the kentucky pharmacist, vol. 7, #4

News & Information for Members

of the Kentucky Pharmacists Association

Vol. 7, No. 4

July 2012

TTHEHE KKENTUCKYENTUCKY

PPHARMACISTHARMACIST

RELEVANCE AND

RELATIONSHIPS

2012-13 KPhA President

Kimberly Sasser Croley

2012-13 KPhA President Kimberly S. Croley with her family, Bob, Robbie and Rachel.

July 2012

THE KENTUCKY PHARMACIST 2

Table of Contents

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3, 6-7 KPhA Professional Awards 4-5 KPERF Golf Scramble 8 2012 KPhA House of Delegates Report 9-10 134th KPhA Annual Meeting 11-15 July CE—GLP-1 Agonists Therapy 16-25 July Pharmacist/Pharmacy Tech Quiz 26 Pharmacy Time Capsules 27 From Your Executive Director 28 Bowl of Hygeia 29

Pharmacy Technician Certification Board 30 August CE— Asprin: Evolving Evidence 31-37 August Pharmacist/Pharmacy Tech Quiz 38 Pharmacists Mutual Companies 39 Pharmacy Law Brief 40-41 New Members of KPhA Board of Directors 42-43 Academy of Consultant Pharmacists Update 44 Sullivan University College of Pharmacy Graduates 45 Pharmacy Policy Issues 46-47 Fink named KPhA Professor in Leadership at UK 48 UK College of Pharmacy Graduates 49 KPhA Board of Directors 50 Frequently Called and Contacted 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.

Kentucky Pharmacists Association

The mission of the Kentucky Pharmacists Associa-

tion is to promote the profession of pharmacy, en-

hance the practice standards of the profession, and

demonstrate the value of pharmacist services within the

health care system.

Editorial Office:

© Copyright 2012 to the Kentucky Pharmacists Asso-ciation. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of member-ship 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 [email protected]. Website http://www.kphanet.org.

The Kentucky Pharmacy Education and Research Foun-

dation (KPERF), established in 1980 as a non-profit sub-

sidiary corporation of the Kentucky Pharmacists Associa-

tion (KPhA), fosters educational activities and research

projects in the field of pharmacy including career coun-

seling, student assistance, post-graduate education, con-

tinuing and professional development and public health

education and assistance.

It is the goal of KPERF to ensure that pharmacy in Ken-

tucky and throughout the nation may sustain the continu-

ing need for sufficient and adequately trained pharma-

cists. KPERF will provide a minimum of 15 continuing

pharmacy education hours. In addition, KPERF will pro-

vide at least three educational interventions through oth-

er mediums — such as webinars — to continuously im-

prove 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 im-

prove the overall programming designed by KPERF.

July 2012


President’s Perspective

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 member-

ship. They also provide the key to our movement to-

ward advancing the practice in new and innovative

ways.

Our Executive Director, Bob McFalls, and I recently

attended a leadership weekend co-sponsored by

Pharmacists’ Mutual Insurance and NASPA. It was

mediated by a lovely woman who really made us

delve deeply into what our perceptions of how we

could meet our membership’s needs versus what cur-

rent literature tells us that our membership states they

need. On some accounts, we were close to correct.

On others we were not in the ballpark. Toward the

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 remind-

ed 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 be-

tween 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”) work-

ing 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 stu-

dents going to pharmacy school interviews, don’t say

“I want to be a pharmacist because I want to help

people.” I cannot fathom why they say that because

in my mind (and my heart) that is exactly what we do.

By embracing our differences, we older practitioners

can stay RELEVANT by learning new skills from the

new practitioners (especially technological skills) and

in turn we can help them learn how to build RELA-

TIONSHIPS.

Continued on Page 6

Kimberly Sasser

Croley

KPhA President

2012-2013


July 2012


134th KPhA Annual Meeting

KPhA Professional Awards 2012

George F. Hammons, Barbourville, Ky., Bowl of Hygeia Award sponsored by the American Phar-

macists Association Foundation and the National Alliance of State Pharmacy Associations with sup-

port 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

July 2012



Patricia Robinson, Whitesburg, Ky., Technician of

the Year

Stacy Rowe, Louisville, Ky., Distinguished Young

Pharmacist of the Year, sponsored by Pharmacists

Mutual Insurance

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

July 2012



Continued from page 3

The digital age and smart phones have turned many

of us into isolationists without us realizing that is what

is happening. I see young people sitting around a ta-

ble together but not talking to one another because

they are busy texting someone else or surfing on the

Internet. By not having practiced talking to other peo-

ple they are at a disadvantage to those of us who talk

all the time (like me). We can teach active listening

skills and imprinting skills to younger pharmacists

making them more effective healthcare providers.

Working together, generations hand in hand, we all

become better pharmacists and find new relationships

that help us all move forward.

RELEVANCE also relates back to our colleges of

pharmacy. The student pharmacists who come to my

practice site are extremely well educated. Most an-

nounce to me on their first day that they plan to be a

clinical pharmacist not a

retail pharmacist. I am

afraid that I often shatter

their hopes on that first day

because I tell them that

every pharmacist is a clini-

cal pharmacist if they want

to be and that there are

many wonderful community

pharmacies but I do not

use the word retail unless I

am describing a clothing

store. In the recent report

to the Surgeon General on

the value of the pharmacist,

it was noted that 270+ mil-

lion people visit a community pharmacy each week.

There is absolutely no other profession that has that

kind of “Face Time” and they don’t have to own an

iPhone. We must parlay our accessibility as a strong-

hold for health and wellness. We must work with phy-

sicians to show them how we complement what they

do, not compete. KPhA’s honorees for Pharmacist of

the Year and Bowl of Hygeia have done just that. The

FDA is again discussing a “Pharmacist only” Class of

Drugs. But to prove our ability to manage disease,

monitor medication therapy, manage medication ther-

apy and take responsibility for dispensing our own

class of drugs, we are going to have to unchain the

computer stations and TALK TO PEOPLE. I realize

that the spot in front of the terminal is warm and

friendly but we are not computer programmers, we

are pharmacists and we don’t write in COBOL any-

more. We talk to patients and provide healthcare. Our

relationships with our patients make a difference to

their healthcare; take time to introduce yourself to new

patients. “Hello, my name is Kim Croley, and I am

your pharmacist.” Actively engage every patient on

refills; there is no better measure of adherence or abil-

ity to qualify appropriateness of therapy than by ask-

ing questions at the time of refills. In the hospital, take

the initiative to speak to patients on the nursing units.

Volunteer to work with the medication reconciliation

process at your hospital, I guarantee you will be able

to spot problems at the initial review.

At KPhA, we will be working alongside CAPP, our two

colleges of pharmacy at

UK and Sullivan, KSHP,

KY-ASCP Chapter and our

local affiliates to promote

our profession and its rele-

vance to the other profes-

sions within the healthcare

team, payers, legislators

and patients. Conversa-

tions will be held on your

behalf thru Rx Therapy

Management with other

entities to add new con-

tracts and clients for Medi-

cation Therapy Manage-

ment services. We will continue to add relevance to

our current contract with the Kentucky Retirement

System by helping their beneficiaries improve their

health and wellness. We will continue our conversa-

tions with the Medicaid managed care entities to show

the value added by the pharmacists and pharmacies

within their network and that by helping them “manage

care” thru appropriate medication use we have in es-

sence helped them “manage cost” which seems to be

a primary objective. Our Kentucky Pharmacy Educa-

tion and Research Foundation will be put to good use

KPhA President Kim Croley shares her vision with at-

tendees at the 2012 Ray Wirth Banquet.

July 2012



helping us provide and coordinate continuous profes-

sional 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 Or-

ganization (QIO) also known as Health Care Excel to

engage in research opportunities that promote phar-

macists’ 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 net-

work promoting grass-

roots involvement and

the Government Af-

fairs contributions will

enhance our lobby-

ists’ efforts in show-

ing the relevance that pharmacists bring to the table.

I am going to ask our KPhA Board this year to stand

with me on your behalf and tell the world who we are

and what we do. We are healthcare providers and

medication use experts. We provide clinical services

and healthcare information that positively impacts dai-

ly life. We deserve compensation for the added value

we bring to the healthcare team whether it is fee for

service or a portion of a bundled payment. We should

have the authority to manage drug therapy as it re-

lates to disease states and we should have ready ac-

cess to all clinical information we need to make deci-

sions on our patients’ behalf. We are relevant to Man-

aged Care because we reduce unnecessary medica-

tions 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 be-

cause 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 com-

munity pharmacies of all kinds because we build RE-

LATIONSHIPS with patients who

return to us time and again seeking

our knowledge, ex-

pertise, and care.

Every pharmacist in

every practice set-

ting is relevant and brings value to the healthcare

team. We must recognize that the small differences

between our practice choices simply add “different

flavorings” and don’t change the underlying greater

common human heart of us all. We must believe that

the trust forged in our relationships with patients is a

factor not often discussed but extremely relevant to

their health!

We must support each other in our pursuit of excel-

lence and relevance. “APRPh” is possible! We make

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

July 2012


134th KPhA Annual Meeting-KPERF Golf Scramble

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.

July 2012


134th KPhA Annual Meeting-House of Delegates

Tyler Whisman, PharmD – 2012 Speaker of the

House

Matt Martin, PharmD – 2012 Vice-Speaker and

Chair of the Reference Committee

Joey Mattingly, PharmD – 2012 Parliamentarian

As usual, the 2012 KPhA Annual Meeting was quite a

success. While the meeting provides excellent contin-

uing education, networking opportunities and an in-

formative exhibit hall, the importance of the House of

Delegates can’t be understated. According to the

KPhA Bylaws, the House of Delegates meets at the

Annual Meeting to address important issues facing

the profession and the Association. A geographically

and professionally diverse group of Delegates from

the Commonwealth gathered to debate and make rec-

ommendations that will help shape the profession of

pharmacy.

Opening Session

The Opening Session of the House was held on

Thursday afternoon. Delegates received Committee

reports from the Professional Affairs, Government Af-

fairs and Organizational Affairs standing committees,

New Practitioner and Policy Review Ad Hoc commit-

tees and from Executive Officers. As you will see be-

low, the Board of Directors and each of the Commit-

tees 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 Vice-

Speaker of the 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, Bar-

ry Eadens, Kim Croley, Matt Carrico, Jamie Moline,

Lance Murphy, Ron Poole and Joey Mattingly

(Parlimentarian).

Closing Session

The closing House session was held on Saturday

morning where, after discussion of the Reference

Committee recommendations, the following resolu-

tions were passed:

2012.01 – Dues Change

The Board of Directors recommended a dues in-

crease effective January 1, 2013 as follows:

Active Member $225 Joint Member $335 Retired Member $120 1st Year Tier $70 2nd Year Tier $140 Joint Retired $180 Associate Member $225 Technician Member $50

2012.02 – Bylaws Change: Article 5.21 – Election

and Installation of Officers and Directors

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 Organiza-

tional Affairs Committee.

Upon recommendation from the Reference Commit-

tee, the House charged the KPhA Board of Directors

to develop a policy establishing equitable representa-

tion on the Board. This policy shall be brought for-

ward for a vote at the 2013 KPhA House of Dele-

gates.

2012.03 – Bylaws Change: Article 1.14 – Techni-

cian Members

Any individual who is a Certified Registered Pharma-

cy Technician in good standing with the Pharmacy

Technician Certification Board Board of Pharmacy is

eligible for technician membership. Technician mem-

bers shall not be eligible to vote or hold office in the

Report of the 134th KPhA House of Delegates

July 2012


134th KPhA Annual Meeting-House of Delegates

Association except as may be

provided by Article 9.15.

2012.04 – Compensation Trans-

parency

KPhA supports the development

of a transparent national standard

database for the cost of multi-

source 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 nega-

tive impact on the citizens of the

Commonwealth.

KPhA supports legislative and law-enforcement ef-

forts 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 Ken-

tucky’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 appro-

priately sworn in as Vice-Speaker of the House of

Delegates. The House also approved the five candi-

dates to be submitted to the Governor for considera-

tion of appointment to the Board of Pharmacy. The

individuals are: Clinton Joseph Carr – Daviess Coun-

ty; 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, Ange-

la Onkst and Tera McIntosh).

Looking Toward the Future

As previously stated, the House of Delegates once

again proved to be a forum for passionate debate re-

garding 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 ad-

dresses 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!

2012 Speaker of the House Tyler Whisman presides over the 134th KPhA House

of Delegates Opening Session at the 134th KPhA Annual Meeting at the Griffin

Gate Marriott Resort in Lexington, Ky. Below: The Reference Committee meets.

July 2012



Thousands of

“Words” from

the 134th KPhA

Annual Meeting

All Photos

by Kelly Flora

Photography

except where

noted

Marriott Griffin Gate

Resort and Spa Lexington, KY

June 13-16, 2012

July 2012



KPhA Would Like to Thank Our 2012 Sponsors

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

J. Clay Rhodes Richard Slone, in memory of

Donald Lippert Glenn Stark Leah Tolliver

Tyler Whisman Lewis Wilkerson

Sam Willett

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.

July 2012



Abbott Diabetes Care

Aethon

Aligon Pharmaceuticals, Inc.

American Pharmacy Cooperative, Inc.

AmerisourceBergen

American Pharmacy Services Corp.

Cardinal Health

Dr. Comfort

Eli Lilly & Co.

EPIC Pharmacies

HD Smith

Humana

Kentucky Cabinet for Health &

Family Services

Kentucky Renaissance Pharmacy

Museum

KY Office of Health Information

Exchange

Kentucky Spirit Health Plan

Merck

National Government Services

Perform Rx

Pfizer

Pharmacists Mutual Companies

Pharmacy Plus

QS/1

Rite Aid

Rx Therapy Management

Samuels Products, Inc.

Smith Drug Company

SUCOP Student Organizations

UK COP Experiential Ed/ CAPP

UK Student Organizations

Vertex

Walgreens

… and our 2012 Exhibitors

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

July 2012



NASPA-NMA Student

Pharmacist Self-Care

Championship

The Judges: Dr. Joseph Fink, Dr. Mykel

Tydwell, Dr. Joey Mattingly

The Host:

KPhA 2011-12 President

Lewis Wilkerson

Teams of student pharmacists from Sullivan University Col-

lege 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 an-

swer the questions.

This program will be an

annual event at the

KPhA Annual Meeting.

Special thanks to Dr.

Holly Divine, Dr. Mela-

nie Mabins and Dr.

Misty Stutz for tailoring

this program for KPhA

and our students.

The Winners: Elizabeth Riner - UK, Lance Murphy - Sullivan,

Brooke Herndon - UK, Danielle Waymeyer - UK,

July 2012


July 2012 CE-GLP-1 Agonists Therapy

GLP-1 Agonists Therapy in Individuals with

Type 2 Diabetes Mellitus:

A Review of Safety and Tolerability By: Lalita Prasad, PharmD, MS, BCPS, Assistant Professor of Clinical and Admin-

istrative Sciences, Sullivan University College of Pharmacy

Kristal L. Williams, PharmD, CDE, Assistant Professor of Pharmacy Practice, Butler University Col-

lege of Pharmacy and Health Sciences

Acknowledgements: Tracy Costello, assistant professor of pharmacy practice, Butler University Col-

lege 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)

Objectives: At the conclusion of this lesson, the reader should be able to:

1. Explain the role of the incretin system in the development of diabetes and dis-

cuss the place in therapy for GLP-1 agonists.

2. Compare and contrast the adverse effects and safety profiles of the two FDA-

approved GLP-1 agonists, exenatide and liraglutide.

3. Discuss the appropriate use and recommendations of GLP-1 agonists in terms

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.

KPERF offers all

CE articles to

members online at

www.kphanet.org

“GLP-1 Agonists Therapy in

Individuals with Type 2 Diabe-

tes Mellitus: A Review of Safe-

ty and Tolerability” is one in a

series of continuing education

articles authored and gener-

ously contributed to the Ken-

tucky Pharmacists Association

by the Indiana Pharmacists

Alliance.

Recent medication advances in the treatment of type

2 diabetes mellitus (T2DM) have evolved around the

incretin system, specifically with a focus on the gluca-

gon-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 mecha-

nisms.1,2,3 GLP-1 hormones exert their effects by

binding to structurally distinct receptors which are lo-

cated 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, decreas-

ing hepatic gluconeogenesis, increasing insulin sensi-

tivity and glucose uptake, decreasing glucagon secre-

tion, increasing satiety and decreasing gastric empty-

ing, 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) en-

zyme.1,2,3 This cleavage of the biologically active

July 2012



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 en-

zyme, 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 in-

crease in insulin secretion after oral ingestion of glu-

cose 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 via-

ble treatment option.1,3,4

Clinical investigations found that intravenous admin-

istration of recombinant human GLP-1 resulted in in-

creased insulin secretion, decreased glucagon re-

lease, and subsequently lowered fasting and post-

prandial levels in individuals with T2DM. While these

GLP-1 Agonist Adult Dosing Dosing in Renal Impairment

Exenatide (Byetta®)5

Available in pre-measured pens of 5- and 10 mcg

5 mcg twice daily for 30 days then, if tolerated, titrate to 10 mcg twice daily thereafter.

Inject subcutaneously within 60 minutes before breakfast and dinner (separate doses by at least 6 hours).

Severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease: Avoid therapy

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 de-velopment 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

Inject subcutaneously daily regardless of timing of meals.

Note: 0.6 mg daily is ineffective for glycemic control

No renal adjustment needed. Exercise caution when initiating or increasing therapy.

Exenatide extended re-

lease (Bydureon®)7

Available as a carton of 4-single dose trays which include:

One vial containing 2 mg exenatide (as a white to off-white powder)

One prefilled syringe delivering 0.65 mL diluent

One vial connector

Two custom needles (23G, 5/16”) spe-cific to this deliv-ery system

2 mg once every 7 days.

Inject subcutaneously weekly regard-less of timing of meals.

If a dose is missed and the next regu-larly scheduled dose is due one or two days later, the patient should not ad-minister the missed dose and instead resume BYDUREON with the next regularly scheduled dose.

Severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease: Avoid therapy

Moderate renal impairment (creatinine clearance 30 to 50 ml/min): Apply caution when initiating or increasing therapy

Table 1: GLP-1 Prescribing Information

July 2012



findings did demonstrate the positive therapeutic out-

comes that are associated with restoring and enhanc-

ing 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 hor-

mones have a positive impact on B-cell proliferation

and reduces apoptosis.2,4 Additionally, although fur-

ther studies are needed, it appears that both ex-

enatide and liraglutide exhibit the ability to preserve

beta cell function and improve cardiac function, in-

cluding but not limited to improving blood pressure,

lipid concentrations, myocardial function and cardiac

output, specifically by reducing left ventricular end di-

astolic pressure, all of which are possible concomitant

medical conditions in patients with T2DM.2,4 Thus,

the development of chemically enhanced GLP-1 re-

ceptor (GLP-1R) agonists with superior pharmacoki-

netic profiles and resistance to DPP4 enzyme degra-

dation has become the pharmacological target for the

treatment of T2DM.2,4 To date, there are two chemi-

cally modified GLP-1R agonists available in the Unit-

ed States, exenatide and liraglutide.

Exenatide (Byetta®, Amylin Pharmaceuticals Inc, San

Diego, California, and Eli Lilly, Indianapolis, Indiana),

a synthetically modulated version of GLP-1 made

from the venom of the Gila-monster, was Federal

Drug Administration (FDA) approved in April 2005 for

monotherapy or combination therapy with metformin,

a thiazolidinedione (TZD) or a sulfonylurea to improve

glycemic control in patients with T2DM.5 In October

2011, exenatide received FDA approval for its’ use in

combination with glargine insulin.5 Exenatide shares

53 percent homology with native human GLP-1 hor-

mones.2,3,5 Liraglutide (Victoza®, Novo Nordisk Inc,

Princeton, New Jersey), on the other hand, is de-

signed by recombinant DNA technology, shares 97

percent homology to native human GLP-1 hormones,

and was FDA-approved in January 2010 as adjunct to

diet and exercise to improve glycemic control in pa-

tients with T2DM.2,3,6 It is important to mention that

unlike exenatide, the manufacturer does not recom-

mend liraglutide as first-line therapy for the treatment

of T2DM.5,6 Recently, in February 2012, another long-

acting formulation, exenatide-extended release

(Bydureon®) was FDA approved.7 Bydureon® is ad-

ministered as a 2mg injection once weekly7. In clinical

trials, when compared to exenatide twice daily, pa-

tients on exenatide once weekly had significantly

greater reductions in their blood glucose without in-

creasing the risk of adverse effects, such as hypogly-

cemia.8 Both exenatide products and liraglutide,

which are all available via subcutaneous administra-

tion, mimic all of the glucose lowering actions of na-

tive human GLP-1 hormones.1-4,7 Specific dosing in-

formation can be found in Table 1.

According the to American Association of Clinical En-

docrinologists/American College of Endocrinology

(AACE/ACE) Glycemic Control Algorithm for individu-

als with T2DM published in 2009, GLP-1R agonists

are indicated as an option for first line therapy, partic-

ularly in individuals with elevated post-prandial glu-

cose concentrations.9 Furthermore, it recommends

GLP-1R agonists as an option for the second compo-

nent 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

associated weight loss and unique multifactorial

mechanism of action, the safety profile of GLP-1R ag-

onists emerges as a concern.3,10 Efficacy, tolerability

and their adverse effect profiles, are some of the key

parameters considered when initiating and titrating

medication therapy. Clinical trials and post-marketing

surveillance for both exenatide and liraglutide have

demonstrated concerns with patient tolerability and

safety, specifically in regards to gastrointestinal intol-

erances, pancreatitis and the possibility of thyroid ma-

lignancies.3,10 The purpose of this article is to review

the safely profile of GLP-1R agonists and to educate

the pharmacist regarding recommendations for their

safe use in the treatment of diabetes.

GASTROINTESTINAL INTOLERANCES

Gastrointestinal (GI) disturbances, specifically nausea

and vomiting, are the most common treatment emer-

gent side effects associated with the use of GLP-1R

agonists.3,11,12,13 These GI side effects are most com-

monly experienced upon medication initiation and

dose escalations.10 In most cases, GLP-1R agonist

induced nausea and vomiting was transient and clas-

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 concentra-

tions at the time of medication exposure, slowed gas-

tric emptying and stimulation of neutral GLP-1R re-

ceptors.8,12 In several studies, GLP-1R agonist asso-

ciated 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 ago-

nist 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 ex-

enatide twice daily, a significantly less proportion of

patients experienced treatment related-nausea with

the long-acting formulation when compared to twice-

daily administration.8 Clinical trials report the inci-

dence 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 disturb-

ances 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

Strategies to prevent or alleviate GI intolerances as-

sociated with GLP-1R agonists include titrating doses

conservatively after initiating therapy.12 For ex-

enatide, if nausea occurs upon dosage escalation,

maintenance at the lower initial dose of 5 mcg twice

daily is appropriate; however, for liraglutide the target

dose should be at least 1.6 mg daily, as lower doses

are ineffective for glycemic control.5,6 Patients should

also be counseled that nausea is most often transi-

ent, to eat smaller meals to prevent gastrointestinal

intolerances and, if on exenatide twice daily, to ad-

minister the injection immediately prior to meal-time.3

One of the mechanisms by which GLP-1R agonists

lower post-prandial glucose concentrations is by de-

laying gastric emptying. As a result, GLP-1R agonists

may not be appropriate for individuals with gastro-

paresis, an autonomic disorder often complicated by

hyperglycemia. Exenatide use is not recommended in

patients with gastroparesis.5 While the product infor-

mation for liraglutide does not currently provide any

recommendations for its use in patients with gastro-

paresis secondary to insufficient data, the medication

guide for Liraglutide instructs patients to inform their

healthcare provider if they have or experience symp-

toms of gastroparesis.6

HYPOGLYCEMIA

The possibility of hypoglycemia is an ongoing con-

cern for medications with insulin secreting properties,

such as GLP-1 agonists, sulfonylureas and megliti-

nides, 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 hypo-

glycemia with liraglutide daily and exenatide once

weekly was less than that observed with sulfonylure-

as and twice daily exenatide.15 It is hypothesized that

the lower risk of hypoglycemia with GLP-1R agonists

is related two distinct characteristics. One character-

istic 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 ac-

tion of glucagon, thus allowing for a rise in glucose.16

Although, the 2009 American Diabetes Association

and the European Association for the Study of Diabe-

tes (ADA/EASD) diabetes management algorithm

classifies GLP-1R agonists as less validated tier 2

therapies, it recommends these medications, particu-

larly exenatide (the only FDA-approved GLP-1R ago-

nist at the time of algorithm publication) as a pre-

ferred adjunctive therapy for those individuals with

hazardous employment, such as vehicle or machin-

ery operators (i.e. truck, bus or forklift drivers and air-

line pilots, etc.) or construction workers in whom hy-

poglycemia is less desired.17 In clinical trials, patients

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 experi-

enced 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 hypoglyce-

mic risk with concomitant therapy, the prescribing in-

formation for GLP-1R agonists includes a recommen-

dation 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 recom-

mends considering a dosage reduction for the insulin

dose, which should be considered upon GLP-1R ago-

nist initiation and dose escalation to lower the risk of

hypoglycemia.5

PANCREATITIS AND PANCREATIC CANCER

Post-marketing surveillance reports of acute pancrea-

titis in patients treated with exenatide prompted the

FDA to investigate the causality, and subsequently

include pancreatitis as a precaution to the product in-

formation for GLP-1R agonists (both exenatide and

liraglutide). Thirty cases of exenatide-induced acute

pancreatitis and six cases of hemorrhagic or necrotiz-

ing pancreatitis were cited in the FDA Adverse Re-

porting System (AERS) in 2008.5 A retrospective

chart review utilizing the AERS database was con-

ducted between 2004 and the third quarter of 2009 to

determine if there is sufficient data correlating pancre-

atitis to exentatide use.18,19 Although there were sev-

eral 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 thiaz-

alidinediones or meglitinides).18,19 These findings

however, were inconsistent with other data analyses

and retrospective reviews, which reported similar inci-

dences of exenatide-induced pancreatitis to compara-

tor therapy.18,19 One of these studies, a retrospective

review of pharmacy claims data, evaluated the inci-

dence of pancreatitis over a one-year period of 28,000

prescriptions. In this study, 0.13 percent of the pa-

tients treated with exenatide experienced acute pan-

creatitis, which was comparable to rates observed

with other diabetes treatments, such as metformin or

sulfonylureas.20 An additional concern is the risk asso-

ciation between pancreatitis and pancreatic cancer.

Regarding pancreatic cancer event rates, the FDA

AERS study found a 2.9-fold increase when com-

pared to control agents.19

Regarding possible liraglutide-induced pancreatitis, in

clinical trials a total of seven cases were reported, in-

cluding acute pancreatitis, chronic pancreatitis and

necrotizing pancreatitis with deaths occurring in five,

two and one case(s), respectively.6 The overall occur-

rence of pancreatitis was higher in the liraglutide-

treated group than that observed with the comparator

agents (2.2 vs. 0.6 cases per 1000-patient-years).6

Despite these reports, an absolute causation of GLP-

1R agonists and pancreatitis has been difficult to es-

tablish, as both diabetes and obesity are associated

with their own risk of pancreatitis. The risk of develop-

ing pancreatitis in an individual with T2DM confers a

2.8-fold increase when compared to individuals with-

out T2DM.16 Obese individuals with T2DM are likely to

be prescribed a GLP-1R agonist due to a positive im-

pact on weight reduction and glycemic control; howev-

er, these patients are also at a higher risk of develop-

ing pancreatitis secondary to their concomitant medi-

cal conditions. Other risk factors for pancreatitis in-

clude hypertriglyceridemia, excessive alcohol intake,

gallstones and previous history of pancreatitis.21 Spe-

cific 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 ex-

enatide 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 complica-

tions.23

Practitioners should exercise caution when prescrib-

ing GLP-1R agonists for patients at risk of developing

pancreatitis, should educate patients of warning signs

July 2012



of pancreatitis and inform them to immediately discon-

tinue therapy and seek medical attention if pancreati-

tis is suspected.23

If pancreatitis is confirmed, GLP-1

therapy should not be re-initiated.3,5 This is a key ed-

ucational 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. How-

ever, one comparator patient had evidence of pre-

exisiting 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 Alt-

hough 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 con-

traindicated in patients with a family history of medul-

lary thyroid cancer or in patients with a history of mul-

tiple endocrine neoplasia syndrome type 2.6 The pro-

posed mechanism by which liraglutide causes C-cell

hyperplasia, and possibly cancer, is through in-

creased stimulation of calcitonin release, which is a

biomarker for medullary cancer. A two-year study

evaluating calcitonin concentrations in liraglutide-

treated patients did not show a difference when com-

pared to other anti-diabetes medications; however,

when compared to placebo, concentrations were ele-

vated.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 mon-

itor 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 can-

cer among liraglutide-treated patients to those who

are liraglutide naïve.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 in-

sert.5

ALTERED KIDNEY FUNCTION

Post-marketing reports of both altered and worsening

kidney function exist for both exenatide and lirag-

lutide. In November 2009, the FDA released infor-

mation for healthcare professionals regarding 78 cas-

es of altered kidney function associated with ex-

enatide 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 dis-

ease, revisions were made to the product labeling re-

garding the evaluation for and dosing of exenatide in

kidney dysfunction.25 The product information for li-

raglutide 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 dehydra-

tion, 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 con-

cern is identified. The REMS program is designed to

provide both practitioners and patients with infor-

mation regarding medication safety concerns. In

most cases, the REMS will include a communication

plan for practitioners and a medication guide for pa-

July 2012



tients. Practitioner information highlights safety con-

siderations, current findings and makes recommen-

dations 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 patho-

genesis of diabetes have focused on the multiple hor-

monal deficiencies that result in clinical hyperglyce-

mia. The GLP-1R agonists represent a novel class of

treatment agents that add promise to the diabetes

treatment armamentarium, as they target these un-

derlying 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, in-

cluding pharmacists, should be aware of treatment-

related toxicities and assess the risk vs. benefit when

initiating or escalating therapy with these agents. A

clear understanding of patient risk factors for the de-

velopment of adverse effects, as well as familiarity

with the signs and symptoms of potential treatment-

related toxicities can aid in disease management. In

summary, the GLP-1R agonists can provide an effec-

tive means for glycemic control, when used in the

proper clinical situation.

REFERENCES

1. Pinkney J, Fox T, Ranganath L. Selecting GLP-1

agonists in the management of type 2 diabetes:

differential pharmacology and therapeutic benefits

of liraglutide and exenatide. Ther Clin Risk

Manag. 2010;6:401-411.

2. Drucker DJ. The biology of incretin hormones Cell

Metabolism 2006:3; 153-165

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 Clini-

cal Implications. The American Journal of Medi-

cine. 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: Amy-

lin Pharmaceuticals; 2012.

8. Drucker DJ, Buse JB, Taylor K, Kendall DM, Tra-

utmann M, Zhaung D, et al. Exenatide once

weekly versus twice daily for the treatment of type

2 diabetes: a randomized, open-label, non-

inferiority study. Lancet. 2008;372(9645):1240-

1250.

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 En-

docrinology (AACE/ACE) Consesus Panel on

Type 2 Diabetes Mellitus: an algorithm for glyce-

mic control. Available at: http://www.aace.com/

pub/pdf/GlycemicControlAlgorithm.pdf. Accessed

May 4, 2011.

10. Gilbert Mp, Pratley RE. Efficacy and Safety of In-

cretin-Based Therapies in Patients with Type 2

Diabetes Mellitus. The American Journal of Medi-

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11. Gentilella R, Bianchi C, Rossi A, Rotella CM. Ex-

enatide: a review from pharmacology to clinical

practice. Diabetes, Obesity and Metabolism

2009;11:544-556.

REMS Requirements

Safety Concerns Exenatide Liraglutide

Pancreatitis / Pancreatic Cancer P P

Thyroid Cancer n/a P

Kidney Impairment P n/a

Table 2: Overview of REMS with Exenatide & Liraglutide21-25

http://www.aace.com/pub/pdf/GlycemicControlAlgorithm.pdf

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12. Ellero C, Han J, Bhavsar S, Cirincione BB,

DeYoung MB,Gray AL, et al. Prophylactic use of

anti-emetic medications reduced nausea and

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retrospective analysis of an open-label, parallel-

group, single-dose study in healthy subjects. Dia-

bet Med. 2010;27(10):1168-1173.

13. Joffe D. Liraglutide: A once-daily human glucagon

-like peptide-1 analogue for type 2 diabetes melli-

tus. Am J Health-System Pharm. 2010; 67

(16):1326-1336.

14. Buse JB, Rosenstock J, Sesti G, Schmidt WE,

Montanya E, Brett JH, et al. Liraglutide once a day

versus exenatide twice a day for type 2 diabetes:

a 26 week randomized, parallel-group, multina-

tional, open-label trial (LEAD-6). Lancet. 2009;

374(9683):39-47.

15. Aroda VR, Ratner R. The safety and tolerability of

GLP-1 receptor agonists in the treatment of type 2

diabetes: a review [published online ahead of print

June 2, 2011]. Diabetes Metab Res. doi:10.1002/

dmrr.1202.

16. Campbell RK, Cobble ME, Reid TS, Shomali ME.

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S9.

17. Nathan DM, Buse JB, Davidson MB, Ferrannini E,

Holman RR, Sherwin R, et al. Medical manage-

ment of hyperglycemia in type 2 diabetes: a con-

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18. Elashoff M, Matveyenko AV, Gier B, Elashoff R,

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19. Elashoff M, Matveyenko AV, Gier B, Elashoff R,

Butler PC Pancreatitis, Pancreatic and thyroid

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doi:10.1053/j.gastro.2011.02.018

20. Dore DD, Seeger JD, Chan KA. Use of a claims-

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21. Information for Healthcare Professionals: Ex-

enatide (marketed as Byetta) - 8/2008 Update

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PostmarketDrugSafetyInformationforPa-

tientsandProviders/ucm124713.htm Accessed

10.26.11

22. Victoza: Victoza (liraglutide [rDNA origin]) Injec-

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Pancreatitis [Posted 06/13/2011] http://

www.fda.gov/Safety/MedWatch/SafetyInformation/

SafetyAlertsforHumanMedicalProducts/

ucm258826.htm Accessed 10.26.11

23. Byetta Safety Update for Healthcare Profession-

als: http://www.fda.gov/Drugs/DrugSafety/


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DrugSafetyInformationforHeathcareProfessionals/

ucm190406.htm. Accessed 10.26.11

24. Questions and Answers - Safety Requirements for

Victoza (liraglutide). http://www.fda.gov/Drugs/

DrugSafety/


tientsandProviders/ucm198543.htm Accessed

10.26.11

25. Information for Healthcare Professionals: Reports

of Altered Kidney Function in patients using Ex-

enatide (Marketed as Byetta)http://www.fda.gov/

Drugs/DrugSafety/


tientsandProviders/

DrugSafetyInformationforHeathcareProfessionals/

ucm188656.htm. Accessed 10.26.11

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm




http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190406.htm















July 2012



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, KPhA’s ACPE ac-credited 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 educa-tion 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 li-cense 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 e-Profile 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 [email protected] 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

[email protected] Tel: 847-391-4406 Fax: 847-391-4502 Hours: M-F, 9 AM to 5 PM central

About the Authors

Dr. Prasad is assistant professor of clinical & administrative sciences, Sullivan University College of Pharmacy, and clini-

cal 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, In-

diana University Health Methodist Family Medicine Center, Indianapolis.

mailto:[email protected]

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 hor-mones 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 regard-ing 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 com-

pared 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 5. HB, a 55-year old female with type 2 diabetes and mild renal impairment, recently completed 2 weeks of liraglutide therapy. Her practitioner is interested in in-creasing her dose from 1.2 mg daily to 1.8 mg daily. Which of the following GLP-1 agonist associated side effects should be evaluated upon the dosage increase? (Objective 3) A. Thyroid Cancer B. Pancreatitis C. Kidney Dysfunction D. b and c 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, vomit-

ing 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 condi-tions 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 10. Liraglutide requires a dosage adjustment in patients with renal impairment. A. True B. False

KPhA Social Media Links www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc

July 2012



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 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. 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)

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.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. 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 _________________________________


July 2012


1987—Twenty-five years ago:

Major pharmacy issue of the year was the increase in 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 Wal-Mart (Arkansas) were formed.

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 Marine Hospital Service (predecessor agency to the U.S. Public Health Service (PHS).

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 satis-faction 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

Pharmacy Time Capsules

The following broad guidelines should guide an au-

thor to completing a continuing education article for

publication in The Kentucky Pharmacist.

Average length is 4-10 typed pages in a word pro-

cessing document (Microsoft Word is preferred).

Articles are generally written so that they are per-

tinent to both pharmacists and pharmacy techni-

cians. If the subject matter absolutely is not perti-

nent to technicians, that needs to be stated clearly

at the beginning of the article.

Article should begin with the goal or goals of the

overall program – usually a few sentences.

Include 3 to 5 objectives using SMART and meas-

urable verbs.

Feel free to include graphs or charts, but please

submit them separately, not embedded in the text

of the article.

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.

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 should address topics designed to narrow

gaps between actual practice and ideal practice in

pharmacy. Please see the KPhA website

(www.kphanet.org) under the KPERF link to see pre-

viously published articles.

Articles must be submitted electronically to the KPhA

director of communications and continuing education

([email protected]) by the 15th of the month pre-

ceding publication.

Have an idea for a continuing education article? WRITE IT!

Continuing Education Article Guidelines

Pharmacy Time Capsules

http://www.aihp.org

July 2012


From Your Executive Director

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls

T his edition of The Kentucky Pharmacist fea-tures the 2012 graduating classes of the Sul-livan 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 profes-sion. 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 cele-brate as the photos tell the story of pharmacists and pharmacy technicians coming together to learn, net-work, 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 al-so 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 De-partment 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 disas-ter events that occur within the Commonwealth. Since 2000, the nation has recorded more than 760 federal-ly 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 im-pacted 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 Execu-tive, I cannot but note that we find ourselves at a crossroad in the practice of pharmacy when one con-siders 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 dis-cussions 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 encour-age you to do so. (see http://www.kphanet.org/Communications.aspx). The report utilizes objective data to advance the discussion of how models of in-novative care—that both include and involve pharma-cists—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 mem-bers, 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 ide-as. 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!

July 2012


Help support the Bowl of Hygeia Award!

Bowl of Hygeia Fundraising Efforts

This year another 50+ Bowl of Hygeia recipi-ents will be added to our ranks. All are dedi-cated pharmacists who take community service seriously and endeavor to make a difference in a way that is meaning-ful. Their stories are in-spiring, and their atti-tudes are humble. All will make you proud. The Bowl of Hygeia has a rich history within

pharmacy and it represents well members of our pro-fession. That’s why I’m excited to be helping to carry forth the Bowl of Hygeia tradition through collabora-tion 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 Phar-macy groups assumed responsibility for the Bowl, this prestigious award was in jeopardy of being extin-guished. If it were not for their agreement to carry for-ward the honor through a professional collaboration, 2010 would have been the last year the Bowl of Hy-geia was awarded. Given that this is an award presented at the state lev-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 or-der to sustain the award, each state association is working together to build an endowment sufficient to generate dividends that will fund the program in per-petuity. The APhA Foundation, a national nonprofit 501 (c) (3), has agreed to be the home of the endowment ac-count, 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 lead-er 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 com-munity service in our profession. That’s why I am per-

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 ad-dress.

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 Bowl of Hygeia Award Recipient, 2012

July 2012


Pharmacy Technician Certification Board

July 2012


Aug. 2012 CE-Aspirin: Evolving Evidence

Aspirin: Evolving Evidence and Recommendations for

Use in Cardiovascular Disease

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.

KPERF offers all

CE articles to

members online at

www.kphanet.org

Introduction

ASA is a potent inhibitor of both platelet aggregation

and prostaglandin synthesis. For more than 10 years,

ASA has been used and promoted as a cost-effective

agent for reducing the occurrence of further vascular

events in those with occlusive vascular disease.1-3

When used for secondary prevention in those with a

cardiovascular event history, the evidence is clear;

ASA reduces the risk of myocardial infarction (MI) by

one-third, stroke by one-quarter and vascular death

by one-sixth, with benefits far exceeding risks.4,5 For

those without history of an event (primary prevention),

evidence for the use of ASA is less clear and contro-

versial. Recent and emerging evidence provides

some clarification regarding the use of ASA for prima-

ry prevention in a variety of situations including diabe-

tes, atrial fibrillation, as combination therapy and in

the elderly. The purpose of this article is to review the

evolving evidence concerning ASA and CVD preven-

tion and highlight the current recommendations for

use based upon this data.

ASA in Diabetes

Diabetes is a chronic and progressive disease that

affects more than 340 million people worldwide.6 In

the United States, more than 26 million people have

diabetes, with this number expected to reach 30.3

million in the year 2030.7,8 As those with diabetes ap-

pear to have a two- to four-fold higher risk of CVD,

this increasing prevalence has led to greater con-

cerns for CVD development, the major cause of death

with the disease.6,9-11 In 2009, 7 million people in the

United States with diabetes also reported a CVD con-

dition.12 Over the past 10 years, the prevalence of di-

abetes in Kentucky has increased from 6.4 percent to

10.1 percent, in contrast to the national increase of

6.0 percent to 8.7 percent.13

In 1999, an American Heart Association (AHA) state-

ment concerning CVD and diabetes recommended

ASA for primary prevention unless contraindicated.14

The American Diabetes Association (ADA) and AHA

updated these recommendations for ASA as primary

prevention in 2007. In this statement, ASA was rec-

ommended for those with increased cardiovascular

risk defined as: >40 years old or with additional risk

factors for CVD (family history, hypertension, tobacco

use, dyslipidemia or albuminuria).2 Evidence support-

ing this recommendation was inconclusive and stud-

July 2012



ies using ASA have been designed to more clearly

identify treatment strategies that reduce the CVD as-

sociated with diabetes.

Evidence for Primary Prevention

The 2009 Antithrombotic Trialists’ (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 re-

duction in nonfatal MI was significant whereas the re-

duction in stroke and vascular death was not. Howev-

er, extracranial and gastrointestinal bleeding was in-

creased by 55 percent in patients with diabetes, fur-

ther questioning the overall risk versus benefit in pri-

mary prevention.5

The Japanese Primary Prevention of Atherosclerosis

with Aspirin for Diabetes (JPAD) and the Prevention

of Progression of Arterial Disease and Diabetes

(POPADAD) trials were designed to provide more

conclusive evidence for the use of ASA. Both of these

multicenter trials included patients with no prior histo-

ry of CVD.11,15

The JPAD trial included 2,539 participants ages 30 to

85 years with controlled type 2 diabetes, randomized

to low-dose ASA or placebo. The primary endpoint

was occurrence of any cardiovascular event including

coronary, cerebrovascular or peripheral. The differ-

ence in events between the groups over the median

follow-up of 4.37 years was insignificant, with 68 in

the ASA group versus 86 with placebo. However, in

those 65 and older, there was a significant 32 percent

reduction in events with ASA, suggesting a benefit for

older patients. Overall, JPAD results suggest only a

small benefit for the use of ASA as primary prevention

in diabetes. Interpretation of the data is difficult be-

cause the study was underpowered due to the low

number of overall events.11

The POPADAD trial included 1,276 participants 40

years or older with type 1 or 2 diabetes and an ankle

brachial pressure index of 0.99. The trial evaluated if

the use of ASA and antioxidants, alone or combined,

would reduce cardiovascular events. Participants

were randomized to ASA plus placebo, antioxidant

plus placebo, ASA and antioxidant, or double place-

bo. The two primary endpoints were either a compo-

site 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 end-

point, again questioning any benefit of ASA for prima-

ry prevention of CVD in diabetes.15

Collaboration of Evidence and Recommendations for

Use

In an effort to reconcile results, the ADA, AHA, and

American College of Cardiology Foundation (ACCF)

conducted a meta-analysis including the primary pre-

vention trials in the ATT meta-analysis, JPAD and

POPADAD. The authors concluded that ASA use pro-

duced an insignificant risk reduction of 9 percent and

15 percent, respectively, in fatal and nonfatal MI and

stroke.16

Based on these results, the combined groups con-

clude that ASA only modestly reduces CVD risk in

diabetes by about 10 percent, with the most benefit

seen in those with the greatest risk. They now recom-

mend that the use of ASA be based on the overall

cardiovascular risk profile. Use of the Framingham

risk assessment for this and suggestions for ASA use

are identified in the Table on page 30. Concurrent

therapies for reducing CVD risk are encouraged in-

cluding smoking cessation, control of hypertension,

uses of statins and lifestyle changes. These therapies

should be adopted first and may lower CVD risk to a

level that does not warrant ASA use. Other assess-

ment tools can also be used including the UKPDS

Risk Engine, the ARIC CHD Calculator and the ADA

Risk Assessment Tool. Since gastrointestinal bleed-

ing presents the greatest complication with ASA use,

a thorough evaluation for this risk also should occur

prior to initiation.16

July 2012



ASA as Comparative or Combination Therapy -

Atrial Fibrillation and Acute Coronary Syndrome

Warfarin and ASA

Though warfarin is the drug of choice for primary pre-

vention of stroke in atrial fibrillation, it may not be suit-

able for all patients. A recent Danish study examined

the efficacy and safety of warfarin, ASA, the combina-

tion of warfarin plus ASA, or no treatment by linking

nationwide registries and identifying patients dis-

charged with non-valvular atrial fibrillation

(n=132,372). Study results supported that ASA alone

is neither safe nor effective in preventing stroke in

atrial fibrillation, with no net clinical benefit (stroke ver-

sus bleeding) at any level of stroke risk. Stroke risk

was calculated using CHADS2 and CHA2DS2-VASc

scores, while bleeding risk was evaluated using HAS-

BLED. Patients were further stratified based upon

risks of stroke and bleeding. Hazard ratios showed

that warfarin alone consistently lowered the risk of

thromboembolism/stroke greater than ASA alone or

no treatment, while the combination of warfarin plus

ASA provided no additional benefit.17

For patients at each thromboembolic risk level, the

risk of bleeding was increased in all treatment groups

compared to no treatment. Warfarin therapy alone

had a net clinical benefit in all but the lowest risk

group (CHA2DS2-VASc score of 0 and 1) where bene-

fits were neutral. Furthermore, the net clinical benefit

with warfarin was greatest in patients with the highest

bleeding risk. Researchers suggested that this could

be because this group had the highest stroke risk.

This study provides additional support for the lack of

ASA efficacy in atrial fibrillation, alone or in combina-

tion with warfarin, and should guide providers away

from this use.17

Clopidogrel and ASA

Clopidogrel plus ASA was compared to warfarin in the

Atrial Fibrillation Clopidogrel Trial with Irbesartan for

Prevention of Vascular Events (ACTIVE-W) trial. In

this trial, patients had an average of two risk factors

for stroke. Primary outcomes included first occurrence

of stroke, noncentral nervous systemic embolism, MI

or vascular death. Warfarin was superior to

clopidogrel plus ASA for prevention of vascular

events, with 165 events compared to 234 with the

combination. Rates of major hemorrhage were simi-

lar between groups; however, the clopidogrel plus

ASA group had more minor and total bleeds.18

Based

on these results, the combination of ASA and

clopidogrel is not recommended over warfarin when

patients are candidates for warfarin therapy.18,19

The Effect of Clopidogrel Added to Aspirin in Patients

with Atrial Fibrillation (ACTIVE-A) trial was conducted

to evaluate ASA plus clopidogrel versus ASA alone in

patients where warfarin was not an option due to risk

of bleeding, physician judgment, or patient prefer-

ence. The primary outcome was the composite of

stroke, MI, noncentral nervous systemic embolism, or

death from vascular causes. The annual rate of the

composite endpoint after a median of 3.6 years

follow-up was 6.8 percent in the clopidogrel-ASA

group versus 7.6 percent with ASA alone. The differ-

ence was attributed primarily to a reduction in the rate

of stroke (2.4 percent clopidogrel-ASA versus 3.3 per-

cent ASA). When evaluating adverse events, howev-

er, major bleeding was significantly increased in the

clopidogrel-ASA group (2.0 percent versus 1.3 per-

cent per year), including an excess of 13 fatal epi-

sodes.20

Based upon information from these studies, the AC-

CF/AHA/Heart Rhythm Society (HRS) included a rec-

ommendation concerning combination therapy in the

2011 Focused Update on the Management of Pa-

tients with Atrial Fibrillation. The class IIb recommen-

dation states that the combination of clopidogrel and

ASA might be considered as an option for primary

prevention of major vascular events in atrial fibrillation

when warfarin therapy is unsuitable.18-20

CHEST Guideline Updates

The recent CHEST guidelines published in February

2012 give updated recommendations regarding the

use of ASA in atrial fibrillation. For patients with a low

risk of stroke (CHADS2 score of 0), it is suggested

that no therapy be used. However, if medication ther-

apy is elected, ASA is recommended over oral antico-

agulation or combination therapy with ASA and

clopidogrel. For patients with an intermediate risk of

stroke (CHADS2 score of 1) and consistent with the

ACTIVE-W trial, oral anticoagulation is suggested

over no therapy, ASA or combination therapy with

July 2012



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 al-

so 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 throm-

botic 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, ti-

cagrelor resulted in a decreased incidence of compo-

site death from vascular causes, MI or stroke (9.8 per-

cent versus 11.7 percent). All patients in this trial re-

ceived 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 per-

cent 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 as-

pect of CAD treatment, the leading cause of death in

the elderly. In a 2002 ATT Collaboration meta-

analysis, 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 recommenda-

tions for the use of low-dose ASA for secondary pre-

vention in elderly patients with ACS, chronic stable

angina, and undergoing PCI.27-29 As in PLATO, low-

dose versus high-dose ASA appears to be equally

effective in the elderly.3,24

Despite the evidence for ASA as secondary preven-

tion in this population, the support for primary preven-

tion remains inconclusive. The magnitude of risk ver-

sus benefit remains unknown and researchers em-

phasize 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 ap-

proach 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

*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,

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

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 re-

duction in MI for those at moderate to high risk of

CVD events is closely balanced with the increase in

major bleeds.21

ASA Discontinuation

It is estimated that approximately 50 percent of pa-

tients taking ASA for secondary prevention discontin-

ue therapy, with multiple reviews linking this to ad-

verse cardiovascular outcomes.30,31 A case-control

study using a primary care database specifically eval-

uated the risk of MI and death after ASA discontinua-

tion. Included were patients 50-84 years of age who

had ever received ASA for secondary prevention; cas-

es 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 com-

bined 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 con-

cluded that patients taking ASA for secondary preven-

tion who abruptly discontinue the medication place

themselves at a higher risk of MI compared to those

continuing treatment.31

Conclusion

Pharmacists frequently encounter patients who are on

ASA therapy and are in a unique role to influence pa-

tient care and decisions particularly in the area of

over-the-counter medications. Recent trials and re-

views have further enhanced our knowledge and

guided the continued effort to identify strategies for

the appropriate use of ASA in various situations in-

cluding the primary prevention of CVD. This infor-

mation 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 be-

fore ASA is recommended, as those with a higher

baseline risk appear to have a greater absolute bene-

fit from therapy in some indications. By understanding

issues related to therapy, we can effectively impact

disease management and patient outcomes.

References

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ohrms/dockets/ac/03/briefing/4012B1_03_Appd%201-

Professional%20Labeling.pdf

2Buse 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.

3Campbell CL, Smyth S, Montalescot G, Steinhubl

SR. Aspirin dose for the prevention of cardiovascular

disease: a systematic review. JAMA. 2007;297

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4Antithrombotic Trialists’ Collaboration. Collaborative

meta-analysis of randomised trials of antiplatelet ther-

apy for prevention of death, myocardial infarction, and

stroke in high risk patients. BMJ. 2002;324(7329):71-

86.

5Antithrombotic Trialists’ (ATT) Collaboration, Baigent

C, Blackwell L, Collins R, et al. Aspirin in the primary

and secondary prevention of vascular disease: collab-

orative meta-analysis of individual participant data

from randomised trials. Lancet. 2009;373(9678):1849-

60.

6Diabetes [internet]. Washington, DC: World Health

Organization; 2011-. Available from: http://

www.who.int/mediacentre/factsheets/fs312/en/

index.html

7Wild 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.

8National Diabetes Fact Sheet. Centers for Disease

Control and Prevention Web site. http://www.cdc.gov/

diabetes/pubs/pdf/ndfs_2007.pdf.

9Diabetes Statistics [internet]. Alexandria, VA: Ameri-

can Diabetes Association; c1995-2011 Available from:

http://www.diabetes.org/diabetes-basics/diabetes-

statistics/

July 2012



10Haffner SM. Coronary heart disease in patients with

diabetes. N Engl J Med. 2000 Apr 6;342(14):1040-

11Japanese 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.

12Number (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.

13Diabetes Data and Trends. Centers for Disease

Control and Prevention Web site. http://www.cdc.gov/

diabetes/index.htm.

14Grundy SM, Benjamin IJ, Burke GL, et al. Diabetes

and cardiovascular disease: a statement for

healthcare professionals from the American Heart

Association. Circulation. 1999;100:1134-46.

15Prevention of Progression of Arterial Disease and

Diabetes Study Group, Belch J, MacCuish A, Camp-

bell I, et al. The prevention of progression of arterial

disease and diabetes (POPADAD) trial: factorial ran-

domised placebo controlled trial of aspirin and antioxi-

dants in patients with diabetes and asymptomatic pe-

ripheral arterial disease. BMJ. 2008;337:a1840.

16Pignone M, Alberts MJ, Colwell JA, et al. Aspirin for

primary prevention of cardiovascular events in people

with diabetes: a position statement of the American

Diabetes Association, a scientific statement of the

American Heart Association, and an expert consen-

sus document of the American College of Cardiology

Foundation. Circulation. 2010;121(24):2694-701.

17Olesen JB, Lip GY, Linhardsen J, et al. Risks of

thromboembolism with thromboprophylaxis in patients

with atrial fibrillation: A net clinical benefit analysis

using a ‘real world’ nationwide cohort study. Thromb

Haemost. 2011;106(4):739-49.

18The ACTIVE Investigators. Clopidogrel plus aspirin

versus oral anticoagulation for atrial fibrillation in the

Atrial fibrillation Clopidogrel Trial with Irbesartan for

prevention of Vascular Events (ACTIVE W):a random-

ised controlled trial. Lancet. 2006;367:1903-12.

19Wann 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.

20The ACTIVE Investigators. Effect of clopidogrel add-

ed to aspirin in patients with atrial fibrillation. N Engl J

Med. 2009;360:2066-78.

21Guyatt GH, Crowther M, Gutterman DD, Shuune-

mann HJ. Executive summary: antithrombotic therapy

and prevention of thrombosis, 9th ed: American Col-

lege of Chest Physicians evidence-based clinical

practice guidelines. Chest. 2012;141;7S-47S.

22Nawarskas JJ, Clark SM. Ticagrelor: a novel re-

versible oral antiplatelet agent. Cardiology in Review.

2011;19(2):95-100.

23Wallentin L, Becker RC, Budaj A, el al for the PLA-

TO Investigators. Ticagrelor versus clopidogrel in pa-

tients with acute coronary syndromes. N Engl J Med.

2009;361(11):1045-57.

24Mahaffey KM, Wojdyla DM, Carroll K, et al on behalf

of the PLATO Investigators. Ticagrelor compared with

clopidogrel by geographic region in the Platelet Inhibi-

tion and Patient Outcomes (PLATO) Trial. Circulation.

2011;124:544-54.

25AstraZeneca. Brilinta (ticagrelor) tablets [prescribing

information]. Wilmington (DE): 2011 Jul.

26Capodanno D, Angiolillo DJ. Antithrombotic therapy

in the elderly. J Am Coll Cardiol. 2010;56(21):1683-

92.

27Anderson JL, Adams CD, Antman EM, Bridges, et

al. ACC/AHA 2007 guidelines for the management of

patients with unstable angina/non–ST-elevation myo-

cardial infarction: a report of the American College of

Cardiology/American Heart Association Task Force

on practice guidelines (writing committee to revise the

2002 guidelines for the management of patients with

unstable angina/Non–ST-elevation myocardial infarc-

tion). J Am Coll Cardiol. 2007;20(7):e1-57.

28Fraker TD Jr., Fihn SD, Gibbons RJ, et al. 2007

http://www.nejm.org/toc/nejm/360/20/

July 2012



Chronic angina focused update of the ACC/AHA

2002 guidelines for the management of patients with

chronic stable angina: a report of the American Col-

lege of Cardiology/American Heart Association Task

Force on Practice Guidelines Writing Group to devel-

op 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 up-

date): 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.

30Sud A, Kline-Rogers EM, Eagle KA, et al. Adher-

ence to medications by patients after acute coronary

syndromes. Ann Pharmacother. 2005;39:1792-7.

31Rodriguez LA, Cea-Soriano L, Martin-Merino E, Jo-

hansson 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. 2. Based upon recent recommendations, all patients with Type 2 diabetes should receive ASA as primary CVD prevention. A. TRUE B. FALSE 3. In general, for preventing stroke in atrial fibrillation, ASA is: A. an alternative to warfarin. B. useful in combination with warfarin. C. is neither safe nor effective. 4. For decreasing vascular events in atrial fibrillation, the ACTIVE-W trial showed that: A. warfarin is equal to ASA plus clopidogrel. B. ASA plus clopidogrel is superior to warfarin. C. warfarin is superior to ASA plus clopidogrel. 5. The ACCF/AHA/HRS recommendations concern-ing therapy for primary prevention of major vascular events in patients with atrial fibrillation suggest that clopidogrel plus ASA might be an option when warfa-rin is unsuitable. A. True B. False

6. According to the recent CHEST guideline recom-mendations, patients with atrial fibrillation and at low risk of stroke should receive: A. ASA. B. clopidogrel. C. no therapy. D. warfarin. 7. To reduce the rate of thrombotic cardiovascular events in patients with ACS, ticagrelor should be tak-en with: A. clopidogrel. B. warfarin. C. aspirin. D. prasugrel. 8. Based upon PLATO results and prescribing infor-mation, the recommended daily maintenance dose of ASA to be taken with ticagrelor is: A. 75-100 mg. B. 325 mg. C. 650 mg. 9. Higher doses of ASA are needed in the elderly for both primary and secondary CVD prevention. A. True B. False 10. Discontinuing treatment with ASA for secondary CVD prevention is associated with: A. a higher risk of MI or death. B. no change in the risk for MI or death. C. a lower risk of MI or death.

July 2012



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 3. A B C 5. A B 7. A B C D 9. A B 2. A B 4. A B C 6. A B C D 8. A B C 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 _________________________________


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.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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 3. A B C 5. A B 7. A B C D 9. A B 2. A B 4. A B C 6. A B C D 8. A B C 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 _________________________________


July 2012


Pharmacists Mutual

July 2012


Pharmacy Law Brief

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 dis-

pense 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 perspec-

tives 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 sui-

cide, about which the pharmacist has a strong reli-

gious or moral issue. These laws permit the pharma-

cist to refuse patients certain medications or treat-

ments while protecting the pharmacist from any liabil-

ity arising from such refusals.

Conscience clauses arose initially out of the US Su-

preme 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 inter-

fere 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 or-

der, have gone the opposite direction and mandated

that pharmacists must honor all legitimate prescrip-

tions presented to them.

Where has this issue gone? While conscience clause

advocates still work for their goal of relieving pharma-

cists from having to accept objectionable prescrip-

tions, the issue has certainly seemed to go dormant.

The overwhelming reason for this is that every case

to date regarding this issue has been decided in court

in favor of the patient, with the courts’ continuing reli-

ance on Roe and the ruling that the choice of therapy

belongs to the patient, not the pharmacist. Choice of

therapy refers back to – and is a part of – the court’s

ruling, the right of privacy and freedom of expression.

Without a substantial argument to negate this Consti-

tutional line of thought, and such an argument does

not seem to exist, state boards of pharmacy are cur-

rently 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 his-

tory to attempt to see how a pharmacy case here

might be decided, one must look at analogous profes-

sions. Attorneys may refuse certain clients where

their strong moral opposition to the client’s case might

be detrimental to the client’s best interests. Physi-

cians may refuse to perform certain procedures re-

quiring 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 pharma-

cists in any jurisdiction, to my knowledge. The act of

properly preparing a prescription is not so demanding

of professional skills, courts have decided, to extend

these examples to our profession.

Other guidance is notably lacking. The APhA and the

AMA have both issued guidelines or passed resolu-

tions on the matter. In both cases, the results are

vague and not very helpful; while sympathy is extend-

ed to an objecting pharmacist, the patient and her

needs, both sets of guidelines emphasize, must be

met. At least one commentator says that pharmacy

schools should weed out those with objections prior to

admission to a pharmacy program!

Submit Questions: [email protected]

July 2012


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 [email protected] 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 [email protected]

Pharmacy Law Brief

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 phar-

macist could ask the patient to return when another,

non-objecting pharmacist was on duty or even refer

the patient to another pharmacy where that objection-

able 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 pharma-

cist shortage that employers may take a more strict

approach. This could include preferably hiring phar-

macists who convey no moral or religious issues to

their potential employers and even terminating phar-

macists who exhibit these issues in practice. Addition-

ally, some worry that honoring all legitimate prescrip-

tions may become a prerequisite for hiring.

Employee pharmacists certainly face some hard

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 malprac-

tice 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 intend-

ed for educational use and to stimulate professional

discussion among colleagues. It should not be con-

strued as legal advice. There is no way such a brief

discussion of an issue or topic for educational or dis-

cussion 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

accordance with the full information.

July 2012


KPhA Board Welcomes New Members

KPhA sends email announcements weekly.

If you aren’t receiving:

eNews, Legislative Updates, Grassroots Alerts and other

important announcements, send your email address to

[email protected] to get on the distribution list.

Vice Speaker of House of Delgates — Cassandra

Beyerle is a 2010 graduate from the University of Ken-

tucky College of Pharmacy. In

2011, she completed a PY1

community pharmacy residency

with Sullivan University and

Medica Pharmacy and Wellness

Center. She is currently em-

ployed by Sullivan University

College of Pharmacy as an As-

sistant Professor in the Clinical

and Administrative Science De-

partment, with a clinical site at

Family Health Center Port-

land. Her ambulatory care clinic

services the patients of Family Health Center through dia-

betes and anticoagulation management. Cassy is an active

member of JCAP and the KPhA New Practitioner Commit-

tee.

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 pro-

gram, an immunization clinic, a

340B program and a scholar-

ship 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 advance-

ment of our profession.

Sullivan University College of

Pharmacy Student Representa-

tive — Lance Murphy is the Stu-

dent 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 Presi-

dent. He was a three-time letter

winner, playing football, and re-

ceived his Bachelors of Science

in Biology from Morehead State

University in 2011.

Director — Robert Oakley is a 1977 graduate of the Uni-

versity 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.

Welcome to the new members

July 2012


KPhA Board Welcomes New Members

Past President — Donnie Riley graduated from the Uni-

versity of Kentucky College of

Pharmacy in 1979. He is Presi-

dent 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 Presi-

dent-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 Uni-

versity 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 Lau-

ren Riley Stafford, PharmD.

University of Kentucky College of Pharmacy Student

Representative — Molly

Trent was born and raised in

the Lexington area and cur-

rently lives in Georgetown.

She completed her under-

graduate studies at the Uni-

versity of Kentucky and is now

a third-year student pharma-

cist at the UK College of Phar-

macy. She serves as the

APhA-ASP Chapter President

and is an active member of

Rho Chi and Phi Lambda Sig-

ma. When she’s not studying or participating in extracurric-

ular activities through school, she enjoys cheering on the

CATS and horseback riding.

of the KPhA Board of Directors

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, Presi-

dent Lewis Wilker-

son. Willett was

reelected for an-

other term and

Stark was appoint-

ed Treasurer by

the board.

July 2012


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

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 dis-

cuss new officers for the Academy of Consultant

Pharmacists. Elisha Bischoff is the Chair, the vice-

chair position remains open and the three new direc-

tors are Peggy Canler, Terry Seiter and Gary Rice.

Let’s welcome them as new officers for the long-term

care Academy!

As a member of the KPhA Academy, an annual con-

tinuing education program is provided for all members

of KPhA. CE is free for Academy members. A contin-

uing education program was held April 29, 2012 at

the Kentucky Pharmacy Renaissance Museum. There

were 25 attendees, some of which joined as a new

Academy member! The CE programs included an up-

date in federal regulations that impact long-term care

pharmacy and Beers Criteria for Potentially Inappro-

priate 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 provid-

ing relevant information that impacts long-term care

pharmacy throughout the year.

Please contact President Elisha Bischoff,

[email protected], for information

about joining the Academy.

mailto:[email protected]

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 Presi-dent Glenn Sullivan, and heard a commencement address delivered by Mr. Michael Burleson, Executive Director of the Kentucky Board of Pharmacy and President of the Na-tional Association of Boards of Phar-macy.

The ceremony culminated with the recitation of the Oath of a Pharmacist delivered by Dr. Hieu T. Tran, Vice-President of the College of Health Sciences and Founding Dean and Professor of the College of Pharma-cy.

Sullivan University College of Pharmacy Class of 2012

July 2012


Pharmacy Policy Issues

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 phar-

macy school.

Issue: Further action on the part of the medical community needs to be taken in regards to minimizing medi-

cation misadventures and, in turn, reducing the costs they have on society.

Discussion: Medication misadventures, including duplicate therapy, insufficient therapy, improper dis-pensing and avoidable adverse drug events, cost pa-tients, insurance companies and providers both finan-cially 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 pre-ventable medication related adverse events and inap-propriate 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.

In regard to pharmacy practice and our role in com-bating this issue, little regulatory action has been tak-en in recent years. The most recent and outstanding regulatory action that was implemented was the Om-nibus Budget Reconciliation Act of 1990 (OBRA ’90). In requiring drug utilization reviews and the offer to counsel patients on prescriptions dispensed, OBRA ’90 placed pharmacists at the forefront of medical pro-fessionals who can review and intervene upon medi-cation misadventures. But, even with these regula-tions and the expanded power and responsibility pharmacists gained from them, a significant amount of misadventures still occur everyday.

In 1995, nearly 17 million hospital visits in this country were due to a drug related illness which in turn equat-ed to $76.6 billion in health care costs. That same year, it was also estimated that for every dollar spent on pharmaceuticals, another dollar was spent on treating problems that stemmed from sub-optimal medication use. The money spent on remedying pre-ventable medication misadventures is outstanding and an absolute waste of health care resources that could be better spent in various other areas of patient care.

Over the past couple of decades and into today, more and more individuals are being put on medications for chronic disease states. With the number of prescrip-tions being dis-pensed having in-creased by 39 per-cent from 1999 to 2009, coupled with only a nine percent increase in popula-tion over that same period of time, there is an in-creased risk of medication misad-ventures now more than ever. We also are continually see-ing new drugs be-ing brought to the market. All of this, combined with the increasing age of our population, has created a state of health care where patients are at risk for medication misadven-tures.

There has been a recent push toward expanding an-cillary services in pharmacies including vaccination services and medication therapy management. These services are designed to reduce the risk of disease and/or thoroughly monitor drug therapies, thereby op-timizing medication use and reducing the risk of medi-cation misadventures. These added services will no doubt help improve health outcomes in patients as well as reduce the risk of medication misadventures. But, with the ever-increasing amount of prescriptions dispensed, the increasing discovery of new and inno-vative medications available to treat myriad disor-ders, and the relatively new implementation and evo-

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This column is designed to

address timely and practical

issues of interest to

pharmacists, pharmacy

interns and pharmacy

technicians with the goal

being to encourage thought,

reflection and exchange

among practitioners.

Suggestions regarding topics

for consideration are

welcome. Please send them

to [email protected].

July 2012


Pharmacy Policy Issues

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(This information is in accordance with KRS 121. 150)

Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601

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lution of healthcare laws and services aimed at mini-mizing medication misadventures, awareness of this issue must be brought to light and policies regarding this issue must continue to be developed and promul-gated.

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.) Phar-maceutical 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 Pharma-cists: The Impact of the Omnibus Budget Reconcilia-tion Act of 1990 a Decade Later”. Am. J. of Thera-peutics 10 (2): 92-103.

http://www.kff.org/

July 2012


Dr. Fink named KPhA Endowed Professor in Leadership

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 peo-

ple across Kentucky, the nation and the world.”

Fink, highly respected as a pharmacist, lawyer and

educator within Kentucky and across the nation, is the

first UK College of Pharmacy faculty member to be

named the KPhA Professor in Leadership.

“Having been a member of the Kentucky Pharmacists

Association for many years, it is, indeed, an honor

and privilege to be named to this professorship,” said

Fink, who received his professional education in phar-

macy at the Philadelphia College of Pharmacy and

Science, and holds the degree Doctor of Law from

Georgetown University Law Center.

Fink's participation and leadership within professional

associations is extensive. He holds membership in a

number of professional organizations in both pharma-

cy and law, including KPhA, the American Pharma-

cists Association (APhA) and the American Bar Asso-

ciation. 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 inter-

ested in the delegate process.

He was founder and first president of the American

Society for Pharmacy Law and, while a pharmacy stu-

dent, was National President of the Student American

Pharmaceutical Association. He has encouraged, ad-

vised and mentored countless student leaders over

the years while serving as faculty advisor for the

APhA Academy of

Student Pharmacists

(APhA-ASP) organi-

zation and the Ken-

tucky Alliance of

Pharmacy Students.

The Kentucky Phar-

macists Association recognized him as "Pharmacist of

the Year" in 1988 and in 2002 conferred on him the

Distinguished Service Award for significant contribu-

tions to the profession over an extended period of

time.

In March 2012, he was recognized with the Linwood

F. Tice Award by the APhA-ASP for his personal com-

mitment to, and passionate support of, student phar-

macists 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 men-

tored 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 de-

serving 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 Col-

lege.”

Dr. Joseph L. Fink, III with UKCOP Dean Timothy Tracy

and KPhA President Lewis Wilkerson.

July 2012


University of Kentucky College of Pharmacy Class of 2012

Congratulations UKCOP Class of 2012

The University of Kentucky College of Pharmacy hon-

ored 148 students at the 2012 Graduation Recogni-

tion Ceremony May 4 at the UK Singletary Center for

the Arts.

Of those completing requirements for degrees, 14

students earned a PhD in pharmaceutical sciences,

seven students received a Master's degree in phar-

maceutical sciences and 127 students were awarded

the Doctor of Pharmacy (PharmD) degree.

Associate Dean Kelly M. Smith welcomed graduates

and their families and greetings from the College

were provided by Dean Timothy S. Tracy.

Following the presentation of diplomas, PharmD

graduates recited the Pharmacist's Oath led by Lewis

Wilkerson, president of the Kentucky Pharmacists

Association.

July 2012


KPhA BOARD OF DIRECTORS

Lewis Wilkerson, Frankfort Chairman

[email protected] 502.695.6920

Kimberly Croley, Corbin President


Duane Parsons, Richmond President-Elect


Frankie Hammons Abner, Barbourville Secretary


Glenn Stark, Frankfort Treasurer

[email protected]

Donnie Riley, Russelville Past President

[email protected]

Directors

Molly Trent, Georgetown Student Representative

[email protected]

Lance Murphy, Louisville Student Representative

[email protected]

Matt Carrico, Louisville

[email protected]

Chris Clifton, Erlanger

[email protected]

Trish Freeman, Lexington*

[email protected]

Joey Mattingly, Prospect

[email protected]

Matt Martin, Louisville

[email protected]

Jeff Mills, Louisville

[email protected]

Bob Oakley, Louisville

[email protected]

Richard Slone, Hindman

[email protected]

Leah Tolliver, Lexington

[email protected]

Sam Willett, Mayfield

[email protected]

* At-Large Member to Executive Committee

HOUSE OF DELEGATES

Matt Martin, Louisville Speaker of the House

[email protected]

Cassandra Beyerle, Louisville Vice Speaker of the House

[email protected]

KPERF ADVISORY COUNCIL

Kim Croley, Corbin

[email protected]

Ann Amerson, Lexington

[email protected]

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

[email protected]

Matt Worthy, PharmD

Director of Professional & Clinical Services

[email protected]

Scott Sisco, MA

Director of Communications and Continuing Education

[email protected]

Kelli Sheets

Office Manager

[email protected]

Christine Richardson, PharmD

Clinical Pharmacist

[email protected]

Darcie Nixon

Administrative Coordinator & Billing Specialist

[email protected]

Nancy Baldwin

Receptionist/Office Assistant

[email protected]

KPhA Board of Directors

July 2012


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 [email protected]

Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

Frequently Called and Contacted

Frequently Called and Contacted

KPhA Remembers KPhA desires to honor members

who are no longer with us.

Please keep KPhA informed by sending this information to [email protected].

Deceased members for each year will be honored permanently

at the KPhA office with a White Coat.

July 2012


THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601

the kentucky pharmacist, vol. 7, #4

Documents

kentucky pharmacy education

profession of pharmacy

field of pharmacy

kpha members

kpha professor

pharmacy time capsules

kpha professional awards

pharmacy law brief