The Kentucky Pharmacist Vol. 9, No. 4

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Vol. 9, No. 4 July 2014 T T T HE HE HE K K K ENTUCKY ENTUCKY ENTUCKY P P P HARMACIST HARMACIST HARMACIST News & Information for Members of the Kentucky Pharmacists Association Get Involved—Stay Involved Membership Matters in YOUR KPhA 2014-15 KPhA President Bob Oakley with his family — daughter, Lauren; wife, Janice; son, Rob and his wife, Amanda.

description

July 2014 issue of the peer reviewed journal of the Kentucky Pharmacists Association

Transcript of The Kentucky Pharmacist Vol. 9, No. 4

Page 1: The Kentucky Pharmacist Vol. 9, No. 4

Vol. 9, No. 4 July 2014

TTTHEHEHE KKKENTUCKYENTUCKYENTUCKY

PPPHARMACISTHARMACISTHARMACIST

News & Information for Members of the Kentucky Pharmacists Association

Get Involved—Stay Involved

Membership Matters in YOUR KPhA

2014-15 KPhA President Bob Oakley with his family — daughter, Lauren; wife, Janice; son, Rob and his wife, Amanda.

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Table of Contents

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 KPhA 2014 Professional Awards 4 From your Executive Director 6 KPERF Golf Scramble 8 136th KPhA Annual Meeting and Convention 9 136th KPhA Annual Meeting and Convention Sponsors 12 136th KPhA Annual Meeting and Convention Exhibitors 13 APSC 14 After Banquet Party 15 Technician Review 16 July 2014 CE — Hypertension Management 17 July Pharmacist/Pharmacy Tech Quiz 24

Continuing Education Changes 25 KPhA Emergency Preparedness 27 Meet the New Dean of SUCOP 28 KPhA Mid-Year Conference on Legislative Priorities 29 KPhA Open House 30 KPPAC/KPhA Government Affairs Contribution Forms 31 Kentucky Renaissance Pharmacy Museum 34 KPhA New and Returning Members 36 KPhA wins Bowl of Hygeia Fundraising Contest 38 Pharmacy Law Brief 40 Pharmacy Policy Issues 42 Pharmacists Mutual 44 Cardinal Health 45 KPhA Board of Directors 46 50 Years Ago/Frequently Called and Contacted 47

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 entrusted by the public.

Kentucky Pharmacists Association

The mission of the Kentucky Pharmacists

Association is to promote the profession of

pharmacy, enhance the practice standards of the

profession, and demonstrate the value of pharmacist

services within the health care system.

Editorial Office:

© Copyright 2014 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of 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

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

subsidiary corporation of the Kentucky Pharmacists

Association (KPhA), fosters educational activities and

research projects in the field of pharmacy including career

counseling, student assistance, post-graduate education,

continuing and professional development and public health

education and assistance.

It is the goal of KPERF to ensure that pharmacy in Kentucky

and throughout the nation may sustain the continuing need

for sufficient and adequately trained pharmacists. KPERF will

provide a minimum of 15 continuing pharmacy education

hours. In addition, KPERF will provide at least three

educational interventions through other mediums — such as

webinars — to continuously improve healthcare for all.

Programming will be determined by assessing the gaps

between actual practice and ideal practice, with activities

designed to narrow those gaps using interaction, learning

assessment, and evaluation. Additionally, feedback from

learners will be used to improve the overall programming

designed by KPERF.

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THE KENTUCKY PHARMACIST 3

Adapted from President

Oakley’s address at the

2014 Ray Wirth Banquet

Get Involved — Stay Involved

I would like to thank everyone for the opportunity to serve

as President of YOUR KPhA. It is an honor and a privilege

to be in this position. There have been many excellent

pharmacists who have preceded me in this role. I would like

to recognize all of the past presidents of KPhA for their

years of service to the profession. Next, I would like to rec-

ognize all of the students that are attended the KPhA Annu-

al Meeting and Convention. I would like for everyone to pay

close attention to this group. Look closely and you will see

in this group several future Presidents of KPhA. This group

represents the future of our organization and our profes-

sion.

So, how did I get here? One theory is that I just don’t know

how to say “no” when asked. I would prefer to think of it

another way. I chose to get involved and stay involved in

professional organizations, throughout my career. It started

in pharmacy school and it continued long after graduation.

There are many others in this room who also have chosen

to get involved and stay involved throughout their careers.

If we can do it, all of the students in this room can do so as

well. You also do not have to limit yourself to just one pro-

fessional organization to be a member of. I am also an ac-

tive member of KSHP, ASHP, JCAP and Kappa Psi. It

doesn’t matter where you live or where you work, get in-

volved and stay involved. This is a theme that Duane Par-

sons discussed in his September article in the KPhA Jour-

nal.

During my career, I have practiced pharmacy in Florida,

Virginia and Kentucky. I was an active member of the asso-

ciations in each of these states and I was fortunate to be

treasurer of VSHP and President of the Southside Pharma-

cist Association in Virginia. When I returned to Kentucky in

1988, I rejoined the Kentucky Associations (JCAP, KSHP

and KPhA). I became a Board member of JCAP and be-

came president in 1992. I was then asked to run for Presi-

dent of KPhA in 1995. I lost, but it did not bother me that I

lost. I remained involved and stay involved in all of my pro-

fessional associations. I lost to Anne Policastri who was a

great President for KPhA. In 2001, Dwaine Green, Execu-

tive VP of KSHP asked if I would like to run for president. It

occurred to me to ask him who I was running against and

he told me Anne Policastri. I respectfully declined to run at

that time; however, I was elected president-elect of KSHP

in 2003. In 2012, I was appointed to the KPhA Board of

Directors. In 2013, I was elected President-Elect of KPhA

and here I am. It is all because I got involved and stay in-

volved. My goal was not to achieve any elected office; it

was to serve the profession.

For the students, you may be asking yourselves why get

involved in the first place? What’s in it for me? There is sig-

nificant benefit for you personally, your career and your

profession. I will review what I consider to be three of the

most important reasons, but these are by no means the

only reasons to get involved and stay involved. The first

benefit is networking. Yes, you can get all of the CE you

need these days on-line, but there is no substitute for op-

portunities such as this meeting to meet and talk to your

peers. You will learn as much (or more) from networking

with your peers and discussing the challenges you have in

work every day and learning ways to deal with those chal-

lenges. Another benefit of networking is job opportunities.

There are now over 14,000 graduates per year from phar-

macy schools. Networking gives you a leg up on the com-

petition.

The second benefit is service. Service to the profession,

your patients and to yourself. Those of you reading this

article chose to get involved when you started in pharmacy

school so why would you not continue to stay involved after

graduation? Being active in your professional organizations

is a means of providing service to the profession.

The third benefit is promotion of the profession. Laws and

regulations define the scope of pharmacy practice. The

only way you can change the scope of practice and your

profession is through the efforts of organizations such as

KPhA and yourself. If you are not involved, changes will

happen to you and the profession. You may not like these

changes because they will be decisions made by others

outside of our profession that will have a significant impact

on our profession. KPhA, in addition to its role as the prima-

ry professional organization of pharmacy in the state, is

PRESIDENT’S

PERSPECTIVE

Robert Oakley

KPhA President

2014-2015

President’s Perspective

Continued on Page 7

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THE KENTUCKY PHARMACIST 4

136th KPhA Annual Meeting and Convention

2014 KPhA Professional Awards Jerry White, Russellville,

Bowl of Hygeia Award

sponsored by the Ameri-

can Pharmacists Associa-

tion Foundation and the

National Alliance of State

Pharmacy Associations

with support from

Boehringer Ingelheim. Pic-

tured with his partner and

nominator Donnie Riley

and KPhA 2014-15 Chair

Duane Parsons.

KPhA

Distinguished

Service Award

William Grise

Lexington

Judy Minogue

Louisville

Jill Rhodes, Louisville KPhA Pharmacist of the Year

Christopher Harlow

Louisville

KPhA Distinguished

Young Pharmacist of

the Year, Sponsored

by Pharmacists

Mutual Insurance.

Tracy Curtis

presented for

Pharmacists Mutual.

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THE KENTUCKY PHARMACIST 5

136th KPhA Annual Meeting and Convention

Brooke Hudspeth, Lexington, KPhA Excellence in

Innovation Award sponsored by Upsher-Smith

Laboratories, Inc.

Cassandra

Beyerle

Louisville

KPhA

Professional

Promotion

Award

Don

Carpenter,

Morehead,

KPhA

Technician

of the Year

Amber Cann, Louisville, Cardinal Health Generation

Rx Award, presented by Todd Wright, Cardinal Health

Retail Sales Manager

KPhA Meritorious Service Award Senator Tom Buford (R-Nicholasville) and David Switzer

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From Your Executive Director

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls

Roamey Marches On—Traverses the Commonwealth

Since his appearance about a year ago, Roamey has really

enjoyed meeting and making so many acquaintances

across the Commonwealth, roaming far and wide to pro-

mote Membership Matters in YOUR KPhA! He has attend-

ed state and national conventions and also has studied

pharmacy topics with the brightest students at the UK Col-

lege of Pharmacy and at Sullivan University College of

Pharmacy. And, as many of you are aware, he loves hav-

ing his photo taken when he is roaming to local pharmacies

where he quickly befriends pharmacists, technicians and

patients alike. As Roamey continues to build his legacy,

like you — our members — he seeks to make a difference

for others every day. Edward Everett Hale said, "I am only

one, but I am one. I cannot do everything, but I can do

something. And I will not let what I cannot do interfere with

what I can do." Keep up the great work. The value of

YOUR actions is recognized by the public and has signifi-

cant outcomes in terms of both short-term recovery and in

long term living results for your patients.

During late spring and throughout the summer, Kentucky

pharmacists ranks were again strengthened with gradua-

tion ceremonies and licensure achievement. Congratula-

tions to our newest members of the Kentucky pharma-

cist family of professionals. In a similar endeavor,

Roamey has found the power to be cloned. Past President

Duane W. Parsons presented each of the 2013-2014 Direc-

tors and staff with her/his own personalized Roamey at the

KPhA Annual Meeting & Convention in recognition of their

service to YOUR KPhA. Roamey can now be found living

at more than 25 geographic locations throughout Kentucky,

and he looks forward to receiving even more photos of en-

gagement with local pharmacies with this expansion to add

to his growing photo gallery on KPhA's web site. In addi-

tion, Roamey has visited 28 pharmacies in six counties this

summer, bringing his total face-to-face visits to 129 for the

past year. If he has not come to see you yet, he will! And,

he is honored when he is requested to visit as well as when

members "like" his posts on Facebook. Thank you for your

reception and support of Roamey! In addition, due to his

popularity, KPhA is pleased to offer members the oppor-

tunity to purchase their per-

sonally engraved KPhA Mem-

bership Matters Roamey for

$25 delivered to your pharma-

cy or home. If you would like

to purchase your very own

Roamey, please let me or any

KPhA staff member know.

In mid June, President Bob

Oakley, Jill Rhodes and I

were privileged to attend a

Ceremonial Bill Signing on the

Parity for Oral Chemotherapy

legislation (HB 125) with Gov-

ernor Steve Beshear, bill

sponsors Senator Tom Buford

and Representative Bob Dam-

ron, along with several cancer

survivors and other support-

ers and partners. These pa-

tients were very involved in

advocating for this legislation

which will become effective in January. Having lost two

dear family members to cancer this year, I am personally

honored to have been involved with KPhA in advancing this

important issue. Along with Jill Rhodes, I also want to thank

members Jeff Mills and Anne Policastri for their participaton

and assistance in advancing this issue.

Also, I am pleased to report that KPhA is finalizing its ap-

pointment of the Pharmacy Technical Advisory Committee

to Medicaid. Ten well-qualified individuals were nominated

from all practice settings to serve on the Pharmacy TAC.

While only five can be appointed, the interest and engage-

ment in helping advance pharmacist and pharmacy issues

with Medicaid is made all the stronger with this level of in-

volvement. We salute and thank all of our nominees.

I also am pleased to update you that conversations are

continuing with the Department of Insurance on ways to

strengthen our PBMTransparency for Drug Reimbursement

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THE KENTUCKY PHARMACIST 7

From Your Executive Director

also the primary group that lobbies on behalf of the profes-

sion in Frankfort. The past couple of years have been very

successful legislatively for the profession thanks to the ef-

forts of Bob McFalls and Jan Gould. There were many bills

passed that benefited our patients and profession. Unfortu-

nately this year, the BIG one got away. The effort to change

the collaborative care agreement section of the pharmacy

practice act (SB 76) was not passed by the Kentucky

House. This will be one of our top legislative priorities for

the 2015 session; however, it will not be the only one.

There are many other issues out there currently facing our

profession that will need to be addressed as well. For us to

be successful, it will take the efforts of everyone in this

room and more. There is also legislation on the federal lev-

el introduced by Representative Brett Guthrie of Kentucky

to recognize pharmacists as providers under Medicare.

This has huge potential impact for the profession and it

needs everyone’s support. Think how the practice of phar-

macy will be revolutionized if this passes! If you get in-

volved and stay involved, you can help make this happen.

In conclusion, I have been blessed in my personal life be-

cause of my wife Janice who has supported me these

many years and our children (Rob and Lauren), profession-

ally for the career opportunities that I have had and the pa-

tients I have served, the people that I have had the oppor-

tunity to work with over the years and my service to the

profession of pharmacy through my work in organizations

such as KPhA. You never know where the paths we

choose in life will take us until you follow them. Who knows,

you could wind up a few years from now giving a speech

tonight like me.

For the students, let us know what you would like to get

from YOUR KPhA and help make it happen and next time

bring a friend! For the current members of KPhA, I would

like to see you do the same. For all of you, get involved to

shape your future and stay involved to protect your future.

Thank you.

Continued from Page 3

(or MAC) legislation (often referred to as Senate Bill 107).

We will be providing an educational session on this topic at

KPhA's Mid-Year Conference on November 14 as well

along with related webinar educational opportunities. Look

for additional details in your weekly KPhA eNews. Along

these lines, I also want to encourage you to save the date

and calendar your participation in the 137th KPhA Annual

Meeting and Convention for June 25-28, 2015 which will

be in Bowling Green at the Holiday Inn University Plaza/

Slone Convention Center.

Roamey, his friends and I look forward to seeing you at

your place of employment and at one or all of these ven-

ues very soon!

Gov. Steve

Beshear signs

HB 125, which

included

language for Oral

Chemotherapy

Parity. KPhA

President Bob

Oakley, member

Jill Rhodes and

Executive

Director Robert

McFalls attended

the ceremony in

mid-June.

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2014 KPERF Golf Scramble

2014 KPERF Golf Scramble

First Place: Eric Pitts,

Ryan Russell, Nevin

Goebel, Jamie Ferrell

Second Place:

Terry Seiter, Jim

Geil, Ron

Nieporte, Tim

Kroger

Closest To the Pin:

Lewis Wilkerson

Longest Drive:

Tim Wilson

Not Pictured: Last

Place: Jan Gould,

Cheryl Gould, Gay

Dwyer, Mike Burleson

Save the Date

KPERF Golf Scramble

June 25, 2015

Crosswinds Golf Course

Bowling Green

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136th KPhA Annual Meeting and Convention

The KPhA Annual Meeting Q&A with a 4th Year Pharmacy Student

By: Laurel Taylor

As much as I hate to admit it, this was my first year attend-

ing the Annual Meeting. I regret this because I’ve missed

out on three years of learning, networking and becoming

part of the family that is OUR KPhA. I wanted to take this

opportunity to let others know the importance of attending

this event and what a great value it is to your present and

future practice as a pharmacist.

To give a little background about myself, I am a 4th year

pharmacy student at the University of Kentucky College of

Pharmacy. During the time of the Annual Meeting, I was on

a pharmacy organization management rotation that corre-

lated perfectly with assisting in the preparations for the An-

nual Meeting. Luckily, I was able to spend one day at the

KPhA office in Frankfort helping them prepare for the event.

While I was only able to see a small part of the preparation,

I can’t sing enough praises for the hardworking staff at

KPhA for all the effort they put into organizing this meeting.

For those of you who haven’t been able to experience the

KPhA Annual Meeting in the past, I hope the answers to the

following questions will persuade you into attending!

Q: Why should I attend the KPhA Annual Meeting?

A: This meeting incorporates programming and events for

everyone involved in the pharmacy profession; whether you

are a student, resident, pharmacist or technician, there is

something for you! I particularly enjoyed the Drugs of

Abuse in Kentucky presentation by Van Ingram, and based

on the many thought-provoking questions afterward, others

seemed to appreciate it as well. The update on Pharma-

cists Provider Status by Rebecca Snead, Executive Vice

President & CEO of the National Alliance of State Pharma-

cy Associations, was interesting for everyone, as it has

many implications on the future of our practice. I found that

my fellow students and I were very interested in attending

the CMS Medicare Star Ratings presentation by Cathy

Hanna because it is very relevant to current practice but

isn’t something we get much exposure to in the classroom

setting. Some other presentations that people look forward

to from year-to-year are the New Drugs presentation by

Trish Freeman and the Kentucky Legislative and Law Up-

date by Ralph Bouvette. There is also a technician track

that included programming like Inventory Management and

Calculations for Technicians by Don Carpenter. As you can

see, you shouldn’t be worried you won’t find something to

interest you!

There also is ample time to network and socialize with old

friends. You might possibly even meet a future employer or

coworker. I was able to meet my preceptors for many of my

upcoming rotations and also learn more about them from

students currently on the rotation.

Q: What types of events occur at these meetings?

A: There are preconference events, such as the Delivering

Medication Therapy Management Services certificate train-

ing program. There is programming on current and relevant

issues for the pharmacy profession that will meet the needs

of students, residents, pharmacists and technicians. Some

special events this year consisted of the Kentucky Mobile

Pharmacy Unit display and a financial planning seminar for

new practitioners and student pharmacists. There also was

a post conference event on adult immunization training.

Q: What will I gain from attending the meeting?

A: Everyone always can benefit from a little networking,

and this is a great meeting to be able to accomplish this

because there are pharmacists from a variety of settings.

Whether you are interested in hospital or health systems,

community, retail, consultant or long term care pharmacy,

there are individuals you can speak to concerning each of

these areas. There were 87 pharmacists, 75 students, 11

pharmacy technicians and 10 guests in attendance, so

there was never a shortage of people to talk to about any

subject! For those practicing pharmacists, this is a great

place to obtain CPE Credits that are relevant to current

pharmacy issues. Attending these events also helps update

you on current events, changing practices, and, last but not

least, assists you in being the best student or practitioner

possible.

Q: What is your favorite part of the meeting?

A: My favorite part of the meeting was being able to learn

things I wasn’t taught in school. For example, I didn’t know

much about CMS Medicare Star Ratings other than the few

passing comments made in the classroom, but this was a

fantastic opportunity to learn this information.

Q: What are the other “perks” from attending the meet-

ing?

A: I can’t believe I haven’t mentioned the incredible food

Continued on Page 10

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136th KPhA Annual Meeting and Convention

and snacks served at the meeting, but you will definitely

never be hungry. There are also luncheons, preconference

events and post conference events. It all ended with the

Ray Wirth Banquet, a Gatsby Themed Party where cos-

tumes were encouraged!

Q: How can I participate?

A: Students are encouraged to participate in the Student

Pharmacist Self-Care Championship which always ends up

being a nice refresher course in pharmacy and a great, en-

tertaining way to end the first day of programming. I also

know the staff at KPhA will always welcome those who

want to lend a helping hand in the meeting preparation.

Suggestions are always welcome for future programming

and events as well!

All in all, this was an incredible first experience attending

the KPhA Annual Meeting. It was a great atmosphere and,

despite not knowing many people, I felt welcomed by eve-

ryone as soon as I arrived. It was such a nice touch that

they included the United We Stand ribbons which further

unified this tight-knit group of people. I expanded my phar-

macy knowledge more than you could imagine, and many

of these things I know I will use on my upcoming rotations.

In addition, I was able to meet my future preceptors, learn

more about my upcoming rotations and also learn more

about my future career interests. I highly encourage every-

one to attend this meeting. You will not regret it!

Continued from Page 9

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136th KPhA Annual Meeting and Convention

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THE KENTUCKY PHARMACIST 12

KPhA Would Like to

Thank Our 2014 Sponsors

Event Sponsors

American Pharmacy Services Corporation

Humana

Jefferson County Academy of Pharmacists

KPhA District 1

Kroger Corporation

Northern Kentucky Pharmacists Association

Pharmacists Mutual Co. Insurance

Poole’s Pharmacy Care

Rx Therapy Management

University of Kentucky College of Pharmacy

KPERF Golf Hole Sponsors

AmerisourceBergen

Booneville Discount Drug

The Clifton Family

George Hammons, Frankie Abner &

Tom Houchens

Harrod & Associates

Medica Pharmacy and Wellness Center,

Bardstown-Shepherdsville-Bloomfield

Pharmacists Mutual Co. Insurance

Poole’s Pharmacy Care

Republic Bank & Trust

Rite Aid

Rx Discount Pharmacy

The Save-Rite Family of

Pharmacies

Sullivan University College of

Pharmacy—INCAPS

Tolliver Management Group

Warner Medical

Wayne’s Pharmacy

Annual Meeting Supporters

Rx Systems, Inc.

Samford University McWhorter School of

Pharmacy

Cardinal Health

Customers in Kentucky

Matt Carrico

Kimberly Croley

Brian Fingerson

Humana

Kentucky Heart Disease &

Stroke and Diabetes

Prevention & Control

Programs—Department

for Public Health

Medica Pharmacy and

Wellness Center

Bardstown-Shepherdsville-

Bloomfield

National Association of

Chain Drug Stores

Bob Oakley

Duane W. Parsons

Clay & Jill Rhodes

Donnie Riley

Richard & Zena Slone

Sullivan University

College of Pharmacy

Tolliver Management

Group

Wellcare of Kentucky

Lewis Wilkerson

Sam Willett

Sponsoring Pharmacy’s Future

136th KPhA Annual Meeting and Convention

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THE KENTUCKY PHARMACIST 13

American Pharmacy Cooperative, Inc.

AmerisourceBergen

American Pharmacy Services Corp.

Astrazeneca

Cardinal Health

Dr. Comfort

EPIC Pharmacies

HD Smith

Kentucky Cabinet for Health & Family

Services (KASPER)

Kentucky Renaissance Pharmacy

Museum

Kentucky Heart Disease & Stroke

Kentucky Diabetes Prevention

& Control Programs—Department for

Public Health

KHELPS

Kirby Lester

McKesson Corporation

Merck

Miami Luken

Morris & Dickson

Noven Pharmaceuticals

Passport Health Plan/Magellan

Pharmacists Mutual Companies

QS/1

R&S Northeast.com

Rite Aid

Samuels Products, Inc.

Smith Drug Company

SUCOP Student Organizations

UK COP Experiential Ed/ CAPP

UK Student Organizations

Walgreens

Warner Medical

… and our 2014 Exhibitors

Save the Date

137th KPhA Annual

Meeting & Convention

June 25-28, 2015

Holiday Inn University Plaza and Sloan

Convention Center Bowling Green, KY

136th KPhA Annual Meeting and Convention

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THE KENTUCKY PHARMACIST 14

American Pharmacy Services Corporation

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THE KENTUCKY PHARMACIST 15

A GRAND TIME

BANQUET AFTER-PARTY

Following the Ray Wirth Banquet, attendees partied into the night to

benefit the Kentucky Renaissance Pharmacy Museum. Costumes were

encouraged and the Museum sold hats and headbands for those who

needed an extra accessory. Make sure you mark your calendar for

June 25-28, 2015 so you don’t miss out on the fun! On to Bowling Green!

136th KPhA Annual Meeting and Convention

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THE KENTUCKY PHARMACIST 16

Technician Review

KPhA Technician members are eligible for Free CE modeled on PTCB standards by becoming a member of the KPhA Pharmacy Technician Academy. All KPhA Technician Members are eligible for Academy Membership at no additional cost.

FREE

CE

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]

Technician Review From the KPhA Academy of Technicians

KPhA members,

The KPhA Pharmacy Technician Academy invites all KPhA

members to get involved with the Academy. Only techni-

cians may become members, but we hope the KPhA phar-

macists will increase their involvement also. The Academy

is devoted to the improvement of the pharmacy technician

profession; we can be a strong foundation for our pharma-

cists to work with and help improve patient care.

Pharmacists, please encourage your technicians to be-

come involved with KPhA and the Academy to help

strengthen our voice. If you would like to see increased

responsibility for technicians or have suggestions for need-

ed changes, please let us know. We developed a set of

proposals that would help guide our profession in the fu-

ture. The pharmacy profession is changing. In fact, the only

thing in pharmacy that does not change is the fact that we

are always changing. As providers struggle to grasp the

new era of healthcare, pharmacists have the opportunity to

fill that void. The Academy is here to help technicians by

being a voice for all technicians. If you are interested in

learning more about the Academy, please visit the Acade-

my webpage through the KPhA website or contact Don

Carpenter at [email protected].

Page 17: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 17

July 2014 CE — Hypertension Management

Hypertension Management: New Guidelines and Recommendations By: Brett Smith, PharmD, Jessica Everitt, PharmD and Deborah Minor, PharmD; G.V. (Sonny) Montgomery VA Med-

ical Center Department of Pharmacy and The University of Mississippi Medical Center, Departments of Pharmacy

and Medicine, Jackson, Mississippi

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 # 0143-9999-14-007-H01-P&T

1.5 Contact Hour (0.15 CEU)

Goal: The purpose of this review is to increase the awareness and understanding of recent recommendations for the treatment and management of hypertension among pharmacy practitioners.

Objectives

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

1. Review recent guideline updates and recommendations for the treatment and management of hypertension. 2. Identify changes in blood pressure goals and thresholds for treatment in reference to specific patient populations. 3. Discuss recommendations for treatment of hypertension based on race or concurrent disease states. 4. Describe the influence of lifestyle modifications on hypertension prevention and treatment.

KPERF offers all CE

articles to members

online at

www.kphanet.org

After a gap of more than 10 years, we now have new rec-

ommendations in the United States for the treatment of hy-

pertension. Within a matter of days, two different guidelines

were released by members of the Eighth Joint National

Committee (JNC 8) and the American and International

Societies of Hypertension (ASH/ISH). Because hyperten-

sion is such a significant global public health problem and

the most common chronic condition for which people seek

health care in the United States, the release of updated

recommendations has been anxiously awaited. The Nation-

al Heart, Lung and Blood Institute (NHLBI) publication of

“JNC-Wait” or “-Late,” as some have referred to the over-

due guidelines, was delayed and then abruptly cancelled in

June 2013 when the agency announced that it was no

longer going to release guidelines. Subsequently, panel

members of the development committee elected to release

their recommendations independently, as JNC 8. Within

days of the JNC 8 release, the ASH/ISH also released its

hypertension guidelines. Both guidelines were released in

December 2013, and later published in January 2014.

The burden of hypertension is significant primarily due to its

place as a major modifiable risk factor for cardiovascular

and kidney disease. Approximately one third of United

States adults have hypertension. Kentucky has one of the

highest prevalence rates of hypertension (35.6 percent ver-

sus 29.1 percent nationally) along with one of the highest

rates for cardiovascular disease (CVD) mortality. Hyperten-

sion is typically defined as systolic blood pressure of > 140

mmHg or diastolic blood pressure of > 90 mmHg or taking

antihypertensive medication. The prevalence of hyperten-

sion does not vary significantly by gender but is significant-

ly and independently associated with increasing age, in-

creasing body mass index (BMI, kg/m2), being African-

American and having less education.

From the initial gathering of the JNC 8 committee, the

charge was clear: to utilize recent literature to produce evi-

dence-based guidelines. The JNC 8 committee based its

research and resultant recommendations on three core

questions which addressed blood pressure thresholds for

therapy initiation, blood pressure goals and the effect of

antihypertensive regimens on health outcomes. Unlike the

JNC 7 authors, who reviewed any peer-reviewed literature

relevant to critical concepts, the JNC 8 committee solely

included randomized controlled trials (RCTs) of good quali-

ty with a defined population size and follow-up outcomes.

Studies from 1966-2009 were reviewed, with large multi-

center trials after 2009 meeting other criteria added in a

bridge review. For treatment recommendations, JNC 8 only

considered RCTs that compared a member of one drug

class to another class, rather than to placebo. Though the

result is clearly more evidence-based and focused than

predecessors, five of the nine listed recommendations were

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July 2014

THE KENTUCKY PHARMACIST 18

July 2014 CE — Hypertension Management

consensus-based for the ultimate panel decision. The full

evidence reviews and statements are included in a 300-

page online supplemental review.

Authors of the ASH/ISH recommendations acknowledge

that there is insufficient clinical data to develop purely evi-

dence-based guidelines for hypertension. Rather, the goal

of their publication was to serve as a broad curriculum of

recommendations for practical use based on both literature

and expert opinion. The authors emphasize the importance

of individual patient care environments and clinical judg-

ment as the driving forces behind ultimate hypertension

therapy decisions. JNC 8 and the ASH/ISH guidelines con-

tain important similarities and differences. The purpose of

this review is to increase the awareness and understanding

of these recent recommendations for the treatment and

management of hypertension among pharmacy practition-

ers.

RECOMMENDATIONS FOR BLOOD PRESSURE

THRESHOLDS AND GOALS

In general, thresholds for treatment and blood pressure

goals recommended for adults in the 2014 guidelines are

more consistent across the population and relaxed than

those recommended in previous guidelines. In contrast to

JNC 7, the JNC 8 and ASH/ISH guidelines identify blood

pressure goals primarily based on age and do not desig-

nate lower goals for patients with specific comorbidities

such as diabetes and chronic kidney disease (CKD). The

included table highlights and compares thresholds, goals

and selected considerations for treatment of hypertension

according to the JNC 8 and ASH/ISH guidelines, as well as

the 2014 American Diabetes Association (ADA) recommen-

dations. Of note, other disease-focused guidelines (e.g.,

heart failure, acute management) may include recommen-

dations for alternative blood pressure goals, in the pres-

ence of concurrent conditions.

Blood Pressure Goals – General Population

JNC 8 separates the thresholds for treatment of hyperten-

sion between younger adults and those aged 60 years and

above, while ASH/ISH does the same but at 80 years or

older. For the younger population (< 60 or 80 years, re-

spectively), treatment should be initiated when systolic

blood pressure is 140 mmHg or higher or diastolic blood

pressure is 90 mmHg or higher, with a goal of treating to

below this threshold.

For those > 60 years, JNC 8 recommends initiating phar-

macologic treatment to lower blood pressure at a systolic

blood pressure of 150 mmHg or higher or diastolic blood

pressure of 90 mmHg or higher, and treating to < 150/90

mmHg. ASH/ISH recommend these same thresholds and

goals for patients > 80 years of age.

Both guidelines note that while their recommendations and

definitions are based on the evidence to date, there is an

absence of evidence regarding the benefits of treatment for

much of the population. More research is needed to identify

optimal goals. For example, there are no good quality

RCTs evaluating the benefits of treating elevated diastolic

blood pressure in adults younger than 30 years, hence the

recommendations are based on opinion. In contrast, there

is moderate to high quality evidence (Grade A) to support

the JNC 8 recommendation of < 150/90 mmHg in the gen-

eral population aged 60 years and older, and also some

evidence that setting a lower goal in this age group pro-

vides no additional benefit. Despite this evidence, this rec-

ommendation was highly debated among the ASH panel.

Some members expressed concern that raising the goal for

this general population (from < 140 mmHg) would inadvert-

ently influence hypertension management for many pa-

tients that may benefit from a lower blood pressure. For

high-risk groups, including blacks, those with CVD, and

those with multiple risk factors, there is insufficient evi-

dence of the lack of benefit with the lower target. Because

of this, a corollary recommendation was added to the pri-

mary recommendation for this age group. The panel

acknowledged that there are many hypertensive patients

with systolic blood pressures of < 140 mmHg and treatment

need not be adjusted if there are no adverse effects on

health or quality of life. In a subsequent January 2014 pub-

lication, five of the JNC 8 authors further elaborated on

their cause of disagreement with the differential age goals.

They detailed the major clinical and public health implica-

tions associated with adoption of this recommendation and

the lack of sufficient evidence for increasing the systolic

blood pressure target.

The ASH/ISH age recommendation is based on clinical

trials in the aged 80 and older population, where achieving

a systolic blood pressure of < 150 mmHg was associated

with strong cardiovascular and stroke protection.

Blood Pressure Goals – Diabetes

The JNC 8 and ASH/ISH guidelines both recommend that a

patient with diabetes should be treated to a systolic goal of

< 140 mmHg and a diastolic goal of < 90 mmHg. Despite

the evidence-based direction, this recommendation is pri-

marily based on expert opinion. There is a moderate

amount of evidence to support a systolic blood pressure

goal of < 150 mmHg, while the < 140 mmHg goal is solely

supported by ACCORD-BP. Both guidelines note that there

is insufficient evidence to recommend the previous JNC 7

diastolic goal of < 80 mmHg.

For many years, ADA recommended a systolic blood pres-

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July 2014

THE KENTUCKY PHARMACIST 19

July 2014 CE — Hypertension Management

sure goal of < 130 mmHg and a diastolic goal of < 80

mmHg for patients with diabetes, consistent with JNC 7

recommendations. The ADA Standards of Care 2013 re-

vised this goal by modifying the systolic goal to < 140

mmHg (based on ACCORD-BP), while retaining the dias-

tolic goal of < 80 mmHg. The 2014 ADA guidelines main-

tained these recommendations, noting that a systolic goal

of < 130 mmHg may be appropriate for younger patients or

those at less risk of falls due to treatment-induced hypoten-

sion.

Blood Pressure Goals - Chronic Kidney Disease

Consistent with recommendations from the National Kidney

Foundation, JNC 7 recommended a blood pressure goal of

< 130 mmHg systolic and < 80 mmHg diastolic for patients

with CKD. In contrast, JNC 8 recommends a goal of < 140

mmHg systolic and < 90 mmHg diastolic. Based on their

review, the panel reports that there is evidence of no bene-

fit on kidney disease progression associated with the previ-

ously recommended lower goal. They also note that a low-

er goal is not necessary for patients with albuminuria,

2014 Hypertension Treatment Guidelines

Joint National Committee (JNC ) 8

American/International Society of

Hypertension

American Diabetes Association

Blood Pressure Thresholds for

Treatment (i.e., >) and Goals (mm/Hg)

<140/90, <60 years <150/90, ≥60 years CKD: <140/90 Diabetes: <140/90

<140/90, < 80 years <150/90, ≥80 years; optional <140/90 with CKD or diabetes CKD w/ albuminuria: consider <130/80

<140/80, <130/80 optional (e.g., younger patients)

Initial Treatment by Race*

Nonblack Thiazide, CCB, ACEI, or ARB <60 years: ACEI or ARB ≥60 years: CCB or thiazide No race-specific

recommendations Black Thiazide or CCB CCB or thiazide

Initial Treatment by Selected Concurrent Disease States*

Chronic Kidney Dis-ease (CKD)

ACEI or ARB as initial or add-on; thiazide or CCB also an option in those >75 years. For black patients without proteinuria, thiazide, CCB, ACEI or ARB for initial.

ACEI or ARB

Diabetes As per recommendations by race.

ACEI or ARB; CCB or thiazide acceptable in black patients

Regimen to include ACEI or ARB

Stroke - ACEI or ARB -

Coronary Artery Disease

- B-blocker + ARB or ACEI

-

Symptomatic Heart Failure

- ARB or ACEI + B-blocker + diuretic + spironolactone

-

Selected Recommendations

In those ≥60 years and BP <150/90, no need to adjust medications to increase BP if no adverse events.

Lifestyle modifications for BP lowering can be attempted for 6-12 months in patients with stage 1 HTN and no evidence of abnormal cardiovascular findings.

Promptly initiate drug therapy along with lifestyle modifications when BP > 140/80. Administer one or more antihypertensives at bedtime.

*Medication classes recommended for initial add-on therapy include ACEIs, ARBs, CCBs, or thiazides. Other classes (e.g., B-blockers, aldosterone antagonists, centrally acting agents) may be needed for specific conditions or subsequent therapy.

Page 20: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 20

July 2014 CE — Hypertension Management

based on the evidence. The ASH/ISH guidelines also rec-

ommend a general blood pressure goal of < 140/90 mmHg

in patients with CKD but acknowledge that some experts

promote a goal of < 130/80 mmHg when albuminuria is

present.

From another perspective, Sarafidis and Ruilope evaluated

the effects of blood pressure reduction in patients with

CKD. They concluded that blood pressure goals in this

population should be based on the type of CKD (diabetic

versus nondiabetic) and the degree of proteinuria. Goals of

< 125/75 mmHg were suggested for nondiabetic patients

with proteinuria greater than 1 gram/day. A blood pressure

goal of < 130/80 mmHg was justifiable, according to their

review, if proteinuria was between 0.25 grams and 1 gram/

day. The recommendation for diabetic patients without pro-

teinuria was a diastolic blood pressure of < 80 mmHg and

systolic target between 130 and 140 mmHg, to provide op-

timal cardioprotective benefits of blood pressure lowering.

These recommendations are not consistent with those of

JNC 8 and ASH/ISH and reflect the differences in method-

ology, review criteria and levels of evidence.

RECOMMENDATIONS FOR TREATMENT

OF HYPERTENSION

Unlike JNC 7, the JNC 8 guidelines do not highly empha-

size medication selection based on compelling indications.

Along with the streamlined blood pressure goals, popula-

tion-specific treatment recommendations in JNC 8 are pri-

marily based on race (nonblack and black) and whether the

patient has CKD or diabetes. The guidelines by ASH/ISH

recommend treatment based on race, age and concurrent

conditions.

Both JNC 8 and ASH/ISH guidelines recommend angioten-

sin-converting enzyme inhibitors (ACE-I), angiotensin re-

ceptor blockers (ARB), calcium channel blockers (CCB) or

thiazide-type diuretics for the initial treatment of hyperten-

sion. As most patients will require more than one drug to

achieve and maintain blood pressure control, additional

drug therapy should be selected from within the classes

suggested. An exception to this is the combination of an

ACE-I and ARB, which should not be used together. All

patients should have a thorough evaluation before starting

treatment for hypertension. Evaluation should optimally

include personal history, physical examination and selec-

tive testing and laboratory assessments. Both JNC 8 and

ASH/ISH guidelines identify general dosing suggestions for

individual agents in the recommended classes of drugs as

well as acceptable strategies for medication initiation and

dosing. Therapy may be initiated with one drug, with subse-

quent titration to a maximum dose, and then addition of

another drug if needed. An alternative approach would be

to start with one drug and then add a second drug, in lieu of

up-titration of the first drug. A third approach would be to

begin with two drugs, particularly when systolic blood pres-

sure is > 20 mmHg and/or diastolic blood pressure is > 10

mmHg above goal, then add a third drug if needed. In se-

lection of a treatment strategy, consideration should be giv-

en to the individual patient circumstances, clinician and

patient preferences and drug tolerability.

The clearest departure from previous guidelines is the lack

of inclusion of beta-adrenergic blockers (BBs) for the initial

treatment of hypertension. With the availability of newer

classes [i.e., diuretic, ACE-I, ARB, CCB] and evidence of

more favorable outcomes, BBs are no longer a preferred

initial class for treatment of hypertension. Historically, BBs

have been widely used as antihypertensive agents and re-

main among the most commonly prescribed medications. A

meta-analysis of 13 trials comparing BBs to other antihy-

pertensives or placebo revealed a higher risk of stroke and

no difference in myocardial infarction in patients taking

BBs. BBs remain indicated and are considered standard of

care for many of the cardiovascular conditions that often

accompany hypertension, including heart failure, atrial fibril-

lation and coronary artery disease. Evidence clearly sup-

ports the value of BBs in reducing morbidity and mortality

among patients with a history of myocardial infarction or

heart failure. While BBs may not be first line for hyperten-

sion, most patients with these other cardiovascular condi-

tions have hypertension as a concurrent or contributing risk

factor.

Treatment of Hypertension – Nonblack Population

For all nonblack patients, JNC 8 recommends initiating

medication therapy with either an ACE-I, ARB, CCB or thia-

zide-type diuretic. The authors do not differentiate the order

of treatment for these drug classes, and all four are consid-

ered equally reasonable as a first line option unless there is

consideration for other conditions.

The initial drug choice recommended in nonblack patients

varies by age group in the ASH/ISH guidelines. For pa-

tients < 60 years of age, an ACE-I or ARB is recommend-

ed, while a CCB or thiazide-type diuretic is recommended

in those > 60 years, with a CCB generally preferred.

Treatment of Hypertension – Black Population

JNC 8 recommends thiazide-type diuretics or CCBs as first

line therapy for the general black population. This recom-

mendation is supported by the ALLHAT study, which

demonstrated better cerebrovascular, heart failure and car-

diovascular outcomes with a thiazide-type diuretic com-

pared to an ACE-I in black patients. In this population,

ACE-Is also were associated with a higher rate of stroke

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July 2014

THE KENTUCKY PHARMACIST 21

July 2014 CE — Hypertension Management

and less effective blood pressure control than CCBs.

Though the CCB was less effective than the diuretic in pre-

venting heart failure in the black ALLHAT population, there

were no differences in other outcomes. Per JNC 8 authors,

this recommendation for thiazide diuretics and CCBs ap-

plies to black patients with diabetes as well, though this is

considered a weak recommendation. The ASH/ISH recom-

mendations for initial drug treatment for the black popula-

tion align with those from JNC 8, again with a CCB general-

ly preferred over a thiazide-type diuretic.

Treatment of Hypertension – With Chronic Kidney

Disease

For the treatment of hypertension in all patients with CKD,

JNC 8 and ASH/ISH recommend utilizing an ACE-I or ARB

as initial or add-on therapy. These recommendations are

unchanged from JNC 7. These classes of medications

have been shown to improve renal outcomes and slow the

progression to end-stage renal disease; however, there is

less evidence to support improved cardiovascular out-

comes compared to other classes. JNC 8 also lists thiazide

-type diuretics and CCBs as options for initial therapy in

those > 75 years of age, as well as for black patients with-

out proteinuria.

Treatment of Hypertension – With Diabetes

JNC 8 makes no specific recommendations for the pharma-

cologic treatment of hypertension in patients with diabetes

but states therapy should follow the race-based recommen-

dations. A review of trials including those with diabetes

showed no difference in major cardiovascular or cerebro-

vascular outcomes from those in the general population

and no strong evidence that one particular class leads to

better outcomes.

The ASH/ISH guidelines suggest use of an ACE-I or ARB,

particularly if the patient also has CKD, but also list CCBs

and thiazide diuretics as acceptable alternatives in black

patients with diabetes. The ADA guidelines suggest the use

of an ACE-I or ARB in the hypertension treatment regimen

of patients with diabetes and make no recommendations

for therapy based on race.

Treatment of Hypertension – With Heart Failure

JNC 7 guidelines specified heart failure as a compelling

indication for which ACE-I, ARB and BBs were recom-

mended as optimal therapy. JNC 8 suggests that heart fail-

ure alone does not require alternate therapy options. There

is some evidence that supports better heart failure out-

comes with ACE-Is compared to CCBs, but the panel de-

termined that alternative classes could also be acceptable

first line agents.

The ASH/ISH guidelines recommend that most patients

with heart failure should receive an ACE-I or ARB, BB, diu-

retic and spironolactone regardless of blood pressure due

to the benefits in heart failure outcomes. Dihydropyridine

CCBs can be added if needed to achieve blood pressure

goals.

LIFESTYLE MODIFICATIONS

Lifestyle interventions or modifications are pivotal in the

management of hypertension and should be the foundation

of treatment. Appropriate modification of lifestyle factors

can directly influence blood pressure and other cardiovas-

cular risk factors. Weight loss, increased physical activity

and sodium restriction are recommended for all patients

with hypertension and as the initial approach to treating

most patients with prehypertension. Limitations on alcohol

intake and smoking cessation also can positively impact

cardiovascular risk. Even more far-reaching than the value

in the treatment of established hypertension is the potential

for disease prevention.

While a review of lifestyle modifications effective for hyper-

tension management was not conducted by the authors of

JNC 8, the guidelines do promote a healthy diet, weight

control and regular exercise in order to improve blood pres-

sure control and potentially reduce the need for medica-

tions. The ASH/ISH guidelines also highlight effective life-

style interventions. For specific recommendations on life-

style modifications shown to improve blood pressure con-

trol, the JNC 8 authors refer readers to the recommenda-

tions of the NHLBI 2013 Lifestyle Work Group. This group

reviewed and assessed evidence related to dietary pat-

terns, nutrient intake and physical activity for prevention

and treatment of CVD through modifiable risk factors, in-

cluding blood pressure.

Healthy Diet

The Work Group recommends a dietary pattern that em-

phasizes the consumption of vegetables, fruits and whole

grains. The diet should include low-fat dairy products, poul-

try, fish, legumes, nontropical vegetable oils and nuts, while

sweets, sugar-sweetened beverages and red meat should

be limited. Plans that follow this pattern include the Dietary

Approaches to Stop Hypertension (DASH) diet, United

States Department of Agriculture (USDA) Food Pattern and

the American Heart Association Diet. Evidence shows that

following the DASH diet decreased blood pressure by 5 –

6/3 mmHg compared to the typical American diet. This ef-

fect was seen regardless of gender, race, age or presence

of a hypertension diagnosis. These dietary-related effects

on blood pressure are independent of changes in weight

and sodium intake. This degree of blood pressure reduction

Page 22: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 22

is sufficient to prevent progression to hypertension from

prehypertension, promote blood pressure lowering in pa-

tients with hypertension and supplement pharmacologic

therapy.

The Work Group also promotes a decrease in sodium in-

take to lower blood pressure. Reducing sodium to less than

2,400 mg per day has been shown to lower blood pressure.

For maximum blood pressure lowering, sodium intake

should be reduced to less than 1,500 mg per day. Again,

the benefits of blood pressure lowering due to decreased

sodium intake are seen regardless of age, gender, race or

hypertension diagnosis. In adults 22 to 80 years of age with

blood pressures of 120-159/80-95 mmHg, combining sodi-

um reduction with the DASH diet decreased blood pressure

more than reduced sodium intake alone. In addition, a re-

duction in daily sodium consumption by at least 1,000 mg

may reduce overall risk of CVD events and is recommend-

ed even if goal sodium intake is not yet achieved.

Weight Control

The relationship between weight and blood pressure is

clear. Over 70 percent of adults with hypertension are over-

weight or obese, with the prevalence of high blood pressure

increasing progressively with increasing BMI. In the Fram-

ingham Heart Study, 70 percent of the new cases of hyper-

tension were attributable to excess body weight and for

every 10-pound weight gain, systolic blood pressure in-

creased an average of 4.5 mmHg. Obesity, specifically ex-

cess body weight, is the single most important cause of

primary hypertension. Obesity also is recognized as an epi-

demic and independent risk factor for CVD that is strongly

associated with other risk factors. Weight loss or prevention

of excess weight gain is the most obvious approach to pre-

venting hypertension.

Weight reductions of as little as 5-10 percent can improve

blood pressure and amplify the pharmacologic treatment for

hypertension, potentially reducing the amount of medica-

tions needed to reach goals. Several studies demonstrate

that weight loss lowers blood pressure in obese subjects

and may prevent hypertension even when compared to

sodium reduction. Patients should be encouraged that even

modest weight loss can lead to blood pressure reduction.

Regular Exercise

Physical inactivity is associated with hypertension. The

combination of exercise with weight reduction may have

additive effects on blood pressure reduction. The Lifestyle

Work Group recommends a goal for all adults to accumu-

late approximately 160 minutes of moderate to vigorous

physical activity per week (over three to four sessions, av-

erage 40 minutes).

CONCLUSIONS

The treatment of hypertension is challenging for patients

and health care providers alike. The link between CVD and

hypertension is well established. Goals for treatment and

therapeutic decisions for hypertension management should

be based on a constellation of factors. The new guidelines

for management of hypertension offer recommendations

and guidance and should meet the clinical needs of most

patients. In deciding the application of particular recommen-

dations, clinical judgment and the individual characteristics

and circumstances of each patient must be considered.

Therapeutic decisions should be based on identification of

known causes of high blood pressure, age of the patient,

potential for adverse effects, response to therapy and iden-

tification of other cardiovascular risk factors or concomitant

disorders that may define prognosis and guide treatment.

Undoubtedly debate will continue regarding ideal blood

pressure goals and recommendations for the population as

a whole. Further evidence will contribute to our existing

gaps in knowledge.

Pharmacists encounter patients with hypertension on a dai-

ly basis. We are in a unique position to influence patient

care and decisions, particularly in the areas of medication

use and selection. By understanding current recommenda-

tions for therapy, we can effectively impact disease man-

agement and outcomes for many patients with hyperten-

sion.

REFERENCES

1. James PA, Oparil S, Carter BL, et al.: 2014 evidence-

based guideline for the management of high blood

pressure in adults: report from the panel members ap-

pointed to the Eighth Joint National Committee (JNC 8).

JAMA 2014, 311(5):507-520.

2. Weber MA, Schiffrin EL, White WB, et al.: Clinical prac-

tice guidelines for the management of hypertension in

the community: a statement by the American Society of

Hypertension and the International Society of Hyperten-

sion. J Clin Hypertens 2014, 16(1):14-26.

3. Chobanian AV, Bakris GL, Black HR, et al.: The sev-

enth report of the Joint National Committee on Preven-

tion, Detection, Evaluation, and Treatment of High

Blood Pressure: the JNC report. JAMA 2003, 289:2560

-2572.

4. Ong KL, Cheung BM, Man YB, et al.: Prevalence,

awareness, treatment, and control of hypertension

among United States adults 1999-2004. Hypertension

2007, 49(1):69-75.

5. Wright JT, Fine LJ, Lackland DT, et al.: Evidence sup-

July 2014 CE — Hypertension Management

Page 23: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 23

porting a systolic blood pressure goal of less than 150

mm in patients aged 60 years or older: the minority

view. Ann Intern Med 2014, 160(7):499-503.

6. Lithovius R, Harjutsalo V, Forsblom C, et al.: Antihyper-

tensive treatment and resistant hypertension in patients

with type 1 diabetes by stages of diabetic nephropathy.

Diabetes Care 2014, 37(3):709-17.

7. American Diabetes Association. Standards of medical

care in diabetes-2013. Diabetes Care 2013, 36 Suppl

1:S11-66.

8. American Diabetes Association. Standards of medical

care in diabetes-2014. Diabetes Care 2014, 37 Suppl

1:S14-80.

9. Sarafidis PA, Ruilope LM. Aggressive blood pressure

reduction and renin-angiotensin system blockade in

chronic kidney disease: time for re-evaluation. Kidney

Int 2014, 85(3):536-46.

10. Eckel RH, Jakicic JM, Ard JD, et al.: 2013 AHA/ACC

Guideline on Lifestyle Management to Reduce Cardio-

vascular Risk: A Report of the American College of

Cardiology/American Heart Association Task Force on

Practice Guidelines. J Am Coll Cardiol Epub 2013.

July 2014 — Hypertension Management: New Guidelines and Recommendations

1. The following risk factors are independently associated with development of hypertension: a. Increasing age. b. Increasing BMI. c. African American race. d. Lower education level. e. All of the above. 2. The blood pressure goal for the general population aged 60 years and older according to JNC 8 is: a. < 120/80 mmHg. b. < 130/80 mmHg. c. < 140/90 mmHg. d. < 150/90 mmHg. 3. The blood pressure goal for patients with diabetes according to JNC 8 and ASH/ISH is: a. < 130/80 mmHg. b. < 140/80 mmHg. c. < 140/90 mmHg. d. < 150/90 mmHg. 4. All of the following medication classes are recommended by new guidelines as first line treatment options for the general nonblack population EXCEPT: a. Angiotensin-converting enzyme inhibitors. b. Angiotensin receptor blockers. c. Beta blockers. d. Calcium channel blockers. e. Thiazide-type diuretics. 5. The following should be considered when selecting a medication regimen for treatment of hypertension: a. Patient preference. b. Clinician preference. c. Drug tolerability. d. All of the above.

6. Beta blockers have been shown to reduce morbidity and mortality in patients with a history of: a. Hypertension. b. Myocardial infarction. c. Heart failure. d. Both B & C. 7. According to JNC 8 ACE-Is are an appropriate first-line treatment for the general black population. a. True b. False 8. JNC 8 lists thiazide-type diuretics and CCBs as initial therapy options for CKD patients with hypertension who: a. Are > 75 years old. b. Are black without proteinuria. c. Are black with proteinuria. d. Both A & B. 9. In people with hypertension, the recommended daily sodium intake for maximal blood pressure lowering is: a. 1,500 mg. b. 2,400 mg. c. 3,000 mg. d. 3,500 mg. 10. A weight reduction of at least 20 percent is necessary for blood pressure reduction. a. True b. False

The August 2014 Continuing

Education Article will appear in

the September issue of The

Kentucky Pharmacist.

July 2014 CE — Hypertension Management

Page 24: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 24

July 2014 CE — Hypertension Management

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 July 2014 — Hypertension Management: New Guidelines and Recommendations (1.5 contact hours) Universal Activity # 0143-9999-14-007-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D 5. A B C D 7. A B 9. A B C D 2. A B C D 4. A B C D E 6. A B C D 8. A B C D 10. A B Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

Personal

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

Expiration Date: July 31, 2017 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. July 2014 — Hypertension Management: New Guidelines and Recommendations (1.5 contact hours) Universal Activity # 0143-9999-14-007-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D 5. A B C D 7. A B 9. A B C D 2. A B C D 4. A B C D E 6. A B C D 8. A B C D 10. A B Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

Personal

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

Page 25: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 25

Continuing Education Changes

YOUR KPhA wants YOU to be informed Continuing Education changes that YOU need to

know

By: Scott Sisco, Director of Communications and Continuing Education

You should have noticed several changes in continuing

pharmacy education over the past few years. Many of

these changes were necessitated with the new credit track-

ing mechanism, CPE Monitor.

CPE Monitor was developed through collaboration between

the Accreditation Council for Pharmacy Education (ACPE)

and the National Association of Boards of Pharmacy

(NABP) to create an electronic system for pharmacists and

pharmacy technicians to track completed continuing educa-

tion credits. The Kentucky Pharmacy Education and Re-

search Foundation (KPERF) implemented CPE Monitor in

September 2012, and all ACPE Accredited Providers were

required to implement the service by Jan. 1, 2013.

The biggest change that you have probably noticed by

now is that you no longer receive certificates for your credit.

All credit is uploaded through the CPE Monitor program to

your profile. ACPE does not recognize any credit outside of

CPE Monitor. When you log into your profile at

www.mycpemonitor.net, you can check your credit and

print statements. It is recommended that you do print a

copy of your credit, though the Board of Pharmacy has ac-

cess to check your credit through CPE Monitor.

Timing Issues and Completion Dates

In April 2014, ACPE released a few updates on CPE Moni-

tor. Beginning May 1, ACPE enabled a 60-day submission

rule for activities. What does this mean for you? Probably

not much for live activities, such as the ones at the KPhA

Annual Meeting and Convention and the Mid-Year Confer-

ence. YOUR KPERF Administrator (that would be Scott

Sisco, KPhA Director of Communications and Continuing

Education) must have activities uploaded to CPE Monitor

within 60 days of the activity. On home activities (the CE

articles in these pages each issue), activities must be up-

loaded within 60 days of the completion date. So make

sure you send in your quizzes soon after you complete

them.

In regards to the completion date for home activities,

which is next to your signature on the answer sheets for the

CE quizzes, ACPE considers this date to determine when

the credit for the activity is valid. So, if you put a completion

date on a quiz in December 2014, but mail it to KPhA for

credit in January 2015, it will count toward your total for

2014.

The expiration date for home-based CE programs remains

the same as it always has. Programs are valid for three

years after the release date. KPERF lists the expiration

date at the top of the page of answer sheets. You can still

complete CE activities from past years for current year

credit, as long as the program hasn’t expired. All KPERF

CE articles are available online for KPhA members under

the Education tab on www.kphanet.org.

Pharmacy Technician Changes

Technicians who are certified through the Pharmacy Tech-

nician Certification Board (PTCB) have seen several

changes this year as well. In addition to the 1 hour of law

requirement, technicians now also must complete 1 hour of

patient safety CE as part of the 20 hours per two-year peri-

od. PTCB also requires technician specific CE.

Universal Activity Number

One question that we get quite often is how do you tell if a

program is law or patient safety. It’s all in the numbers –

the ACPE Universal Activity Number to be precise. This is

the number under the article name in the answer sheets for

journal articles or under the title of a live presentation on

Tips for Successful CE

Always include your CORRECT NABP eProfile ID

and Birthdate (MONTH AND DAY).

Write legibly.

Check your date of participation to make sure it is within the year you are seeking credit.

Be aware of deadlines for certification or registration.

Don’t procrastinate.

Include an email address and/or a phone number in case there is an issue with your CE submission.

Copy the quizzes you send in in case they are lost in the mail.

Check your CPE Monitor profile to make sure all of your credit has been applied to your account.

Page 26: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 26

The following broad guidelines should guide an au-

thor to completing a continuing education article for

publication in The Kentucky Pharmacist.

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

cessing document (Microsoft Word is preferred).

Articles are generally written so that they are per-

tinent to both pharmacists and pharmacy techni-

cians. If the subject matter absolutely is not perti-

nent to technicians, that needs to be stated clearly

at the beginning of the article.

Article should begin with the goal or goals of the

overall program – usually a few sentences.

Include 3 to 5 objectives using SMART and meas-

urable verbs.

Feel free to include graphs or charts, but please

submit them separately, not embedded in the text

of the article.

Include a quiz over the material. Usually between

10 to 12 multiple choice questions.

Articles are reviewed for commercial bias, etc. by

at least one (normally two) pharmacist reviewers.

When submitting the article, you also will be

asked to fill out a financial disclosure statement to

identify any financial considerations connected to

your article.

Articles should address topics designed to narrow

gaps between actual practice and ideal practice in

pharmacy. Please see the KPhA website

(www.kphanet.org) under the Education link to see

previously published articles.

Articles must be submitted electronically to the KPhA

director of communications and continuing education

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

ceding publication.

YOUR KPhA Needs YOU! Have an idea for a continuing education article? WRITE IT!

Continuing Education Article Guidelines

Continuing Education Changes

the evaluation sheet and announcement. It has six parts.

Here’s a sample: 0143-0000-14-006-H01-P&T. The 0143 is

the ACPE Accredited Provider number (KPERF). All activi-

ties that begin with 0143 are accredited by KPERF. The

next part, 0000 shows that this is a KPERF activity. The

other option for this area is 9999, which shows that another

organization is presenting this activity, but KPERF is still

accrediting the program as a joint provider (a new term

ACPE adopted in June 2014).

The third section (14) is the year the activity was accredit-

ed, and the fourth section (006) is the sequence of the ac-

tivity. This is the sixth activity accredited for 2014 by

KPERF.

The fifth part (H01) is the important one for determining the

type of the activity. The “H” shows that this is a home-

based activity. If it were a live activity, this would be an “L”.

The 01 is the topic designator. ACPE has five topic desig-

nators for CE: 01 - Drug therapy related, 02 - AIDS therapy

related, 03 - Law topics, 04 - General Pharmacy Topics,

05 - Patient Safety. Most of KPERF’s topics are Drug

Therapy Related or General Pharmacy Topics, but we are

working to add patient safety topics. The January 2014 arti-

cle about changes to HIPAA is designated as a Law topic.

The final part of the UAN designates this credit either for

pharmacists (P) or pharmacy technicians (T). This designa-

tion is why we have two answer sheets in the journal for

each article and separate evaluation sheets for live activ-

ies. For most of KPERF articles, the objectives for techni-

cians and pharmacists are the same, but some articles

have separate objectives. For live activities, pharmacists

and technicians have separate sheets. Often the only dif-

ference is this section of the UAN. But this is a very im-

portant designation. If the administrator entering the credit

doesn’t know the participants, pharmacists could end up

with technician credit on their CPE Monitor profile and vice

versa.

Questions?

NABP Customer Service is available to answer your ques-

tions about CPE Monitor at [email protected] or on the

telephone Monday through Friday 9 a.m. to 5 p.m. Central

Time at 847-391-4406. If you have trouble logging in to

your profile or forget your user name or password, they can

help you with those issues.

If you have any other questions about continuing education

or if you are interested in writing a CE article or presenting

a CE topic at a meeting, let Scott Sisco know. KPERF is

YOUR trusted source for quality continuing pharmacy edu-

cation.

Page 27: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 27

KPhA Pharmacy Emergency Preparedness

KPhA Pharmacy Emergency Preparedness Initiative Interest Form

Name: ______________________ 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)

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.

Emergency Preparedness begins at home Before you can help others, you should make sure

you and your family are prepared in case of an

emergency. Here are some tips to get you started:

- Don't run out of your medications!

* Have an extra supply of medications on hand.

* Check with health care providers on proper storage of medications during a power outage.

-Have a 'Grab and Go' bag on hand.

* Includes extra medications, including over-the counter in waterproof zippered bags.

* Keep each medication in its original container.

* Check for expired and discontinued medications twice a year.

* Include pet medications and records.

- Make a kit for your home

* Flashlight, water (1 gallon per person), radio and batteries, first aid kit, whistle, plastic bags,

toilet paper, canned food, peanut butter, crackers, duct tape, blankets.

- Things to grab and go

*Car keys, house keys, identification, family files, eye glasses, medicine, hearing aid, batteries.

*List of phone numbers

*Doctor, school, poison control hot line, emergency phone numbers, local police/state police.

Pharmacy Personnel Training Program KPhA Director of Pharmacy Emergency Preparedness Leah Tolliver, PharmD, is developing a training program for Phar-

macy Personnel on preparing for a disaster, both in the pharmacy and at home. Watch the KPhA eNews and the calen-

dar on www.kphanet.org for dates and more information.

Page 28: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 28

Getting to Know Dr. Cindy Stowe

Getting To Know Dr. Cindy Stowe: The New Dean of Sullivan University College of Pharmacy

By: Heather M. Bryan, PharmD candidate and Irina Yaroshenko, PharmD candidate, Sullivan University College of Pharmacy (SUCOP) Class of 2015

Dr. Cindy Stowe is a graduate of the University of Ken-

tucky College of Pharmacy, where she also completed a

general clinical residency and a pediatric specialty residen-

cy. Following residency, she fin-

ished a pediatric pharmacotherapy

research fellowship at LeBonheur

Children’s Medical Center in Mem-

phis, Tenn. Dr. Stowe was a mem-

ber of the medical staff at Arkan-

sas Children’s Hospital from 1996-

2014 and has extensive teaching

experience at both the University

of Arkansas for Medical Sciences

(UAMS) College of Pharmacy and

the College of Medicine. While at UAMS, she served as

Associate Dean of Academic Affairs, Associate Dean for

Professional Education. In the two years prior to joining

Sullivan, she held the title of Associate Dean for Adminis-

trative & Academic Affairs.

What is your favorite part of the pharmacy profession?

While practicing, my favorite part of the profession was

working with the other members of health care team. I en-

joyed direct patient care, but the aspect that I liked the

most is working with other health care providers, both as a

collaborator and educator.

What made you decide to choose a career in academ-

ia?

As a child, I always wanted to be a teacher. I did not think

about pharmacy as a profession until I got into high school.

Once I decided to go through residency, going into aca-

demia just made sense. Being a faculty member was not

something that I envisioned early on in my career because

I envisioned my role would be educating patients and other

health care providers, not necessarily being in academic

pharmacy. Having done a residency and fellowship pre-

pared me to take on a faculty position.

Why did you decide to return to the state of Kentucky?

I was at the point of my career when I was looking for other

opportunities and new challenges. The next logical step

was deanship and the opening at Sullivan got my attention.

I did my homework and learned what Sullivan was all

about and the rest is history. Getting to return to Kentucky

was a plus and definitely a positive.

What interests you in the Dean position at SUCOP?

I had a good fortune to work for an excellent Dean at

UAMS and that position gave me the confidence to do this.

I like challenges and I want to make a difference, so when I

learned about Sullivan University, the Sullivan family and

what they believe in, it seemed right. I like learning new

things and making a difference so this was a perfect oppor-

tunity for me. When I interviewed at SUCOP, what im-

pressed me the most was the faculty and students. The

faculty is young and enthusiastic and really committed to

the profession, while the student body is diverse and driv-

en. My on-site visit confirmed that this would be a great

place for me.

What goals do you have for SUCOP?

Initially, my goal is to get to know Sullivan, the faculty and

staff, students and people externally – build relationships.

In terms of long-term goals, my main focus is for SUCOP

to be structurally sound then dream big. We have some

strong faculty that are well prepared, and we need to figure

out our niche, create an identity for ourselves and make

clear goals for the College.

What is your outlook on provider status for pharma-

cists?

Provider status is a topic that never goes away because

Dr. Cindy Stowe visits with KPhA Chair Duane Parsons

at the 136th KPhA Annual Meeting and Convention. Dr.

Stowe was introduced at the KPhA Awards Luncheon.

Page 29: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 29

2014 KPhA Mid-Year Conference on Legislative Priorities

we haven't been successful at achieving it. Sometimes you

may not achieve your end result, but what you do achieve

is still beneficial for the profession. As a Dean, it is my job

to help support initiatives that move the profession forward.

I think there are a lot of barriers to earn provider status, and

we just have to continue to work toward that end result. I

am hopeful that with healthcare reform, there will be ex-

panded opportunities for pharmacists, one of them provider

status.

How do you think the pharmacy field will change in the

next 10 years and why?

I believe the pharmacy field will be drastically different in

the next 10 years, driven by healthcare reform to achieve

access to quality healthcare at a reasonable cost. I believe

payment models will drive a shift to a service-based model

with less emphasis on dispensing a product. Pharmacists

will continue to become more dependent on technology

and this should include access to the entire medical record

regardless of location. The role of pharmacy technicians

will continue to evolve to support direct patient care.

What advice can you give to new pharmacy graduates?

Innovate, innovate, innovate! It is an awesome time to be a

new graduate. New graduates hold the key to the future

because you are better prepared for the new practice mod-

els than my generation. Finally, I hope every graduate finds

their place in practice where they get to do what they love

each day. I feel like I have been blessed to have found a

career where I get to do just that – it’s a great deal of fun!

Save

the

Date!

Nov. 14-15, 2014

Griffin Gate Marriott, Lexington, KY

CE

Networking

Legislative Presentations

PBM Transparency Update

MTM Certification Program

Immunization Training

Page 30: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 30

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.

2014 KPhA Open House

YOU’RE INVITED!

KPhA Open House to celebrate

National/Kentucky Pharmacists Month

1 p.m. Thursday, Oct. 2, 2014

at KPhA Headquarters at 1228 US 127 South

Frankfort, KY

Page 31: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 31

Government Affairs/KPPAC

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.

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)

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)

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

Page 32: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 32

Treasures of Kentucky Pharmacy History

Treasures of Kentucky Pharmacy History:

Currently Collecting Dust and Seeking Hope By: Lauren VanHook UK APPE 2

As a part of my second advanced pharmacy practice expe-

rience rotation at Laurel Heights Nursing Home in London,

Ky., I had the opportunity to visit the KPhA office in Frank-

fort and the great honor of meeting the one and only Gloria

Doughty. She is the chairperson and founder of the Ken-

tucky Renaissance Pharmacy Museum and Fountain, a not

for profit organization. The highlight of my day was sitting

down with this amazing woman to listen to stories about

her life and how the dream of a museum came to be a re-

ality. I discovered she was truly a trailblazer for women in

the profession as she was the first female member of the

Kentucky Board of Pharmacy, and she was one of only two

women in her pharmacy graduating class. As we talked, I

could see that her passion for history burned just as bright-

ly as her passion for the profession of pharmacy.

Today, the museum’s vast collection of pharmaceutical

trinkets, treasures and artifacts lies packed away in card-

board in the very basement Gloria and I talked in. Regret-

tably, the museum was recently forced to relocate from its

previous location in the old Fayette County courthouse.

There was just one small prob-

lem; they had no location to relo-

cate to. With limited resources to

dedicate to locating and securing

a new home for the museum,

the only option left was to store it

temporarily at the KPhA office. I

was only able to get glimpses of

a couple pieces when Gloria ac-

companied me into a back room to explore and admire.

One item that stood out to me in particular was a shadow

box filled with pins, medals and ribbons from some of the

very first annual pharmacy meetings. As a fourth year stu-

dent at the University of Kentucky College of Pharmacy

I’ve had the opportunity to travel to many of the same an-

nual meetings with fellow pharmacy classmates and pro-

fessionals where we too collected 21st century versions of

the aged memorabilia protected under the glass. It was a

simple connection, but an important one…a personal one.

In a science based career such as pharmacy, it is easy to

forget about history amongst the chemistry, physiology and

biology we work with daily. Pharmacy is constantly moving

forward as a profession and between long work weeks,

continuing education and the general obligations of life,

pharmacists and pharmacy students alike are just trying to

keep up. In the race to stay up-to-date, it’s easy to dismiss

what has come before us. To most of us the history of

pharmacy sits in the back of our minds covered in a heavy

layer of dust just like the boxes in

the KPhA office basement in Frank-

fort, but how can we ever hope to

better ourselves as a profession if

we abandon pharmacy’s past?

Kentucky has one of the most (if not

the most) extensive collection of

historical pharmacy artifacts, and it

needs immediate help in the form of

dedication and passion from the very profession it repre-

sents. It is our obligation as pharmacists to be responsible

for maintaining our history. We owe it to the generations of

pharmacists and druggists that have come before us to

preserve their story. It was through their efforts and profes-

sionalism that pharmacy has become the respected pro-

fession it is today. So what are you going to do? Be apa-

thetic and let these Smithsonian worthy items collect dust

or take action so that these treasures can once again see

the light of day? Join KPhA in its mission and contact

KPhA staff or Museum representatives (see next page)

today to see what you can do to help find a permanent

home for the Kentucky Renaissance Pharmacy Museum

and Fountain.

“A generation which

ignores history has no

past: and no future” -

Lazarus Long

Page 33: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 33

In 2009 the Centers for Medicare and Medicaid Services

(CMS) implemented Surety Bond Requirements for sup-

pliers of Durable Medical Equipment, Prosthetics and

Supplies (CMS-6006-F). This ruling requires that each

existing supplier must have a $50,000 surety bond to

CMS.

Pharmacists Mutual Insurance Company, through its

subsidiary Pro Advantage Services, Inc. d/b/a Pharma-

cists 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 other products,

please contact us:

Call 800.247.5930 Extension 4260

E-mail [email protected]

Contact a Pharmacists Mutual Field Representative 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

Treasures of Kentucky Pharmacy History

2014 Mid-Year Conference on Legislative Priorities

Nov. 14-15, 2014

Griffin Gate Marriott Resort, Lexington, KY

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]

For more information on the museum, see

www.pharmacymuseumky.org or contact Gloria Doughty at

[email protected] or Lynn Harrelson at [email protected].

Page 34: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 34

KPhA Board of Directors

Secretary Brooke Hudspeth (pictured

at right) is a clinical diabetes care phar-

macist for Kroger Pharmacy and serves

as the Program Coordinator for Kroger’s

American Diabetes Association–

recognized Diabetes Self-Management

Education Program. She received her

doctor of pharmacy degree from the Uni-

versity of Kentucky College of Pharmacy

in 2007. Upon graduation, Dr. Hudspeth

completed a postgraduate (PGY1) resi-

dency with an emphasis in community

care with the University of Kentucky and

Kroger Pharmacy. Dr. Hudspeth’s practice

interests include medication therapy man-

agement and disease state management,

particularly diabetes.

In addition to her clinical practice activi-

ties, Dr. Hudspeth is Assistant Professor

at the University of Kentucky College of

Pharmacy. She serves as a preceptor for

the University of Kentucky College of

Pharmacy/Kroger Community Pharmacy

Residency Program. She also is on the

faculty of the American Pharmacists As-

sociation’s certificate training program The Pharmacist and

Patient-Centered Diabetes Care.

Director Tony Esterly graduated from

the University of Kentucky College of

Pharmacy in 2006 where he served a

year as Regent for the Upsilon chapter of

Kappa Psi. He has worked in a broad

range of pharmacy settings (some over-

lapping) which include retail at Kroger,

compounding with

Wickliffe Veterinary Compounding,

managed care at Humana and his own

consulting business. Today he is em-

ployed as a contracting consultant for

Humana Trade Relations.

Director Matt Foltz is a 2003 graduate

of University of Kentucky College of

Pharmacy and has been the Director of Operations for Med

Care Pharmacy in Florence since 2007. Prior to that, he

was a pharmacy manager for Kroger in Louisville. In 2013,

he joined the Board of Directors for the Northern Kentucky

Pharmacist Association and has been on the Government

Affairs committee for KPhA the last two years.

University of Kentucky College of Pharmacy Student

Representative Mallory Megee (pictured above) is cur-

rently a third year student pharmacist at the University of

Kentucky College of Pharmacy. She graduated from the

University of Kentucky in 2012 with a Bachelors of Science

in Biology before moving across the street to the College of

Pharmacy. She is actively involved in the Kentucky Alli-

ance of Pharmacy Students (KAPS), Phi Lambda Sigma

(PLS) and PediaKats. During her free time, she enjoys

reading and volunteering at the College of Pharmacy.

Sullivan University College of Pharmacy Representa-

tive Christian Polen (pictured above) is from Bowling

Welcome to the New Directors of

the KPhA Board of Directors

Outgoing Chair Kim Croley with re-elected Director Richard Slone, SUCOP

Student Representative Christian Polen, Secretary Brooke Hudspeth and

UKCOP Student Representative Mallory Megee.

Page 35: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 35

KPhA Board of Directors

Directors Richard Slone and Chris Killmeier were re-elected to three-year terms. Director Tony Esterly was appointed to

fill a two year term vacated when Chris Clifton was elected President-Elect.

Green, Ky. He graduated from the University of Kentucky in

2012 with a B.S. in Biology, and in 2013 enrolled as a stu-

dent at Sullivan University College of Pharmacy (SUCOP).

At SUCOP, he was elected President of the SUCOP chap-

ter of the American Pharmacists Association- Academy of

Student Pharmacists (APhA-ASP). As President of APhA-

ASP, he enjoys working with an incredible executive com-

mittee to implement and participate in various community

outreach programs in the city of Louisville. In the Fall, he

will enter the dual degree program at SUCOP, and will pur-

sue an MBA along with a PharmD. At this time, he does not

know what he wants to do after graduation, but he does

know that he wants to remain in the great state of Ken-

tucky.

Past President Representative Ray Bishop is married to

Joan and has five children, Karen, Lisa,

Ray, Jean Marie and Brian. He graduat-

ed from St. Xavier High School and

Mercer Pharmacy School. Ray retired

after more than 40 years of practice. His

career included Director of Pharmacy

for Taylor Drug Stores and finishing his

career at Rite Aid. He also has been

very active in pharmacy associations

having served as president of both Jefferson County Acad-

emy of Pharmacy and Kentucky Pharmacists Association in

1990. He is a member of Kappa Psi Graduate Chapter and

is Secretary/Treasurer of the Veteran Drug Club and pres-

ently serves as Past President Representative on the KPhA

Board of Directors.

2014-15 Chair Duane Parsons

presents outgoing chair Kim Croley with the

Chair’s Plaque for her dedicated service.

Trish Freeman is recognized for

serving as KPhA’s delegate to USP.

Special Thank Yous

Page 36: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 36

KPhA New and Returning Members

KPhA Welcomes New and Renewing Members

May-June 2014 Cathy Adams

Pineville

Diane Akin

Bowling Green

Katelyn Alexander

Johnson City, Tenn.

Christina Amburgey

Nicholasville

Jeffrey Arnold

Florence

Rosana Aydt

Villa Hills

Terri Bailey

Elizabethtown

Jeffrey Baize

Louisville

Jason Baker

Louisville

Jennifer Baker

Louisville

Greg Baker

Louisville

James Ball

Elizabethtown

Larry Barnett

South Williamson

Margaret Beeler

Lebanon Junction

Crystal Belt

Annville

Mike Berry

Maysville

John Beville

Shelbyville

Cindy Biecker

Edgewood

Stefani Billington

Mayfield

Joshua Blackwell

Hazard

David Bowman

Columbia

Debra Brock

Wallins Creek

Richard Brooks

Louisville

Benjamin Brown

Louisville

Greg Browning

Louisville

Dianna Bryant

Hartford

John Bushong

Tompkinsville

Robert Cain

Hanson

Breanna Capps

Middlesboro

Paulette Caron-Turner

Louisville

Thomas Carter

Lexington

Wayne Carter

The Villages, Fla.

Jessika Chinn

Beaver Dam

Margaret Christopher

Winchester

Aimee Cloud

Louisville

Arica Collins

Albany

Teresa Collison

Summersville

Erin Conkright

Owensboro

Susan Conn

Forest Hills

Paul Cooper

Morehead

Robert Croley

Corbin

Kimberly Croley

Corbin

Sue Dailey

Lexington

Johnnie Dando

Liberty

Heather Daniels

Hazard

Alan Daniels

Georgetown

Floyd Davis

Louisville

Steven Dawson

McDowell

Dave Dickerson

Morehead

James Dixon

Barbourville

Anna Lee DuPont

Louisville

Margret Easterling

Jenkins

Michael Eastridge

Lebanon

Joseph Elmes

Louisville

Kevin Emberton

Edmonton

Chad Evans

Maysville

John Evans

Henderson

Lorie Evans

Quincy

Justin Fink

Fort Wright

Alan Flener

Glasgow

Patricia Freeman

Lexington

Mary Fricke

Corbin

Donald Fritts

Morganfield

Dennis Gawronski

Prestonsburg

Susan Gibson

Lexington

Misty Glin

Louisville

Andrew Goble

Louisa

Sherry Goeing

Melvin

Charles “Len” Gore

Nicholasville

Ben Gower

Henderson

Dwaine Green

The Villages, Fla.

Scott Greenwell

Prospect

Charles Gross

Hazard

Larry Hadley

Frankfort

Thomas Hall

Martin

Matthew Harman

Dublin, Ohio

Kin Harmon

Louisville

Jim Harned

Louisville

Billy Hart

Frankfort

Pamela Hays

McKee

Gregory Hines

Bowling Green

Chrystyanna Hoefler

Brooksville

Tom Houchens

London

Jan Houchens

London

Reymonda Howard

London

James Howard

Fountain Run

Joseph Huff

Hodgenville

Jennifer Jaber

Louisville

Page 37: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 37

KPhA New and Returning Members

Tim Jenkins

Louisville

Mason Kash

Winchester

Dana Kays

Bardstown

William Keck

Corbin

Christi Keckley

Shelbyville

Paul Koenig

Louisville

Mike Leake

Danville

Ken Lewis

Louisville

Carlos Lopez Leal

Lexington

Rick Loudermelt

Williamsburg

Robert Lucas

Flatwoods

Christopher Mack

Simpsonville

Richard Manuel

Frankfort

Thomas Mason

Fairfield

Joey Mattingly

Baltimore, Md.

William McConnell

Kuttawa

Jill McIntosh

Louisville

Brittany McQueary

Russell Springs

Laurie Meeks

Lexington

Mike Menard

Mt. Sterling

Florence Merrifield

Louisville

Mark Milburn

Louisville

Jeffry Mills

Louisville

Janet Mills

Louisville

Dan Minogue

Louisville

Judy Minogue

Louisville

Christy Mulberry

Alexandria

James Murphy

Whitley City

Chanin Nelson

Middlesboro

Brad Newcomb

Paducah

Patrick Noonan

Louisville

Mark Nybo

Crescent Springs

Jamie Otte

Florence

Thomas Parker

Pikeville

Jarred Patrick

Greenup

Brittany Pauly

Union

Michael Perdue

Catlettsburg

Brookes Pickard

Louisville

Hilary Pohn

Prospect

Richard Potter

Bowling Green

Carmel Powell

Clarkson

Amanda Powers

Boaz

Richard Preece

Ashland

Mary Probst

Louisville

John Rasche

Bonnyman

Megan Reynolds

Louisville

Gary Rice

Corbin

Christine Richardson

Louisville

Amber Riesselman

Louisville

Hanson Roberts

Staffordsville

Frank Romanelli

Lexington

Helen Rose

Kevil

Ann Rule

Newark, Del.

Thomas Runge

Union

Jessica Salmons

Hazard

Anthony Schmid

Grand Rapids, Mich.

Lisa Schwartz

Crestview Hills

Craig Seither

Ludlow

Harold Shields

Ashland

David Shipley

Henderson

Jennifer Shugars

Liberty

Sarah Slabaugh

Louisville

Kelly Smith

Lexington

Marla Smoot

Crittenden

Stephanie Southern

Paducah

Scott Spille

Edgewood

William Spoo

Louisville

Michael Stephens

Columbia

Paula Straub

Louisville

Brittany Sullivan

Melber

Patricia Sullivan

Louisa

Lisa Terry

Elizabethtown

Gene Thomas

Owenton

Marla Tolley

Ashland

Leah Tolliver

Lexington

Danny Tsai

Louisville

Clifford Tsuboi

Lexington

John Turner

Paintsville

Melissa Vice

Dry Ridge

Samuel Waddell

Sitka

Jason Wallace

Dry Ridge

Virgil Webb

Bellevue

Brian Wells

Owensboro

Leonard Westbay

Louisville

Tonya Westmoreland

Lowmansville

Lenville White

Irvine

Kerri Woods

Hamilton, N.Y.

Grady Wright

Georgetown

Michael Wyant

Finchville

MEMBERSHIP MATTERS:

To YOU, To YOUR Patients To YOUR

Profession!

Page 38: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 38

Bowl of Hygeia Challenge

Kentucky is No. 1! KPhA wins the 2013-14 Bowl of Hygeia Challenge Thanks to the generosity of sev-

eral KPhA members, Kentucky

blew away the competition in the

APhA Foundation Bowl of Hyge-

ia Challenge 2.0. We raised

$9,660.00 during the campaign.

KPhA kicked off year two of the

challenge with a bang thanks to

2013 Kentucky Bowl of Hygeia

winner Leon Claywell’s pledge to

match up to $5,000 in contribu-

tions toward the campaign.

The APhA Foundation is raising

funds to make sure this award

continues to be awarded each

year. Each state pharmacy or-

ganization was asked to raise

$5,000, and thanks to the do-

nors from Kentucky, we nearly

doubled that.

KPhA thanks each of the donors

who made this victory possible.

KPhA acknowledges all of the donors to the APhA Bowl of Hygeia Endowment Fund,

including those in attendance at the KPhA Annual Meeting and Convention in June.

Leon and Margaret Claywell with the Bowl of Hygeia at the 2014

Bowl of Hygeia Reception at the APhA Annual Meeting.

$9,660.00!

2012 KPhA Bowl of Hygeia recipient

George Hammons makes inaugural gift and

chairs Kentucky's Campaign in Year 1 of

the APhA Foundation State Pharmacy As-

sociation Challenge .

Page 39: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 39

Bowl of Hygeia Challenge

Kentucky Donors

American Pharmacy Services Corp.

Cassandra Beyerle

Booneville Discount Drugs

Kenneth Calvert

Mike Cayce

Cayce's Pharmacy, Inc.

Leon & Margaret Claywell

Brian Fingerson

Charles Fletcher

Dwaine Green

George Hammons

Tom Houchens

Chris Killmeier

Philip Losch

Matthew & Aleshea Martin

Robert McFalls

Medica Pharmacy and Wellness Center

Bob Oakley

Duane Parsons

Donald Riley

Patricia Thornbury

Tolliver Management Group

Jerry White

Simon Wolf

Above: Executive Director Robert McFalls presents Margaret & Leon Clay-

well with the KPhA Trailblazer Award, Leading KPhA to be No. 1 in the

2014 APhA Foundation Bowl of Hygeia Challenge at the 2014 Ray Wirth

Banquet during the 136th KPhA Annual Meeting and Convention. Leon

was the 2013 KPhA Bowl of Hygeia winner, and pledged to match up to

$5,000 in contributions from Kentucky donors for the Bowl of Hygeia cam-

paign.

Below: Kentucky was presented with a Certificate of Recognition in recog-

nition of YOUR KPhA leading the way among all state pharmacy associa-

tions in Year 2 of the Bowl of Hygeia State Association Challenge.

Mindy D. Smith, RPh, Executive Direc-

tor of the APhA Foundation with Bob

McFalls at the 2014 Bowl of Hygeia Re-

ception at the APhA Annual Meeting.

Page 40: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 40

Pharmacy Law Brief

Pharmacy Law Brief: The Federal False Claims Act

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: I continually see mention of a federal law

known as the Federal False Claims Act and, in association

with that, read strange phrases and words such as “Quit

Tam Action” and “Relator.” What is all that?

Response: The Federal False Claims Act (FCA) is a

federal statute that creates potential criminal and civil liabil-

ity for those who would defraud the federal government.

This can apply either to individuals or to companies. The

contemporary statute traces its origins to the Civil War

when a variety of vendors sold defective or adulterated

products to the federal government. Enactment of this stat-

ute during the administration of President Lincoln has re-

sulted in this sometimes being referred to as the “Lincoln

Law.” It can be found at 31 U.S.C. §3729.

One unusual feature of the statute is that it permits or au-

thorizes individuals having no affiliation with the federal

government to initiate legal actions on behalf of the govern-

ment when they have knowledge of nefarious activities that

might run afoul of the law. These people are sometimes

referred to as “whistleblowers” and the resultant filings are

called whistleblower lawsuits.

If the lawsuit is successful the person who filed the suit,

referred to by the title “relator,” can be rewarded with 15-30

percent of the amount recovered. This provision authorizing

an individual to file the lawsuit on behalf of the federal gov-

ernment and creating the entitlement to a portion of the

amount recovered is called the qui tam provision. Those

two words are a key portion of a long legal phrase in Latin

that essentially means “he who sues in this matter for the

king as well as for himself.”

Two of the key provisions in the False Claims Act serve to

prohibit [1] knowingly presenting, or causing to be present-

ed, a false claim for approval or payment, and [2] knowingly

making, using or causing to be made or used, a false rec-

ord or statement materials to a false or fraudulent claim. So

either making the false claim or crafting documents to justi-

fy or support that false submission can run afoul of the law.

It should be borne in mind that the statute mandates treble

damages plus the court can impose additional penalties of

between $5,500 and $11,000 per false claim.

There have been interesting shifts with the statute over

time. During the Civil War the transgressions that first led to

enactment of the statute primarily related to sales of materi-

el to the federal government for prosecuting the war. That

focus on military-related purchase continued for quite some

time. In fact, during World War II the statute was enacted to

reduce the share of proceeds directed to the relator. Up

through the 1980s the activities of defense contractors con-

tinued to be a principle focus of FCA-related activities. It is

noteworthy, however, that by the late 1990s that focus had

shifted to health care fraud. It is reported that false claims

related to provision of health care goods and services now

comprise a majority of cases filed under the statute.

The pharmaceutical industry, pharmacy chains and individ-

ual pharmacies have all come under scrutiny using the Fed-

eral False Claims Act. During recent years GlaxoSmithKline

entered into a $750 million settlement with federal govern-

ment under the False Claims Act and Ranbaxy Pharmaceu-

ticals paid a $500 million settlement, both for allegedly re-

leasing adulterated medications into interstate commerce.

The Department of Justice reports that the pharmaceutical

industry was one of the largest contributors to settlements,

with the predominant violation being alleged off-label pro-

motional activities. Advent of Part D of Medicare with more

direct, expanded federal payment for pharmaceuticals and

pharmacy services has increased potential exposure in this

area.

Submit Questions: [email protected]

Disclaimer: The information in this column is intended

for educational use and to stimulate professional discus-

sion among colleagues. It should not be construed as legal

advice. There is no way such a brief discussion of an issue

or topic for educational or discussion purposes can ade-

quately and fully address the multifaceted and often com-

plex issues that arise in the course of professional prac-

tice. It is always the best advice for a pharmacist to seek

counsel from an attorney who can become thoroughly fa-

miliar with the intricacies of a specific situation, and render

advice in accordance with the full information.

Page 41: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 41

24th Annual UKCOP Alumni & Friends Scholarship Golf Outing

@KyPharmAssoc

@KPhAGrassroots

Facebook.com/KyPharmAssoc

KPhA Company Page

Are you connected

to YOUR KPhA?

Join us online!

Between 2009 and 2012 the federal government recovered

$9.5 billion under this statute. In FY 2013 alone the U.S. De-

partment of Justice recovered $3.8 billion in civil settlements

and judgments under the FCA. Of that total, $2.9 billion was

recovered through qui tam actions. There were 752 qui tam

actions filed during FY 2013, over 100 more than during the

previous year.

Member Update Amber Cann, Louisville, was selected as the AACP chair-

elect for the TiPEL (technology in pharmacy education and

learning) special interest group.

September 15, 2014

Champion Trace Golf Club

Golf Registration begins at 10 a.m.

Lunch available at 11 a.m.

Shotgun Start at Noon

Followed by Dinner, Awards Ceremony & Auction

Registration available at www.ukalumni.net/pharmgolf2014

For more information on Sponsorship Opportunities or Individual/Team

Registration, please contact Amber Bowling at 859.218.1305, [email protected]

Page 42: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 42

Pharmacy Policy Issues

PHARMACY POLICY ISSUES:

The Implementation of iPLEDGE™ to Manage Serious Risks

Author: Allie E. Curlin is a second professional year PharmD student at the University of Kentucky College of Pharmacy

and is concurrently pursuing the degree Master of Business Administration at the Gatton College of Business and Eco-

nomics. She completed her pre-professional academic work at the University of Kentucky and is a native of Fulton, Ky.

Issue: FDA approval of pharmaceuticals for marketing involves balancing risk versus benefit. Is there an example of

extremely serious risks being outweighed by the anticipated benefits from use of the product? This issue might arise

more frequently in the context of seriously ill patients in the hospital but how about in community pharmacy practice?

How can a manufacturer keep a product with horrific side effects on the market and meet the burdens that arise from risk

management programs?

Discussion: Thirty years ago, Roche Pharmaceuticals

introduced the first medication for severe recalcitrant nodu-

lar acne known as Accutane™. Isotretinoin (Accutane™)

is still considered the top acne drug by many today but is

unfortunately the cause of many horrific side effects, most

specifically teratogenicity. In response to the serious con-

traindications, Hoffman-La Roche, Inc. created several pro-

grams to reduce pregnancy exposure to allow isotretinoin

to remain on the market.1 This ultimately led to the program

known today as iPLEDGE™.

In 2005, the FDA approved iPLEDGE™ under its regula-

tion 21 CFR §314, Subpart H, a regulation governing

“Accelerated Approval of New Drugs for Serious or Life-

Threatening Illnesses.” Specifically, iPLEDGE™ falls under

21 CFR § 314.520, which is for FDA approval with re-

strictions to assure safe use.2 In this case the distribution is

restricted to certain facilities or physicians with special

training or experience. With iPLEDGE™, Accutane™ spon-

sors agreed “to implement a program that requires registra-

tion in the iPLEDGE™ program of wholesalers, prescrib-

ers, pharmacies and patients who agree to accept specific

responsibilities designed to minimize pregnancy exposures

in order to distribute, prescribe, dispense and use Accu-

tane.”3

In 2010, the iPLEDGE™ program took further steps to en-

sure isotretinoin and similar acne products remained on the

market when the iPLEDGE™ Risk Evaluation and Mitiga-

tion Strategies (REMS) initiative was accepted.4 Most ele-

ments for the iPLEDGE™ program were previously defined

before the REMS approval; however, the REMS additional-

ly required that a medication guide be included with each

prescription dispensed.5

Unfortunately, with increased security measures have

come increased complaints. According to the article,

“Ethical Challenges of Pregnancy Prevention Programs,”

the iPLEDGE™ program and other pregnancy prevention

programs are so cumbersome they create ethical issues.6

The authors of the article claim that the programs interrupt

the usual relationship between the prescriber, patient and

pharmacist. In many cases it creates a barrier between the

patient and the medication due to overwhelming qualifica-

tion procedures.6 The stipulations also create an ethical

barrier by requiring patients to report and share their per-

sonal information.6 Many healthcare providers commend

the FDA for attempting to address an evident problem but

feel that the current process is greatly flawed.

The FDA realizes that the iPLEDGE™ program requires

additional cooperation from all involved in the isotretinoin

prescribing and dispensing process and understands the

importance of minimizing the burden on patients. The FDA,

however, also recognizes that with this medication there is

a need for increased regulation to ensure patient aware-

ness and proper use.1 iPLEDGE™ is a model in the phar-

maceutical industry as a risk management program. It inno-

vatively involves healthcare from the beginning of prescrib-

ing to the end of therapy, ensuring the patient is included in

all steps. Overall, the main point is patient safety, even

when there are some inconveniences present. The great-

est issue is that there is currently no safer alternative avail-

able. The iPLEDGE™ program has allowed a viable medi-

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].

Page 43: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 43

The Kentucky Pharmacist online

cal option for severe recalcitrant nodular acne to remain on

the market, and without it, isotretinoin and similar medica-

tions may have been removed a long time ago. While

isotretinoin continues to be the “wonder drug” of choice, the

FDA must be diligent in keeping patients as safe as possi-

ble.

References

1. U.S. Food and Drug Administration [Internet]. Accutane

(isotretinoin) Questions and Answers. [updated 2009 Feb 22;

cited 2013 Oct 21]. Available from: http://www.fda.gov/Drugs/

DrugSafety/

PostmarketDrugSafetyInformationforPatientsandProviders/

ucm094308.htm#register.

2. 21 C.F.R. §314.520 (2013).

3. U.S. Food and Drug Administration [Internet]. Public Health

Advisory: Strengthened Risk Management Program for

Isotretinoin Public Health Advisory. [updated 2013 Aug 16;

cited 2013 Oct 21]. Available from: http://www.fda.gov/Drugs/

DrugSafety/

PostmarketDrugSafetyInformationforPatientsandProviders/

DrugSafetyInformationforHeathcareProfessionals/

PublicHealthAdvisories/ucm164132.htm.

4. U.S. Food and Drug Administration [Internet]. Questions and

Answers on the Federal Register Notice on Drugs and Bio-

logical Products Deemed to Have Risk Evaluation and Mitiga-

tion Strategies. [updated 2009 Jun 18; cited 2013 Oct 21].

Available from: http://www.fda.gov/RegulatoryInformation/

Legislation/FederalFoodDrugandCosmeticActFDCAct/

SignificantAmendmentstotheFDCAct/

FoodandDrugAdministrationAmendmentsActof2007/

ucm095439.htm.

5. 21 C.F.R. §208.24 (2013)

6. Bonebrake R, Casey MJ, Huerter C, Ngo B, O’Brien R, Ren-

dell M. Ethical Challenges of Pregnancy Prevention Pro-

grams. CUTIS [Internet]. 2008 Jun [cited 2013 Oct 21];81:494

-500. Available from: http://www.cutis.com/index.php?

id=27148&cHash=071010&tx_ttnews[tt_news]=196898.

In Memoriam

KPhA offers condolences for the families of Emil Baker, of Mt. Sterling and

Kristian Lynn Linton, of Lexington.

Page 44: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 44

Pharmacists Mutual

Page 45: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 45

Cardinal Health

Page 46: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 46

KPhA BOARD OF DIRECTORS

Duane Parsons, Richmond Chair

[email protected] 502.553.0312

Bob Oakley, Louisville President

[email protected]

Chris Clifton, Villa Hills President-Elect

[email protected]

Brooke Hudspeth, Lexington Secretary

[email protected]

Glenn Stark, Frankfort Treasurer

[email protected]

Raymond J. Bishop Past President

[email protected] Representative

Directors

Matt Carrico, Louisville*

[email protected]

Tony Esterly, Louisville

[email protected]

Matt Foltz, Villa Hills

[email protected]

Chris Killmeier, Louisville

[email protected]

Mallory Megee, Nicholasville University of Kentucky

[email protected] Student Representative

Jeff Mills, Louisville

[email protected]

Chris Palutis, Lexington

[email protected]

Christian Polen Sullivan University

[email protected] Student Representative

Richard Slone, Hindman

[email protected]

Mary Thacker, Louisville

[email protected]

Sam Willett, Mayfield

[email protected]

* At-Large Member to Executive Committee

HOUSE OF DELEGATES

Ethan Klein, Louisville Speaker of the House

[email protected]

Chris Harlow, Louisville Vice Speaker of the House

[email protected]

KPERF ADVISORY COUNCIL

Kim Croley, Corbin

[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]

Angela Gibson

Director of Membership & Administrative Services

[email protected]

Leah Tolliver, PharmD

Director of Pharmacy Emergency Preparedness

[email protected]

Elizabeth Ramey

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.

Page 47: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

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 Pharmacy 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 information to [email protected]. Deceased members for each year will be honored permanently

at the KPhA office.

50 Years Ago at KPhA WHO KNOWS? THIS MAY BE THE RIGHT DIRECTION

(From E. Murphy Josey’s Scoops ‘n’ Scraps report from APhA meeting) Speaking before

the American Pharmaceutical Association’s annual meeting in the New York Hilton, Dr.

Henry T. Clark, Jr., administrator, Division of Health Affairs, University of North Carolina,

challenged the profession of pharmacy to develop more purely professional pharmacies to

keep pace with the specialization of medicine.

Commenting on the increasingly important role of the pharmacist as drug consultant to the

physician, Dr. Clark said, “serious consideration should be given to developing a new type of specialist in pharmacy

practice, a man who would have a Master’s or Ph.D. degree, would under normal circumstances function as the head of

the professional pharmacy and would be fully qualified and accepted as full consultant to the physician.

As a further stride in improving the quality of pharmacy services, Dr. Clark suggested that practitioners be re-examined

at various stages in their careers to keep them professionally competent and up-to-date on the latest advances in their

science.

- From The Kentucky Pharmacist, August 1964, Volume XXVII, Number 8.

Page 48: The Kentucky Pharmacist Vol. 9, No. 4

July 2014

THE KENTUCKY PHARMACIST 48

THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601

For more upcoming events, visit www.kphanet.org.

Save the Date 137th KPhA Annual Meeting

& Convention June 25-28, 2015

Holiday Inn University Plaza and Sloan Convention Center

Bowling Green, KY

Mark your Calendar Or we’ll send Duane and Kim after you!

2014 Mid-Year Conference

on Legislative Priorities

November 14-15, 2014 Griffin Gate Marriott Resort

Lexington, KY