the kentucky pharmacist vol. 10, no. 4

Vol. 10, No. 4 July/August 2015

TTTHEHEHE KKKENTUCKYENTUCKYENTUCKY

PPPHARMACISTHARMACISTHARMACIST

News & Information for Members of the Kentucky Pharmacists Association

Membership Matters in YOUR KPhA

President Chris Clifton with his family: daughters Finley and Mallory; wife, Katy; son Brady; parents Charles and Susan.

UNITED WE STAND

July/August 2015

THE KENTUCKY PHARMACIST 2

Table of Contents

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 137th KPhA Annual Meeting & Convention 4 From your Executive Director 6 APSC 8 2015 KPhA House of Delegates Report 9 2015 KPhA Professional Awards 10 137th KPhA Annual Meeting & Convention Sponsors/Exhibitors 12 Increasing Access to Naloxone in our Communities 13 2015-16 KPhA Board Members 14 Happy Retirement to Mike Burleson 15 June 2015 CE — Contractual Relationships 16

June Pharmacist/Pharmacy Tech Quiz 22 July 2015 CE — Companion Animals Medications 24 July Pharmacist/Pharmacy Tech Quiz 30 August 2015 CE — Andropause 31 August Pharmacist/Pharmacy Tech Quiz 40 2015 KPERF Golf Scramble 43 KPhA New and Returning Members 44 KPhA Emergency Preparedness 47 Pharmacy Law Brief 48 Pharmacy Policy Issues 50 Pharmacists Mutual 52 Cardinal Health 53 KPhA Board of Directors 54 50 Years Ago/Frequently Called and Contacted 55

Oath of a Pharmacist

At this time, I vow to devote my professional life to the service of all humankind through the profession of

pharmacy.

I will consider the welfare of humanity and relief of human suffering my primary concerns.

I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy

outcomes for the patients I serve.

I will keep abreast of developments and maintain professional competency in my profession of pharmacy.

I will embrace and advocate change in the profession of pharmacy that improves patient care.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Kentucky Pharmacists Association

The mission of the Kentucky Pharmacists

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 2015 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.

Editor-in-Chief: Robert McFalls

Managing Editor: Scott Sisco

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.

July/August 2015


I would like to thank everyone for coming to this year’s

KPhA Annual Meeting and allowing me to be YOUR

President for the Kentucky Pharmacists Association for

2015-2016. I cannot begin to tell you how humbled I

am to be standing up here in front of so many colleagues

and friends as the leader of this professional association.

There are some people here tonight that have played an

important role in my development, both personally and pro-

fessionally, and I would be remiss if I didn’t mention them.

First and foremost to my parents, Charlie and Susan Clif-

ton, thank you for being such loving and devoting parents

and always being supportive wherever life took your chil-

dren. Thank you to the Kroger Company, and especially my

Pharmacy Sales Manager Ron Huening for being here to-

night; Kroger has been my second home since I was 16

years old, and I appreciate them allowing me and all their

employees to be advocates for the profession. Thank you

to all of my college professors and staff at UK: especially

Dr. Frank Romanelli, Susan Jay, Gina Caldwell, and

Dwaine Green; you all helped push me both academically

and professionally. A special thank you to a great friend

and colleague Justin Fink for being here tonight. I can’t tell

you how much it means to me personally that you made the

trip here this weekend, thank you. Also special thank you to

some family friends and mentors, Pat Mattingly, Duane

Parsons and Steve Broering for making me believe that I

could take on this role. And last, but not least, a huge

thanks to my better half, my wife Katy Clifton and my three

children, Brady, Finley and Mallory. You have never once

complained or been upset for me being away from home,

with whatever activity I put myself in and your patience and

devotion to knowing how important it is to me and our pro-

fession is second to none. You are a wonderful wife and

mother to our children, and I thank and love you very much.

I have seen this profession go through so many changes

through the years, as a young boy watching my father in his

pharmacy, to a 16-year-old technician, a student and now a

pharmacist. Some good and some not so good, but we

have all always been there to serve the best interests of our

patients and our profession. Again today we are at the

crossroads of our profession as we seek recognition and

payment for the services we have always provided to our

patients — finally doing what we were educated to do in

our schooling. H.R. 592, introduced by our very own Con-

gressman Brett Guthrie, who we recognized earlier today

and signed on by all six Kentucky Representatives, will help

our patients receive pharmacists’ services to those medi-

cally underserved areas of our state. This legislation is

about more than recognizing pharmacists. This is about

increasing patient access to health care and the value that

pharmacists can provide to patients and the health care

system. And this is only the beginning as more people see

the benefits of their pharmacist and what services we pro-

vide to better their health, the possibilities can be endless.

This isn’t something that is going to happen overnight, and

it has taken a lot of hard work to get to this point. Much

thanks needs to be given to the Advancing Pharmacy Prac-

tice in Kentucky Coalition, led by our very own President-

Elect Dr. Trish Freeman, as well as all the participating

members; KPhA, Kentucky Board of Pharmacy, KSHP,

APSC, Sullivan University College of Pharmacy and the

University of Kentucky College of Pharmacy. This shows a

truly UNITED front for our profession in our state, and we

have made Kentucky a leader in helping better our profes-

sion and advancing it on behalf of this fine Commonwealth.

Henry Ford once said, “Coming together is a beginning;

keeping together is progress; working together is success.”

We can be successful as long as we ALL work together.

So what can you do? And this goes for pharmacists, stu-

dent pharmacists and technicians. Be an advocate for

YOUR profession, whether it’s through time (like being at

this convention), monetarily donating (with membership,

government affairs or the PAC) or getting involved political-

ly yourself. We as pharmacists have been apathetic long

enough, and now is our time to get off that train and get

into the fight. We are all in this together and we must be

UNITED as one voice to make ourselves be heard loud and

proud. We want to HEAR from you, we need YOUR input.

Be PROUD of what you can do and don’t be afraid to

SHOW it. The stronger we are as one, the further this pro-

PRESIDENT’S

PERSPECTIVE

Chris Clifton

KPhA President

2015-2016

President’s Perspective

Continued on Page 7

Adapted from President Clifton’s address to the

membership gathered at the Ray Wirth Banquet

June 27, 2015

July/August 2015


137th KPhA Annual Meeting & Convention

Scenes from the

July/August 2015



July/August 2015


From Your Executive Director

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls

The healthcare landscape continues to evolve. Recently, I

read an interesting article about the rising number of ePa-

tients, and I wondered if we are prepared to serve this new

cohort of digitally active health consumers? Technology is

driving more and more of our lives, and healthcare is cer-

tainly not being spared. I marvel at most of its applications,

genuinely enjoy many of them

and am intermittently amused at

how some individuals misuse or

abuse them. The one constant

of which we may be assured in

healthcare is change. Yet, our

generation is not alone in this

regard. Think back to the words

of Henry Ward Beecher, “Our

days are a kaleidoscope. Every

instant a change takes place. ... New harmonies, new con-

trasts, new combinations of every sort. ... The most famil-

iar people stand each moment in some new relation to

each other, to their work, to surrounding objects.”

Knowing you have a strong professional association like

YOUR KPhA as your partner to help manage that change

is essential. As pharmacists, pharmacy technicians, resi-

dents and student pharmacists all too readily know,

change can and indeed does come from anywhere. In ad-

dition to the technology drivers, changes in federal or state

policy, changes in the governmental landscape, changes

in the marketplace, changes in consumer needs, all are

having a dramatic impact on how you currently and will

continue to provide patient care. Launched in 1852 in Phil-

adelphia, the first national organization for pharmacists

was the American Pharmaceutical (now Pharmacists) As-

sociation. Not long afterwards, Kentucky pharmacists unit-

ed in 1877 to assume leadership control of your profession

through the creation of the Kentucky Pharmacists Associa-

tion. KPhA continues to be the “umbrella” organization in

the Commonwealth where all pharmacists can come to-

gether regardless of specialty area of practice.

As you will recall, I joined YOUR KPhA as Executive Di-

rector in July 2011 at a time when the state had made a

decision to transition from FFS to Medicaid Managed

Care. This transition in the healthcare delivery system has

certainly ushered in a new paradigm at multiple levels and

pharmacy has had to adapt accordingly. Along these lines,

KPhA has initiated a process, in conjunction with our new-

ly reconstituted Pharmacy Technical Advisory Committee,

of looking at the changes in Medicaid and how we can re-

think the future with respect to our

role in the evolving landscape with

the intent of focusing on how we

can innovate. Preliminary data

from the Department for Medicaid

Services has shown an overall

growth related to the state’s ex-

pansion of Medicaid whereby the

total pharmacy benefit is ap-

proached almost $900b in Year 4

of the program (i.e., November 2013 to October 2014, re-

membering that the state’s transition to Medicaid managed

care was effective 11-01-11) with 18,314,897 prescriptions

filled for some 913,672 patients. The four-year history is

reflected in the chart, recognizing that the first year data

should be viewed within the historical perspective of “flux”

given that it was a year of transition and reporting mecha-

nisms were being adjusted as the managed care system

approach was being implemented. What is missing from

this initial snapshot is the difference that pharmacists

made on the quality side of the equation in terms of im-

pacting quality outcomes. We are continuing to explore

what differences have been made and/or are possible for

the immediate future.

Speaking of change, the Foundation for a Healthy Ken-

tucky recently released initial health data from its multi-

year initiative to study how the Affordable Care Act (ACA)

is impacting Kentuckians. The Foundation is contracting

with the State Health Access Data Assistance Center, a

health policy research institute, at the University of Minne-

sota. While public and professional opinions remain sharp-

ly divided about the ACA, I think it behooves us to monitor

its outcomes and impacts as a profession.

Highlights of the initial health data snapshot that the Foun-

dation released include:

July/August 2015


From Your Executive Director

fession can go in the future. I guess my question is why

wouldn’t you or anyone else give back to the profession that

has afforded you so much in your lives? I know we are all

busy, and we have tons of other activities going on in our

lives, trust me I live it on a daily basis. Isn’t there time today

and everyday, to give back to this profession and help its

continued future success for the students today and the

students of tomorrow? There is, and I would ask for your

continued support to help build on these successes and

growth of this profession. Go back and help US gain a

member or two, and let’s make pharmacy the strongest pro-

fession in the state. As Kentuckians if we all STAND UNIT-

ED as one, we can do anything; “sticks one by one may be

readily broken, but cannot when several are bound together

in a bundle, UNITY gives strength.” Unless we as “sticks”

come together, we will be defeated.

Thank you again for your support, I look forward to hopeful-

ly hearing from and seeing you all in the coming year.

Please let me, the KPhA staff or any KPhA board members

know if there is anything that you, as our MEMBER needs.

We are here for our members and rely on your feedback

and information to better YOUR association. Thank you so

much for your time and attendance here tonight, don’t forget

we have lots of great CE tomorrow, and I look forward to a

great year for YOUR KPhA.

Continued from Page 3

Kentucky’s 10.6 percentage point drop in the rate of

uninsured residents has outpaced our neighboring

states of Illinois, Indiana, Missouri, Ohio, Tennessee,

Virginia and West Virginia which averaged a 2.9 per-

centage point drop. During this time period, the nation-

al decline in uninsured was 4.2 percentage points.

Uncompensated hospital care, which reflects hospital

care performed without payment, dropped substantially

for both urban and rural hospitals in Kentucky.

Medicaid enrollment by region: 32 percent eastern

Kentucky, 25 percent western Kentucky, 19 percent

greater Louisville, 16 percent greater Lexington, 8 per-

cent northern Kentucky.

During the quarter, Medicaid funded 9,314 breast can-

cer screenings, 4,586 Hepatitis C screenings and thou-

sands of other preventive services.

Kentucky Silver plans were selected by the majority (52

percent) of those on the kynect marketplace; 35-54

year olds made up the largest kynect group.

In yet another area of change and opportunity, Kentucky is

currently assessing its need for change in the healthcare

landscape in an initiative termed by CMS as “Where Inno-

vation is Happening.” In conjunction with its “State Innova-

tion Models (SIM) Initiative”, CMS is currently working with

the Cabinet for Health and Family Services to develop and

test new state-led, multi-payer healthcare payment and

service delivery models with the goal of improving health

system performance, increasing quality of care and de-

creasing costs for Medicare, Medicaid and Children’s

Health Insurance Program (CHIP) beneficiaries. KPhA and

several of you as members have been participating in

these discussions via structured workgroup and stakehold-

er meetings conducted by state healthcare officials. It is

crucial that we be involved in these planning efforts and

related discussions in order to advance the profession and,

moreover, to ensure that you have a place at the emerging

model design for healthcare delivery in the coming years.

During this time of change and evolution in the healthcare

world, financial resources face significant challenges on

multiple levels. At the state level, the economic recovery

continues to improve; however, the demands on state re-

sources also are increasing. At the federal level, the uncer-

tain political climate has created an environment of unfund-

ed mandates and untested payment models. It is crucial

that we UNITE as a profession. YOUR KPhA is committed

to being that strong voice for the profession and continuing

to strengthen relationships with healthcare thought leaders

at both the state and federal levels to develop win-win solu-

tions to eradicate the need for future reductions and to ad-

vance the contributions that pharmacists are prepared to

make. Although there have been changes in KPhA over the

years, one continuous dynamic has been the willingness of

our members to play an active role in the leadership of the

association and in its advocacy and professional practice

advancement efforts. This makes our association and the

profession stronger, and it gives it a more influential voice

when it comes to stating a position on change. If you are

interested in becoming more involved, I encourage you to

contact President Chris Clifton and myself to learn more.

We at the Kentucky Pharmacists Association know that

there are future changes ahead for the profession of phar-

macy and those whom we serve. We are committed to

working with you and being your partner in working through

and directing those changes. On the base of Robert Ait-

ken’s sculpture, “The Future”—located outside the National

Archives Building in our nation’s capitol—one can read,

“What is past is prologue.”* As we assimilate these words,

we are reminded that we must study the past in order to

better anticipate and prepare for the future.

*Shakespeare, W. The Tempest, Act 2, Scene 1.

July/August 2015


APSC

July/August 2015


2015 KPhA House of Delegates

Kentucky Pharmacists Association—House of Delegates Minutes & Report of Action Items

Bowling Green, Kentucky June 26-28, 2015

Ethan Klein, PharmD—2015 Speaker Chris Harlow, PharmD—2015 Vice-Speaker and Chair of the Reference Committee Kim Croley, PharmD, CGP, FASCP, FAPhA—Parliamentarian

At the 2015 KPhA House of Delegates members from

throughout the Commonwealth gathered to discuss, debate

and make recommendations to not only shape YOUR

KPhA, but also to push forward YOUR beloved profession.

Opening Session

The opening session was on Friday morning, delegates

were slated and annual reports of the association were pre-

sented.

Chair’s Report: Duane Parsons

President’s Report: Bob Oakley

Treasurer’s Report: Glenn Stark by Duane Parsons

Executive Director’s Report: Robert McFalls

Appreciation awards were presented for outgoing KPhA

Board members.

Committee Reports were presented; Organizational Affairs,

Public and Professional Affairs, Government Affairs com-

mittees.

Delegates present: 60 Total Delegates

35 percent Pharmacy Students, 16.7 percent Board of Di-

rectors, 10 percent JCAPS, 6.7 percent Sullivan, 6.7 per-

cent Past Presidents, 5 percent APSC, 5 percent Academy

Consultant Pharmacist, over 3 percent UKCOP, over 3 per-

cent SUCOP, 1 Delegate each from the following: Laurel

Lake Region, KSHP, Lincoln Trail Region, Fourth District,

Academy of Technicians, Northern Kentucky Pharmacist,

Owensboro Region, and Bluegrass District.

Nominations were requested for Vice-Speaker: Lance Mur-

phy was nominated.

Reference Committee

The Reference Committee met Saturday morning to dis-

cuss resolutions and make recommendations to the House.

The meeting, as always, was open to all KPhA members.

The members of the committee were Chris Harlow (Chair,

Vice Speaker), Lance Murphy, Mary Thacker, Mallory Me-

gee, Catherine Serratore, Kim Croley and Cassandra

Beyerle.

Closing Session

The closing session took place Saturday. During this ses-

sion recommendation of the reference committee were dis-

cussed and vote for Vice-Speaker commenced.

Delegates Present: Total Delegates 64

Reference Committee Recommendations and the action of

the House are listed below. Each of the below were recom-

mended for adoption by the Reference Committee.

Article 1 Section 1.111- 1st Tier Active Members. Pro-

posed to change to New Practitioner 1st Year Active

Members – Recommend adoption as presented. – Ap-

proved .

Article 1 Section 1.112- 2nd

Tier Active Members. Pro-

posed to change to New Practitioner 2nd

Year Active

Members—Recommend adoption as presented.—

Approved.

Article 1 Section 1.112- Add New Practitioner 3rd

Year

Active Members—Recommend adoption as present-

ed—Approved.

Article 1 Section 1.121- Non Pharmacist Spouse Asso-

ciate Members. Proposed to eliminate Section 1.121 in

its entirety—Recommend adoption as presented—

Approved.

Article 1 Section 1.3- Suspension Reinstatement- Pro-

posed to change to suspending members after 5 days

in arrears—Recommend to keep original language of

30 days—Approved to retain original language.

Article 1 Section 1.16- Retired Pharmacist Members-

Proposed new section of bylaws for Retired Pharmacist

Members, bylaws are silent on this Membership, for

which there is a Membership Category (since 2002)—

Recommend adopting- (note to Organizational Affairs

Committee: consider adding dues definition to retired

pharmacist to match senior pharmacist.)—Defeated.

Article 1 Section 1.17- Honorary Life Members—

Continued on Page 41

July/August 2015


2015 KPhA Professional Awards


Larry Stovall, Scottsville, Bowl of Hygeia Award sponsored by the American Pharmacists Asso-

ciation Foundation and the National Alliance of State Pharmacy Associations, with support from

Boehringer Ingleheim.

Claire Love, Lexington, KPhA Pharmacist of the

Year (Pictured with her parents, Buddy and Lucy

Wheeler)

Mike Burleson, Lexington,

KPhA Distinguished Service Award

(Pictured with KPhA 2015-16 Chair Bob Oakley,

KPhA 2014-15 Chair Duane Parsons, and Board of

Pharmacy President Joel Thornbury)

July/August 2015



KPhA Meritorious Service Awards:

Congressman Brett Guthrie,

Bowling Green (Pictured with KPhA

Executive Director Robert McFalls, KPhA

2015-16 President Chris Clifton, Board of

Pharmacy President Joel Thornbury,

2014-15 KPhA Chair Duane Parsons,

APSC Executive Vice President Ralph

Bouvette, KPhA 2015-16 Chair Bob Oak-

ley, KPhA 2015-16 President-Elect and

Director of the Center for the Advance-

ment of Pharmacy Practice at UK Trish

Freeman, SUCOP Dean Cindy Stowe

and KSHP Executive Vice President

Anne Policastri.

Representative John Tilley,

Hopkinsville, joined by KPhA member

Mike Cayce.

Kerry Hettinger, Louisville,

KPhA Professional

Promotion Award

Matt Carrico, Louisville, KPhA

Excellence in Innovation Award

sponsored by Upsher-Smith

Laboratories, Inc.

Heather Daniels, Hazard,

KPhA Technician of the Year

Cassandra Beyerle, Louisville, KPhA

Distinguished Young Pharmacist of the

Year, sponsored by Pharmacists Mutual

Insurance

July/August 2015



APCI

AmerisourceBergen

APSC

Astrazeneca

BD Medical

Cardinal Health

CareSource

Codonics

Coventry Cares of Kentucky

Dr. Comfort

EPIC Pharmacies

Fred’s Pharmacy

Harmonyx Diagnostics

HD Smith

Kentucky Cabinet for Health &

Family Services (KASPER)

Kentucky Renaissance Pharmacy

Museum

KPhA Emergency Preparedness

McKesson Pharmaceutical

Merck

Miami Luken

Mylan

Pfizer

Pharmacists Mutual Companies

QS/1

Rite Aid

Samuels Products, Inc.

Sanofi US

Smith Drug Company

SoFi

Sunovion Pharmaceuticals

SUCOP Student Organizations

Teva Pharmaceuticals

UK COP Experiential Ed/ CAPP

UK Student Organizations

Union Springs Integrative

Medicine

Walgreens

KPhA Would Like to Thank Our 2015 Sponsors

Event Sponsors American Pharmacy Services Corporation

Cardinal Health Customers in Kentucky

Center for the Advancement of Pharmacy Practice

Jefferson County Academy of Pharmacists

KPhA District 1

Kroger Corporation

Northern Kentucky Pharmacists Association

Pharmacists Mutual Co. Insurance

Rx Therapy Management

Samford University McWhorter School of Pharmacy

Sullivan University College of Pharmacy

Union Springs Integrative Medicine

University of Kentucky College of Pharmacy

KPERF Golf Hole Sponsors Ad-Venture Promotions

AmerisourceBergen

Bingham Greenebaum Doll LLP

Booneville Discount Drug

The Clifton Family

Corum Family Pharmacy

Duncan Prescription Center

Fred’s Pharmacies

George Hammons, Frankie Abner & Tom Houchens

Harrod & Associates

Medica Pharmacy and Wellness Center, Bardstown-Bloomfield

Pharmacists Mutual Co. Insurance

Republic Bank & Trust

Rite Aid

Rx Discount Pharmacy

The Save-Rite Family of Pharmacies

Sullivan University College of Pharmacy

Tolliver Management Group

Walgreens

Wayne’s Pharmacy

Your Community Pharmacy Commons and St. Matthews

Cardinal Health Customers

in Kentucky

Matt Carrico

Kimberly Croley

Brian Fingerson

Kentucky Heart Disease &

Stroke and Diabetes

Prevention & Control

Programs

National Association of

Chain Drug Stores

Bob Oakley

Duane W. Parsons

Passport Health Plan

Poole’s Pharmacy Care

Clay & Jill Rhodes

Donnie Riley

Richard & Zena Slone

Sullivan University

College of Pharmacy

University of Kentucky

College of Pharmacy

WellCare of Kentucky

Lewis Wilkerson

Annual Meeting Supporters Rx Systems, Inc.

Medica Pharmacy and Wellness Center Bardstown-Bloomfield

… and our 2015 Exhibitors

Sponsoring Pharmacy’s Future

July/August 2015


Increasing Access to Naloxone

Increasing Access to Naloxone in our Communities: Implementation of Kentucky Senate Bill 192

Drug addiction and overdose are seri-

ous public health issues. Since the

1990s, rates of opioid abuse - including

prescription pain medications and heroin

- have skyrocketed across the nation.

Between 1999 and 2013, an almost four

-fold increase in overdose deaths was

attributed to prescription pain medica-

tions. Between 2012 and 2013, heroin

overdose deaths increased 39 percent.

To address this growing public health

crisis, Kentucky legislators passed com-

prehensive anti-heroin legislation on

March 25, 2015. Senate Bill 192 was

the result of a conference committee

comprised of key legislators from both

chambers and is commonly referred to

as the ‘Heroin Bill.’ Although SB 192

addresses many different aspects of the

heroin and opioid abuse problem, one

section of the bill contains provisions

designed to increase access to naloxone (Narcan®) and

make it easier for healthcare providers to prescribe and

dispense naloxone to individuals to take home and have on

hand should a future opioid overdose situation arise.

Specifically, SB 192 amends KRS 217.186 to allow a li-

censed health care provider, acting in good faith, to pre-

scribe or dispense naloxone to a third-party (person or

agency) without fear of disciplinary action from professional

licensing boards. Additionally, the bill authorizes a person

(or agency) to receive a prescription for naloxone, possess

naloxone and the equipment needed for its administration,

and to administer naloxone to an individual suffering from

an apparent opioid-related overdose.

SB 192 also includes a provision authorizing pharmacists to

initiate the dispensing of naloxone under a physician-

approved protocol. To initiate the dispensing of naloxone in

this manner — without an individual prescription - pharma-

cists must receive training in the use of naloxone for opioid

overdose prevention and apply for certification from the

Kentucky Board of Pharmacy. Once certified, they can work

with a collaborating physician to develop a protocol agree-

ment that stipulates the criteria for identifying eligible per-

sons to receive naloxone under the protocol; the specific

medications, doses and routes of administration the phar-

macist is authorized to dispense; the education that must

be provided to the person receiving the naloxone prescrip-

tion; and the procedures for documenting the naloxone dis-

pensation.

May 14, 2015, the Kentucky Board of Pharmacy filed an

emergency administrative regulation (201 KAR 2:360E) to

address pharmacists initiation of naloxone dispensing. The

Kentucky Board of Medical Licensure provided significant

input to the Kentucky Board of Pharmacy on the regulation.

Finally, SB 192 specifies that a person, acting in good faith,

who administers naloxone to an individual suspected of

opioid overdose shall be immune from criminal and civil

liability for the administration, unless personal injury results

from the gross negligence or willful or wanton misconduct

of the person administering the medication. The bill also

contains a Good Samaritan clause that stipulates a person

shall not be charged with or prosecuted for a criminal of-

fense related to the possession of a controlled substance or

the possession of drug paraphernalia if they seek medical

assistance for a drug overdose.

Physicians and pharmacists should note that the new regu-

lations relative to pharmacists initiating the dispensing of

naloxone under a physician-approved protocol do not apply

to individual, patient-specific prescriptions issued by physi-

cians. Pharmacists can continue to dispense naloxone pre-

scriptions written by physicians and other licensed prescrib-

ers without attaining naloxone certification.

Senate Bill 192 provides the statutory authority and liability

protections needed to accomplish third-party prescribing

and dispensing of naloxone. Working together, physicians

and pharmacists can reduce morbidity and mortality associ-

ated with opioid overdose by ensuring individuals in our

communities have access to naloxone for rescue therapy

during a suspected opioid overdose.

Trish R. Freeman, RPh, PhD

Clinical Associate Professor, University of Kentucky College of Pharmacy

KPhA President-Elect

The online training program can be found at the following link on the KPhA website:

http://www.kphanet.org/?page=NaloxoneCert2015

The cost of the training is $5 for KPhA members, and $10 for non-KPhA members. After successfully completing the

course, credit will be applied to your CPE Monitor Profile and you will be emailed a certificate of completion.

July/August 2015


New 2015-16 KPhA Board of Directors

2015-16 KPhA Board of Directors

Newly installed members of the KPhA Board of Directors include Director Matt Carrico of Louisville, UKCOP Student

Representative Kevin Mercer of Louisville, Director Chad Corum of Manchester, President-Elect Trish Freeman of Har-

rodsburg, Treasurer Chris Palutis of Richmond, Speaker of the House Chris Harlow of Louisville, Vice Speaker of the

House Lance Murphy of Louisville, SUCOP Student Representative Catherine Serratore of Louisville and Director Sam

Willett of Mayfield. Duane Parsons of Richmond (standing at podium) will serve as past president representative.

2015-16 KPhA Chair Bob Oakley recognizes Ethan

Klein for his service as 2014-15 Speaker of the House

of Delegates.

2015-16 KPhA Chair Bob Oakley recognizes Glenn

Stark for his service as Treasurer from 2013-2015.

July/August 2015


Happy Retirement!

Happy

Retirement!

KPhA wishes Mike Burleson a

very happy retirement as he

transitioned out of the

executive director’s role at the

Kentucky Board of Pharmacy

at the end of July.

Steve Hart (pictured with

Board President Joel

Thornbury and Burleson) is the

new executive director.

KPhA acknowledges 2014 Partners & Supporters

Todd Wright, sales manager for Cardinal Health,

accepts the Partner Recognition on behalf of Ken-

tucky Customers of Cardinal Health.

Ron Poole, President/CEO of APSC, accepts the

Gold Supporter Recognition for APSC.

138th KPhA Annual Meeting and Convention June 2-5, 2015 Louisville Marriott Downtown

July/August 2015


June 2015 CE — Contractual Relationships

Advancing Professional Practice by

Understanding the Basic Nature

of Contractual Relationships By: Joseph L. Fink III, B.S.Pharm., J.D., D.Sc.(Hon), FAPhA, Professor of Pharmacy Law

and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and

Science, UK College of Pharmacy

The author declares no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-15-007-H03-P&T

1.5 Contact Hours (1.5 CEU)

Goal: To assist pharmacists and pharmacy technicians in understanding basic principles of the law of contracts that can impact their relationships with others including patients and other health professionals.

Objectives:

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

1. Differentiate offers that indicate contractual intention from those that do not; 2. Describe which parties to a contract must provide lawful consideration; 3. Provide an example of a proposed contract that is not for a lawful purpose; and 4. Identify one group of individuals who in the eyes of the law lack the legal capacity to enter into a contract.

KPERF offers all CE

articles to members

online at

www.kphanet.org

Introduction

The vast majority of people enter into multiple contractual

arrangements each day; pharmacists and pharmacy techni-

cians are no exception. Certainly some of those contracts

are more significant or important than others but an under-

standing of some of the basic principles of contract law can

position one to advance the profession and maximize ser-

vice to patients.

Some contracts relate to the professional aspects of phar-

macy, e.g., collaborative care agreements, contracts with

facilities where patients reside, contracts to provide consult-

ing services, etc., while others relate to business relation-

ships, e.g., employment contracts, leases, contracts with

insurance companies and suppliers, and on and on.

At the outset it is important to differentiate a contract from a

promise; a mere promise is not legally enforceable. In order

for a contract to exist there must be specific elements or

components that come together in a certain way. Those

elements comprise the definition of a legally enforceable

contract: [1] an agreement [2] supported by consideration

and [3] made for lawful purpose [4] between competent par-

ties. Each of those elements will be discussed in turn.

Elements - The Agreement

The possibility of a contract comes into existence when one

person, known as the offeror, extends an offer to enter into

the agreement to another person, the offeree. This offer

may be limited to just one person or it may be broadcast at

large for acceptance by anyone, e.g., poster announcing a

$25 reward for return of a lost pet.

The offer must indicate intent to enter into a contract. An

example of this rule coming into play occurs when someone

makes an offer as a joke. There is no contractual intent by

the speaker, the offeror, so even if the offeree says the offer

is accepted no contract will result. The offer also must have

sufficient detail included that, if necessary, the essential

terms of the contracts could be determined by a court. In

one state the Medicaid agency was required by federal

mandate to terminate the existing provider contracts with

pharmacies. The state Medicaid agency then sent an offer

of contract to pharmacy owner it wanted to sign up for the

program worded this way: “Provider will be paid a dispens-

ing fee to be determined at a later time.” That provision

lacks specificity – price is always an essential element of a

contract – so it could not be the basis for a legally enforcea-

ble contact. The Medicaid agency needed to revise the offer

to add specificity.

Once an offer has been extended to the offeree how long

does it continue to be in play, i.e., be available for ac-

ceptance? There can be several answers to that. First, if

the offeree declines the offer that kills it; the offer is no long-

er in effect after rejection. If the offeror revokes the offer

July/August 2015



before it is accepted that will work to terminate the over-

ture, but it should be noted that the termination only is ef-

fective when the offeree has indeed received the notifica-

tion, not when it is dispatched. It also is permissible for the

offeror to include a deadline for acceptance when com-

municating the offer and that will be effective. If no deadline

was specified, the offer will lapse after a reasonable period

of time.

But what if the offeree needs some time to settle on a re-

sponse, e.g., needs some time to line up financing for the

deal? Can the offeree “lock in” the offer so it will not expire

while he or she is pursuing financing? The answer is yes,

and that is done by entering into a subservient or minor

supporting contract, known as an option, which addresses

how long the offer will remain viable. In order for the option

to be effective it must itself meet all the criteria for a con-

tract.

Acceptance of the offer must be communicated to the offe-

ror and, as a general rule, silence cannot constitute ac-

ceptance. The offeror is not permitted to couch the offer in

words that would make silence equal acceptance, e.g.,

“Unless I hear from you by ___ I’ll consider the offer ac-

cepted.” An acceptance will be considered to be effective

when it has left the control of the offeree. Note that the noti-

fication of acceptance could be out of the control of the of-

feree but not yet received by the offeror yet a contract has

come into existence. For example, if you have extended an

offer of employment to a pharmacist and she has placed

her letter of acceptance in a mailbox this morning, then that

acceptance of your offer was effective when it left her hand

and fell into the mailbox.

The assent to enter into the contract must be genuine.

There can be no fraud, meaning no misrepresentation of a

material fact which is known, or should be known, by the

person making it, to be false and made with intent of induc-

ing the other party to enter into the contract. Further, there

must be no duress, meaning threat of force, or undue influ-

ence, e.g., taking advantage of a confidential relationship.

Application: It’s been a rough day at the pharmacy so

you’re enjoying the change of pace that the meeting of the

local pharmacy association represents. It’s a chance to

catch up with friends who share your passion for the pro-

fession. You’re commiserating with a colleague about a

particularly difficult interaction you had with a patient today

and your frustration surfaces when you say. “I’d sell my

ownership interest in the pharmacy for $10.” Your col-

league immediately brightens up and says, “I accept.” Do

you have a contract to sell your ownership interest in the

pharmacy?

Response: No, your statement of “offer” was not made with

the intent to enter into a valid, enforceable contract. That

was frustration speaking. There was no valid offer out there

to be accepted by your colleague so that element of an

agreement, and hence, of an offer is absent, so no contract

results.

Elements - Supported by Consideration

A contract must impose a duty on both the offeror and the

offeree to either (1) do something he or she is not other-

wise bound to do, or (2) refrain from doing something that

he or she has a right to do. Examples may help clarify the

distinction. At the end of the term of an employment con-

tract the employee is free to go work elsewhere. Should the

pharmacist decide to continue working there that consti-

tutes “doing something he or she is not otherwise bound to

do.” So the employee pharmacist is providing considera-

tion. When the employer extended the offer for the pharma-

cist to stay on, that is the employer “doing something he or

she is not otherwise bound to do.”

That same scenario also could be viewed as meeting the

second definition of consideration – refraining from doing

something that he or she has the right to do. The employee

pharmacist who is at the end of the employment contract is

free to go work somewhere else. By staying on there, the

pharmacist is refraining from doing something – going to

work elsewhere – that he or she has the right to do. Alter-

natively, from the employer’s perspective, the employer

also is refraining from doing something he or she has the

right to do – hiring a different pharmacist.

In order for a contract to result from the agreement there

must be consideration provided by both parties – it must be

mutual; both parties must be obligated.

Application: Your pharmacy has been located in a small

shopping mall for years. Recently a free-standing building

across the street came on the market and it is the right size

and location to make relocating the pharmacy attractive.

The timing also is good because your lease with the owner

of the shopping mall expires in six months, enough time to

get the new location whipped into shape. You’ve been in

purchase negotiations with the owner of the building but the

owner of the shopping mall caught wind of the possibility

that you might be departing. That would be a major blow to

the mall and its other business tenants because of the pop-

ularity of your pharmacy staff with a very loyal clientele.

The owner of the mall offers to extend your lease with a

guarantee of no increase in the rental rate for 10 years plus

he’ll commit to resurfacing the pothole-laced parking lot

within two years. If you accept that offer to remain where

you have been do you have a contract?

July/August 2015



Response: Yes, the owner of the mall is doing several

things he is not otherwise bound to do so there is consider-

ation on his side of the deal. If you accept and opt to re-

main in place after your current lease expires you are doing

something you don’t have to do so you are providing con-

sideration as well. We have mutual consideration with both

sides doing something they are not otherwise legally bound

to do so we have that element of a legally enforceable con-

tract present.

Elements - Made for Lawful Purpose

The general rule in this area is that if a contract would vio-

late public policy or the performance of which would violate

the law then there is no contract. The law will not permit a

court to be placed in the position of having to order one of

the parties to do something illegal in order to enforce the

provisions in a contract. Examples of types of “contracts”

that run afoul of this requirement include those where an

excessive, unlawful (known as usurious) interest rate is

charged for a loan, Kentucky Revised Statutes establish a

general rate of 8 percent, but allows parties to agree on

higher rates in certain cases, so long as the rate does not

exceed the lesser of 4 percent over the federal discount

rate on 90-day commercial paper, or 19 percent.[1] Another

example of an unlawful contract would be a contract involv-

ing bribery of a public official.

The law is rife with exceptions to rules and an exception to

this rule is encountered relatively frequently in pharmacy.

When an ongoing business concern, such as a community

pharmacy, is being sold, the seller often agrees not to com-

pete with the purchaser. That’s because included as an

element of the purchase price is something known as

“goodwill.” Goodwill has a dollar value because it repre-

sents the value of purchasing an ongoing business with an

established clientele as opposed to starting a business

from scratch. Such an agreement or provision in the con-

tract of sales is known as a noncompetition clause. Collo-

quial terminology is often used that refers to this as a “non-

compete.”

The provision specifies that the seller will refrain from doing

anything to recapture that goodwill that has just been sold,

e.g., opening a competing pharmacy across the street. Or-

dinarily such an agreement would be contrary to public poli-

cy because it restrains trade, a violation of the antitrust

laws. Nonetheless, if the terms of the noncompetition

clause are reasonable with regard to the locale covered,

the activities covered and the duration of the prohibition,

then it will be legally permissible and enforceable.[2] An

attorney should be consulted to assess the reasonableness

of those provisions.

Application: You have been offered a position to join a multi

-specialty medical practice as a member of the group to

work with patients on complex drug therapy regimens. The

group is composed principally of young physicians who

saw the tremendous impact a pharmacist could have with

patients while they were in both their medical school edu-

cation program and their residency training. They are

aware that a competing medical group in the next county

over has not been so innovative to incorporate a pharma-

cist in the group. This has given rise to a concern that once

you’ve established yourself with the local patients you

might want to move over to the other medical group, which

is larger and more established. As a result, they want to

include a “non-compete” clause in your employment con-

tract under which you would agree not to work for any other

group in the specified adjacent county for five years after

departure from the employing group. Could such a provi-

sion be enforceable if included in the contract of employ-

ment?

Response: In general, such a provision would be enforcea-

ble if the five-year term is considered reasonable under the

circumstances. That can best be assessed by one familiar

with the local business competition environment so local

counsel should be consulted. If you do agree to proceed to

sign the contract with that provision in there it may be en-

forceable, something that should be borne in mind both

while entering into the agreement and employment relation-

ship as well as for the future should thoughts of departing

arise.

Elements - Between Competent Parties

Parties entering into a legally enforceable contract must

have legal capacity to do so. One who lacks legal compe-

tence to make the contract may later avoid the obligations

contained in the contract. Minors under the age of 18 are

generally considered to lack legal competence. Other cate-

gories of individuals deemed to lack legal capacity to enter

into contracts are insane persons or those intoxicated with

alcohol or other drugs that can impair judgment. The legal

test that is used is whether the person’s mental state is

such that he or she is not aware of what they’re doing.

Application: A young woman in your community known to

you through youth athletics and other events comes to the

pharmacy to present a prescription for oral contraceptives.

Before presenting it she asks whether she can trust you to

preserve her personal health information, even from her

parents. You ask her age and learn that she is 17. You

agree to the confidentiality and proceed to prepare the

medication for dispensing. You take it out to her and com-

plete the patient counseling appropriate for a first-time user

July/August 2015



of products in this category. Then she informs you that she

didn’t bring enough money with her and asks whether she

can charge it. You’ve known her virtually all her life so you

agree to that. If she fails to honor that commitment to pay

would you have a solid legal basis to pursue collection?

Response: No, as a minor the patient lacked legal capacity

to enter into a contract. You’ll encounter legal difficulty

should you decide to pursue collection of this relatively

modest amount owed. Chalk that one up to experience.

Remedies for Breach of Contract

One who does not perform those obligations willingly as-

sumed when entering into a contract is said to have

breached the contract. There are a number of remedies

available to the non-breaching party, both legal remedies

and remedies through the somewhat parallel doctrines of

equity.

The most commonly encountered form of legal remedy is

compensatory damages. That is a measure of monetary

damages designed to compensate the non-breaching in-

jured party by placing him or her in as good a position as

he or she would have been if the contract had been per-

formed. The party not in breach of the contract is required

to take steps to minimize the extent of the damages; that is

known as mitigating the damages.

An alternative form of legal damages encountered with cer-

tain types of contracts is liquidated damages. This form of

damages is agreed on by the parties at the outset of the

arrangement; if either party breaches the contract the

amount of damages to be paid is specified in the terms of

the contract. The amount of liquidated damages must be

reasonable to be enforceable. This form of damages is

commonly encountered in construction contracts where

time is very important. An example would be where a phar-

macy owner is entering into a contract with a builder to con-

struct a new pharmacy building and wants to have the pro-

ject completed by a certain date. The liquidated damages

clause might read something along the lines of “For each

day occupancy is delayed because construction runs be-

yond a certain date, the payment to the contractor will be

reduced by a specified amount.”

In certain circumstances an alternative remedy might be

available through equity. Equity is a system of jurispru-

dence developed in England to supplement the law by cre-

ating flexibility in crafting remedies in areas where the com-

mon law is very inflexible. As a general rule, the only reme-

dy law can give is money. But sometimes a financial award

is insufficient to properly address the situation.

Many equitable principles have been carried forward to the

U.S. legal system. One such equitable remedy is specific

performance. This is where a court orders the breaching

party to a contract to perform one or more specific acts,

usually the duties voluntarily assumed when entering into

the contract. This is typically seen when the subject matter

of the contract is unique or irreplaceable. Since all real es-

tate is considered by the law to be unique, specific perfor-

mance is available should one of the parties breach a con-

tract for sale of real property. Interestingly, courts also have

applied this remedy when enforcing the noncompetition

clause discussed above under “Elements – Made for Law-

ful Purpose.”

Application: With the same facts as existed for the Applica-

tion under Elements - Made for Lawful Purpose above,

you have now decided to leave the medical group practice.

Word of that decision reaches the other medical group in

the next county over and they make an overture to you

about joining them. You also are approached by a third

medical group practice located 50 miles away. While con-

sidering all these expressions of interest you want to factor

in that non-compete clause to which you agreed when ac-

cepting your current position. Could your current group go

to court to seek a court order preventing you from working

for either potential employer?

Response: An offer from the medical group in the adjacent

county could be problematic. If the decision is to pursue

that offer your current employer may well have available

the equitable remedy of specific performance to enforce

your non-compete agreement with them. However, the

same would not be true with the offer from the medical

group 50 miles away. Presumably the wording of your non-

competition clause is not that geographically extensive so it

would not apply.

Defenses Against an Allegation of Breach

If you are on the receiving end of an allegation that a con-

tract has been breached, what defense might you assert to

get out of that jam? First, in order for the other party to

maintain a legal action against you, there must in fact be a

legally enforceable contract. One set of rules that address-

es whether a contract is legally enforceable are contained

in the Statute of Frauds. This doctrine has its roots in Eng-

land in 1677. The Statute of Frauds was enacted to prevent

people from coming into court to claim existence of a con-

tract when in fact none existed. The Statute of Frauds re-

quires that certain types of contracts must be in writing to

be enforceable and must be signed by the party from whom

recovery is sought. Each state in the U.S. has enacted its

own contemporary version. For Kentucky this is found at

K.R.S. 371.010. This rule gets activated in the following

July/August 2015



Donate online to the Kentucky Pharmacists Political Advocacy Council!

Go to www.kphanet.org and click on the Advocacy tab for more information about

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circumstances, for example:

A promise to pay the debt of another; [3]

Agreements for the sale of real estate or an interest in

real estate, including a lease for more than one year;

[4]

Agreements not to be performed within one year from

their making [5]; and

Agreements for the sale of personal property with a

value in excess of $5,000 [6].

Another approach that may be available lies in a rule of

evidence known as the Parol Evidence Rule. If a written

contract prepared at the conclusion of negotiations exists

that covers all material terms of an agreement, a court will

not permit evidence or oral testimony to be introduced that

shows terms in addition or at variance with those in the

written document. [7]

A final legal strategy that may serve as a defense is Statute

of Limitations, a legislatively imposed time limit within which

a legal action must be commenced. If the deadline is

missed, the plaintiff has lost the opportunity to file the law-

suit. Several examples exist in Kentucky law:

Claims based on a contract must be brought within 10

years [8];

Lawsuits based on a sales transaction must be com-

menced within four years [9]; and

An allegation of professional negligence must be initiat-

ed within one year [10].

Application: You have been providing medications to a

number of patients in a local extended care facility, all of

whom pay their medication bills directly, not through the

facility. One patient has fallen substantially behind with her

payments but you are reluctant to cut off her medication

supply. One day a fellow shows up at your pharmacy and

introduces himself as that patient’s son from out west. He

pays her outstanding balance and asks that in the future

such bills be sent to him; he’ll cover her medication ex-

penses. You send the bills to him and they’re paid. Then

the payments stop coming. You’d like to file suit against

him to collect what has now become a very substantial out-

standing balance due. What are your chances of prevailing

in such a legal action?

Response: Not good is the short answer. If one agrees to

pay the debt of another that must be in writing to be en-

forceable. Without a written contract, children have no legal

obligation to cover the financial obligations of a parent.

Conclusion

Contacts and principles of contract law are extremely per-

vasive. Think of all the times you’ve dropped money into a

vending machine to purchase something, thereby entering

into a sales contract with the owner of the machine. Con-

sider all the aspects of your life governed by contractual

arrangements – where you live, where you work, where

you dine, and on and on. The same is true for a wide varie-

ty of professional relationships. Understanding some of the

basic principles of contract can facilitate steering around

potential legal entanglements and position pharmacists to

use all their abilities to benefit patients.

Necessary Professional Disclaimer: The information in

this article is intended for educational use and to stimulate

professional discussion among colleagues. It should not be

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

discussion of an issue or topic for educational or discussion

purposes can adequately and fully address the multifaceted

and often complex issues that arise in the course of profes-

sional practice. It is always the best advice for a pharmacist

to seek counsel from an attorney who can become thor-

oughly familiar with the intricacies of a specific situation,

and render advice in accordance with the full information.

References

1] K.R.S 360.010(1).

2] Crowell v. Woodruff, 245 S.W.2d 447,449 (Ky.App.

1951).

3] K.R.S. 371.010(4).

4] K.R.S. 371.010(6).

5] K.R.S. 371.010(7)

6] K.R.S. 355.1-206.

7] Bryant v. Troutman, 287 S.W. 918, 920 (Ky. 1956).

8] K.R.S. 413.090(2).

9] K.R.S. 355.2-725.

10] K.R.S. 413.245.

July/August 2015



Save the Date

June 2015 — Advancing Professional Practice by Understanding the Basic Nature of Contractual Relationships

1. The time limit for initiating a lawsuit comes from: A. A statute enacted by the legislature. B. A regulation adopted by an administrative agency. C. A court decision. D. There is no time limit. 2. The individual extending an offer to enter into a contract is known as the: A. Offender. B. Offeree. C. Offeror. D. Contractor. 3. Acceptance of an offer is effective when: A. Drafted by the offeree. B. Dispatched by the offeree. C. Received by the offeror. D. Acknowledged by the offeror. 4. Revocation of an offer is effective when: A. Drafted by the offeror. B. Dispatched by the offeror. C. Received by the offeree. D. Acknowledged by the offeree. 5. The Statute of Limitations: A. Sets a time limit within which notification of acceptance

must occur. B. Sets a minimum or limit above which a contract must

be in writing to be enforceable. C. Sets a time limit within which an offer will expire after

being extended to the offeree. D. Sets a time limit within which a lawsuit must be

commenced. 6. You are a recent pharmacy graduate and you have been negotiating your first position at a community pharmacy. You think you’ve crossed off your list everything you wanted in the way of compensation, etc., and the employer has all that in the written contract. You’re looking over the final written contract that arrived in the mail today. Down the road, if something you wanted in there turns out not to be there, how will the Parol Evidence Rule impact things? A. That rule will make it easier for you to legally argue that

the missing element should have been in the written contract.

B. That rule will make it harder for you to legally argue that the missing element should have been in the written contract.

C. That rule would have no application to this situation. D. That rule would neither make it harder or easier to

legally argue that the missing element should have been in the written contract.

7. A contract to provide consulting services to a long-term care facility is required to be in writing in order to be enforceable if it runs for longer than: A. One month. B. Six months. C. One year. D. It is never required to be in writing although that is a

good idea. 8. In a contract to document a Collaborative Care Agreement the offeror could be: A. Either a physician or a pharmacist. B. A physician. C. A pharmacist. D. Neither – it is a document mandated by statute. 9. The Statute of Limitations applicable to a lawsuit alleging that a pharmacist performed professional acts in a negligence fashion would need to be filed: A. Within five years. B. Within two years. C. Within one year. D. Within six months. 10. Individuals who lack the legal capacity to enter into a legally enforceable contract include: A. Minors. B. Insane persons. C. Intoxicated persons. D. All the above.

July/August 2015



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 June 2015 — Advancing Professional Practice by Understanding the Basic Nature of Contractual Relationships (1.5 contact hours) Universal Activity # 0143-0000-15-007-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

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

Expiration Date: August 1, 2018 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEU.

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

TECHNICIANS ANSWER SHEET. June 2015 — Advancing Professional Practice by Understanding the Basic Nature of Contractual Relationships (1.5 contact hours) Universal Activity # 0143-0000-15-007-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.


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July/August 2015


Pharmacy Quality/PTCB

July/August 2015


July 2015 CE—Companion Animal Medications

Companion Animal Anti-Inflammatories and

Analgesics Dispensed Through

Retail Pharmacies By: Kelsey Sproles*, PharmD candidate; Ann-Elizabeth Hancock*, B.S., PharmD

candidate; Lydia Vance*, B.S., PharmD candidate; James R. Carson†, DVM; Inder Sehgal*, DVM, Ph.D.

*Marshall University School of Pharmacy, Huntington, W.Virg. †Carson Veterinary Clinic, Lafayette, La.

There are no financial relationships that could be perceived as real or apparent conflicts of interest.


2.0 Contact Hours (2.0 CEU)

Goals: Pharmacists and Pharmacy Technicians should be able to counsel clients treating their pets about the proper use, expected improvement and potential adverse effects of anti-inflammatories and analgesics they dispense to enhance companion animal patient care.

Objectives


1. Explain the main indications for anti-inflammatories and analgesics that may be referred to retail pharmacies from veterinarians. (Pharmacists and Pharmacy Technicians)

2. Recognize the adverse effects associated with common human anti-inflammatories and analgesics in companion species. (Pharmacists and Pharmacy Technicians)

3. Apply knowledge of differences between humans and pets with regard to indications and dosing. (Pharmacists)

KPERF offers all CE

articles to members

online at

www.kphanet.org

Introduction

Several human anti-inflammatories and analgesics are

more often being prescribed by veterinarians to be dis-

pensed by pharmacists. This allows the veterinarian to

maintain a smaller drug inventory and/or to avoid some

regulatory burdens associated with scheduled drugs. This

article will cover some frequently used non-steroidal anti-

inflammatories (NSAIDs), but will focus more on common

opiates that are referred from veterinarians to retail phar-

macies. Also included is a discussion of indications and

effects for corticosteroids referred as pet prescriptions. Alt-

hough the pharmacodynamic mechanisms at the molecular

level are all the same for these drugs in pets as they are in

humans, the overall disease indications may be different

than the pharmacist or pharmacy technician are accus-

tomed to encountering in filling day-to-day prescriptions

and counseling for human patients. In addition, the dose is

often higher in pets on a dose per body weight basis. This

will be noticeable with prescriptions intended for medium to

large size dogs. A pharmacist or pharmacy technician dis-

pensing dog or cat anti-inflammatories and analgesics

should also realize that the display of beneficial and ad-

verse effects to these drugs in dogs and cats are different

than observed in humans. Pharmacist-to-client counseling

should take into account these differences in explaining or

responding to questions. Pharmacists can access online

client information sheets (CIS) to use in discussions with

pet owners receiving some common human drugs for their

pets at https://sites.google.com/site/vetpharmcis/. These

CIS were written by students enrolled in the Veterinary

Comparative Counseling elective at Marshall University’s

School of Pharmacy.1 If the client poses questions or con-

cerns that the pharmacy staff is not comfortable answering,

or if the pharmacy staff themselves have questions regard-

ing a pet prescription, the client or the pharmacist should

always contact the prescribing veterinarian.

Recognizing a Pet’s Pain

The main forms of analgesics prescribed for companion

animals are NSAIDs, opiates and neurotransmitter ana-

logues such as gabapentin. Prior to discussing specific

analgesics commonly referred to pharmacies, it is useful to

be aware of some symptoms of pain displayed in dogs and

cats. Understanding these symptoms can help the client

and pharmacist appreciate the adequacy to the pet’s pain

control. Dogs are generally more demonstrative of their

pain than are cats, with behavioral changes serving as key

benchmarks of discomfort or irritation. The client, or owner,

who knows their pet is the best judge of these changes,

which span a broad spectrum from restlessness, trembling

or aggression to lethargy, sleepiness and/or depression.

https://sites.google.com/site/vetpharmcis/

July/August 2015



Dogs also may chew, lick or bite themselves excessively.

They may show a sudden drop in appetite and/or breathe

abnormally. Limping is a give-away for orthopedic pain.

Dogs also seem to know to communicate directly with an

owner by vocalization or whining. Dogs obviously cannot

say they feel nausea; but excessive salivation is a strong

indicator.

Cats display pain more subtly. They drool when experienc-

ing stomach or mouth pain. They take longer to aim a jump

or jump and miss because of back pain. Like dogs, fur lick-

ing, hesitating to touch a paw down and lack of appetite

can indicate pain. Some cats also may display pain more

overtly by meowing, increased agitation and aggression.

Others will hide or avoid people and other animals.2 Poor

self-grooming leading to an unkempt appearance may be

the most noticeable indicator in these individuals.

Non-Steroidal Anti-Inflammatories: A Brief Overview of

Three

NSAIDs are the most common analgesics in veterinary and

human medicine. NSAID anti-inflammatories have an indi-

rect pain-reducing effect by reducing pro-inflammatory mol-

ecules and tissue swelling. NSAIDs will not be broadly cov-

ered in this article since veterinarians often prescribe ani-

mal-specific agents such as carprofen (trade named Ri-

madyl) or the COX-2 selective deracoxib (Deramaxx) from

their hospital pharmacy. However, acetaminophen and the

oxicams — meloxicam and piroxicam — will be briefly dis-

cussed.

Acetaminophen is not a useful anti-inflammatory in dogs

and cats since its effects on the COX-1 enzyme are weak

to non-existent. In pets, the most frequent exposures to this

drug comes through acute intentional consumption out of

curiosity (dogs) and intentional administration by people

(cats). In humans, the main toxic concern that pharmacists

would be trained to warn about is hepatotoxicity, which also

occurs in pets. However, both dogs and cats show a more

immediate risk of methhemoglobinemia. Cats are especial-

ly sensitive to acetaminophen induced methhemoglo-

binemia as they lack strong phase II glucuronyl conjugation

capacity. Methhemoglobinemia occurs when the iron in

hemoglobin is oxidized from Fe 2+

to Fe 3+

and this oxida-

tion results from metabolites of acetaminophen.3 The oxi-

dized iron has less oxygen carrying capacity. Symptoms of

methhemoglobinemia include rapid breathing and heart

rate, weakness and brown or rust-colored blood visible in

the oral mucous membranes. These symptoms are an

emergency warranting immediate intervention.

The oxicam, meloxicam (Mobic), is the only NSAID ap-

proved for humans, dogs and cats.4 As a class, NSAIDs

are one of the few drugs in which the dosing for dogs (and

cats) is sig-

nificantly

less than for

humans.

Since

meloxicam

tablets avail-

able for hu-

mans are

most likely

too high in

strength for

most dogs,

a typical

pharmacy

referral would be for the oral suspension. This oral suspen-

sion contains xylitol5 as a sweetener as well as sorbitol and

saccharin. Large quantities of xylitol can be fatal to dogs,

as the sugar alcohol is interpreted by the canine pancreas

as a sugar. This stimulates the inappropriate release of

insulin which lowers blood sugar levels. Veterinarians are

aware of xylitol toxicity; however, sweetener levels in the

suspension are below toxicity thresholds and would not be

of concern when administered at therapeutic levels.6 Alt-

hough meloxicam has a substantial margin of safety in

dogs, it has the same potential adverse profile as other

NSAIDs, i.e., risk for gastric irritation, ulcers, hemorrhage,

potential perforation and nephron-tubular toxicity. Unless

otherwise advised by their veterinarian, clients should be

encouraged to administer meloxicam to their pet (as well as

piroxicam, below) with food.

Piroxicam (Feldene) could be referred to a retail pharmacy

to treat musculoskeletal conditions in dogs and sometimes

in cats. However, in companion animal medicine, it is more

commonly used as part of a combination of drugs to treat

various cancers including prostate (dogs), transitional cell

bladder carcinoma (dogs & cats), hemangiosarcoma (dogs)

and rectal cancer (dogs).7 Thus, a client with a dog pre-

scription for Feldene may need to be counseled in the con-

text of malignancy treatment rather than anti-inflammatory

and pain. The adverse effects (gastrointestinal irritation and

ulceration and nephrotoxicity) still will be the same for

counseling.

Flurbiprofen is an NSAID compounded for topical applica-

tion on humans. Although dogs may be prescribed flurbi-

profen ophthalmic solution, it is not indicated for topical or

systemic use in dogs or cats. The Food and Drug Admin-

istration’s Center of Veterinary Medicine recently reported

that several cats have suffered toxicities, including death,

following exposure to flurbiprofen-containing cream.8 This

exposure may have resulted from contact with the hands or

July/August 2015


other skin areas of people who were topically applying

flurbiprofen. These toxicities underscore the vulnerability of

pets, particularly cats, to NSAID toxicity. Compounding

pharmacists should consider advising patients who are ap-

plying flurbiprofen cream to avoid contact that exposes

cats.

Opioid Analgesics Referred to Retail Pharmacies

Tramadol (Ultram, ConZip, Theratramadol) is an opioid an-

algesic. It is a relatively weak opiate, but a metabolite non-

opiate effectively suppresses pain. It is used for pain relief

associated with canine arthritis, cancer or following assort-

ed types of soft tissue surgery in the dog.9 It is synergistic

with NSAIDs, although tramadol is often used in place of

NSAIDs. Tramadol pro-

vides an example of the

relatively larger compara-

tive dosing of many human

drugs in dogs. An adult per-

son could be dosed 25 mg

up to four times daily for

moderate chronic pain. A

dog with the same pain

would be dosed at 1-4 mg/

kg two to three times daily.

For a 25 kg dog, this could

be 75 mg per dose; thus,

pharmacists and techni-

cians should be aware of

the normal “high” dose.

Adverse reactions include nausea (anorexia), panting and

constipation, with the latter an almost certainty. Although

pharmacists can refer people with opiate induced constipa-

tion to a variety of laxatives and stool softeners, for dogs 1-

2 tablespoons of canned pumpkin is a far easier and very

effective remedy. As previously mentioned, acetaminophen

is not a useful addition to companion animal analgesia and

can lead to toxicity; therefore a substitution such as Ul-

tracet (tramadol plus acetaminophen) should not be made.

Hydrocodone (Tussigon, Hycodan) is an opioid pain medi-

cation that can be prescribed to treat mild to moderately

severe pain and cough in humans and cough in dogs.10

Often, the indication is for dry kennel cough, which is a

combination bacterial and viral infection, or chronic bronchi-

tis. In addition, it may be used to manage the cough associ-

ated with tracheal collapse. Hydrocodone acts to directly

suppress the cough center in the medulla oblongata. Po-

tential adverse effects are most commonly sedation, but

also include constipation or vomiting. Cats are seldom ad-

ministered hydrocodone as they are sensitive to opiates in

general. As with tramadol, the dosing for dogs will seem

high for pharmacists or technicians familiar with human

doses only. While an adult person may receive four to six 5

mg doses daily, a 25 kg dog would receive 6.25 mg two to

four times daily. In the U.S., hydrocodone bitartrate is not

available as a single entity but is manufactured as a com-

bined product with homatropine methylbromide to discour-

age abuse by humans. Frequently, retail pharmacies do not

carry hydrocodone/homatropine syrup, but they often stock

hydrocodone and acetaminophen oral solutions (such as

Hycet). Acetaminophen-containing solutions should NOT

be substituted for the prescribed hydrocodone/homatropine

since acetaminophen lacks efficacy and holds an unac-

ceptable risk of toxicity for dogs. A substitution of hydroco-

done/homatropine tablets for the syrup may be considered

on a case by case basis.

Fentanyl (Duragesic) is a

synthetic opiate and one of

the strongest analgesics for

dogs. For dogs, fentanyl is

normally used in the form of

a skin patch which releases

medication over hours. The

dosing interval for fentanyl

is 72 hours. A typical dog

indication would be to con-

trol postoperative pain; alt-

hough, since it takes 12-24

hours for full effect, the dog

would have previously re-

ceived an analgesic, such

as parenteral opiates. The patch also can be used pre-

operatively to have analgesia on-board, for chronic pain

such as cancer, long term pain associated with trauma,

spinal fractures, thoracic surgery, mastectomy and burns.

For a 25 kg dog, a dosing level of 75 mcg/hour is appropri-

ate.11

In humans, patches at levels of >50 mcg/hour are

typically placed on patients already tolerant to opioid thera-

py. The client should be warned that their pet may demon-

strate marked behavioral effects such as hyperactivity, hy-

per-responsiveness to external stimuli, panting, defecation

and hypersalivation. They also may experience decreases

in respiration rate, heart rate and temperature. The drop in

breathing is most problematic and may warrant consulta-

tion with the prescribing veterinarian. The client may notice

listlessness and general lethargy. Alternatively, a sense of

euphoria may promote either excessive eating (until vomit-

ing) or anorexia depending on the dog.

Gabapentin As an Analgesic

Gabapentin (Neurontin) is a gamma amino butyric acid

(GABA)-analogue that acts in the central nervous system.


July/August 2015


In humans, it is indicated for treatment of postherpetic neu-

ralgia and as an adjunct for partial onset seizures.12

In

dogs, it is being commonly prescribed for therapy of chron-

ic arthritis pain and neuropathic pain.13

Gabapentin also

can be used in cats for pain and for car sickness nausea

and to treat dog seizures as an alternative to phenobarbital

fails. Gabapentin may be added along with an NSAID and/

or an opioid such as tramadol or administered as solo

agent. The dosing for a 25 kg dog could reasonably be 250

mg given once or twice a day; this fits into the lower range

of human dosing for postherpetic neuralgia of between 300

and 1800 mg/day. Sedation is to be expected in dogs and

cats and clients should be warned against abruptly stop-

ping the drug. To verify pain-reducing efficacy, the client

should follow up with the veterinarian.

Intermediate-Acting Glucocorticoids: Comparative

Dosing and Effects

Corticosteroids such as prednisone, methylprednisone and

prednisolone are administered to relieve immune-mediated

conditions.14

In dogs and cats, systemic glucocorticoids

such as prednisone and prednisolone can be administered

at one of 3 dose levels: anti-itch (anti-pruritic) ≈0.5 mg/kg/

day; anti-inflammatory ≈1.0 mg/kg/day; and immunosup-

pressive ≈5.0 mg/kg/day. Dosing may be doubled and giv-

en every other day to reduce adrenal suppression. This is

an example of a class of human drugs used commonly for

pets that is often administered by a different route (orally to

a dog/cat) than it would be to a person (topically) with a

similar disease condition such as cutaneous pruritus. Oral

corticosteroids are prescribed for humans as an escalation

up from topical use if topical application cannot be effec-

tive. In dogs and cats, because of the presence of hair, cor-

ticosteroids are often prescribed by systemic administra-

tion. If a topical rinse or lotion alone was effective, these

would likely have been dispensed directly by the veterinari-

an.

In pets, systemic administration of corticosteroids may be

used to manage seasonal atopic dermatitis (“atopy”) which

is an allergic dermatitis if it is refractory to more conserva-

tive therapies. Oral glucocorticoids are inexpensive, work

rapidly, are easily administered and reach large areas of

the dermis through systemic circulation more readily than a

topical steroid will penetrate through the hair and epider-

mis. For atopic itching, a 25 kg dog would start at an anti-

inflammatory dose, then taper down to the anti-pruritic. A

25 kg dog could receive 50 mg every other day, which

would fit within a dose for a 70 kg adult person.

Methylprednisolone has a slightly longer half-life than pred-

nisolone and is prescribed at 80 percent of the prednisone/

prednisolone dose.

As with people, corticosteroids also have several prominent

adverse effects. A pharmacist or pharmacy technician may

counsel clients that their pet will have polyuria (PU) and

polydipsia (PD). This PU/PD is especially noticeable in a

dog. They also may have polyphagia. Polyuria results from

the corticosteroid feedback inhibition of arginine vasopres-

sin (AVP; a.k.a. antidiuretic hormone [ADH]) secretion.

Less AVP/ADH means the dog urinates more then needs

to drink to maintain fluid homeostasis. The pet must have

access to water, and they must have the opportunity to void

1-2 hours after the dosing. Pharmacists know to counsel

human patients to take systemic corticosteroids in the

morning to coincide with natural circadian cortisol release.

Dogs have a similar pattern; however, a prudent counseling

question would be to ask if the dog is kenneled in the morn-

ing when the client leaves for work/school. If so, the corti-

costeroid should not be administered in the morning.

Methylprednisolone could be recommended as an alterna-

tive to prednisone/prednisolone as it causes less PU-PD;

however, it is more expensive. If corticosteroids are admin-

istered long term, pets can develop behavioral changes;

iatrogenic hyperadrenocorticism (Cushing’s syndrome);

adrenal suppression; infections, or parasitic diseases. Cor-

ticosteroid use also is associated with one adverse effect

that is unique to dogs and cats: when used concomitantly

with NSAIDs, corticosteroids are associated with a signifi-

cant risk of gastrointestinal ulcers/perforations.15

Therefore,

these two types of anti-inflammatories are rarely combined;

rather they should be separated by 3 to 5 days. Also, when

transitioning off a corticosteroid and onto an NSAID, some

veterinarians believe it is of benefit to co-administer over-

the-counter omeprazole (approximately 0.7 mg/kg once a

day or 1 x 20mg tablet for a 25 kg dog) with the NSAID to

reduce the potential for gastritis.

Cats should receive only prednisolone and not prednisone,

because many cats cannot metabolically convert the pro-

drug prednisone to the active prednisolone. Cats display

fewer adverse reactions to corticosteroids.

Conclusion

Along with antimicrobials, veterinary referrals of analgesics

and anti-inflammatories to retail pharmacies are becoming

more commonplace. Although the pharmacist or pharmacy

technician should not replace the counseling of the pre-

scribing veterinarian, they should be able to discuss with

clients the general indications, doses and effects — both

therapeutic and adverse, of drugs dispensed for dogs and

cats. By distinguishing the aspects of analgesic and anti-

inflammatory agents that people and pets share and differ

in, the pharmacy staff will optimize client communication

and maximize animal patient care.


July/August 2015


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

References

1. Client Information Sheets (CIS) of human drugs dis-

pensed in retail pharmacies for pets.


2. Onsior. Symptoms that your cat may be in pain after sur-

gery. http://us.onsior.com/supporting-recovery/cat-pain-

symptoms.html

3. McConkey SE, Grant DM, Cribb AE. The role of para-

aminophenol in acetaminophen-induced methemoglo-

binemia in dogs and cats. J Vet Pharmacol Ther. 2009, 32

(6):585-95.

4. FDA Approved Animal Drug Products (Green Book)

http://www.fda.gov/downloads/AnimalVeterinary/Products/

ApprovedAnimalDrugProducts/UCM042860.pdf

5. Mobic. Drugs.com http://www.drugs.com/pro/mobic.html

6. Calculations based on 0.1 mg/kg toxicity for xylitol. 0.2

mg/kg dosing with a 7.5 mg/ml suspension.

7. Alkan, FU, Ustüner O, Bakırel T, Cınar S, Erten G, Deniz

G. The effects of piroxicam and deracoxib on canine mam-

mary tumour cell line. Scientific World Journal. 2012, Article

976740.

8. FDA Warns of Illnesses and Deaths in Pets Exposed to

Prescription Topical Pain Medications Containing Flurbi-

profen http://www.fda.gov/AnimalVeterinary/NewsEvents/

CVMUpdates/ucm443333.htm

9. A CIS for tramadol can be found at

https://sites.google.com/site/vetpharmcis/tramadol

10. A CIS for hydrocodone can be found at

https://sites.google.com/site/vetpharmcis/hydrocodone

11. The Merck Veterinary Manual.

http://www.merckvetmanual.com

12. Neurontin. Drugs.com

http://www.drugs.com/pro/neurontin.html

13. Crociolli GC, Cassu RN, Barbero RC, Rocha TL,

Gomes DR, Nicácio GM. Gabapentin as an adjuvant for

postoperative pain management in dogs undergoing mas-

tectomy. J Vet Med Sci. 2015 epub.

14. A CIS for prednisone/prednisolone: https://

sites.google.com/site/vetpharmcis/prednisone-prednisolone

15. Dowling P. Corticosteroid & Nonsteroidal Antiinflamma-

tory Drug Interactions. NAVC Clinician’s Brief. March 2011,

pp. 89-92. http://www.cliniciansbrief.com/sites/default/files/

sites/cliniciansbrief.com/files/complications.pdf



http://us.onsior.com/supporting-recovery/cat-pain-symptoms.html

http://us.onsior.com/supporting-recovery/cat-pain-symptoms.html

http://www.drugs.com/pro/mobic.html

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm443333.htm

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm443333.htm

https://sites.google.com/site/vetpharmcis/tramadol

https://sites.google.com/site/vetpharmcis/hydrocodone

http://www.merckvetmanual.com

http://www.drugs.com/pro/neurontin.html

https://sites.google.com/site/vetpharmcis/prednisone-prednisolone

https://sites.google.com/site/vetpharmcis/prednisone-prednisolone

http://www.cliniciansbrief.com/sites/default/files/sites/cliniciansbrief.com/files/complications.pdf

http://www.cliniciansbrief.com/sites/default/files/sites/cliniciansbrief.com/files/complications.pdf

July/August 2015


July 2015 — Companion Animal Anti-Inflammatories and Analgesics Dispensed Through Retail Pharmacies

1. If a client poses questions or concerns that the pharmacy staff is not comfortable answering, what is the best option? A. Refer the client to the Wikipedia. B. Refer the client to 1800petmeds. C. Give the pet client your best guess. D. Refer the client back to their veterinarian. 2. Dogs are generally more demonstrative of their pain than cats. A. True B. False 3. Who is best able to judge changes in a pet’s behavior? A. The veterinarian B. The owners C. The pharmacist 4. A symptom of nausea in the dog is __________. A. Polyuria B. Constipation C. Walking in circles D. Increased salivation 5. Acetaminophen is an efficacious anti-inflammatory in both dogs and cats. A. True B. False 6. What is the one NSAID approved for humans, dogs and cats? A. Meloxicam B. Acetaminophen C. Ibuprofen D. Naproxen 7. As a general rule, human medication doses are higher for dogs than for people; however one major class of drugs is an exception to this rule. The class is/are: A. Opiates. B. NSAIDs. C. Glucocorticosteroids. D. Thyroid hormone replacements. 8. Gabapentin (Neurontin) is prescribed in dogs for therapy of: A. Chronic arthritis pain. B. Postherpetic neuralgia. C. Inflammation. D. Flea allergies.

9. A simple option to manage opiate-induced constipation in dogs is: A. Docusate calcium. B. Administer a tablespoon or two of canned pumpkin with

meals. C. Polyethylene glycol 3350. D. Lubiprostone (Amitiza). 10. It would be appropriate to substitute Hydrocodone Bitartrate and Acetaminophen Oral Solution for Hydrocodone Bitartrate and Homatropine methylbromide syrup. A. True B. False 11. In dogs and cats, systemic glucocorticoids such as prednisone and prednisolone can be administered at one of 3 dose levels. These are? A. Anti-itch (anti-pruritic) ≈0.1 mg/kg/day;

anti-inflammatory ≈0.5 mg/kg/day; and immunosuppressive ≈1.0 mg/kg/day.

B. Anti-itch (anti-pruritic) ≈5.0 mg/kg/day; anti-inflammatory ≈10.0 mg/kg/day; and immunosuppressive ≈50.0 mg/kg/day.

C. Anti-itch (anti-pruritic) ≈0.5 mg/kg/day; anti-inflammatory ≈1.0 mg/kg/day; and immunosuppressive ≈5.0 mg/kg/day.

D. Anti-itch (anti-pruritic) ≈0.1 mg/kg/day; anti-inflammatory ≈0.2 mg/kg/day; and immunosuppressive ≈1.0 mg/kg/day.

12. Anticipated effects a pharmacist or pharmacy technician should discuss with a client when her dog is dispensed prednisone include all EXCEPT? A. Increased need and urge to urinate B. Increased need for water C. Increased appetite D. Increased itching 13. Corticosteroids should not routinely be administered along with: A. Opiates. B. Heartworm preventatives. C. NSAIDs. D. Flea and tick preventatives.

Send Potential CE topics

to Scott Sisco at

[email protected]


July/August 2015









ID # and Birthdate will not be accepted.

PHARMACISTS ANSWER SHEET July 2015 — Companion Animal Anti-Inflammatories and Analgesics Dispensed Through Retail Pharmacies (2.0 contact hours) Universal Activity # 0143-0000-15-008-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C 5. A B 7. A B C D 9. A B C D 11. A B C D 13. A B C D 2. A B 4. A B C D 6. A B C D 8. A B C D 10. A B 12. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.


Personal


Expiration Date: August 3, 2018 Successful Completion: Score of 80% will result in 2.0 contact hours or .2 CEU.


TECHNICIANS ANSWER SHEET. July 2015 — Companion Animal Anti-Inflammatories and Analgesics Dispensed Through Retail Pharmacies (2.0 contact hours) Universal Activity # 0143-0000-15-008-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C 5. A B 7. A B C D 9. A B C D 11. A B C D 13. A B C D 2. A B 4. A B C D 6. A B C D 8. A B C D 10. A B 12. A B C D Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.




July/August 2015


Andropause: Benefits and

Risks of “Low T” Therapy By: Alaina Rotelli, PharmD; Holly Byrnes, PharmD, BCPS, Sullivan University College

of Pharmacy

There are no financial relationships that could be perceived as real or apparent conflicts of interest.


1.0 Contact Hour (1.0 CEU)

Objectives


1. Discuss the etiology and clinical presentation of andropause. 2. Compare the risk versus benefits of testosterone therapy. 3. Discuss other comorbidities such as diabetes, metabolic syndrome and human immunodeficiency virus (HIV) that may

impact testosterone levels. 4. List treatment options for andropause. 5. Identify appropriate monitoring parameters for testosterone therapy and counseling points.

KPERF offers all CE

articles to members

online at

www.kphanet.org

Among men, there

has been a growing

concern over testos-

terone levels and

the prospect of hav-

ing justified “low T.”

This growing con-

cern has led to a 3-

fold increase in an-

drogen use in men

with a mean age of

greater than 40

years (0.81 percent

in 2000 to 2.91 per-

cent in 2011).1

In

2009, over $1 billion

was spent on tes-

tosterone therapy in

the United States, all promising improved sexual function,

muscle mass and improved mood.2 Because of this ag-

gressive marketing, the use of testosterone therapy should

be evaluated, considering the lessons learned during the

Women’s Health Initiative and the adverse effects associat-

ed with hormone therapy in post-menopausal women.

Andropause or “male menopause” is postpubertal hy-

pogonadism or late-onset hypogonadism. The mainstay of

treatment for hypogonadism includes androgen therapy,

specifically testosterone. The loss of testosterone is a slow-

ly evolving process in which men lose testosterone at a

rate of 1 percent per year after the age of 30.3 Twenty per-

cent of men in their

60s have biochemi-

cal evidence of an-

drogen deficiency,

increasing to 50

percent of men in

the eighth decade

of life, as seen in

Figure 1.4

Background

Hypogonadism is a

condition in which

the body does not

produce enough

testosterone and

can present either

pre or post-puberty.

A number of hypothalamic-pituitary-gonadal (HPG) axis

defects may induce hypogonadism. These defects include

primary (hypergonadotropic) hypogonadism, which is asso-

ciated with low testosterone levels and elevated luteinizing

hormone (LH) and follicle stimulating hormone (FSH) lev-

els, secondary (hypogonadotropic) hypogonadism, which is

associated with low testosterone levels and normal LH lev-

els, hyperprolactinemia and pituitary disorders (Table 1).

Additionally, several agents may be associated with low

circulating testosterone (Table 2).5

Testosterone is synthesized from cholesterol in the Leydig

cells and is formed from androstenedione secreted by the

Figure 14: Prevalence of Low Levels of Total and Bioavailable Testosterone

According to Decade of Life

August 2015 CE—Andropause

July/August 2015


adrenal cortex. In the Leydig cells, LH initiates the produc-

tion of pregnenolone, which is hydroxylated in the 17 posi-

tion by 17α-hydroxylase to form dehydroepiandrosterone

(DHEA). DHEA is rapidly converted to testosterone via an-

drostenediol and androstenedione.

As noted previously, testosterone decline is essentially a

process of aging for males. As men age, there is an age-

related reduction in gonadotropin-releasing hormone

(GnRH), which results in a decrease in the production of LH

by the pituitary gland. There is a decrease in the number of

testicular Leydig cells, resulting in a decreased production

of testosterone.3 Overall, this decline in testosterone caus-

es an increase in serum gonadotropin, FSH and LH result-

ing from negative feedback on the hypothalamus.

This decline in testosterone is a slow process which can

cause subtle clinical signs and symptoms. Andropause will

typically present as a loss of libido, sexual dysfunction or

impotence, progressive decrease in muscle mass and

strength, fatigue, hot flashes, depression and other mood

disorders and poor ability to concentrate.6 Furthermore,

one or more of the signs and symptoms may be present

simply due to aging, despite serum testosterone levels re-

maining within normal limits.7 For example, if a man is ac-

customed to a serum testosterone level in the higher to

normal range, reduction to a lower level, (even though it is

still normal) may no longer be sufficient to maintain well-

being.3

Diagnosis

In addition to the classical signs and symptoms of low tes-

tosterone, laboratory measurements of sex hormone-

binding globulin (SHBG) and total serum testosterone are

performed. SHBG levels are utilized because the majority

of testosterone is bound to either SHBG or albumin while in

circulation. For young adult men, the breakdown of testos-

terone in circulation is 2 percent free testosterone, 30 per-

cent tightly bound to SHBG and 68 percent weakly bound

to albumin.8

The normal ranges for total and free testosterone in healthy

young men vary among laboratories and assays; therefore,

the lower limit of normal should be established based on

the laboratory used. In general, laboratories consider the

lower limit of normal testosterone in healthy young men to

be 280 to 300 ng/dL.6 For those patients with exceedingly

low levels of testosterone (less than 150 ng/dL), the Ameri-

can Association of Clinical Endocrinologists (AACE) guide-

lines suggests pituitary imaging even in the absence of oth-

er signs and symptoms.8 In order to obtain the most accu-

rate measure, total testosterone should be measured be-

tween 0800 and 1100, when testosterone levels are peak-

ing in healthy young men. For men with advancing age or

who are already receiving certain testosterone replacement

therapy, the circadian rhymicity of testosterone may be de-

stroyed or suppressed; therefore, testosterone levels could

be misleading.5

There has not been any additional recom-

Table 1: Hypothalamic-Pituitary Gonadal Axis Defects5

Primary Hypogonadism Secondary Hypogonadism Hyperprolactinemia Pituitary Disorders

Testicular Disorders

Leydig Cell Hypoplasia

Testicular Unresponsiveness

Androgen-Resistant States and Enzyme Defects

External Testicular Insults

Autoimmune Syndromes

Sertoli-Cell Only Syndrome

Gonadotropin-releasing hormone (GnRH) Deficiency

Isolated GnRH Deficiency

Prader-Willi Syndrome

Lawrence-Moon-Bardet Biedl Syndrome

Alstrom Syndrome

Fertile-Eunuch Syndrome

Familial Cerebellar Syndrome

Hemochromatosis

Neurosarcoid

Myotonic Dystrophy

Prolactinoma

Medications

Isolated LH Deficiency

Tumors

Pituitary Infarction

Empty Sella Syndrome

Hemochromatosis

Cranial Trauma

Irradiation

Hypophysitis

T= Testosterone, serum T= serum Testosterone, LH= luteinizing hormone (normal in adult males= 1.8 to 2 mIU/mL) ULN= upper limit normal Primary Hypogonadism: serum T < 231 ng/dL with LH > 1.5 x ULN Secondary Hypogonadism: T < 231 ng/dL without LH elevations Leydig-cell failure: T= 231 to 432 ng/dL with LH > 1.5 x ULN Androgen Resistance: T > 864 ng/dL with LH > 1.5 x ULN


July/August 2015


mendations for a time in which testosterone levels should

be drawn in older men.

Benefits of Therapy

The main goal of therapy is to not only improve symptoms,

but also to improve quality of life. Reports have suggested

positive effects on mood, increased sense of well-being

and increased energy. Smaller studies have shown in-

creases in lean body mass, decreases in body fat, increas-

es in muscle size and increases in weight. Most men are

typically prescribed testosterone to help improve erectile

dysfunction, especially since 36 percent of men with erec-

tile dysfunction have low testosterone.9 Increased libido

and sexual function have been associated with testos-

terone therapy in smaller studies based on self-reported

parameters.10

Conversely, a randomized trial of 140 men

with low testosterone levels (less than 330 mg/dL), demon-

strated that adding testosterone to sildenafil therapy did not

improve erectile function.11

Although many times testosterone therapy is associated

with negative effects on cardiovascular health due to

changes in the lipid profile, there is evidence to support

improvement in cardiovascular health. Improvements were

seen in the direct arterial vasodilatory effect and prolonga-

tion of time until ischemia with exercise. Another study

demonstrated that there were no deleterious changes in

cholesterol profiles, even showing improvement in total

cholesterol in older men treated with testosterone.3 Overall,

without any large, long-term placebo controlled trials, the

benefits associated with testosterone are still debatable

and should be considered on a patient by patient basis.

Risks Associated with Therapy

The biggest controversy surrounding testosterone therapy

is the associated risks. Based on current data, the long-

term effects of testosterone replacement therapy are un-

clear. Testosterone therapy has been associated with in-

creased risks of cardiovascular events, polycythemia, ve-

nous and arterial thromboembolisms and increased risk of

prostate cancer. Most recently, the FDA announced a new

warning that is required on all testosterone products relat-

ed to the risk of venous blood clots. As of January 2014,

the FDA has been evaluating the potential risk of cardio-

vascular events (myocardial infarction, stroke and death)

related to blood clots in the arteries of men using testos-

terone therapy.12

A 2013 meta-analysis of 27 placebo-controlled randomized

trials of testosterone therapy among men lasting 12-plus

weeks evaluated the cardiovascular risks associated with

therapy. Of note, cardiovascular-related events varied with

source of funding. Overall, trials not funded by the pharma-

ceutical industry, demonstrated that exogenous testos-

terone increased the risk of cardiovascular-related events

(OR 2.06, 95 percent CI, 1.34 to 3.17 vs OR 0.89, 95 per-

cent CI, 0.5 to 1.6).13

Another worry associated with testosterone therapy in-

cludes an increase in prostatic disease such as benign

prostatic hyperplasia (BPH) and increased risk of prostate

cancer. Studies have demonstrated a slight increase in

prostate-specific antigen (PSA) levels, but it has not been

concluded that there is a clear association with an in-

creased risk in prostate cancer occurrence.3 Other com-

mon side effects include acne, mild fluid retention, breast

enlargement, worsening sleep apnea and decreased testic-

ular size.

Comorbid Conditions

With rates of diabetes rising in the United States to approx-

imately 9 percent of the population, rates of low testos-

terone are bound to increase as well. Based on data found

in the HIM study, a man with diabetes (specifically Type 2

DM) was approximately twice as likely to be hypogonadal

compared with a man without diabetes.14

Overall hy-

pogonadism prevalence was estimated to be between 33-

50 percent for men with diabetes.15

Based on gonadotropin

levels, this can be considered secondary hypogonadism.

Unlike other diabetes complications, there is no relation

between the degree of hyperglycemia and testosterone

concentration. Interestingly, patients with diabetes and hy-

pogonadism were found to have increased C-reactive pro-

tein, anemia, increased adipose tissue and low bone min-

eral density (BMD).16,17

Finally, it was observed that pros-

tate-specific antigen (PSA) is significantly lower in Type 2

DM patients as a result of their lower plasma testosterone

concentrations.18

Data from the NHANES III survey

showed that men in the lowest free testosterone percentile

Table 2: Agents That May Cause Low Testosterone5

Cytotoxic Agents

Spironolactone

Corticosteroids, Ketoconazole, Aminoglutethimide, Ethanol

Decrease Leydig-cell testosterone production

Anticonvulsants, Hepatic Microsomal Liver Enzyme Inducers

Augment testosterone metabolism

GnRH agonists, Estrogens, Anabolic Steroids, Psychotropic Medications, Immunosuppressants, Corticosteroids and Ethanol

Reduce gonadotropin secretion


July/August 2015


Chart 1-Available Testosterone Products

Dosage Form Agent Dosing Comments

Oral Preparations Fluoxymesterone (Androxy ®) Methyltestosterone (Android®, Methitest®, Testred®)

5 to 20 mg once daily 10 to 50 mg once daily

Variable Response

Adverse lipid changes

Hepatotoxicity

Self-administration

Immediate discontinuation

Parenteral Preparations Testosterone cypionate (Depo-Testosterone®) Testosterone enanthate (Delatestryl®) Testosterone undeconoate (Aveed®)

Cypionate and Enanthate: 50 to 400 mg IM every 2-4 weeks 750 mg IM once, repeat at 4 weeks, then every 10 weeks

Fluctuations in testosterone levels

Injection site reactions/pain

Aveed®- REMS program required -potential for pulmonary oil microembolism reactions and anaphylaxis

Excessive erythrocytosis

Transdermal Patch Androderm® 4 mg/day patch applied to back, abdomen, upper arms, or thighs at night

Mimics normal testosterone level changes

Skin irritation may occur

May require multiple patches

Transdermal Gels and Solution

AndroGel ®- 1 percent AndroGel®- 1.62 percent Fortesta®-2 percent Testim®-1 percent Axiron®-2 percent (Solution)

50 mg once daily applied to shoulder, upper arms, or abdomen. May increase to 100 mg. 40.5 mg (2 pumps) applied once daily in the morning to shoulders and upper arms. Max dose-81 mg/day. 40 mg (4 pumps) once daily applied in the morning to thighs. Max dose is 70 mg each day. 50 mg one daily applied to shoulders or upper arms. May increase to 100 mg if needed 60 mg (2 pumps) applied to underarm each morning. May increase to 120 mg daily.

Less skin irritation

May transfer gel or solution from one person to another (make sure to wash hands after application and cover application site with clothing)

Apply deodorant before Axiron

AndroGel 1.62 percent has reduced bioavailability when applied to abdomen


July/August 2015


were four times more likely to have diabetes as those in the

highest free testosterone percentile.19

A recent study also

showed that a small dose (50 mg/day) of testosterone gel

improved both glycemic control and insulin sensitivity over

greater than the improvements resulting from diet and exer-

cise.20

Central obesity, hypertension, reduced HDL, elevated tri-

glycerides or elevated fasting plasma glucose characterizes

metabolic syndrome, resulting in a higher risk for coronary

artery disease. All of these elements also are correlated

with testosterone concentrations. As such, it is not surpris-

ing that hypogonadism is associated with metabolic syn-

drome. Low testosterone levels increase fat mass and de-

crease lean muscle, resulting in increased adipose tissue.

Specifically, adipose tissue affects testosterone levels by

increasing the aromatization of testosterone to estradiol.

Since the aromatase enzyme is concentrated in adipocytes,

this will further reduce serum and tissue testosterone lev-

els.

Another strong association with androgen deficiency occurs

with AIDS wasting syndrome. Testosterone therapy in HIV-

positive hypogonadal men increases lean body and muscle

mass and perceived well-being, and decreases depression.

Around 20-50 percent of HIV-infected men receiving an-

tiretroviral therapy are hypogonadal. This hypogonadism is

most likely resultant of lipodystrophy induced by anti-

retroviral medications, testicular atrophy caused by oppor-

tunistic infection, and disruption of the HPG axis resulting

from malnutrition.21

Treatment

It is highly debated on when to initiate a patient on testos-

terone therapy. Some experts suggest treating symptomat-

ic, older men with testosterone levels below the lower limit

of normal for healthy young men (300 ng/dL), while others

recommend levels less than 200 ng/dL. A general consen-

sus was made that patients with testosterone levels less

than 230 ng/dL will usually benefit from testosterone treat-

ment. If levels are between 230 ng/dL and 350 ng/dL, re-

peat testing may be beneficial.10

Testosterone replacement therapy comes in many dosage

forms, which can be chosen based on patient preference,

side effects and cost. The goal of therapy is to improve the

symptoms of andropause. Ideally, testosterone treatment

should mimic physiologic levels and with each dosage

form, responses vary. Chart 1 discusses the available dos-

age forms, agents and dosing of testosterone products.

There are over-the-counter andropause formulas that in-

clude natural products such as vitamin E, zinc, niacin, L-

arginine, yohimbe, ashwagandha, maca and gingko biloba.

Yohimbe hydrochloride has been demonstrated in various

clinical trials to be effective in the treatment of erectile dys-

function and is dosed at 5-100 mg daily for 2 to 8 weeks of

therapy.22

Ashwagandha acts as an “adaptogenic” herb that helps the

body resist physiological and psychological stress. Used

orally at a dose of 2 to 6 grams daily, immunomodulatory

effects, improved cognitive function, decreased inflamma-

tion, prevention of the effects of aging and infertility have all

been seen. One study of 150 men, showed decreased oxi-

dative stress and improved indicates of semen quality in-

cluding testosterone, LH, FSH and prolactin levels.22

Maca acts to help with energy, stamina, athletic perfor-

mance and male infertility. Typical doses include 1.5 to 3

gm per day orally. Preliminary evidence from an uncon-

trolled trial of males taking 1.5-3 gm daily for 4 months

showed increases in semen volume, sperm count and

sperm motility in healthy men age 22 to 44 years. One oth-

er study of men age 21 to 57 years received 1.5-3 gm daily

for 12 weeks showed an increase in sexual desire.22

Before

making an overall recommendation for these products,

pharmacists should assess all available studies, quality of

the product, drug interactions and side effects.

Monitoring

With each testosterone product available, monitoring of

testosterone differs. For example, Striant® suggests moni-

toring testosterone levels 4 to 12 weeks after initiation while

Testopol® recommends checking testosterone levels at the

Pellet Testopol ® 150-450 mg subcutaneously every 3 to 6 months

Inflammation and pain at pellet site

Convenient

Varied absorption: 33 percent in 1st month, 25 percent in

the 2nd

month, and 17 percent in the 3rd

month

Buccal Preparation Striant® One buccal tablet every 12 hours

Alternate side with each application

May cause mouth/gum irritation or taste alteration

Avoid chewing or swallowing

Does not dissolve completely

Modified from PL Detailed-Document, Comparison of Testosterone Products. Pharmacist’s Letter/Prescriber’s Letter. July 2013.


July/August 2015



end of the dosing interval. The Endocrine Society recom-

mends monitoring testosterone levels three to six months

after initiation of testosterone therapy.6 Other options for

monitoring include checking serum testosterone levels mid-

way between injections, at least one week after initiate of

transdermal gels, or 3 to 12 hours after application of the

patch.23

Goal therapeutic levels for younger men should be

in the middle of the normal range, and for those older men

(typically 65 years or older) aim for the lower part of the

normal range.8

Additional monitoring includes a baseline PSA and a digital

rectal exam for those men 40 years or older who have a

baseline PSA greater than 0.6 ng/mL prior to therapy, and

again at 3 to 6 months. Hematocrit levels should be moni-

tored at baseline as well, then every 3 to 6 months in the

first year and then annually according to the Endocrine So-

ciety.6 Liver function tests, hemoglobin and lipid panels al-

so should be performed periodically during therapy.2 Alt-

hough currently not recommended, there has been sugges-

tions for baseline screenings for Factor V Leiden, prothrom-

bin mutations and homocysteine, to assess thromboembol-

ic risk.1

Patient Education

Key points to highlight when educating patients vary de-

pending on dosage form and product. For transdermal

products, patients should apply in the morning to clean

skin. It is important for patient to wash hands after applica-

tion to avoid transferring the gel to others. Women and chil-

dren should avoid contact with the application site at all

times. The site should not be washed for several hours and

should dry before dressing. Products such as AndroGel ®

and Testim ®, should be applied to the upper arm and

shoulder, while Foresta ® should be applied to the front

and inner thigh.

Patches should be applied to clean, dry areas of skin on

the back, abdomen, upper arms or thigh. Patients should

avoid showering, washing the site or swimming for three

hours after application, so it is best to apply at night. Appli-

cation sites should be rotated, allowing seven days be-

tween applying to the site. Mucoadhesive for buccal appli-

cation should be applied to a comfortable area above the

incisor tooth. Hold in place for 30 seconds to ensure adhe-

sion by pushing down on the outside of the upper lip. Make

sure to rotate sides of mouth with each application. If the

mucoadhesive falls out within the first eight hours of dos-

ing, a new adhesive should be placed for a total of 12

hours from the placement of the first mucoadhesive. Pa-

tients should never chew or swallow the mucoadhesive and

it should be removed 12 hours after application, for it will

not dissolve.

Patients also should be informed that testosterone is a con-

trolled substance. All dosage forms are listed as a C-III

medication and is defined as a drug with a moderate to low

potential for physical and psychological dependence. As

such, these medications should not be shared with anyone

other than the patient who it was prescribed.

Recent Studies

In March 2015, four studies were released in support of

testosterone therapy and its cardiovascular safety. In the

first study, a retrospective cohort of 102,650 testosterone-

treated and 102,650 untreated hypogonadal men assessed

testosterone therapy’s link to venous thrombotic events.

Idiopathic venous thrombotic events had a hazard ratio of

1.08 for all patients receiving testosterone therapy, 1.07 for

those using the topical products and 1.32 for those using

injectable agents. Overall, the results of the study do not

support an association between exogenous testosterone

therapy and an increased risk of venous thrombotic

events.24

One additional retrospective cohort analysis as-

sessed testosterone therapy with major adverse cardiovas-

cular events (MACE) in patients with documented stable

coronary heart disease or recent acute coronary syndrome.

This study only had a total of 217 men (1 percent) using

testosterone therapy and suggested that testosterone ther-

apy is not associated with an increased risk of MACE in

men with well-characterized coronary artery disease.25

An-

other study obtained records from a large community-

based healthcare system to examine effects of testos-

terone therapy on cardiovascular outcomes (acute myocar-

dial infarction, stroke or death). A total of 7,245 men were

identified with a mean age of 54 years and a mean follow

up period of 1.78 years. The combined event rate of acute

myocardial infarction, stroke or death at three years was

low in the treated (5.5 percent) and untreated groups (6.7

percent).26

Finally, one meta-analysis of 29 studies and

122,889 men, showed testosterone therapy did not cause

statistically significant adverse cardiovascular events

among men (RR 1.168, CI 0.794 to 1.718, p = 0.431).27

Conclusions and Future Considerations

Due to the controversial use of testosterone and lack of

data surrounding testosterone therapy’s long-term effects,

many are urging for further studies. Conclusions by Glueck

and colleagues suggest, that testosterone therapy should

be restricted to men with well-defined androgen deficiency

syndromes. The authors found there was a short time be-

tween initiation of testosterone therapy and either throm-

botic (4.5 months) or cardiovascular events (3 months),

suggesting a shared pathophysiology.1

Currently, there is a

large-scale multicenter randomized, double blind placebo-

controlled trial conducted by the National Institute of Aging

July/August 2015



examining the effect of testosterone therapy in older men

(NCT00799617). This study is composed of seven different

trials each with primary outcomes related to physical func-

tion, vitality, cognitive function, cardiovascular disease,

bone density and anemia. There is hope that this study can

help to draw conclusions towards the benefits or risks asso-

ciated with testosterone therapy. Until we have conclusive

evidence, testosterone therapy should be appropriately

assessed before initiation.

References

1. Glueck CJ and Wang P. Testosterone therapy, throm-

bosis, thrombophilia, cardiovascular events. Metabo-

lism. 2014;63(8):989-994.

2. PL Detail-Document. The use of testosterone and the

aging male. Pharmacist’s Letter/Prescriber Letter. Oc-

tober 2013.

3. Brawer MK. Testosterone replacement in men with an-

dropause: an overview. Rev Urol. 2004;6 Suppl: S9-

S15.

4. Rhoden E and Morgentaler A. Medical Progress: risks

of testosterone-replacement therapy and recommenda-

tions for monitoring. N Engl J Med. 2004; 350(5):482-

492.

5. Seftel A. Male hypogonadism. Part II: etiology, patho-

physiology, and diagnosis. Int J Impot Res. 2006;18

(3):223-228.

6. Bhasin S, Cunningham GR, Hayes FJ, et al. Testos-

terone therapy in men with androgen deficiency syn-

dromes: an Endocrine Society clinical practice guide-

line. J Clin Endocrinol Metab. 2010;95(6):2536-2559.

7. Liverman CT and Blazer DG. Testosterone and Aging:

Clinical Research Directions (2004). Institute of Medi-

cine/Board on Health Sciences Policy.

http://www.nap.edu/books/0309090636/html/.

Accessed Nov. 20, 2014.

8. Petak Sm, Nankin HR, Spark RF, et al. American Asso-

ciation of Clinical Endocrinologists Medical Guidelines

for clinical practice for the evaluation and treatment of

hypogonadism in adult male patients-2002 update. En-

docr Pract. 2002;8(6):440-456.

9. Qaseem A, Snow V, Denbert TD, et al. Hormonal test-

ing and pharmacologic treatment of erectile dysfunc-

tion: a clinical practice guideline form the American

College of Physicians. Ann Intern Med. 2009;151

(9):639-649.

10. Wang C, Nieschlag E, Swerdloff RS, et al. ISA, ISSAM,

EAU, EAA, and ASA recommendations: investigation,

treatment and monitoring of late-onset hypogonadism

in males. Aging Male. 2009(1):5-12.

11. Spitzer M, Basaria S, Travison TG, et al. Effect of tes-

tosterone replacement on response to sildenafil citrate

in men with erectile dysfunction: a parallel, randomized

trial. Ann Intern Med. 2012;157(10):681-691.

12. FDA/Drug Safety and Availability resource page. Food

and Drug Administration Web site. http://www.fda.gov/

drugs/drugsafety/ucm401746.htm. Published June 19,

2014. Accessed Nov. 15, 2014.

13. Xu L, Freeman G, Cowling BJ, et al. Testosterone ther-

apy and cardiovascular events among men: a system-

atic review and meta-analysis of placebo controlled

randomized trials. BMC Medicine. 2013;11:108.

14. Mulligan T, Frick MF, Zuraw QC et al. Prevalence of

hypogonadism in males aged at least 45 years: the

HIM study. Int J Clin Pract. 2006;60(7): 762–769.

15. Dhindsa S, Prabhakar S, Sethi M, et al. Frequent oc-

currence of hypogonadotropic hypogonadism in type 2

diabetes. J Clin Endocrinol Metab. 2004;89(11): 5462-

5468.

16. Bhatia V, Chaudhuri A, Tomar R et al. Low testos-

terone and high C-reactive protein concentrations pre-

dict low hematocrit in type 2 diabetes. Diabetes Care.

2006;29(10):2289–2294.

17. Dhindsa S, Bhatia V, Dhindsa G et al. The effects of

hypogonadism on body composition and bone mineral

density in type 2 diabetic patients. Diabetes Care.

2007;30(7): 1860–1861.

18. Dhindsa S, Upadhyay M, Viswanathan P et al. Rela-

tionship of prostate-specific antigen to age and testos-

terone in men with type 2 diabetes mellitus. Endocr

Pract. 2008;14(8): 1000–1005.

19. Selvin E, Feinleib M, Zhang L et al. Androgens and

diabetes in men: results from the Third National Health

and Nutrition Examination Survey (NHANES III). Diabe-

tes Care. 2007;30(2): 234–238.

20. Dandona P and Rosenberg MT. A practical guide to

male hypogonadism in the primary care setting. Int J

Clin Pract. 2010;64(6):682-696.

21. Kalyani RR, Gavini S, Dobs AS. Male hypogonadism in

systemic disease. Endocrinol Metab Clin North Am.

2007;36(2): 333–48.

22. Yohimbe, Ashwagandha, and Maca. In: Natural Stand-

http://www.nap.edu/books/0309090636/html/

http://www.fda.gov/drugs/drugsafety/ucm401746.htm

http://www.fda.gov/drugs/drugsafety/ucm401746.htm

July/August 2015


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.


ard [online database]. Somerville, MA: Therapeutic Re-

search, Inc. 2015. Available at

http://naturalmedicines-therapeuticresearch-com.

Accessed Jan. 23, 2015.

23. Cunningham GR and Toma SM. Clinical review: why is

androgen replacement in males controversial? J Clin

Endocrinol Metab. 2011;96(1):38-52.

24. Li H, Ostrowski NL, Benoit K, et al. Assessment of the

association between the use of testosterone replace-

ment therapy (TRT) and the risk of venous thrombotic

events among TRT-treated and untreated hypogonadal

men. The Endocrine Society Annual Meeting, March 7,

2015, San Diego, CA. Abstract OR34-2.

25. Janmohamed S, Cicconetti G, Koro CE, et al. The as-

sociated between testosterone use and major adverse

cardiovascular events (MACE): an exploratory retro-

spective cohort analysis of two large, contemporary,

coronary heart disease clinical trials. The Endocrine

Society Annual Meeting, March 7, 2015, San Diego,

CA. Abstract OR 34-4.

26. Ali Z, Greer DM, Shearer R, et al. Effects of testos-

terone supplement therapy in men with low testos-

terone. American College of Cardiology 2015 Scientific

Sessions, March 14, 2015, San Diego, CA. Abstract

1126M-13.

27. Patel P, Arora B, Molnar J, et al. Effect of testosterone

therapy on adverse cardiovascular events among men:

a meta-analysis. American College of Cardiology 2015

Scientific Sessions, March 15, 2015, San Diego, CA.

Abstract 1195-376.

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KPhA Headquarters Rebuilding Campaign

August 2015 — Andropause: Benefits and Risks of “Low T” Therapy

1. Which symptom is least consistent with a clinical presentation of low testosterone? A. Decreased libido B. Fatigue C. Increased muscle mass D. Hot flashes E. Sexual dysfunction 2. What is the lower limit of normal for total testosterone levels? A. 101 to 120 ng/dL B. 180 to 200 ng/dL C. 201 to 220 ng/dL D. 280 to 300 ng/dL E. 301 to 320 ng/dL 3. What laboratory test(s) is/are considered for the diagnosis of low testosterone? A. Total serum testosterone B. Luteinizing hormone (LH) C. Sex hormone-binding globulin (SHBG) D. A and B E. A and C 4. The best time to draw levels for total serum testosterone is: A. 0400 to 0700. B. 0800 to 1100. C. 1200 to 1500. D. 1600 to 1900. E. 2000 to 2300. 5. AndroGel ® is applied to which part of the body? A. Thigh B. Back C. Chest D. Abdomen E. Shoulders

6. Which medication(s) can lead to low testosterone levels? A. Ketoconazole B. Spironolactone C. Sildenafil D. A and B E. B and C 7. What dosage form(s) is Testopol® available as? A. Transdermal Solution. B. Transdermal Patch. C. Transdermal Gel. D. Pellet. E. A, B, and C. 8. A REMS program for the risk of pulmonary oil micro-embolisms is associated with what medication(s)? A. Delatestryl ® B. Aveed ® C. Testopol ® D. Testim ® E. Both A and B 9. What is the dosing for Striant, the buccal testosterone product? A. One buccal tablet every 12 hours B. One buccal tablet daily C. One buccal tablet after each meal D. Two buccal tablets daily E. Two buccal tablets every 12 hours 10. Before initiating testosterone therapy, the following test(s) should be monitored: A. Hemoglobin. B. Lipid Panel. C. Total serum testosterone. D. A and B. E. A and C.

July/August 2015



PHARMACISTS ANSWER SHEET August 2015 — Andropause: Benefits and Risks of “Low T” Therapy (1.0 contact hour) Universal Activity # 0143-0000-15-009-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E 10. A B C D E 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 If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.


Personal








Expiration Date: August 14, 2018 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEU.


TECHNICIANS ANSWER SHEET. August 2015 — Andropause: Benefits and Risks of “Low T” Therapy (1.0 contact hour) Universal Activity # 0143-0000-15-009-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E 10. A B C D E 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 If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.




ID # and Birthdate will not be accepted.

July/August 2015



Proposed An Honorary Life member is defined as a

pharmacist who has achieved exemplary distinction

exceptional accomplishments in or for pharmacy and/or

the Association. This said member may be nominated

by any member of the association and shall be select-

ed by a two-thirds three-fourths vote at a meeting of the

Board of Directors and reported to approved by the

House of Delegates at the Annual Meeting. No dues

shall be collected for an honorary life member.—

Approved as amended.

Article 1 Section 1.2 Election to Membership- Recom-

mend referring to OAC for more research—Approved.

Article 6 Section 6.6 Duties of the Board of Directors-

Subsection 6:62: The Board of Directors shall have

sole and exclusive authority to approve and amend the

annual budget and shall review the year-to-date finan-

cial records of the Association at each meeting of the

Board. The Board at its discretion shall engage an in-

dependent CPA to audit the accounts and financial rec-

ords of the Association no less than every three years.

Additionally, in non-audit years, the Board shall assure

an accounting review, compilation or other financial

engagement designed to fully evaluate the financial

transactions of the Association from an independent

CPA—Recommend to not adopt this current change

based on the testimony given this morning. There ap-

pear to be different definitions of different levels of fi-

nancial reviews. Defeated Reference committee rec-

ommendation. Amendment made to original language

to include changes as noted. Adopted as amended.

Article 9 Section 9.1- Composition Subsection 9.11—

The House of Delegates shall be composed of active

pharmacist members of the Association, five pharmacy

technician delegates selected by their Academy, other

groups recognized by the Board of Directors and stu-

dent delegates as outlined in Section 9.17. Each of

these delegates shall have one vote.—Reference Com-

mittee recommends amending—Approved as amend-

ed.

Article 9 Sections 9.12-9.18, excluding 9.17—Eliminate

these sections and renumber accordingly.—

Recommend Amendment of 9.17—Each student chap-

ter of an accredited school/college of pharmacy in Ken-

tucky shall be entitled to representation in the House by

one delegate for the first five members of the Kentucky

Pharmacists Association and one additional delegate

for each additional 20 members or major fraction there-

of. —Approved as Amended. Removal of sections

9.12-9.18, excluding 9.17—Approved.

Article 9 Section 9.3 Delegates Subsections 9.31-9.35

and Section 10.8—Recommend eliminating these sec-

tions and renumber accordingly—Approved.

Article 9 Section 9.43 and 9.44 House of Delegates—

Credentialing of delegates can be determined by a reg-

istration process of active pharmacist members and

other delegates.—Recommend not approving.—

Approved.

Article 10 Section 10.4 Section—The Compounding

Academy is inactive and has no members.—

Recommend removing Compounding Academy—

Approved.

Article 12 Section 12.1 Amendments—Any member of

the Association may submit a proposal in writing to

amend these Bylaws. Such proposals must be submit-

ted at least 60 days prior to the Annual Meeting. The

House may waive the 60 days with three-fourths major-

ity vote.—Recommend not adopting.—Approved refer-

ence committee recommendation.

Board Recommendations:

Election to Honorary Membership

Bob Lichtenfeld, RPh, Retired; KPhA Executive Direc-

tor, 1965-1978

R. David Cobb, KPhA President, 1975-76 (went on to

serve as APhA President)

Reference Committee recommends adopting each resolu-

tion—Approved Honorary membership was bestowed upon

pharmacists Robert Lichtenfeld and R. David Cobb.

A Resolution honoring the service of Michael Burleson,

RPh, Executive Director of the Kentucky Board of Phar-

macy, October 1, 2004 to July 31, 2015.

Reference Committee recommends adopting- Adopted.

Recommendation that dues for New Practitioner 1st

Year be set at $0.00, and that new membership cate-

gories be established for New Practitioner 2nd

Year and

New Practitioner 3rd

year.

Reference Committee recommends adopting—Adopted.

Recommendation of the amount of dues for all classes

of membership—Maintain the Dues structure at the

same level for the next 3 years and the Board of Direc-

tors shall re-evaluate in 3 years.

Reference Committee recommends adopting—Adopted.

Continued from Page 9

July/August 2015



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.

Annual Meeting Venue (Future Consideration)

Reference Committee recommends sending to Board

of Directors—Adopted.

Capital Campaign — KPhA Board of Directors are ask-

ing to proceed with establishing the Capital Campaign.

Reference Committee recommends moving forward

with the Capital Campaign—Adopted.

The nomination was made for Vice-Speaker; Lance Mur-

phy. A vote via paper ballots was held. Lance Murphy was

officially elected and appropriately sworn in as Vice-

Speaker of the House of Delegates.

Ethan Klein, the outgoing Speaker of the House, was rec-

ognized for his service. Outgoing Treasurer Glenn Stark,

also was recognized.

The incoming Directors and Treasurer of the Kentucky

Pharmacists Association were installed.

The 2015 House of Delegates, once again, was a time for

discussion and debate. This is when we decide the next

steps of YOUR KPhA and look forward to more involve-

ment and discussion in the House as we advance our pro-

fession. Speak up to become involved, serve on a commit-

tee, become a delegate in the House and voice YOUR

stance. KPhA is here for YOU.

“Know Pain, Know Gain”

Pharmacy Patient Pain

Counseling Competition

Sullivan University College of Pharmacy rising

third-year student Ryan Hatfield (second from

left) won the “Know Pain, Know Gain” Pharmacy

Patient Pain Counseling Competition at the 137th

KPhA Annual Meeting and Convention. Ryan

counseled mock patient Melinda Joyce and was

judged as the best of three finalists. The Judging

panel was Ron Poole, Kim Croley and Barbara

Jolly. Barry Eadens served as the moderator.

The participants were Hatfield, Urvi Patel, Kevin

Mercer, Erica Krantz, Justin Tossey and Ellen

Schuler. Hatfield, Patel and Tossey survived a

question and answer round to advance to the

one-on-one counseling portion.

July/August 2015


KPERF Golf Scramble

2015 KPERF Golf Scramble

First Place: Kevin

Lamping, Ed Prater,

Robby Ryan, Brian Jones

Second Place: J.T. Roby,

Duane Parsons, Sam

Willett, Leon Claywell

Longest Drive:

Aaron Smith

Closest to

the Pin: Ron

Nieporte

Last Place:

Joe Carr,

Mike

Burleson,

Steve Hart,

Chris

Killmeier

July/August 2015


KPhA New and Returning Members

KPhA Welcomes New and Renewing Members

May-June 2015

Cathy Adams Pineville John Adams Lebanon Kasey Alford Smiths Grove Christina Amburgey Nicholasville Mark Antis South Portsmouth Karen Arlinghaus Ft. Wright Kimberly Arvin Fort Thomas William Ashby Canton Rosana Aydt Villa Hills James Ball Elizabethtown Christopher Barker Morehead Larry Barnett South Williamson Richard Baudendistel Cincinnati, Ohio Morgan Beck Madisonville Daniel Beebe Cincinnati, Ohio Margaret Beeler Lebanon Junction Crystal Belt Annville Caleb Benningfield Bowling Green William Bentley South Shore Alexander Bessler Newport John Beville Shelbyville

Danny Biliter Richmond Sherry Bilyeu Russellville Kenneth Boggs Hazard Michael Bordes Williamsburg Ralph Bouvette Frankfort Charlotte Bowling London David Bowman Columbia Terry Box Cynthiana Abigail Breit Louisville Benjamin Brown Louisville Kyle Bryan Lebanon Junction Dianna Bryant Hartford William Bucy Bowling Green Dana Burns Covington John Byassee Clinton Holly Byrnes Louisville Joseph Carroll Salyersville Dave Cavanah Hopkinsville Jessika Chinn Beaver Dam Margaret Christopher Winchester Kenneth Clayton Elkton

Richard Clements Morganfield Arica Collins Albany Elizabeth Coomes Bardstown Paul Cooper Morehead Kim Croley Corbin Robert Croley Corbin Heather Crump Flemingsburg Jeffrey Danhauer Owensboro Sharon Davidson East Bernstadt Steven Dawson McDowell Dave Dickerson Morehead Jackie Dickerson-Galer Inez James Dixon Barbourville Steve Doom Elizabethtown Elisha Dougherty Benton Michael Eastridge Lebanon David Edmundson Bowling Green Kevin Emberton Edmonton Ashley Eschenbach Louisville John Evans Henderson Lorie Evans Garrison

Warren Fegenbush Crestwood Brooke Feltner London Jamie Ferrell Mount Sterling Jaime Fields Hindman Justin Fink Fort Wright Timothy Finley Florence Celeste Flick Crestview Hills Raymond Float Danville Veronica Foster Munfordville Cathy Francisco Pikeville Patricia Freeman Lexington Johnathan Fuller Beaver Dam Charles Galer Inez Roy Gentry Monterey, Tenn.

MEMBERSHIP MATTERS:

To YOU, To YOUR Patients

To YOUR Profession!

July/August 2015



Aaron Gilbert Butler Michelle Gilbert Butler Thomas Glover Providence Tamara Goff Hartford Patricia Gooch Pikeville Dwaine Green The Villages, Fla. Melissa Greenlee Burlington Monte Gross Stanton Donald Gubser Independence Larry Hadley Frankfort Carolyn Hale Columbia Kelsey Hall Louisville William Hall Whitesburg Joan Haltom Danville Catherine Hanna Lexington Kathy Hardy Smiths Grove Lisa Hart Frankfort Steve Hart Frankfort Clara Hartgrove Martin Kyle Hatterick Cynthiana Melodie Hawkins Mt Sterling Jonathan Hayes Prospect Pamela Hays McKee

J Henry Greenville James Hicks Whitesburg Gregory Hines Bowling Green Carolynn Horn Philpot Jan Houchens London Tom Houchens London James Howard Fountain Run Reymonda Howard London Mark Huffmyer Lexington Robert Hughes Lexington Michael Ingram Cynthiana Joseph Johnson Campbellsville Daniel Jones Paducah Karen Jones Gilbertsville Kyle Katterjohn Paducah Ann Keown Scottsville Brian Key Pineville Scott King Hazard Steven King Bloomfield Patricia Kinney Erlanger Kristy Klebeck Maysville Sarah Lawrence Louisville Mike Leake Danville

Penny Liles Vanceburg Michelle Lowe Paducah Robert Lucas Flatwoods Thomas Mason Fairfield Kelly Maston Woodburn Joey Mattingly Baltimore, Md. Sunni Mauk Paducah Velda McDaniel Georgetown John McFarland London Michael McQuade Edgewood Lynita McWaters Paducah Mark Meador Scottsville Anne Megibben Finchville John Milam Lexington Kelly Mink Lancaster Dan Minogue Louisville Judith Minogue Louisville Bernardine Miracle Whitesburg Jeffrey Moore Middlesboro Sonya Muncy Russell Erica Neff Florence Owen Neff Centerville, Ohio Brad Newcomb Paducah

Frank Nicks Bowling Green John Nie Independence Christopher Noetzel Flemingsburg David O'Quinn West Liberty Jamie Otte Florence Kelly Owens Phoenix, Az. Paul Patrick London Kenneth Pearce Danville Megan Pendley Lexington Risa Perry Almo Brookes Pickard Louisville Larry Powell Richmond Amanda Powers Boaz Elizabeth Prather Florence Timothy Quillen Greenup Gary Rice Corbin Herbert Rice Grand Rivers Marcella Robinson Paducah Alyson Roby Bardstown Frank Romanelli Lexington Thomas Runge Union Donald Ruwe Fort Thomas Jessica Salmons Hazard

July/August 2015



KPhA Honorary Life Members

Ralph Bouvette Leon Claywell R. David Cobb Gloria Doughty

Bob Lichtenfeld Kenneth Roberts Ann Amerson Stewart

Joanna Sames Shelbyville Denise Schickling Villa Hills Lisa Schwartz Crestview Hills Jan Scott Earlington Kimberly Scott Frankfort William Sewell Utica Mohammon Shajiudoin Radcliff Anna Sharp Campbellsville Edwin Shelton Owensboro Gina Sherrow Brodhead David Shipley Henderson John Simkins Somerset Alan Simon Prospect

Lisa Smith Dry Ridge Michael Smithson Frankfort Edwin Snider Louisville Walter Soja Taylorsville Rodney Stacey Cumberland James Stallard Neon Scott Stephens Cynthiana Dan Stevenson Portsmouth, Ohio Christopher Stovall London Jacquelyn Strickland Hopkinsville David Stultz Greenup J. Sutton London Juliana Swiney Prospect

David Tabb Elizabethtown Joanne Taheri Louisville Francis Thompson London Gene Thompson Lexington Leah Tolliver Lexington Jason Underwood Flemingsburg Joseph Vennari Lexington Brett Vickey Wilmore Sarah Vickey Wilmore Samuel Waddell Sitka Jason Wallace Dry Ridge Earnest Watts Cornettsville Catherine Webb Scottsville

Cary White Lexington Lenville White Irvine Rodney Whittington Princeton Gary Wientjes Morehead Charlsie Williams Paducah Cindi Williams Hazard James Wiseman Benton Reginald Woolf South Fulton, Tenn. Maribeth Wright Nicholasville Whitney Wright Dixon Michael Wyant Finchville Jeanne Zeis Covington

Know someone who should be

on this list? Ask them to join YOU in

supporting YOUR KPhA!

July/August 2015


KPhA Emergency Preparedness

KPhA Pharmacy Emergency Preparedness Initiative Interest Form

Name: ______________________ Status (Pharmacist, Technician, Other): ___________________

Email: ______________________________ Phone: ___________________________

Interest in serving as a volunteer: Yes____ No ____

Interest in serving as a Volunteer District Coordinator: Yes____ No _____

You also may join the Medical Reserve Corps by following the 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.

KPhA Director of Pharmacy Emergency Preparedness

Leah Tolliver participated in a full scale SNS exercise that

was conducted June 16-18, 2015 by the Kentucky Depart-

ment for Public Health.

The overall goal was to measure the time it would take to

dispense and treat the public with either doxycycline or

ciprofloxacin due to an anthrax exposure. The CDC guide-

lines recommend that the federal SNS assets be released

within 12 hours upon being contacted by a state depart-

ment for public health, 12 hours to be delivered to the site

and 24 hours to be dispensed to the public. The goal for

packaging and labeling the medication before it can be

dispensed to the public was to measure the amount of time

it took to package and label 1,065 prescriptions. With the

number of volunteers that participated in the exercise, the

rate of dispensing is 75 Rxs/per person/hour. The state

cache contains enough medication to treat 15,000 first re-

sponders and their families (10 day supply of medica-

tion). Therefore it will take 200 hours to package and label

enough medication to treat them.

KPhA participates in Kentucky SNS Drill

July/August 2015


Pharmacy Law Brief

Pharmacy Law Brief: Legalization of Marijuana Use - Civil Law Issues-I

Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy

Question: I keep seeing on television and reading in

the newspaper about states taking steps to legalize the use

of marijuana, usually for “medicinal purposes.” A lot of the

coverage relates to the criminal law aspects of the issue.

But I saw a segment on “60 Minutes” about the marijuana

“dispensaries” having issues with banking their flow of cash

along with other unusual business law issues. What are

those issues we hear so much less about?

Response: There are quite a few non-criminal law is-

sues facing operators of marijuana dispensaries in states

where such activity has been legalized. In fact, there are so

many that they will be divided into two groups for consider-

ation. In this installment, we will consider issues related to

money and finances. Then the subsequent column will fo-

cus on consideration of a variety of other issues facing

those who operate marijuana dispensaries.

The approach of banks to handling a marijuana business’s

proceeds can best be summed up by a quotation from a

spokesperson for Wells Fargo Bank: “We abide by all feder-

al laws, and the distribution and sale of marijuana is illegal,

so we don’t bank the proceeds from sale of medical or rec-

reational marijuana.” Banks reportedly will not accept de-

posits from firms involved with production or distribution of

marijuana. Nor can credit cards be used for the transac-

tions because credit card processing must be linked to a

bank account. This creates a challenge for the business

operator in dealing with all the cash the enterprise takes in

and disburses. Think about security measures necessitated

by having all that cash around. In February 2014, the U.S.

Department of the Treasury issued a guidance statement to

banks about dealing with marijuana business, but financial

industry spokesmen indicated that the guidance would not

ease their concerns about opening accounts for or making

loans to marijuana operators.

Taxation issues also can be quite significant for marijuana

dealers. There is a specific provision in the federal Internal

Revenue Code that addresses such activities: “No deduc-

tion…shall be allowed for any amount paid…in carrying on

any trade or business if such business…consists of traffick-

ing on controlled substances…” [26 U.S.C. §280E – Ex-

penditure in Connection with Illegal Sale of Drugs]. This

provision was inserted largely to punish drug dealers. Think

about that – what are some customary or traditional

“deductions” that could be disallowed under this sections?

Rent, wages, supplies, utility costs and on and on. Because

those may not be deductible as they would be for a tradi-

tional business in order to determine net income subject to

taxation, the operator of a marijuana business would be

expected to pay tax on those ordinarily-deductible business

expenses. The thinking behind this approach of taxing the

gross amount of revenue, rather than the net, was to punish

dealers in illegal drugs. This provision in the Internal Reve-

nue Code has been in place since 1982.

Real estate-related issues arise in a number of ways. What

limitations exist regarding possession and use of marijuana

on federal lands, e.g., VA hospitals, national parks, military

installations, etc.? Further, a commonly encountered provi-

sion in a lease is that the lessee, member of the lessee’s

household, guest or other person under the leaseholder’s

control shall not engage in illegal activity. The occupant of

“drug-free housing” is prohibited from participating in drug-

related illegal activity. Also, being a medical marijuana user

is not covered under the Americans with Disabilities Act nor

under the Fair Housing Amendments Act of 1988 so there

is no requirement that the landlord provide “reasonable ac-

commodation.” What about other tenants and their “right to

quiet enjoyment” of the premises they leased? What about

issues with commercial versus residential property? Mariju-

ana growing consumes enormous amounts of electricity.

Does the tenant pay the electric bill? What about issues

related to smoke, odors, mold and pests? Should the tenant

be required to pay for installing exhaust fans? What about

the increased flow of traffic in the parking lot or purchasers

“medicating” in the parking lot?

Submit Questions: [email protected]

Disclaimer: The information in this column is intended for

educational use and to stimulate professional discussion among

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

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

al or discussion purposes can adequately and fully address the

multifaceted and often complex issues that arise in the course of

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

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

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

advice in accordance with the full information.

July/August 2015


Pharmacy Law Brief

@KyPharmAssoc

@KPhAGrassroots

Facebook.com/KyPharmAssoc

Facebook.com/

KPhANewPractitioners

KPhA Company Page

Are you connected

to YOUR KPhA?

Join us online!

Finally, what if the marijuana business is not as successful

as the optimistic founder anticipated? Issues can arise un-

der the federal bankruptcy laws such as a case last fall

when a federal judge in Denver denied a wholesale mariju-

ana producer and distributor access to federal bankruptcy

protection from creditors. This decision matched a prior

decision in that state as well as two parallel decisions in

federal bankruptcy courts in California. The judge stated

that “Violations of federal law create significant impedi-

ments to the debtors' ability to seek relief from their debts

under federal bankruptcy laws in a federal bankruptcy

court.” The judge continued by emphasizing the

“contradictions that dueling marijuana laws pose to liquidat-

ing assets and distributing the proceeds among creditors.”

The bankruptcy trustee cannot take control of assets or

liquidate the inventory without running afoul of federal law,

he said. Nor can the debtors convert the case to Chapter

13, which would allow them to pay off debts over time, be-

cause the plan would be funded "from profits of an ongoing

criminal activity under federal law" and involve the trustee

in distribution of funds derived from violation of the law.

The next installment will identify and discuss briefly a num-

ber of addi-

tional issues

arising from

these devel-

opments

around the

country.

SAVE THE DATE

July/August 2015


Pharmacy Policy Issues

PHARMACY POLICY ISSUES: Limitations on the Treatment of Narcotic Dependence and its Effect on Pediatric

Pharmacy Practice Author: Rachel N. Hulette is a third-year PharmD student at the University of Kentucky College of Pharmacy. A native of

Frankfort, she completed her pre-professional coursework as a Chemistry major at Eastern Kentucky University.

Issue: Over the last 10 years, there has been an increase in prescription opioid abuse along with increasing incidence of

children born addicted. How does the current legal and regulatory framework put limitations on the treatment of their

narcotic dependence and what role do pharmacists have in this issue?

Discussion: Neonatal Abstinence Syndrome (NAS) in-

cludes a collection of symptoms displayed as a result of

neonatal drug withdrawal after intrauterine exposure to a

substance during pregnancy. Infants born under these cir-

cumstances have an increased risk of many complications.

This syndrome is commonly seen with exposure to opioids,

but also can be caused by exposure to other drugs as well.

Opioid use and dependence continues to be a significant

public health issue and leads to many major problems in

pregnancy and potentially devastating outcomes for the

developing fetus.

In the year 2000, fewer than 30 infants were diagnosed

with NAS in Kentucky. For the year 2013, that number was

more than 950.1 This increasing number of infants being

born with NAS has had an impact on length of hospital

stay, overcrowding of Neonatal Intensive Care Units and

has led to significant increase in cost for patients as well as

hospitals.

DEA regulations found at 21 CFR §1306.07 “Administering

or dispensing of narcotic drugs” has had a great impact in

terms of the management of neonatal opioid withdrawal

and treatment of NAS.2 Methadone therapy was initially

used as treatment in the hospital for withdrawal symptoms,

and then a taper was continued upon discharge. Many phy-

sicians thought this was appropriate for newborns with

NAS who had no other health conditions, as opposed to

having them admitted for withdrawal treatment. This treat-

ment significantly decreased their length of stay, reduced

cost to the family as well as the hospital and allowed the

baby a safer recovery away from exposure to other illness-

es that could be present in the hospital. However, 21 CFR

§1306.07 has set limitations on the medication treatment

physicians can provide to a “narcotic dependent person for

the purpose of maintenance or detoxification treat-

ment” (emphasis added) in these circumstances.2

In 2001, the Federal Interagency Narcotic Treatment Policy

Review Board (INTPRB) decided that the use of opioids for

infants and children suffering from withdrawal did not fall

under the Narcotic Addict Treatment Act (NATA) and was

not subject to the same rules and regulations.3 This made

an exception for the treatment of infants suffering from

NAS, even though current state and federal laws did not

allow methadone to be prescribed to treat opiate withdraw-

al. It was declared that a physician treating a child with

NAS may issue a prescription for any opioid, including

methadone, based on clinical judgment, existing standards

of practice and as well as the patient’s response to therapy.

However, despite these actions taken by the INTPRB,

many physicians do not utilize their right to do this because

they are skeptical and fearful of not complying with the

standards in place.

What is the role of pharmacists in this issue? A project has

been initiated by the Kentucky Perinatal Quality Collabora-

tive that was introduced in June of 2014 at the Kentucky

Pharmacists Association annual meeting. The goal of this

project is to start collecting information from hospitals in

Kentucky about the best practices for treating infants with

NAS in hopes of distributing the information they find to

hospitals and maternal-infant health care providers.1 There

may not be a clear solution yet; however, pharmacists can

play an active role in helping to work towards a standard-

ized treatment involving interventions of both medication

and non-medical treatments to improve the outcomes of

Have an Idea?:

This column is designed to address timely and practical

issues of interest to pharmacists, pharmacy interns and

pharmacy technicians with the goal being to encourage

thought, reflection and exchange among practitioners.

Suggestions regarding topics for consideration are

welcome. Please send them to [email protected].

July/August 2015


KPhA Government Affairs/KPPAC

both mother and infants that are affected by NAS.

References:

1. Bond G, Fisher B. Health Collaborative to Look at Best

Practices for Neonatal Abstinence Syndrome. Cabinet

for Health and Family Services; c2014 [updated 2014

June 20, cited 2014 October 16]; [about 2 screens];

Available form: http://chfs.ky.gov/news/

NAS+program.htm.

2. Drug Enforcement Administration: Administering or

dispensing narcotic drugs; 21 C.F.R. §1306.07 [Oct.

25, 1974, as amended at 70 FR 36344, June 23, 2005;

cited 3014 October 16]; Available from:

http://www.deadiversion.usdoj.gov/21cfr/

cfr/1306/1306_07.htm.

3. NABP.net [Internet]. National Association of Boards of

Pharmacy Foundation, Inc. c2012 [updated 2012

March; cited 2014 October 16]’ [about 4 screens].

Available form: http://www.nabp.net/publications/

assets/WV032012.pdf.

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

July/August 2015


Pharmacists Mutual

July/August 2015


Cardinal Health

July/August 2015


KPhA BOARD OF DIRECTORS

Bob Oakley, Louisville Chair

[email protected]

Chris Clifton, Villa Hills President

[email protected]

Trish Freeman President-Elect

[email protected]

Brooke Hudspeth, Lexington Secretary

[email protected]

Chris Palutis, Lexington Treasurer

[email protected]

Duane Parsons, Richmond Past President

[email protected] Representative

Directors

Matt Carrico, Louisville*

[email protected]

Chad Corum

[email protected]

Tony Esterly, Louisville

[email protected]

Matt Foltz, Villa Hills

[email protected]

Chris Killmeier, Louisville

[email protected]

Kevin Mercer University of Kentucky

[email protected] Student Representative

Jeff Mills, Louisville

[email protected]

Catherine Serratore 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

Chris Harlow, Louisville Speaker of the House

[email protected]

Lance Murphy, Louisville Vice Speaker of the House

[email protected]

KPERF ADVISORY COUNCIL

Matt Carrico, Louisville

[email protected]

Kim Croley, Corbin

[email protected]

Kimberly Daugherty, Louisville

[email protected]

Christen Schenkenfelder

[email protected]

Mary Thacker, Louisville

[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.

July/August 2015


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 (PTCB) 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

50 Years Ago at KPhA E. MURPHY JOSEY, R.PH. 1908-1965

MURPH

To those of us who have had the privilege of passing through part of this world in the presence

of E. Murphy Josey, epitaphs and black bordered obituaries seem completely out of place. So

great have been his contributions of both friendship and leadership in the pharmaceutical in-

dustry that a part of Josey will always be very much alive in the Kentucky Pharmaceutical Association.

Throughout Kentucky there are hundreds of young men and women who are better pharmacists today because of the

work of Murph Josey in the association, work-shops, conventions and districts. His talents as an executive secretary

were passed on each year as he guided and directed leadership in all phases of pharmacy.

His enthusiasm for better pharmacy through research and education lives on in the expanded program of the College of

Pharmacy, a part of pharmacy he cherished. His counsel and support were felt by many.

Frankfort, Kentucky was his home, but the whole state of Kentucky was his interest. Even on the national level of phar-

macy Josey was respected and loved by all, as was shown by his many appointed offices and positions with the Ameri-

can Pharmaceutical Association, the National Association of Retail Druggists, and the National Boards of Pharmacy.

Murph Josey stood a man among men, aware of his obligations to his family, his pharmacists, his friends, his communi-

ty, his church, his association, and faithful to all. And so, although we shall miss him, and there is a void in our future

which he would have so capably filled, we cannot remember him with black borders. Instead, we remember the part of

Murph Josey that has made the Kentucky Pharmaceutical Association a finer organization for the pharmacists of the

future and the people they serve—the part of him which will live forever.

To Mrs. Mary George Josey and Ann Forrest Josey we say, “thank you for sharing your husband and father with us.”

Fourth District Pharmaceutical Association, Jim Arnold, President; Robert Graves, Secretary-Treasurer

- From The Kentucky Pharmacist, July 1965, Volume XXVIII, Number 7.

Editor’s Note: Mr. Josey was the last individual to serve both the Kentucky Board of Pharmacy and the

Kentucky Pharmacists Association as each organization’s Executive at the same time of service.

July/August 2015


THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601

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

Show your Pharmacist Pride with a

KPhA Roamey Window Cling ($5) or

your own personalized Roamey ($25)!

All proceeds benefit

the KPhA Building Fund

Available at the KPhA Online Store www.kphanet.org, click on About Tab,

Online Store

the kentucky pharmacist vol. 10, no. 4

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