The Kentucky Pharmacist Vol. 8 No. 5

48
Vol. 8, No. 5 September 2013 T T HE HE K K ENTUCKY ENTUCKY P P HARMACIST HARMACIST News & Information for Members of the Kentucky Pharmacists Association Does your profile look like John Q. Pharmacist? Log in today at www.kphanet.org to update your information! For more informaon and to register, go to www.kphanet.org Marriott Griffin Gate Resort, Lexington, KY November 15-16, 2013 5 Hours of LIVE CE!

description

September 2013 issue of KPhA's peer-reviewed journal.

Transcript of The Kentucky Pharmacist Vol. 8 No. 5

Vol. 8, No. 5

September 2013

TTHEHE KKENTUCKYENTUCKY

PPHARMACISTHARMACIST

News & Information for Members of the Kentucky Pharmacists Association

Does your profile

look like

John Q.

Pharmacist?

Log in today at

www.kphanet.org

to update your

information!

For more information and to register, go to www.kphanet.org Marriott Griffin Gate Resort, Lexington, KY November 15-16, 2013

5 Hours of

LIVE CE!

September 2013

THE KENTUCKY PHARMACIST 2

Table of Contents

Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of phar-macy.

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 out-comes 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 en-trusted 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 2013 to the Kentucky Pharmacists Asso-ciation. The Kentucky Pharmacist is the official jour-nal of the Kentucky Pharmacists Association pub-lished bi-monthly. The Kentucky Pharmacist is dis-tributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email [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.

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 Travels of Roamey, The KPhA Gnome 4 KPhA Immunization Training 5 2013 KPhA Mid-Year Conference 6 Message from Your Executive Director 7 APSC 8 2013-14 KPhA Committees 9 KPPAC Contribution Form 10 Pharmacists Mutual/PTCB 11 Bowl of Hygeia 12 Sept. 2013 CE: Type 2 Diabetes Mellitus 13 Sept. Pharmacist/Pharmacy Tech Quiz 20 KPhA Emergency Preparedness 21 Oct. 2013 CE: Migraine Headache 22

Oct. Pharmacist/Pharmacy Tech Quiz 30 Kentucky Renaissance Pharmacy Museum 31 KPhA New and Returning Members 32 KPhA Government Affairs/Pharmacy Health Screenings 34 Medicare Counseling 35 HIPAA Privacy Changes 36 APhA-ASP Summer Leadership Institute 37 Cooper/Clayton Smoking Cessation Sessions 38 Technician Review 39 Pharmacy Law Brief 40 Senior Care Corner 41 Pharmacy Policy Issues 42 Pharmacy Time Capsules 43 Pharmacists Mutual 44 Cardinal Health Generation Rx Award 45 KPhA Board of Directors 46 50 Years Ago/Frequently Called and Contacted 47

September 2013

THE KENTUCKY PHARMACIST 3

The past couple of months as the

president of your association have been, though hectic at

times, quite a rewarding personal experience for me. Bob,

Scott, and I, along with “Roamey,” have been able to visit

with many of you in your workplaces. That alone is a great

reward, but the excitement and passion for our profession

exhibited by those we visited was just over the top. That was

so encouraging, but then I thought, “I should expect that be-

cause for the most part we are visiting with pharmacists and

associates that are involved in their profession and their as-

sociations. Why doesn’t that excitement and passion extend

itself to all members of our profession?”

The word that came to my mind was apathy. “Apathy” is de-

fined as a lack of interest or emotion or just an indifference.

We’ve all experienced this at points in our lives. I truly be-

lieve we create our own career apathy by not being and stay-

ing involved in our own professional organizations and pro-

fessional opportunities. When we relegate ourselves as phar-

macists to the humdrum of standing behind a counter—“lick,

stick and pouring”—we create our own arenas for apathy.

Those we have visited aren’t doing that. They are involved

with their patients, their profession and the organizations that

support them.

The question becomes, “Why does an attitude of apathy

creep in on some and not others?” For those of us who have-

n’t experienced apathy in our professional lives, the answer

is fairly simple. We stay involved. The challenge for us is to

make sure our colleagues don’t become a victim of apathy.

We need to challenge them to get and stay involved.

None of us have the time we need to do everything we want

to do in our lives, but we always find time to do the important

things. It might not mean that we devote lots of time to doing

everything, but we devote some time to things that matter.

Our profession matters.

When others have asked throughout my career what I do, I

always start with, “I am a pharmacist.” I can always follow

that with professional experience. I believe our main strength

aside from our technical knowledge is a deep passion and

respect for our profession and our desire to provide quality

care for our patients in whatever practice setting we serve.

Pharmacy has always been a very dynamic profession.

Changes come at a very rapid pace. We have to stay in-

volved to affect these changes in a positive manner. One of

the most important benefits KPhA provides for the profession

is the alerts and information on bills that will impact everyday

practice no matter the practice setting. None of us have the

time to do this on an almost daily basis. KPhA provides that

service. When there is a bill that we should either be against

or support, KPhA provides a platform for all of us to voice

comments and join grassroots efforts to affect the outcome of

that bill. The lobbying done on our behalf is invaluable to

each of us.

How to get others involved is often a difficult opportunity. We

just need to keep encouraging others. Those who are in-

volved usually have others that we look to for mentoring our

professional involvement. That was probably not an easy

task for our own mentors either, but they kept persevering.

We can, too. We need to challenge each non KPhA member

to join the organization and become involved now. They

might not have time to serve on the Board of KPhA, but they

might have time to serve on a committee or work group.

They, too, can become mentors to other members of the pro-

fession. As we go about our daily routine, we need to keep

on encouraging involvement to whatever level. Ask others if

the changes and challenges we face in our practices will af-

fect them. If the answer is “Yes”, remind them that they need

to join the KPhA Team and support what’s going on in our

profession. Otherwise, we might not even be invited to com-

ment on issues of how we can better serve our patients.

There is a definitive strength in numbers speaking with a loud

voice. We need for that voice to become even louder. Our

legislators listen to those speaking in great volume. They

hear concerns of those speaking that represent great num-

bers of their constituents. Let’s grow that number to such a

large volume that we can’t be ignored. We affect the daily

lives of the patients we serve in greatly positive ways. We

need for our legislators to be fully aware of our impact.

We desire to be recognized with more opportunistic opportu-

nities for collaborative care agreements. We desire to be rec-

ognized with provider status within the healthcare system. To

get there we must speak out even more. MEMBERSHIP

MATTERS!!!

I hope to visit many more of you in the coming months and

look forward to hearing your ideas and comments on how we

can work together to advance this great profession.

PRESIDENT’S

PERSPECTIVE

Duane W. Parsons

KPhA President

2013-2014

President’s Perspective

September 2013

THE KENTUCKY PHARMACIST 4

Roamey, the KPhA Membership Matters Gnome

Follow Roamey on the

KPhA Facebook Page,

www.facebook.com/

KyPharmAssoc and on

the KPhA Website

(Roamey the KPhA

Gnome link at the

bottom of the home

page).

September 2013

THE KENTUCKY PHARMACIST 5

2013 KPhA Immunization Trainings

2013 KPhA Immunization Training

Roamey traveled to all

three trainings and had to

have a picture with the

trainees!

During August, KPhA offered three Adult Immun-

ization Training sessions around the Common-

wealth. Special thanks to Cathy Hanna, Director of

Research and Education with the American Phar-

macy Services Cooperative, for traveling with us

and providing excellent hands-on training!

Kentucky Dam Village State Resort Park

Barren River

Lake State

Resort Park

Natural Bridge State Resort Park

September 2013

THE KENTUCKY PHARMACIST 6

2013 KPhA Mid-Year Conference

Marriott Griffin Gate Resort

Lexington, KY

November 15-16, 2013 $95 for Pharmacist Members

$35 for Technician members

$5 for Student Pharmacists

For the second straight year, YOUR KPhA will hold the

Mid-Year Conference on Legislative Priorities. The

schedule will include legislative presentations as well as

continuing education on relevant topics like HIPAA

changes implemented this fall, Hazardous Waste Dis-

posal, Emergency Preparedness and Legislative Advo-

cacy.

We also will discuss the legislative priorities for the 2014

Kentucky Legislative Session. See you there!

Watch your eNews and the KPhA website for

the latest information!

Register now at www.kphanet.org!

September 2013

THE KENTUCKY PHARMACIST 7

From Your Executive Director

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls

Fall in Kentucky is a beautiful time. The leaves on many of

our deciduous trees begin to change colors to vivid shades

of red, orange and yellow along the miles and miles of

backroads and, for us daily commuters, scenic interstates.

Autumn is especially beautiful in the Great Smokey Moun-

tains, and a drive to southeastern Kentucky is one of my

favorite treks where the beauty reveals more of the Crea-

tor’s handiwork while benefitting from less mobile clog in

other environs during this special time of year. President

Parsons, Roamey the KPhA Membership Matters Gnome,

Scott Sisco and I have been traveling many of these road-

ways since our Annual Meeting, meeting pharmacists and

pharmacy technicians in your workplaces. We’ve enjoyed

spending a few minutes discussing KPhA and the issues

faced by all members of the pharmacy profession in Ken-

tucky and look forward to more visits and working together

to address the challenges and opportunities. If you have

not already done so, be sure to check out Roamey’s travels

on our Facebook page (www.facebook.com/

KyPharmAssoc) or on the KPhA Website (the link is at the

bottom of our home page www.kphanet.org).

As the seasons begin to change and we bask in the beauty

of Fall, it is a great time to reflect on the first half of 2013.

KPhA has had a wonderful year, beginning with the suc-

cess of passing Senate Bill 107 (with NO DISSENTING

VOTES) which requires PBMs to disclose information to

help you make better decisions for your business. We had

a great Annual Meeting in Louisville with more than 250

pharmacists, pharmacy technicians and student pharma-

cists coming together to learn, laugh, network and establish

Association policy.

We also witnessed the creation of the new KPhA Academy

of Pharmacy Technicians. This dedicated group is working

on proposals to strengthen the profession and move the

position of pharmacy technician from a job to a career. To

help support this mission, members of the KPhA Academy

will receive access to FREE online CE that is modeled after

the Pharmacy Technician Certification Board’s exam. This

will include 10 hours per year so that technicians can get

the 20 hours over two years they need to renew their certifi-

cation. Technician members of KPhA are eligible to be-

come members of the Academy at no additional cost

(membership is $50 per year). For more information on the

Academy and the FREE CE, see page 39 for a message

from Academy Chair Don Carpenter.

It’s also a good time to look forward to the final few months

of the year and beyond. Last year, KPhA brought back the

Mid-Year Conference with great reviews. We will continue

to build on the success of that event with this year’s Mid-

Year Conference on Legislative Priorities November 15-16

at the Marriott Griffin Gate Resort in Lexington. We’re plan-

ning continuing education programs on changes to HIPAA,

Legislative Advocacy, Hazardous Material Disposal and

Emergency Preparedness. We also will have legislative

presentations to ramp up energy heading into the 2014

Kentucky Legislative Session. For the latest information on

this event, be sure to check the KPhA Website

(www.kphanet.org) and read your eNews. Stay connected

to YOUR KPhA to receive the updates!

Looking even further forward to a future season, I want to

encourage you to mark your calendars for the 136th KPhA

Annual Meeting and Convention June 5-8, 2014 at the Mar-

riott Griffin Gate Resort in Lexington. This year marks the

100th anniversary of the first time KPhA held its annual

meeting in Lexington. Special thanks to Gloria Doughty and

the Kentucky Renaissance Museum for that historical fac-

toid. Plan to be there and join in the celebration!

It’s an exciting time in the pharmacy profession. Many

changes are happening around all of us, and we want to do

all we can to drive those changes together. YOUR KPhA is

here to keep you informed and to advocate with YOU and

on YOUR behalf. If you have questions, suggestions or just

need an ear to bend for a few minutes, feel free to call on

us, email me or drop in at the Association’s office in Frank-

fort. This is YOUR KPhA!

September 2013

THE KENTUCKY PHARMACIST 8

APSC

September 2013

THE KENTUCKY PHARMACIST 9

2013-14 KPhA Committees

2013-2014 KPhA Committees

Executive Committee

Kim Croley- Chair

Frankie Abner

Jeff Mills

Bob Oakley

Duane Parsons

Glenn Stark

Past Presidents

Ron Poole - Chair

Donnie Riley – Vice-Chair

Johnny B. Anneken

Joe Carr

Jessika Chinn

Leon Claywell

George Hammons

Melinda Joyce

Dwaine Green

Greg Naseman

Anne Policastri

Clay Rhodes

Richard Slone

Joel Thornbury

Lewis Wilkerson

Organizational Affairs

Chris Clifton – Chair

Lewis Wilkerson

– Vice Chair

Ralph Bouvette

BC Childress

Shane Fogle

Matt Harman

Brooke Herndon

Casey Humes

Joey Mattingly

Pat Mattingly

Judy Minogue

Lance Murphy

Duane Parsons

Joel Thornbury

Professional Affairs/

Public Affairs

Cassy Beyerle – Chair

Anne Policastri – Vice-Chair

Heather Bryan

Justin Chafin

Danielle Corbett

Candace Robinson Cottle

Allison Cubit

Mark Edwards

Cathy Hanna

Jennifer M. Jaber

Amy Larkin

Jill Lee

Jeff Mills

Elizabeth Moore

Meghann New

Duane Parsons

Misty Stutz

Lisa Tang

Molly Trent

AD HOC

COMMITTEES

Budget & Audit

Glenn Starks – Chair

Frankie Abner

Kim Croley

Trish Freeman

Chris Killmeier

Bob Oakley

Duane Parsons

Sam Willett

Government Affairs

Richard Slone – Chair

Ralph Bouvette

Matthew Burke

Peggy Canler

Matt Carrico

Leon Claywell

Barry Eadens

David Figg

Larry Hadley

Katie Herren

Steve Hill

Tom Houchens

Chris Killmeier

John McFarland

Anne Policastri

Jill Rhodes

Leah Tolliver

Jonathan Van Lahr

Kelly Whitaker

New Practitioner

Amanda Jett – Co-Chair

Chad Corum – Co-Chair

Alex Brewer

Amanda Burton

Khaai Le

Meghann New

Duane Parsons

Megan Pendley

Membership Engagement

Bob Oakley - Chair

Ellen Barger

Chad Corum

Kim Croley

Kyle Harris

Alex Hughes

Ashley Lanham

Benjamin Mudd

Duane Parsons

Brent Simpkins

Vance Smith

Molly Trent

WORK GROUPS

Emergency Preparedness

Leah Caudill

Len Gore

Kyle Harris

Duane Parsons

Jacob Wishnia

Health Information

Technology

Larry Blandford – Chair

Barry Eadens

Kyle Harris

Ryan Hickson

Duane Parsons

Patricia Robinson

Joel Thornbury

Qurratulain Waheed

Provider Status

Trish Freeman – Chair

Nancy Barker

Cassy Beyerle

Ralph Bouvette

Sarah Brouse

Leon Claywell

Holly Divine

Barry Eadens

Jan Gould

Bill Grise

Cathy Hanna

Brooke Hudspeth

Melinda Joyce

Chris Killmeier

Tracey Macaulay

Bob McFalls

Duane Parsons

Bob Oakley

Jill Rhodes

Alyson Schwartz

For descriptions

of the

Committees and

contact

information for

committee

members, go to

www.kphanet.org

and click on

About,

Committees.

September 2013

THE KENTUCKY PHARMACIST 10

Kentucky Pharmacists Political Advocacy Contribution Form

Name: _________________________________ Pharmacy: ___________________________

Address: _______________________ City: ________________ State: _____ Zip: ________

Phone: ________________ Fax: __­­_______________ E-Mail: __________________________________

Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)

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

CONTRIBUTION LIMITS

The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election.

Individuals may contribute no more than $1,500 per year to all PACs in the aggregate.

In-kind contributions are subject to the same limits as monetary contributions.

Cash Contributions: $50 per contributor, per election. Con-tributions by cashier’s check or money order are lim-ited to $50 per election unless the instrument identi-fies the payor and payee. KRS 121.150(4)

Anonymous Contributions: $50 per contributor, per elec-tion, maximum total of $1,000 per election.

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

KPPAC Contribution Form

September 2013

THE KENTUCKY PHARMACIST 11

In 2009 the Centers for Medicare and Medicaid

Services (CMS) implemented Surety Bond Re-

quirements for suppliers of Durable Medical

Equipment, Prosthetics and Supplies (CMS-6006

-F). This ruling requires that each existing suppli-

er must have a $50,000 surety bond to CMS.

Pharmacists Mutual Insurance Company, through

its subsidiary Pro Advantage Services, Inc. d/b/a

Pharmacists Insurance Agency (in California), led

the way to meet this requirement by negotiating

the price of the bond from $1,500 down to $250

for qualifying risks.

To see if you qualify for a $250 Medicare Surety

Bond, or would like information regarding our oth-

er products, please contact us:

Call 800.247.5930 Extension 4260

E-mail [email protected]

Contact a Pharmacists Mutual Field Repre-

sentative or Sales Associate http://

www.phmic.com/phmc/services/ibs/Pages/

Home.aspx

In Kentucky, contact Bruce Lafferre at

800.247.5930 ext. 7132 or 502.551.4815 or

Tracy Curtis at 800.247.5930 ext. 7103 or

270.799.8756.

Pharmacists Mutual Insurance

offers Medicare Surety Bond

Pharmacists Mutual/PTCB

September 2013

THE KENTUCKY PHARMACIST 12

Bowl of Hygeia

Bowl of Hygeia Recipient Leon Claywell Gives Back to Community and Bowl of Hygeia Endowment Fund By Megan Roberson, Communications Manager for APhA Foundation

Leon Claywell, BSPharm,

R.Ph., FACA, the 2013 Bowl

of Hygeia Award recipient

for Kentucky, has an-

nounced that he will match

all contributions from Ken-

tucky pharmacists to the

Bowl of Hygeia endowment

fund made after June 8,

2013. The owner of Medica

Pharmacies in Bardstown and Shepherdsville, Claywell

has a strong passion for community pharmacy and has

dedicated his life to building a healthier community.

As a community pharmacy owner, Claywell has devoted

much of his time to community service. He is an active

member of St. Joseph Parish in Bardstown, and for the

past four years has provided medical supplies from his

pharmacy to St. Joseph’s sister parish in Haiti. Claywell

has also instituted a free vitamin program at the local ele-

mentary school and supported local youth sports teams by

providing free first aid kits and offering use of his pharmacy

parking lot for team fundraisers. Additionally, Claywell has

provided countless health screenings for thousands of local

patients as well as free and reduced flu vaccine clinics.

Claywell is passionate about promoting awareness of is-

sues related to current and proposed rules and regulations

governing pharmacy. He advocates for community phar-

macy through his membership in professional pharmacy

organizations, boards, and committees, including his ser-

vice as chairman of the Kentucky Pharmacists Political Ad-

vocacy Council. He also frequently communicates with

elected representatives at the local, state and federal lev-

els about a variety of issues.

When asked about his advice for young pharmacists, Clay-

well says they should look for opportunities to promote

themselves and their pharmacy through service to the

community. He encourages young pharmacists to become

knowledgeable about each patient – his or her medical

condition, as well as his or her personal and family situa-

tion. He feels it is important to understand patients’ needs

in order to identify the appropriate course of action that will

contribute to an improved quality of life.

Claywell describes re-

ceiving the Bowl of Hy-

geia Award as “a plum

after a long career in

pharmacy.” He is hum-

bled and truly honored

to receive recognition

for his service to the

community. The inspira-

tion for his generous

offer to match all dona-

tions from Kentucky to

the Bowl of Hygeia en-

dowment fund stems

from his love for phar-

macy and community

service.

Claywell describes the

Bowl of Hygeia Award

as the premier state

pharmacy association

award, and a means of

honoring community

service and achieve-

ments of an individual pharmacist over time. He says he

feels it is important that pharmacists understand that histor-

ically the Bowl has been financially supported by drug

manufacturers. Personal sponsorship of the award has

been a challenge, but he believes the award should have a

permanent home and sponsor. “The APhA, NASPA and

the APhA Foundation are ideally situated to become that

home,” says Claywell. “I think that individual pharmacists

and pharmacist-supported organizations should consider

taking on the responsibility of perpetuating the award for

recognizing our deserving pharmacists of the future.”

Claywell is a powerful example of how pharmacists can

make a significant impact on the lives and health of pa-

tients in their community. We applaud him for his career-

long service to the community and are grateful for his gen-

erous contribution to the Bowl of Hygeia. Through these

gifts we are building the Bowl of Hygeia endowment so that

pharmacists of his caliber can continue to be recognized

for their service. To join Claywell in making a personal con-

tribution to the Bowl of Hygeia endowment, visit the Bowl of

Hygeia webpage at www.aphafoundation.org.

Reprinted with permission

of the APhA Foundation. Kentucky Contributors

as of Aug. 26, 2013

Cassandra Beyerle

Cayce's Pharmacy, Inc.

Leon and Margaret Claywell

Brian Fingerson

George Hammons

Tom Houchens

Matthew and Aleshea Martin

Duane Parsons

Donald Riley

Patricia Thornbury

Simon Wolf

$3,410 total contributions

Help KPhA earn Leon’s Pledge!

Visit the Bowl of Hygeia page at

www.aphafoundation.org

to donate today!

September 2013

THE KENTUCKY PHARMACIST 13

Sept. 2013 CE-Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus – Management with a Patient-Centered Approach By: Allison Meyer, PharmD, Auburn University Harrison School of Pharmacy Department of

Pharmacy Practice, Mobile, AL; and Debbie Minor, PharmD, The University of Mississippi Medi-

cal Center Department of Medicine; Jackson, MS

Reprinted with permission of the authors and the Mississippi Pharmacists Association where this arti-

cle originally appeared. This activity may appear in other state pharmacy association journals. There are no financial rela-

tionships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-9999-13-009-H01-P&T

1.5 Contact Hours (0.15 CEU)

Goal

To review guidelines for the management of type 2 diabetes mellitus and highlight recent updates that emphasize the need for a patient-centered approach.

Objectives

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

1. Identify risk factors that influence the development of type 2 diabetes. 2. Describe recommendations for the screening and diagnosis of type 2 diabetes mellitus. 3. Review goals and considerations in the treatment of diabetes. 4. Discuss the management of diabetes, highlighting the need for a patient-centered approach.

KPERF offers all

CE articles to

members online at

www.kphanet.org

INTRODUCTION

Diabetes mellitus is one of the most prevalent diseases and

the seventh leading cause of death in the United States.1

This devastating disease affects more than 25 million

Americans, approximately 8.3 percent of the population

ages ≥ 20 years old, and often leads to cardiovascular

events as well as kidney failure, amputations and blind-

ness. Approximately 90-95 percent of adults with diabetes

have type 2 diabetes mellitus.1 Recent guidelines for man-

agement of this disease discuss a patient-centered and

personalized approach to care. This review highlights com-

ponents of the 2012 American Diabetes Association (ADA)/

European Association for the Study of Diabetes Position

Statement for the Management of Diabetes and the ADA

Standards of Medical Care in Diabetes.2,3

RISK FACTORS AND GUIDELINES FOR SCREENING

Testing to identify asymptomatic individuals with type 2 dia-

betes mellitus is based on age and the presence of risk

factors. The ADA recommends screening all people for dia-

betes starting at age 45 and as early as age 10 in individu-

als who are overweight (Body Mass Index [BMI] > 25 kg/

m2) and have risk factors (Table 1).

2,4 Screening should be

repeated every three years if a diagnosis of diabetes is not

made. In patients who are at an increased risk of develop-

ing diabetes, screenings should be performed more fre-

quently (Tables 1, 2).2

DIAGNOSIS AND GOALS FOR TREATMENT

Unlike many other diseases, there is no distinction between

the tests used for screening and diagnosis of diabetes

mellitus. The diagnosis of diabetes can be made by A1c,

fasting glucose, random glucose or a 2-hour plasma glu-

cose after a 75 g glucose load (Table 2).2,4

Of these validat-

ed measures, A1c is a more stable and long-term measure

of glucose and may be more convenient since fasting is not

required.2 Though using A1c has advantages, it can be

more costly than a fasting glucose and may vary based on

race, age and other characteristics.2 Any of these tests

should be repeated on a separate day if the first is elevat-

ed. If two different tests are performed, e.g., A1c and fast-

ing glucose, the diabetes diagnosis is confirmed if both

measures are above the threshold. If only one measure is

increased, that specific test should be repeated and a diag-

nosis made if that result also is elevated.4

Ideally, fasting glucose levels should be between 70 and

130 mg/dL and post-prandial glucose levels less than 180

mg/dL for all patients with diabetes. The ADA recommends

an A1c goal of < 7 percent for most patients, though a more

or less stringent goal can be considered in selected pa-

tients. Targets for A1c should be individualized based on

patient considerations (i.e., expected treatment efforts, po-

tential risks, disease duration, life expectancy, important

comorbidities, resources) and clinical judgment. The de-

sires and values of the patient, along with consideration of

September 2013

THE KENTUCKY PHARMACIST 14

Sept. 2013 CE-Type 2 Diabetes Mellitus

potential benefits and

risks, need to be ap-

plied with every treat-

ment decision (Table

3). 2,6

These recommenda-

tions for individualiza-

tion of A1c and treat-

ment goals are based

on the results of studies suggesting that not all patients

benefit from aggressive glucose management.2 The

UKPDS study evaluated the effect of medications

(metformin, insulin or sulfonylurea) vs. dietary restriction in

newly diagnosed patients with diabetes on cardiovascular

events and microvascular complications (vitreous hemor-

rhage, retinopathy, nephropathy). After a 10-year follow-up,

patients receiving medications had a significant decrease in

microvascular disease, myocardial infarctions and all-cause

mortality. These findings support the recommendation for

more aggressive glucose management in newly diagnosed

patients, with the hope of preventing cardiovascular and

microvascular complications.5 The ACCORD, ADVANCE

and VADT trials evaluated patients with cardiovascular dis-

ease or risk factors and longstanding diabetes. These trials

did not show a cardiovascular benefit with intensive glyce-

mic control (A1c < 6 percent vs. A1c 7-8 percent) in the

overall populations and

support a less stringent

A1c goal for some pa-

tients.3 Though the risk of

microvascular and

macrovascular complica-

tions of diabetes are

clearly related to glyce-

mia, a patient-centered

approach will more ap-

propriately align the needs, preferences and tolerances of

each patient.3

ANTIHYPERGLYCEMIC THERAPY

Lifestyle

Over-nutrition and sedentary lifestyle are the major environ-

mental factors that increase the risk of developing type 2

diabetes; hence, diet, exercise and education are a critical

part of management and prevention. Progression to diabe-

tes can be slowed or potentially prevented through thera-

peutic lifestyle changes (TLC) and possibly medications.4

The Diabetes Prevention Program, a study of 3,234 pre-

diabetic patients over 2.8 years, highlights the value of life-

style behaviors in diabetes prevention. This study random-

ized patients to placebo or metformin 850 mg twice daily,

both with standard lifestyle recommendations, or intensive

Table 1: Risk Factors and Screening for Diabetes2,4

Screen people with no risk factors starting at age 45 years. With normal results, repeat screenings every 3 years.

Screen asymptomatic adults at any age with a BMI > 25 kg/m

2 and one or more risk factors.

With normal results, repeat screenings at 3-year intervals or more frequently if clinically warranted (e.g. pre-diabetes, risk status).

RISK FACTORS

Physical inactivity

Family history of diabetes (1st degree relative)

Ethnicity (e.g. African American, Latino, Native American, Asian American, Pacific Islander)

Delivery of a baby > 9 lbs or diagnosis with gestational diabetes

Blood pressure > 140/90 or taking antihypertensives

HDL-cholesterol < 35 mg/dL and/or triglycerides > 250 mg/dL

Polycystic ovary syndrome (PCOS)

Pre-diabetes (see table 2)

Cardiovascular disease

Conditions with insulin resistance (e.g. severe obesity, acanthosis nigricans)

Screen asymptomatic children starting at age 10 years or at onset of puberty if overweight plus 2

additional risk factors.

Repeat screenings every 3 years.

Family history of diabetes (1st or 2

nd degree relative)

Ethnicity (as above)

Signs of insulin resistance (e.g. hypertension, dyslipidemia, PCOS, acanthosis nigricans)

Maternal history of diabetes or gestational diabetes during child’s gestation

Table 2: Diagnosis of Pre-Diabetes and Diabetes2,4

Increased Risk for Diabetes (Pre-Diabetes)

Diabetes Diagnosis

A1c 5.7-6.4 percent Impaired fasting glucose

(100 -125 mg/dL) Impaired glucose tolerance

(140 -199 mg/dL, 2 hours after 75 g glucose load)

A1c > 6.5 percent 8-hour fasting plasma glucose

> 126 mg/dL 2-hour plasma glucose > 200

mg/dL (after 75 g glucose load)

Symptoms and random glucose > 200 mg/dL

September 2013

THE KENTUCKY PHARMACIST 15

Sept. 2013 CE-Type 2 Diabetes Mellitus

lifestyle modifications alone. Patients randomized to inten-

sive lifestyle changes underwent an individualized 16-

course curriculum with a focus on healthy eating habits (low

-fat, low-calorie diet) and moderate exercise (150 minutes

per week) to achieve a 7 percent weight loss from baseline.

The incidence of new-onset diabetes was lowest in the in-

tensive lifestyle group and highest with placebo, with signifi-

cant differences between all three groups. Based on these

results, 6.9 patients would need to undergo intensive life-

style modifications and 13.9 would need to take metformin

to prevent one case of diabetes in three years.6 Weight loss

and exercise also improve coincident cardiovascular risk

factors and other consequences of obesity.3,7

All newly diagnosed patients and those at risk for develop-

ing diabetes should be counseled on necessary TLC.2,3

Suggestions for dietary interventions, physical activity and

weight reduction should be personalized with considerations

for the individual’s preferences and culture. Ideally, TLC

consists of moderate exercise for at least 150 minutes per

week and a healthy diet to include increased fiber and

whole grains and decreased saturated fat, carbohydrates

and calories. A modest weight reduction of 5 to 10 percent

can improve glycemic control and other cardiovascular risk

factors. Patients that are highly motivated and have an A1c

near target (<7.5 percent) can be given a 3 to 6 month trial

of TLC before pharmacotherapy. For those with a higher

A1c, successful TLC can allow for modification or possible

discontinuation of pharmacotherapy. TLC requires periodic

assessment and counseling should be an integrated part of

maintenance treatment. 3

Pharmacotherapy

With the frequent emergence of new medications, it can be

difficult to know which treatment options are best for a pa-

tient. When choosing agents and treatment goals, a patient-

centered approach should be utilized. Specific patient and

medication characteristics should be considered, including

the efficacy of the drug, potential for hypoglycemia, effect on

weight, potential side effects, costs and preferences. For

example, older patients with long-standing diabetes are at

more risk for hypoglycemia, which can cause unsteadiness,

falls and potentially fractures. They also are more likely to

have comorbidities, such as renal disease, heart failure and

osteoporosis, which can limit the use of certain medications

or increase the risk of adverse effects. Because most pa-

tients with diabetes are overweight or obese, the effect of

medications on weight is an important concern.3

Metformin, if not contraindicated, should be initiated in most

patients unable to achieve their A1c goal with TLC. Based

on an individual patient’s needs or preferences or if metfor-

min cannot be used, a sulfonylurea, thiazolidinedione (TZD),

dipeptidyl peptidase 4 DPP-4 inhibitor (DPP-4I), glucagon-

like peptide-1 (GLP-1) agonist or insulin may be a reasona-

ble option as first, second or third line therapy. In general, if

glucose targets are not achieved after 3 months of therapy

with TLC and metformin or baseline A1c is high (> 9 per-

cent), combination therapy with one or two additional agents

from the above classes is recommended (Table 4). Other

agents or classes (e.g. meglitinides, alpha-glucosidase in-

hibitors, bile acid sequestrants, amylin mimetics, dopamine-

2 agonists) also may be appropriate for selected patients.3

Metformin, sulfonylureas, TZDs and GLP-1 agonists reduce

A1c by 1-1.5 percent, whereas the other non-insulin agents

lower A1c by only 0.5-1%. For this reason, patients with an

A1c > 9 percent at diagnosis can reasonably be started on a

two-drug regimen and potentially insulin. Initiating insulin

should be highly considered in patients with severely uncon-

trolled diabetes with catabolism, either at the time of diagno-

sis or later in treatment. Those with fasting glucose levels >

250 md/dL, consistent random glucoses > 300 mg/dL, keto-

nuria, an A1c > 10 percent or symptomatic diabetes, should

receive insulin to rapidly lower glucose levels. Eventually

many patients require insulin therapy, including basal and

shorter-acting.2,3,7

Metformin

Metformin, a biguanide, is first line therapy for most patients

with type 2 diabetes.2,3,7

This medication works primarily by

lowering fasting glucose and decreasing hepatic glucose

production. The most common side effects of metformin are

gastrointestinal upset and diarrhea. These side effects can

be minimized by taking the medication with food, starting

with 500 mg daily and slowly titrating to 1000 mg twice daily

as tolerated. Metformin is contraindicated in patients at risk

Table 3: A1c Goals and Considerations2,3

A1c < 7 percent Most patients

Consider A1c < 6.5 percent

Younger patients

Recently diagnosed

No frequent/severe hypoglycemia

No significant cardiovascular disease

Highly motivated

Consider A1c < 8 percent

Elderly patients

Longstanding diabetes

Frequent/severe hypoglycemia

Significant cardiovascular disease or cardiovascular risk factors

Extensive comorbidities

Difficult-to-treat diabetes

September 2013

THE KENTUCKY PHARMACIST 16

Sept. 2013 CE-Type 2 Diabetes Mellitus

of lactic acidosis (e.g., advanced renal insufficiency, alco-

holism) and prescribing guidelines warn against use in pa-

tients with a serum creatinine > 1.5 mg/dL in males or > 1.4

mg/dL in females. Recent studies and clinical experience

suggest, however, that metformin is safe unless the esti-

mated glomerular filtration rate falls below 30 mL/minute.

The major non-glycemic effect of metformin is either weight

stability or modest weight loss. This provides an additional

benefit for obese patients, though it also is effective in lean-

er patients. This medication does not cause hypoglycemia

and is inexpensive, making it a well-tolerated and conven-

ient first line agent for most patients.2,3,7

In the 10-year fol-

low-up of the UKPDS study, metformin reduced cardiovas-

cular events and mortality compared to dietary manage-

ment. Patients receiving metformin as initial therapy had

fewer cardiovascular events than patients receiving a sul-

fonylurea or insulin.6

Sulfonylureas

Sulfonylureas are the oldest marketed class of oral diabetes

medications.2,3

The most commonly used medications in

this class are the 2nd

generation agents: glimepiride, glipiz-

ide and glyburide. Sulfonylureas stimulate insulin release

from pancreatic beta cells and reduce hepatic glucose out-

put.3,7

The glucose-lowering effects are rapid in comparison

to some other classes and are near fully realized at half-

maximal doses; higher doses should generally be avoided.

Because insulin release is independent of glucose intake,

the potential for prolonged hypoglycemia is high, particular-

ly in the elderly. Glyburide is associated with a substantially

greater risk of hypoglycemia compared with other 2nd

gen-

eration sulfonylureas and thus is non-preferred. An average

weight gain of approximately 2 kg is common with therapy.7

Sulfonylureas reduced myocardial infarction and microvas-

cular disease compared to dietary management in the 10-

year follow-up of the UKPDS study.6 The low cost of sul-

fonylureas is attractive for many patients.

Thiazolidinediones

Pioglitazone and rosiglitazone increase insulin sensitivity by

activation of the nuclear transcription factor PPAR-γ.7

These agents do not generally cause hypoglycemia and

may be more effective in overweight individuals; however,

they are associated with weight gain. Because TZDs com-

monly cause edema, they are contraindicated in NYHA

Class III/IV heart failure. TZDs also have been linked to

bone fractures.7 In 2010, the FDA restricted access to

rosiglitazone due to increased risk of myocardial infarction

and other cardiovascular disease events.8 Use currently is

limited to patients already controlled on this medication or

who cannot be controlled on other anti-diabetic agents.

Practitioners and special mail-order pharmacies wanting to

provide rosiglitazone must be enrolled in the Avandia-

Rosiglitazone Medicines Access Program.8 Because of

these restrictions, pioglitazone is more widely used.2,3

This

agent may decrease triglyceride and increase HDL-

cholesterol levels, the typical pattern of dyslipidemia in pa-

tients with diabetes. A recent study with pioglitazone

showed a potential risk of bladder cancer, though this medi-

cation is not renally cleared and requires no dosage reduc-

tion in kidney disease. Pioglitazone has a modest cardio-

vascular benefit when added to standard diabetes regimens

in patients with macrovascular disease.2,3

Incretin System: DPP-4Is and GLP-1 Agonists

The oral DPP-4Is (alogliptin, linagliptin, saxagliptin,

sitagliptin) and injectable GLP-1 agonists (exenatide, lirag-

lutide) work through the incretin system. These medications

either mimic the actions of the physiologic hormone GLP-1

or prevent the degradation of GLP-1 and glucose-

dependent insulinotropic peptide (GIP) by DPP-4. These

incretin hormones are secreted in the small intestine in a

glucose-dependent manner. Ingestion of food triggers GLP-

1 release which then lowers glucose levels by stimulating

insulin and inhibiting glucagon secretion. GLP-1 agonists

and DPP-4Is primarily decrease post prandial glucose;

however, they also lower fasting plasma glucose.2,3,7

The

GLP-1 agonists also slow gastric emptying and decrease

appetite, offering an attractive option for many obese pa-

tients as they modestly decrease weight. The DPP-4Is are

Table 4: Treatment of Diabetes2,3

Therapeutic Lifestyle Changes for All Patients

Initial Drug Therapy Metformin

Two-Drug Regimen ADD Sulfonylurea

ADD TZD ADD DPP-4I

ADD GLP-1 Agonist

ADD Insulin

Three-Drug Regimen

ADD TZD or DPP-4I or GLP-1 agonist or Insulin

ADD Sulfonylurea or DPP-4I or GLP-1 agonist or Insulin

ADD Sulfonylurea or TZD or Insulin

ADD Sulfonylurea or TZD or Insulin

ADD TZD or DPP-4I or GLP-1 agonist

Complex Insulin Regimen

Multiple daily doses of insulin

September 2013

THE KENTUCKY PHARMACIST 17

July 2013 CE—Pediatric OTC

weight neutral. Neither of these incretin-based classes

cause hypoglycemia. The most common side effects of

GLP-1 agonists are nausea and vomiting, particularly early

in therapy. DPP-4Is are generally well tolerated, though

reports of urticarial and angioedema have occurred. Pan-

creatitis has questionably been associated with both clas-

ses. In animals, GLP-1 agonists have been linked to thyroid

tumors. DPP-4Is and GLP-1 agonists are not recommend-

ed for combination as they target the same pathway. GLP-

1 agonists and DPP-4 antagonists may also decrease car-

diovascular risk factors, but long-term benefits have not

been studied.2,3,7

Insulin

Diabetes progression causes dysfunction and loss of pan-

creatic beta-cells.2,3

When the pancreas can no longer pro-

duce and secrete enough insulin to maintain normal glu-

cose levels, patients require exogenous insulin.2,3

Basal insulin, either intermediate-acting (NPH) or long-

acting (glargine and detemir), is initiated prior to meal time

insulin in most patients.2,3

The long-acting insulins are typi-

cally dosed once daily and may be associated with less

nocturnal hypoglycemia. NPH usually is dosed twice daily

and is generally a less expensive option than the long-

acting insulins.2,3

Initially, patients should be started on ba-

sal insulin at approximately 0.1-0.2 units/kg/day.2,3,7

Many

patients can be educated to self-titrate, with small dose

increases (e.g., 1-2 units) once or twice a week until fasting

glucose targets are achieved.3 Allowing self-titration engag-

es the patient as an active member of the care team and is

more convenient, though the practitioner should maintain

frequent contact.

Patients unable to maintain goal glucose levels with a non-

insulin regimen along with basal insulin should receive

prandial insulin.2,3

Rapid insulin – lispro, aspart and glulis-

ine – has a quick onset of action and is dosed just prior to

meals. The onset of action of regular insulin is about 30

minutes, which may be an inconvenience. These shorter-

acting insulin regimens should be titrated and individualized

based on a patient’s typical diet, changes in carbohydrate

intake and exercise to achieve goal glucose levels.2,3

One

approach involves adding insulin to one meal at a time,

starting with the meal with the highest carbohydrate intake.

This highly individualized approach takes into account the

patient’s diet and typical post-prandial glucose measure-

ments. A second approach involves using a fixed combina-

tion of intermediate-acting insulin with a prandial insulin

administered twice daily with breakfast and dinner. This

approach is less flexible compared to the insulin dose of

the components; however, it may be convenient and ac-

ceptable for patients with regular eating habits and a need

for a more simplistic regimen.3,7

For most patients, metformin should be continued once

insulin is initiated as it increases insulin sensitivity. Insulin

secretagogues (e.g., sulfonylureas, meglitinides), however,

do not provide additional benefit and increase the risk of

hypoglycemia. These agents may be continued if the pa-

tient is only receiving basal insulin, but should be discontin-

ued once prandial insulin is initiated. All insulin regimens

have been associated with weight gain. TZDs in combina-

tion with insulin also may cause excessive edema and

weight gain. Insulin clearance may be slower in renal dis-

ease; caution should be used when titrating. In patients

with advanced liver disease, insulin is the preferred agent.

Recent data suggests that GLP-1 agonists with insulin may

be beneficial in some patients.3

Meglitinides, Alpha-Glucosidase Inhibitors, Sodium-

Glucose Co-Transporter 2 Inhibitor, Bile Acid Seques-

trants, Amylin Mimetics, Dopamine-2 Agonists

The following medications and classes are used less com-

monly because of either limited efficacy, a high propensity

for adverse effects or higher costs. However, for selected

patients, they each may offer an acceptable option based

on individual preference or need.

The meglitinides, nateglinide and repaglinide, stimulate

insulin secretion, similar to the sulfonylureas.2,3,7

These

medications, however, have a much shorter half-life and

must be dosed with each meal, which may affect compli-

ance. Side effects are similar to the sulfonylureas, though

they may cause less hypoglycemia.2,3,7

Acarbose and miglitol are alpha-glucosidase inhibitors that

slow carbohydrate absorption in the gut, decreasing post-

prandial glucose.2,3,7

They require dosing with each meal,

and because of their site of action, they frequently cause

gastrointestinal symptoms, such as flatulence.2,3,7

Canagliflozin, the newest medication for diabetes, is a sodi-

um-glucose co-transporter 2 (SGLT2) inhibitor that lowers

the renal threshold for glucose and increases urinary glu-

cose excretion. This medication specifically reduces reab-

sorption of glucose filtered through the renal tubules and

lowers A1c approximately 1 percent. It has been studied as

both mono- and combination therapy. Increased urination,

myocotic infections and urinary tract infections were ob-

served in clinical trials.9 The overall role of canagliflozin in

diabetes management is yet to be determined.

Colesevelam is a bile acid sequestrant more commonly

used in hyperlipidemia to decrease LDL cholesterol.2,3,7

The mechanism of action in diabetes is poorly understood.

September 2013

THE KENTUCKY PHARMACIST 18

Sept. 2013 CE-Type 2 Diabetes Mellitus

Colesevelam may increase triglyceride levels and may

cause constipation. There is a potential for drug interac-

tions by binding to other medications.2,3,7

Pramlintide works through the incretin system and activates

amylin receptors. It is administered subcutaneously and

has effects similar to the GLP-1 agonists. Use is limited

because of modest efficacy, side effects and frequent dos-

ing schedule. It is typically reserved for patients treated with

intensive insulin therapy.3,7

The dopamine-2 agonist bromocriptine modulates hypotha-

lamic regulation of metabolism and increases insulin sensi-

tivity. Though it does not cause hypoglycemia, use is lim-

ited by the high cost and dopaminergic-type adverse ef-

fects.3

CONCLUSION

Diabetes is a disease that is associated with numerous

complications, increased medical costs and increased mor-

bidity and mortality. The risk factors for this disease are

epidemic in our population. Methods for diagnosis have

evolved over the years with A1c as the most recent addi-

tion. Based on recent research and findings, the goals of

therapy and recommendations for the management of indi-

vidual patients have been refined. With the many options

available for treatment, the choice to use specific agents in

type 2 diabetes mellitus should be patient-centered, focus-

ing on both patient and disease factors. Communication

and engaging the patient in medication selection will help

ensure compliance, avoidance of adverse effects and ap-

propriate disease management. Motivating patients to ad-

dress necessary TLC remains a critical part of manage-

ment. Ultimately, it is the patient who decides how well his/

her diabetes will be managed. Using a patient-centered

approach encourages attention to the variable and progres-

sive nature of type 2 diabetes and is crucial for improving

outcomes.

Pharmacists and pharmacy technicians encounter patients

with diabetes on a daily basis. We are in a unique position

to influence patient care and decisions, particularly in the

areas of medication use and selection and lifestyle behav-

iors. By understanding current issues related to therapy, we

as a team can effectively impact disease management and

outcomes for many patients with diabetes.

REFERENCES

1. Centers for Disease Control and Prevention. National

diabetes fact sheet: national estimates and general

information on diabetes and prediabetes in the United

States, 2011. Atlanta, GA: U.S. Department of Health

and Human Services, Centers for Disease Control and

Prevention, 2011.

2. American Diabetes Association. Standards of Medical

Care in Diabetes – 2013. Diabetes Care 2013;36:S11-

S66.

3. Inzucchi SE, Bergenstal RM, Buse JB, et al. Manage-

ment of Hyperglycemia in Type 2 Diabetes: A Patient-

Centered Approach. Diabetes Care 2012;35:1364-79.

4. Inzucchi SE. Diagnosis of Diabetes. NEJM

2012;367:542-50.

5. Holman RR, Paul SK, Bethel MA, et al. 10-year follow-

up of intensive glucose control in type 2 diabetes. N

Engl J Med 2008;359:1577–1589.

6. Diabetes Prevention Program Research Group. Reduc-

tion in the incidence of type 2 diabetes with lifestyle

intervention or metformin. NEJM 2002;346:393-403.

7. Nathan DM, Buse JB, Davidson MB, et al. Medical

management of hyperglycemia in type 2 diabetes: a

consensus algorithm for the initiation and adjustment of

therapy: a consensus statement of the American Dia-

betes Association and the European Association for the

Study of Diabetes. Diabetes Care. 2009;32:193-203.

8. FDA Drug Safety Communication: Updated Risk Evalu-

ation and Mitigation Strategy (REMS) to Restrict Ac-

cess to Rosiglitazone-containing Medicines including

Avandia, Avandamet, and Avandaryl. FDA Website:

http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm.

9. INVOKANA™(canagliflozin) product labeling. 2013

Janssen Pharmaceuticals, Inc. Titusville, NJ.

Marriott Griffin Gate Resort

Lexington, KY

November 15-16, 2013

$95 for Pharmacist Members

$35 for Technician members

$5 for Student Pharmacists

Register today at www.kphanet.org

September 2013

THE KENTUCKY PHARMACIST 19

Sept. 2013 CE-Type 2 Diabetes Mellitus

Nominate your peers for a new feature in

The Kentucky Pharmacist

We are looking for members to profile in coming editions of

The Kentucky Pharmacist who are making the world a better place. Do you know

someone who goes above and beyond the “above and beyond the call of duty”? Let

us know!

Email Scott Sisco at [email protected] with a brief description of the story or

to schedule a time to discuss.

September 2013 — Type 2 Diabetes Mellitus – Management with a Patient-Centered Approach

1. All people should be screened for diabetes beginning at age: A. 10 years. B. 45 years. C. 60 years. 2. Which of the following would not warrant a diabetes screening prior to age 45? A. Family history of diabetes B. African American ethnicity C. LDL-cholesterol > 160 mg/dL D. Polycystic ovarian syndrome 3. Based on results of the Diabetes Prevention Program, the most effective way to prevent progression of pre-diabetes to diabetes is: A. metformin. B. intensive lifestyle modification. C. insulin. D. glipizide. 4. For most patients with diabetes, an A1c goal of < 6.5 percent is acceptable. A. True B. False 5. An 80 year old woman has had diabetes for 15 years. She has osteoporosis and frequently becomes hypogly-cemic. What is the most appropriate A1c goal for her? A. < 7 percent B. < 10 percent C. < 6.5 percent D. < 8 percent 6. Patient A has an A1c of 6.8 percent and fasting glu-cose of 135 mg/dL. Does this patient have diabetes? A. Yes B. No

7. What initial treatment would be reasonable for Patient A? (Assume no co-morbidities and normal renal function) A. TLC B. TLC and metformin C. TLC and pramlintide D. Either A. or B. 8. Sulfonyureas are associated with all of the following EXCEPT: A. hypoglycemia. B. glucose-dependent insulin secretion. C. weight gain. D. rapid glucose lowering. 9. Weight gain is associated with all of the following classes of medications EXCEPT: A. sulfonylureas. B. insulin. C. GLP-1 agonists. D. TZDs. 10. For most patients, insulin is most appropriately initi-ated as: A. basal insulin once or twice daily. B. prandial insulin with each meal. C. prandial plus basal insulin twice daily. 11. Colsevelam and bromocriptine are less frequently used in diabetes because of: A. cost. B. side effects. C. less relative efficacy. D. one or all of the above.

September 2013

THE KENTUCKY PHARMACIST 20

Sept. 2013 CE-Type 2 Diabetes Mellitus

This activity is a FREE service to members of the Kentucky Pharmacists Association. The

fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South,

Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

The Kentucky Pharmacy Education & Research Foundation is

accredited by The Accreditation Council for Pharmacy

Education as a provider of continuing Pharmacy education.

Quizzes submitted without NABP eProfile

ID # and Birthdate cannot be accepted.

PHARMACISTS ANSWER SHEET September 2013 — Type 2 Diabetes Mellitus – Management with a Patient-Centered Approach Universal Activity # 0143-9999-13-009-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C 3. A B C D 5. A B C D 7. A B C D 9. A B C D 11. A B C D 2. A B C D 4. A B 6. A B 8. A B C D 10. A B C Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD)

Expiration Date: September 10, 2016 Successful Completion: Score of 80% will result in 1.5 contact hour or 0.15 CEU.

Participants who score less than 80% will be notified and permitted one re-examination.

TECHNICIANS ANSWER SHEET. September 2013 — Type 2 Diabetes Mellitus – Management with a Patient-Centered Approach Universal Activity # 0143-9999-13-009-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C 3. A B C D 5. A B C D 7. A B C D 9. A B C D 11. A B C D 2. A B C D 4. A B 6. A B 8. A B C D 10. A B C Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD)

September 2013

THE KENTUCKY PHARMACIST 21

For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative,

contact Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness at 502-227-2303 or by email at

[email protected]. KPhA is a partner with the Kentucky Department of Public Health for emergency pre-

paredness and disaster response. For more resources, visit YOUR www.kphanet.org and

click on Resources—Emergency Preparedness.

KPhA Pharmacy Emergency Preparedness Initiative Interest Form

Name: __________________________________ QS/1 Experience: Yes____ No _____

Status (Pharmacist, Technician, Other): ___________________________

Email: ______________________________ Phone: ___________________________

For Pharmacists: Interest in serving as a volunteer: Yes____ No _____

If yes, please go to KHELPS link on KPhA Website to register (www.kphanet.org under Resources)

____ I would like to serve as pharmacy district coordinator (PDC). PDCs will serve as a point of contact in

their respective county and may assist in dispensing activities on the mobile pharmacy if deployed in the

event of a disaster.

Please send this information to Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness via email

at [email protected], fax to 502-227-2258 or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601.

KPhA, in conjunction with the Kentucky Renaissance

Pharmacy Museum, is planning an Open House to cel-

ebrate Pharmacists Month in October at KPhA Head-

quarters in Frankfort. We plan to have the Mobile Phar-

macy set up for demonstrations to the public and se-

lected exhibits from the museum. Watch eNews for

more information.

As KPhA leaders travel around the state to pharmacies,

we are promoting the emergency preparedness pro-

gram. When KPhA visits your pharmacy, be sure to ask

about how you can help in the event of a disaster!

If you are interested in hosting an Emergency Prepar-

edness CE program in your area, please contact Leah

Tolliver at 502-227-2303 or [email protected].

September is Emergency Preparedness Month

KPhA Pharmacy Emergency Preparedness

October is American and Kentucky

Pharmacists Month!

Share your pictures of celebrations

on our Facebook Page:

facebook.com/KyPharmAssoc

September 2013

THE KENTUCKY PHARMACIST 22

Migraine Headache: Updated Recommendations for Preventive Therapy By: Emily White, PharmD, Kris Harrell, PharmD, and Deborah Minor, PharmD, University of Mississippi Medical Center, Departments of Pharmacy, Pharmacy Practice and Medicine Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared. This activity may appear in other state pharmacy association journals. There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-9999-13-010-H01-P&T 2.0 Contact Hours (0.2 CEUs)

Goal: To discuss migraine headaches and recent guideline updates for evidence-based preventive treatment.

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

1. Review the pathophysiology and clinical presentation of migraine 2. Discuss indications for and considerations in selection of preventive migraine therapy 3. Describe preventive therapy recommendations based on evidence provided in recent guideline updates

KPERF offers all

CE articles to

members online at

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INTRODUCTION

Headache is one of the most common complaints encoun-

tered by healthcare practitioners and among the top three

reasons given by adults for visiting United States emergen-

cy departments. Migraine headache, one of the most com-

mon primary headache disorders, affects approximately 6

percent of men and 18 percent of women and occurs dur-

ing the most productive years of life (18 to 59 years of

age).1,2

The pain and other associated symptoms of mi-

graine can not only diminish the quality of life for those with

the headache, but also have a great impact on family mem-

bers and employers.

Despite the high prevalence of migraine headaches, stud-

ies indicate that most headache sufferers do not seek ap-

propriate medical care. Patients with migraines are under-

diagnosed and undertreated.1,2

In 2004, it was found that

only one-half of patients with evident symptoms of migraine

had been formally diagnosed by a physician.2 Appropriate

care with an individualized approach to treatment can result

in a reduction in attack frequency and severity, thus mini-

mizing headache-related disability and emotional distress

and improving the patient’s quality of life.1,2

Treatment strategies for migraine must address both imme-

diate and long-term goals. Acute migraine therapies should

provide consistent, rapid relief and enable the patient to

resume normal activities at home, school or work. Recur-

rence of symptoms and treatment-related adverse effects

should be minimal. When migraine attacks occur frequently

or symptomatic therapies are ineffective, preventive thera-

py should be considered.2 In April 2012, new recommenda-

tions for the treatment of episodic migraine prevention in

adults were released from the collaborative efforts of the

American Academy of Neurology (AAN) and the American

Headache Society (AHS).3,4

These guidelines build upon

the previous standards and review contemporary evidence

supporting the use of pharmacologic, nonsteroidal anti-

inflammatory drug (NSAID) and complementary therapies

for migraine prevention.3,4

The goal of this review is to dis-

cuss the general pathophysiology and clinical presentation

of migraine headaches and describe options for preventive

therapy, in reference to the recently published guidelines

for preventive treatment.

PATHOPHYSIOLOGY OF MIGRAINE

Migraine headaches are defined as episodic, neurovascu-

lar events involving severe, pulsating head pain often ac-

companied by a wide variety of secondary symptoms. The-

ories of the etiology and pathophysiology of migraine have

evolved over the past decade, but remain less than com-

pletely understood.2,5

Migraines appear to result from com-

plex central nervous system (CNS) dysfunctions in the tri-

geminovascular system.6 Cerebral vascular tone and noci-

ception are altered and the associated pain and symptoms

are a combination of altered perceptions resulting from

neural suppression and activation of subcortical structures

and trigeminal systems. Neuronal and broad sensory pro-

cessing are thought to be regulated at least in part by sero-

tonergic neurons in the brainstem. Genetic factors appear

to influence CNS sensitivity to migraine-specific triggers or

environmental factors and the susceptibility to attack occur-

rence and frequency.2,7

CLINICAL PRESENTATION OF MIGRAINE

The clinical presentation of the migraine attack can typically

be divided into several phases (Table 1).2,8

Migraine head-

aches, with or without aura, typically begin with a gradual

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onset of pain, most often unilaterally, near the frontal or

temporal regions of the brain. The pain can become more

generalized as the headache progresses. “Premonitory

symptoms” are experienced by 20 percent to 60 percent of

migraineurs and can occur in the hours or days before the

onset of headache. These symptoms can vary widely

among migraineurs but usually are consistent within an

individual. The terms “prodrome” and “warning symptoms”

should be avoided as these are often used mistakenly to

include aura. Approximately one-third of migraine patients

do experience auras, a multifaceted combination of focal

neurological symptoms that occur just before or occasional-

ly during a migraine attack.2,7,8

Migraines frequently occur in early mornings, but can hap-

pen at any time of day. Secondary symptoms including

sensory, cognitive and especially gastrointestinal-related

can accompany the headache and further impair daily ac-

tivities. Even after the headache pain dissipates, psycho-

logical or neurological symptoms may persist for hours.2,8

CONSIDERATIONS FOR PREVENTIVE TREATMENT

Approximately 25 percent of patients who suffer from se-

vere migraines experience four or more attacks over a

month.5 Frequent use of acute treatments is less than opti-

mal management and can exacerbate headaches, leading

to the development of medication-overuse or rebound

headaches. To prevent medication-overuse headaches

from occurring, it is recommended that acute treatments be

limited and prophylactic therapy be considered.2 Unfortu-

nately, it is estimated that only 3 to 13 percent of the 38

percent of patients who qualify for migraine preventive ther-

apy actually receive it.1

Preventive therapy should be considered in the setting of

Table 1: Clinical Presentation of Migraine Headache

General

Common, recurrent, severe primary headache disorder that interferes with normal functioning. Two major subtypes - migraine without aura and migraine with aura. A thorough headache history should include age at onset, attack frequency and timing, duration of attacks, precipitating or aggravating factors, ameliorating factors, description of neurologic symptoms, characteristics of the headache pain (quality, intensity, location and radiation) and associated signs and symptoms.

Signs and Symptoms

Characterized by recurring episodes of throbbing pain, that last from 4 to 72 hours when untreated. Signs include a sta-ble pattern, absence of daily headache, positive family history for migraine, normal neurologic examination, presence of triggers, menstrual association, long-standing history, improvement with sleep and subacute evolution. Premonitory Symptoms

Occur in the hours or days before headache onset. Include neurologic (e.g., allodynia, phonophobia, photophobia, hy-perosmia, difficulty concentrating), psychological (e.g., anxiety, depression, euphoria, irritability, drowsiness, fatigue, hyperactivity, restlessness), autonomic (e.g., polyuria, diarrhea, constipation) and constitutional symptoms (e.g., ano-rexia, food cravings, stiff neck, excessive yawning, extreme thirst).

Aura

A complex of positive and negative focal neurologic symptoms that precede or accompany an attack. Aura is most often visual, frequently affecting half the visual field. Sensory and motor symptoms (e.g., paresthesias or numbness of arms/face, dysphasia or aphasia, weakness, hemiparesis) also may occur. Symptoms typically evolve over 5 to 20 minutes and last < 60 minutes, with headache usually occurring within 60 minutes of the end of the aura.

Headache

Pain is usually gradual in onset, peaking in intensity over minutes to hours and often severe. Headache is typically uni-lateral, in the frontotemporal region, but can occur anywhere or become generalized during the attack. Gastrointestinal symptoms almost invariably accompany the headache (e.g., nausea, vomiting, diarrhea, cramping). Other systemic symptoms (e.g., facial/scalp/periorbital edema, nasal stuffiness) and sensory hyperacuity (e.g., photophobia, phonopho-bia, osmophobia) also are common. Pain is usually aggravated by physical activity. Not all symptoms are present at every attack.

Resolution

As the headache pain wanes, various symptoms and mood changes are experienced. Symptoms range from tiredness, irritability, malaise, impaired concentration and scalp tenderness to feeling unusually refreshed or euphoric.

Table 2: Goals of Therapy in Long-Term Migraine Treatment Reduce migraine frequency, severity

and disability Reduce reliance on poorly tolerated, ineffective or

unwanted acute pharmacotherapies Improve quality of life Prevent headache Avoid escalation of headache medication use Educate and enable patients to manage their

disease Reduce headache-related distress and

psychological symptoms

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recurring migraines that produce significant disability; fre-

quent attacks requiring symptomatic medication more than

twice per week; symptomatic therapies that are ineffective,

intolerable or contraindicated; if migraines are more severe

and/or have a risk of neurological damage; or, if patients

prefer this approach. Preventive therapy also may be ad-

ministered preemptively or intermittently when headaches

recur in a predictable pattern (e.g., exercise-induced mi-

graine or menstrual migraine). The goals of therapy for

long-term migraine treatment are identified in Table 2.2,5,9-11

The preventive management of migraine should begin with

the identification and avoidance of factors that consistently

provoke migraine attacks in susceptible individuals. Pa-

tients should be encouraged to keep a headache diary to

document the frequency, severity and duration of attacks

as well as responses to medications and potential trigger

factors. Patients also can benefit from adherence to a gen-

eral wellness program that includes regular sleep, exercise

and eating habits, avoidance of headache triggers, smok-

ing cessation and limited caffeine intake.2,5,10,11

Table 3: Preventive Migraine Therapies

Drug Initial Dose Usual Range Comments

β-Adrenergic antagonists

AtenololB 50 mg/day 50–200 mg/day

MetoprololA 100 mg/day in divided

doses

100-200 mg/day in divided doses

Dose short-acting 4 times a day and long-acting 2 times a day; available as extended release

NadololB 40-80 mg/day 80–240 mg/day

PropranololA 40 mg/day in divided doses 40–160 mg/day in divided

doses

Dose short-acting 2-3 times a day and long-acting 1-2 times a day; available as extended release

TimololA 20 mg/day in divided doses 20–60 mg/day in divided

doses

Antidepressants

AmitriptylineB 10 mg at bedtime 20–50 mg at bedtime

VenlafaxineB 37.5 mg/day

75-150 mg/day Available as extended

release; increase dose after 1 week

Antiepileptics

TopiramateA 25 mg/day 50-200 mg/day

in divided doses

As effective as amitriptyline, propranolol or valproate; increase by 25 mg/week

Valproic acid/ divalproex sodium

A

250-500 mg/day in divided doses, or daily for extended release

500–1,500 mg/day in divided doses, or daily for extended release

Monitor levels if compliance is an issue

Nonsteroidal anti-inflammatory drugs

IbuprofenB 400-1,200 mg/day in

divided doses

Use intermittently, such as for menstrual migraine prevention; daily or prolonged use may lead to medication-overuse headache and is limited by potential toxicity

KetoprofenB 150 mg/day in divided

doses

Naproxen sodiumB 550-1,100 mg/day in

divided doses

Triptans

FrovatriptanA 2.5 mg/day or 5 mg/day in

divided doses

Taken in the perimenstrual period to prevent menstrual migraine. Naratriptan

B 2 mg/day in divided doses

ZomitriptanB 5-7.5 mg/day in divided

doses

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Preventive migraine therapies are usually administered on

a daily basis with the goal of reducing the frequency, se-

verity and duration of attacks and improving responsive-

ness to symptomatic therapies.3,5

The lowest effective

dose should be used for initiation and then gradually titrat-

ed upward until a therapeutic effect is achieved or side

effects become intolerable. Drug doses for migraine

prophylaxis are often lower than those necessary for other

indications.5,9

Though some reduction in attack frequency may be evi-

dent after the first month, 2 to 3 months is usually neces-

sary to achieve an observable clinical benefit. An adequate

therapeutic trial (usually 6 months) should be given to

judge maximal efficacy. Patients should be counseled and

monitored closely for therapeutic response, adverse reac-

tions, abortive therapy needs and management compli-

ance.3,5,9

Overuse of acute headache medications can in-

terfere with the effects of preventive treatment.11

Prophy-

lactic treatment should usually be continued for at least 6

to 12 months after the frequency and severity of head-

aches have diminished. Gradual dosage reduction or dis-

continuation of therapy may be reasonable after a pro-

longed headache-free interval. Many patients with mi-

graines experience less severe and fewer attacks over a

lengthy period following discontinuation of prophylactic

medications or taper to a lower dose.3,5

The selection of an agent for migraine prophylaxis should

be based on patient response, tolerability, convenience of

the drug formulation and coexisting conditions.3,11

The re-

cent guideline updates provide recommendations as to the

level of efficacy for particular agents, though there is insuf-

ficient evidence as to how to choose one therapy over an-

other. Those with the highest level of efficacy should be

used for treatment, with consideration of individual patient

factors.3,4

RECOMMENDATIONS FOR PREVENTIVE TREATMENT

To develop the recent guidelines, the AAN and AHS re-

viewed and evaluated studies of preventive migraine ther-

apies. To be included in the analysis, trials had to be ran-

domized, controlled studies with masked outcome assess-

ments of safety and efficacy (considered class I or II stud-

ies).3,4

Results of the included studies were then catego-

rized into levels based upon the proven efficacy of each

therapy. Agents were considered effective if they reduced

migraine frequency, the number of migraine days or the

severity of migraine attacks. Therapies with definitive evi-

dence of treatment efficacy were assigned a Level A rec-

ommendation and Level B where evidence indicated prob-

able effectiveness.3,4

Therapies recognized with Level A

and B recommendations, along with dosages and general

medication comments, are summarized in Table 3.2-4

Fur-

ther information regarding the specific details from their

evaluation can be found within the published updates and

at the website, www.neurology.org.3,4

Of note, though other agents have established or probable

efficacy, only propranolol, timolol, divalproex sodium and

topiramate are currently approved by the Food and Drug

Administration for migraine prophylaxis.2

Beta Adrenergic Antagonists

Beta blockers have a long history of established use and

evidence for migraine prevention. Metoprolol, propranolol

and timolol have the strongest evidence of efficacy (Level

A), reducing the frequency of attacks by 50 percent in

greater than 50 percent of patients. Atenolol and nadolol

are classified as probably effective (Level B), while nebivo-

lol and pindolol are possibly effective.3 The mechanism for

migraine prevention with beta blockers is not fully under-

Table 3 Continued

Miscellaneous

HistamineB 1-10 ng 2 times/week May cause transient itching

and burning at injection site

Magesium gluconateB 400 mg/day 800 mg/day in divided

doses

May be more helpful in migraine with aura and menstrual migraine

MIG-99B (feverfew) 10-100 mg/day in divided

doses

Withdrawal may be associated with increased headaches

PetasitesA 100-150 mg/day in divided

doses

150 mg/day in divided doses

Use only commercial preparations, plant is carcinogenic

RiboflavinB 400 mg/day in divided

doses

400 mg/day in divided doses

Benefit only after 3 months

ALevel A - established efficacy; should be used (> 2 Class I studies)

BLevel B - probably effective (1 Class I or 2 Class II studies)

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stood. They appear to raise the migraine threshold by af-

fecting adrenergic or serotonergic neurotransmission in

specific CNS pathways.2 Agents possessing intrinsic sym-

pathomimetic activity are typically not effective for migraine

prevention.5

Beta blockers are generally well tolerated. Side effects can

include drowsiness, fatigue, sleep disturbances, memory

disturbances, depression, impotence, bradycardia, hypo-

tension and weight gain. These medications should gener-

ally be prescribed with caution in patients with preexisting

asthma, peripheral vascular disease, cardiac conduction

disturbances, bradycardia, depression and hypotension.

Although not used first line to treat hypertension, beta

blockers may be useful along with other therapies in mi-

graine patients with hypertension or angina.2,3,5

Antidepressants

Various classes of antidepressants have been used for mi-

graine prevention, with beneficial effects that are independ-

ent of their antidepressant activity.2,5

The anti-migraine

properties of antidepressants may be related to downregu-

lation of central 5-HT2 receptors, increased levels of syn-

aptic norepinephrine and enhanced endogenous opioid

receptor activity. The only antidepressants with probable

effectiveness for migraine prevention (Level B) are the tri-

cyclic antidepressant (TCA) amitriptyline and serotonin-

norepinephrine reuptake inhibitor (SNRI) venlafaxine. The

use of other antidepressants is based primarily on clinical

and anecdotal experience. No selective serotonin reuptake

inhibitors, including fluoxetine, have demonstrated effec-

tiveness as prophylactic therapy.3

Anticholinergic properties limit the use of TCAs in patients

with benign prostatic hypertrophy or glaucoma. Orthostatic

hypotension and cardiac toxicity also can occur. Sedation,

increased appetite and weight gain are more common side

effects with TCAs. The most common side effects reported

with venlafaxine are drowsiness, nausea and vomiting.2,3

Concomitant therapy of SNRIs and triptans can potentially

cause serotonin syndrome. Although it appears that the

likelihood of CNS adverse events is extremely low, regula-

tory agencies caution against concurrent administration.

The potential risk of these combinations should be carefully

considered and discussed with each patient.2

Antiepileptics

Antiepileptic medications are increasingly popular and have

emerged as important therapeutic options for migraine pre-

vention. Topiramate is the most extensively studied medi-

cation for migraine prevention to date. Per the guidelines,

topiramate and valproic acid/divalproex sodium have estab-

lished efficacy and Level A recommendations for use. An-

tiepileptic drugs have multiple proposed mechanisms in

migraine prevention, including increased inhibition facilitat-

ed by γ-aminobutyric acid (GABA), modulation of the re-

duction of excitatory neurotransmitter glutamate and hin-

dering sodium and calcium ion channel activity. This class

is particularly useful in migraineurs with comorbid seizure,

bipolar illness or anxiety disorders.2,3

Common early side effects with valproic acid/divalproex

sodium are nausea and vomiting. These are typically self-

limiting and less frequently to occur with gradual titration.

Other side effects include alopecia, tremor, asthenia, som-

nolence and weight gain. The risk of hepatotoxicity appears

to be low in patients with no underlying metabolic or neuro-

logic disorder; however, liver function tests should be ob-

tained at baseline and with dosage adjustments or symp-

toms. Valproates are contraindicated in pregnant women

and patients with a history of chronic liver disease or pan-

creatitis.2,3

Topiramate should be initiated at a low dose and slowly

titrated upward to minimize adverse effects. Approximately

50 percent of patients treated to target doses are respond-

ers with a 50 percent or greater reduction in mean head-

ache frequency. Benefits can be observed within as early

as two weeks of beginning therapy, with significant reduc-

tions in migraine frequency within the first month. Paresthe-

sia, fatigue, anorexia, diarrhea, weight loss, memory/

language problems, taste perversion and nausea are ad-

verse events associated with treatment. Weight loss occurs

in 9 to 12 percent of patients and is a unique adverse ef-

fect, as weight gain is a common reason for discontinuation

of other preventive medications. Topiramate should be

used with caution or avoided in patients with a history of

cognitive impairment or kidney stones.2,3,5

As more evi-

dence is available, there may be a role for other antiepilep-

tics in migraine prevention. Carbamazepine is possibly ef-

fective, and a recent study evaluated gabapentin, though

data are insufficient to determine efficacy. Lamotrigine is

classified as possibly or probably ineffective according to

the guidelines.3

Nonsteroidal Anti-inflammatory Drugs

Regular or daily use of NSAIDs for the treatment of mi-

graine attacks or other headaches may be associated with

the development of medication overuse headache. Howev-

er, intermittent use of NSAIDs to prevent headaches that

recur in a predictable pattern, such as menstrual migraine,

can be a reasonable option.4 Administration of NSAIDs in

the perimenstrual period can be beneficial in women with

true menstrual migraine. NSAIDs should be initiated 1 to 2

days prior to the expected onset of headache and contin-

ued during the period of vulnerability.2 Agents that have

demonstrated probable effectiveness (Level B) include ibu-

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profen, ketoprofen and naproxen sodium.4 NSAIDs inhibit

prostaglandin synthesis and appear to prevent neurogeni-

cally mediated inflammation in the trigeminovascular sys-

tem. Potential gastrointestinal and renal toxicity limit the

prolonged use of these agents, and NSAIDs should be

avoided or used cautiously in patients with previous ulcer

disease, renal disease or hypersensitivity to aspirin.2

Serotonin Receptor Agonists

Three of the available serotonin receptor agonists (triptans)

have been shown to have some efficacy for short-term pre-

vention of menstrually associated migraine.3 Frovatriptan,

the triptan with the longest half-life, has the most conclu-

sive evidence (Level A). Naratriptan and zolmitriptan are

probably effective and should be considered (Level B).

Triptans work through vasoconstriction of intracranial arter-

ies, inhibition of vasoactive peptide release and inhibition of

neural transmission.2 Adverse effects to the triptans are

common but usually mild to moderate in nature and of

short duration. These include paresthesias, fatigue, dizzi-

ness, flushing, warm sensations and somnolence.2,3

“Triptan sensations,” including tightness, pressure, heavi-

ness or pain in the chest, neck or throat also are reported

by up to 25 percent of patients. The mechanism of these

symptoms is unknown, but a cardiac source of pain seems

unlikely in most patients.12

The triptans are contraindicated

in patients with a history of ischemic heart disease (e.g.,

angina pectoris, Prinzmetal’s angina or previous myocardi-

al infarction), uncontrolled hypertension and cerebrovascu-

lar disease. For migraine prevention, the triptan is usually

started 1 or 2 days before the expected onset of headache

and continued during the time of vulnerability.2,3

A separate

indication for pure menstrual migraine currently is being

deliberated by regulatory authorities.

Complementary Treatments

Various complementary therapies have been used and

studied for the prevention of migraine. Butterbur, or peta-

sites, is the only herbal treatment with established efficacy

(Level A) and appears to act on calcium channels, prevent-

ing peptide-leukotriene formation. Riboflavin, or vitamin B2,

has been found to have probable effectiveness (Level B)

and appears to work centrally, increasing energy efficiency.

It is well tolerated by most patients; however, the benefits

of therapy became significant only after 3 months. Various

formulations of magnesium have been studied for migraine

prevention with mixed results, though overall probable ef-

fectiveness (Level B). CNS levels of magnesium are known

to be significantly low during migraine attacks and supple-

mentation is thought to decrease neuronal excitability.

Magnesium may be particularly useful in patients experi-

encing migraines accompanied by auras or those associat-

ed with menstruation. MIG-99, the relatively stable extract

of feverfew, is the most studied herbal preparation for mi-

graine prevention. Feverfew, also Level B, may work by

inhibiting the release of serotonin as well as prostaglandin

synthetase, thereby reducing inflammation.2,4,5

Subcutane-

ous histamine has been compared to traditional therapies

(i.e., sodium valproate, topiramate) with favorable results in

improving headache frequency, duration and intensity, indi-

cating probable effectiveness (Level B).4

Possibly Effective and Other Agents

The guidelines review various other agents that have been

used for migraine prevention. Based on limited evidence,

some of these are considered possibly effective and may

be considered for migraine prevention. Others, such as

verapamil, have been widely used but have conflicting or

inadequate evidence to support or refute their use.3

The angiotensin-converting enzyme inhibitor lisinopril and

the angiotensin II receptor blocker candesartan provided

effective migraine prevention in recent studies and are con-

sidered possibly effective.3 Selection of one of these

agents could be useful in patients with hypertension, diabe-

tes mellitus, renal disease or those needing secondary

stroke prevention; however, they should be used cautiously

in those with hypotension.3 Based on other studies,

telmisartan is probably ineffective.2,3

Clonidine and guanfacine have demonstrated possible effi-

cacy, though use is limited by common side effects (e.g.,

depression, drowsiness).3 Coenzyme Q10 was well tolerat-

ed and effective for migraine prevention in a small, con-

trolled study.4,5

In one study, cyproheptadine (4 mg/day)

was as effective as propranolol (80 mg/day) in reducing

migraine frequency, duration and severity, while the com-

bination was more effective in reducing the frequency of

attacks.3,4

The calcium channel blockers have been widely used for

preventive treatment, though evidence supporting their use

is inadequate or conflicting. Extensive clinical experience

with verapamil suggests a possible role in migraine preven-

tion and choosing this medication may be valuable in pa-

tients with hypertension. Side effects of verapamil can in-

clude constipation, hypotension, bradycardia, atrioventricu-

lar block and exacerbation of congestive heart failure.2,3,5

CONCLUSION

Many migraineurs receive inadequate care and experience

substantial levels of pain and disability. Improvements in

migraine diagnosis and treatment can improve the quality

of life for these patients and those around them. Recent

guideline updates for preventive therapy identify agents

with established and probable efficacy. These recommen-

dations should be considered when selecting an agent and

medications with the highest level of efficacy should be

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Oct. 2013 CE — Migraine Headache

used. There is insufficient evidence as to how to choose

one therapy over another. Selection of an agent should be

based on individual patient response, tolerability, conven-

ience of dosing, coexisting conditions and preference. Pa-

tient counseling and careful monitoring are essential in initi-

ating the most appropriate pharmacotherapy, documenting

therapeutic successes and failures, identifying medication

contraindications and preventing or minimizing adverse

events.

References

1. Lipton RB, Bigal ME, Diamond M, et al. The American

Migraine Prevalence and Prevention Advisory Group.

Migraine prevalence, disease burden, and the need for

preventive therapy. Neurology 2007;68:343-349.

2. Minor DS. Headache Disorders. In: DiPiro JT, Talbert

RL, Yee GC, et al., eds. Pharmacotherapy: A Patho-

physiologic Approach, 8th ed. New York City: McGraw-

Hill;April 2011, 1061-1075.

3. Silberstein SD, Holland S, Freitag F, et al. Evidence-

based guideline update: pharmacologic treatment for

episodic migraine prevention in adults: report of the

Quality Standards Subcommittee of the American

Academy of Neurology and the American Headache

Society. Neurology 2012;78:1337-1345.

4. Holland S, Silberstein SD, Freitag F, et al. Evidenced-

based guideline update: NSAIDs and other comple-

mentary treatments for episodic migraine prevention in

adults: report of the Quality Standards Subcommittee

of the American Academy of Neurology and the Ameri-

can Headache Society. Neurology 2012;78:1346-1353.

5. Bigal ME, Lipton RB. The preventative treatment of

migraine. Neurologist 2006;12(4):204-213.

6. Goadsby PJ. Pathophysiology of migraine. Neurol Clin.

2009;27(2):335-360.

7. Cutrer FM, Bajwa ZH, Sabahat A. Pathophysiology,

clinical manifestations, and diagnosis of migraine in

adults. UpToDate 2012;12:1-23.

8. Headache Classification Committee of the International

Headache Society. The international classification of

headache disorders, 2nd ed. Cephalalgia 2004;24

(Suppl 1):1–151.

9. Silberstein SD, Dodick D, Freitag F, et al. Pharmaco-

logical approaches to managing migraine and associat-

ed comorbidities – clinical considerations for monother-

apy versus polytherapy. Headache 2007;47:585-599.

10. Bajwa ZH, Sabahat A. Preventive treatment of migraine

in adults. UpToDate 2012;14:1-13. www.uptodate.com.

11. Buse DC, Rupnow FT, Lipton RB. Assessing and man-

aging all aspects of migraine: migraine attacks, mi-

graine-related functional impairment, common comor-

bidites, and quality of life. Mayo Clin Proc 2009;84

(5):422-435.

12. Loder E. Triptan therapy in migraine. N Engl J Med

2010;363:63-70.

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September 2013

THE KENTUCKY PHARMACIST 29

Oct. 2013 CE — Migraine Headache

October 2013 — Migraine Headache: Updated Recommendations for Preventive Therapy

1. Migraine headaches affect approximately what per-cent of women? A. 5 percent B. 10 percent C. 18 percent D. 25 percent 2. Migraines appear to result from CNS neurovascular dysfunctions in which system? A. trigeminovascular B. neurofundibular C. nigrostriatal D. vagosomatic 3. Auras are experienced by approximately what per-cent of patients with migraine headache? A. 10 percent B. 25 percent C. 33 percent D. 50 percent 4. Each of the following is a reason to start prophylac-tic migraine therapy EXCEPT: A. attacks are infrequent and controlled with acute thera-

py. B. the patient prefers that approach. C. migraines cause significant impairment. D. acute therapies are contraindicated. 5. Patients should take preventive therapies: A. only when not taking acute therapies. B. only if they experience aura associated with head-

aches. C. usually daily regardless of migraine occurrence.

6. Based on the updated guidelines, all of the follow-ing beta blockers are recommended for migraine pre-vention EXCEPT: A. Atenolol. B. Metoprolol. C. Propranolol. D. Acebutolol. 7. Based on the updated guidelines, which of the fol-lowing antidepressants is recommended for migraine prevention? A. bupropion B. fluoxetine C. sertraline D. venlafaxine 8. Based on the updated guidelines, which of the fol-lowing antiepileptic drugs should NOT be used for mi-graine prevention? A. divalproex sodium B. lamotrigine C. topiramate D. valproic acid 9. Of the triptans, _________ has the most evidence of efficacy for menstrually associated migraine. A. frovatriptan B. naratriptan C. sumatriptan D. zolmitriptan 10. Among complementary therapies, ________ has demonstrated the most effectiveness in preventing mi-graines. A. niacin B. petasites C. St John’s Wort D. thiamine

KPhA MEMBERSHIP BENEFIT As a KPhA member, you are eligible for a discount on Lexicomp online or

mobile app. Lexicomp online is $547 for one user, and as an optional add-on,

you may purchase Lexi Mobile for $143 one user.

To get the discounted price or if you have questions about the LexiComp

products, contact Amy Norkus 317-735-5361, [email protected].

September 2013

THE KENTUCKY PHARMACIST 30

This activity is a FREE service to members of the Kentucky Pharmacists Association. The

fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South,

Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

The Kentucky Pharmacy Education & Research Foundation is

accredited by The Accreditation Council for Pharmacy

Education as a provider of continuing Pharmacy education.

Quizzes submitted without NABP eProfile

ID # and Birthdate cannot be accepted.

Oct. 2013 CE — Migraine Headache

PHARMACISTS ANSWER SHEET October 2013 — Migraine Headache: Updated Recommendations for Preventive Therapy Universal Activity # 0143-9999-13-010-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D 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 eProfile ID #_____________________________ Birthdate ___________________(MM/DD)

Expiration Date: September 13, 2016 Successful Completion: Score of 80% will result in 2.0 contact hour or 0.2 CEU.

Participants who score less than 80% will be notified and permitted one re-examination.

TECHNICIANS ANSWER SHEET. October 2013 — Migraine Headache: Updated Recommendations for Preventive Therapy Universal Activity # 0143-9999-13-010-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD)

September 2013

THE KENTUCKY PHARMACIST 31

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]

Kentucky Renaissance Pharmacy Museum

Due to a significant amount of lead-based paint, the historic

Fayette County Courthouse was closed earlier this year

and therefor, forced Kentucky’s only pharmacy museum to

relocate. Many volunteers were needed to make this move

possible, which entailed packing up many unique and

priceless pieces from various collections donated from

across the state. The founder, Ms. Gloria Doughty, is re-

sponsible for not only the existence of this museum but

also for its accomplishment of being nationally recognized.

She has worked diligently to provide a place where Ken-

tucky’s pharmacy heritage could be shared with the public

and “contribute to the understanding, development and

history of Pharmacy in Kentucky.”

As fourth year pharmacy students, with no prior knowledge

of this museum’s existence, we were astounded at the

number of collections it held, as well as the uniqueness of

the pieces. Even more astonishing was that Ms. Gloria

could tell you the history behind each and every piece; her

love, devotion and excitement for each piece that makes

up the museum was very evident, and we felt lucky to be

able to share in its final moments in Lexington.

On August 14, the collections were moved to the KPhA

building in Frankfort, where some of the collection will be

on display. All other items are currently in storage until a

new location is found. We were grateful for the opportunity

to learn more about Kentucky’s pharmacy history and only

hope that we will get to see it restored in a new location

someday soon!

- Megan Martin and Kristina Huey

4th year UKCOP students

Megan and Kristina are currently on APPE rotation at Lau-

rel Heights with Tom Houchens, RPh. and Kim Croley,

PharmD, RPh. who were delighted to be able to loan them

to Ms. Gloria Doughty, RPh. to assist with this massive un-

dertaking!

Kentucky Renaissance Pharmacy Museum

moves to KPhA with help from students

September 2013

THE KENTUCKY PHARMACIST 32

KPhA New and Returning Members

KPhA Welcomes New and Renewing Members

July-August 2013

Jennifer Anderson Morehead, KY Samuel T Armes Crossville, TN John E Ausenbaugh Dawson Springs, KY Deronda Kay Back Jackson, KY Richard B Bergman Sarasota, FL Elisha Bischoff Louisville, KY Jacqueline E Blair Mason, OH Larry Blandford Goshen, KY Charles Boggs Dandridge, TN Charlotte Lanae Bowling London, KY Terry Box Cynthiana, KY Lanny G Branstetter Horse Cave, KY Phillip Brewer London, KY Mark A Britt Louisville, KY Brenda C Brown Scottsville, KY Wendell Doug Butler Burkesville, KY Kenneth D Calvert Glasgow, KY Mary Campbell Shepherdsville, KY Peggy Canler Louisville, KY Michelle Casto-Litton Zionsville, IN Vickie Chaudry Corbin, KY

Terri L Chism Brandenburg, KY Lisa Clontz Prospect, KY Aimee Cloud Louisville, KY Kimberly Lynn Corley Owensboro, KY Allison R Cubit Lexington, KY Casey B Culyer Erlanger, KY Marcelle R Curtis Shelbyville, KY Michael F Daniels Taylor Mill, KY Kimberly Daugherty Louisville, KY Patrick Deluca Lexington, KY James Denton Georgetown, KY Marie Denton Georgetown, KY David Dubrock Arlington, KY Everett Dunaway Jackson, KY Portia Dunaway Jackson, KY Michael Durbin McKee, KY Mary Enzweiler Covington, KY Peggy A Fishburn Scottsville, KY Jennifer L Fitch Lexington, KY Lindsey K Flanders Bowling Green, KY Matthew Flanders Bowling Green, KY

Timothy L Ford Campbellsville, KY Sherri Forrest Brentwood, TN Julian Simms Frank Paris, KY Donald T Fritts Morganfield, KY Judy Gallagher Madisonville, KY Timothy L Gallagher Madisonville, KY Joyce M Gardner Hodgenville, KY Gale M Garner Paducah, KY Daniel K Gray London, KY Charles J Gross Hazard, KY Erik Grove Madison, IN Philip S Hamilton Ludlow, KY Kyle Harris London, KY Jeffrey Harrison Tompkinsville, KY Phillip Layne Hatcher Pikeville, KY Shirley Henson Smithland, KY Kevin Higgins Benton, KY Julie Hinkel Ft. Thomas, KY Carolynn Horn Philpot, KY Jerry J Horwitz Cincinnati, OH Jan Houchens London, KY

H. Harper Housman Paducah, KY Bryan Howze St. Augustine, FL James Howze St. Augustine, FL Jacob Hutti Louisville, KY Constance H. Jones Russell Springs, KY Helen Jones Columbia, KY William Keck Corbin, KY Jerry Knifley Columbia, KY Robert Knott Paducah, KY Amy Tackett Larkin Lexington, KY Judith Lawson Monticello, KY Ken Lewis Louisville, KY Leslie Little Berea, KY Pamela Luebbe-Haeberlin Louisville, KY John Lutz Louisville, KY Laura Maples Villa Hills, KY Nicholas Maroudas Williamson, WV John Marshall Henderson, KY Catherine Mcclish Louisville, KY Jennifer Mccreary Louisa, KY Sheldon Mccreary Louisa, KY

September 2013

THE KENTUCKY PHARMACIST 33

KPhA New and Returning Members

Donate online to the

Kentucky

Pharmacists Political

Advocacy

Council!

Go to www.kphanet.org

and click on the Advocacy

tab for more information

about KPPAC and the

donation form.

Leeann Mcdonald Dunnville, KY Laurie Meeks Lexington, KY Jesica Mills Louisville, KY Boyd Minnich Mount Sterling, KY Laura Murphy Somerset, KY Daniel Nall Louisville, KY David Nation Owensboro, KY James Rodney Neat Louisville, KY William Nebel Kuttawa, KY Johnny Nixon Tompkinsville, KY Jamie Norman Russellville, KY Elizabeth Pablo Clarkson, KY Dennis Parker Glasgow, KY Myron M Pass Louisville, KY Charles Peal Lexington, KY Andrea Pearson Bowling Green, KY Charles C Pearson Bowling Green, KY Michael Perdue Catlettsburg, KY Bernard Poe Owenton, KY Shirley Price Owensboro, KY John Russell Prine Bowling Green, KY Thomas Ranz Louisville, KY Wendy Renfrow Barlow, KY

Levi Rice Beaver Dam, KY James Robinette London, KY Richard L Roeding Lakeside Park, KY Denise Rueff Louisville, KY Bonnie Russell Elizabethtown, KY Larry Russell Elizabethtown, KY Thomas Rust Cold Spring, KY Angela Sandlin Louisville, KY Phillip Sandlin Louisville, KY Stanley Scates Lexington, KY Aron Schwartz Louisville, KY Benjamin Scott Lexington, KY George Shackleford Corbin, KY Charles Shannon Louisville, KY Edwin Shelton Owensboro, KY Nancy K Shepherd Paducah, KY Frances Sherrill Paducah, KY Thomas Shively Owensboro, KY Sherri Short Richmond, KY Angela Slaughter Covington, KY John Sorrell Cynthiana, KY Francis Southall Lebanon, KY Stephanie Southern Paducah, KY

Larry Spears Crittenden, KY William Spoo Louisville, KY Glenn Stark Frankfort, KY Sandra Staton Albany, KY Cheryl Steiner Hopkinsville, KY Martha Stepp Harlan, KY Doris Stone Kevil, KY David Riley Stultz Greenup, KY Patrick Sumner Louisville, KY Richard Sutton Paducah, KY Anthony Tagavi Louisville, KY Mary L. Thacker Louisville, KY Joel Thornbury Pikeville, KY Patricia Thornbury Lexington, KY Sandra Thornbury Dorton, KY Timothy Tracy Lexington, KY Charles Turk Williamson, WV John Vaal Edgewood, KY Kelly Walker Philpot, KY Robert Wallace Dry Ridge, KY Norman Walton Bardstown, KY Jeffrey Warner Jamestown, KY L Dwayne Watson Paducah, KY

Kim Wheately Bardstown, KY Angela G Whetstone Tiline, KY Kelly Lynn Whitaker Hickory, KY David Whitley Russellville, KY Kimberly Wilkerson Frankfort, KY Lewis Wilkerson Frankfort, KY James Wilson Paducah, KY Franklin Wishnia Louisville, KY Simon Wolf Louisville, KY William D Wooden Leitchfield, KY David E Wren Louisville, KY Sue E Wynn Whitley City, KY Barbara Sue Yates Horse Cave, KY

September 2013

THE KENTUCKY PHARMACIST 34

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: _______

CVV: ______________

Billing address (if different from above)

___________________________________________________________________________________

Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601

Pharmacy Health Screening Provide state of the art health screenings to help improve

YOUR patients’ health and your bottom line.

Schedule a Health Screening Day at your pharmacy to offer YOUR patients a

service to improve their health and potentially catch dangerous issues early!

The health screenings offer multiple advantages for your business including

immediate profit from the screening process and the early recognition of diseases

that are usually treated with medications as well as increase the health and longevity

of your patients.

The process is a partnership between the Kentucky Pharmacists Association and Xcel

Diagnostics and YOUR pharmacy to bring state of the art health screenings to your patients.

The net profit is divided among the partners, including your pharmacy.

Call Xcel Diagnostics today to schedule your screening day.

(606) 218-5483

KPhA Government Affairs/Pharmacy Health Screenings

September 2013

THE KENTUCKY PHARMACIST 35

Medicare Counseling

If you’re a pharmacist with Medicare patients, you’re proba-

bly used to fielding their questions about which Part D plan

they should choose for an upcoming enrollment opportuni-

ty. If so, you know that it can be a time-consuming process.

And while you love serving your patients, when it comes to

comparing Medicare plans, you’re often just too busy.

But helping seniors through the Medicare enrollment pro-

cess has mutual benefits for both the customer and the

pharmacy. Seniors come to you with these questions be-

cause pharmacists are in the best position to help. Unlike

insurance brokers, the pharmacist already has access to

the list of medications a patient is taking, which is crucial

knowledge when choosing a Medicare plan.

In addition to providing that valuable service, you also can

inform seniors of the Part D plans that allow them to contin-

ue coming to your pharmacy for all of their needs.

Depending on which Part D plan a senior selects, they

could end up enrolled in a plan that doesn’t fully pay for

their necessary drugs—or even prevents them from using

the beloved pharmacy that has served them for years, forc-

ing them instead to another pharmacy miles away because

it’s the plan’s “preferred pharmacy.” Besides all the incon-

venience, choosing the wrong Part D plan also can cost

seniors thousands of dollars extra per year.

So where does the pharmacist come in? There are re-

sources to help seniors through this process. The govern-

ment’s website, Medicare.gov, is difficult to navigate so that

seniors with several prescriptions may find its plan compar-

ison process harder than doing their taxes. The Medicare

plan literature seniors receive in the mail is may be biased

towards whichever insurance company sent it.

Hence, seniors often ask for help from family or an insur-

ance broker, who too often lack an understanding of all the

options available, or plan requirements like Quantity Limits,

Step Therapy or Prior Authorization. Failing to account for

those technical factors can have huge impacts on the cost

and hassle seniors will face when filling prescriptions.

Pharmacists, on the other hand, combine the best of both

worlds. You are one of the most trusted healthcare provid-

ers, studies have shown, and independent pharmacies pro-

vide a more thorough level of pharmaceutical care by

scheduling time to conduct MTM, screen for interactions

and answer questions. Because pharmacists have a wealth

of medication knowledge and experience dealing with

Quantity Limits, Step Therapy and Prior Auths, they can

even suggest substituting therapeutically equivalent drugs

that can lower a patient’s prescriptions costs.

So what’s in it for the pharmacist to help seniors choose a

Medicare plan? Pharmacists already know the value of

seniors’ loyalty to their drugstore. Pharmacies using iMedi-

care have already seen big benefits from offering the ser-

vice: Seniors flock to those pharmacies, seeking profes-

sional expertise in picking a Medicare plan.

With the average Medicare patient on six drugs, each new

customer can be worth at least $900 in additional profit for

the pharmacy. So with one extra Medicare patient a year,

iMedicare pays for itself.

We’ve seen time and time again that our pharmacy cus-

tomers who provide the most services—including medica-

tion therapy management and Medicare plan consulta-

tions—see the greatest increases in customers, revenues

and profits. If you’re a pharmacy, start helping more pa-

tients with Medicare and grow your business!

Why pharmacists are better than insurance brokers for Medicare

Counseling seniors on which Medicare plan is right for them

Flaviu Simihaian, CEO

Phone: (704) 769-0540

http://iMedicare.com

YOUR KPhA has

partnered with iMedicare

as an endorsed vendor to

provide KPhA

Members with a discount

on iMedicare Products.

For more information,

contact iMedicare and

request YOUR KPhA

Membership Discount!

September 2013

THE KENTUCKY PHARMACIST 36

HIPAA Privacy Changes

September 23rd Is Here; Are You Prepared? In January, the Department of Health and Human Services

published a Final Rule containing numerous changes to the

HIPAA Privacy, Security, Breach Notification and Enforce-

ment Rules. The Rule took effect on March 26, 2013, but

pharmacy covered entities (and their business associates)

have until Sept. 23, 2013, to include the new requirements

in business associate agreements effective after Jan. 25,

2013.

For “BA agreements” or “BAAs” which were in effect prior to

Jan. 25, 2013, the new requirements do not have to be in-

cluded until the earlier of when the agreement is renewed

or modified, or by Sept. 22, 2014.

Two of the changes that pharmacies need to be aware of

under the revised rules are: (i) changes to business associ-

ate agreements; and (ii) changes to Notices of Privacy

Practices. These changes do not affect the fundamental

nature of HIPAA compliance, but they do introduce a spe-

cific “to do” list for pharmacies.

Business Associate Agreements

Under the Final Rule, business associates now will be di-

rectly obligated to comply with the HIPAA Privacy and Se-

curity Rules. Further, a subcontractor of a business associ-

ate that handles PHI on behalf of the business associate

now also is considered a business associate. Thus, a busi-

ness associate agreement will now be required for entities

that receive PHI from the covered entity pharmacy and for

that entity’s downstream contractors who handle the PHI.

This change is so significant that it is difficult to overstate its

importance. For example, beginning on Sept. 23, 2013, a

data storage vendor of a business associate also will be

considered, separately, a business associate.

Specifically, in addition to existing obligations required by

the Privacy Rule, the Final Rule requires that business as-

sociate agreements include the following provisions:

1) The business associate must limit its uses and disclo-

sures of PHI to meet the covered entity’s minimum neces-

sary policies and procedures (and business associates’ will

want to ensure that the covered entity is required to make

those policies available to the business associate).

2) The business associate must implement safeguards for

electronic PHI in accordance with the HIPAA Security Rule.

3) The business associate must notify the covered entity of

a security breach, including the information required under

the new Breach Reporting Rule.

4) The business associate must enter into a business asso-

ciate agreement with any subcontractor to which the busi-

ness associate discloses PHI.

5) If the agreement delegates any of the covered entity’s

HIPAA compliance obligations to the business associate,

the business associate must fulfill those obligations to the

same extent as the covered entity.

Covered entities should act swiftly to incorporate the new

requirements into their business associate agreements,

and existing business associates must begin to evaluate

which of their subcontractors handles PHI and to negotiate

a business associate agreement appropriate for the ar-

rangement to ensure that the subcontractors will appropri-

ately safeguard PHI.

Changes to Notices of Privacy Practices

The Final Rule requires important additions to a pharma-

cy’s Notice of Privacy Practices to be provided to pharmacy

patients effective Sept. 23, 2013.

The Final Rule requires pharmacy Notice of Privacy Prac-

tices to explain that patient authorization is required before

PHI may be used for marketing or fundraising purposes,

with limited exceptions. Another significant change for the

Notice is to inform patients that they will receive a breach

notification in the event their PHI is compromised as provid-

ed in the Breach Notification Rule.

The Final Rule ushers in extensive changes to the HIPAA

landscape. Pharmacies should work swiftly to implement

these changes in order to ensure compliance by the dead-

line. The risk of ignoring HIPAA responsibilities is danger-

ous and costly.

Clay B. Wortham is an attorney with McBrayer, McGinnis,

Leslie & Kirkland, PLLC. Clay is a member of the firm’s

health law department in the Lexington office. He can be

reached at 859.231.8780 or [email protected].

HIPAA Privacy Changes

For more on HIPAA Changes, register for

the KPhA Mid-Year Conference

Nov. 15-16, 2013

www.kphanet.org

September 2013

THE KENTUCKY PHARMACIST 37

The Kentucky Pharmacist is online!

Go to www.kphanet.org, click on Communications

and then on The Kentucky Pharmacist link.

Would you rather receive the journal electronically?

Email [email protected] to be placed

on the Green list for electronic delivery.

Once the journal is published, you will receive an email

with a link to the online version.

APhA-ASP Summer Leadership Institute

A Weekend of Leadership Training and Advocating for Pharmacy By: Brooke Herndon, PharmD Candidate 2015

Serving as the Chapter President of the American Pharma-

cists Association – Academy of Student Pharmacists

(APhA-ASP) at the University of Kentucky College of Phar-

macy provides vast opportunities for learning experiences

outside the classroom. The APhA-ASP Summer Leader-

ship Institute (SLI) in Washington, D.C. is a three-day event

which brings student pharmacists together from across the

nation for networking and unique learning opportunities.

Each year the college sends a leader within APhA-ASP to

involve her in the legislative process and learn skills on

how to become a more effective leader. This year I was

privileged to have the opportunity to attend SLI and engage

in meaningful networking with fellow student pharmacists

and have dialogue with legislators regarding issues perti-

nent to pharmacists.

The weekend started with visits to Capitol Hill, where I had

meetings with staff members from Senator Mitch

McConnell’s and Representative John Yarmuth’s offices to

discuss the importance of provider status for pharmacists.

Each meeting lasted between 15-20 minutes and allowed

constituents of the legislators to provide information for the

groundwork of moving towards provider status for pharma-

cists. This provided a unique opportunity to become in-

volved in the legislative process and begin advocating for

the profession.

The following day was devoted to leadership development

training. This workshop provided information on how to as-

sess your leadership ability and helped to identify areas of

weakness in leadership skills. After helping to identify areas

of weakness, the speaker provided information on how to

maximize these skills to make you the best leader possible.

From this training workshop, I

learned that you have to modify

your leadership skills to match the

styles of different teams you are

working with throughout diverse

situations. It is important to be flexi-

ble in your leadership approach so

you can work with fellow leaders to

accomplish mutual goals.

The rest of the weekend was spent

networking with fellow student

pharmacists from across the na-

tion. I was provided the opportunity

to visit APhA Headquarters on the

National Mall in Washington, D.C., and receive a tour of

local historical sites on Friday evening. Throughout the

weekend, student pharmacists from across the nation were

able to exchange ideas regarding chapter goals and

achievements, fundraising ideas and unique membership

opportunities. Being afforded the time to spend with stu-

dent pharmacists from across the nation was invaluable

and served to increase knowledge regarding APhA and

make contacts with national leaders to help throughout my

year as Chapter President.

I will continue to use the skills I learned at SLI throughout

my term as Chapter President and hopefully motivate oth-

ers to become involved with national organizations. It also

is important as a leader to train your upcoming officers to

continue the achievements of previous years. Thank you to

the Kentucky Pharmacists Association for providing me the

ability to learn so much about leadership and begin advo-

cating for my profession.

Brooke Herndon

September 2013

THE KENTUCKY PHARMACIST 38

Cooper/Clayton Smoking Cessation

Cooper/Clayton Smoking Cessation Method and

the Impact of Free Nicotine Replacement and

Pharmacist-Led Sessions on Smoking Cessation By: Tracy McWhirter, PharmD, MBA and Julie Burris, PharmD

Smoking is the leading cause of preventable death with

approximately 450,000 deaths per year. There also have

been a few studies that have demonstrated that greater

utilization of pharmacists in cessation efforts could have a

significant impact on smoking rates, as well as the preven-

tion of tobacco-related diseases and overall improvement in

public health across the U.S.1 The InterNational Center for

Advanced Pharmacy Services (INCAPS) at the Sullivan

University College of Pharmacy has implemented a suc-

cessful smoking cessation program following the Cooper/

Clayton Method.

The Cooper/Clayton Smoking Cessation Method is a highly

successful program started in 1985 by Dr. Thomas Cooper,

DDS, a heavy smoker for 36 years, and Dr. Richard Clay-

ton, a sociologist and internationally recognized expert on

addictions. This 12-week program incorporates education,

skills training and social support, along with the use of nico-

tine replacement products including patches, gum and loz-

enges. Patients continue to smoke the first week, keeping a

diary of cigarette use to assess the patient’s level of addic-

tion, which helps make them aware of situations that may

trigger increased smoking habits. The weekly hour-long

support sessions include videos encouraging patients to

stay on track and discuss possible hurdles in the smoking

cessation process such as depression, anxiety, overeating

and cravings. The duration for nicotine replacement prod-

ucts is approximately 10 weeks and includes titration

throughout the course with the goal of ending the program

nicotine free.2

The InterNational Center for Advanced Pharmacy Services

(INCAPS) held its first Cooper/Clayton Smoking Cessation

Method course in the fall of 2012. The United States De-

partment of Health reports the average smoking cessation

rate for a given smoking cessation method of at least eight

weeks’ duration is approximately 25 percent.3 INCAPS’ first

class enrolled 18 participants of which 11 finished the pro-

gram smoke free, correlating to a 61 percent success rate

after the 12-week program. An additional session took

place in early 2013 with 13 of 23 (57 percent) participants

completing that program. The 2013 spring program had 14

of 26 (54 percent) participants scheduled to complete the

program.

INCAPS has partnered with the Louisville Metro Depart-

ment of Health and Wellness to procure free nicotine re-

placement products for Cooper/Clayton class participants

and has worked with the Kentucky Cancer Program (KCP)

on training new facilitators. On May 24, 2013, Sullivan Uni-

versity College of Pharmacy hosted a facilitator training

session for second-year student pharmacists, along with

about 30 outside community members. Through the efforts

of KCP and the Kentucky Department for Public Health,

local health departments and numerous community part-

ners have ongoing classes and training as well conducted

throughout the state.

Potential participants can be directed to the Louisville Metro

Department of Health and Wellness website or by phone at

(502) 574-STOP (7867). Those interested in learning more

about being a facilitator may visit the KCP website at:

http://www.kcp.uky.edu/CC-facilitator training.html. INCAPS

at Sullivan University College of Pharmacy began its fourth

session on Aug. 13, 2013.

References:

1. Dent LA, Harris KJ, Noonan CW, et. al. Randomized

trial assessing the effectiveness of a pharmacist-

delivered program for smoking cessation. Ann Phar-

macother 2009; 43:194-201.

2. The Cooper/Clayton Method to Stop Smoking: A

Twelve Week Comprehensive Program. The Institute

for Comprehensive Behavioral Smoking Cessation.

http://www.stopsmoking4ever.org/. Accessed June 20,

2013.

3. U.S. Department of Health and Human Services. Clini-

cal Practice Guideline: Treating tobacco use and de-

pendence: May 2008 update.

Update your profile today at www.kphanet.org

September 2013

THE KENTUCKY PHARMACIST 39

Technician Review

Technician Review From the KPhA Academy of Technicians

The KPhA Pharmacy Technician Academy is working for

you. The Academy’s proposals have been submitted to the

KPhA Board, the KSHP Board and the Advisory Council to

the Board of Pharmacy. The Advisory Council was the first

group to meet and discuss the proposals. After some open

dialogue the Council decided that the proposals will be re-

viewed by the KPhA and KSHP boards so they could be

prepared to discuss all of the proposals. Our proposals are

intended to keep the pharmacy profession advancing. In

our continually evolving profession, the goal is to enhance

the patient’s pharmaceutical care in all settings.

We continue to recruit new members to the Pharmacy

Technician Academy in order to increase our voice. If you

are a KPhA Pharmacy Technician member, you can be an

academy member with no extra cost. The KPhA Board ap-

proved our recommendation to contract with CEI, an online

CE provider. The KPhA Pharmacy Technician Academy

members will have access to free CE online that is de-

signed around the Pharmacy Technician Certification

Board exam.

For more information please contact Don Carpenter at

[email protected].

FREE CE KPhA Technician members are eligible for

Free CE modeled on PTCB standards by becoming a member of the KPhA Pharmacy Technician Academy.

KPhA Member Pharmacy Technicians

The mission of the KPhA Academy of Pharmacy Technicians is:

To unite the pharmacy technicians throughout the Commonwealth to have one

voice toward the advancement of our profession.

To follow what is currently happening with your profession

please read our newsletter articles and become involved.

For more information contact Don Carpenter via email at [email protected]

September 2013

THE KENTUCKY PHARMACIST 40

Pharmacy Law Brief

Pharmacy Law Brief: National Practitioner Data Bank – What Is It? Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Associ-

ation Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy

Question: A physician colleague who has applied for

privileges at a new hospital made a comment about his ap-

plication being run through the “National Practitioner Data

Bank.” What is that? Does that have any connection to that

National Provider Identifier number I got several years ago?

Response: The National Practitioner Data Bank

(NPDB) was established through legislation enacted by

Congress having the multiple goals of protecting the public,

improving the quality of health care services and combating

fraud and abuse in the health care arena. It serves as a

national repository for data on a wide variety of transgres-

sions by health professionals and businesses in the broad

health care industry, with the most common, and perhaps

most important, being damage awards in malpractice law-

suits, actions by state licensing board that result in loss of

professional licensure and actions by state or federal au-

thorities that exclude the professional or a business from

participating in Medicare or Medicaid. Other entries may

come from negative findings or actions by peer review or-

ganizations or private accreditation organizations plus cer-

tain final adverse actions taken by state law enforcement

agencies or Medicaid Fraud Control Units.

The government’s website for the program describes it as a

“confidential information clearinghouse.” It goes on to pro-

vide this more detailed description – it is “primarily an alert

or flagging system intended to facilitate a comprehensive

review of the professional credentials of health care practi-

tioners, health care entities, providers and suppliers.” Thus,

it is designed to collect in one place data from a variety of

sources about adverse decisions or actions regarding cov-

ered individuals or firms. Nonetheless, the government

website cautions that “the information from the Data bank

should be used in conjunction with, not in replacement of,

information from other sources.”

Information in the database is not available to the public

like, say, opinion ratings on Angie’s List™. The Data Bank

treats as confidential the information reported to it. Detailed

federal regulations govern disclosure of the facts. So who

may access the entries there? There is a long list of entities

with such authority and commonly encountered examples

would be hospital credentialing offices, peer review groups,

state licensure boards and Medicaid Fraud Control Units.

And yes, an individual practitioner may enter the system to

view his or her own profile.

Turning to the final question, the National Provider Identifier

(NPI) number is totally unrelated. The 1996 statute known

as HIPAA mandated creation of this system and NPI’s were

first issued by CMS during 2006. The goal was to facilitate

electronic transactions by easing identification of the pro-

fessional or business entity providing goods or services.

Finally, as a gratuitous addition, one other number looming

large in the lives of pharmacists should be mentioned. The

National Association of Boards of Pharmacy has created a

database to record and track a pharmacist’s participation in

continuing pharmacy education. Designated as “CPE Moni-

tor” by NABP, this activity requires that the pharmacist have

an “NABP e-Profile ID”, a six digit number associated with

your continuing education records. That number looming in

the professional lives of pharmacists does not connect to

what is discussed above.

Submit Questions: [email protected]

@KyPharmAssoc

@KPhAGrassroots

Facebook.com/KyPharmAssoc

KPhA Company Page Are you connected

to KPhA?

Join us online!

Disclaimer: The information in this column is intended for

educational use and to stimulate professional discussion among

colleagues. It should not be construed as legal advice. There is

no way such a brief discussion of an issue or topic for education-

al or discussion purposes can adequately and fully address the

multifaceted and often complex issues that arise in the course of

professional practice. It is always the best advice for a pharma-

cist to seek counsel from an attorney who can become thorough-

ly familiar with the intricacies of a specific situation, and render

advice in accordance with the full information.

September 2013

THE KENTUCKY PHARMACIST 41

Senior Care Corner

Senior Care Corner from the KPhA Academy

of Consultant Pharmacists

The KPhA Academy of Consultant Pharmacists recently elected new

officers. Congratulations to the new leaders of this important section of

KPhA Members!

Chair - Chris Mills

Vice Chair - Joey Mattingly

Director of Organizational Affairs - Julie Owen

Director of Public/Professional Affairs - Darren Parks

Peggy Canler will continue as Director of Government Affairs

Joseph L. Fink III, Professor of Pharmacy

Law and Policy as well as the Kentucky

Pharmacists Association Professor of Lead-

ership in the UK College of Pharmacy, has

been elected to serve a three-year term as a

Public Member of the Liaison Committee on

Medical Education, the agency that accredits

M.D. degree programs in the U.S. and Cana-

da. His term began July 1, 2013.

The purpose of LCME accreditation is to pro-

tect the public by advancing the quality of

medical care provided to patients and, there-

by, reducing morbidity and mortality. The

Liaison Committee on Medical Education

(LCME) was founded in 1942 to unify the

separate accreditation activities of the Asso-

ciation of American Medical Colleges

(AAMC) and the Council on Medical Educa-

tion and Hospitals of the American Medical

Association (AMA). Since the advent of the

Higher Education Act adopted by the United

States government in 1965, the LCME has

been recognized by the U.S. Department of

Education as the reliable authority for the

accreditation of programs of allopathic medi-

cal education leading to the M.D. degree.

The LCME has 19 members including medi-

cal educators and administrators, practicing

physicians, two medical students and two

public members.

A faculty member at UK since 1981, Dr. Fink

also is a Professor in the College of Public

Health, Professor in the Martin School of

Public Policy and Administration and Profes-

sor of Clinical Leadership and Management

in the UK College of Health Sciences. He

received his professional education in phar-

macy at the Philadelphia College of Pharma-

cy and Science and then completed his legal

education at Georgetown University Law

Center.

KPhA congratulates Dr. Fink on his election

to this leadership opportunity.

Fink Elected to Medical

School Accreditation

Organization

September 2013

THE KENTUCKY PHARMACIST 42

Pharmacy Policy Issues

PHARMACY POLICY ISSUES:

Pediatric Oncology Medication Shortages:

A Hindrance to Successful Treatment? Author: Danielle E. Corbett is a second professional year pharmacy student at the University of Kentucky College of

Pharmacy. She was born and raised in Lexington, Ky., and completed her pre-pharmacy coursework at the University of

Kentucky.

Issue: There has been quite a bit in the media recently about medication shortages. What is behind this development

and what is being done about it? I understand injectables and especially oncology medications may be in short supply.

Discussion: Drug shortages are

defined as “a situation in which the

total supply of all clinically inter-

changeable versions of a FDA-

related drug is inadequate to meet

the current or projected demand at

the user level.”1 In 2011, drug

shortages affected 251 medically

necessary drugs with 73 percent of

these including sterile-injectable

products such as chemotherapy

agents.2 The problems emerging

from these drug shortages for pedi-

atric oncology patients are accu-

mulating, and in the past few years

there has been an increasing num-

ber of relapse patients. A study at

the University of Utah Drug Infor-

mation Service showed that the

amount of drug shortages of oncol-

ogy medications has almost doubled in the past six years.

These studies further demonstrate that patients who re-

ceived alternative drug therapies due to chemotherapy

drug shortages are relapsing and, as a result, requiring

more aggressive measures such as stem cell treatments.

The majority of drug shortages are believed to be due to

the lack of quality in drugs being manufactured leading to

numerous recalls. Current manufacturers are facing a ma-

jor dilemma of being in a “bad market equilibrium” due to

lack of rewarding high quality drug manufacturing.3 There-

fore, companies are making budget cuts and the first thing

appearing to be eliminated from the list are quality invest-

ments such as equipment mainte-

nance. An additional setback is that

drug companies do not have the

desire to compound these pediatric

chemotherapy agents due to the

decreased opportunities for profit in

manufacturing them. Of the approxi-

mately 1.7 million new cases of can-

cer diagnosed each year, only

12,000 to 15,000 of them involve

children under 15 years of age.4

Fortunately, the FDA has taken

steps to mitigate the consequences

of the numerous drug shortages oc-

curring. In 2011, they were able to

prevent up to 195 drug shortages

and although this amount decreased

to 100 in 2012, this is a tremendous

improvement. The FDA’s success in

preventing these shortages is simply

due to the fact that manufacturers are notifying the FDA of

their potential drug shortage more promptly. Additionally,

President Obama placed Executive Order No. 13588 which

encourages manufacturers to quickly notify the FDA of all

potential drug shortages.5 Congress was quick to follow up

this order and passed the Food and Drug Administration

Safety and Innovation Act in July 2012, which encourages

pediatric drug development. FDA Commissioner Margaret

D. Hamburg stated that, “Support for FDA user fees is a

testament to the important role FDA plays in America’s

healthcare continuum. FDA’s medical product decisions sit

at the intersection of public health, innovation and com-

Have an Idea?: This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and phar-

macy 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].

September 2013

THE KENTUCKY PHARMACIST 43

Pharmacy Policy Issues

merce and touch the lives of nearly every American every

day."

In conclusion, the only way that healthcare professionals

can delay this unprecedented amount of shortages is to

promote the importance of action by manufacturers. The

FDA has been working diligently to prevent these shortag-

es but communication between manufacturers and the

FDA is key. With this communication, the FDA can work

with other companies to help avert the shortage issues and

increase production of oncology medications. With that in

mind, health professionals can work as a team to not only

prevent the future risk of shortages but also reduce the

impact on thousands of pediatric oncology patients.

References:

1. Center for Drug Evaluation and Research (CDER) at

Food and Drug Administration (FDA): Drug Shortage

Management. http://www.fda.gov/downloads/

AboutFDA/CentersOffices/CDER/

ManualofPoliciesProcedures/ucm079936.pdf. Ac-

cessed on March 15, 2013.

2. Economic and Technological Drivers of Generic Sterile

Injectable Drug Shortages J Woodcock and M Wosin-

ska

3. http://www.bostonglobe.com/lifestyle/health-

wellness/2012/12/27/drug-shortage-linked-increased-

chance-relapse-childhood-

cancer/9eoABZJMtCqK0BBaR3YEpI/story.html.

4. http://www.dukechronicle.com/articles/2012/02/27/

cancer-drug-shortage-threatens-patients.

5. http://www.whitehouse.gov/the-press-

office/2011/10/31/executive-order-reducing-

prescription-drug-shortages.

Pharmacy Time Capsules

2013 Third Quarter 1988—Twenty-five years ago:

American College of Physicians called for enhanced educa-

tion in rational therapeutics including “increased communica-

tion with pharmacists, as health care professionals with par-

ticular knowledge in this area.”

RU-486 (mifepristone) first marketed in France as a safe

and effective method of early abortion.

1963—Fifty Years Ago:

Oncovin (vincristine), an alkaloid derived from rosy periwin-

kle, was used as a folk medicine for diabetes. Eli Lilly & Co

discovered it to be an effective treatment for several forms of

leukemia.

1938—Seventy-five Years Ago:

APhA undertook a national campaign to work

with dental associations and dentists to increase

appropriate prescribing.

1913—One hundred Years Ago:

University of Puerto Rico formed.

By: Dennis B. Worthen, PhD, Cincinnati, OH

One of a series contributed by the American Institute of the History

of Pharmacy, a unique non-profit society dedicated to assuring that

the contributions of your profession endure as a part of America's

history. Membership offers the satisfaction of helping continue this

work on behalf of pharmacy, and brings five or more historical publi-

cations to your door each year. To learn more, check

out: www.aihp.org

September 2013

THE KENTUCKY PHARMACIST 44

Pharmacists Mutual

September 2013

THE KENTUCKY PHARMACIST 45

Cardinal Health Generation Rx Award

September 2013

THE KENTUCKY PHARMACIST 46

KPhA BOARD OF DIRECTORS

Kimberly Croley, Corbin Chair

[email protected] 606.304.1029

Duane Parsons, Richmond President

[email protected] 502.553.0312

Bob Oakley, Louisville President-Elect

[email protected] 502.897.8192

Frankie Hammons Abner, Barbourville Secretary

[email protected] 606.627.7575

Glenn Stark, Frankfort Treasurer

[email protected]

Ron Poole, Central City Past President

[email protected]

Directors

Heather Bryan, Mt. Washington Sullivan University

[email protected] Student Representative

Matt Carrico, Louisville

[email protected]

Chris Clifton, Erlanger

[email protected]

Trish Freeman, Lexington

[email protected]

Brooke Herndon, Louisville University of Kentucky

[email protected] Student Representative

Chris Killmeir, Louisville

[email protected]

Jeff Mills, Louisville*

[email protected]

Chris Palutis, Lexington

[email protected]

Richard Slone, Hindman

[email protected]

Mary Thacker, Louisville

[email protected]

Sam Willett, Mayfield

[email protected]

* At-Large Member to Executive Committee

HOUSE OF DELEGATES

Cassandra Beyerle, Louisville Speaker of the House

[email protected]

Ethan Klein, 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

www.twitter.com/KPhAGrassroots

www.youtube.com/KyPharmAssoc

Robert McFalls, M.Div.

Executive Director

[email protected]

Scott Sisco, MA

Director of Communications & Continuing Education

[email protected]

Kelli Sheets

Office Manager

[email protected]

Leah Tolliver, PharmD

Director of Pharmacy Emergency Preparedness

[email protected]

Nancy Baldwin

Receptionist/Office Assistant

[email protected]

KPhA Board of Directors/Staff

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 list.

September 2013

THE KENTUCKY PHARMACIST 47

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-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org [email protected]

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 Phar-macy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222

Frequently Called and Contacted

50 Years Ago/Frequently Called and Contacted

KPhA Remembers KPhA desires to honor members who

are no longer with us. Please keep KPhA informed by sending this infor-

mation to [email protected]. Deceased members for each year will

be honored permanently at the KPhA office.

50 Years Ago at KPhA CONVENTION RESOLUTIONS

Be it Resolved that the Kentucky Pharmaceutical Association condemns the commercial

promotion of prescription legend drugs to the public, by any manner, including advertising

which is likely to induce, directly or indirectly, the procurement of such drugs.

Adopted

***

Be It Resolved that the Kentucky Pharmaceutical Association introduces at the 1964 session of the State Legislature

an act insuring the complete control of pharmacies by pharmacists.

Not Adopted

- A selection of the resolutions presented at the 86th Annual Convention of the Kentucky Pharmaceutical Association

printed in The Kentucky Pharmacist, September 1963, Volume XXVI, Number 9.

KPhA Classifieds

Clean Room Class 10,000 (ISO 7)

USP 797 for sterile compounding. Laminar flow hood,

antechamber and clean room. Aluminum and glass

walls. Sink+plumbing, inspection box, HEPA filtration.

Buyer transports. $15,000. [email protected]

or Call Joel at 606-432-2274.

September 2013

THE KENTUCKY PHARMACIST 48

THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601

136th KPhA Annual Meeting

and Convention

June 5-8, 2014 Marriott Griffin Gate Resort and Spa

Lexington, KY

SAVE THE DATES

November 15-16, 2013 Marriott Griffin Gate Resort and Spa

Lexington, KY

October 2013 Share YOUR photos at

facebook.com/KyPharmAssoc