the kentucky pharmacist vol. 10, no. 4
DESCRIPTION
July/August edition of the peer reviewed journal of the Kentucky Pharmacists AssociationTRANSCRIPT
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
THE KENTUCKY PHARMACIST 3
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
THE KENTUCKY PHARMACIST 4
137th KPhA Annual Meeting & Convention
Scenes from the
July/August 2015
THE KENTUCKY PHARMACIST 5
137th KPhA Annual Meeting & Convention
July/August 2015
THE KENTUCKY PHARMACIST 6
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
THE KENTUCKY PHARMACIST 7
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
THE KENTUCKY PHARMACIST 8
APSC
July/August 2015
THE KENTUCKY PHARMACIST 9
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
THE KENTUCKY PHARMACIST 10
2015 KPhA Professional Awards
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
THE KENTUCKY PHARMACIST 11
2015 KPhA Professional Awards
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
THE KENTUCKY PHARMACIST 12
137th KPhA Annual Meeting & Convention
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
THE KENTUCKY PHARMACIST 13
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
THE KENTUCKY PHARMACIST 14
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
THE KENTUCKY PHARMACIST 15
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
THE KENTUCKY PHARMACIST 16
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
THE KENTUCKY PHARMACIST 17
June 2015 CE — Contractual Relationships
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
THE KENTUCKY PHARMACIST 18
June 2015 CE — Contractual Relationships
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
THE KENTUCKY PHARMACIST 19
June 2015 CE — Contractual Relationships
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
THE KENTUCKY PHARMACIST 20
June 2015 CE — Contractual Relationships
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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
THE KENTUCKY PHARMACIST 21
June 2015 CE — Contractual Relationships
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
THE KENTUCKY PHARMACIST 22
June 2015 CE — Contractual Relationships
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.
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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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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
THE KENTUCKY PHARMACIST 23
Pharmacy Quality/PTCB
July/August 2015
THE KENTUCKY PHARMACIST 24
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.
Universal Activity # 0143-0000-15-006-H01-P&T
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
At the conclusion of this Knowledge-based article, the reader should be able to:
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.
July/August 2015
THE KENTUCKY PHARMACIST 25
July 2015 CE—Companion Animal Medications
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
THE KENTUCKY PHARMACIST 26
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 2015 CE—Companion Animal Medications
July/August 2015
THE KENTUCKY PHARMACIST 27
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 2015 CE—Companion Animal Medications
July/August 2015
THE KENTUCKY PHARMACIST 28
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-
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Articles are generally written so that they are per-
tinent to both pharmacists and pharmacy techni-
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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
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your article.
Articles should address topics designed to narrow
gaps between actual practice and ideal practice in
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Continuing Education Article Guidelines
References
1. Client Information Sheets (CIS) of human drugs dis-
pensed in retail pharmacies for pets.
https://sites.google.com/site/vetpharmcis/
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
July 2015 CE—Companion Animal Medications
July/August 2015
THE KENTUCKY PHARMACIST 29
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
July 2015 CE—Companion Animal Medications
July/August 2015
THE KENTUCKY PHARMACIST 30
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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.
Signature ____________________________________________Completion Date___________________________
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NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD)
Expiration Date: August 3, 2018 Successful Completion: Score of 80% will result in 2.0 contact hours or .2 CEU.
Participants who score less than 80% will be notified and permitted one re-examination.
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.
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July 2015 CE—Companion Animal Medications
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THE KENTUCKY PHARMACIST 31
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.
Universal Activity # 0143-0000-15-009-H01-P&T
1.0 Contact Hour (1.0 CEU)
Objectives
At the conclusion of this Knowledge-based article, the reader should be able to:
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
THE KENTUCKY PHARMACIST 32
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
August 2015 CE—Andropause
July/August 2015
THE KENTUCKY PHARMACIST 33
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
August 2015 CE—Andropause
July/August 2015
THE KENTUCKY PHARMACIST 34
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
August 2015 CE—Andropause
July/August 2015
THE KENTUCKY PHARMACIST 35
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.
August 2015 CE—Andropause
July/August 2015
THE KENTUCKY PHARMACIST 36
August 2015 CE—Andropause
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
THE KENTUCKY PHARMACIST 37
August 2015 CE—Andropause
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.
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4. Rhoden E and Morgentaler A. Medical Progress: risks
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22. Yohimbe, Ashwagandha, and Maca. In: Natural Stand-
July/August 2015
THE KENTUCKY PHARMACIST 38
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.
August 2015 CE—Andropause
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.
The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's
leading preservation organization for pharmacy.
While contributions of any size are greatly appreciated, the following levels of annual giving have been established
for your consideration.
Friend of the Museum $100 Proctor Society $250
Damien Society $500 Galen Society $1,000
Name______________________________________ Specify gift amount________________________
Address ____________________________________ City____________________Zip______________
Phone H____________________W________________ Email___________________________________
Employer name_____________________________________________________for possible matching gift.
Tributes in honor or memory of_____________________________________________________
Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax
deductible contributions will be mailed to you annually.
Questions: Contact Lynn Harrelson @ 502-425-8642 or [email protected]
For more information on the Kentucky Renaissance Pharmacy Museum, see
www.pharmacymuseumky.org or contact Gloria Doughty at
[email protected] or Lynn Harrelson at [email protected].
July/August 2015
THE KENTUCKY PHARMACIST 39
August 2015 CE—Andropause
Watch eNews and
subsequent editions of
The Kentucky Pharmacist for
more information on ways YOU
can help rebuild YOUR KPhA
Headquarters!
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
THE KENTUCKY PHARMACIST 40
August 2015 CE—Andropause
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.
Signature ____________________________________________Completion Date___________________________
Personal
NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD)
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.
Expiration Date: August 14, 2018 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEU.
Participants who score less than 80% will be notified and permitted one re-examination.
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.
Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD)
Quizzes submitted without NABP eProfile
ID # and Birthdate will not be accepted.
July/August 2015
THE KENTUCKY PHARMACIST 41
2015 KPhA House of Delegates
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 42
2015 KPhA House of Delegates
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
THE KENTUCKY PHARMACIST 43
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
THE KENTUCKY PHARMACIST 44
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
THE KENTUCKY PHARMACIST 45
KPhA New and Returning Members
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
THE KENTUCKY PHARMACIST 46
KPhA New and Returning Members
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
THE KENTUCKY PHARMACIST 47
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
THE KENTUCKY PHARMACIST 48
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
THE KENTUCKY PHARMACIST 49
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
THE KENTUCKY PHARMACIST 50
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
THE KENTUCKY PHARMACIST 51
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.
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July/August 2015
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THE KENTUCKY PHARMACIST 54
KPhA BOARD OF DIRECTORS
Bob Oakley, Louisville Chair
Chris Clifton, Villa Hills President
Trish Freeman President-Elect
Brooke Hudspeth, Lexington Secretary
Chris Palutis, Lexington Treasurer
Duane Parsons, Richmond Past President
[email protected] Representative
Directors
Matt Carrico, Louisville*
Chad Corum
Tony Esterly, Louisville
Matt Foltz, Villa Hills
Chris Killmeier, Louisville
Kevin Mercer University of Kentucky
[email protected] Student Representative
Jeff Mills, Louisville
Catherine Serratore Sullivan University
[email protected] Student Representative
Richard Slone, Hindman
Mary Thacker, Louisville
Sam Willett, Mayfield
* At-Large Member to Executive Committee
HOUSE OF DELEGATES
Chris Harlow, Louisville Speaker of the House
Lance Murphy, Louisville Vice Speaker of the House
KPERF ADVISORY COUNCIL
Matt Carrico, Louisville
Kim Croley, Corbin
Kimberly Daugherty, Louisville
Christen Schenkenfelder
Mary Thacker, Louisville
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THE KENTUCKY PHARMACIST 55
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
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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 56
THE
Kentucky PHARMACIST
1228 US 127 South
Frankfort, KY 40601
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