Y K C U T N E K E H T T S I C A M PHAR Vol. 7, No. 4 July 2012
RELEVANCE AND RELATIONSHIPS
2012-13 KPhA President Kimberly Sasser Croley
2012-13 KPhA President Kimberly S. Croley with her family, Bob, Robbie and Rachel. News & Information for Members of the Kentucky Pharmacists Association
Table of Contents
July 2012 Pharmacy Technician Certification Board August CE— Asprin: Evolving Evidence August Pharmacist/Pharmacy Tech Quiz Pharmacists Mutual Companies Pharmacy Law Brief New Members of KPhA Board of Directors Academy of Consultant Pharmacists Update Sullivan University College of Pharmacy Graduates Pharmacy Policy Issues Fink named KPhA Professor in Leadership at UK UK College of Pharmacy Graduates KPhA Board of Directors Frequently Called and Contacted
Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective KPhA Professional Awards KPERF Golf Scramble 2012 KPhA House of Delegates Report 134th KPhA Annual Meeting July CE—GLP-1 Agonists Therapy July Pharmacist/Pharmacy Tech Quiz Pharmacy Time Capsules From Your Executive Director Bowl of Hygeia
2 3, 6-7 4-5 8 9-10 11-15 16-25 26 27 28 29
30 31-37 38 39 40-41 42-43 44 45 46-47 48 49 50 51
Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will keep abreast of developments and maintain professional competency in my profession of pharmacy. I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.
The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance.
Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.
It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation. Additionally, feedback from learners will be used to improve the overall programming designed by KPERF.
Editorial Office: © Copyright 2012 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bimonthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.
2
THE KENTUCKY PHARMACIST
President’s Perspective
President’s Perspective
Kimberly Sasser Croley KPhA President 2012-2013
Adapted from KPhA President’s Address at Ray Wirth Banquet, June 16, 2012
The Mission Statement of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the healthcare system. That certainly should be easy, right?! RELEVANCE and RELATIONSHIPS Get used to hearing these two words. Everything I do or say in this coming year will be related directly back to RELEVANCE and RELATIONSHIPS. Why am I using these two words to define my second term as your President of KPhA? Because I believe they are the quintessential ingredients to successfully keeping KPhA strong, vibrant and meaningful to our membership. They also provide the key to our movement toward advancing the practice in new and innovative ways.
July 2012 end of the meeting, she reminded us that the word “Association” is built around the word “Social” and that it is truly human nature that is driving the Social Media market not the other way around. She reminded us that with FOUR GENERATIONS currently in the workplace attempting to work together that BUILDING RELATIONSHIPS and MAINTAINING RELEVANCE is the only way to bridge the gap between these generations. Each generation looks at another and asks, “Why do they do it like that?” It is a right of passage that when you become old enough to enter the workforce that you are allowed to ask that question! At no other time has this question had more relevance than now. We literally have pharmacists (like myself) who started their career typing labels on a manual typewriter (in my case a 1949 black Royal with no number 1 so I used the lower case “L”) working alongside pharmacists who were not alive when the Internet did not exist. We read articles all the time discussing “digital natives” and I often wonder if I qualify as even a “digital immigrant.” More often than not I find myself an adapter rather than an adopter because I have to wait until someone else shows me how to use the technology on a daily basis. When I think back to the proud feeling I had in college when I wrote my first loop program in COBOL and now it is a defunct computer language that most of you have never heard of, I feel the weight of always playing catch up to the younger people surrounding me.
Now, you are wondering how this relates back to my two words, RELEVANCE and RELATIONSHIPS. I believe for pharmacy to not only survive but flourish as a healthcare profession that we must embrace the different skill sets found between the generations and use them to our advantage. Pharmacy is a “people profession!” So often I hear pharmacists advise students going to pharmacy school interviews, don’t say “I want to be a pharmacist because I want to help Our Executive Director, Bob McFalls, and I recently people.” I cannot fathom why they say that because attended a leadership weekend co-sponsored by in my mind (and my heart) that is exactly what we do. Pharmacists’ Mutual Insurance and NASPA. It was By embracing our differences, we older practitioners mediated by a lovely woman who really made us can stay RELEVANT by learning new skills from the delve deeply into what our perceptions of how we new practitioners (especially technological skills) and could meet our membership’s needs versus what cur- in turn we can help them learn how to build RELArent literature tells us that our membership states they TIONSHIPS. need. On some accounts, we were close to correct. Continued on Page 6 On others we were not in the ballpark. Toward the 3
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012
KPhA Professional Awards 2012
George F. Hammons, Barbourville, Ky., Bowl of Hygeia Award sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations with support from Boehringer Ingelheim. Pictured with Amy Nicholas, Associate Director Healthcare Quality and Outcomes at Boehringer Ingelheim and 2011-12 KPhA Chairman Clay Rhodes
Alyson Schwartz, Bardstown, Ky. Pharmacist of the Year Pictured with 2011-12 President Lewis Wilkerson and Rhodes
Glenn Stark, Frankfort, Ky. Distinguished Service Award
4
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012
Stacy Rowe, Louisville, Ky., Distinguished Young Pharmacist of the Year, sponsored by Pharmacists Mutual Insurance
Patricia Robinson, Whitesburg, Ky., Technician of the Year
Brian E. Fingerson, Louisville, Ky., Cardinal Health Generation Rx Champions Award sponsored by Cardinal Health Foundation. Pictured with Todd Wright, Cardinal Health
Sullivan University College of Pharmacy student chapter of APhA-ASP, Professional Promotion Award
Lynn Harrelson, Louisville, Ky., Excellence in Innovation Award sponsored by Upsher-Smith Laboratories, Inc.
Senator Robert Stivers, (R-Manchester) Meritorious Service Award
5
THE KENTUCKY PHARMACIST
President’s Perspective
July 2012
Continued from page 3
apy and take responsibility for dispensing our own The digital age and smart phones have turned many class of drugs, we are going to have to unchain the of us into isolationists without us realizing that is what computer stations and TALK TO PEOPLE. I realize is happening. I see young people sitting around a ta- that the spot in front of the terminal is warm and friendly but we are not computer programmers, we ble together but not talking to one another because they are busy texting someone else or surfing on the are pharmacists and we don’t write in COBOL anyInternet. By not having practiced talking to other peo- more. We talk to patients and provide healthcare. Our ple they are at a disadvantage to those of us who talk relationships with our patients make a difference to their healthcare; take time to introduce yourself to new all the time (like me). We can teach active listening patients. “Hello, my name is Kim Croley, and I am skills and imprinting skills to younger pharmacists your pharmacist.” Actively engage every patient on making them more effective healthcare providers. refills; there is no better measure of adherence or abilWorking together, generations hand in hand, we all become better pharmacists and find new relationships ity to qualify appropriateness of therapy than by asking questions at the time of refills. In the hospital, take that help us all move forward. the initiative to speak to patients on the nursing units. RELEVANCE also relates back to our colleges of Volunteer to work with the medication reconciliation pharmacy. The student pharmacists who come to my process at your hospital, I guarantee you will be able practice site are extremely well educated. Most anto spot problems at the initial review. nounce to me on their first day that they plan to be a At KPhA, we will be working alongside CAPP, our two clinical pharmacist not a colleges of pharmacy at retail pharmacist. I am UK and Sullivan, KSHP, afraid that I often shatter KY-ASCP Chapter and our their hopes on that first day local affiliates to promote because I tell them that our profession and its releevery pharmacist is a clinivance to the other profescal pharmacist if they want sions within the healthcare to be and that there are team, payers, legislators many wonderful community and patients. Conversapharmacies but I do not tions will be held on your use the word retail unless I behalf thru Rx Therapy am describing a clothing Management with other store. In the recent report entities to add new conto the Surgeon General on KPhA President Kim Croley shares her vision with attracts and clients for Medithe value of the pharmacist, tendees at the 2012 Ray Wirth Banquet. cation Therapy Manageit was noted that 270+ milment services. We will continue to add relevance to lion people visit a community pharmacy each week. our current contract with the Kentucky Retirement There is absolutely no other profession that has that System by helping their beneficiaries improve their kind of “Face Time” and they don’t have to own an iPhone. We must parlay our accessibility as a strong- health and wellness. We will continue our conversahold for health and wellness. We must work with phy- tions with the Medicaid managed care entities to show sicians to show them how we complement what they the value added by the pharmacists and pharmacies do, not compete. KPhA’s honorees for Pharmacist of within their network and that by helping them “manage the Year and Bowl of Hygeia have done just that. The care” thru appropriate medication use we have in esFDA is again discussing a “Pharmacist only” Class of sence helped them “manage cost” which seems to be a primary objective. Our Kentucky Pharmacy EducaDrugs. But to prove our ability to manage disease, monitor medication therapy, manage medication ther- tion and Research Foundation will be put to good use
6
THE KENTUCKY PHARMACIST
President’s Perspective
July 2012
helping us provide and coordinate continuous professional development. We will actively solicit continuing education articles that broaden the knowledge base and add to the skill sets of our members. We will work with CAPP and our colleges of pharmacy and other entities such as the state’s Quality Improvement Organization (QIO) also known as Health Care Excel to engage in research opportunities that promote pharmacists’ clinical activities and value to the healthcare team. The Foundation will also look into setting up a special fund for scholarships or grants and aids that may accept memorial or honorary contributions from members as part of its funding. Our Legislative network promoting grassroots involvement and the Government Affairs contributions will enhance our lobbyists’ efforts in showing the relevance that pharmacists bring to the table.
cess to all clinical information we need to make decisions on our patients’ behalf. We are relevant to Managed Care because we reduce unnecessary medications thus reducing cost. We are relevant to Health Systems because we understand evidence-based protocols and can operate independently within those parameters. We are relevant to long-term care because we understand the complex drug regimens coupled with the physiology of the senior adult. We are relevant to Pediatrics because Dr. Kuhn has taught us without a shadow of a doubt that pediatric patients are not little adults! We are relevant to community pharmacies of all kinds because we build RELATIONSHIPS with patients who return to us time and again seeking our knowledge, expertise, and care. Every pharmacist in every practice setting is relevant and brings value to the healthcare team. We must recognize that the small differences I am going to ask our KPhA Board this year to stand between our practice choices simply add “different with me on your behalf and tell the world who we are flavorings” and don’t change the underlying greater and what we do. We are healthcare providers and common human heart of us all. We must believe that medication use experts. We provide clinical services the trust forged in our relationships with patients is a and healthcare information that positively impacts daifactor not often discussed but extremely relevant to ly life. We deserve compensation for the added value their health! we bring to the healthcare team whether it is fee for service or a portion of a bundled payment. We should We must support each other in our pursuit of excellence and relevance. “APRPh” is possible! We make have the authority to manage drug therapy as it relates to disease states and we should have ready ac- a difference! We are Pharmacists!
RELEVANCE RELATIONSHIPS
2012-13 KPhA Officers Lewis Wilkerson — Chairman Kimberly Sasser Croley — President Duane Parsons — President-Elect Frankie Hammons Abner — Secretary Glenn Stark — Treasurer
7
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting-KPERF Golf Scramble
July 2012
2012 KPERF Golf Scramble
1st Place: Robby Ryan, Cade Slaughter, Kevin Lamping, Andy Young. 2nd Place: Chad Downing, Brian Smith, Rahman Maniyar, Jarrod Carter. Last Place: Mike Burleson, Kyle Burleson, Steve Hart, Luke Hart. Closest to Pin: Joel Thornbury. Longest Drive: Chris Boling.
8
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting-House of Delegates
July 2012
Report of the 134th KPhA House of Delegates Tyler Whisman, PharmD – 2012 Speaker of the House
Closing Session The closing House session was held on Saturday morning where, after discussion of the Reference Committee recommendations, the following resolutions were passed:
Matt Martin, PharmD – 2012 Vice-Speaker and Chair of the Reference Committee Joey Mattingly, PharmD – 2012 Parliamentarian
2012.01 – Dues Change As usual, the 2012 KPhA Annual Meeting was quite a success. While the meeting provides excellent contin- The Board of Directors recommended a dues inuing education, networking opportunities and an increase effective January 1, 2013 as follows: formative exhibit hall, the importance of the House of Active Member $225 Delegates can’t be understated. According to the Joint Member $335 KPhA Bylaws, the House of Delegates meets at the Retired Member $120 1st Year Tier $70 Annual Meeting to address important issues facing 2nd Year Tier $140 the profession and the Association. A geographically Joint Retired $180 and professionally diverse group of Delegates from Associate Member $225 the Commonwealth gathered to debate and make recTechnician Member $50 ommendations that will help shape the profession of pharmacy. 2012.02 – Bylaws Change: Article 5.21 – Election Opening Session and Installation of Officers and Directors The Opening Session of the House was held on Thursday afternoon. Delegates received Committee reports from the Professional Affairs, Government Affairs and Organizational Affairs standing committees, New Practitioner and Policy Review Ad Hoc committees and from Executive Officers. As you will see below, the Board of Directors and each of the Committees were active over the past year and presented several items for the House to consider. In addition to committee and officer reports, Cassandra Beyerle was nominated for the position of 2012-2013 ViceSpeaker of the House of Delegates.
In addition to a President, President-elect, Secretary, Treasurer and Chair of the Board of Directors, the Board of Directors shall have nine Directors. No more than two of these nine Directors may be from the same geographic region. Geographic regions shall be determined by the Board of Directors every five years with the advice and consent of the Organizational Affairs Committee. Upon recommendation from the Reference Committee, the House charged the KPhA Board of Directors to develop a policy establishing equitable representation on the Board. This policy shall be brought forward for a vote at the 2013 KPhA House of Delegates.
Reference Committee Per KPhA House Rules, the Reference Committee met on Friday morning to discuss the resolutions and provide recommendations to the House. This meeting was open to all KPhA members and was chaired by Matt Martin. Members of the committee included, Barry Eadens, Kim Croley, Matt Carrico, Jamie Moline, Lance Murphy, Ron Poole and Joey Mattingly (Parlimentarian).
2012.03 – Bylaws Change: Article 1.14 – Technician Members Any individual who is a Certified Registered Pharmacy Technician in good standing with the Pharmacy Technician Certification Board Board of Pharmacy is eligible for technician membership. Technician members shall not be eligible to vote or hold office in the
9
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting-House of Delegates
July 2012
Association except as may be provided by Article 9.15. 2012.04 – Compensation Transparency KPhA supports the development of a transparent national standard database for the cost of multisource generic products that is updated in real time to be used in determination of compensation from payers. 2012.05 – Pseudoephedrine KPhA strongly supports efforts to reduce or eliminate the misuse of pseudoephedrine and its nega2012 Speaker of the House Tyler Whisman presides over the 134th KPhA House tive impact on the citizens of the of Delegates Opening Session at the 134th KPhA Annual Meeting at the Griffin Commonwealth. Gate Marriott Resort in Lexington, Ky. Below: The Reference Committee meets.
dates to be submitted to the Governor for consideration of appointment to the Board of Pharmacy. The individuals are: Clinton Joseph Carr – Daviess County; Larry Allen Hadley – Franklin County; Don Bryan Kupper – Oldham County; Peter Joseph Orzali, Jr. – Campbell County and Joel Craig Thornbury – Pike County. Additionally, the House approved the Board of Directors’ recommendation for new appointments to the RxTM Board of Managers (Clay Rhodes, Angela Onkst and Tera McIntosh). KPhA supports legislative and law-enforcement efforts to curtail the misuse of pseudoephedrine and encourages policies that will provide access to the best tools for that purpose which may include, but is not limited to making pseudoephedrine a legend or Scheduled drug without compromising patient care. Our unique perspective from the front-lines of Kentucky’s healthcare system gives us valuable insight as to how those tools might be best utilized once they are identified. In addition to official policy statements that were adopted, the House addressed other items as well. Cassandra Beyerle was officially elected and appropriately sworn in as Vice-Speaker of the House of Delegates. The House also approved the five candi-
Looking Toward the Future As previously stated, the House of Delegates once again proved to be a forum for passionate debate regarding the future of the profession. KPhA now has an official policy statement that will support efforts to combat the misuse of pseudoephedrine in our state. Furthermore, KPhA adopted a statement that addresses the compensation of multiple source products and expanded opportunities for membership into the Association. As we look toward the future, continued change in the profession has to be acknowledged and expected. Thus, if you are interested in helping shape the future of the profession, consider serving on a committee or becoming a delegate to the 135th KPhA House of Delegates in 2013! 10
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012
Thousands of “Words” from the 134th KPhA Annual Meeting Marriott Griffin Gate Resort and Spa Lexington, KY June 13-16, 2012 All Photos by Kelly Flora Photography except where noted
11
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012
KPhA Would Like to Thank Our 2012 Sponsors J. Clay Rhodes Richard Slone, in memory of Donald Lippert Glenn Stark Leah Tolliver Tyler Whisman Lewis Wilkerson Sam Willett
Event Sponsors American Pharmacy Services Corporation Humana Jefferson County Academy of Pharmacists KY Governor’s Office of Health Information Exchange KPhA District 1 Kentucky Independent Pharmacist Alliance Kroger Co. Medica Pharmacy Northern Kentucky Pharmacists Association Perform Rx Poole’s Pharmacy Care Rx Therapy Management Sullivan University College of Pharmacy University of Kentucky College of Pharmacy
Sponsoring Pharmacy’s Future KPhA Board of Directors Frankie Hammons Abner Amanda Stark Burton Leon Claywell Chris Clifton Kimberly Croley Trish Freeman Joey Mattingly Matt Martin Jeff Mills Duane Parsons
Cardinal Health Robert McFalls and staff National Association of Chain Drug Stores
KPERF Golf Hole Sponsors AmerisourceBergen American Pharmacy Services Corp. Capital Pharmacy and Medical Equipment Leon and Margaret Claywell in honor of Alyson Schwartz, Pharmacist of the Year The Clifton Family Grant County Drugs & Custom Compounding George Hammons, Frankie Abner, Tom Houchens Medica Pharmacy Pharmacists Mutual Companies Republic Bank & Trust Richard Slone, in memory of Donald Lippert Rite Aid Wayne’s Pharmacy Wal-Mart Pharmacies
Annual Meeting Supporter Community Trust Bank
Rx Systems, Inc. 12
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012
‌ and our 2012 Exhibitors Abbott Diabetes Care
Kentucky Spirit Health Plan
Aethon
Merck
Aligon Pharmaceuticals, Inc.
National Government Services
American Pharmacy Cooperative, Inc.
Perform Rx
AmerisourceBergen
Pfizer
American Pharmacy Services Corp.
Pharmacists Mutual Companies
Cardinal Health
Pharmacy Plus
Dr. Comfort
QS/1
Eli Lilly & Co.
Rite Aid
EPIC Pharmacies
Rx Therapy Management
HD Smith
Samuels Products, Inc.
Humana
Smith Drug Company
Kentucky Cabinet for Health & Family Services
SUCOP Student Organizations UK COP Experiential Ed/ CAPP
Kentucky Renaissance Pharmacy Museum
UK Student Organizations
KY Office of Health Information Exchange
Walgreens
Vertex
13
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012 Special thanks to David Sanders, Director of Federal Government Relations for the National Community Pharmacists Association, for serving as the keynote speaker for the Saturday luncheon, sponsored by the Sullivan University College of Pharmacy. From left, KPhA Executive Director Robert McFalls, 2012-13 President Kim Croley, Sanders, SUCOP Dean Hieu Tran. Photo by Kelli Sheets
14
THE KENTUCKY PHARMACIST
134th KPhA Annual Meeting
July 2012
NASPA-NMA Student Pharmacist Self-Care Championship Teams of student pharmacists from Sullivan University College of Pharmacy and the University of Kentucky College of Pharmacy competed in this Jeopardy-like game to answer questions about over-the-counter medications. The teams were allowed to pick a life-line from the audience to help answer the questions.
The Judges: Dr. Joseph Fink, Dr. Mykel Tydwell, Dr. Joey Mattingly
This program will be an annual event at the KPhA Annual Meeting. Special thanks to Dr. Holly Divine, Dr. Melanie Mabins and Dr. Misty Stutz for tailoring this program for KPhA and our students.
The Host: KPhA 2011-12 President Lewis Wilkerson
The Winners: Elizabeth Riner - UK, Lance Murphy - Sullivan, Brooke Herndon - UK, Danielle Waymeyer - UK,
15
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
GLP-1 Agonists Therapy in Individuals with KPERF offers all Type 2 Diabetes Mellitus: A Review of Safety and Tolerability
CE articles to members online at www.kphanet.org
By: Lalita Prasad, PharmD, MS, BCPS, Assistant Professor of Clinical and Administrative Sciences, Sullivan University College of Pharmacy Kristal L. Williams, PharmD, CDE, Assistant Professor of Pharmacy Practice, Butler University College of Pharmacy and Health Sciences Acknowledgements: Tracy Costello, assistant professor of pharmacy practice, Butler University College of Pharmacy and Health Sciences Reprinted with permission of the authors and the Indiana Pharmacists Alliance where this article originally appeared. This activity may appear in other state pharmacy association journals. There are no financial considerations that could be perceived as real or apparent conflicts of interest.
Universal Activity # 0143-9999-12-007-H01-P&T 1.5 Contact Hours (0.15 CEUs)
“GLP-1 Agonists Therapy in Individuals with Type 2 DiabeObjectives: At the conclusion of this lesson, the reader should be able to: tes Mellitus: A Review of Safe1. Explain the role of the incretin system in the development of diabetes and dis- ty and Tolerability” is one in a series of continuing education cuss the place in therapy for GLP-1 agonists. articles authored and gener2. Compare and contrast the adverse effects and safety profiles of the two FDA- ously contributed to the Kenapproved GLP-1 agonists, exenatide and liraglutide. tucky Pharmacists Association 3. Discuss the appropriate use and recommendations of GLP-1 agonists in terms by the Indiana Pharmacists Alliance. of their safety profile.
4. Discuss the patient education that should be provided upon prescribing and/or dispensing exenatidine and liraglutide based on the REMS system. 5. Discuss the proposed mechanism and risk factors the GLP-1 agonist safety concerns. Recent medication advances in the treatment of type 2 diabetes mellitus (T2DM) have evolved around the incretin system, specifically with a focus on the glucagon-like peptide-1 (GLP-1) hormone. Research has shown that GLP-1 hormones and receptors play an integral and multifactorial role in the homeostasis of glucose via pancreatic and extrapancreatic mechanisms.1,2,3 GLP-1 hormones exert their effects by binding to structurally distinct receptors which are located in the α- and β-pancreatic islet cells, in addition to the kidneys, lungs, heart, brain and the nervous system.1,2 Through a constellation of activities, such
as stimulating insulin synthesis and release, decreasing hepatic gluconeogenesis, increasing insulin sensitivity and glucose uptake, decreasing glucagon secretion, increasing satiety and decreasing gastric emptying, the native GLP-1 hormones aid in regulating both post-prandial and fasting glucose concentrations.1,2,3 However, shortly after release from the distal L cells of the gastrointestinal tract in a nutrient-dependent manner, biologically active native GLP-1 hormones are rapidly cleaved at the N-terminal into an inactive form by the dipeptidyl peptidase 4 (DPP4) enzyme.1,2,3 This cleavage of the biologically active
16
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
GLP-1 Agonist
Adult Dosing
Exenatide (Byetta®)5
5 mcg twice daily for 30 days then, if tolerated, titrate to 10 mcg twice daily thereafter.
Available in pre-measured pens of 5- and 10 mcg
Dosing in Renal Impairment
Severe renal impairment (creatinine clearance <30 ml/ min) or end-stage renal disease: Avoid therapy
Inject subcutaneously within 60 minutes before breakfast and dinner (separate doses by at least 6 hours).
Moderate renal impairment (creatinine clearance 30 to 50 ml/min): Apply caution when initiating or increasing therapy
Normal renal function: Monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need suspect exenatide induced kidney dysfunction Liraglutide (Victoza®)6 Available in pre-measured pen with a dose titration feature
0.6 mg daily for 7 seven days, then increase to 1.2 mg or 1.8 mg
No renal adjustment needed. Exercise caution when initiating or increasing therapy.
Inject subcutaneously daily regardless of timing of meals.
Note: 0.6 mg daily is ineffective for glycemic control Exenatide extended release (Bydureon®)7 Available as a carton of 4single dose trays which include: One vial containing 2 mg exenatide (as a white to offwhite powder) One prefilled syringe delivering 0.65 mL diluent
2 mg once every 7 days.
Inject subcutaneously weekly regardless of timing of meals.
Severe renal impairment (creatinine clearance <30 ml/ min) or end-stage renal disease: Avoid therapy
If a dose is missed and the next regularly scheduled dose is due one or two days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.
Moderate renal impairment (creatinine clearance 30 to 50 ml/min): Apply caution when initiating or increasing therapy
One vial connector Two custom needles (23G, 5/16”) specific to this delivery system Table 1: GLP-1 Prescribing Information
GLP-1, results in a half-life of approximately 1.5 minutes and limits the glucose-lowering action of GLP-1.1,2 In addition to degradation by the DPP4 enzyme, the physiological activity of native GLP-1 is further limited by its’ rapid clearance from circulation via the kidney.2 Furthermore, studies have shown the incretin effect, which is the phenomenon that the increase in insulin secretion after oral ingestion of glucose is greater than that seen with IV glucose admin-
istration, particularly in postprandial states, is blunted in individuals with T2DM, impeding the achievement of euglycemia, further supporting their use as a viable treatment option.1,3,4 Clinical investigations found that intravenous administration of recombinant human GLP-1 resulted in increased insulin secretion, decreased glucagon release, and subsequently lowered fasting and postprandial levels in individuals with T2DM. While these 17
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
findings did demonstrate the positive therapeutic outcomes that are associated with restoring and enhancing the incretin action of GLP-1 hormones, clinical use was limited by a short-half life and inconvenient route of administration.1-4 In addition to the aforementioned glucose lowering effects, findings suggest GLP-1 hormones have a positive impact on B-cell proliferation and reduces apoptosis.2,4 Additionally, although further studies are needed, it appears that both exenatide and liraglutide exhibit the ability to preserve beta cell function and improve cardiac function, including but not limited to improving blood pressure, lipid concentrations, myocardial function and cardiac output, specifically by reducing left ventricular end diastolic pressure, all of which are possible concomitant medical conditions in patients with T2DM.2,4 Thus, the development of chemically enhanced GLP-1 receptor (GLP-1R) agonists with superior pharmacokinetic profiles and resistance to DPP4 enzyme degradation has become the pharmacological target for the treatment of T2DM.2,4 To date, there are two chemically modified GLP-1R agonists available in the United States, exenatide and liraglutide.
ministered as a 2mg injection once weekly7. In clinical trials, when compared to exenatide twice daily, patients on exenatide once weekly had significantly greater reductions in their blood glucose without increasing the risk of adverse effects, such as hypoglycemia.8 Both exenatide products and liraglutide, which are all available via subcutaneous administration, mimic all of the glucose lowering actions of native human GLP-1 hormones.1-4,7 Specific dosing information can be found in Table 1.
According the to American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Glycemic Control Algorithm for individuals with T2DM published in 2009, GLP-1R agonists are indicated as an option for first line therapy, particularly in individuals with elevated post-prandial glucose concentrations.9 Furthermore, it recommends GLP-1R agonists as an option for the second component of dual therapy, in combination with metformin, the cornerstone of therapy, or a TZD.9 Despite their attractive efficacy, as demonstrated by A1c reductions of approximately 0.8 and 1.5 percent for exenatide twice daily and liraglutide once daily respectively, their Exenatide (Byetta®, Amylin Pharmaceuticals Inc, San associated weight loss and unique multifactorial Diego, California, and Eli Lilly, Indianapolis, Indiana), mechanism of action, the safety profile of GLP-1R aga synthetically modulated version of GLP-1 made onists emerges as a concern.3,10 Efficacy, tolerability from the venom of the Gila-monster, was Federal and their adverse effect profiles, are some of the key Drug Administration (FDA) approved in April 2005 for parameters considered when initiating and titrating monotherapy or combination therapy with metformin, medication therapy. Clinical trials and post-marketing a thiazolidinedione (TZD) or a sulfonylurea to improve surveillance for both exenatide and liraglutide have glycemic control in patients with T2DM.5 In October demonstrated concerns with patient tolerability and 2011, exenatide received FDA approval for its’ use in safety, specifically in regards to gastrointestinal intolcombination with glargine insulin.5 Exenatide shares erances, pancreatitis and the possibility of thyroid ma53 percent homology with native human GLP-1 horlignancies.3,10 The purpose of this article is to review mones.2,3,5 Liraglutide (Victoza®, Novo Nordisk Inc, the safely profile of GLP-1R agonists and to educate Princeton, New Jersey), on the other hand, is dethe pharmacist regarding recommendations for their signed by recombinant DNA technology, shares 97 safe use in the treatment of diabetes. percent homology to native human GLP-1 hormones, GASTROINTESTINAL INTOLERANCES and was FDA-approved in January 2010 as adjunct to Gastrointestinal (GI) disturbances, specifically nausea diet and exercise to improve glycemic control in pa2,3,6 and vomiting, are the most common treatment emertients with T2DM. It is important to mention that gent side effects associated with the use of GLP-1R unlike exenatide, the manufacturer does not recom3,11,12,13 These GI side effects are most commend liraglutide as first-line therapy for the treatment agonists. 5,6 of T2DM. Recently, in February 2012, another long- monly experienced upon medication initiation and dose escalations.10 In most cases, GLP-1R agonist acting formulation, exenatide-extended release (Bydureon®) was FDA approved.7 Bydureon® is ad- induced nausea and vomiting was transient and clas18
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
sified as mild to moderate.3,12 The nausea associated with GLP-1R agonists is thought to be related to a multitude of effects, including peak drug concentrations at the time of medication exposure, slowed gastric emptying and stimulation of neutral GLP-1R receptors.8,12 In several studies, GLP-1R agonist associated nausea and vomiting were reported at a higher incidence than non-GLP-1R agonist comparators, such as sulfonylureas, metformin and TZDs.10 The LEAD-6 study, which compared exenatide 5 mcg twice daily titrated up to 10 mcg twice daily after 4 weeks, to liraglutide 0.6 mg titrated up to 1.8 mg after 2 weeks, demonstrated the duration of GLP-1R agonist induced nausea and vomiting was prolonged with shorter acting agents. In this study, the majority of the liraglutide-treated patients were nausea-free by week 6, compared to week 22 for the twice daily exenatide group.14 Similarly, in the DURATION-1 trial, which evaluated 2 mg exenatide once weekly to 10 mcg exenatide twice daily, a significantly less proportion of patients experienced treatment related-nausea with the long-acting formulation when compared to twicedaily administration.8 Clinical trials report the incidence of nausea between 33 – 57.1 percent and of vomiting between 12 – 17.4 percent for exenatide 10 mcg twice daily.11 Nausea rates observed in phase 3 trials of lirglutide 1.8 mg daily, were less than those reported with twice daily exenatide and ranged from 7 – 40 percent.10 For some individuals, the GI disturbances limited the use of GLP-1R agonist therapy, as witnessed by the GI-induced discontinuation rates of 3 – 9 percent for exenatide 10 mcg twice daily.11
lower post-prandial glucose concentrations is by delaying gastric emptying. As a result, GLP-1R agonists may not be appropriate for individuals with gastroparesis, an autonomic disorder often complicated by hyperglycemia. Exenatide use is not recommended in patients with gastroparesis.5 While the product information for liraglutide does not currently provide any recommendations for its use in patients with gastroparesis secondary to insufficient data, the medication guide for Liraglutide instructs patients to inform their healthcare provider if they have or experience symptoms of gastroparesis.6 HYPOGLYCEMIA
The possibility of hypoglycemia is an ongoing concern for medications with insulin secreting properties, such as GLP-1 agonists, sulfonylureas and meglitinides, as well as insulin. In clinical trials the incidence of hypoglycemia amongst treatment groups for both exenatide and liraglutide were generally comparable to placebo; and when mild to moderate hypoglycemia was noted, it was associated with sulfonylurea use.1,8,14 Furthermore, despite the improved glycemic outcomes of the long-acting agents, the risk of hypoglycemia with liraglutide daily and exenatide once weekly was less than that observed with sulfonylureas and twice daily exenatide.15 It is hypothesized that the lower risk of hypoglycemia with GLP-1R agonists is related two distinct characteristics. One characteristic is its glucose-dependent mechanism of action. The other is the fact that when an individual’s blood glucose concentration is <65mg/dl (hypoglycemia), GLP-1R agonists do not inhibit the secretion and acStrategies to prevent or alleviate GI intolerances astion of glucagon, thus allowing for a rise in glucose.16 sociated with GLP-1R agonists include titrating doses Although, the 2009 American Diabetes Association conservatively after initiating therapy.12 For exand the European Association for the Study of Diabeenatide, if nausea occurs upon dosage escalation, tes (ADA/EASD) diabetes management algorithm maintenance at the lower initial dose of 5 mcg twice classifies GLP-1R agonists as less validated tier 2 daily is appropriate; however, for liraglutide the target therapies, it recommends these medications, particudose should be at least 1.6 mg daily, as lower doses larly exenatide (the only FDA-approved GLP-1R agoare ineffective for glycemic control.5,6 Patients should nist at the time of algorithm publication) as a prealso be counseled that nausea is most often transiferred adjunctive therapy for those individuals with ent, to eat smaller meals to prevent gastrointestinal hazardous employment, such as vehicle or machinintolerances and, if on exenatide twice daily, to adery operators (i.e. truck, bus or forklift drivers and airminister the injection immediately prior to meal-time.3 line pilots, etc.) or construction workers in whom hyOne of the mechanisms by which GLP-1R agonists poglycemia is less desired.17 In clinical trials, patients
19
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
treated with exenatide monotherapy experienced mild to moderate hypoglycemia at a rate of 4-9 percent, while 0-12 percent of patients on liraglutide experienced mild to moderate hypoglycemia, which was lower than the incidence observed with glimepiride monotherapy, where hypoglycemia occurred in 24 percent of patients.16 However, due to the hypoglycemic risk with concomitant therapy, the prescribing information for GLP-1R agonists includes a recommendation to reduce the dose of secretagogues when used in combination.5,6 Presently, only exenatide is FDA-approved for combination therapy with insulin glargine. Its prescribing information, likewise recommends considering a dosage reduction for the insulin dose, which should be considered upon GLP-1R agonist initiation and dose escalation to lower the risk of hypoglycemia.5
with other diabetes treatments, such as metformin or sulfonylureas.20 An additional concern is the risk association between pancreatitis and pancreatic cancer. Regarding pancreatic cancer event rates, the FDA AERS study found a 2.9-fold increase when compared to control agents.19 Regarding possible liraglutide-induced pancreatitis, in clinical trials a total of seven cases were reported, including acute pancreatitis, chronic pancreatitis and necrotizing pancreatitis with deaths occurring in five, two and one case(s), respectively.6 The overall occurrence of pancreatitis was higher in the liraglutidetreated group than that observed with the comparator agents (2.2 vs. 0.6 cases per 1000-patient-years).6
PANCREATITIS AND PANCREATIC CANCER Post-marketing surveillance reports of acute pancreatitis in patients treated with exenatide prompted the FDA to investigate the causality, and subsequently include pancreatitis as a precaution to the product information for GLP-1R agonists (both exenatide and liraglutide). Thirty cases of exenatide-induced acute pancreatitis and six cases of hemorrhagic or necrotizing pancreatitis were cited in the FDA Adverse Reporting System (AERS) in 2008.5 A retrospective chart review utilizing the AERS database was conducted between 2004 and the third quarter of 2009 to determine if there is sufficient data correlating pancreatitis to exentatide use.18,19 Although there were several limitations to the methodology used, the study found a >6-fold increase in the risk of pancreatitis with the exentadine group when compared to the control group (which consisted of patients treated with thiazalidinediones or meglitinides).18,19 These findings however, were inconsistent with other data analyses and retrospective reviews, which reported similar incidences of exenatide-induced pancreatitis to comparator therapy.18,19 One of these studies, a retrospective review of pharmacy claims data, evaluated the incidence of pancreatitis over a one-year period of 28,000 prescriptions. In this study, 0.13 percent of the patients treated with exenatide experienced acute pancreatitis, which was comparable to rates observed
Despite these reports, an absolute causation of GLP1R agonists and pancreatitis has been difficult to establish, as both diabetes and obesity are associated with their own risk of pancreatitis. The risk of developing pancreatitis in an individual with T2DM confers a 2.8-fold increase when compared to individuals without T2DM.16 Obese individuals with T2DM are likely to be prescribed a GLP-1R agonist due to a positive impact on weight reduction and glycemic control; however, these patients are also at a higher risk of developing pancreatitis secondary to their concomitant medical conditions. Other risk factors for pancreatitis include hypertriglyceridemia, excessive alcohol intake, gallstones and previous history of pancreatitis.21 Specific to exenatide therapy, the incidence of pancreatitis was observed upon dose escalation to 10 mcg twice a day.21 Recommendations are to observe patients for pancreatitis after a dose escalation for either exenatide or liraglutide. 21,22 Both exenatide and liraglutide have boxed warnings in their label information regarding pancreatitis.5,6 As a mandate from the FDA, Amylin Pharmaceuticals Inc. must conduct six post-marketing studies on exenatide to further explore the mechanism, incidence and risk factors for the development of acute pancreatitis with and without hemorrhagic and necrotizing complications.23 Practitioners should exercise caution when prescribing GLP-1R agonists for patients at risk of developing pancreatitis, should educate patients of warning signs
20
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
of pancreatitis and inform them to immediately discontinue therapy and seek medical attention if pancreatitis is suspected.23 If pancreatitis is confirmed, GLP-1 therapy should not be re-initiated.3,5 This is a key educational parameter that should be reinforced by the pharmacist upon medication dispensing. THYROID The development of malignant thyroid tumors was found in pre-clinical animal studies amongst rodents who received liraglutide doses that were eight times higher than the recommended human doses.6,24 In clinical trials, five cases of papillary thyroid carcinoma occurred in liraglutide-treated patients, compared to two cases reported in the non-liraglutide group. However, one comparator patient had evidence of preexisiting disease.6 Nonetheless, these findings raised concerns about the development of C-cell hyperplasia and medullary thyroid cancer in humans, prompting the prescribing information for liraglutide to carry a boxed warning for thyroid C-cell hyperplasia.24 Although this specific type of cancer is rare in humans, and the FDA warning states that the human relevance of these findings is unclear, liraglutide therapy is contraindicated in patients with a family history of medullary thyroid cancer or in patients with a history of multiple endocrine neoplasia syndrome type 2.6 The proposed mechanism by which liraglutide causes C-cell hyperplasia, and possibly cancer, is through increased stimulation of calcitonin release, which is a biomarker for medullary cancer. A two-year study evaluating calcitonin concentrations in liraglutidetreated patients did not show a difference when compared to other anti-diabetes medications; however, when compared to placebo, concentrations were elevated.22,24 In an effort to attain definitive information regarding the association of liraglutide and thyroid cancer in humans, the FDA has mandated that the manufacturer, Novo Nordisk, institute two surveillance systems. One is to establish a cancer registry to monitor the incidence of medullary thyroid cancer over the next 15 years and the other is to conduct a five-year epidemiological study, using a large healthcare claims database, to compare the development of thyroid cancer among liraglutide-treated patients to those who are liraglutide na誰ve.22,24
The FDA AERS database study also evaluated the present data correlating thyroid cancer to exenatide use.19 It found a statistically significant increase of thyroid cancer in the exenatide-treated group.19 Therefore, the manufacturer of exenatide, Amylin Pharmaceuticals Inc., acknowledges the presence of benign C-cell tumors in rats treated with the exenatide and has included this information in the package insert.5 ALTERED KIDNEY FUNCTION Post-marketing reports of both altered and worsening kidney function exist for both exenatide and liraglutide. In November 2009, the FDA released information for healthcare professionals regarding 78 cases of altered kidney function associated with exenatide therapy.25 Between April 2005 and October 2008, 62 cases of acute renal failure and 16 cases of renal insufficiency were noted. Although some cases were reported in individuals with pre-existing renal disease or with at least one risk factor for kidney disease, revisions were made to the product labeling regarding the evaluation for and dosing of exenatide in kidney dysfunction.25 The product information for liraglutide also acknowledges post-marketing reports of increased serum creatinine, acute renal failure, and the development or worsening of chronic renal failure, which in some cases, required hemodialysis.6 Unlike exenatide, however, liraglutide is not renally excreted and does not require renal dosage adjustments.5,6 Common GLP-1R associated side effects, including nausea, vomiting, diarrhea and subsequent dehydration, may increase the risk of kidney abnormalities.5,6 As a result, exenatide and liraglutide manufacturers recommend caution when initiating or increasing the dose in patients with renal impairment.5,6 REMS The Risk Evaluation and Mitigation Strategy (REMS), was developed by the FDA in an effort to be proactive on patient safety measures once a medication concern is identified. The REMS program is designed to provide both practitioners and patients with information regarding medication safety concerns. In most cases, the REMS will include a communication plan for practitioners and a medication guide for pa-
21
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012 REMS Requirements
Safety Concerns Pancreatitis / Pancreatic Cancer Thyroid Cancer Kidney Impairment
Exenatide
Liraglutide
P
P
n/a
P
P
n/a
tients. Practitioner information highlights safety considerations, current findings and makes recommendations regarding appropriate pharmacotherapy for specific patient populations. The patient medication guide informs the individual about possible risk(s), warning signs and appropriate action to take in the event of a concern. Both exenatide and liraglutide have a REMS. Table 2 outlines the REMS with these agents. Recent advances in the understanding of the pathogenesis of diabetes have focused on the multiple hormonal deficiencies that result in clinical hyperglycemia. The GLP-1R agonists represent a novel class of treatment agents that add promise to the diabetes treatment armamentarium, as they target these underlying hormonal defects and may even have the potential to delay disease progression by preserving beta-cell functioning.2,4 Despite their overall benefit on glycemic control, widespread use may be limited by their toxicity profiles. Health care practitioners, including pharmacists, should be aware of treatmentrelated toxicities and assess the risk vs. benefit when initiating or escalating therapy with these agents. A clear understanding of patient risk factors for the development of adverse effects, as well as familiarity with the signs and symptoms of potential treatmentrelated toxicities can aid in disease management. In summary, the GLP-1R agonists can provide an effective means for glycemic control, when used in the proper clinical situation.
Table 2: Overview of REMS with Exenatide & Liraglutide21-25
3. Kruger DF, Bode B, Spollett GR. Understanding GLP-1 Analogs and Enhancing Patient Success. Diabetes Educ. 2010;36(suppl 3):44S-72S. 4. Nauck, MA Incretin-Based Therapies for Type 2 Diabetes Mellitus: Properties, Function, and Clinical Implications. The American Journal of Medicine. 2011;124:S3-S18. 5. Byetta [package insert]. San Diego, CA: Amylin Pharmaceuticals; 2011. 6. Victoza [package insert]. Princeton, NJ: Novo Nordisk; 2010. 7. Bydureon {package insert]. San Diego, CA: Amylin Pharmaceuticals; 2012. 8. Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhaung D, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomized, open-label, noninferiority study. Lancet. 2008;372(9645):12401250. 9. Rodbard HW, Jellinger PS, Bloomgarden ZT, AACE/ACE Glycemic Control Algorithm Consesus Panel. Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Consesus Panel on Type 2 Diabetes Mellitus: an algorithm for glycemic control. Available at: http://www.aace.com/ pub/pdf/GlycemicControlAlgorithm.pdf. Accessed May 4, 2011.
REFERENCES
10. Gilbert Mp, Pratley RE. Efficacy and Safety of Incretin-Based Therapies in Patients with Type 2 1. Pinkney J, Fox T, Ranganath L. Selecting GLP-1 Diabetes Mellitus. The American Journal of Mediagonists in the management of type 2 diabetes: cine. 2009;122:S11-S24 differential pharmacology and therapeutic benefits of liraglutide and exenatide. Ther Clin Risk 11. Gentilella R, Bianchi C, Rossi A, Rotella CM. ExManag. 2010;6:401-411. enatide: a review from pharmacology to clinical practice. Diabetes, Obesity and Metabolism 2009;11:544-556.
2. Drucker DJ. The biology of incretin hormones Cell Metabolism 2006:3; 153-165 22
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy 12. Ellero C, Han J, Bhavsar S, Cirincione BB, DeYoung MB,Gray AL, et al. Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallelgroup, single-dose study in healthy subjects. Diabet Med. 2010;27(10):1168-1173.
July 2012 19. Elashoff M, Matveyenko AV, Gier B, Elashoff R, Butler PC Pancreatitis, Pancreatic and thyroid Cancer with Glucagon-like Peptide-1 based therapies. Gastroenterology 2011;141(1):150-156. doi:10.1053/j.gastro.2011.02.018
20. Dore DD, Seeger JD, Chan KA. Use of a claimsbased active drug safety surveillance system to 13. Joffe D. Liraglutide: A once-daily human glucagon assess the risk of acute pancreatitis with ex-like peptide-1 analogue for type 2 diabetes mellienatide or sitagliptin compared to metformin or tus. Am J Health-System Pharm. 2010; 67 glyburide. Curr Med Res Opin. 2009; 25(4):1019â&#x20AC;&#x201C; (16):1326-1336. 1027. 14. Buse JB, Rosenstock J, Sesti G, Schmidt WE, 21. Information for Healthcare Professionals: ExMontanya E, Brett JH, et al. Liraglutide once a day enatide (marketed as Byetta) - 8/2008 Update versus exenatide twice a day for type 2 diabetes: http://www.fda.gov/Drugs/DrugSafety/ a 26 week randomized, parallel-group, multinaPostmarketDrugSafetyInformationforPational, open-label trial (LEAD-6). Lancet. 2009; tientsandProviders/ucm124713.htm Accessed 374(9683):39-47. 10.26.11 15. Aroda VR, Ratner R. The safety and tolerability of 22. Victoza: Victoza (liraglutide [rDNA origin]) InjecGLP-1 receptor agonists in the treatment of type 2 tion: REMS - Risk of Thyroid C-cell Tumors, Acute diabetes: a review [published online ahead of print Pancreatitis [Posted 06/13/2011] http:// June 2, 2011]. Diabetes Metab Res. doi:10.1002/ www.fda.gov/Safety/MedWatch/SafetyInformation/ dmrr.1202. SafetyAlertsforHumanMedicalProducts/ ucm258826.htm Accessed 10.26.11 16. Campbell RK, Cobble ME, Reid TS, Shomali ME. Safety, tolerability, and nonglycemic effects of in- 23. Byetta Safety Update for Healthcare Professioncretin-based therapies. Supplement to The Jourals: http://www.fda.gov/Drugs/DrugSafety/ nal of Family Practice. 2010;59(9 Suppl 1):S-5PostmarketDrugSafetyInformationforPaS9. tientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ 17. Nathan DM, Buse JB, Davidson MB, Ferrannini E, ucm190406.htm. Accessed 10.26.11 Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: a con- 24. Questions and Answers - Safety Requirements for sensus algorithm for the initiation and adjustment Victoza (liraglutide). http://www.fda.gov/Drugs/ of therapy: a consensus statement of the AmeriDrugSafety/ can Diabetes Association and the European AssoPostmarketDrugSafetyInformationforPaciation for the Study of Diabetes. Diabetes Care. tientsandProviders/ucm198543.htm Accessed 2009;32(1):193-203. 10.26.11 18. Elashoff M, Matveyenko AV, Gier B, Elashoff R, 25. Information for Healthcare Professionals: Reports Butler PC. Increased incidence of pancreatitis and of Altered Kidney Function in patients using Excancer among patients given glucagon like pepenatide (Marketed as Byetta)http://www.fda.gov/ tide-1 based therapy. [published online ahead of Drugs/DrugSafety/ print February 18,2011]. Gastroenterology. doi: PostmarketDrugSafetyInformationforPa10.1111/j.1464-5491.2010.03085.x. tientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ ucm188656.htm. Accessed 10.26.11
23
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
About the Authors Dr. Prasad is assistant professor of clinical & administrative sciences, Sullivan University College of Pharmacy, and clinical pharmacist, University of Louisville Adult Internal Medicine Clinic, University of Louisville Hospital, Louisville. Dr. Williams is assistant professor of pharmacy practice, Butler University College of Pharmacy and Health Sciences, clinical instructor, Indiana University School of Medicine, and family medicine residency program clinical pharmacist, Indiana University Health Methodist Family Medicine Center, Indianapolis.
ATTENTION ALL PHARMACISTS AND PHARMACY TECHNICIANS WHO RECEIVE CE CREDIT THROUGH KPERF KPERF WILL FULLY IMPLEMENT CPE Monitor SEPTEMBER 1, 2012 CPE Monitor, the continuing pharmacy education (CPE) tracking service developed by ACPE and the National Association of Boards of Pharmacy is now ready for use. KPERF, KPhAâ&#x20AC;&#x2122;s ACPE accredited provider of continuing education, initiated a trial run of the system during the 134th KPhA Annual Meeting. Following the success of the trial run, KPERF will upload all continuing education credits to the CPE Monitor beginning Sept. 1, 2012. The major change is CE statements of credit will no longer be mailed. Quizzes from The Kentucky Pharmacist will be graded as usual, submitted to ACPE, which will validate the information before sending it to NABP for the CPE Monitor. After CPE credits are processed by ACPE and NABP, you will be able to log into your NABP e-Profile and view all of your ACPE completed continuing education. No more keeping up with the certificates, misplacing them when you move on or producing them when asked by investigators. In order to process your credit, KPERF MUST have your correct NABP e-Profile ID number and your birth month and day. This is YOUR PERSONAL NABP e-Profile ID, and it is not your license number. If you need to verify your number or have not yet registered, please visit www.MyCPEMonitor.net as soon as possible. If you are unable to use a computer, you can call the NABP Customer Service line at 847-391-4406 to set up your profile and obtain your NABP eProfile ID. After September 1, if KPERF receives quizzes or evaluation sheets from live programs without the NABP e-Profile number and birthdate information, the credit WILL NOT be processed until that information is provided. If you have any questions, contact Scott Sisco at ssisco@kphanet.org or call the NABP Customer Service Line at 847-391-4406 Monday through Friday 9 a.m. to 5 p.m. central time. NABP Customer Service custserv@nabp.net Tel: 847-391-4406 Fax: 847-391-4502 Hours: M-F, 9 AM to 5 PM central
24
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
July 2012 — GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability
1. Glucagon like peptide-1 (GLP-1) are peptide hormones secreted from the: (Objective 1) A. Gastrointestinal tract B. Kidney C. Liver D. Muscle E. Pancreas 2. Which of the following mechanisms play a role in the development of type 2 diabetes? (Objective 1) A. Abnormal glucagon production B. Altered hepatic gluconeogenesis C. Decreased insulin secretion D. Increased insulin resistance E. All of the above 3. Which of the following statements are TRUE regarding GLP-1 agonists and the side effect of nausea? (Objective 3) A. Commonly experienced upon medication initiation B. Commonly experienced upon dose escalation C. Often transient and classified as mild to moderate D. Occurs at a higher rate with GLP-1 agonist compared to other cornerstone therapies E. All of the above 4. According to the manufacturer recommendations, which of the following medications should be adjusted by a dosage reduction upon initiation of GLP-1 agonist in an effort to decrease the incidence of hypoglycemia? (Objective 3,5) A. Glipizide B. Insulin C. Nateglinide D. a and b E. all of the above
6. The proposed mechanism for C-cell hyperplasia and papillary thyroid carcinoma is: (Objective 5) A. Currently unknown B. Induction dehydration secondary to nausea, vomiting and diarrhea C. Inhibition of glucagon release D. Stimulation of calcitonin release E. Stimulation of β-cells on the thyroid gland 7. Both exenatide and liraglutide require a REMS for which of the following safety concerns? (Objective 4) A. Hypoglycemia B. Nausea and vomiting C. Pancreatitis D. Thyroid Cancer E. Kidney Impairment 8. Patients with which of the following medical conditions and/or factors should not be a candidate for GLP-1 agonist therapy? (Objective 3,5) A. Gastroparesis B. Moderate creatinine clearance (30 – 50 ml/min) C. Machinery operator (i.e. airline pilot) D. Family history of hypertriglyceridemia E. Metformin use 9. In the glycemic control algorithm developed by the American Association of Clinical Endocrinologist and the American College of Endocrinology (AACE/ACE), GLP-1 agonists are recommended as first line therapy particularly for individuals with which of the following conditions/factors? (Objective 1) A. Elevated fasting blood glucose concentrations B. Elevated post-prandial blood glucose concentrations C. BMI > 40 kg/m2 D. b and c E. all of the above
5. HB, a 55-year old female with type 2 diabetes and mild renal impairment, recently completed 2 weeks of 10. Liraglutide requires a dosage adjustment in patients liraglutide therapy. Her practitioner is interested in inwith renal impairment. creasing her dose from 1.2 mg daily to 1.8 mg daily. A. True Which of the following GLP-1 agonist associated side B. False effects should be evaluated upon the dosage increase? (Objective 3) A. Thyroid Cancer B. Pancreatitis C. Kidney Dysfunction D. b and c www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc E. All of the above
KPhA Social Media Links
25
THE KENTUCKY PHARMACIST
July 2012 CE-GLP-1 Agonists Therapy
July 2012
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601. Expiration Date: July 15, 2015 Successful Completion: Score of 80% will result in 1.5 contact hours or 0.15 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. July 2012 — GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability TECHNICIANS ANSWER SHEET. Universal Activity # 0143-9999-12-007-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 2. A B C D E
3. A B C D E 4. A B C D E
5. A B C D E 6. A B C D E
7. A B C D E 8. A B C D E
9. A B C D E 10.A B
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD) July 2012 — GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability Universal Activity # 0143-9999-12-007-H01-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 2. A B C D E
3. A B C D E 4. A B C D E
5. A B C D E 6. A B C D E
7. A B C D E 8. A B C D E
9. A B C D E 10.A B
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
26
THE KENTUCKY PHARMACIST
Pharmacy Time Capsules
July 2012
Pharmacy Time Capsules 1937—Seventy-five Years Ago: Cook County Hospital in Chicago, Illinois was the site of the first blood bank, set up by Bernard Fantus. 1912—One hundred Years Ago: Phenobarbital (Luminal) first marketed by Bayer in 1912. 1887---One hundred twenty-five years ago: The National Institutes of Health established. The National Institutes of Health traces its roots to 1887, when a one-room laboratory was created within the 1987—Twenty-five years ago: Marine Hospital Service (predecessor agency to the Major pharmacy issue of the year was the increase in U.S. Public Health Service (PHS). physician office based dispensing. Acuvue launched by J&J was the first disposable soft contact lens. 1962—Fifty Years Ago: Trivalent oral polio vaccine (Sabin) was licensed in the U.S.. Rite-Aid (Pennsylvania), Meijer’s Michigan), and WalMart (Arkansas) were formed.
By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH
One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org
Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to completing a continuing education article for publication in The Kentucky Pharmacist.
Include a quiz over the material. Usually between 10 to 12 multiple choice questions.
Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.
Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).
When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.
Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not pertinent to technicians, that needs to be stated clearly Articles should address topics designed to narrow at the beginning of the article. gaps between actual practice and ideal practice in Article should begin with the goal or goals of the pharmacy. Please see the KPhA website overall program – usually a few sentences. (www.kphanet.org) under the KPERF link to see preInclude 3 to 5 objectives using SMART and meas- viously published articles. urable verbs.
Articles must be submitted electronically to the KPhA director of communications and continuing education Feel free to include graphs or charts, but please submit them separately, not embedded in the text (ssisco@kphanet.org) by the 15th of the month preceding publication. of the article. 27
THE KENTUCKY PHARMACIST
From Your Executive Director
July 2012
MESSAGE FROM YOUR
EXECUTIVE DIRECTOR Robert “Bob” McFalls
T
his edition of The Kentucky Pharmacist features the 2012 graduating classes of the Sullivan University College of Pharmacy and the University of Kentucky College of Pharmacy. Graduates: KPhA sincerely congratulates you and welcomes you as the newest members of the profession. Know that we look forward to your involvement and engagement as active members of the Kentucky Pharmacists Association. This edition also features highlights from our 134th Annual Meeting & Convention. There is much to celebrate as the photos tell the story of pharmacists and pharmacy technicians coming together to learn, network, debate policy and socialize together. This was my second Annual Meeting with you, and I thoroughly enjoyed every minute of it. I only wish that there had been more time to visit individually, and I look forward to having those opportunities in the coming days and at the 135th Annual Meeting next year. Stay tuned as we work to finalize details for 2013! We think you also will enjoy getting to know your new Directors and Officers along with finding relevance as you relate to the message from KPhA’s new President, Kimberly S. Croley. I also am pleased to inform you that your Association has been awarded a new grant by the Kentucky Department of Public Health to advance our profession’s emergency readiness plans in terms of being able to assist with medication needs from affected patients and to be able to respond accordingly to future disaster events that occur within the Commonwealth. Since 2000, the nation has recorded more than 760 federally recognized natural disasters that have disrupted normal living patterns. And Kentucky’s history has been one whereby we are likely to be more adversely affected—our state is 1.6 times more likely to be impacted on average. The new grant will help KPhA to advance our planning efforts and put operational plans into place. The Board has established a new Emergency Preparedness Committee that will provide needed guidance with our new work plan.
As I begin my second year of service as your Executive, I cannot but note that we find ourselves at a crossroad in the practice of pharmacy when one considers the transition of the state Medicaid program to managed care, the aging of our state's population with its increasing chronic health care needs and medication reconciliation issues as well as critical discussions with respect to the potential for building upon the trusted role of the pharmacist. In the last few months, we witnessed the release of a national report, Improving Patient and Health System Outcomes through Advanced Pharmacy Practice: A Report to the U.S. Surgeon General 2011. If you have not yet had the chance to review the report, I would encourage you to do so. (see http://www.kphanet.org/ Communications.aspx). The report utilizes objective data to advance the discussion of how models of innovative care—that both include and involve pharmacists—can begin the process of alleviating demands on our health care system while improving outcomes from several perspectives that include, among others, access, safety, quality, cost and provider shortages. The Report also describes existing, accepted, and successful models of health care delivery and patient care using pharmacists as health care providers and essential members of the health care team. Along these lines, I enjoy hearing from you, our members, about these types of opportunities to discuss and strengthen the profession of pharmacy as a whole in accordance with our Association's mission. To bring clarity to these emerging issues, the Board of Directors will initiate a strategic discussion in August about our collective future. As we work together to develop a strategic plan, along with President Croley and the entire Board of Directors, I want to encourage you to contact any one of us with respect to your ideas. We welcome your suggestions for responding to the challenges and opportunities that lie before all of us. And we promise to keep everyone posted on these emerging discussions as we work to address these challenges and opportunities together. This is your KPhA--let us hear from you!
28
THE KENTUCKY PHARMACIST
Bowl of Hygeia Fundraising Efforts
July 2012
Help support the Bowl of Hygeia Award! This year another 50+ Bowl of Hygeia recipients will be added to our ranks. All are dedicated pharmacists who take community service seriously and endeavor to make a difference in a way that is meaningful. Their stories are inspiring, and their attitudes are humble. All will make you proud. The Bowl of Hygeia has a rich history within pharmacy and it represents well members of our profession. That’s why I’m excited to be helping to carry forth the Bowl of Hygeia tradition through collaboration with the Kentucky Pharmacists Association as our Association works with the “stewards” of the Bowl of Hygeia, the National Alliance of State Pharmacy Associations, the APhA Foundation and the American Pharmacists Association. Before these national Pharmacy groups assumed responsibility for the Bowl, this prestigious award was in jeopardy of being extinguished. If it were not for their agreement to carry forward the honor through a professional collaboration, 2010 would have been the last year the Bowl of Hygeia was awarded.
sonally giving to this fund, and it’s why I think you’ll be interested to join me in making an investment in the future of the award. After all, it is the future recipients of the award that guarantee the legacy of our own awards. Our goal is to raise $5,000 as a collective gift from members of the Kentucky Pharmacists Association. And we’re eager to show our state pride by either meeting or exceeding this goal. Won’t you please help by making a contribution? There are two ways to give: Online at: http://bit.ly/APhAFoundationDonation and choose the Bowl of Hygeia endowment button. Kentucky will get credit by your address. Or, you can send your check to: AphA Foundation – Bowl of Hygeia 2215 Constitution Ave., NW Washington, DC 20037-2985 Thank you in advance for joining me in this effort. Sincerely in Service I am,
George Hammons, RPh Owner/President Knox Professional Pharmacy Given that this is an award presented at the state lev- Bowl of Hygeia Award Recipient, 2012 el, the State Pharmacy Associations — including your Kentucky Pharmacists Assocaiation — along with NASPA, are working together to help make sure this award we hold so dearly is never at risk again. In order to sustain the award, each state association is working together to build an endowment sufficient to generate dividends that will fund the program in perpetuity. The APhA Foundation, a national nonprofit 501 (c) (3), has agreed to be the home of the endowment account, and to date we are almost half way to our goal of $600,000. As a recipient of the award, I am excited to be a leader in helping the Kentucky Pharmacists Association kick off its campaign. I want to be sure the Bowl of Hygeia continues to represent the hallmark of community service in our profession. That’s why I am per-
29
THE KENTUCKY PHARMACIST
Pharmacy Technician Certification Board
July 2012
30
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence
July 2012
Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease
KPERF offers all CE articles to members online at www.kphanet.org
By: Lindsay Rogers, PharmD; Erika Webster, PharmD, BCPS, CDE; and Debbie Minor, PharmD G.V. (Sonny) Montgomery VA Medical Center Department of Pharmacy and The University of Mississippi Medical Center Department of Medicine Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared. There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-9999-12-008-H01-P&T 1 Contact Hour (0.1 CEUs)
The goal of this review is to describe current recommendations for the use of aspirin (ASA) in cardiovascular disease (CVD) prevention based on recent and evolving evidence. Objectives: 1. Discuss recent findings and updates regarding the use of ASA for primary CVD prevention in diabetes. 2. Review the role of ASA as comparative or combination therapy in the management of atrial fibrillation and acute coronary syndrome (ACS). 3. Highlight issues related to the use of ASA in the elderly. 4. Describe concerns with ASA discontinuation and potential consequences. affects more than 340 million people worldwide.6 In the United States, more than 26 million people have ASA is a potent inhibitor of both platelet aggregation diabetes, with this number expected to reach 30.3 and prostaglandin synthesis. For more than 10 years, million in the year 2030.7,8 As those with diabetes apASA has been used and promoted as a cost-effective pear to have a two- to four-fold higher risk of CVD, agent for reducing the occurrence of further vascular this increasing prevalence has led to greater conevents in those with occlusive vascular disease.1-3 cerns for CVD development, the major cause of death When used for secondary prevention in those with a with the disease.6,9-11 In 2009, 7 million people in the cardiovascular event history, the evidence is clear; United States with diabetes also reported a CVD conASA reduces the risk of myocardial infarction (MI) by dition.12 Over the past 10 years, the prevalence of dione-third, stroke by one-quarter and vascular death abetes in Kentucky has increased from 6.4 percent to by one-sixth, with benefits far exceeding risks.4,5 For 10.1 percent, in contrast to the national increase of those without history of an event (primary prevention), 6.0 percent to 8.7 percent.13 evidence for the use of ASA is less clear and controversial. Recent and emerging evidence provides In 1999, an American Heart Association (AHA) statesome clarification regarding the use of ASA for prima- ment concerning CVD and diabetes recommended ry prevention in a variety of situations including diabe- ASA for primary prevention unless contraindicated.14 tes, atrial fibrillation, as combination therapy and in The American Diabetes Association (ADA) and AHA the elderly. The purpose of this article is to review the updated these recommendations for ASA as primary evolving evidence concerning ASA and CVD preven- prevention in 2007. In this statement, ASA was rection and highlight the current recommendations for ommended for those with increased cardiovascular use based upon this data. risk defined as: >40 years old or with additional risk factors for CVD (family history, hypertension, tobacco ASA in Diabetes use, dyslipidemia or albuminuria).2 Evidence supportDiabetes is a chronic and progressive disease that ing this recommendation was inconclusive and studIntroduction
31
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence ies using ASA have been designed to more clearly identify treatment strategies that reduce the CVD associated with diabetes. Evidence for Primary Prevention
July 2012 would reduce cardiovascular events. Participants were randomized to ASA plus placebo, antioxidant plus placebo, ASA and antioxidant, or double placebo. The two primary endpoints were either a composite of death from stroke or coronary heart disease (CHD), nonfatal MI or stroke, and amputation above the ankle due to ischemia or death from CHD or stroke. After a median follow-up of 6.7 years, the composite endpoint occurred in 117 participants not on ASA versus 116 on ASA, with death from CHD or stroke alone occurring in 35 not on ASA versus 43 on ASA. The differences between the ASA and non-ASA groups were not statistically significant for either endpoint, again questioning any benefit of ASA for primary prevention of CVD in diabetes.15
The 2009 Antithrombotic Trialistsâ&#x20AC;&#x2122; (ATT) Collaboration meta-analysis examined the use of ASA in six primary prevention trials (n=95,000, n=4,000 with diabetes) with outcomes of serious vascular events (MI, stroke or vascular death). Overall, 1,671 serious vascular events occurred in the ASA group versus 1,883 in the control, representing a 12 percent reduction. The reduction in nonfatal MI was significant whereas the reduction in stroke and vascular death was not. However, extracranial and gastrointestinal bleeding was increased by 55 percent in patients with diabetes, furCollaboration of Evidence and Recommendations for ther questioning the overall risk versus benefit in priUse mary prevention.5 In an effort to reconcile results, the ADA, AHA, and The Japanese Primary Prevention of Atherosclerosis American College of Cardiology Foundation (ACCF) with Aspirin for Diabetes (JPAD) and the Prevention conducted a meta-analysis including the primary preof Progression of Arterial Disease and Diabetes vention trials in the ATT meta-analysis, JPAD and (POPADAD) trials were designed to provide more POPADAD. The authors concluded that ASA use proconclusive evidence for the use of ASA. Both of these duced an insignificant risk reduction of 9 percent and multicenter trials included patients with no prior histo15 percent, respectively, in fatal and nonfatal MI and ry of CVD.11,15 stroke.16 The JPAD trial included 2,539 participants ages 30 to Based on these results, the combined groups con85 years with controlled type 2 diabetes, randomized clude that ASA only modestly reduces CVD risk in to low-dose ASA or placebo. The primary endpoint diabetes by about 10 percent, with the most benefit was occurrence of any cardiovascular event including seen in those with the greatest risk. They now recomcoronary, cerebrovascular or peripheral. The differmend that the use of ASA be based on the overall ence in events between the groups over the median cardiovascular risk profile. Use of the Framingham follow-up of 4.37 years was insignificant, with 68 in risk assessment for this and suggestions for ASA use the ASA group versus 86 with placebo. However, in are identified in the Table on page 30. Concurrent those 65 and older, there was a significant 32 percent therapies for reducing CVD risk are encouraged inreduction in events with ASA, suggesting a benefit for cluding smoking cessation, control of hypertension, older patients. Overall, JPAD results suggest only a uses of statins and lifestyle changes. These therapies small benefit for the use of ASA as primary prevention should be adopted first and may lower CVD risk to a in diabetes. Interpretation of the data is difficult belevel that does not warrant ASA use. Other assesscause the study was underpowered due to the low ment tools can also be used including the UKPDS number of overall events.11 Risk Engine, the ARIC CHD Calculator and the ADA Risk Assessment Tool. Since gastrointestinal bleedThe POPADAD trial included 1,276 participants 40 years or older with type 1 or 2 diabetes and an ankle ing presents the greatest complication with ASA use, brachial pressure index of 0.99. The trial evaluated if a thorough evaluation for this risk also should occur 16 the use of ASA and antioxidants, alone or combined, prior to initiation.
32
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence
July 2012
combination. Rates of major hemorrhage were similar between groups; however, the clopidogrel plus ASA group had more minor and total bleeds.18 Based Warfarin and ASA on these results, the combination of ASA and Though warfarin is the drug of choice for primary pre- clopidogrel is not recommended over warfarin when vention of stroke in atrial fibrillation, it may not be suit- patients are candidates for warfarin therapy.18,19 able for all patients. A recent Danish study examined The Effect of Clopidogrel Added to Aspirin in Patients the efficacy and safety of warfarin, ASA, the combinawith Atrial Fibrillation (ACTIVE-A) trial was conducted tion of warfarin plus ASA, or no treatment by linking to evaluate ASA plus clopidogrel versus ASA alone in nationwide registries and identifying patients dispatients where warfarin was not an option due to risk charged with non-valvular atrial fibrillation of bleeding, physician judgment, or patient prefer(n=132,372). Study results supported that ASA alone ence. The primary outcome was the composite of is neither safe nor effective in preventing stroke in stroke, MI, noncentral nervous systemic embolism, or atrial fibrillation, with no net clinical benefit (stroke verdeath from vascular causes. The annual rate of the sus bleeding) at any level of stroke risk. Stroke risk composite endpoint after a median of 3.6 years was calculated using CHADS2 and CHA2DS2-VASc follow-up was 6.8 percent in the clopidogrel-ASA scores, while bleeding risk was evaluated using HASgroup versus 7.6 percent with ASA alone. The differBLED. Patients were further stratified based upon ence was attributed primarily to a reduction in the rate risks of stroke and bleeding. Hazard ratios showed of stroke (2.4 percent clopidogrel-ASA versus 3.3 perthat warfarin alone consistently lowered the risk of cent ASA). When evaluating adverse events, howevthromboembolism/stroke greater than ASA alone or er, major bleeding was significantly increased in the no treatment, while the combination of warfarin plus clopidogrel-ASA group (2.0 percent versus 1.3 perASA provided no additional benefit.17 cent per year), including an excess of 13 fatal epiFor patients at each thromboembolic risk level, the sodes.20 risk of bleeding was increased in all treatment groups Based upon information from these studies, the ACcompared to no treatment. Warfarin therapy alone CF/AHA/Heart Rhythm Society (HRS) included a rechad a net clinical benefit in all but the lowest risk group (CHA2DS2-VASc score of 0 and 1) where bene- ommendation concerning combination therapy in the fits were neutral. Furthermore, the net clinical benefit 2011 Focused Update on the Management of Pawith warfarin was greatest in patients with the highest tients with Atrial Fibrillation. The class IIb recommenbleeding risk. Researchers suggested that this could dation states that the combination of clopidogrel and ASA might be considered as an option for primary be because this group had the highest stroke risk. prevention of major vascular events in atrial fibrillation This study provides additional support for the lack of 18-20 ASA efficacy in atrial fibrillation, alone or in combina- when warfarin therapy is unsuitable. tion with warfarin, and should guide providers away CHEST Guideline Updates from this use.17 The recent CHEST guidelines published in February Clopidogrel and ASA 2012 give updated recommendations regarding the Clopidogrel plus ASA was compared to warfarin in the use of ASA in atrial fibrillation. For patients with a low risk of stroke (CHADS2 score of 0), it is suggested Atrial Fibrillation Clopidogrel Trial with Irbesartan for that no therapy be used. However, if medication therPrevention of Vascular Events (ACTIVE-W) trial. In apy is elected, ASA is recommended over oral anticothis trial, patients had an average of two risk factors for stroke. Primary outcomes included first occurrence agulation or combination therapy with ASA and of stroke, noncentral nervous systemic embolism, MI clopidogrel. For patients with an intermediate risk of stroke (CHADS2 score of 1) and consistent with the or vascular death. Warfarin was superior to ACTIVE-W trial, oral anticoagulation is suggested clopidogrel plus ASA for prevention of vascular over no therapy, ASA or combination therapy with events, with 165 events compared to 234 with the ASA as Comparative or Combination Therapy Atrial Fibrillation and Acute Coronary Syndrome
33
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence
July 2012
Table: Use of Low-dose (75-162 mg/day) ASA for Primary CVD Prevention in Diabetes* Recommended:
High CVD risk (10-year risk >10 percent)a AND no increased risk of bleeding
Not recommended:
Low CVD risk (10-year risk <5 percent)b
Possibly consider:
Intermediate CVD risk (10-year risk 5-10 percent)c
*Based on Framingham 10-year risk assessment. In general, most: a Men ≥50 and women ≥60 years with one additional risk factor: smoking, hypertension, family history of premature CVD,
ASA and clopidogrel. If warfarin is unsuitable or the patient chooses not to take warfarin, combination therapy with ASA and clopidogrel is suggested over ASA alone. Consistent with the findings of the Danish study evaluating warfarin and ASA, the guidelines also recommend the use of warfarin alone over the combination of warfarin and ASA in patients with atrial fibrillation and stable coronary artery disease (CAD).21 Ticagrelor and ASA Ticagrelor (Brilinta®), a new antiplatelet agent that acts by binding and reversibly antagonizing adenosine diphosphate, is indicated to reduce the rate of thrombotic cardiovascular events in patients with ACS.22 In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor was found to be superior to clopidogrel in secondary prevention of vascular events and death with ACS. When comparing the two medications, ticagrelor resulted in a decreased incidence of composite death from vascular causes, MI or stroke (9.8 percent versus 11.7 percent). All patients in this trial received concomitant ASA 75-100 mg or a dose of 325 mg, if they had not been taking ASA prior to the trial.23 An interesting finding and limitation of the PLATO trial was that ticagrelor had a relative lack of benefit in North America compared to other sites throughout the world. Recently, a subgroup analysis investigated this finding; Cox regression analyses were performed to assess the relationship between certain factors and the regional differences in outcomes. It was identified that North Americans received ASA doses of ≥300 mg/day more frequently than at other sites (53.6 percent versus 1.7 percent, respectively). Out of the many factors investigated, ASA dose was found to be the main contributing factor accounting for regional differences. Conclusions suggested that low-dose
concomitant ASA (75-100 mg), compared to higher doses (≥300 mg), was associated with the lowest risk of primary outcomes with ticagrelor versus clopidogrel.25 Based upon this information and per the approved prescribing information, it is recommended that a maintenance dose of ASA, 75-100 mg daily, be taken with ticagrelor.23-25 ASA in the Elderly Antithrombotic therapy represents an important aspect of CAD treatment, the leading cause of death in the elderly. In a 2002 ATT Collaboration metaanalysis, ASA used for secondary prevention had a similar MI, stroke and death relative risk reduction in the elderly (>65 years, 19.4 percent) compared to younger patients (23.1 percent), with greater absolute benefit (4.5 percent versus 3.3 percent, respectively) in the elderly, who have a higher risk of vascular events.4,26 This supports the ACC/AHA recommendations for the use of low-dose ASA for secondary prevention in elderly patients with ACS, chronic stable angina, and undergoing PCI.27-29 As in PLATO, lowdose versus high-dose ASA appears to be equally effective in the elderly.3,24 Despite the evidence for ASA as secondary prevention in this population, the support for primary prevention remains inconclusive. The magnitude of risk versus benefit remains unknown and researchers emphasize the need for specific trials in the elderly. The various age-related changes in pharmacokinetic and dynamic parameters as well as physiology increase their risk for bleeding and other complications. Current recommendations suggest a risk stratification approach for the use of ASA for primary prevention in the elderly population.26 The recent CHEST guidelines suggest daily low-dose ASA (75 to 100 mg) over no
34
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence
July 2012
ASA therapy for those 50 years of age or older as primary prevention. Per this recommendation, ASA slightly reduces total mortality if taken over 10 years, regardless of the cardiovascular risk profile. The reduction in MI for those at moderate to high risk of CVD events is closely balanced with the increase in major bleeds.21
issues related to therapy, we can effectively impact disease management and patient outcomes. References 1
Bayer Corporation. Aspirin [prescribing information]. Morristown (NJ). Available from: http://www.fda.gov/ ohrms/dockets/ac/03/briefing/4012B1_03_Appd%201Professional%20Labeling.pdf
ASA Discontinuation It is estimated that approximately 50 percent of patients taking ASA for secondary prevention discontinue therapy, with multiple reviews linking this to adverse cardiovascular outcomes.30,31 A case-control study using a primary care database specifically evaluated the risk of MI and death after ASA discontinuation. Included were patients 50-84 years of age who had ever received ASA for secondary prevention; cases of MI or death were prospectively reviewed in those continuing ASA versus those who did not.31 After a mean follow-up of 3.2 years, 876 patients had a non-fatal MI and 346 died from CAD. The significant outcomes included increased incidence of the combined endpoint (non-fatal MI, death) and non-fatal MI alone. When analyzed for recent versus distant ASA discontinuation, those with a recent discontinuation were at greater risk for outcomes. The authors concluded that patients taking ASA for secondary prevention who abruptly discontinue the medication place themselves at a higher risk of MI compared to those continuing treatment.31
2
Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007;115(1)114-26. 3
Campbell CL, Smyth S, Montalescot G, Steinhubl SR. Aspirin dose for the prevention of cardiovascular disease: a systematic review. JAMA. 2007;297 (18):2018-246. 4
Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324(7329):7186. 5
Antithrombotic Trialists’ (ATT) Collaboration, Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009;373(9678):184960.
Conclusion
6
over-the-counter medications. Recent trials and reviews have further enhanced our knowledge and guided the continued effort to identify strategies for the appropriate use of ASA in various situations including the primary prevention of CVD. This information concludes that ASA may be appropriate for some patients, but in many situations its use is not recommended. More emphasis has been placed on assessing a patient’s overall cardiovascular risk before ASA is recommended, as those with a higher baseline risk appear to have a greater absolute benefit from therapy in some indications. By understanding
7
Diabetes [internet]. Washington, DC: World Health Pharmacists frequently encounter patients who are on Organization; 2011-. Available from: http:// ASA therapy and are in a unique role to influence pa- www.who.int/mediacentre/factsheets/fs312/en/ index.html tient care and decisions particularly in the area of Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27 (5):1047-53. 8
National Diabetes Fact Sheet. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/ diabetes/pubs/pdf/ndfs_2007.pdf. 9
Diabetes Statistics [internet]. Alexandria, VA: American Diabetes Association; c1995-2011 Available from: http://www.diabetes.org/diabetes-basics/diabetesstatistics/ 35
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence
July 2012
10
Haffner SM. Coronary heart disease in patients with prevention of Vascular Events (ACTIVE W):a randomdiabetes. N Engl J Med. 2000 Apr 6;342(14):1040ised controlled trial. Lancet. 2006;367:1903-12. 11
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators, Ogawa H, Nakayama M, Morimoto T, et al. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008;300(18):2134-41.
19
12
20
Number (in millions) of persons with diabetes aged 35 years and older with self-reported cardiovascular disease conditions, United States, 1997– 2007.Centers for Disease Control and Prevention Web site. http://www.cdc.gov/diabetes/statistics/cvd/ fig1.htm. May 12, 2009.
Wann SL, Curtis AB, January CT, et al. 2011 ACCF/ AHA/HRS Focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): A report of American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123:104-23. The ACTIVE Investigators. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009;360:2066-78. 21
Guyatt GH, Crowther M, Gutterman DD, Shuunemann HJ. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American Col13 Diabetes Data and Trends. Centers for Disease lege of Chest Physicians evidence-based clinical Control and Prevention Web site. http://www.cdc.gov/ practice guidelines. Chest. 2012;141;7S-47S. diabetes/index.htm. 22 Nawarskas JJ, Clark SM. Ticagrelor: a novel re14 Grundy SM, Benjamin IJ, Burke GL, et al. Diabetes versible oral antiplatelet agent. Cardiology in Review. and cardiovascular disease: a statement for 2011;19(2):95-100. healthcare professionals from the American Heart 23 Wallentin L, Becker RC, Budaj A, el al for the PLAAssociation. Circulation. 1999;100:1134-46. TO Investigators. Ticagrelor versus clopidogrel in pa15 Prevention of Progression of Arterial Disease and tients with acute coronary syndromes. N Engl J Med. Diabetes Study Group, Belch J, MacCuish A, Camp- 2009;361(11):1045-57. bell I, et al. The prevention of progression of arterial 24 Mahaffey KM, Wojdyla DM, Carroll K, et al on behalf disease and diabetes (POPADAD) trial: factorial ranof the PLATO Investigators. Ticagrelor compared with domised placebo controlled trial of aspirin and antioxiclopidogrel by geographic region in the Platelet Inhibidants in patients with diabetes and asymptomatic petion and Patient Outcomes (PLATO) Trial. Circulation. ripheral arterial disease. BMJ. 2008;337:a1840. 2011;124:544-54. 16
Pignone M, Alberts MJ, Colwell JA, et al. Aspirin for 25AstraZeneca. Brilinta (ticagrelor) tablets [prescribing primary prevention of cardiovascular events in people information]. Wilmington (DE): 2011 Jul. with diabetes: a position statement of the American 26 Capodanno D, Angiolillo DJ. Antithrombotic therapy Diabetes Association, a scientific statement of the in the elderly. J Am Coll Cardiol. 2010;56(21):1683American Heart Association, and an expert consen92. sus document of the American College of Cardiology 27 Anderson JL, Adams CD, Antman EM, Bridges, et Foundation. Circulation. 2010;121(24):2694-701. al. ACC/AHA 2007 guidelines for the management of 17 Olesen JB, Lip GY, Linhardsen J, et al. Risks of patients with unstable angina/non–ST-elevation myothromboembolism with thromboprophylaxis in patients cardial infarction: a report of the American College of with atrial fibrillation: A net clinical benefit analysis Cardiology/American Heart Association Task Force using a ‘real world’ nationwide cohort study. Thromb on practice guidelines (writing committee to revise the Haemost. 2011;106(4):739-49. 2002 guidelines for the management of patients with unstable angina/Non–ST-elevation myocardial infarc18 The ACTIVE Investigators. Clopidogrel plus aspirin tion). J Am Coll Cardiol. 2007;20(7):e1-57. versus oral anticoagulation for atrial fibrillation in the 28 Atrial fibrillation Clopidogrel Trial with Irbesartan for Fraker TD Jr., Fihn SD, Gibbons RJ, et al. 2007 36
THE KENTUCKY PHARMACIST
July 2012
Aug. 2012 CE-Aspirin: Evolving Evidence Chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to develop the focused update of the 2002 guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol. 2007;50:2264 –74. 29
Kushner FG, Hand M, Smith SC, et al. 2009 Focused updates: ACC/AHA guidelines for the management of patients with ST elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI
guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;54 (23):2205– 41. 30
Sud A, Kline-Rogers EM, Eagle KA, et al. Adherence to medications by patients after acute coronary syndromes. Ann Pharmacother. 2005;39:1792-7. 31
Rodriguez LA, Cea-Soriano L, Martin-Merino E, Johansson S. Discontinuation of low-dose aspirin and risk of myocardial infarction: case-control study in UK primary care. BMJ. 2011;343:d4094.
August 2012 — Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease
1. As primary prevention, ASA appears to decrease CVD risk in diabetes by approximately: A. 50 percent. B. 10 percent. C. 25 percent. D. 75 percent.
6. According to the recent CHEST guideline recommendations, patients with atrial fibrillation and at low risk of stroke should receive: A. ASA. B. clopidogrel. C. no therapy. D. warfarin.
2. Based upon recent recommendations, all patients with Type 2 diabetes should receive ASA as primary CVD prevention. A. TRUE B. FALSE
7. To reduce the rate of thrombotic cardiovascular events in patients with ACS, ticagrelor should be taken with: A. clopidogrel. B. warfarin. 3. In general, for preventing stroke in atrial fibrillation, C. aspirin. ASA is: D. prasugrel. A. an alternative to warfarin. B. useful in combination with warfarin. 8. Based upon PLATO results and prescribing inforC. is neither safe nor effective. mation, the recommended daily maintenance dose of ASA to be taken with ticagrelor is: 4. For decreasing vascular events in atrial fibrillation, A. 75-100 mg. the ACTIVE-W trial showed that: B. 325 mg. A. warfarin is equal to ASA plus clopidogrel. C. 650 mg. B. ASA plus clopidogrel is superior to warfarin. C. warfarin is superior to ASA plus clopidogrel. 9. Higher doses of ASA are needed in the elderly for both primary and secondary CVD prevention. 5. The ACCF/AHA/HRS recommendations concern- A. True ing therapy for primary prevention of major vascular B. False events in patients with atrial fibrillation suggest that clopidogrel plus ASA might be an option when warfa- 10. Discontinuing treatment with ASA for secondary rin is unsuitable. CVD prevention is associated with: A. True A. a higher risk of MI or death. B. False B. no change in the risk for MI or death. C. a lower risk of MI or death.
37
THE KENTUCKY PHARMACIST
Aug. 2012 CE-Aspirin: Evolving Evidence
July 2012
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601. Expiration Date: July 20, 2015 Successful Completion: Score of 80% will result in 1.0 contact hours or 0.10 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. August 2012 — Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease TECHNICIANS ANSWER SHEET. Universal Activity # 0143-9999-12-008-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B
3. A B C 4. A B C
5. A B 6. A B C D
7. A B C D 8. A B C
9. A B 10.A B C
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD) August 2012 — Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease Universal Activity # 0143-9999-12-008-H01-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B
3. A B C 4. A B C
5. A B 6. A B C D
7. A B C D 8. A B C
9. A B 10.A B C
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD)
The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
38
THE KENTUCKY PHARMACIST
Pharmacists Mutual
July 2012
39
THE KENTUCKY PHARMACIST
Pharmacy Law Brief
July 2012
Pharmacy Law Brief: Current Status of Conscience Clause Legislation Author: Peter P. Cohron, B.S.Pharm., J.D., Practicing pharmacist and attorney, Henderson, KY. Question: Several years ago we heard a great deal about pharmacists around the country refusing to dispense medications in certain categories. That seems to have quieted down some. What is the current state of the law on this, both around the country and in Kentucky? Can you comment on this from both the perspectives of the employer and the employee pharmacist? Response: First of all, a conscience clause, or “refusal clause,” is a statute or regulation that allows pharmacists to refuse to perform certain services, usually dealing with abortion or clinically assisted suicide, about which the pharmacist has a strong religious or moral issue. These laws permit the pharmacist to refuse patients certain medications or treatments while protecting the pharmacist from any liability arising from such refusals. Conscience clauses arose initially out of the US Supreme Court’s ruling in Roe v. Wade in 1973 where females were given the right to choose to do as they desired with their bodies. Government could not interfere with a patient’s personal, private choice. Four states – not Kentucky – have enacted conscience clause legislation specific to pharmacists, while four more have “broad spectrum” clauses for health care providers in general. Almost as many states, led by former Illinois Governor Blagojevich’s emergency order, have gone the opposite direction and mandated that pharmacists must honor all legitimate prescriptions presented to them.
Submit Questions: jfink@uky.edu tutional line of thought, and such an argument does not seem to exist, state boards of pharmacy are currently shying away from addressing the issue. Why spend time and effort on an issue that seems certain to lose in the first round of any court action brought by a patient?
Kentucky at this time does not have a conscience clause in place for pharmacists. Relying on case history to attempt to see how a pharmacy case here might be decided, one must look at analogous professions. Attorneys may refuse certain clients where their strong moral opposition to the client’s case might be detrimental to the client’s best interests. Physicians may refuse to perform certain procedures requiring a level of skill that might be unattainable when the doctor has a strong objection to the procedure. Unfortunately, this has not been extended to pharmacists in any jurisdiction, to my knowledge. The act of properly preparing a prescription is not so demanding Where has this issue gone? While conscience clause of professional skills, courts have decided, to extend advocates still work for their goal of relieving pharmathese examples to our profession. cists from having to accept objectionable prescriptions, the issue has certainly seemed to go dormant. Other guidance is notably lacking. The APhA and the The overwhelming reason for this is that every case AMA have both issued guidelines or passed resoluto date regarding this issue has been decided in court tions on the matter. In both cases, the results are in favor of the patient, with the courts’ continuing reli- vague and not very helpful; while sympathy is extendance on Roe and the ruling that the choice of therapy ed to an objecting pharmacist, the patient and her belongs to the patient, not the pharmacist. Choice of needs, both sets of guidelines emphasize, must be therapy refers back to – and is a part of – the court’s met. At least one commentator says that pharmacy ruling, the right of privacy and freedom of expression. schools should weed out those with objections prior to Without a substantial argument to negate this Consti- admission to a pharmacy program! 40
THE KENTUCKY PHARMACIST
Pharmacy Law Brief
July 2012
Employers have been generous in the past by asking their pharmacists to make their objections known and taking steps to put in place a policy to help a patient when an objecting pharmacist is on duty. The pharmacist could ask the patient to return when another, non-objecting pharmacist was on duty or even refer the patient to another pharmacy where that objectionable prescription would be honored. The employers’ attitudes toward objecting pharmacists seemed to be one of empathy but also patient-oriented. There is some concern that in light of the end of the pharmacist shortage that employers may take a more strict approach. This could include preferably hiring pharmacists who convey no moral or religious issues to their potential employers and even terminating pharmacists who exhibit these issues in practice. Additionally, some worry that honoring all legitimate prescriptions may become a prerequisite for hiring.
choices. Our profession needs to be prepared for both a demanding public and an unsympathetic employer. Along with this, pharmacists should be reminded that taking a stand might be very expensive, as malpractice insurance generally does not cover conscience issues. Taking a moral stand may be harder than ever in the evolving world of pharmacy.
Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in Employee pharmacists certainly face some hard accordance with the full information.
Do you have a story to tell? Coming in future editions of The Kentucky Pharmacist : My Story: A Profile of a KPhA Member The Kentucky Pharmacists Association is looking for members with a story to tell. Have a patient success story to share? Find a new way to provide a service to the community? What makes you stand out in a crowd? Why did you become a pharmacist? Email Scott Sisco at ssisco@kphanet.org with a brief description of your story.
The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration. Friend of the Museum $100 Proctor Society $250 Damien Society $500 Galen Society $1,000 Name_________________________________ Specify gift amount________________________ Address ______________________________ City____________________Zip______________ Phone H_______________W____________ Email___________________________________ Employer name_____________________________________________for possible matching gift Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually. Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com 41
THE KENTUCKY PHARMACIST
KPhA Board Welcomes New Members
July 2012
Welcome to the new members Vice Speaker of House of Delgates — Cassandra Beyerle is a 2010 graduate from the University of Kentucky College of Pharmacy. In 2011, she completed a PY1 community pharmacy residency with Sullivan University and Medica Pharmacy and Wellness Center. She is currently employed by Sullivan University College of Pharmacy as an Assistant Professor in the Clinical and Administrative Science Department, with a clinical site at Family Health Center Portland. Her ambulatory care clinic services the patients of Family Health Center through diabetes and anticoagulation management. Cassy is an active member of JCAP and the KPhA New Practitioner Committee. Director — Matt Carrico currently is a pharmacist/owner of Booneville Discount Drug in Booneville, Ky. Matt graduated in 2010 from the University of Charleston in West Virginia and previously worked for Walgreens as a pharmacist in Louisville and as a corporate intern in Chicago. In his time with Booneville Discount Drug, Matt helped setup a MTM program, an immunization clinic, a 340B program and a scholarship for graduating seniors of
Owsley County High School. He is excited to be a part of KPhA and looks forward to playing a role in the advancement of our profession. Sullivan University College of Pharmacy Student Representative — Lance Murphy is the Student Representative to the KPhA Board of Directors from Sullivan University College of Pharmacy. He is a P-2 student representing SUCOP as its APhA-ASP President. He was a three-time letter winner, playing football, and received his Bachelors of Science in Biology from Morehead State University in 2011. Director — Robert Oakley is a 1977 graduate of the University of Kentucky College of Pharmacy. He also earned an M.S. degree from the University of Florida in 1982 and completed a two-year ASHP Residency at Shands Teaching Hospital. He is a Fellow of KSHP and ASHP and a past president of KSHP, JCAP and served as a board member for both organizations. Oakley won the JCAP Pharmacist of the Year Award (2006) and was co-winner of the KPhA Professional Promotion Award (2001). He has been director of pharmacy at Baptist Hospital East in Louisville since 1988.
KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the distribution list. 42
THE KENTUCKY PHARMACIST
July 2012
KPhA Board Welcomes New Members
of the KPhA Board of Directors Past President — Donnie Riley graduated from the University of Kentucky College of Pharmacy in 1979. He is President of Riley White, Inc. and Riley White Drugs- Russellville & Clinic Pharmacy- Bowling Green. He has served on the KPhA Professional Affairs Committee for numerous years, and served on the KPhA Board of Directors 1997 to 2000. He also served as President-Elect/President/ Chairman of the Board 2000 to 2003. He currently serves on the APSC Board of Directors and is the APSC Secretary/Treasurer. Riley was the recipient of the KPhA Distinguished Service Award in 2005 and the University of Kentucky College of Pharmacy Preceptor of the Year in 2008. He has been married to Lillian B. Riley for 33 years and they have two children, Lindsey Riley and Lauren Riley Stafford, PharmD.
University of Kentucky College of Pharmacy Student Representative — Molly Trent was born and raised in the Lexington area and currently lives in Georgetown. She completed her undergraduate studies at the University of Kentucky and is now a third-year student pharmacist at the UK College of Pharmacy. She serves as the APhA-ASP Chapter President and is an active member of Rho Chi and Phi Lambda Sigma. When she’s not studying or participating in extracurricular activities through school, she enjoys cheering on the CATS and horseback riding.
Thank you to our outgoing KPhA Board Members From left: 2011-12 Chairman Clay Rhodes, UK Rep. Kelley Ratermann, Sam Willett, SUCOP Rep. Amanda Jett, Amanda Burton, Glenn Stark, President Lewis Wilkerson. Willett was reelected for another term and Stark was appointed Treasurer by the board.
43
THE KENTUCKY PHARMACIST
July 2012
Academy of Consultant Pharmacists
Senior Care Corner from the KPhA Academy of Consultant Pharmacists Submitted by Leah Tolliver PharmD, KPhA Board of Directors and Academy member At the 134th KPhA Annual Meeting, June 13-16, 2012, the consultant pharmacist members met to discuss new officers for the Academy of Consultant Pharmacists. Elisha Bischoff is the Chair, the vicechair position remains open and the three new directors are Peggy Canler, Terry Seiter and Gary Rice. Letâ&#x20AC;&#x2122;s welcome them as new officers for the long-term care Academy!
were 25 attendees, some of which joined as a new Academy member! The CE programs included an update in federal regulations that impact long-term care pharmacy and Beers Criteria for Potentially Inappropriate Medication Use in Older Adults-2012 Update. During the KPhA conference, a business meeting was held for consultant pharmacists. We look forward to adding new members and providing relevant information that impacts long-term care pharmacy throughout the year.
As a member of the KPhA Academy, an annual continuing education program is provided for all members of KPhA. CE is free for Academy members. A contin- Please contact President Elisha Bischoff, uing education program was held April 29, 2012 at Elisha.bischoff@pcapharmacy.com, for information the Kentucky Pharmacy Renaissance Museum. There about joining the Academy.
KPhA Government Affairs Contribution Name: ______________________________________________________________
Pharmacy: ___________________________________________________________ Email: ______________________________________________________________ Address: _____________________________________________________________ City: _______________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs) Credit Card (AMEX; Discover; MasterCard; VISA) Account #: ____________________________________________________ Expiration date: _______ Address to which credit card statement is mailed (if different from above) ___________________________________________________________________________________
Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601
44
THE KENTUCKY PHARMACIST
Sullivan University College of Pharmacy Class of 2012
July 2012
Congratulations SUCOP Class of 2012 The Sullivan University College of Pharmacy celebrated the graduation of its second class on June 7, 2012 at the Block Auditorium at Southeast Christian Church in Louisville, Ky. The 88 graduates of the Class of 2012 were offered congratulations by Chancellor A. R. Sullivan and President Glenn Sullivan, and heard a commencement address delivered by Mr. Michael Burleson, Executive Director of the Kentucky Board of Pharmacy and President of the National Association of Boards of Pharmacy. The ceremony culminated with the recitation of the Oath of a Pharmacist delivered by Dr. Hieu T. Tran, VicePresident of the College of Health Sciences and Founding Dean and Professor of the College of Pharmacy.
45
THE KENTUCKY PHARMACIST
Pharmacy Policy Issues
July 2012
PHARMACY POLICY ISSUES: The Overwhelming Cost of Medication Misadventures Author: Tyler Stewart is a fourth-year pharmacy student at the University of Kentucky College of Pharmacy. A native of Goshen, Ky., Tyler earned a B.S. in chemistry from Georgetown College prior to enrolling in pharmacy school. Issue: Further action on the part of the medical community needs to be taken in regards to minimizing medication misadventures and, in turn, reducing the costs they have on society. Discussion: Medication misadventures, including duplicate therapy, insufficient therapy, improper dispensing and avoidable adverse drug events, cost patients, insurance companies and providers both financially and in terms of health outcomes. The current state of health care in this country, and more relevant to this discussion, the current state of our medication use system, has created a landscape in which preventable medication related adverse events and inappropriate drug therapies abound. Efforts have been made in the past to combat and minimize preventable medication errors or misadventures, but it is evident that more attention needs to be brought and efforts need to be made in order to preserve positive health and financial outcomes for our patients.
Over the past couple of decades and into today, more and more individuals are being put on medications for chronic disease Have an Idea?: states. With the number of prescriptions being disThis column is designed to pensed having inaddress timely and practical creased by 39 perissues of interest to cent from 1999 to pharmacists, pharmacy 2009, coupled with interns and pharmacy only a nine percent technicians with the goal increase in population over that same being to encourage thought, period of time, reflection and exchange there is an inamong practitioners. creased risk of In regard to pharmacy practice and our role in comSuggestions regarding topics medication misadbating this issue, little regulatory action has been takfor consideration are ventures now more en in recent years. The most recent and outstanding than ever. We also welcome. Please send them regulatory action that was implemented was the Omare continually seeto jfink@uky.edu. nibus Budget Reconciliation Act of 1990 (OBRA â&#x20AC;&#x2122;90). ing new drugs beIn requiring drug utilization reviews and the offer to ing brought to the counsel patients on prescriptions dispensed, OBRA market. All of this, combined with the increasing age â&#x20AC;&#x2122;90 placed pharmacists at the forefront of medical proof our population, has created a state of health care fessionals who can review and intervene upon mediwhere patients are at risk for medication misadvencation misadventures. But, even with these regulatures. tions and the expanded power and responsibility pharmacists gained from them, a significant amount There has been a recent push toward expanding ancillary services in pharmacies including vaccination of misadventures still occur everyday. services and medication therapy management. These In 1995, nearly 17 million hospital visits in this country services are designed to reduce the risk of disease were due to a drug related illness which in turn equatand/or thoroughly monitor drug therapies, thereby oped to $76.6 billion in health care costs. That same timizing medication use and reducing the risk of mediyear, it was also estimated that for every dollar spent cation misadventures. These added services will no on pharmaceuticals, another dollar was spent on doubt help improve health outcomes in patients as treating problems that stemmed from sub-optimal well as reduce the risk of medication misadventures. medication use. The money spent on remedying preBut, with the ever-increasing amount of prescriptions ventable medication misadventures is outstanding dispensed, the increasing discovery of new and innoand an absolute waste of health care resources that vative medications available to treat myriad disorcould be better spent in various other areas of patient ders, and the relatively new implementation and evocare. 46
THE KENTUCKY PHARMACIST
July 2012
Pharmacy Policy Issues lution of healthcare laws and services aimed at minimizing medication misadventures, awareness of this issue must be brought to light and policies regarding this issue must continue to be developed and promulgated. References: Johnson JA, Bootman JL. Drug-related morbidity and mortality: A cost-of illness model. Ann. Internal Med. 1995; 155:1949-56 Kaiser Family Foundation. “Prescription Drug
Trends”. 2010. www.kff.org Nau DP, Kirking DM. Why is medication use less than appropriate? in Fulda TR, Wertheimer Al (eds.) Pharmaceutical Public Policy, New York: Haworth Press (2007), pp. 477-98 Schatz R, Belloto RJ, White DB, Bachmann K. 2003. “Provision of Drug Information to Patients by Pharmacists: The Impact of the Omnibus Budget Reconciliation Act of 1990 a Decade Later”. Am. J. of Therapeutics 10 (2): 92-103.
Support the Candidates who Support YOU!
KPPAC Contribution
Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)
CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election. Contributions from a PAC to a school board candidate are limited to $200 per election. Individuals may contribute no more than $1,500 per year to all PACs in the aggregate. In-kind contributions are subject to the same limits as monetary contributions. Cash Contributions: $50 per contributor, per election. Contributions by cashier’s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election. (This information is in accordance with KRS 121. 150)
Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601
47
THE KENTUCKY PHARMACIST
Dr. Fink named KPhA Endowed Professor in Leadership
July 2012
Fink named first KPhA Endowed Professor Joseph L. Fink III, Professor of Pharmacy Law and Policy in the UK College of Pharmacy, has been named the Kentucky Pharmacists Association (KPhA) Endowed Professor in Leadership. He was formally recognized at KPhA’s Annual Meeting on June 14, 2012. “Dr. Fink embodies the mission of KPhA,” said KPhA President Lewis Wilkerson. “Over his distinguished career, he has continued to promote the profession of pharmacy, enhance the practice standards, and demonstrate the value of pharmacy to countless people across Kentucky, the nation and the world.” Dr. Joseph L. Fink, III with UKCOP Dean Timothy Tracy
Fink, highly respected as a pharmacist, lawyer and and KPhA President Lewis Wilkerson. educator within Kentucky and across the nation, is the APhA Academy of first UK College of Pharmacy faculty member to be Student Pharmacists named the KPhA Professor in Leadership. (APhA-ASP) organi“Having been a member of the Kentucky Pharmacists zation and the KenAssociation for many years, it is, indeed, an honor tucky Alliance of and privilege to be named to this professorship,” said Pharmacy Students. Fink, who received his professional education in pharThe Kentucky Pharmacy at the Philadelphia College of Pharmacy and macists Association recognized him as "Pharmacist of Science, and holds the degree Doctor of Law from the Year" in 1988 and in 2002 conferred on him the Georgetown University Law Center. Distinguished Service Award for significant contribuFink's participation and leadership within professional tions to the profession over an extended period of associations is extensive. He holds membership in a time. number of professional organizations in both pharmacy and law, including KPhA, the American Pharmacists Association (APhA) and the American Bar Association. He is a Fellow of APhA and a former Vice Speaker of the House of Delegates of the Association. He chaired the committee for the latest revision of the APhA Code of Ethics for Pharmacists and currently serves the Association as its Parliamentarian for the House of Delegates, where he mentors others interested in the delegate process. He was founder and first president of the American Society for Pharmacy Law and, while a pharmacy student, was National President of the Student American Pharmaceutical Association. He has encouraged, advised and mentored countless student leaders over the years while serving as faculty advisor for the
In March 2012, he was recognized with the Linwood F. Tice Award by the APhA-ASP for his personal commitment to, and passionate support of, student pharmacists throughout his career. “When you think of pharmacy leadership, you think of Joe Fink,” said Tim Tracy, Dean of the UK College of Pharmacy. “Joe has quite literally trained and mentored a generation of pharmacy leaders and continues to impact the next generation of leaders every day here at the UK College of Pharmacy. He is most deserving of this professorship.” “I also applaud the Kentucky Pharmacists Association for their support for the UK College of Pharmacy. The KPhA Professor of Leadership is another example of how they continue to be a great partner for our College.”
48
THE KENTUCKY PHARMACIST
University of Kentucky College of Pharmacy Class of 2012
July 2012
Congratulations UKCOP Class of 2012
The University of Kentucky College of Pharmacy honored 148 students at the 2012 Graduation Recognition Ceremony May 4 at the UK Singletary Center for the Arts.
the Doctor of Pharmacy (PharmD) degree.
Of those completing requirements for degrees, 14 students earned a PhD in pharmaceutical sciences, seven students received a Master's degree in pharmaceutical sciences and 127 students were awarded
Following the presentation of diplomas, PharmD graduates recited the Pharmacist's Oath led by Lewis Wilkerson, president of the Kentucky Pharmacists Association.
Associate Dean Kelly M. Smith welcomed graduates and their families and greetings from the College were provided by Dean Timothy S. Tracy.
49
THE KENTUCKY PHARMACIST
KPhA Board of Directors
July 2012
KPhA BOARD OF DIRECTORS
HOUSE OF DELEGATES
Lewis Wilkerson, Frankfort rphs2@aol.com
Chairman 502.695.6920
Matt Martin, Louisville matt67martin@gmail.com
Kimberly Croley, Corbin kscroley@yahoo.com
President 606.304.1029
Cassandra Beyerle, Louisville Vice Speaker of the House cbeyerle01@gmail.com
Duane Parsons, Richmond dandlparsons@roadrunner.com
President-Elect 502.553.0312
KPERF ADVISORY COUNCIL
Frankie Hammons Abner, Barbourville frankiehammons@gmail.com
Secretary 606.627.7575
Glenn Stark, Frankfort glennwstark@aol.com
Treasurer
Donnie Riley, Russelville Past President donnierileyatclinicpharmacy@msn.com Directors Molly Trent, Georgetown mjtren2@uky.edu
Student Representative
Lance Murphy, Louisville lmurph8942@my.sullivan.edu
Student Representative
Matt Carrico, Louisville rxcarricojr@gmail.com Chris Clifton, Erlanger chrisclifton@hotmail.com Trish Freeman, Lexington* trish.freeman@uky.edu Joey Mattingly, Prospect joeymattingly@gmail.com Matt Martin, Louisville matt67martin@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Bob Oakley, Louisville roborx13@aol.com Richard Slone, Hindman richardkslone@msn.com Leah Tolliver, Lexington leahtolliver@tollivergroup.net
Speaker of the House
Kim Croley, Corbin kscroley@yahoo.com Ann Amerson, Lexington amerson@insightbb.com
KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Matt Worthy, PharmD Director of Professional & Clinical Services mworthy@kphanet.org Scott Sisco, MA Director of Communications and Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Christine Richardson, PharmD Clinical Pharmacist crichardson@kphanet.org Darcie Nixon Administrative Coordinator & Billing Specialist dnixon@kphanet.org Nancy Baldwin Receptionist/Office Assistant nbaldwin@kphanet.org
Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee
50
THE KENTUCKY PHARMACIST
Frequently Called and Contacted
July 2012
Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org Kentucky Society of Health Systems Pharmacists 1501 Twilight Trail Frankfort, KY 40601 (502) 223-5322 www.kshp.org
Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu
KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to ksheets@kphanet.org. Deceased members for each year will be honored permanently at the KPhA office with a White Coat. 51
THE KENTUCKY PHARMACIST
July 2012
THE
Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601
52
THE KENTUCKY PHARMACIST