


6. Which of the following statements is FALSE? 
a. Shingles mainly occur March to May. 
b. Herpes zoster is acommon name for shingles. 
c. Shingles is more prevalent after age 60. 
d. A person cannot catch shingles from someone 
else. 


7. Alesion with a flat base surrounding a solid 
elevation in the center can be described as: 

a. dermatomal. c. pustular. 

b. maculopapular. d. vesicular. 


8. The most debilitating complication of Herpes 
zoster 1s: 

a. arthralgia. 

b. myalgia. 

c. neuralgia. 


9. When Varivax is given to a patient older than 13 
years of age, the number of doses required is (are): 
a. one. c. three. 
b. two. d. four. 


10. Varivax and Zostavax are: 
a. not interchangeable. 
b. interchangeable. 


Page 23 


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Pharmacists Mutual Companies have the solution 
for your Insurance and Financial needs. 


Secure your peace of mind with protection from 
Pharmacists Mutual Insurance Company, the company 
that specializes exclusively in serving pharmacists. The 
Pharmacists Mutual Companies offer the following coverages: 
¢ Individual Disability’ (Association members are eligible 
for discounts of up to 30%) 
¢ Financial Planning &Investments”™ 
e Workers Compensation 
¢ Professional Liability e 
e Businessowners 
¢ Home/Auto 


Life / Health 


vr a 


Dave Geoghegan 
P.O. Box 177 
Kingsville, MD 21087 


800-247-5930 ext. 7141 


Pharmacists Mutual is endorsed by the Maryland Pharmacists Association (compensated endorsement). 


Pp h Aa rm ac I sts * Pharmacists Mutual Insurance Co. 


¢Pharmacists Life Insurance Co. 


Mutual Companies *Pro Advantage Services, Inc. 


800-247-5930 ° P.O.Box370, Algona, lowa50511 * www.phmic.com 


*Disability insurance has limitations and exclusions. For costs and complete details of coverage, contact your Pharmacists Mutual 
financial representative. Program subject to state approval; program not available in California. Disability insurance is issued by 
Principal Life Insurance Company, Des Moines, IA 50392. Policy form HH 750. 


**Securities offered through Berthel Fisher & Company Financial Services, Inc. Member NASD & SIPC. 219 E. State St., Algona, IA, 
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‘Notice: This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800-247-5930. 


Not all products available in every state. Not all companies licensed in all states. Check with your representative or the company for 
details on coverages and carriers. 


VOLUME 83 No. 3 
_ President’s Statement 
Joseph Marrocco, PD. 


Membership 


Investment Form 


Medication Disposal Guides 
“What Pharmacists Need to Know” 


Continuing Education 
“Current Guidelines for Home PLL... 

: Joseph Marrocco, 
use of Ipecac Syrup in Treatment President 
of Ingested Poisons” 


“4s nl 


ea) 


PD. 


ae 4 5: . 


JULY/AUG./SEPT. 2007 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 
410-727-0746 
www.marylandpharmacist.org 


MPhA Officers 2007 - 2008 


Joe: Marrocco, P.O ooo. aes President 
Magaly Rodriguez deBittner, Pharm.D. 

Vice President 
Walter Abel, P.D. 230. a. Treasurer 
Robert Beardsley, Ph.D. ... Honorary President 


House Officers 


Ruth Blatt 2D. sce ee Speaker 
Carol Stevenson, Pharm.D. Vice Speaker 


MPhA Staff 


Howard Schiff, PD... s. Executive Director 
Elsie Prince Office Manager 
Nancy Ruskey Administrative Assistant 


MPhA Trustees 


Ginger Apyar, P.D. ......i0.2..- Chairperson 
Michelle Ando. PD .4J.Dei ee 2008 
Buich Henderson RPA: 22. ees: 2009 
Brian Hose; Pnarm: 0. 4 ee 2010 
Mary Kremzner, Pharm.D. 2009 
Neil Leikach. P.D. 2806.5. 02 eee. 2010 
David RUSSO. R.Phie 5644 2008 
Doris Voigt, Pharm:Do sca ee, 2008 
Claire Leocha ASP President 


Ex-Officio Members 
Natalie Eddington, Ph.D. .........4 5.) Dean 
UMB School of Pharmacy 
Jennifer Thomas, Pharm.D. 
MSHP Representative 


Maryland State Board of Pharmacy 


Donald Taylor, P.D., President 
Mike Souranis, P.D. Treasurer 
David R. Chason; RiPhs .........- Secretary 
Cynthia Anderson, M.S., R.Ph. 

Margie A. Bonnett 

Lynette Bradley-Baker, Ph.D. 


Alland Leandre, M.S., M.B.A. 

Mayer Handelman, P.D. 

Lenna Israbian-Jamgochian, Pharm.D. 
Harry Finke, Jr., P.D. 

Rodney Taylor, Pharm.D. 

Reid Zimmer, R.Ph. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


Presidents” Statementacyy. 201i. tacit Aen t | eae een noe ere. 
Joseph Marrocco, P.D. 


Medicare Prescription Drug Coverages ............cccccccccccccccscccccccecces © 
Patient Rights 


PMeuntergisiplinaby EXperience ... rere aitataades bay Tetiet latte seen hee 7 
A Student Pharmacist’s Perspective 


WIETIDERSIP wretettes aie's)n sic ste celts oe Lae te ee Ne ee STROM Us AO" | 
Investment Form 


RSNSAn CENCE OAW a PeEe te... s: <<<. 2c CPOE Poa eT Ree re. ee NEG Foes bel q] 
National Practitioner Data Bank 


Medication: Disposal, Guidelines <'25 femmes eet ferele le Sass « oeisesiscats Shrcedindletaeeyes (17 
What Pharmacists Need to Know 


Contin eehaucavoOnmeeer arene. SFT tee OF ORT me fe, 119 
“Current Guidelines for Home use of Ipecac Syrup in Treatment of Ingested Poisons” 


Advertiser’s Index 


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Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 650 West Lombard 
Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals postage paid at Baltimore, MD and at additional 
mailing office. Articles and editorials that appear do not necessarily reflect the official positions of the Maryland Pharmacists Association and may 
contain views and opinions for which the authors hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West 
Lombard Street, Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


Solutions For Your Future 


Pharmacists Mutual Companies have the solution 
for your Insurance and Financial needs. 


Secure your peace of mind with protection from 

Pharmacists Mutual Insurance Company, the company 

that specializes exclusively in serving pharmacists. The 
Pharmacists Mutual Companies offer the following coverages: 


¢ Individual Disability’ (Association members are eligible 
for discounts of up to 30%) 


Financial Planning &Investments™ 
Workers Compensation 
Professional Liability 
Businessowners 

Home/Auto 

Life /Health 


Dave Geoghegan 
P.O. Box 177 
Kingsville, MD 21087 


800-247-5930 ext. 7141 


Pharmacists Mutual is endorsed by the Maryland Pharmacists Association (compensated endorsement). 


¢Pharmacists Life Insurance Co. 


Mu tu a | Companies ¢Pro Advantage Services, Inc. 


800-247-5930 ¢ P.O.Box370, Algona,Iowa50511 ° www.phmic.com 


*Disability insurance has limitations and exclusions. For costs and complete details of coverage, contact your Pharmacists Mutual 
financial representative. Program subject to state approval; program not available in California. Disability insurance is issued by 
Principal Life Insurance Company, Des Moines, IA 50392. Policy form HH 750. 


**Securities offered through Berthel Fisher & Company Financial Services, Inc. Member NASD & SIPC. 219 E. State St., Algona, IA, 
50511. 


‘Notice: This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800-247-5930. 


Not all products available in every state. Not all companies licensed in all states. Check with your representative or the company for 
details on coverages and carriers. 


Presidents’ Statement 


During a recently televised interview on the CBS “60 Minutes” news 
program, U.S. Comptroller General, David Walker, warned that the new 
Medicare Plan D prescription drug program is so “financially 
irresponsible” that it could plunge the entire Medicare program into 
bankruptcy. Walker said that, when the first wave of baby boomers start 
receiving Medicare benefits in 3 years, the result will be a “tsunami of 
spending that could swamp our ship of state if we don’t get serious” about 
controlling health care and entitlement program costs. 

Walker, the nation’s top accountant and head of the Government 
Accountability Office, characterized the new prescription drug benefit as 
the final straw for an already fiscally shaky Medicare program. 


It is my desire to encourage 
and engage our pharmacy 
colleagues in all facets of practice 
to focus on the way medications are 
used, rather than what they cost us 
to buy. Today’s financial 
incentives are short term, 1.e. 
generic usage. A shift with the P3 
Project and E-prescribing 
communications, medication 
problems and drug misadventures 
can be prevented thus allowing 
pharmacists to rely more on these 
services and less on dwindling 
prescription reimbursements. 


The emerging medication 
therapy management programs 
serve as an avenue for payors to 
develop incentives that reward 
pharmacies for assuming a critical 
advisory role in the health care 
system. Pharmacists must be able to 
communicate with prescribers via 
the e-prescribing system and allow 
information re insurance benefits, 
eligibility, and formulary. 
Information on patient medication 
histories, data on drug interactions, 
cost comparisons, and therapeutic 
alternatives to a medication 
prescribed are vital. To service the 
patient now and not a couple days 
later, the system must allow for the 
ability to transmit and process 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


prior-authorization requests, and 
the cancellation of—or changes 
to—any prescription already 
transmitted. 


MPhA strongly supports 
pharmacists who show a willing- 
ness to participate in these 
programs, and in so doing will 
ensure a future that is both more 
secure and even more valuable to 
others. 


To accomplish these goals, I 
invite all of our pharmacist 
colleagues to become member of 
our state association, and an 
ACTIVE one at that. MPhA is a 
team of equals—there is no 
“pecking” order. There are no try- 
outs, no cuts, everyone makes the 
varsity squad. While growing up, 
my dad would advise me that the 
good Lord created us with two 
eyes, two ears, but just one mouth 
for a reason. I assure you that 
MPhA will continue to be a pro- 
active, not merely reactive associat- 
ion. I encourage your participation, 
in any matter or means you feel an 
interest, desire, or passion. “Doc” 
Fred Abramson always advises his 
students to surround yourself with 
SMART people—and I know there 
are a lot of you out there. 


‘aaa pnd 


Joseph Marrocco, P.D. 
President 


Dr. George Voxakis, who is 
one of our Maryland pharmacy 
icons, spoke at a pharmacy dinner 
meeting and remarked, two of the 
best choices in life one can make 
are the field of study and career 
path we choose, and who we 
partner with. Dean David Knapp, 
Professors Magaly Rodriguez de 
Bittner, Cynthia Boyle, Robert 
Beardsley, et al, continually raise 
the bar for our pharmacy profession 
and always keep us in the loop re 
pharmacy knowledge, trends, 
research and development. Howard, 
Cynthia, Matt, and Ginger, you 
have taken MPhA to new and 
higher heights and expectations...I 
pledge to ALL PHARMACISTS to 
continue this charted course—with 
our fellow colleagues and 
profession in mind—you deserve 
our TRUST. 


Page 5 


e Centers for Medicare & Medicaid Services (CMS) requires network pharmacies to post the “Medicare 
Prescription Drug Coverage and Your Rights” notice within the pharmacy, or to distribute it to patients. 
This notice advises Medicare beneficiaries of their rights to contact their plans to obtain a coverage 
determination or request an exception if they disagree with the information provided by the pharmacist. 


Additionally, CMS requires long-term-care (LTC) pharmacies on and off-site to send this notice to the 
location in the LTC facility designated to accept such notices. 


Please post this notice in a location that is easily seen by your patients. 


Medicare Prescription Drug Coverage and Your Rights 


You have the right to get a written explanation from your Medicare drug plan if: 


e Your doctor or pharmacist tells you that your Medicare drug plan will not cover a prescription drug in 
the amount or form prescribed by your doctor. 

e You are asked to pay a different cost-sharing amount than you think you are required to pay for a 
prescription drug. 


The Medicare drug plan’s written explanation will give you the specific reasons why the prescription drug is 
not covered and will explain how to request an appeal if you disagree with the drug plan’s decision. 


You have the right to ask your Medicare drug plan for an exception if: 

e You believe you need a drug that is not on your drug plan’s list of covered drugs. The list of covered 
drugs is called a “formulary;” or 

e You believe you should get a drug you need at a lower cost-sharing amount. 

What you need to do: 

e Contact your Medicare drug plan to ask for a written explanation about why a prescription is not 
covered or to ask for an exception if you believe you need a drug that is not on your drug plan’s 
formulary or believe you should get a drug you need at a lower cost-sharing amount. 

e Refer to the benefits booklet you received from your Medicare drug plan or call 1-800-MEDICARE to 
find out how to contact your drug plan. 

e When you contact your Medicare drug plan, be ready to tell them: 

1. The prescription drug(s) that you believe you need. 


2. The name of the pharmacy or physician who told you that the prescription drug(s) is not covered. 


3. The date you were told that the prescription drug(s) is not covered. 


Page 6 Maryland Pharmacist ¢ July/Aug./Sept. 2007 


The Interdisciplinary Experience : A Student Pharmacist’s Perspective 


By Velma U. Nwosu, PharmD Candidate 


As a fourth year student I find myself in reflection. Of all the academic experience that I have 
accumulated whilst attending the University of Maryland, School of Pharmacy, most resonant in my 
mind are my interdisciplinary pursuits. Among them are those in the areas of palliative care, geriatrics, 
psychiatry, and childhood obesity. This analysis underscores the value and essential nature of an 
interdisciplinary pharmacy education. My objective is to charge students of pharmacy and other 
professions with the task of more frequent involvement in interdisciplinary learning opportunities. 


What is interdisciplinary learning? 
Understanding the interdisciplinary team 
revolves around the premise that we, as health 
professionals, are enlisted to assist those in our 
community. To this end, we have also been 
enlisted as community learners, gathering 
professional knowledge from one another. The 
procurement of such knowledge is facilitated via 
communication, collaboration, and cooperation, 
three of the most important tenants of effective 
interdisciplinary relationships. 


The structure of interdisciplinary working 
relationships consists of disciplines or team 
members from various areas of expertise, but 
each discipline learns together, tackling topics 
that are usually problem-based and/ or patient- 
based. Comprehensive patient care is paramount 
and the common goal in the interdisciplinary 
healthcare setting is the creation of feasible or 
useful outcomes.’ Integration of patient-specific 
needs and simultaneous instruction, make the 
interdisciplinary experience unique. An 
interdisciplinary learning experience combines 
therapeutic instruction with social and 
professional interactions amongst participants. 
There are some areas that are inherently 
interdisciplinary, such as gerontology, while 
there are others that do not lend themselves to 
this type of practice model. 


Many often interchange interdisciplinary 
practice with multidisciplinary endeavors. The 
reality is these two terms are at odds not merely 


in their execution but also in the manner with 
which providers communicate when engaged in 
either multidisciplinary versus interdisciplinary 
groups. In the multidisciplinary team, members 
usually work in parallel, drawing information 
from one another but do not have a common 
understanding of issues that could influence 
interventions, while interdisciplinary groups 
utilize more inclusive language and share 
information between team members. ” 


Why contribute to interdisciplinary learning? 
There has been a considerable paradigm shift 
from a product-centered focus towards a patient- 
centered focus in pharmacy.’ The Accreditation 
Council for Pharmacy Education (ACPE) 
Standards have since newly approved 
guidelines, effective in 2007, which mandate 
that pharmacy graduates should be able to 
provide pharmaceutical care in cooperation with 
patients, prescribers, and other members of an 
inter-professional health care team, to promote 
health improvement, wellness, and disease 
prevention.” The Institute of Medicine (IOM) 
stipulates that proficiency while working as part 
of an interdisciplinary team is one of the five 
core attributes that students and practicing 
health professionals should possess.” Given this 
paradigm shift in pharmacy, interdisciplinary 
collaborative opportunities are the best way to 
actively link or integrate students’ education 
with future clinical practice. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 Page 7 


Aside from driving educational expectations, 
patient-centered pharmacy practice has been 
underscored by the provision of population- 
based healthcare. Interdisciplinary teams are a 
means of enhancing access to healthcare in rural 
and urban underserved populations in the United 
States. Unlike medical students and nurses, 
pharmacy students can still graduate from 
colleges of pharmacy with hardly any patient 
contact throughout their studies.” It is important 
that we look toward our peers in medicine, 
nursing, allied healthcare, and social work to 
supplement our knowledge of patient 
populations as we select appropriately indicated, 
effective, safe, and convenient drug therapy. 
Collaborative teams have proven to be a 
successful model for the management of a host 
of chronic illnesses, including but not limited to, 
diabetes® and chronic kidney disease’. 


REFERENCES 


Pharmacists, working in tandem with primary 
care providers, aid in the prevention of 
secondary consequences and the promotion of 
therapy maintenance, through discharge 
planning and medication-therapy management. 


Conclusions 

Interdisciplinary course offerings, at the 
University of Maryland, School of Pharmacy 
have been the most enjoyable and fully 
integrative experiences, combining pharmacy 
training and interprofessional communication 
skills. Overall, these opportunities have 
bestowed me with a sense of educational 
satisfaction and a feeling of confidence. In fact, 
true understanding of clinical pharmacy and 
therapeutics did not come about until I was 
exposed to an interdisciplinary team. 


1. Geriatric Interdisciplinary Team Training. Ed. Eugenia L. Siegler, et al. New York: Springer 


Publishing Company, 1998. 


2. Sheehan D, Robertson L, Ormond T. (2007). Comparison of language used and patterns of 
communication in interprofessional and multidisciplinary teams. J Interprof Care. 21(1):17-30. 
3. Droege, M. (2003). The Role of Reflective Practice in Pharmacy. Education for Health, \(16): 


68-74. 


4. ACPE Revised Standards and Guidelines Draft. http://www.acpe-accredit.org/standards/ 


default.asp 


5. Greiner A, Knabel E, eds. A Bridge to Quality. Institute of Medicine, Committee on Health 
Professions Education. Washignton, DC: National Academies Press; 2001. 

6. Coast-Senior EA, Kroner BA, Kelley CL, Trilli LE. (1998). Management of patients with type 2 
diabetes by pharmacists in primary care clinics. Ann Pharmacother, 32(6):636-41. 

7. Clinical Pharmacists as Multidiscilinary Health Care Providers in the Management of CKD: A 
joint Opinion by the Nephrology and Ambulatory Care Practice and Research Networks of the 
American College of Clinical Pharmacy. Amer J of Kidney Diseases 2005, 45(6): 1105-1118. 


Page 8 Maryland Pharmacist ¢ July/Aug./Sept. 2007 


MARYLAND PHARMACISTS ASSOCIATION 


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PHARMACY MARKETING GROUP, INC 


AND THE LAW 


By Kyle J. Starostka 
And Don R. McGuire Jr., R-Ph., J.D. 


This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your 
State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing 
quality products and services to the pharmacy community. 


NATIONAL PRACTITIONER DATA BANK 


Malpractice claims are brought against 
practitioners more often than wanted in the 
health care system. Although many malpractice 
claims arise from legitimate negligence, there are 
also frivolous lawsuits that are pursued by over- 
litigious parties that cloud the system. The real 
concern is protecting patients from practitioners 
that are truly being negligent. Congress became 
aware of problems arising nationwide from the 
increasing occurrence of medical malpractice 
claims and the NPDB was one solution to these 
problems. 


While pharmacists may not be aware of the 
NPDB, they are included in the system. The 
NPDB is a system that provides a vast amount of 
information that is helpful in evaluating the 
performance of pharmacists, doctors, dentists, 
and other health care professionals. The 
database was enacted under the Health Care 
Quality Improvement Act of 1986 in response to 
increasing criticism about the failure of medical 
licensing authorities to protect patients from 
negligent health practitioners, including 
pharmacists. The NPDB was established to 
ensure that unprofessional or incompetent health 
care practitioners are not able to move from state 
to state and compromise the quality of health 
care. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


The NPDB obtains submitted information from 
state licensing boards, hospitals, professional 
societies, medical malpractice payers (for 
example, insurance carriers), the U.S. Drug 
Enforcement Administration, and other health 
care entities. These organizations submit 
information pertaining to payments made to 
satisfy medical malpractice claims and adverse 
actions taken against practitioners with respect to 
their professional competence or conduct. 
Medical malpractice payments that do not 
identify individual practitioners are not to be 
reported to the NPDB. For example, if a 
payment is made solely for an entity (i.e. 
hospital, clinic, or pharmacy) and does not 
identify an individual practitioner, it can not be 
reported to the NPDB. The Health Care Quality 
Improvement Act requires health care entities to 
report adverse actions to the data bank which 
concern suspension, curtailment, or revocation of 
a practitioner’s clinical privileges and similarly 
requires that state licensing boards report any 
licensure revocation, suspension, or reprimand to 
a health care practitioner’s license. Hospitals, 
professional societies, and state licensing boards 
have access to information available in the 
NPDB and can query the data bank to help assist 
in conducting investigations of the qualifications 


Page 11 


of the health care practitioner to whom they seek 
to license, hire, or grant clinical privileges. 
Health care practitioners may do a self-query on 
themselves at any time for a set fee. Plaintiffs 
representing themselves or plaintiff's attorneys 
may query the data bank only under certain 
circumstances. As of now, the NPDB is not a 
consumer education tool and does not allow the 
general public to access information. 


The data bank processes information exactly how 
it is filed, so reporting entities are responsible for 
the accuracy of the information that they submit 
and changes to a report may be submitted only 
by reporting entities. Subject(s) involved in a 
report will be notified by mail after the NPDB is 
finished processing information. Subjects that 
receive a notification letter should thoroughly 
review the report for accuracy. If inaccurate 
information is found, the subject involved must 
contact the reporting entity and request a 
correction to the report. If the reporting entity 
declines to change the report and the 
disagreement cannot be resolved between the 
subject and reporting entity, the subject must go 
through the NPDB to add a personal statement to 
the report or initiate the dispute process. 

Personal statements added allow the subject to 
tell their side of the story. The dispute process 
allows subjects to dispute the factual accuracy of 


© Kyle J. Starostka and Don R. McGuire, Jr. 
Kyle J. Starostka is a Pharm. D. candidate at the 
University of Wyoming. Don R. McGuire Jr., 
R.Ph., J.D., is General Counsel at Pharmacists 
Mutual Insurance Company. 


This article discusses general principles of law 
and risk management. It is not intended as legal 
advice. Pharmacists should consult their own 
attorneys and insurance companies for specific 
advice. Pharmacists should be familiar with 
policies and procedures of their employers and 
insurance companies, and act accordingly. 


Page 12 


the report (for example, an incorrect adverse 
action code or payment date) and to argue 
whether a report was submitted in accordance 
with NPDB reporting requirements (for example, 
an adverse clinical privileges action lasting for 
30 days or less; or the ineligibility of the 
reporting entity). Keep in mind that the NPDB 
guidebook states, “The dispute process is not an 
avenue to protest a payment or to appeal the 
underlying reasons of an adverse action 
affecting the subject’s license, clinical privileges, 
or professional society membership.” 


The NPDB is not an end all solution to 
protecting patients from negligent practitioners, 
but it has been a positive start. The NPDB, in 
conjunction with other sources of information, 
have been very influential for health care 
employers in decision-making regarding 
practitioners. The Health Care Quality 
Improvement Act of 1986 has met its intent of 
protecting patients from negligent practitioners 
by establishing the NPDB. Pharmacists should 
be aware that the NPDB encompasses more than 
just physicians and that claims payments and 
adverse credentialing decisions are reportable for 
pharmacists too. For complete information about 
the NPDB, please visit the NPDB’s website at 


www.npdb-hipdb.hrsa.gov. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


“Therapeutically Speaking..." 


Drug Therapy in Older Adults 


Myron Weiner, RPh, PhD, Associate Professor, University of Maryland School of Pharmacy and 


Sarah J. Brody, PharmD Candidate 2008 


he elderly, defined as 65 years and older, are expected to increase in number to 70 million people by 2030, increasing 

from 13% to 20% of the population. Although they represent only 13% of the population at present, the elderly 
receive 35% of all prescription drugs and 40% of nonprescription medications. This disproportionate drug use also 
results in a higher incidence of adverse drug events. One student showed that seniors are more than twice as likely as 
non-seniors to experience an adverse drug reaction requiring treatment in an emergency room while they were almost 
seven times more likely to be hospitalized. To put this in practical terms, the number of adverse events in the elderly 
which results in hospital emergency department admissions approaches figures for auto accidents. One third of adverse 
reactions to drugs in the elderly were caused by 3 drugs: warfarin, insulin and digoxin. 


In the first Institute of Medicine report dealing with 
medication errors, “To Err is Human,” in 1999, 
medication errors were responsible for 44,000 deaths 
annually. In the more recent Institute of Medicine 
report from the Interdisciplinary Committee on 
Identifying and Preventing Medication Errors, it is 
estimated that one medication error occurs per 
hospitalized patient per day. Approximately 400,000 
medication errors occur each year in hospitals, 800,000 
in long term care facilities, and over 500,000 occurring 
among Medicare recipients in outpatient clinics, the 
majority of which are preventable. In the United States, 
Hanlon et al found 365 of 397 frail elderly patients 
received at least one inappropriate medication. 
Internationally, a Norwegian study found greater than 
20% of hospital patient’s deaths were associated with a 
prescription drug with the risk being higher in elderly 
patients. Greater than 50% of drug-associated deaths 
were due to drug errors, defined as patients receiving an 
inappropriate drug, a wrong dose, or the wrong route of 
administration. Older adults have an increased number 
of comorbidities, necessitating an increased number of 
chronic medications. Unsurprisingly, polypharmacy 
increases the risk of drug interactions and adverse effects 
in elderly patients. 

Just what is an “inappropriate” drug? The term 
“inappropriate” has been applied to drugs found to have 
a greater potential for causing adverse events than drugs 
that were deemed equally-effective alternatives. Beers 
et al first listed criteria used to identify inappropriate 
medications for the frail elderly. They examined 
risk/benefit ratios of drugs in elderly patients and listed 
33 drugs considered inappropriate in the elderly in 
nursing homes. This list was revised in 1997 when 
Beers applied the criteria to all people over the age of 65, 
not just frail elderly in nursing homes. Fick further 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


updated the criteria by also listing drugs that were not 
only inappropriate, but should generally be avoided in 
the elderly because of ineffectiveness or their posing an 
unnecessarily high risk for older persons with a safer 
alternative being available. They listed 48 medications 
or classes of drugs to avoid, shown in Table 1. Studies 
using the criteria expressed by Beers et al and Fick et al 
have determined that 1 in 5 elderly Americans have 
received potentially inappropriate drugs. The suggested 
list of inappropriate drugs for older patients is a useful 
guide for community pharmacists. 

There are many reasons why older adults are at 
greater risk for adverse drug events, including 
pharmacokinetic and pharmacodynamic changes 
associated with aging. Pharmacokinetics refers to how 
the body handles a drug, including absorption, 
distribution, metabolism and excretion. Of the four, 
absorption is the least affected by aging. Most studies 
indicate that drug absorption is not changed in the 
elderly, but absorption of vitamin B)», iron and calcium 
via active transport mechanisms is decreased. The 
volume of distribution of drugs can be modified by 
changes in body composition that frequently changes 
with age. For example, lipid soluble drugs such as 
diazepam may have a longer half-life because of 
increased body fat associated with aging, resulting in an 
increased volume of distribution. Therefore, lower 
maintenance doses of diazepam are appropriate in the 
elderly. On the other hand, water-soluble drugs such as 
gentamicin, digoxin and theophylline, may have an 
increased blood level because of decreases in both total 
body water and muscle mass. In this case, loading doses 
and possibly maintenance doses of these drugs need to 
be decreased in the elderly. 

Drug metabolism by some liver enzymes is less 
efficient in elderly patients. The cytochrome P450 


Page 13 


content in liver biopsies of 226 patients was found to be 
decreased by 30% in patients over 70 years of age. 
However, the form of cytochrome P450 is important, 
since the content of cytochrome P4503A4 (CYP3A4), 
the isoenzyme responsible for the majority of clinically- 
used drugs, is primarily decreased compared to other 
forms. Thus, drugs that are primarily metabolized to 
inactive compounds by CYP3A4 can have higher serum 
concentrations and an enhanced pharmacological effect. 
Some of these drugs are alprazolam, triazolam, 
lovastatin, and atorvastatin. Furthermore, the “first 
pass” metabolism of many drugs is decreased with aging 
due to a reduction in both liver mass and hepatic flood 
flow. Medications affected by this include propranolol, 
labetalol, and lidocaine. With reduced metabolism, the 
patient may experience a heightened pharmacologic 
response. 

A decline in renal excretion simply resulting from 
normal aging is the most common pharmacokinetic 
modification in elderly patients. Renal mass and renal 
blood flow decreases with age and the decrease in 
glomerular filtration rate (GFR) with age results in a 
clinically significant decrease in the excretion of drugs or 
active metabolites primarily excreted unchanged by the 
kidney. Since serum creatinine does not change with age 
because muscle mass and creatinine production decreases 
with age, it is not a useful indicator of renal function. 
Instead, creatinine clearance is used and estimated by the 
Cockcroft-Gault equation, the most commonly used 
equation to clinically estimate GFR in the elderly. It takes 
into account the patient’s age, weight (in kg) and serum 
creatinine level. Therefore, drugs or pharmacologically 
active drug metabolites that are excreted by the kidneys 
may require dosage adjustment to prevent an adverse drug 
event. For example, drugs that have a narrow therapeutic 
index or margin of safety need to have their dosage 
decreased to compensate for their reduced clearance such 
as lithium, digoxin, aminoglycoside (e.g. gentamicin) and 
most cephalosporin (e.g. cefaclor) antibiotics and beta 
blocking agents (e.g. atenolol). Methotrexate is 
increasingly being used in patients with rheumatoid 
arthritis. It is eliminated primarily by renal excretion and 
its clearance 1s decreased with age. 

Pharmacodynamics refers to the pharmacologic, or 
intended drug response, and it too may also be affected 
by aging (increased or decreased). Physiologic changes 
in the elderly that influence pharmacodynamic changes 
in drug responses are more difficult to predict and to 
study. While the majority of drug responses modified by 
aging are pharmacokinetic in nature, pharmacodynamic 
modifications exist. For example, the elderly have 
physiologic changes that increase the likelihood of falls 
with subsequent fractures, etc. These changes include a 
decrease in baroreceptor mechanisms caused by an 


Page 14 


increased thickness of blood vessels and a decreased 
blood vessel resiliency; there is an accompanying 

slowed reflex activity and a decrease in muscle strength. 
Thus elderly are susceptible to sedatives that can make 
the elderly dizzy and lose their balance, and to 
antihypertensives like alpha adrenergic blocking agents 
that cause postural hypotension. When comparing the 
clinical effect of a given serum concentration of 
diazepam, older adults show an enhanced drug effect 
when compared to younger counterparts. Therefore 
giving the same dose to in elderly and non-elderly 
subjects can lead to an increase in adverse effects in the 
aged. In addition to this modified sensitivity mechanism, 
metabolism, handled by the CYP3A4 system, is 
decreased in these drugs. Thus, a pharmacokinetic effect 
that allows increased plasma levels to cause an increased 
intensity and duration of action is also possible with 
these agents. 

One of the most frequently prescribed sedative- 
hypnotics on the market is zolpidem (Ambien). The 
enzyme CYP3A4 is responsible for almost 60% of the 
metabolism of zolpidem, which may be reduced in older 
patients. This, combined with a likely exaggerated 
pharmacodynamic response to zolpidem can increase the 
risk of adverse effects with older adults. Olubodun et al 
demonstrated that zolpidem indeed is cleared much more 
slowly than in younger subjects (by approximately one 
third) and the half-life is twice as long. Their findings 
support the earlier recommendation that zolpidem 
dosage be decreased in the elderly. Failure to modify 
dosage of sedative-hypnotic agents could lead to 
sedation, confusion, ataxia, vertigo, falls, fractures, and 
overall health deterioration. | 

Warfarin certainly is a drug that is classified as 
having a narrow therapeutic index. Older adults have 
been shown to be more sensitive to the effects of 
warfarin, and may experience an increased anticoagulant 
effect. Conversely, the effects of both beta adrenergic 
agonists and blockers are reduced in the elderly. Thus, 
drugs like salbutamol (a beta-2 receptor agonist) and 
propranolol (a beta receptor blocker) show reduced 
responses to the same plasma levels of drug in elderly 
patients. The mechanism appears to be due to a reduced 
postreceptor event (i.e. a reduced cyclic AMP synthesis 
after receptor stimulation). 

What can the pharmacist do in working with the 
elderly? Chéck their medications for appropriateness in 
terms of use and dosage, potential drug interactions, 
adverse effect monitoring or communication of what the 
patient should watch for and what to do if an effect 
occurs. Become familiar with the inappropriate drug 
lists shown in Table 1. The Centers for Medicare and 
Medicaid Services recently placed in its reference 


Guidance to Surveyors of Long Term Care Facilities 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


their adoption of the Beers’ list of inappropriate drugs as 
an indicator of quality care in nursing homes. The 
community pharmacist is in an excellent position to 


Selected References: 


partner with prescribers to optimize health care 
outcomes for older adults, and provide outstanding 
patient education on drug therapy. 


e Hanlon JT et al. Inappropriate medical use among frail elderly inpatients. Ann. Pharmcother. 2004; 38:9-14. 
¢ Beers MH et al. Explicit criteria for determining inappropriate medication use in nursing home residents. Arch. 


Intern. Med. 1991; 151:1825-1832. 


e Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly. Arch. Intern. 


Med. 1997; 157:1531-1536. 


e Fick DM etal. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch. Intern 


Med. 2003; 163:2716-2724. 


¢  Olubodun JO et al. Pharmacokinetic properties of zolpidem in elderly and young adults; possible modulation by 
testosterone in men. Br. J. Clin. Pharmacol. 2003; 56:297-304. 


Complete reference list available upon request. Edited by: Mary Lynn McPherson, Pharm.D., BCPS 


Professor, University of Maryland School of Pharmacy 


Table 1 — Potentially Inappropriate Drugs in Older Adults 


Propoxyphene (Darvon) and combination products 

Indomethacin (Indocin and Indocin SR) 

Pentazocine (Talwin) 

Trimethobenzamide (Tigan) 

Muscle relaxants and antispasmodics (e.g. methocarbamol 
(Robaxin), cyclobenzaprine (Flexeril) 

Flurazepam (Dalmane) 

Amitriptyline (Elavil) and combinations 

Doxepin (Sinequan) 

Meprobamate (Miltown and Equamil) 

Long-acting benzodiazepines [e.g. diazepam (Valium), 
chlorazepate (Tranxene)] 

Doses of short-acting benzodiazepines greater than lorazepam 
(Ativan), 3 mg; oxazepam (Serax), 60 mg; alprazolam 
(Xanax), 2 mg 

Disopyramide (Norpace, Norpace CR) 

Digoxin (Lanoxin) (not exceeding >0.125 mg/d except to treat 
atrial arrhythmias) 

Short-acting dipyridamole (Persantine) 

Methyldopa (Aldomet) and methyldopa-hydrochlorothiazide 
(Aldoril) 

Reserpine at doses >0.25 mg 

Chlorpropamide (Diabenese) 

GI antispasmodic drugs [e.g. dicyclomine (Bentyl); 
propantheline (Pro-Banthine)] 

Anticholinergics and antihistamines [e.g. diphenhydramine 
(Benadryl); hydroxyzine (Vistaril, Atarax)] 

Ergot mesyloids (Hydergine) and cyclandelate (Cyclospasmol) 

Ferrous sulfate>325 mg/d 

All barbiturates (except Phenobarbital) except when used to 
control seizures 


Meperidine (Demerol) 

Ticlopidine (Ticlid) 

Ketorolac (Toradol) 

Amphetamines and anorexic agents 

Long-term use of full-dosage, longer half-life, non-COX- 
selective NSAIDs: naproxen (Naprosyn, Avaprox, Aleve), 
oxaprozin (Daypro), and piroxicam (Feldene) 

Daily Fluoxetine (Prozac) 

Amiodarone (Cordarone) 

Orphenadrine (Norflex) 

Guanethidine (Ismelin) 

Guanadrel (Hylorel) 

Cyclandelate (Cyclospasmol) 

Isoxsuprine (Vasodilan) 

Nitrofurantoin (Macrodantin) 

Doxazosin (Cardura) 

Methyltestosterone (Android, Virilon, Testrad) 

Thioridazine (Mellaril) 

Mesoridazine (Serentil) 

Short-acting nifedepine (Procardia and Adalat) 

Clonidine (Catapres) 

Mineral oil 

Cimetidine (Tagamet) 

Ethacrynic acid (Edecrin) 

Desiccated thyroid 

Amphetamines (excluding methylphenidate and anorexics) 

Estrogens only (oral) 

Long-term use of stimulant laxatives [e.g. bisacodyl 
(Dulcolax)] 


Ref: Fick DM et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch. Intern Med. 2003; 163:2716-2724. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


Page 15 


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Page 16 Maryland Pharmacist ¢ July/Aug./Sept. 2007 


this line 


ee ee ee ee ee ee ee 


Trim along 


pen 


— a a a a 


ee ee ee ee 


Medication disposal guidelines: 


What pharmacists need to know « 


© 2007 by the American Pharmacists Association. All rights reserved. 


Researchers writing in the November 


2006 Journal of the American Board of 


Family Medicine surveyed 301 patients 
at an outpatient pharmacy and found that 
more than 50% reported storing unused 
or expired medications and 50% said they 
had flushed these medications. Fewer than 
20% of respondents indicated that they 
had ever been advised by a health care 
provider on medication disposal. 


APhA has teame d with the U.S. Fish and 
Wildlife Service (FWS) to begin to fill this 
knowledge gap among consumers regard- 
ing the proper disposal of unused medica- 
tions. In July 2006, the two groups met, 
along with 50 government stakeholders, 
pharmaceutical manufacturers, conserva- 
tionists, and environmentalists to discuss 
the various aspects of this problem. After 
subsequent meetings with key stakehold- 
ers, FWS and APhA created the SMARxT 
DISPOSAL program. A memorandum of 
understanding was signed at APhA2007 in 
Atlanta to launch the program, which aims 
to get the message to consumers NOT TO 
FLUSH. 


What to tell your patients: 

™ Check for state or local medication col- 
lection or take-back programs. 

™ Check with hazardous waste facilities 
for disposal programs. 

™ DO NOT FLUSH, unless the medica- 
tion label specifically says to do so. 

™ Crush unused solid medications and 
dissolve liquid ones. 

® Mix with cat litter, coffee grounds, or 
other solid waste. 

™ Place in plastic bag and seal to avoid the 
risk of poisoning children or pets. 

™ Remove all identifying personal infor- 
mation from medication container. 

®™ Place in garbage can. 

®™ Proper disposal of medications will 
prevent them from being diverted and 
used illegally. 


Take-back program 

Thinking about organizing a prescription 
drug take-back program in your area? 
Pharmacists in Rock County, Wis., took 
the next step in safe medication disposal 
by setting up medication take-back days 
at two different locations in their county. 
APhA Trustee Jerald Sveum, BPharm, 
recently spoke with Pharmacy Today 


sThe .., 
_/.\ne Minute 


SMA T 


DISPOSAL 


Dee Loar Gv eL) ble ats RaVahe b 
AMERICAN PHARMACISTS ASSOCIATION 


about the prescription drug disposal days. 
The group advertised the take-back days 
with posters announcing that medication 
drop-off was confidential and free. No 
preregistration was required, and volun- 
teers provided drive-up service so donors 
did not have to leave their cars. The flyers 
also specified that radioactive materi- 
als, chemotherapy drugs, and sharps or 
needles would not be accepted. 


Each drop-off donation was collected by 
a volunteer, who passed it on to a phar- 
macist. A team of pharmacists sorted the 
drugs into controlled and noncontrolled 
substances. The controlled substances 
were identified by name and quantity, 
logged in, and placed in special contain- 
ers. Law enforcement officers sealed the 
containers when full; they took possession 
of all the collected drugs and transported 
them to an incineration facility, where they 
were weighed and marked for disposal. 


During the first 4-hour session, volun- 
teers collected 261 pounds of drugs. 
Sveum said, “We collected one medica- 
tion from 1969.” Organized by the Rock 
County Health Department in coopera- 
tion with local pharmacists, the Board 
of Health, and law enforcement, the 
program also collected 37 pounds of 
controlled substances in tablets and cap- 
sules and 3,050 mL in liquid form that 
first day. Sveum added, “The amount 
of controlled substances—especially 
schedule II medications—that were col- 
lected was substantial. It was really good 
to get these out of the homes where they 
could be available to children and teens 
and to do it in a way that protects the 
environment.” 


© § American Pharmacists Association’ 
x4 


APhA 


TOM MACKENZIE, U.S. FISH AND WILDLIFE SERVICE. 


For a healthier environment, use 
SMAR,,.T medication disposal 


© 2007 by the American Pharmacists Association. All rights reserved. 


What do you do with your unused pre- 
scription medications? Do you flush 
them down the toilet or sink? What are 
the consequences of these drugs entering 
our sewer systems and making their way 
into our streams and lakes? A 2002 study 
by the Toxic Substances Hydrology 
Program of the U.S. Geological Survey 
found low concentrations of human and 
veterinary drugs in the waterways it sam- 
pled. Researchers found antibiotics, nat- 
ural and synthetic hormones, detergent 
metabolites, plasticizers, insecticides, 
and fire retardants in waters downstream 
from urban areas and animal farmlands. 
One or more of these chemicals were 
found in 80% of the streams sampled. 
Half of the streams contained 7 or more 
of these chemicals, and about one-third 
of the streams contained 10 or more of 
the chemicals. 


THuUSH 


Most of these substances find their way 
into waterways through our sewer sys- 
tems and septic tanks. Below are some 
ways you can help prevent this growing 
problem. Follow these simple steps, and 
check with your pharmacist if you are 
unsure about how to dispose of your 
medication. 


1. Check for state or local medication 
collection or take-back programs. 


i) 


. Check with hazardous waste facilities 
for disposal programs. 

3. If these options are not available, dis- 

pose of medications properly in the 

trash; DO NOT FLUSH unless the 

medication label specifically states to 

do so. 


John A. Gans, PharmD, APhA Executive Vice 
President and CEO, demonstrates proper disposal 
of expired medications. 


DISPOSAL 


Wy 504 akal nulla & Wu L Deltlal Gand eRaviekt Ok 
AMERICAN PHARMACISTS ASSOCIATION 


What you'll need: 
™ Cat litter or coffee grounds 
™ Sealable plastic bag 


™ Hammer and/or water 


Before you toss 
Here is what to do with your medication 
before you throw it in the trash: 


™ Crush unused solid medications and 
dissolve liquid medications. 

™ Mix the medication with cat litter, cof- 
fee grounds, or other solid waste. 

™ Place the medication in a plastic bag 
and seal to avoid the risk of poisoning 
children or pets. 


™ Remove all identifying personal 
information from the medication 
container. 


® Place the bag and the drug container in 
a garbage can. 


oe 


Besides protecting the environment from 
drugs in the water supply, proper disposal 
of your medications will prevent them 
from being diverted and used illegally. 


(—_— = = a se oe 


Continuing Education 
for Pharmacists 


Women’s Health: 
Guidelines for 
Prevention of 
Cardiovascular 
Disease 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 


Ohio Northern University 
Ada, Ohio 


and 


J. Richard Wuest, R.Ph., 
PharmD 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


Goal. The goal of this lesson is to 
discuss the 2007 American Heart 
Association (AHA) guidelines for 
prevention of cardiovascular disease 
(CVD) in women. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. differentiate cardiovascular 
morbidity and mortality data for 
men and women in the United 
States; 

2. identify common risk factors 
for cardiovascular disease and 
recognize how their modification 
can benefit overall health; 

3. demonstrate an understand- 
ing of the therapeutic role of aspirin 
in primary and secondary preven- 
tion of cardiovascular events; and 

4. differentiate the AHA guide- 
lines for prevention of CVD in 
women. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


Background 

More women in the United States 
die from cardiovascular disease 
(CVD) than from all forms of cancer 
combined, yet in one survey of 
women, only 8 percent of respon- 
dents considered CVD to be their 
greatest health threat. Prevention of 
CVD is paramount; fortunately, 
most CVD in women is preventable. 


CVD in Women 
The public health impact of CVD in 
women is not related solely to the 
high mortality rate. In the United 
States, 38.2 million women (34 
percent) are living with CVD, and 
the population at-risk is even larger. 
There are several reasons why 
mortality from CVD is so high in 
women. Women with symptoms of 
myocardial infarction (MI) are less 
likely than men to seek emergency 
treatment and more likely to die 
within a year of their event. Women 
may not experience the classic 
syndrome of angina characteristic 
for men. They are more likely than 
men, for example, to feel angina at 
rest and during sleep. Their pain 
may predominate in areas other 
than the anterior chest, including 
the lower jaw, both arms, shoulders, 
back, and epigastrium. Women are 
more likely to experience fatigue, 
nausea, vomiting, sweating, dysp- 
nea, presyncope, or palpitations 


Volume XXV, No. 8 


rather than chest pain. Women also 
experience more silent MIs, with 
nearly half of the events remaining 
unrecognized. 

Women represented only 38 
percent of subjects in National 
Institutes of Health (NIH)-funded 
cardiovascular studies. Women who 
are at risk for CVD are often not 
referred for appropriate diagnostic 
testing. Women with acute MI may 
be treated less frequently and less 
aggressively with thrombolytic and 
other cardioprotective therapy than 
men. They are less likely than men 
to receive aspirin within 24 hours of 
admission into a hospital witha 
cardiovascular event (83 versus 87 
percent), have aspirin prescribed at 
discharge (84 versus 87 percent), or 
receive beta-blockers on admission 
(67 versus 70 percent). Women 
undergo fewer coronary angiography 
and revascularization procedures, 
and experience greater rates of 
complications and mortality follow- 
ing revascularization. Women are 
also less likely to participate in 
cardiac rehabilitation after an MI. 
Following an MI, women experience 
a higher death rate during hospital- 
ization than men in similar age 
ranges. Within one year of a first 
MI, an estimated 38 percent of 
women versus 25 percent of men 
will die. 


Guidelines for Prevention of 
CVD in Women 

The first female-specific recommen- 
dations from the AHA for preventive 
cardiology were published in 1999 as 
an aid to health care professionals 
and their patients. The guide was 
intended to provide health care 
professionals with a comprehensive 
approach to patient care of women 
across a broad spectrum of risks. 


Page 19 


Table 1 


Guidelines for Prevention of Cardiovascular Disease in Women’ 


Lifestyle Therapy 
Cigarette smoking. Do not smoke. 


Provide counseling, nicotine replace- 
ment & other therapy along witha 
behavioral program or formal smok- 
ing cessation program. (Class I, Level 
B) 

Physical activity. Perform a 
minimum of 30 minutes of moderate- 
intensity physical activity every day 
of the week. (Class I, Level B) If 
overweight, perform a minimum of 60- 
90 minutes of exercise every day. 
(Class I, Level C) 

Rehabilitation. Engage in a physi- 
cian-directed comprehensive risk- 
reduction regimen if have a recent 
cardiovascular event or peripheral 
artery disease, or current/prior 
symptoms of heart failure & LVEF 
<40%. (Class I, Level B) 

Dietary intake. Consume a diet rich 
in fruits & vegetables; whole-grain & 
high-fiber foods; oily fish (at least 
twice a week); limit saturated fat to 
<10% of energy (if possible to <7%), 
cholesterol to <300 mg/day, alcohol to 
1 drink/day limit, & sodium intake to 
<2.3 g/d. Limit trans-fatty acids to 
<1% of energy. (Class I, Level B) 

Body weight. Maintain a BMI 
between 18.5 and 24.9 kg/m? & waist 
circumference <35 in. (Class I, Level 
B) 

Omega-3 fatty acids. Women with 
CHD may consume 850 to 1000 mg, in 
capsule form, of EPA and DHA; higher 
doses (2 to 4 g) if have high triglycer- 
ide levels. (Class IIb, Level B) 

Depression. Women with CHD 
| should be treated for depression when 
indicated. (Class Ila, Level B) 


Major Risk Factor Interventions 
| Blood pressure. Maintain blood 


pressure of <120/80 mm Hg or lower 
‘through lifestyle therapy. (Class I, 
Level B) Drugs indicated when blood 
pressure is >140/90 mm Hg or even 
lower when chronic kidney disease or 
diabetes is present (>130 mm Hg). 
Thiazides should be included for most 
patients unless contraindicated or 
there are compelling indications for 
other drugs. Initial treatment of high- 
risk women should be with f-blockers 
_and/or ACE-I/ARBs, with additional 
_drugs as needed. (Class I, Level A) 


Lipid & lipoprotein levels. Strive 
for levels of LDL-C <100 mg/dL, HDL- 
C >50 mg/dL, triglycerides <150 mg/ 
dL, and non-HDL-C (total cholesterol 
minus HDL cholesterol) <130 mg/dL 
(Class I, Level B). Women at high risk 
or with hypercholesterolemia should 
restrict saturated fat to <7% and 
cholesterol intake to <200 mg/dL. 
(Class I, Level B). Drugs indicated 
along with lifestyle therapy in women 
with CHD to achieve LDL-C <100 mg/ 
dL (Class I, Level A) & similarly in 
women with other atherosclerotic 
CVD or diabetes or 10-yr absolute risk 
>20% (Class I, Level B). A reduction to 
<70 mg/dL is reasonable in very-high- 
risk women with CHD. (Class Ila, 
Level B) 

Lipids in other at-risk women. 
Drugs indicated along with lifestyle 
therapy if LDL-C level is >130 
mg/dL & there are multiple risk fac- 
tors even if 10-yr absolute risk is 10% 
to 20%. (Class I, Level B) Use drugs 
with lifestyle therapy if LDL-C level is 
>160 mg/dL and multiple risk factors 
even if 10-yr absolute risk is <10% 
(Class I, Level B). Use drugs with 
lifestyle therapy if LDL-C level is >190 
mg/dL regardless of presence or 
absence of other risk factors or CVD on 
lifestyle therapy. (Class I, Level B) 

Lipids - pharmacotherapy for low 
HDL or elevated non-HDL, in high- 
risk women. Use niacin or fibrate 
therapy when HDL-C is low or non- 
HDL-C is elevated in high-risk women 
after LDL-C goal is achieved. (Class 
IIa, Level B) Consider niacin or fibrate 
therapy when HDL-C is low or non- 
HDL-C is elevated after LDL-C goal is 
achieved in women with multiple risk 
factors and a 10-yr absolute risk 10% 
to 20%. (Class IIb, Level B) 

Diabetes mellitus. Follow lifestyle 
therapy and use drugs as indicated in 
women with diabetes (Class I, Level B) 
to achieve an HbA,,, <7%. (Class I, 
Level C) 

Aspirin. Use aspirin therapy (75-325 
mg/day) in high-risk women unless 
contraindicated. (Class I, Level A); 
Consider aspirin (81 mg/day or 100 mg 
every other day) in women >65 years of 
age if blood pressure is controlled & 
benefit for ischemic stroke and MI 
prevention outweigh risk of gastro- 
intestinal bleeding and hemorrhagic 
stroke (Class Ila, Level B) and in 


women <65 years of age when benefit 
for ischemic stroke prevention out- 
weighs adverse effects of therapy. 
(Class IIb, Level B) 

B-blockers. Use indefinitely in all 
women after MI, acute coronary 
syndrome, or left ventricular dysfunc- 
tion with or without heart failure, 
unless contraindicated. (Class I, Level 
A) 

ACE-I/ARB. Use an ACE-I (unless 
contraindicated) in women after MI 
and those with evidence of heart 
failure or an LVEF <40% or with 
diabetes mellitus. (Class I, Level A). 
In women after MI and those with 
clinical evidence of heart failure or 
LVEF <40% or with diabetes who are 
intolerant of an ACE-I, an ARB should 
be used. (Class I, Level B) 

Aldosterone blockade. Use after 
MI in women who do not have signifi- 
cant renal dysfunction or hyperkal- 
emia who are already receiving 
therapeutic doses of an ACE-I and f- 
blocker, and have LVEF <40% with 
symptomatic heart failure. (Class I, 
Level B) 


*See Evidence-based guidelines for 
cardiovascular disease prevention in 
women: 2007 update. Circulation. 
2007;115:1481-1501. 


LVEF = left ventricular ejection fraction; 
BMI = body mass index; EPA = 
eicosapentaenoic acid; DHA = 
docosahexaenoic acid; ACE-I = angio- 
tensin-converting enzyme inhibitor; ARB 
= angiotensin receptor blocker; LDL-C = 
low-density lipoprotein cholesterol; HDL- 
C = high-density lipoprotein cholesterol. 


A drink equivalent is equal to a 12-0z 
bottle of beer, a 5-oz glass of wine, or a 
1.5-0z shot of 80-proof spirit. 


Classification/Levels of evidence: 

Class I = Intervention is useful & 
effective 

Class Ila = weight of evidence/opinion 
favors usefulness/efficacy 

Class IIb = usefulness/efficacy is less 
well established by evidence/opinion 

Class III = intervention is not useful/ 
effective & may be harmful 

Level A = sufficient evidence from 
multiple randomized trials 

Level B = limited evidence from single 
randomized trial or other nonrandomized 
studies 

Level C = based on expert opinion, case 
studies or standard of care 


Page 20 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


a 


This was updated in 2004, and 
again in 2007. The 2007 update 
(Table 1) lists current clinical 
recommendations for prevention of 
CVD in women >20 years of age. 
Recommendations are based on an 
extensive review of the world 
literature, interpreted by experts in 
cardiology, epidemiology, family 
medicine, gynecology, internal 
medicine, neurology, nursing, public 
health, statistics, and surgery. The 
guidelines cover both primary and 
secondary prevention of chronic 
atherosclerotic vascular diseases. 

Several important changes from 
the 2004 guidelines are noted. The 
approach to consideration of risk 
levels in the updated report places 
greater emphasis on lifetime risk, 
rather than on short-term absolute 
risk, as defined by the Framingham 
global score (see 


www.pubmedcentral.nih.gov/ 


articlerender.fcgi?artid=1494957). 
The 2007 guidelines acknowledge 


that most women are at risk for 
CVD, which underscores the 
relevance in maintaining a heart- 
healthy lifestyle. Moreover, some 
women are at high risk of future 
cardiovascular events because of 
established CVD and/or multiple 
risk factors. These women require 
more aggressive preventative 
therapy. Also, more definitive data 
concerning aspirin and hormonal 
therapies, and folic acid supple- 
ments have become available in 
recent years. Of note is that aspirin 
should be considered for all women 
for stroke prevention, depending on 
the balance of risks and benefits. 
The ability to identify CVD in 
its earliest stages has continued to 
improve over the past several years 
resulting in further blurring of the 
difference between primary and 
secondary prevention. Instead of 
considering CVD as an all-or-none 
condition, there is increasingly 
stronger evidence now to consider it 
as a continuum of CVD risk. The 
2007 update presents a scheme 
(Table 2) for a general approach to 
the female patient that classifies her 
as at high risk, at risk, or at 
optimal risk. Evidence that suggests 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


CVD can be prevented in both 
women and men by eliminating the 
risks is overwhelming. 

Generally, recommendations to 
prevent CVD in women do not differ 
from those for men. In some in- 
stances, the risk-reducing interven- 
tions recommended in these guide- 
lines (e.g., use of ACE inhibitors and 
angiotensin receptor blockers for 
blood pressure control) are contrain- 
dicated in women who are pregnant. 


Lifestyle Modification 

Lifestyle modification includes 
healthy eating, cessation of smok- 
ing, regular exercise, and control of 
blood pressure. Up to 90 percent of 
all CVD in the U.S. may be attrib- 
uted to these, and other, modifiable 
risk factors. Results of long-term 
prospective studies consistently 
confirm that persons with low levels 
of cardiovascular risk factors 
experience lifelong low levels of CVD 
and stroke. The Nurses’ Health 
Study was a prospective observa- 
tional investigation of 87,678 
healthy middle-aged female nurses 
aged 34 to 65 years living in 11 
states who were free of CHD (coro- 
nary heart disease), stroke, and 
cancer at onset. The women com- 
pleted questionnaires at two-year 
intervals for six years, which sought 
information relative to their cardio- 
vascular risk factors, extent of 
aspirin ingestion, and physician 
visits. Study endpoints were first 
occurrence of MI, stroke, all impor- 
tant vascular events, and cardiovas- 
cular death. 

One outcome of the study was 
the observation that women who 
maintained a healthy diet, exercise 
regimen, and desirable body weight, 
and who did not smoke or consume 
more than a moderate amount of 
alcohol could reduce their risk of 
CVD by 84 percent. Nonetheless, 
only 3 percent of the women in the 
study (recall that all of them were 
health care professionals!) were 
included in that category. 

Clearly, most causes of CVD are 
known and modifiable. No single 
risk factor can be considered in 
isolation. While each factor indepen- 


Table 2 
Classification of 
CVD Risk in Women’ 


Risk Status and Criteria 
High Risk 
Established coronary 
heart disease 
Cerebrovascular disease 
Peripheral arterial disease 
Abdominal aortic aneurysm 
End-stage or chronic renal disease 
Diabetes mellitus 
10-Year Framingham global risk™ 
>20 percent” 


At Risk 
>1 major risk factors for CVD, 
including: 

Cigarette smoking, poor diet, 
physical inactivity, obesity 
(especially central adiposity), 
family history of premature 
CVD [CVD at <55 years of age 
in male relative and <65 years 
of age in female relative], hyper- 
tension, dyslipidemia 

Evidence of subclinical vascular 
disease (e.g., coronary calcifica- 
tion) 

Metabolic syndrome 

Poor exercise capacity on tread- 
mill test and/or abnormal 
heart rate recovery after 
stopping exercise 


Optimal Risk 
Framingham global risk” <10 
percent and a healthy lifestyle, 
with no risk factors 


CVD = cardiovascular disease 

“See Evidence-based guidelines for 
cardiovascular disease prevention in 
women: 2007 update. Circulation. 
2007;115:1481-1501. 

“See text 

“Or at high risk on the basis of an- 
other population-adapted tool used to 
assess global risk 


dently modifies the risk of CVD, 
they may work additively and/or 
synergistically to multiply an 
individual’s risk. Risk stratification 
should incorporate known informa- 
tion about interaction between 
multiple risk factors, rather than 
simply counting the number of 
factors. 


Page 21 


The Role of Aspirin in 
Prevention of Cardiovascular 
Events in Women 

The second International Study of 
Infarct Survival (ISIS-2) demon- 
strated that aspirin provided clear 
and conclusive benefit in protecting 
against acute MI. The study en- 
rolled 17,187 individuals (35 percent 
were women) who had symptoms of 
impending MI. Within 24 hours of 
onset of symptoms, those who 
received aspirin at 162 mg/day, had 
a 23 percent lowered risk for vascu- 
lar death. 

The benefit of aspirin for people 
who have no symptoms, principally 
women, is less clear since the 
majority of early trials have focused 
on men. There is, however, suffi- 
cient convincing evidence to affirm 
benefits for women. 

Aspirin’s cardioprotective 
benefit is believed to be due to its 
potent antiplatelet (i.e., antithrom- 
botic) activity by inhibiting prosta- 
glandin synthesis in platelet mem- 
branes to prevent platelet plug 
formation in atherosclerotic vessels. 
Additional sites and possible mecha- 
nisms for aspirin’s role in reducing 
cardiovascular events include an 
antioxidant action, and effects on 
neutrophils, fibrinolysis, thrombin 
generation, and atherogenesis in 
higher doses. Since inflammation 
may also play an important role in 
atherosclerosis, and aspirin modifies 
inflammation, its anti-inflammatory 
action may help modify thrombosis. 

The 2007 guidelines solidify the 
role of aspirin in primary prevention 
of CVD. The updated recommenda- 
tion is to provide low-dose aspirin for 
women 65 years of age or older 
regardless of their cardiovascular 
risk status, if benefit is likely to 
exceed other risks. (Earlier guide- 
lines did not recommend aspirin in 
lower risk- or healthy women). The 
new guidelines also recommend 
aspirin dosage of up to 325 mg/day 
for high-risk women of all ages. 
This represents an increase from 
the previously recommended 162 
mg/day. Moreover, the guidelines 
recommend consideration of aspirin 
for women of all ages, including 


Page 22 


younger women who are at in- 
creased risk for cardiovascular 
events, including ischemic stroke. 


Other Interventions 

A number of interventions are 
deemed to be not useful/effective and 
may be harmful to CVD or MI 
prevention in women. These in- 
clude: 

e Hormonal therapy, including 
selective estrogen-receptor modula- 
tors (SERMs), should not be used for 
primary or secondary prevention of 
CVD; 

e Antioxidant supplements, includ- 
ing vitamins C and E, and beta 
carotene, should not be used for 
primary or secondary prevention of 
CVD; 

e Folic acid, alone or with vitamin 
B,, should not be used for primary 
or secondary prevention of CVD; and 
e Routine use of aspirin in healthy 
women <65 years of age is not 
recommended for preventing MI. 


Patient Counseling 

All individuals should be evaluated 
by a physician before beginning 
daily aspirin dosing. Whether or not 
aspirin can be taken for the primary 
prevention of cardiovascular events 
should be based on an assessment of 
the patient’s risk of an impending 
cardiovascular event without 
aspirin, absolute risk of gastrointes- 
tinal or intracranial hemorrhage 
with aspirin, and the patient’s 
preference including willingness to 
comply with chronic daily dosing. 
Decisions concerning continuance of 
aspirin therapy should be reviewed 
at least every five years, or when 
new vascular risk factors are 
detected. 

Individuals who have not been 
evaluated medically should not be 
encouraged to begin self-therapy 
with aspirin. There is a risk, albeit 
slight, for adverse reactions. There 
is one exception to the general rule 
advising against self-medication for 
cardioprotection. Since the extent of 
heart muscle damage corresponds 
directly to the rapidity of initiating 
aspirin therapy following onset of 
symptoms of MI, an uncoated 


aspirin tablet (325 mg) should be 
taken (best if chewed) at once if an 
MI is suspected. 

The need for patient counseling 
and education is emphasized when 
patterns of aspirin utilization and 
mismedication are considered. 
Numerous surveys confirm the 
health benefits of aspirin in primary 
and secondary prevention of cardio- 
vascular events, and that aspirin is 
underutilized. With respect to 
mismedication, 21 percent of 
patients in one study who were 
prescribed aspirin were mistakenly 
taking acetaminophen (11 percent) 
or non-aspirin NSAIDs (10 percent) 
instead of aspirin. The survey 
authors estimated that according to 
these data, as many as 1.3 million 
people >40 years of age may errone- 
ously be taking acetaminophen or 
non-aspirin NSAIDs for cardiovas- 
cular protection, and another 1.4 
million may be taking these agents 
along with aspirin. Only aspirin has 
been shown to confer cardioprotec- 
tion to women and men. 


Overview and Summary 

CVD is the major cause of prema- 
ture mortality in women living in 
the United States. Recently pub- 
lished guidelines are directed at 
reducing the death rate in this 
population. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 


Continuing Education Quiz 


This month’s questions are taken from the article on “Current Guideline for Home Use of Ipecac Syrup in Treatment of Ingested Poisons”. 
Circle your answers to the following questions and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 
21201-1572. There is no charge for this quiz for MPhA members (non-members $ 10.00). The completed quiz for this issue must be 
received by 3/15/10. A continuing education certificate for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to 


eight weeks. Please type or print clearly. ACPE# 129-144-07-003-H01. 


Name 

Address 

City, State, Zip 
Daytime Phone 


Date Completed 
(Required) 


1. Allofthe following are reasons why mortality 
from CVD is so high in women, with the exception of: 

a. women have more severe MIs than men. 

b. women with symptoms of MI are less likely to 
seek emergency treatment. 

c. women may not experience the classic syndrome 
of angina. 

d. women are more likely to feel angina at rest. 


2. All ofthe following are findings of NIH-funded 
cardiovascular studies with the exception of: 

a. women are less likely to receive aspirin within 
24 hours of admission with a cardiovascular event. 

b. women who are at risk for CVD are often not 
referred for appropriate diagnostic testing. 

c. women are more likely to participate in cardiac 
rehabilitation after an MI. 

d. women undergo fewer coronary angiography and 
revascularization procedures. 


3. All of the following are guidelines for prevention of 
CVD in women EXCEPT: 
a. may consume 850 to 1000 mg of EPA and DHA. 
b. do not take SSRI antidepressants. 
c. exercise a minimum of 30 minutes per day. 
d. do not smoke. 


4. The guidelines recommend the use of which of the 
following lipid-pharmacotherapies for low HDL or 
elevated non-HDL in high risk women after LDL-C 
goal is achieved? 

a. Aspirin or aldosterone blocker 

b. BASR or statin 

c. Ezetimibe or ACE inhibitor 

d. Niacin or fibrate 


The Maryland Pharmacy Continuing 
Education Coordinating Council is 
accredited by the Accreditation Council for 


Pharmacy Education as a provider of 
continuing education for pharmacists. 


5. The guidelines recommend that, in post MI 
women, acute coronary syndrome or left ventricular 
dysfunction, beta-blockers: 
a. can be used indefinitely, unless contraindicated. 
b. should never be used. 


6. The 2007 guidelines place greater emphasis on: 
a. short-term absolute risk. 
b. lifetime risk. 


7. The 2007 update to the classification of CVD risk 
for women has all the following categories of risk 
status and criteria EXCEPT: 

a. at high risk. c. at no risk. 

b. at risk. d. at optimal risk. 


8. One outcome of the study was that women who 
maintain a healthy diet, exercise regimen and 
desirable body weight, and avoid smoking and 
excessive consumption of alcohol, can reduce their 


risk of CVD by: 
a. 24 percent. c. 64 percent. 
b. 44 percent. d. 84 percent. 


9. The second International Study of Infarct Sur- 
vival (ISIS-2) demonstrated that: 

a. aspirin provided clear and conclusive benefit in 
protecting against acute MI. 

b. aspirin provided little benefit in protecting 
against acute MI. 


10. Hormonal therapy for women: 

a. is deemed to be useful for primary and second- 
ary prevention of CVD. 

b. should not be used for primary or secondary 
prevention of CVD. 


Maryland Pharmacist ¢ July/Aug./Sept. 2007 Page 23 


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MCKESSON 


Empowering Healthcare 


VOLUME 83 No. 4 


President’s Commentary 
Imagine... 


Therapeutically Speaking .. . 
Medication Management Across 
the Continuum of Care 


Psychotropic Drugs 
Then and Now 


Continuing Education 
“Meningococcal Disease and 


Available Vaccines” 


Happy Holidays! 


“9 = 48 
a4 : 
aca hs, 
; 


OCTINOVJDEC. 2007 _ 


Maryland Pharmacists Association 
650 W. Lombard Street 
Baltimore, MD 21201 
410-727-0746 
www.marylandpharmacist.org 


MPhA Officers 2007 - 2008 


Joseph: Marrocco;P: Doi coe. President 
Magaly Rodriguez deBittner, Pharm.D. 

Vice President 
WalterAbel_ PB... Treasurer 
Robert Beardsley, Ph.D. ... Honorary President 


House Officers 


Ruth Blath ei Dee i ees 
Carol Stevenson, Pharm.D. 


Speaker 
Vice Speaker 


MPhA Staff 


Howard ochiff; B.D. 2.. 2. Executive Director 
Elsie Prince Office Manager 
Nancy Ruskey Administrative Assistant 


MPhA Trustees 


Ginger Apyal, F.0D... oe Chairperson 
Michelle Andoll, P.D., J.D. ... 22 2008 
Buich Henderson KPA 3 2 

Brian Hose. Pharm.D. 33. 

Mary Kremzner, Pharm.D. 

Neil ieikach- P.D 2 ie aa es 

David RUSSO: RRR eee we eee 2008 
Doris Voigt, Pharm.D. 23 2. as 2008 
Claire Leocha ASP President 


Ex-Officio Members 
Natalie Eddington, Ph.D. 357. ea Dean 
UMB School of Pharmacy 
Jennifer Thomas, Pharm.D. 
MSHP Representative 


Maryland State Board of Pharmacy 


Donald Taylor, P.D., President 
Mike Souranis, P.D. Treasurer 
David R..Chason, RiPhi 2222 eee: Secretary 
Cynthia Anderson, M.S., R.Ph. 

Margie A. Bonnett 

Lynette Bradley-Baker, Ph.D. 


Alland Leandre, M.S., M.B.A. 

Mayer Handelman, P.D. 

Lenna Israbian-Jamgochian, Pharm.D. 
Harry Finke, Jr., P.D. 

Rodney Taylor, Pharm.D. 

Reid Zimmer, R.Ph. 


Maryland Pharmacist 


The Official Publication of the Maryland Pharmacists Association 


ELESIOcnts¢ COMMENTATY)) sets wee. «ec «sc. co « PROB ene Seen eine nanny Pee 
Imagine... 


herapentically,speakin esas WC ey IP) SP) Been ay cone rk naoree Vlei Mh 
Medication Management Across the Continuum of Care 


ESYCHOtOpIG Drugs ich Uesde-ccr. end, hidnbarcnniist ieee eee Ree eee ae ees te a] 0) 
Then and Now 


CONLIN DIN PEON CACO acetic tan Pet oat oe tae AREY 08, wcVn Palma nievaces CLD 
“Meningococcal Disease and Available Vaccines”’ 


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Maryland Pharmacist (ISSN 0025-4347, USPS 332-040) is published quarterly by the Maryland Pharmacists Association, 650 West Lombard 
Street, Baltimore, Maryland 21201-1572. Non-member annual subscription - $ 30. Periodicals postage paid at Baltimore, MD and at additional 
mailing office. Articles and editorials that appear do not necessarily reflect the official positions of the Maryland Pharmacists Association and may 
contain views and opinions for which the authors hold sole responsibility. Postmaster: Send address changes to: Maryland Pharmacist, 650 West 
Lombard Street, Baltimore, MD 21201-1572. Howard Schiff—Editor, & Elsie Prince—Managing Editor. 


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Page 4 Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


[ magine. ie 


In the words of one of the most influential songwriters and groups of 
recent generations, John Lennon of the Beatles, titled one of his classic 
works—Imagine... 


I would share with you, my fellow pharmacist colleagues, that 
Involvement is essential in our profession, as it was in the lyrics and 
thoughts that Beatle, John was also striving to covey in that classic song. 


Kristina Lunner, Vice President of government affairs for the American 
Pharmacist Association recently remarked “Our core task is to make very 
clear how pharmacists help people.”’ Lunner pointed to physicians and 
nurses. “You see and feel the services they provide”’...“‘any product 
component seems to be incidental to their primary role, which is providing 
expert clinical services.” 


Joseph arrocco, P.D. 
President 


I am proud to share with you that in Maryland, we have numerous colleagues who are providing these valued 
services to their patients. The Baltimore Sun newspaper recently had a splendid article with pictures relating 
Pharmacy Supervisor, Butch Henderson and his pharmacist team at Kleins in Harford County. A couple days 
later, the Sun featured a well detailed article that Professor Magaly Rodriguez de Bittner related Pharmacist 
involvement in clinical and community pharmacy practices. 


MPhA Committee Chair, Christine Lee, proudly reports that her P3 Program has more employers on board, and 
is avidly seeking pharmacists to participate in providing these services. Special kudos to Communication Chair, 
Michelle Andoll, who aside from her own pharmacy, drives nearly and hour to offer the valued services to 
Upper Chesapeake Health Care. Kristen Fink, in addition to her full time Kaiser Pharmacist consultant 
position, drives back to eastern Baltimore County to provide these valued services to her Pharmacist, Dad’s 
pharmacy practice in Essex. . 


Brian Hose, is providing P3 services and care, along with immunizations, in the Western Maryland Health 
System, in addition to serving as Committee Chair for the important Legislation arm of MPhA. 


Hoai An Truong, a very recent Maryland Pharmacy School Grad has his Professional Development Committee 
highly engaged in Collaborative Drug Therapy Management that can facilitate writing protocols for Board 
Approval. 


ASP President, Claire Leocha appeared with some of her fellow Maryland Pharmacy School students on WJZ- 
TV and was interviewed by Ron Matz. 


Committee Chair, Doris Voigt, has an outstanding group of Pharmacist speakers and topics arranged for the 


MPhA Mid-Year Meeting, Sunday, January 27, 2008, at the Columbia, MD Sheraton Hotel—the week before 
Super Bowl. Doris has the unique ability to coordinate expert speakers with enlightening topics for all to enjoy. 


... Imagine... ... Involve Yourself... ... Your Profession... 
... Happy Holidays... 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 Page 5 


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Therapeutically Speaking... 


Medication Management Across the Continuum of Care 


Nicole Brandt, PharmD, CGP, BCPP, FASCP 
Associate Professor, University of Maryland, School of Pharmacy 


Appropriate medication management is a critical component of caring for older adults. The majority 
of individuals over the age of 65 live in the community, some live in nursing homes (NHs), and there is a 
rise in the number of individuals residing in assisted living facilities (ALFs). Patients residing in these 
facilities frequently have a high number of comorbid conditions and receive an average of 9 medications, 
putting them at high risk for medication misadventures.’ This article will discuss the role and 


opportunities for pharmacists in NHs and ALFs. 


Medication Management in Nursing Homes 

Medications and pharmacy services are a 
critical part of the care provided to residents in 
nursing homes. The role of pharmacists in 
nursing homes has been well established, and 
includes aspects such as individual resident 
monthly medication regimen reviews, serving on 
the interdisciplinary team, and performing 
routine quality assurance audits. This role has 
been recently better defined with the 
implementation of updated guidance for nursing 
home surveyors with the publication of 
pharmacy “F-Tags” (F 329, F 425, F428 and 
F431) in December 2006. The term “F tag” 
refers to a regulatory requirement(s) that is 
found within the State Operations Manual 
(SOM). In addition to the regulation language, 
there is interpretive guidance for surveyors 
found at the F tag. The guidance provides 
assistance and direction to surveyors during their 
comprehensive assessment of the facility to 
determine if the facility is in compliance. 

The updated guidance found at F tag 329, 
which focuses on unnecessary medications, 
moves the surveyor from a checklist approach of 
determining the presence of potentially 
inappropriate medications in older adults to a 
process of evaluating the impact of all 
medications on the care of each and every 
resident. This has drawn attention to the 
importance and role of the pharmacist as part of 
the interdisciplinary team to optimize 
medication management. Medication 
management includes recognition or 
identification of the problem/need; assessment; 
diagnosis/cause identification; 
management/treatment; monitoring; and revising 
interventions both pharmacologic and non- 


pharmacologic. The intent of the new guidance 
was to expand the surveyor’s assessment beyond 
primarily antipsychotics and other 
psychopharmacological medications (e.g. 
benzodiazepines) to include an evaluation of all 
medications. The intent of the F-tag 329 
regulation (use of unnecessary medications) is to 
ensure that all residents’ are receiving only those 
medications which are necessary to treat or 
manage specified symptoms or conditions, 
allowing the resident to function at their most 
practicable level. Ensuring appropriate 
medication management includes consideration 
of (1) a specified indication for use, (2) 
monitoring parameters for benefits and potential 
adverse consequences, (3) appropriate dose 
and/or duplication of therapy, (4) statement of 
duration of use in accordance with clinical 
practice guidelines, current standards of practice 
or manufacturer’s specifications for the stated 
indication, (5) evaluation for gradual dose 
reduction or tapering, and (6) procedures for 
prevention, identification, and reaction to the 
occurrence of adverse events. Pharmacists are 
held accountable for appropriate medication 
management by providing at least monthly 
medication reviews which is mandated by F-Tag 
428. 


Medication Management in Assisted Living 
Facilities (ALFs) 

ALFs, unlike NHs, are regulated by each 
state; it is estimated that there are at least 36,000 
ALFs in the United States.” The term used to 
describe ALFs varies from region to region and 
includes: assisted living homes, residential care 
facilities for the elderly, assisted living 
residence, and community residence facilities. 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 Page 7 


This makes it confusing to the patient as well as 
the medical community. 

Further differentiating NHs and ALFs is the 
philosophy of care. NHs are highly regulated 
and follow more of a medical model with 
interdisciplinary care. ALF care is more of a 
social model which “maximizes consumers’ 
independence, autonomy and dignity” as well as 
“minimizes the need to move when a resident’s 
needs for services increases.” * This can become 
a double-edged sword when it comes to 
medication management and the variability of 
supportive care services in the ALF. It is 
estimated that up to 77% of residents receive 
help with medication self-administration.* Since 
ALF’s are regulated by the state rather than 
federal government, there is variation in the 
guidelines from state to state. In 2003, the 
Assisted Living Workgroup created a list of 
recommended policies concerning medication 
management in ALFs to help facilities create a 
medication management service that would 
work effectively and provide correct 
medications to the residents (Table I)* 

It is important to note, in states that have 
chosen to implement some or all of these 
policies, variations still exist. Some of the 
variability among states includes: 


e who can administer medications 

e how much training one needs to 
administer medications, 

e who can assess a resident for self- 

administration, 

how is assistance defined, 

is a medication review mandatory, 

who does the medication review, and 

how often a medication review should 

be performed 


For instance in the State of Maryland, the 
regulations note the following: 


“ 10.07.14.21 Medication Management 
1. The assisted living manager shall 
arrange for an on-site review by a 
registered nurse, appropriate 
authorized prescriber, or licensed 
pharmacist at least quarterly for 
each resident who: 
¢ Self-administers 
medications; or 


¢ Requires a reminder to take 
medications or physical 
assistance with opening and 
removing medications from 
the container. 


2. Ifa resident requires that staff 
administer medications as defined 
in Regulation .02B of this chapter, 
and the administration of 
medications has been delegated to 
an unlicensed staff person pursuant 
to COMAR 10.27.11, the assisted 
living manager shall comply with 
COMAR 10.27.11 by arranging for 
an on-site review by the delegating 
registered nurse at least every 45 
days. The delegating nurse shall 
make appropriate recommendations 
to the appropriate authorized 
prescriber, and the assisted living 
manager or designee.” 


Importantly, this regulation is currently under 
revision and has provoked much discussion 
between the Office of Health Care Quality, 
Boards of Nursing and Pharmacy regarding 
medication management and pharmacy review. 


Opportunities for Pharmacists 

The idea of medication management has 
received increased focus from consumers, as 
well as pharmacists due to the requirements and 
opportunities provided by the Medicare 
Modernization Act of 2003. As the population 
ages, the number of medications will increase, 
leading to even more challenges with managing 
medications. Currently, it is estimated that one 
out of every 5 emergency room visits are 
thought to be due to medication related 
problems, and that the identification of 
medication related problems by a consultant 
pharmacist may save the healthy care system 
approximately $2,250 dollars a year per resident 
by preventing unnecessary trips to the ER.° In 
addition, pharmacists can assist in reducing 
medication errors as well as reduce the 
resident’s medication costs by changing to 
generics, less expensive equivalent medications 
or discontinuing medications that are not 
necessary. 


Page 8 Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


The intent of this article was to increase 
awareness of the vast opportunities for 
pharmacists across the continuum of care for 
older individuals, particularly in NHs and ALFs. 
Pharmacists are in a unique position to provide 
clinical services to older adults through various 
settings in which they reside. 


References: 

' Briesacher B et al. “Medication Use by 
Medicare Beneficiaries Living in Nursing 
Homes and Assisted Living Facilities.” Health 
and Human Services Report: June 5, 2002. 

* Polzer K. “Assisted Living State Regulatory 
Review 2007” National Center for Assisted 
Living accessed at 
http://www.ncal.org/about/2007_reg_review.pdf 
September 27,2007. 

* Public Policy Instititute. “An Overview of 
Assisted Living 2004” accessed at 


http://www.aarp.org/research/housing- 
mobility/assistedliving/aresearch-import-923- 


IB72.html September 27, 2007. 
*Losben NL. Medication management - 


programs: A safe investment. Assisted Living 
Consult. January/February 2005.23-25 

> Maryland code 10.07.14.21 accessed at 
http://www.dsd.state.md.us/comar/10/10.07.14.2 
l.htm accessed September 27, 2007. 

° Clark TR. Prevention of medication-related 
problems in assisted living: role of the 
consultant pharmacist. ASCP Issue Paper. 2003. 


Suggested Readings: 
1) CMS website with SOM: 


http://www.cms.hhs.gov/manuals/downl 


oads/som107_Appendicestoc.pdf 
2) CMS website with Survey and 


Certification (S&C) Memos to 
States/Regions: http://www.cms.hhs. 


gov/SurveyCertificationGenInfo/PMSR/ 


list.asp#TopOfPage 
3) Nursing Facility Survey and Regulations 


Briefing Room on ASCP website: 


www.ascp.com/public/pr/nfsurvey or 


WwWww.ascp.com/som 
4) Brandt N. Using Medications 


Appropriately access at: www.extended 
carenews.com from June 2007 


Special thanks to Sarah Brody, Pharm.D. 
Candidate 2008 for assisting in compiling data 
and information on ALFs. 


Edited by Mary Lynn McPherson, Pharm.D., 
BCPS 

Professor, University of Maryland, School of 
Pharmacy 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 Page 9 


Psychotropic Drugs... Then and Now 


Mental illness has currently become a common medical diagnosis within the United States. The U.S. Department of 
Health and Human Services uses “patient care episodes” to estimate the number of people treated each year for mental 
illness. This tracks the number of people treated at psychiatric hospitals, residential facilities for the mentally ill, and 
ambulatory care facilities. In 1955, the government reported 1,675,352 patient care episodes. In 2000, patient-care 
episodes totaled 10,741,243. That is nearly a four-fold per-capita increase in the past 50 years. As the physicians’ 
technique for diagnosing patients with a mental illness refines and improves, the amount of cases increases as well. This 
current rise in diagnosed patients could also be due to increased advertisements for antidepressants and other drugs, 
leading us to believe that the stigma of being treated is decreasing. 


ack in the 1960s, John C. 

Krantz, Jr., a former professor 
of pharmacology and member of 
the U.S. Pharmacopeia, 
commented that psychotropic 
drugs accounted for 10 per cent of 
all the prescriptions written for in 
the United States. Most of these 
prescriptions were written for 
drugs such as phenothiazine 
derivatives including 
chlorpromazine, the rauwolfia 
alkaloids including reserpine, the 
alkyl diols including meprobamate, 
diphenylmethane derivatives such 
as hydroxyzine, benzodiazepams 
such as diazepam, and ethanol. 
These drugs that were used, 
exhibited a broad therapeutic affect 
on the central nervous system, 
treating most of the symptoms, 
however allowing more room for 
adverse side effects. Today, 
physicians and pharmacists 
generally treat anxiety-related 
mental illnesses with 
antidepressants and/or anti-anxiety 
medications that are more targeted 
to specific sites in the brain and 
receptors, ultimately decreasing 
the prevalence of nuisance side 
effects such as fatigue and 
drowsiness. 

These drugs used during the 
1960s and later were considered 
distinct from prior hypnotic 
therapies as they did not confer 
analgesia as do other drugs such as 
the alkaloids of opium. There was 
also no immediate hazard of 


Page 10 


addiction associated with these 
psychotropic drugs. However, 
these former drugs and even 
today’s newer drugs still present 
suspicion as their use may be habit 
forming. 

One formerly popular drug of 
the 1960s was chlordiazepoxide, 
also known by the trade name, 
Librium. This drug was a popular 
drug from the benzodiazepine 
series. Classified as a psycho- 
sedative; chlordiazepoxide evoked 
skeletal muscle relaxation without 
a pronounced hypnotic action. 
Today, chlordiazepoxide is 
generally used for mild to severe 
anxiety, acute alcoholism, and 
apprehension before surgery, 
however, its drowsiness and 
addiction potential limit its use 
today. 

Another historical drug used 
for the treatment of anxiety and 
other mental illnesses was ethanol. 
Alcohol was quite possibly the 
oldest and most generally used of 
the minor psychotropic drugs back 
then. Today, the general public has 
become aware of ethanol’s 
debilitating effects on the mind 
and body, including vital organs 
such as the liver. 

Today, anti-depressants 
known as selective serotonin 
reuptake inhibitors (SSRIs) such 
as fluoxetine (trade name 
Prozac®), make up for the majority 
of the mental illness therapeutics 
market. However, there are a 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


variety of drug options to choose 
from, such as buspirone (trade 
name Buspar®). With the 
introduction of drugs such as 
buspirone, which is classified as an 
anti-anxiety agent that is not 
chemically or pharmacologically 
related to the benzodiazepines, 
barbiturates, or other 
sedative/anxiolytic drugs, 
physicians and pharmacists have 
succeeded in trying to treat mental 
illness while reducing the sedative 
side effects the could potentially 
decrease the patients’ quality of 
life. 

As we look back at the drugs 
used during the early 50s and 60s, 
we are reminded as to how drug 
evolvement has progressed over 
the years. Unfortunately, it also 
reminds us to how frequently 
mental illness has been diagnosed 
in our society. Yet, as pharmacists 
we will strive to continue 
researching and developing new 
psychotropic drugs, as Krantz and 
his associates did in the 1960s, in 
order to become one step closer to 
providing a better therapeutic and 
more safe response to all our 
mentally-ill patients. 


Melike Tunc 

Pharm.D. Candidate 2008 
University of Maryland 
School of Pharmacy 


toxtidbits 


the maryland poison center’s monthly update. news. advances. information 


November 2007 


Haloperidol (Haldol®) Use in Toxicology 


Imagine this... A patient presents to the emergency department with a history of Tylenol® PM 
overdose. She is wildly agitated with dilated pupils, flushed skin, dry mucous membranes, and 
minimal bowel sounds. You want to give her something to calm her down and have two options in 
front of you, haloperidol and lorazepam. 


Which do you choose? All too often haloperidol is given to agitated or psychotic patients with a 
history of overdose. Many times it works and calms the patient down successfully, but what happens 
when the patient starts seizing? Haloperidol can lower the seizure threshold. Therefore, if a patient 
is suspected of overdosing on a substance that can also lower the seizure threshold (Table 1), 
haloperidol should be avoided. Benzodiazepines, usually lorazepam or diazepam, are alternatives. 
They are effective for sedation and have also shown benefit in patients with psychoses and alcohol 
withdrawal. Benzodiazepines are recommended for all toxin-induced seizures. 


Table 1: Common toxins that can induce seizures and agitation in overdose 


Tricyclic antidepressants 
Diphenhydramine (Benadryl®) 


Haloperidol has anticholinergic effects that can compound the effects of other drugs that possess 
anticholinergic effects and lead to increased agitation. Haloperidol interferes with the hypothalamic- 
pituitary axis and heat dissipation mechanisms. The administration of haloperidol to a patient 
suffering from the anticholinergic toxidrome can lead to significant hyperthermia. Haloperidol can 
also cause dystonic reactions. 


The Maryland Poison Center is available 24-7 to answer all questions and assist in the management 
of all poisoned patients. Call 1-800-222-1222 to reach one of our certified specialists in poison 
information. 


Bryan D. Hayes, PharmD, Clinical Toxicology Fellow 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 Page 11 


On November 19, 2007, the Drug Enforcement 
Administration (DEA) will publish in the Federal Register a 
Final Rule titled “Issuance of Multiple Prescriptions for 
Schedule II Controlled Substances.” This rule is effective 
December 19, 2007. 


This Final Rule amends DEA’s regulations to allow 
practitioners to provide individual patients with multiple 
prescriptions for a specific schedule II controlled 
substance, written on the same date, to be filled 
sequentially. The combined effect of such sequential 
multiple prescriptions is that it allows a patient to receive 
over time up to a 90-day supply of that controlled 
substance. The Controlled Substances Act does not 
permit the refilling of schedule II controlled substances, 
requiring that a new prescription be issued for each 
quantity of the substance. 


Following publication, the rule will appear on DEA’s 
Office of Diversion Control website, www.DEAdiversion. 
usdoj.gov under “Federal Register Notices>Rules 2007.” 


U.S. Department of Justice 

Drug Enforcement Administration 
Mark W. Caverly, Chief 

Liaison and Policy Section 

Office of Diversion Control 
www.dea.gov 


Page 12 Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


Electronic Signatures and the Pharmacist’s Responsibility 
John F. Fader II, retired Judge of the Circuit Court for Baltimore County 


Licensed Pharmacist 


Those electronic signatures you 
have seen on prescriptions and 
those photocopies or printouts of 
prescriptions you have been 
receiving are governed by a 
regulation adopted by the 
Maryland Board of Pharmacy. 


Here is what the law says is 
your legal responsibility: (1) to 
make sure that these and every 
prescription presented to you has 
an authentic signature; (2) to 
understand that electronic 
signatures have nothing to do with 
you unless you are a signatory to an 
electronic signature transfer 
agreement in compliance with 
Maryland law or otherwise comply 
with the directive of the Board; and 
(3) accepting a stamped or 
electronic signature photocopy (or 
what looks like a photocopy) does 
not fulfill your legal responsibility 
to assure the authenticity of the 
prescription unless you check to 
verify the prescription. 

As aresult of a student paper 
on “Electronic Prescribing” 
submitted by a pharmacy student as 
part of a MPhA rotation, the 
Association has asked about the 
legal authenticity of signatures 
transmitted electronically. Legal 
responsibility focuses on a Board 
Regulation (COMAR 10.34.20.02). 
Whatever method of transmission, 
the Regulation requires that it must 
ensure: (1) against alterations; 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


(2) that confidentiality is 

preserved; (3) transmission of the 
exact information that comes from 
the prescriber; and (4) that there is 
no interference with the patient’s 
freedom to choose a pharmacy. It is 
the responsibility of the pharmacist 
to assure the validity of every 
prescription and the signature of an 
authorized prescriber. 


What this means as to 
electronic prescriptions is this: 


First: 

_ electronic transmission of a 
prescription (FAX, e-mail, 
etc.) must be through a 
communication method 
acceptable for commerce in 
Maryland. That could occur 
through compliance with the 
provisions of The Maryland 
Uniform Electronic 
Transactions Act — Com. 
Law §§21-101, et. seq. 
which requires you to be a 
signator to an agreement for 
electronic transmission. Ask 
you attorney about this. 

This electronic 
transmission can also be 
accomplished through 
communication between the 
authorized prescriber or 
his/her authorized agent to 
the pharmacist through what 
the regulation calls “audio or 
visual interaction,’ which 


can mean a phone-in (except 
for CDS II) and other 
communication not 

detailed or explained in 

the regulation; and/or 


Second: 


in the words of the 
regulation “Is processed by 
a commercial intermediary, 
which guarantees the 
confidentiality and security 
of the transmission process 
in a manner approved by 
the Board.” Whatever this 
can mean is a mystery. The 
FAX is self verifying. 
Whatever other programs or 
software the physicians are 
buying, you are not bound 
to accept. Write the Board 
(write — do not call), 
explain in detail the process 
that is at issue (sending 
literature on the program 
whenever available) and 
receive a written response 
before using that particular 
transmission process 
without a verbal 
confirmation. In time, the 
Board may well post 
acceptable programs on 
their web site. 


Page 13 


Statement of Ownership, Management and Circulation 


Publication Title Maryland Pharmacist 
Issue Frequency Quarterly 


Complete Address of Known Office of Publication 
Maryland Pharmacists Association 

650 W. Lombard Street 

Baltimore, MD 21201-1572 


Complete Mailing Address of Headquarters or General Business Office of Publisher 
Maryland Pharmacists Association 

650 W. Lombard Street 

Baltimore, MD 21201-1572 


Name and Complete Mailing Address of Publisher, Editor, and Managing Editor 
Publisher Maryland Pharmacists Association 

650 W. Lombard Street 

Baltimore, MD 21201-1572 


Editor Howard Schiff 
Managing Editor Elsie Prince 


Extent and Nature of Circulation 


Reported as: Average number of copies each issue during preceding 12 months/Actual number of copies of single issue published nearest of filing 
date. 


Total number of copies 950/950 
Paid and/or requested circulation 

1. Sales through dealers and carriers, street vendors and counter sales 0/0 

2. Paid or requested mail subscriptions 918/898 
Total paid or requested circulation 918/898 


Free distribution by mail, carrier, or other means, complimentary, or other free copies 0/0 


Total Distribution 918/898 
Copies not distributed 32/52 


Total 950/950 
Percent Paid and/or Requested Circulation 100/100 


Publication No. 0025-4347 
Issues Published Annually 4 


Filing Date October 1, 2007 
Annual Subscription Price $ 30 


I certify that the statements made by me are correct and complete: Howard Schiff, Editor 


Continuing Education _ 
for Pharmacists 


Meningococcal 
Disease and 
Available Vaccines 


Thomas A. Gossel, R.Ph., Ph.D. 
Professor Emeritus 

Ohio Northern University 
Ada, Ohio 


and 


J. Richard Wuest, R.Ph., 
PharmD 

Professor Emeritus 
University of Cincinnati 
Cincinnati, Ohio 


Goals. The goals of this lesson are 
to discuss meningococcal disease 
and its prevention through immuni- 
zation, and describe the vaccines 
available for this use. 


Objectives. At the conclusion of 
this lesson, successful participants 
should be able to: 

1. describe the incidence, 
etiology, communicability and 
clinical presentation of meningococ- 
cal disease; 

2. differentiate between bacte- 
rial and viral meningitis; 

3. list the current ACIP guide- 
lines for preventing meningococcal 
disease through immunization; and 

4. identify principles that define 
similarities and differences between 
the two meningococcal vaccines. 


Background 

Each year, approximately 1400 to 
3000 cases of invasive meningococ- 
cal disease are reported in the 
United States. Although the inci- 
dence is relatively low (0.5 to 1.1 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


per 100,000 population), case- 
fatality rates and sequelae — condi- 
tions that accompany and follow the 
disease — among survivors are 
significant. Death follows in close to 
14 percent of cases, even with 
appropriate antimicrobials and 
adjunctive therapies, with higher 
mortality rates of up to 40 percent 
in patients with sepsis. Sequelae 
include digit or limb amputation, 
neurologic deficits and seizures, 
hearing loss, and stroke in up to 20 
percent of cases. Meningococcal 
disease has traditionally been 
considered a disease of children; 
however, over the past 15 years, 
rates of meningococcal disease 
among adolescents and young adults 
have increased. 


Meningococcal Disease 
Meningococcal disease is an acute, 
potentially severe illness caused by 
the bacterium Neisseria meningiti- 
dis. Despite the availability of an 
effective meningococcal vaccine for 
the past quarter century, meningo- 
coccal disease remains a leading 
cause of meningitis, sepsis, and 
other serious infections in industri- 
alized nations and the developing 
world. The World Health Organiza- 
tion estimates that meningococcal 
disease was the cause of 171,000 
deaths worldwide in 2000. 

To describe meningococcal 
disease simply as “meningitis” or 


Volume XXV, No. 5 


“spinal meningitis” is misleading, 
although meningitis is the most 
common presentation of invasive 
meningococcal infection and out- 
come from transport of the pathogen 
throughout the body via the blood. 
Septicemia occurs without meningi- 
tis in 5 to 20 percent of invasive 
meningococcal infections, and is the 
more serious clinical syndrome. The 
term meningitis describes an 
infection of the covering of the brain 
and spinal cord and can be caused 
by bacteria, fungi, viruses, or 
parasites. 

Before the 1990s, Haemophilus 
influenzae type b (Hib) was the 
leading cause of bacterial meningi- 
tis. With routine use of conjugate 
vaccines that target, and therefore 
protect against Hib and Streptococ- 
cus pneumoniae, another common 
pathogen, Neisseria meningitidis 
has emerged as a leading cause of 
bacterial meningitis in the United 
States. Following onset of illness, 
disease progression is rapid; 60 
percent of individuals are symptom- 
atic for less than 24 hours before 
seeking medical care, and death 
may ensue within 48 hours. 

N. meningitidis is a highly 
contagious aerobic, encapsulated, 
gram-negative diplococcus (i.e., 
meningococcus) closely related to N. 
gonorrhoeae and to several non- 
pathogenic Neisseria species, such 
as N. lactamica. N. meningitidis is 
characterized by at least 13 different 
serogroups (A, B, C, E-29, H, I, K, 
L, M, W-135, X, Y, Z). Serogroups 
are determined by differences in 
protein structure and capsular 
polysaccharides. Five serogroups (A, 
B, C, Y, and W-135) are responsible 
for most meningococcal disease 
worldwide. 


Page 15 


aaa 


| Table 1 
Signs and Symptoms of 
Bacterial Meningitis 


e Stiff neck 

e Fever 

e Headache 

e Nausea with or without vomiting 

e Red or purple rash that does not 
change color if pressed on 

e Confusion 

e Fatigue or extreme sleepiness 

e Seizures 

e Irritability or lethargy (in 
infants, along with poor 
feeding, this may be the only 
symptom of meningitis) 

e Recent flu-like illness or an ear 

or sinus infection may precede 

development of meningitis 


Torpy JM, Lynm C, Glass RM. JAMA. 


2007;297:122. 


Serogroups B, C, and Y are the 
primary causes of meningococcal 
disease in the United States, each 
accounting for approximately one- 
third of cases in persons across all 
age spans. The primary serogroup(s) 
responsible for meningococcal 
disease varies by patient age. 
Serogroup B causes over 50 percent 
of cases in infants less than one 
year of age. Unfortunately, there is 
no vaccine for use in the United 
States that targets serogroup B 
meningococcus. Seventy-five percent 
of cases in persons 11 years of age or 
older are caused by serogroups C, Y, 
or W-135. It is noteworthy that 
meningococci have the ability to 
exchange genetic material that 
determines capsule production, and 
thus can switch from one serogroup 
to another. This may eventually 
become a mechanism for resistance 
of N. meningitidis to vaccines that 
target specific serogroups of the 
organism. 

Communicability. Meningo- 
coccal disease is contagious. The 
bacteria are transmitted by droplet 
aerosol or secretions from the 
nasopharynx of colonized persons. 
The bacteria attach to and multiply 
on the nasopharynx mucosa. Ina 
small number (<1 percent) of 
colonized persons, the organism 


Page 16 


penetrates the mucosal cells and 
enters the blood to spread through- 
out the body. In about 50 percent of 
bacteremic persons, the organism 
crosses the blood-brain-barrier into 
the cerebrospinal fluid (CSF) and 
causes purulent meningitis. A 
concomitant upper respiratory 
infection may be a contributing 
factor. Fortunately, N. meningitidis 
is not spread by casual contact or by 
simply breathing the air when a 
person with meningitis is present. 
Humans are the only natural 
reservoir of meningococcus; as 
many as 10 percent of adolescents 
and adults are asymptomatic 
transient carriers of N. meningitt- 
dis, most strains of which are not 
pathogenic. Meningococcal disease 
occurs throughout the year, how- 
ever, the incidence is highest in the 
late winter and early spring. 

Clinical Presentation. 
Early clinical manifestations of 
meningococcal disease are often 
difficult to distinguish from other, 
more common but less serious 
illness. Sudden onset of high fever, 
nausea with or without vomiting, 
intense headache, and stiff neck are 
common symptoms of meningitis in 
persons older than two years of age. 
A petechial rash with pink macules 
(colored spots on the skin that are 
not elevated above the surface) may 
be present. Blood bacterial loads rise 
quickly to high levels (>10%/mL). 
This activates an inflammatory 
cascade, which leads to myocardial 
depression, endothelial dysfunction 
with extravasation of the circulating 
volume, and disseminated intravas- 
cular coagulation. Clinical signs of 
shock appear with poor capillary 
filling, cool and clammy skin, 
tachycardia, and oliguria (decreased 
urination). Hypotension is a late 
sign in infants and young children 
with its occurrence foreboding an 
ominous outcome. Leaking of 
pulmonary fluid leads to pulmonary 
edema, which may be heralded by 
tachypnea (increased respirations) 
and oxygen desaturation. Evolution 
of disease may proceed so rapidly 
that it outstrips any treatment that 
can be given. 


Symptoms (Table 1) may 
develop over several hours, or take 
one to two days. Other symptoms 
may include photophobia (eye 
sensitivity to light) and an altered 
mental status. In infants, a slower 
onset of nonspecific symptoms 
occurs, and neck stiffness may be 
absent. Morbidity and mortality 
caused by meningococci are higher 
in older, versus younger, children. 
Whereas the proximal cause of 
death in younger adults is often 
brain herniation, older people often 
die of cardiorespiratory failure. 

Early diagnosis and treatment 
are extremely important. Diagnosis 
is usually confirmed by growing 
bacteria from CSF collected by 
lumbar puncture or by detection of 
the meningococcal antigen in fresh 
CSF. Signs and symptoms of 
meningococcal meningitis are 
similar to those of other causes of 
bacterial meningitis, such as H. 
influenzae and S. pneumoniae; 
however, identification of the 
specific pathogen responsible is 
important for selection of appropri- 
ate antibiotic therapy. 

Viral Meningitis. Symptoms 
of bacterial meningitis and viral 
meningitis are often the same. Viral 
(“aseptic”) meningitis is caused by 
infection with one of several types of 
viruses. About 90 percent of viral 
cases are caused by members of a 
group known as enteroviruses, such 
as coxsackieviruses and echovi- 
ruses. Herpesviruses and the 
mumps virus can also cause viral 
meningitis. Between 25,000 and 
50,000 hospitalizations due to viral 
meningitis are reported each year in 
the United States. 

Viral meningitis is serious but 
rarely fatal in persons witha 
normal immune system. Symptoms 
last seven to 10 days and the patient 
usually recovers completely. 

Enteroviruses are most often 
spread through direct contact with 
respiratory secretions from an 
infected person. The viruses can 
also be found in the stool of infected 
persons. The virus is spread 
through this route mainly among 
small children who are not toilet 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


trained or spread to adults while 
changing the diapers of an infected 
infant. The incubation period for 
enteroviruses is normally between 
three and seven days. Virus may be 
spread to other persons beginning 
about three days after infection 
until about 10 days after develop- 
ment of symptoms. 

Currently, there is no vaccine or 
specific treatment for viral meningi- 
tis. Most patients recover completely 
on their own, with bed rest, plenty 
of fluids, and an analgesic/anti- 
pyretic to relieve headache and 
fever. 


Meningococcal Vaccines 

Two meningococcal vaccines are 
approved for use in the United 
States, both manufactured by Sanofi 
Pasteur. Menomune (Meningococcal 
polysaccharide vaccine; MPSV4) 
was licensed in 1978 for use in 
children older than two years and 
adults. Menactra (Meningococcal 
conjugate vaccine; MCV4) was 
licensed in the United States in 
2005 and Canada in 2006 for use in 
children 11 years and older and 
adults through 55 years of age. 
Currently, FDA is considering 

MC V4 for use in children two to 10 
years of age. Both vaccines mediate 
protection against meningococcal 
disease caused by serogroups A, C, 
Y, and W-135 by stimulating 
production of antibodies directed 
toward their surface polysaccha- 
rides. 

Meningococcal Polysaccha- 
ride Vaccine. Each dose of MPSV4 
consists of 50 pg each of the four 
purified meningococcal capsular 
polysaccharides, A, C, Y, and W- 
135. MPSV4 is available in single- 
dose (0.5 mL) and multiple-dose (5 
mL) vials. MPSV4 is administered 
subcutaneously as a single 0.5 mL 
dose. It can be given concomitantly 
with other vaccines at different 
anatomic sites. Protective concen- 
trations of antibodies usually are 
achieved within seven to 10 days of 
immunization. No boost in antibody 
titer occurs with repeated doses. 

Meningococcal Conjugate 
Vaccine. MCV4is a tetravalent 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


meningococcal conjugate vaccine 
that contains 4 pg each of capsular 
polysaccharide antigens from 
serogroups A, C, Y, and W-135 
individually conjugated to 48 pg of 
diphtheria toxoid protein carrier. 
MCV4 is available only in single- 
dose (0.5 mL) vials and is adminis- 
tered by intramuscular injection as 
a single 0.5 mL dose. Protective 
titers of antibodies are achieved 
within eight days of immunization. 
The length of protection is not 
currently known; therefore, booster 
doses are not recommended at this 
time. MCV4 can be administered at 
the same time as other vaccines. All 
vaccines should be given at separate 
sites with different syringes. 

MCV4 confers advantages over 
MPSV4. First, persons receiving a 
second dose have a booster response 
(termed an anamnestic reaction, 
defined as the reappearance of 
antibodies that had previously 
existed and had disappeared from 
the blood). As noted earlier, this 
response is not found after a subse- 
quent dose of MPSV4. Second, a 
longer duration of immunity than 
with MPSV4 is suggested. Third, 
experience gained from European 
studies with the monovalent menin- 
gococcal serogroup C conjugate 
vaccine that demonstrated a reduc- 
tion in nasopharyngeal carriage of 
that serogroup suggests that MCV4 
also will have similar effects. 

Adverse Reactions. Adverse 
reactions to meningococcal vaccine 
are generally mild, consisting 
principally of localized pain and 
redness at the injection site lasting 
one to two days. These reactions 
occur in up to 48 percent of MPSV4 
recipients and 59 percent of MC V4 
recipients. Fever (100° to 103° F) 
within seven days of vaccination is 
reported in 3 percent of MPSV4 
recipients and 5 percent of MCV4 
recipients. Systemic reactions, such 
as headache and malaise, within 
seven days of vaccination are 
reported in approximately 60 
percent of recipients of either 
vaccine; only 3 to 4 percent of 
recipients report these reactions as 
severe. 


Guillain Barré syndrome (GBS) 
is a serious, rare neurological 
disorder that typically causes 
increasing weakness in leg, arm 


’ and other muscles and can be severe 


enough to require hospitalization. 
GBS usually resolves on its own, 
however some people may have 
residual neurological deficits. 
Confirmed cases of GBS associated 
with MCV4 have been reported. All 
individuals to date have recovered. 
While the number of cases suggest a 
small increased risk of GBS follow- 
ing immunization with MCV4, these 
findings need to be viewed with 
caution. At this time, neither the 
Centers for Disease Control and 
Prevention (CDC) nor FDA have 
determined with certainty whether 
the vaccine increases the risk of 
GBS in persons who receive the 
vaccine and, if so, to what degree. 


Recommendations for Vaccine 
Use 

The Advisory Committee on Immu- 
nization Practices (ACIP) to the 
CDC has published recommenda- 
tions for the prevention and control 
of meningococcal disease. By the 
year 2008, the goal is for all adoles- 
cents to receive routine vaccination 
with MCV4 starting at age 11 years. 
For adolescents not previously 
vaccinated with MCV4 at their 
routine preadolescent healthcare 
professional visit, typically at 11 to 
12 years of age, ACIP recommends 
vaccination before entrance into 
high school at approximately 15 
years of age. Vaccination is optional 
for other adolescents to decrease 
their chance of contracting menin- 
gococcal disease. 

ACIP also recommends routine 
vaccination with a meningococcal 
vaccine for individuals at a high 
risk for meningococcal disease 
including: 

e college freshmen living in 

dormitories; 

e microbiologists who are 
routinely exposed to meningo- 
coccal bacteria; 

e U.S. military recruits; 

e persons traveling to, or living 
in, a part of the world where 


Page 17 


|e SN TR ESE TS EL CL, RE EY EY ES EN TE ST IE EE SE EEE I PT Ee IESE FITTS TS 2 8 I LE AE 


meningococcal disease is 
common, such as parts of 
Africa; 

e persons with a damaged 
spleen, or whose spleen has 
been removed; 

e anyone who has terminal 
complement component 
deficiency (an immune 
system disorder); and 

e persons who might have been 
exposed to meningitis during 
an outbreak. 


MCV4 is the preferred vaccine 
for persons 11 to 55 years of age who 
are at high risk, but MPSV4 can be 
used if MCV4 is not available. 
MPSV4 should be used for children 
two to 10 years of age, and adults 
over 55 years, who are at risk since 
MCV4 has not been adequately 
studied in these populations. Al- 
though college freshmen living in 
dormitories have a moderately 
increased risk of disease, most cases 
of which are caused by serogroup C, 
non-freshmen college students are 
at no greater overall risk for menin- 
gococcal disease than the general 
U.S. population. The reason why 
non-freshmen college students are 
not at increased risk is unclear. 
While persons with HIV/AIDS are 
at increased risk for meningococcal 
disease, ACIP does not currently 
recommend routine use of meningo- 
coccal vaccines in this population. 
For persons 11 to 55 years of age 
who have been previously vacci- 
nated with MPSV4, revaccination 
with MCV4 is recommended if three 
to five years have lapsed since 
previous receipt of vaccination. 

Routine vaccination with either 
MPSV4 or MCV4 is recommended to 
control meningococcal outbreaks 
caused by N. meningitidis 
serogroups A, C, Y, or W-135. An 
outbreak is defined as three or more 
confirmed or probable cases of 
meningococcal disease of the same 
serogroup in three or fewer months, 
resulting in a primary disease 
attack rate of 10 or more cases per 
100,000 population. Either vaccine 
can be employed; however, MCV4 is 
preferred if the population to be 


. Page 18 


vaccinated is between 11 and 55 
years of age. 

Persons who should not receive 
the meningococcal vaccine(s) include 
those who have ever experienced a 
severe (life-threatening) allergic 
reaction to a previous dose of either 
meningococcal vaccine or a severe 
(life-threatening) allergy to any 
vaccine component. Persons who are 
moderately or severely ill at the 
time the vaccine is scheduled should 
probably wait until they recover. 
People with a mild illness can 
usually receive the vaccine. Anyone 
who has ever had Guillain-Barré 
syndrome should discuss with their 
physician whether they should 
receive the MCV4 vaccine. Meningo- 
coccal vaccines may be given to 
pregnant women; however, MCV4 
has not been studied in this popula- 
tion as extensively as MPSV4. 
MCV4 vaccine should be used only if 
clearly needed. 


Medical Management of 
Meningococcal Disease 
Meningococcal disease is treated 
with antimicrobials including 
rifampin, penicillin G, ampicillin, 
and third-generation cephalosporins. 
Mortality should be reduced to below 
15 percent, although the risk is 
higher among the elderly. Therapy, 
based on the physician’s experience, 
must be initiated early in the course 
of the disease, as soon as possible 
after the lumbar puncture has been 
completed. Treatment started before 
CSF collection makes it difficult to 
grow the bacteria in culture and 
thus confirm the diagnosis. Few 
penicillin resistant strains of 
meningococcus have been reported 
in the United States. Once N. 
meningitidis has been confirmed, 
penicillin alone is recommended. 
Individuals who qualify as close 
contacts of a person with meningo- 
coccal disease caused by N. 
meningitidis should receive an 
antimicrobial agent as prophylaxis. 
Treatment of contacts of a person 
with Hib meningitis is no longer 
recommended if all contacts four 
years of age or younger are fully 
vaccinated against Hib disease. 


Maryland Pharmacist ¢ Oct./Nov./Dec. 2007 


Vaccine Storage and Handling 
Both vaccines are shipped in insu- 
lated containers to prevent exposure 
to freezing temperature. They 
should be stored at refrigerator 
temperature (35° to 46° F). Vaccine 
exposed to freezing temperature 
should not be used. 

Single-dose vials of MPSV4 
should be used within 30 minutes of 
reconstitution, and multidose vials 
should be discarded 10 days after 
reconstitution. MCV4 should not be 
drawn into a syringe until immedi- 
ately before use. 


Additional Information 

A particularly helpful website that 
lists the ACIP general recommenda- 
tions on immunization is found at 
www.cdc.gov/mmwr/preview/ 
mmwrhtml/rr5515al.htm. Another 
site specific to meningococcal 
disease is www.cdc.gov/nip/publica- 


tions/pink/mening.pdf. The com- 
plete ACIP recommendations for 


prevention and control of meningo- 
coccal disease are available at 


www.cde.gov/mmwr/preview/ 
mmwrhtml/rr5407al.htm. 


5539 


Continuing Education Quiz 


This month’s questions are taken from the article on “Meningococcal Disease and Available Vaccines”. Circle your answers to the following 
questions and mail the entire page to Maryland Pharmacist CE, 650 W. Lombard Street, Baltimore, MD 21201-1572. There is no charge for 
this quiz for MPhA members (non-members $ 10.00). The completed quiz for this issue must be received by 5/15/10. A continuing 
education certificate for one and one-half contact hours (0.15 CEUs) will be mailed to you within six to eight weeks. Please type or print 
clearly. ACPE# 129-144-07-005-HO1. 


Name The Maryland Pharmacy Continuing _ 
Education Coordinating Council is 

Address accredited by the Accreditation Council for 

City, State, Zip Pharmacy Education as a provider of 


continuing education for pharmacists. 
Daytime Phone 6 P 


Date Completed 


(Required) 
1. Death reportedly follows meningococcal disease in 6. Which of the following viruses is most likely to 
close to which of the following percentages of cases? cause viral meningitis? 
a. 4 percent c. 24 percent a. Coxsackievirus 
b. 14 percent d. 35 percent b. Papillomavirus 


c. Rubeolavirus 


d. Varicellavirus 
2. Meningococcal disease is an acute, potentially 


severe illness caused by the bacterium: 7. Meningococcal conjugate vaccine is: 
a. Escherichia colt. a. Menactra, MPSV4. 
b. Haemophilus influenzae. b. Menactra, MCV4. 
c. Neisseria meningitidis. c. Menomune, MPSV4. 
d. Streptococcus pneumoniae. d. Menomune, MCV4. 
3. All of the following are correct descriptors of the 8. Guillain Barré syndrome is a: 
causative organism referred to in question # 2 a. cardiovascular disorder. 
EXCEPT: b. lymphatic disorder. 
a. aerobic. c. encapsulated. c. neurological disorder. 
b. diplococcus. d. gram-positive. d. pulmonary disorder. 
4. The primary causes of meningococcal disease in 9. The Advisory Committee on Immunization 
the U.S. are: Practices to the CDC has recommended that by the 
a. serogroups B, C, and Y. year 2008, the goal is for all adolescents to receive 
b. serogroups C, D, and X. routine vaccination with the vaccine referred to in 
c. serogroups D, E, and W. question # 7 starting at age: 
d. serogroups E, F, and V. a. 9 years. c. 13 years. 
b. 11 years. d. 15 years. 
5. The clinical presentation of pink-colored spots on 
the skin that are not elevated above the surface are 10. Once N. meningitidis has been confirmed, which 
correctly referred to as: of the following antibiotics is recommended? 
a. pustular rash. c. porphyrial rash. a. Cephalosporin c. Penicillin 
b. psoriatic rash. d. petechial rash. b. Doxycycline d. Rifampin 
9 ; ae Maryland Pharmacist * Oct./Nov./Dec. 2007 Page 19 
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