The Kentucky Pharmacist Vol. 10, No. 4

Y K C U T N E K THE T S I C A M R A PH Vol. 10, No. 4 July/August 2015

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

UNITED WE STAND Membership Matters in YOUR KPhA News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

July/August 2015 June Pharmacist/Pharmacy Tech Quiz July 2015 CE — Companion Animals Medications July Pharmacist/Pharmacy Tech Quiz August 2015 CE — Andropause August Pharmacist/Pharmacy Tech Quiz 2015 KPERF Golf Scramble KPhA New and Returning Members KPhA Emergency Preparedness Pharmacy Law Brief Pharmacy Policy Issues Pharmacists Mutual Cardinal Health KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted

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

2 3 4 6 8 9 10 12 13 14 15 16

22 24 30 31 40 43 44 47 48 50 52 53 54 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 ssisco@kphanet.org.

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. 2

THE KENTUCKY PHARMACIST

President’s Perspective

July/August 2015 mother to our children, and I thank and love you very much.

PRESIDENT’S PERSPECTIVE

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 Chris Clifton pharmacist. Some good and some not so good, but we have all always been there to serve the best interests of our KPhA President patients and our profession. Again today we are at the 2015-2016 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 Congressman Brett Guthrie, who we recognized earlier today and signed on by all six Kentucky Representatives, will help our patients receive pharmacists’ services to those mediAdapted from President Clifton’s address to the cally underserved areas of our state. This legislation is membership gathered at the Ray Wirth Banquet about more than recognizing pharmacists. This is about June 27, 2015 increasing patient access to health care and the value that pharmacists can provide to patients and the health care would like to thank everyone for coming to this year’s system. And this is only the beginning as more people see KPhA Annual Meeting and allowing me to be YOUR the benefits of their pharmacist and what services we proPresident for the Kentucky Pharmacists Association for vide to better their health, the possibilities can be endless.

2015-2016. I cannot begin to tell you how humbled I This isn’t something that is going to happen overnight, and am to be standing up here in front of so many colleagues it has taken a lot of hard work to get to this point. Much and friends as the leader of this professional association. thanks needs to be given to the Advancing Pharmacy PracThere are some people here tonight that have played an tice in Kentucky Coalition, led by our very own Presidentimportant role in my development, both personally and pro- Elect Dr. Trish Freeman, as well as all the participating fessionally, and I would be remiss if I didn’t mention them. members; KPhA, Kentucky Board of Pharmacy, KSHP, First and foremost to my parents, Charlie and Susan ClifAPSC, Sullivan University College of Pharmacy and the ton, thank you for being such loving and devoting parents University of Kentucky College of Pharmacy. This shows a and always being supportive wherever life took your chiltruly UNITED front for our profession in our state, and we dren. Thank you to the Kroger Company, and especially my have made Kentucky a leader in helping better our profesPharmacy Sales Manager Ron Huening for being here tosion and advancing it on behalf of this fine Commonwealth. night; Kroger has been my second home since I was 16 Henry Ford once said, “Coming together is a beginning; years old, and I appreciate them allowing me and all their keeping together is progress; working together is success.” employees to be advocates for the profession. Thank you We can be successful as long as we ALL work together. to all of my college professors and staff at UK: especially So what can you do? And this goes for pharmacists, stuDr. Frank Romanelli, Susan Jay, Gina Caldwell, and dent pharmacists and technicians. Be an advocate for Dwaine Green; you all helped push me both academically YOUR profession, whether it’s through time (like being at and professionally. A special thank you to a great friend this convention), monetarily donating (with membership, and colleague Justin Fink for being here tonight. I can’t tell government affairs or the PAC) or getting involved politicalyou how much it means to me personally that you made the ly yourself. We as pharmacists have been apathetic long trip here this weekend, thank you. Also special thank you to enough, and now is our time to get off that train and get some family friends and mentors, Pat Mattingly, Duane into the fight. We are all in this together and we must be Parsons and Steve Broering for making me believe that I UNITED as one voice to make ourselves be heard loud and could take on this role. And last, but not least, a huge proud. We want to HEAR from you, we need YOUR input. thanks to my better half, my wife Katy Clifton and my three Be PROUD of what you can do and don’t be afraid to children, Brady, Finley and Mallory. You have never once SHOW it. The stronger we are as one, the further this procomplained 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 profession is second to none. You are a wonderful wife and

I

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137th KPhA Annual Meeting & Convention

July/August 2015

Scenes from the

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137th KPhA Annual Meeting & Convention

July/August 2015

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From Your Executive Director

July/August 2015

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 ePatients, 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 certainly 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 contrasts, new combinations of every sort. ... The most familiar people stand each moment in some new relation to each other, to their work, to surrounding objects.”

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 newly reconstituted Pharmacy Technical Advisory Committee, of looking at the changes in Medicaid and how we can rethink 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 expansion of Medicaid whereby the total pharmacy benefit is approached almost $900b in Year 4 of the program (i.e., November 2013 to October 2014, remembering 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 Knowing you have a strong professional association like YOUR KPhA as your partner to help manage that change should be viewed within the historical perspective of “flux” given that it was a year of transition and reporting mechais essential. As pharmacists, pharmacy technicians, resinisms were being adjusted as the managed care system dents and student pharmacists all too readily know, change can and indeed does come from anywhere. In ad- approach was being implemented. What is missing from dition to the technology drivers, changes in federal or state this initial snapshot is the difference that pharmacists made on the quality side of the equation in terms of impolicy, changes in the governmental landscape, changes pacting quality outcomes. We are continuing to explore in the marketplace, changes in consumer needs, all are what differences have been made and/or are possible for having a dramatic impact on how you currently and will continue to provide patient care. Launched in 1852 in Phil- the immediate future. adelphia, the first national organization for pharmacists Speaking of change, the Foundation for a Healthy Kenwas the American Pharmaceutical (now Pharmacists) As- tucky recently released initial health data from its multisociation. Not long afterwards, Kentucky pharmacists unit- year initiative to study how the Affordable Care Act (ACA) ed in 1877 to assume leadership control of your profession is impacting Kentuckians. The Foundation is contracting through the creation of the Kentucky Pharmacists Associa- with the State Health Access Data Assistance Center, a tion. KPhA continues to be the “umbrella” organization in health policy research institute, at the University of Minnethe Commonwealth where all pharmacists can come tosota. While public and professional opinions remain sharpgether regardless of specialty area of practice. ly divided about the ACA, I think it behooves us to monitor its outcomes and impacts as a profession.

As you will recall, I joined YOUR KPhA as Executive Director in July 2011 at a time when the state had made a decision to transition from FFS to Medicaid Managed

Highlights of the initial health data snapshot that the Foundation released include: 6

THE KENTUCKY PHARMACIST

From Your Executive Director 

July/August 2015 moreover, to ensure that you have a place at the emerging model design for healthcare delivery in the coming years.

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 percentage point drop. During this time period, the national decline in uninsured was 4.2 percentage points.

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 Uncompensated hospital care, which reflects hospital sources also are increasing. At the federal level, the uncercare performed without payment, dropped substantially tain political climate has created an environment of unfundfor both urban and rural hospitals in Kentucky. ed mandates and untested payment models. It is crucial  Medicaid enrollment by region: 32 percent eastern that we UNITE as a profession. YOUR KPhA is committed Kentucky, 25 percent western Kentucky, 19 percent to being that strong voice for the profession and continuing greater Louisville, 16 percent greater Lexington, 8 per- to strengthen relationships with healthcare thought leaders cent northern Kentucky. at both the state and federal levels to develop win-win solu During the quarter, Medicaid funded 9,314 breast can- tions to eradicate the need for future reductions and to adcer screenings, 4,586 Hepatitis C screenings and thou- vance the contributions that pharmacists are prepared to make. Although there have been changes in KPhA over the sands of other preventive services.  Kentucky Silver plans were selected by the majority (52 years, one continuous dynamic has been the willingness of our members to play an active role in the leadership of the percent) of those on the kynect marketplace; 35-54 association and in its advocacy and professional practice year olds made up the largest kynect group. advancement efforts. This makes our association and the In yet another area of change and opportunity, Kentucky is profession stronger, and it gives it a more influential voice currently assessing its need for change in the healthcare when it comes to stating a position on change. If you are landscape in an initiative termed by CMS as “Where Innointerested in becoming more involved, I encourage you to vation is Happening.” In conjunction with its “State Innovacontact President Chris Clifton and myself to learn more. tion Models (SIM) Initiative”, CMS is currently working with We at the Kentucky Pharmacists Association know that the Cabinet for Health and Family Services to develop and there are future changes ahead for the profession of phartest new state-led, multi-payer healthcare payment and macy and those whom we serve. We are committed to service delivery models with the goal of improving health working with you and being your partner in working through system performance, increasing quality of care and deand directing those changes. On the base of Robert Aitcreasing costs for Medicare, Medicaid and Children’s ken’s sculpture, “The Future”—located outside the National Health Insurance Program (CHIP) beneficiaries. KPhA and Archives Building in our nation’s capitol—one can read, several of you as members have been participating in “What is past is prologue.”* As we assimilate these words, these discussions via structured workgroup and stakeholdwe are reminded that we must study the past in order to er meetings conducted by state healthcare officials. It is better anticipate and prepare for the future. crucial that we be involved in these planning efforts and related discussions in order to advance the profession and, *Shakespeare, W. The Tempest, Act 2, Scene 1.

ED as one, we can do anything; “sticks one by one may be readily broken, but cannot when several are bound together fession can go in the future. I guess my question is why in a bundle, UNITY gives strength.” Unless we as “sticks” wouldn’t you or anyone else give back to the profession that come together, we will be defeated. has afforded you so much in your lives? I know we are all Thank you again for your support, I look forward to hopefulbusy, 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 ly hearing from and seeing you all in the coming year.

Please let me, the KPhA staff or any KPhA board members and everyday, to give back to this profession and help its know if there is anything that you, as our MEMBER needs. continued future success for the students today and the We are here for our members and rely on your feedback students of tomorrow? There is, and I would ask for your and information to better YOUR association. Thank you so continued support to help build on these successes and much for your time and attendance here tonight, don’t forget growth of this profession. Go back and help US gain a member or two, and let’s make pharmacy the strongest pro- we have lots of great CE tomorrow, and I look forward to a fession in the state. As Kentuckians if we all STAND UNIT- great year for YOUR KPhA.

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APSC

July/August 2015

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2015 KPhA House of Delegates

July/August 2015

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 Closing Session throughout the Commonwealth gathered to discuss, debate The closing session took place Saturday. During this sesand make recommendations to not only shape YOUR sion recommendation of the reference committee were disKPhA, but also to push forward YOUR beloved profession. cussed and vote for Vice-Speaker commenced.

Opening Session Delegates Present: Total Delegates 64 The opening session was on Friday morning, delegates Reference Committee Recommendations and the action of were slated and annual reports of the association were prethe House are listed below. Each of the below were recomsented. mended for adoption by the Reference Committee.  Chair’s Report: Duane Parsons  Article 1 Section 1.111- 1st Tier Active Members. Pro President’s Report: Bob Oakley posed to change to New Practitioner 1st Year Active Members – Recommend adoption as presented. – Ap Treasurer’s Report: Glenn Stark by Duane Parsons proved .  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 percent Past Presidents, 5 percent APSC, 5 percent Academy Consultant Pharmacist, over 3 percent UKCOP, over 3 percent 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 discuss 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.

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Article 1 Section 1.112- 2nd Tier Active Members. Proposed to change to New Practitioner 2 nd Year Active Members—Recommend adoption as presented.— Approved.

Article 1 Section 1.112- Add New Practitioner 3rd Year Active Members—Recommend adoption as presented—Approved.

Article 1 Section 1.121- Non Pharmacist Spouse Associate Members. Proposed to eliminate Section 1.121 in its entirety—Recommend adoption as presented— Approved.

Article 1 Section 1.3- Suspension Reinstatement- Proposed 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 MembersProposed 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—

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2015 KPhA Professional Awards

July/August 2015

2015 KPhA Professional Awards

Larry Stovall, Scottsville, Bowl of Hygeia Award sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations, with support from Boehringer Ingleheim.

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)

Claire Love, Lexington, KPhA Pharmacist of the Year (Pictured with her parents, Buddy and Lucy Wheeler)

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2015 KPhA Professional Awards

July/August 2015

KPhA Meritorious Service Awards: Congressman Brett Guthrie, Bowling Green (Pictured with KPhA Executive Director Robert McFalls, KPhA 2015-16 President Chris Clifton, Board of Pharmacy President Joel Thornbury, 2014-15 KPhA Chair Duane Parsons, APSC Executive Vice President Ralph Bouvette, KPhA 2015-16 Chair Bob Oakley, KPhA 2015-16 President-Elect and Director of the Center for the Advancement 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.

Matt Carrico, Louisville, KPhA Excellence in Innovation Award sponsored by Upsher-Smith Laboratories, Inc.

Heather Daniels, Hazard, KPhA Technician of the Year Kerry Hettinger, Louisville, KPhA Professional Promotion Award 11

Cassandra Beyerle, Louisville, KPhA Distinguished Young Pharmacist of the Year, sponsored by Pharmacists Mutual Insurance

THE KENTUCKY PHARMACIST

137th KPhA Annual Meeting & Convention

July/August 2015

KPhA Would Like to Thank Our 2015 Sponsors Event Sponsors

KPERF Golf Hole 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

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

Sponsoring Pharmacy’s Future 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 APCI AmerisourceBergen APSC Astrazeneca BD Medical Cardinal Health CareSource Codonics Coventry Cares of Kentucky Dr. Comfort EPIC Pharmacies Fred’s Pharmacy Harmonyx Diagnostics

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

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

Annual Meeting Supporters Rx Systems, Inc. Medica Pharmacy and Wellness Center Bardstown-Bloomfield

… and our 2015 Exhibitors 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

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Increasing Access to Naloxone

July/August 2015

Increasing Access to Naloxone in our Communities: Implementation of Kentucky Senate Bill 192 Drug addiction and overdose are serious 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 medications. Between 2012 and 2013, heroin overdose deaths increased 39 percent.

Kentucky Board of Pharmacy. Once certified, they can work with a collaborating physician to develop a protocol agreement that stipulates the criteria for identifying eligible persons to receive naloxone under the protocol; the specific medications, doses and routes of administration the pharmacist is authorized to dispense; the education that must be provided to the person receiving the naloxone prescription; and the procedures for documenting the naloxone dispensation.

Trish R. Freeman, RPh, To address this growing public health crisis, Kentucky legislators passed com- PhD prehensive anti-heroin legislation on Clinical Associate March 25, 2015. Senate Bill 192 was Professor, the result of a conference committee University of comprised of key legislators from both Kentucky chambers and is commonly referred to College of as the ‘Heroin Bill.’ Although SB 192 Pharmacy addresses many different aspects of the KPhA heroin and opioid abuse problem, one President-Elect 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.

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 offense related to the possession of a controlled substance or the possession of drug paraphernalia if they seek medical assistance for a drug overdose.

Specifically, SB 192 amends KRS 217.186 to allow a licensed health care provider, acting in good faith, to prescribe 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.

Physicians and pharmacists should note that the new regulations relative to pharmacists initiating the dispensing of naloxone under a physician-approved protocol do not apply to individual, patient-specific prescriptions issued by physicians. Pharmacists can continue to dispense naloxone prescriptions written by physicians and other licensed prescribers without attaining naloxone certification.

SB 192 also includes a provision authorizing pharmacists to initiate the dispensing of naloxone under a physicianapproved protocol. To initiate the dispensing of naloxone in this manner — without an individual prescription - pharmacists must receive training in the use of naloxone for opioid overdose prevention and apply for certification from the

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 associated with opioid overdose by ensuring individuals in our communities have access to naloxone for rescue therapy during a suspected opioid overdose.

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.

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2015-16 KPhA Board of Directors

July/August 2015

New 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 Harrodsburg, 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.

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Happy Retirement!

July/August 2015

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 Kentucky 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 15

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June 2015 CE — Contractual Relationships

July/August 2015

Advancing Professional Practice by offers all CE Understanding the Basic Nature KPERF articles to members online at of Contractual Relationships www.kphanet.org 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.

2.

3.

4.

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

the agreement to another person, the offeree. This offer may be limited to just one person or it may be broadcast at The vast majority of people enter into multiple contractual large for acceptance by anyone, e.g., poster announcing a arrangements each day; pharmacists and pharmacy techni$25 reward for return of a lost pet. cians are no exception. Certainly some of those contracts are more significant or important than others but an under- The offer must indicate intent to enter into a contract. An standing of some of the basic principles of contract law can example of this rule coming into play occurs when someone position one to advance the profession and maximize ser- makes an offer as a joke. There is no contractual intent by vice to patients. the speaker, the offeror, so even if the offeree says the offer Some contracts relate to the professional aspects of phar- is accepted no contract will result. The offer also must have macy, e.g., collaborative care agreements, contracts with sufficient detail included that, if necessary, the essential facilities where patients reside, contracts to provide consult- terms of the contracts could be determined by a court. In ing services, etc., while others relate to business relation- one state the Medicaid agency was required by federal ships, e.g., employment contracts, leases, contracts with mandate to terminate the existing provider contracts with pharmacies. The state Medicaid agency then sent an offer insurance companies and suppliers, and on and on. of contract to pharmacy owner it wanted to sign up for the At the outset it is important to differentiate a contract from a program worded this way: “Provider will be paid a dispenspromise; a mere promise is not legally enforceable. In order ing fee to be determined at a later time.” That provision for a contract to exist there must be specific elements or lacks specificity – price is always an essential element of a components that come together in a certain way. Those contract – so it could not be the basis for a legally enforceaelements comprise the definition of a legally enforceable ble contact. The Medicaid agency needed to revise the offer contract: [1] an agreement [2] supported by consideration to add specificity. and [3] made for lawful purpose [4] between competent parOnce an offer has been extended to the offeree how long ties. Each of those elements will be discussed in turn. does it continue to be in play, i.e., be available for acElements - The Agreement ceptance? There can be several answers to that. First, if The possibility of a contract comes into existence when one the offeree declines the offer that kills it; the offer is no longperson, known as the offeror, extends an offer to enter into er in effect after rejection. If the offeror revokes the offer Introduction

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June 2015 CE — Contractual Relationships

July/August 2015

before it is accepted that will work to terminate the overture, but it should be noted that the termination only is effective when the offeree has indeed received the notification, not when it is dispatched. It also is permissible for the offeror to include a deadline for acceptance when communicating the offer and that will be effective. If no deadline was specified, the offer will lapse after a reasonable period of time.

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 otherwise 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 contract the employee is free to go work elsewhere. Should the pharmacist decide to continue working there that constitutes “doing something he or she is not otherwise bound to do.” So the employee pharmacist is providing consideration. When the employer extended the offer for the pharmaAcceptance of the offer must be communicated to the offe- cist to stay on, that is the employer “doing something he or ror and, as a general rule, silence cannot constitute ac- she is not otherwise bound to do.” ceptance. The offeror is not permitted to couch the offer in That same scenario also could be viewed as meeting the words that would make silence equal acceptance, e.g., second definition of consideration – refraining from doing “Unless I hear from you by ___ I’ll consider the offer ac- something that he or she has the right to do. The employee cepted.” An acceptance will be considered to be effective pharmacist who is at the end of the employment contract is when it has left the control of the offeree. Note that the noti- free to go work somewhere else. By staying on there, the fication of acceptance could be out of the control of the of- pharmacist is refraining from doing something – going to feree but not yet received by the offeror yet a contract has work elsewhere – that he or she has the right to do. Altercome into existence. For example, if you have extended an natively, from the employer’s perspective, the employer offer of employment to a pharmacist and she has placed also is refraining from doing something he or she has the her letter of acceptance in a mailbox this morning, then that right to do – hiring a different pharmacist. acceptance of your offer was effective when it left her hand In order for a contract to result from the agreement there and fell into the mailbox. must be consideration provided by both parties – it must be The assent to enter into the contract must be genuine. mutual; both parties must be obligated.

There can be no fraud, meaning no misrepresentation of a material fact which is known, or should be known, by the Application: Your pharmacy has been located in a small person making it, to be false and made with intent of induc- shopping mall for years. Recently a free-standing building ing the other party to enter into the contract. Further, there across the street came on the market and it is the right size must be no duress, meaning threat of force, or undue influ- and location to make relocating the pharmacy attractive.

The timing also is good because your lease with the owner ence, e.g., taking advantage of a confidential relationship. of the shopping mall expires in six months, enough time to Application: It’s been a rough day at the pharmacy so get the new location whipped into shape. You’ve been in you’re enjoying the change of pace that the meeting of the purchase negotiations with the owner of the building but the local pharmacy association represents. It’s a chance to owner of the shopping mall caught wind of the possibility catch up with friends who share your passion for the pro- that you might be departing. That would be a major blow to fession. You’re commiserating with a colleague about a the mall and its other business tenants because of the popparticularly difficult interaction you had with a patient today ularity of your pharmacy staff with a very loyal clientele. and your frustration surfaces when you say. “I’d sell my The owner of the mall offers to extend your lease with a ownership interest in the pharmacy for $10.” Your col- guarantee of no increase in the rental rate for 10 years plus league immediately brightens up and says, “I accept.” Do he’ll commit to resurfacing the pothole-laced parking lot you have a contract to sell your ownership interest in the within two years. If you accept that offer to remain where pharmacy? you have been do you have a contract?

But what if the offeree needs some time to settle on a response, 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 contract.

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June 2015 CE — Contractual Relationships

July/August 2015

Response: Yes, the owner of the mall is doing several things he is not otherwise bound to do so there is consideration on his side of the deal. If you accept and opt to remain in place after your current lease expires you are doing something you don’t have to do so you are providing consideration 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 contract present.

Elements - Made for Lawful Purpose The general rule in this area is that if a contract would violate 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 involving bribery of a public official.

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 education 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 pharmacist 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 contract 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 provision be enforceable if included in the contract of employment?

Response: In general, such a provision would be enforceable 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 enforceable, something that should be borne in mind both The law is rife with exceptions to rules and an exception to while entering into the agreement and employment relationthis rule is encountered relatively frequently in pharmacy. ship as well as for the future should thoughts of departing When an ongoing business concern, such as a community arise. pharmacy, is being sold, the seller often agrees not to comElements - Between Competent Parties pete with the purchaser. That’s because included as an element of the purchase price is something known as Parties entering into a legally enforceable contract must “goodwill.” Goodwill has a dollar value because it repre- have legal capacity to do so. One who lacks legal compesents the value of purchasing an ongoing business with an tence to make the contract may later avoid the obligations established clientele as opposed to starting a business contained in the contract. Minors under the age of 18 are from scratch. Such an agreement or provision in the con- generally considered to lack legal competence. Other catetract of sales is known as a noncompetition clause. Collo- gories of individuals deemed to lack legal capacity to enter quial terminology is often used that refers to this as a “non- into contracts are insane persons or those intoxicated with compete.” alcohol or other drugs that can impair judgment. The legal test that is used is whether the person’s mental state is The provision specifies that the seller will refrain from doing such that he or she is not aware of what they’re doing. anything to recapture that goodwill that has just been sold, e.g., opening a competing pharmacy across the street. Or- Application: A young woman in your community known to dinarily such an agreement would be contrary to public poli- you through youth athletics and other events comes to the cy because it restrains trade, a violation of the antitrust pharmacy to present a prescription for oral contraceptives. laws. Nonetheless, if the terms of the noncompetition Before presenting it she asks whether she can trust you to clause are reasonable with regard to the locale covered, preserve her personal health information, even from her the activities covered and the duration of the prohibition, parents. You ask her age and learn that she is 17. You then it will be legally permissible and enforceable.[2] An agree to the confidentiality and proceed to prepare the attorney should be consulted to assess the reasonableness medication for dispensing. You take it out to her and comof those provisions. plete the patient counseling appropriate for a first-time user

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June 2015 CE — Contractual Relationships

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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 assumed 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.

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 estate is considered by the law to be unique, specific performance is available should one of the parties breach a contract for sale of real property. Interestingly, courts also have applied this remedy when enforcing the noncompetition clause discussed above under “Elements – Made for Lawful Purpose.”

Application: With the same facts as existed for the Application 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 considering all these expressions of interest you want to factor in that non-compete clause to which you agreed when accepting your current position. Could your current group go to court to seek a court order preventing you from working for either potential employer?

The most commonly encountered form of legal remedy is compensatory damages. That is a measure of monetary damages designed to compensate the non-breaching injured party by placing him or her in as good a position as he or she would have been if the contract had been performed. 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.

Response: An offer from the medical group in the adjacent An alternative form of legal damages encountered with cer- county could be problematic. If the decision is to pursue tain types of contracts is liquidated damages. This form of that offer your current employer may well have available damages is agreed on by the parties at the outset of the the equitable remedy of specific performance to enforce arrangement; if either party breaches the contract the your non-compete agreement with them. However, the amount of damages to be paid is specified in the terms of same would not be true with the offer from the medical the contract. The amount of liquidated damages must be group 50 miles away. Presumably the wording of your nonreasonable to be enforceable. This form of damages is competition clause is not that geographically extensive so it commonly encountered in construction contracts where would not apply. time is very important. An example would be where a pharmacy owner is entering into a contract with a builder to construct a new pharmacy building and wants to have the project 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 beyond 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 jurisprudence developed in England to supplement the law by creating flexibility in crafting remedies in areas where the common law is very inflexible. As a general rule, the only remedy 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

Defenses Against an Allegation of Breach If you are on the receiving end of an allegation that a contract 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 addresses whether a contract is legally enforceable are contained in the Statute of Frauds. This doctrine has its roots in England in 1677. The Statute of Frauds was enacted to prevent people from coming into court to claim existence of a contract when in fact none existed. The Statute of Frauds requires 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

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June 2015 CE — Contractual Relationships

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circumstances, for example:

Response: Not good is the short answer. If one agrees to pay the debt of another that must be in writing to be en A promise to pay the debt of another; [3] forceable. Without a written contract, children have no legal  Agreements for the sale of real estate or an interest in obligation to cover the financial obligations of a parent. real estate, including a lease for more than one year; Conclusion [4] Contacts and principles of contract law are extremely per Agreements not to be performed within one year from vasive. Think of all the times you’ve dropped money into a their making [5]; and vending machine to purchase something, thereby entering  Agreements for the sale of personal property with a into a sales contract with the owner of the machine. Convalue in excess of $5,000 [6]. sider all the aspects of your life governed by contractual Another approach that may be available lies in a rule of arrangements – where you live, where you work, where evidence known as the Parol Evidence Rule. If a written you dine, and on and on. The same is true for a wide variecontract prepared at the conclusion of negotiations exists ty of professional relationships. Understanding some of the that covers all material terms of an agreement, a court will basic principles of contract can facilitate steering around not permit evidence or oral testimony to be introduced that potential legal entanglements and position pharmacists to shows terms in addition or at variance with those in the use all their abilities to benefit patients. 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 lawsuit. Several examples exist in Kentucky law:

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 professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.



Claims based on a contract must be brought within 10 years [8];



Lawsuits based on a sales transaction must be commenced within four years [9]; and



An allegation of professional negligence must be initiat- References ed within one year [10].

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

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 expenses. 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 outstanding balance due. What are your chances of prevailing in such a legal action?

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.

Donate online to the Kentucky Pharmacists Political Advocacy Council!

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

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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.

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.

2. The individual extending an offer to enter into a contract is known as the: A. Offender.

B. Offeree.

C. Offeror.

D. Contractor.

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.

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.

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.

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.

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.

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.

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June 2015 CE — Contractual Relationships

July/August 2015

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

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 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. 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.

Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) 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 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. 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.

Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) 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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Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.

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Pharmacy Quality/PTCB

July/August 2015

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July 2015 CE—Companion Animal Medications

July/August 2015

Companion Animal Anti-Inflammatories and KPERF offers all CE Analgesics Dispensed Through articles to members online at Retail Pharmacies www.kphanet.org 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) Introduction Several human anti-inflammatories and analgesics are more often being prescribed by veterinarians to be dispensed 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 antiinflammatories (NSAIDs), but will focus more on common opiates that are referred from veterinarians to retail pharmacies. Also included is a discussion of indications and effects for corticosteroids referred as pet prescriptions. Although 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 accustomed 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 dispensing dog or cat anti-inflammatories and analgesics should also realize that the display of beneficial and adverse 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 24

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 concerns that the pharmacy staff is not comfortable answering, or if the pharmacy staff themselves have questions regarding 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 analogues 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.

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July 2015 CE—Companion Animal Medications

July/August 2015

Dogs also may chew, lick or bite themselves excessively.

They may show a sudden drop in appetite and/or breathe abnormally. Limping is a give-away for orthopedic pain.

Dogs also seem to know to communicate directly with an owner by vocalization or whining. Dogs obviously cannot say they feel nausea; but excessive salivation is a strong indicator.

Cats display pain more subtly. They drool when experiencing stomach or mouth pain. They take longer to aim a jump or jump and miss because of back pain. Like dogs, fur licking, 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 indirect pain-reducing effect by reducing pro-inflammatory molecules and tissue swelling. NSAIDs will not be broadly covered in this article since veterinarians often prescribe animal-specific agents such as carprofen (trade named Rimadyl) or the COX-2 selective deracoxib (Deramaxx) from their hospital pharmacy. However, acetaminophen and the oxicams — meloxicam and piroxicam — will be briefly discussed.

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 especially sensitive to acetaminophen induced methhemoglobinemia 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 oxidation results from metabolites of acetaminophen.3 The oxidized 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 approved 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 significantly less than for humans.

Since meloxicam tablets available for humans are most likely too high in strength for most dogs, a typical pharmacy referral would be for the oral suspension. This oral suspension 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 Although 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 prescription for Feldene may need to be counseled in the context 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 application on humans. Although dogs may be prescribed flurbiprofen ophthalmic solution, it is not indicated for topical or systemic use in dogs or cats. The Food and Drug Administration’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

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July 2015 CE—Companion Animal Medications 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 applying flurbiprofen cream to avoid contact that exposes cats.

Opioid Analgesics Referred to Retail Pharmacies Tramadol (Ultram, ConZip, Theratramadol) is an opioid analgesic. It is a relatively weak opiate, but a metabolite nonopiate effectively suppresses pain. It is used for pain relief associated with canine arthritis, cancer or following assorted types of soft tissue surgery in the dog.9 It is synergistic with NSAIDs, although tramadol is often used in place of NSAIDs. Tramadol provides an example of the relatively larger comparative dosing of many human drugs in dogs. An adult person 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 technicians 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 constipation to a variety of laxatives and stool softeners, for dogs 12 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 Ultracet (tramadol plus acetaminophen) should not be made.

July/August 2015 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 combined product with homatropine methylbromide to discourage 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 unacceptable risk of toxicity for dogs. A substitution of hydrocodone/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 control postoperative pain; although, since it takes 12-24 hours for full effect, the dog would have previously received an analgesic, such as parenteral opiates. The patch also can be used preoperatively 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 appropriate.11 In humans, patches at levels of >50 mcg/hour are typically placed on patients already tolerant to opioid therapy. The client should be warned that their pet may demonstrate marked behavioral effects such as hyperactivity, hyHydrocodone (Tussigon, Hycodan) is an opioid pain medi- per-responsiveness to external stimuli, panting, defecation cation that can be prescribed to treat mild to moderately and hypersalivation. They also may experience decreases severe pain and cough in humans and cough in dogs.10 in respiration rate, heart rate and temperature. The drop in Often, the indication is for dry kennel cough, which is a breathing is most problematic and may warrant consultacombination bacterial and viral infection, or chronic bronchi- tion with the prescribing veterinarian. The client may notice tis. In addition, it may be used to manage the cough associ- listlessness and general lethargy. Alternatively, a sense of ated with tracheal collapse. Hydrocodone acts to directly euphoria may promote either excessive eating (until vomitsuppress the cough center in the medulla oblongata. Poing) or anorexia depending on the dog. tential adverse effects are most commonly sedation, but Gabapentin As an Analgesic also include constipation or vomiting. Cats are seldom administered hydrocodone as they are sensitive to opiates in Gabapentin (Neurontin) is a gamma amino butyric acid general. As with tramadol, the dosing for dogs will seem (GABA)-analogue that acts in the central nervous system.

26

THE KENTUCKY PHARMACIST

July 2015 CE—Companion Animal Medications

July/August 2015

In humans, it is indicated for treatment of postherpetic neuralgia and as an adjunct for partial onset seizures.12 In dogs, it is being commonly prescribed for therapy of chronic 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 stopping the drug. To verify pain-reducing efficacy, the client should follow up with the veterinarian.

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 vasopressin (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 morning when the client leaves for work/school. If so, the cortiIntermediate-Acting Glucocorticoids: Comparative costeroid should not be administered in the morning.

Dosing and Effects Methylprednisolone could be recommended as an alternaCorticosteroids such as prednisone, methylprednisone and tive to prednisone/prednisolone as it causes less PU-PD; prednisolone are administered to relieve immune-mediated however, it is more expensive. If corticosteroids are adminconditions.14 In dogs and cats, systemic glucocorticoids istered long term, pets can develop behavioral changes; such as prednisone and prednisolone can be administered iatrogenic hyperadrenocorticism (Cushing’s syndrome); at one of 3 dose levels: anti-itch (anti-pruritic) ≈0.5 mg/kg/ adrenal suppression; infections, or parasitic diseases. Corday; anti-inflammatory ≈1.0 mg/kg/day; and immunosupticosteroid use also is associated with one adverse effect pressive ≈5.0 mg/kg/day. Dosing may be doubled and giv- that is unique to dogs and cats: when used concomitantly en every other day to reduce adrenal suppression. This is with NSAIDs, corticosteroids are associated with a signifian example of a class of human drugs used commonly for cant risk of gastrointestinal ulcers/perforations.15 Therefore, pets that is often administered by a different route (orally to these two types of anti-inflammatories are rarely combined; a dog/cat) than it would be to a person (topically) with a rather they should be separated by 3 to 5 days. Also, when similar disease condition such as cutaneous pruritus. Oral transitioning off a corticosteroid and onto an NSAID, some corticosteroids are prescribed for humans as an escalation veterinarians believe it is of benefit to co-administer overup from topical use if topical application cannot be effecthe-counter omeprazole (approximately 0.7 mg/kg once a tive. In dogs and cats, because of the presence of hair, cor- day or 1 x 20mg tablet for a 25 kg dog) with the NSAID to ticosteroids are often prescribed by systemic administrareduce the potential for gastritis. tion. If a topical rinse or lotion alone was effective, these Cats should receive only prednisolone and not prednisone, would likely have been dispensed directly by the veterinaribecause many cats cannot metabolically convert the proan. drug prednisone to the active prednisolone. Cats display In pets, systemic administration of corticosteroids may be fewer adverse reactions to corticosteroids. used to manage seasonal atopic dermatitis (“atopy”) which Conclusion is an allergic dermatitis if it is refractory to more conservative therapies. Oral glucocorticoids are inexpensive, work Along with antimicrobials, veterinary referrals of analgesics rapidly, are easily administered and reach large areas of and anti-inflammatories to retail pharmacies are becoming the dermis through systemic circulation more readily than a more commonplace. Although the pharmacist or pharmacy topical steroid will penetrate through the hair and epidertechnician should not replace the counseling of the premis. For atopic itching, a 25 kg dog would start at an antiscribing veterinarian, they should be able to discuss with inflammatory dose, then taper down to the anti-pruritic. A clients the general indications, doses and effects — both 25 kg dog could receive 50 mg every other day, which therapeutic and adverse, of drugs dispensed for dogs and would fit within a dose for a 70 kg adult person. cats. By distinguishing the aspects of analgesic and antiMethylprednisolone has a slightly longer half-life than pred- inflammatory agents that people and pets share and differ nisolone and is prescribed at 80 percent of the prednisone/ in, the pharmacy staff will optimize client communication prednisolone dose. and maximize animal patient care.

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THE KENTUCKY PHARMACIST

July 2015 CE—Companion Animal Medications

July/August 2015 Prescription Topical Pain Medications Containing Flurbiprofen http://www.fda.gov/AnimalVeterinary/NewsEvents/ CVMUpdates/ucm443333.htm

References 1. Client Information Sheets (CIS) of human drugs dispensed in retail pharmacies for pets. https://sites.google.com/site/vetpharmcis/

9. A CIS for tramadol can be found at https://sites.google.com/site/vetpharmcis/tramadol

2. Onsior. Symptoms that your cat may be in pain after surgery. http://us.onsior.com/supporting-recovery/cat-pain10. A CIS for hydrocodone can be found at symptoms.html https://sites.google.com/site/vetpharmcis/hydrocodone 3. McConkey SE, Grant DM, Cribb AE. The role of paraaminophenol in acetaminophen-induced methemoglobinemia in dogs and cats. J Vet Pharmacol Ther. 2009, 32 (6):585-95.

11. The Merck Veterinary Manual. http://www.merckvetmanual.com 12. Neurontin. Drugs.com http://www.drugs.com/pro/neurontin.html

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

13. Crociolli GC, Cassu RN, Barbero RC, Rocha TL, Gomes DR, Nicácio GM. Gabapentin as an adjuvant for postoperative pain management in dogs undergoing mastectomy. J Vet Med Sci. 2015 epub.

6. Calculations based on 0.1 mg/kg toxicity for xylitol. 0.2 mg/kg dosing with a 7.5 mg/ml suspension.

14. A CIS for prednisone/prednisolone: https:// sites.google.com/site/vetpharmcis/prednisone-prednisolone

7. Alkan, FU, Ustüner O, Bakırel T, Cınar S, Erten G, Deniz G. The effects of piroxicam and deracoxib on canine mammary tumour cell line. Scientific World Journal. 2012, Article 976740.

15. Dowling P. Corticosteroid & Nonsteroidal Antiinflammatory Drug Interactions. NAVC Clinician’s Brief. March 2011, pp. 89-92. http://www.cliniciansbrief.com/sites/default/files/ sites/cliniciansbrief.com/files/complications.pdf

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

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

The following broad guidelines should guide an author to completing a continuing education article for publication in The Kentucky Pharmacist.  

  



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.

Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).  When submitting the article, you also will be Articles are generally written so that they are perasked to fill out a financial disclosure statement to tinent to both pharmacists and pharmacy techniidentify any financial considerations connected to cians. If the subject matter absolutely is not pertiyour article. nent to technicians, that needs to be stated clearly Articles should address topics designed to narrow at the beginning of the article. gaps between actual practice and ideal practice in Article should begin with the goal or goals of the overall program – usually a few sentences.

pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see Include 3 to 5 objectives using SMART and meas- previously published articles. urable verbs.

Articles must be submitted electronically to the KPhA director of communications and continuing education Feel free to include graphs or charts, but please submit them separately, not embedded in the text (ssisco@kphanet.org) by the first of the month preceding publication. of the article.

28

THE KENTUCKY PHARMACIST

July 2015 CE—Companion Animal Medications

July/August 2015

July 2015 — Companion Animal Anti-Inflammatories and Analgesics Dispensed Through Retail Pharmacies 1. If a client poses questions or concerns that the pharmacy staff is not comfortable answering, what is the best option?

A. Refer the client to the Wikipedia.

B. Refer the client to 1800petmeds.

C. Give the pet client your best guess.

D. Refer the client back to their veterinarian.

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).

2. Dogs are generally more demonstrative of their pain than cats.

A. True B. False

10. It would be appropriate to substitute Hydrocodone Bitartrate and Acetaminophen Oral Solution for Hydrocodone Bitartrate and Homatropine methylbromide syrup.

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

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.

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.

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.

8. Gabapentin (Neurontin) is prescribed in dogs for therapy of: A. Chronic arthritis pain.

B. Postherpetic neuralgia.

C. Inflammation.

D. Flea allergies.

Send Potential CE topics to Scott Sisco at ssisco@kphanet.org 29

THE KENTUCKY PHARMACIST

July 2015 CE—Companion Animal Medications

July/August 2015

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

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 2. A B 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B

11. A B C D 12. A B C D

13. 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.

Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) 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 2. A B 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B

11. A B C D 12. A B C D

13. 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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30

Quizzes submitted without NABP eProfile ID # and Birthdate will not be accepted.

THE KENTUCKY PHARMACIST

August 2015 CE—Andropause

July/August 2015

Andropause: Benefits and Risks of “Low T” Therapy

KPERF offers all CE articles to members online at www.kphanet.org

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.

Among men, there has been a growing concern over testosterone levels and the prospect of having justified “low T.” This growing concern has led to a 3fold increase in androgen use in men with a mean age of greater than 40 years (0.81 percent in 2000 to 2.91 percent in 2011).1 In 2009, over $1 billion Figure 14: Prevalence of Low Levels of was spent on tesAccording to Decade of Life tosterone therapy in the United States, all promising improved sexual function, muscle mass and improved mood.2 Because of this aggressive marketing, the use of testosterone therapy should be evaluated, considering the lessons learned during the Women’s Health Initiative and the adverse effects associated with hormone therapy in post-menopausal women.

cent of men in their 60s have biochemical evidence of androgen 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 Total and Bioavailable Testosterone 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 associated with low testosterone levels and elevated luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels, secondary (hypogonadotropic) hypogonadism, which is associated with low testosterone levels and normal LH levAndropause or “male menopause” is postpubertal hyels, hyperprolactinemia and pituitary disorders (Table 1). pogonadism or late-onset hypogonadism. The mainstay of Additionally, several agents may be associated with low treatment for hypogonadism includes androgen therapy, circulating testosterone (Table 2).5 specifically testosterone. The loss of testosterone is a slowly evolving process in which men lose testosterone at a Testosterone is synthesized from cholesterol in the Leydig rate of 1 percent per year after the age of 30.3 Twenty per- cells and is formed from androstenedione secreted by the

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THE KENTUCKY PHARMACIST

August 2015 CE—Andropause

July/August 2015

Table 1: Hypothalamic-Pituitary Gonadal Axis Defects

5



Primary Hypogonadism



Secondary Hypogonadism



Hyperprolactinemia



Pituitary Disorders



Testicular Disorders





Hemochromatosis





Leydig Cell Hypoplasia

Gonadotropin-releasing hormone (GnRH) Deficiency





Neurosarcoid

Isolated LH Deficiency

Isolated GnRH Deficiency

Myotonic Dystrophy



Tumors





Prader-Willi Syndrome

Prolactinoma



Pituitary Infarction





Lawrence-Moon-Bardet Biedl Syndrome



Medications



Empty Sella Syndrome



Alstrom Syndrome



Hemochromatosis



Fertile-Eunuch Syndrome



Cranial Trauma



Familial Cerebellar Syndrome



Irradiation



Hypophysitis



Testicular Unresponsiveness



Androgen-Resistant States and Enzyme Defects



External Testicular Insults



Autoimmune Syndromes



Sertoli-Cell Only Syndrome

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

adrenal cortex. In the Leydig cells, LH initiates the production of pregnenolone, which is hydroxylated in the 17 position by 17α-hydroxylase to form dehydroepiandrosterone (DHEA). DHEA is rapidly converted to testosterone via androstenediol and androstenedione.

Diagnosis In addition to the classical signs and symptoms of low testosterone, laboratory measurements of sex hormonebinding 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 testosterone in circulation is 2 percent free testosterone, 30 percent tightly bound to SHBG and 68 percent weakly bound to albumin.8

As noted previously, testosterone decline is essentially a process of aging for males. As men age, there is an agerelated 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 The normal ranges for total and free testosterone in healthy of testosterone.3 Overall, this decline in testosterone causyoung men vary among laboratories and assays; therefore, es an increase in serum gonadotropin, FSH and LH resultthe lower limit of normal should be established based on ing from negative feedback on the hypothalamus. the laboratory used. In general, laboratories consider the This decline in testosterone is a slow process which can lower limit of normal testosterone in healthy young men to cause subtle clinical signs and symptoms. Andropause will be 280 to 300 ng/dL.6 For those patients with exceedingly typically present as a loss of libido, sexual dysfunction or low levels of testosterone (less than 150 ng/dL), the Ameriimpotence, progressive decrease in muscle mass and can Association of Clinical Endocrinologists (AACE) guidestrength, fatigue, hot flashes, depression and other mood lines suggests pituitary imaging even in the absence of othdisorders and poor ability to concentrate.6 Furthermore, er signs and symptoms.8 In order to obtain the most accuone or more of the signs and symptoms may be present rate measure, total testosterone should be measured besimply due to aging, despite serum testosterone levels re- tween 0800 and 1100, when testosterone levels are peakmaining within normal limits.7 For example, if a man is ac- ing in healthy young men. For men with advancing age or customed to a serum testosterone level in the higher to who are already receiving certain testosterone replacement normal range, reduction to a lower level, (even though it is therapy, the circadian rhymicity of testosterone may be destill normal) may no longer be sufficient to maintain well- stroyed or suppressed; therefore, testosterone levels could being.3 be misleading.5 There has not been any additional recom-

32

THE KENTUCKY PHARMACIST

August 2015 CE—Andropause Table 2: Agents That May Cause Low Testosterone 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

July/August 2015 5

term effects of testosterone replacement therapy are unclear. Testosterone therapy has been associated with increased risks of cardiovascular events, polycythemia, venous and arterial thromboembolisms and increased risk of prostate cancer. Most recently, the FDA announced a new warning that is required on all testosterone products related to the risk of venous blood clots. As of January 2014, the FDA has been evaluating the potential risk of cardiovascular events (myocardial infarction, stroke and death) related to blood clots in the arteries of men using testosterone 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  Reduce gonadotropin secretion therapy. Of note, cardiovascular-related events varied with source of funding. Overall, trials not funded by the pharmamendations for a time in which testosterone levels should ceutical industry, demonstrated that exogenous testosbe drawn in older men. terone increased the risk of cardiovascular-related events (OR 2.06, 95 percent CI, 1.34 to 3.17 vs OR 0.89, 95 perBenefits of Therapy cent CI, 0.5 to 1.6).13 The main goal of therapy is to not only improve symptoms, but also to improve quality of life. Reports have suggested Another worry associated with testosterone therapy inpositive effects on mood, increased sense of well-being cludes an increase in prostatic disease such as benign and increased energy. Smaller studies have shown in- prostatic hyperplasia (BPH) and increased risk of prostate creases in lean body mass, decreases in body fat, increas- cancer. Studies have demonstrated a slight increase in es in muscle size and increases in weight. Most men are prostate-specific antigen (PSA) levels, but it has not been typically prescribed testosterone to help improve erectile concluded that there is a clear association3 with an indysfunction, especially since 36 percent of men with erec- creased risk in prostate cancer occurrence. Other comtile dysfunction have low testosterone.9 Increased libido mon side effects include acne, mild fluid retention, breast and sexual function have been associated with testos- enlargement, worsening sleep apnea and decreased testicterone therapy in smaller studies based on self-reported ular size. parameters.10 Conversely, a randomized trial of 140 men Comorbid Conditions with low testosterone levels (less than 330 mg/dL), demonWith rates of diabetes rising in the United States to approxstrated that adding testosterone to sildenafil therapy did not imately 9 percent of the population, rates of low testosimprove erectile function.11 terone are bound to increase as well. Based on data found Although many times testosterone therapy is associated in the HIM study, a man with diabetes (specifically Type 2 with negative effects on cardiovascular health due to DM) was approximately twice as likely to be hypogonadal 14 changes in the lipid profile, there is evidence to support compared with a man without diabetes. Overall hyimprovement in cardiovascular health. Improvements were pogonadism prevalence was estimated to be between 3315 seen in the direct arterial vasodilatory effect and prolonga- 50 percent for men with diabetes. Based on gonadotropin tion of time until ischemia with exercise. Another study levels, this can be considered secondary hypogonadism. demonstrated that there were no deleterious changes in Unlike other diabetes complications, there is no relation cholesterol profiles, even showing improvement in total between the degree of hyperglycemia and testosterone cholesterol in older men treated with testosterone.3 Overall, concentration. Interestingly, patients with diabetes and hywithout any large, long-term placebo controlled trials, the pogonadism were found to have increased C-reactive probenefits associated with testosterone are still debatable tein, anemia, increased adipose tissue and low bone mineral density (BMD).16,17 Finally, it was observed that prosand should be considered on a patient by patient basis. tate-specific antigen (PSA) is significantly lower in Type 2 Risks Associated with Therapy DM patients as a result of their lower plasma testosterone The biggest controversy surrounding testosterone therapy concentrations.18 Data from the NHANES III survey is the associated risks. Based on current data, the long- showed that men in the lowest free testosterone percentile 33

THE KENTUCKY PHARMACIST

August 2015 CE—Andropause Dosage Form Oral Preparations

Parenteral Preparations

July/August 2015

Chart 1-Available Testosterone Products Agent Dosing Fluoxymesterone (Androxy ®)

5 to 20 mg once daily

Methyltestosterone (Android®, Methitest®, Testred®)

10 to 50 mg once daily

Testosterone cypionate (DepoTestosterone®)

Cypionate and Enanthate: 50 to 400 mg IM every 2-4 weeks

Testosterone enanthate (Delatestryl®)

Transdermal Patch

Transdermal Gels and Solution

    

Variable Response Adverse lipid changes Hepatotoxicity Self-administration Immediate discontinuation

  

Fluctuations in testosterone levels Injection site reactions/pain Aveed®- REMS program required potential for pulmonary oil microembolism reactions and anaphylaxis Excessive erythrocytosis



Testosterone undeconoate (Aveed®)

750 mg IM once, repeat at 4 weeks, then every 10 weeks

Androderm®

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



50 mg once daily applied to shoulder, upper arms, or abdomen. May increase to 100 mg.

 

AndroGel ®1 percent

AndroGel®1.62 percent

40.5 mg (2 pumps) applied once daily in the morning to shoulders and upper arms. Max dose-81 mg/day.

Fortesta®-2 percent

40 mg (4 pumps) once daily applied in the morning to thighs. Max dose is 70 mg each day.

Testim®-1 percent

50 mg one daily applied to shoulders or upper arms. May increase to 100 mg if needed

Axiron®-2 percent (Solution)

Comments

 

 

Mimics normal testosterone level changes Skin irritation may occur May require multiple patches 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

60 mg (2 pumps) applied to underarm each morning. May increase to 120 mg daily.

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THE KENTUCKY PHARMACIST

August 2015 CE—Andropause

July/August 2015

Pellet

Testopol ®

150-450 mg  subcutaneously  every 3 to 6 months 

Buccal Preparation

Striant®

One buccal tablet every 12 hours

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

   

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.

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 exercise.20 Central obesity, hypertension, reduced HDL, elevated triglycerides 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 surprising that hypogonadism is associated with metabolic syndrome. Low testosterone levels increase fat mass and decrease 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 levels.

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 dosage forms, agents and dosing of testosterone products.

There are over-the-counter andropause formulas that include natural products such as vitamin E, zinc, niacin, Larginine, yohimbe, ashwagandha, maca and gingko biloba.

Yohimbe hydrochloride has been demonstrated in various clinical trials to be effective in the treatment of erectile dysfunction 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 inflammation, prevention of the effects of aging and infertility have all Another strong association with androgen deficiency occurs been seen. One study of 150 men, showed decreased oxiwith AIDS wasting syndrome. Testosterone therapy in HIV- dative stress and improved indicates of semen quality inpositive hypogonadal men increases lean body and muscle cluding testosterone, LH, FSH and prolactin levels.22 mass and perceived well-being, and decreases depression.

Around 20-50 percent of HIV-infected men receiving an- Maca acts to help with energy, stamina, athletic perfortiretroviral therapy are hypogonadal. This hypogonadism is mance and male infertility. Typical doses include 1.5 to 3 most likely resultant of lipodystrophy induced by anti- gm per day orally. Preliminary evidence from an unconretroviral medications, testicular atrophy caused by oppor- trolled trial of males taking 1.5-3 gm daily for 4 months tunistic infection, and disruption of the HPG axis resulting showed increases in semen volume, sperm count and sperm motility in healthy men age 22 to 44 years. One othfrom malnutrition.21 er study of men age 21 to 57 years received 1.5-3 gm daily Treatment for 12 weeks showed an increase in sexual desire. 22 Before It is highly debated on when to initiate a patient on testos- making an overall recommendation for these products, terone therapy. Some experts suggest treating symptomat- pharmacists should assess all available studies, quality of ic, older men with testosterone levels below the lower limit the product, drug interactions and side effects. of normal for healthy young men (300 ng/dL), while others recommend levels less than 200 ng/dL. A general consensus was made that patients with testosterone levels less than 230 ng/dL will usually benefit from testosterone treatment. If levels are between 230 ng/dL and 350 ng/dL, repeat testing may be beneficial.10

Monitoring With each testosterone product available, monitoring of testosterone differs. For example, Striant® suggests monitoring testosterone levels 4 to 12 weeks after initiation while Testopol® recommends checking testosterone levels at the

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THE KENTUCKY PHARMACIST

August 2015 CE—Andropause end of the dosing interval. The Endocrine Society recommends monitoring testosterone levels three to six months after initiation of testosterone therapy. 6 Other options for monitoring include checking serum testosterone levels midway 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 monitored at baseline as well, then every 3 to 6 months in the first year and then annually according to the Endocrine Society.6 Liver function tests, hemoglobin and lipid panels also should be performed periodically during therapy.2 Although currently not recommended, there has been suggestions for baseline screenings for Factor V Leiden, prothrombin mutations and homocysteine, to assess thromboembolic risk.1 Patient Education Key points to highlight when educating patients vary depending 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 application to avoid transferring the gel to others. Women and children 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. Application sites should be rotated, allowing seven days between applying to the site. Mucoadhesive for buccal application should be applied to a comfortable area above the incisor tooth. Hold in place for 30 seconds to ensure adhesion 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 dosing, a new adhesive should be placed for a total of 12 hours from the placement of the first mucoadhesive. Patients should never chew or swallow the mucoadhesive and it should be removed 12 hours after application, for it will not dissolve.

July/August 2015 Patients also should be informed that testosterone is a controlled 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 testosteronetreated 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 assessed testosterone therapy with major adverse cardiovascular 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 therapy is not associated with an increased risk of MACE in men with well-characterized coronary artery disease.25 Another study obtained records from a large communitybased healthcare system to examine effects of testosterone therapy on cardiovascular outcomes (acute myocardial 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 between initiation of testosterone therapy and either thrombotic (4.5 months) or cardiovascular events (3 months), suggesting a shared pathophysiology.1 Currently, there is a large-scale multicenter randomized, double blind placebocontrolled trial conducted by the National Institute of Aging 36

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August 2015 CE—Andropause

July/August 2015

examining the effect of testosterone therapy in older men EAU, EAA, and ASA recommendations: investigation, (NCT00799617). This study is composed of seven different treatment and monitoring of late-onset hypogonadism trials each with primary outcomes related to physical funcin males. Aging Male. 2009(1):5-12. tion, vitality, cognitive function, cardiovascular disease, 11. Spitzer M, Basaria S, Travison TG, et al. Effect of tesbone density and anemia. There is hope that this study can tosterone replacement on response to sildenafil citrate help to draw conclusions towards the benefits or risks assoin men with erectile dysfunction: a parallel, randomized ciated with testosterone therapy. Until we have conclusive trial. Ann Intern Med. 2012;157(10):681-691. evidence, testosterone therapy should be appropriately 12. FDA/Drug Safety and Availability resource page. Food assessed before initiation. and Drug Administration Web site. http://www.fda.gov/ References drugs/drugsafety/ucm401746.htm. Published June 19, 1. Glueck CJ and Wang P. Testosterone therapy, throm2014. Accessed Nov. 15, 2014. bosis, thrombophilia, cardiovascular events. Metabo13. Xu L, Freeman G, Cowling BJ, et al. Testosterone therlism. 2014;63(8):989-994. apy and cardiovascular events among men: a system2. PL Detail-Document. The use of testosterone and the atic review and meta-analysis of placebo controlled aging male. Pharmacist’s Letter/Prescriber Letter. Ocrandomized trials. BMC Medicine. 2013;11:108. tober 2013.

14. Mulligan T, Frick MF, Zuraw QC et al. Prevalence of 3. Brawer MK. Testosterone replacement in men with anhypogonadism in males aged at least 45 years: the dropause: an overview. Rev Urol. 2004;6 Suppl: S9HIM study. Int J Clin Pract. 2006;60(7): 762–769.

S15.

15. Dhindsa S, Prabhakar S, Sethi M, et al. Frequent oc4. Rhoden E and Morgentaler A. Medical Progress: risks currence of hypogonadotropic hypogonadism in type 2 of testosterone-replacement therapy and recommendadiabetes. J Clin Endocrinol Metab. 2004;89(11): 5462tions for monitoring. N Engl J Med. 2004; 350(5):4825468.

492.

16. Bhatia V, Chaudhuri A, Tomar R et al. Low testos5. Seftel A. Male hypogonadism. Part II: etiology, pathoterone and high C-reactive protein concentrations prephysiology, and diagnosis. Int J Impot Res. 2006;18 dict low hematocrit in type 2 diabetes. Diabetes Care.

(3):223-228.

2006;29(10):2289–2294.

6. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6):2536-2559.

17. Dhindsa S, Bhatia V, Dhindsa G et al. The effects of hypogonadism on body composition and bone mineral density in type 2 diabetic patients. Diabetes Care.

2007;30(7): 1860–1861.

7. Liverman CT and Blazer DG. Testosterone and Aging: Clinical Research Directions (2004). Institute of Medicine/Board on Health Sciences Policy. http://www.nap.edu/books/0309090636/html/.

Accessed Nov. 20, 2014.

18. Dhindsa S, Upadhyay M, Viswanathan P et al. Relationship of prostate-specific antigen to age and testosterone in men with type 2 diabetes mellitus. Endocr Pract. 2008;14(8): 1000–1005.

19.

8. Petak Sm, Nankin HR, Spark RF, et al. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients-2002 update. En20. docr Pract. 2002;8(6):440-456.

9. Qaseem A, Snow V, Denbert TD, et al. Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline form the American College of Physicians. Ann Intern Med. 2009;151 (9):639-649.

Selvin E, Feinleib M, Zhang L et al. Androgens and diabetes in men: results from the Third National Health and Nutrition Examination Survey (NHANES III). Diabetes Care. 2007;30(2): 234–238.

Dandona P and Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.

21. Kalyani RR, Gavini S, Dobs AS. Male hypogonadism in systemic disease. Endocrinol Metab Clin North Am. 2007;36(2): 333–48.

10. Wang C, Nieschlag E, Swerdloff RS, et al. ISA, ISSAM, 22. Yohimbe, Ashwagandha, and Maca. In: Natural Stand-

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July/August 2015

ard [online database]. Somerville, MA: Therapeutic Research, Inc. 2015. Available at http://naturalmedicines-therapeuticresearch-com.

Accessed Jan. 23, 2015.

cardiovascular events (MACE): an exploratory retrospective 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.

23. Cunningham GR and Toma SM. Clinical review: why is androgen replacement in males controversial? J Clin 26. Ali Z, Greer DM, Shearer R, et al. Effects of testosEndocrinol Metab. 2011;96(1):38-52. terone supplement therapy in men with low testosterone. American College of Cardiology 2015 Scientific 24. Li H, Ostrowski NL, Benoit K, et al. Assessment of the Sessions, March 14, 2015, San Diego, CA. Abstract association between the use of testosterone replace1126M-13. ment therapy (TRT) and the risk of venous thrombotic events among TRT-treated and untreated hypogonadal 27. Patel P, Arora B, Molnar J, et al. Effect of testosterone men. The Endocrine Society Annual Meeting, March 7, therapy on adverse cardiovascular events among men: 2015, San Diego, CA. Abstract OR34-2. a meta-analysis. American College of Cardiology 2015 Scientific Sessions, March 15, 2015, San Diego, CA. 25. Janmohamed S, Cicconetti G, Koro CE, et al. The asAbstract 1195-376. sociated between testosterone use and major adverse 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 Lharrelsonky@aol.com

For more information on the Kentucky Renaissance Pharmacy Museum, see www.pharmacymuseumky.org or contact Gloria Doughty at g.doughty@twc.com or Lynn Harrelson at lharrelsonky@aol.com.

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org.

Deceased members for each year will be honored permanently at the KPhA office.

38

THE KENTUCKY PHARMACIST

August 2015 CE—Andropause

July/August 2015

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

6. Which medication(s) can lead to low testosterone levels?

A. Ketoconazole B. Spironolactone C. Sildenafil D. A and B E. B and C

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

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 microembolisms is associated with what medication(s)?

A. Delatestryl ® B. Aveed ® C. Testopol ® D. Testim ® E. Both A and B

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

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

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.

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.

5. AndroGel ® is applied to which part of the body?

A. Thigh B. Back C. Chest D. Abdomen E. Shoulders

KPhA Headquarters Rebuilding Campaign Watch eNews and subsequent editions of The Kentucky Pharmacist for more information on ways YOU can help rebuild YOUR KPhA Headquarters!

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THE KENTUCKY PHARMACIST

August 2015 CE—Andropause

July/August 2015

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

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 2. A B C D E 4. A B C D E 6. A B C D E

7. A B C D E 8. A B C D E

9. 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) 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 2. A B C D E 4. A B C D E 6. A B C D E

7. A B C D E 8. A B C D E

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

40

Quizzes submitted without NABP eProfile ID # and Birthdate will not be accepted.

THE KENTUCKY PHARMACIST

2015 KPhA House of Delegates

July/August 2015 of. —Approved as Amended. Removal of sections 9.12-9.18, excluding 9.17—Approved.

Continued from Page 9

 

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- Recommend referring to OAC for more research—Approved.

Article 6 Section 6.6 Duties of the Board of DirectorsSubsection 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 financial records of the Association at each meeting of the Board. The Board at its discretion shall engage an independent CPA to audit the accounts and financial records 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 appear to be different definitions of different levels of financial reviews. Defeated Reference committee recommendation. Amendment made to original language to include changes as noted. Adopted as amended.



Article 9 Section 9.3 Delegates Subsections 9.31-9.35 and Section 10.8—Recommend eliminating these sections and renumber accordingly—Approved.

Article 9 Section 9.43 and 9.44 House of Delegates— Credentialing of delegates can be determined by a registration 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 submitted at least 60 days prior to the Annual Meeting. The House may waive the 60 days with three-fourths majority vote.—Recommend not adopting.—Approved reference committee recommendation.

Board Recommendations: Election to Honorary Membership 

Bob Lichtenfeld, RPh, Retired; KPhA Executive Director, 1965-1978



R. David Cobb, KPhA President, 1975-76 (went on to serve as APhA President)

Reference Committee recommends adopting each resolution—Approved Honorary membership was bestowed upon pharmacists Robert Lichtenfeld and R. David Cobb.



Article 9 Section 9.1- Composition Subsection 9.11— The House of Delegates shall be composed of active  A Resolution honoring the service of Michael Burleson, pharmacist members of the Association, five pharmacy RPh, Executive Director of the Kentucky Board of Phartechnician delegates selected by their Academy, other macy, October 1, 2004 to July 31, 2015. groups recognized by the Board of Directors and stuReference Committee recommends adopting- Adopted. dent delegates as outlined in Section 9.17. Each of these delegates shall have one vote.—Reference Com-  Recommendation that dues for New Practitioner 1 st mittee recommends amending—Approved as amendYear be set at $0.00, and that new membership cateed. gories be established for New Practitioner 2 nd Year and



New Practitioner 3rd year.

Article 9 Sections 9.12-9.18, excluding 9.17—Eliminate these sections and renumber accordingly.— Reference Committee recommends adopting—Adopted.

Recommend Amendment of 9.17—Each student chapter of an accredited school/college of pharmacy in Ken-  Recommendation of the amount of dues for all classes of membership—Maintain the Dues structure at the tucky shall be entitled to representation in the House by same level for the next 3 years and the Board of Direcone delegate for the first five members of the Kentucky tors shall re-evaluate in 3 years.

Pharmacists Association and one additional delegate for each additional 20 members or major fraction there- Reference Committee recommends adopting—Adopted.

41

THE KENTUCKY PHARMACIST

2015 KPhA House of Delegates

July/August 2015



Annual Meeting Venue (Future Consideration) Reference Committee recommends sending to Board of Directors—Adopted.



Capital Campaign — KPhA Board of Directors are asking 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 Murphy. A vote via paper ballots was held. Lance Murphy was officially elected and appropriately sworn in as ViceSpeaker of the House of Delegates.

Ethan Klein, the outgoing Speaker of the House, was recognized 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 involvement and discussion in the House as we advance our profession. Speak up to become involved, serve on a committee, 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.

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 ssisco@kphanet.org 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.

42

THE KENTUCKY PHARMACIST

KPERF Golf Scramble

July/August 2015

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

Last Place: Joe Carr, Mike Burleson, Steve Hart, Chris Killmeier

Closest to the Pin: Ron Nieporte

43

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

July/August 2015

KPhA Welcomes New and Renewing Members May-June 2015 Cathy Adams Pineville

Danny Biliter Richmond

Richard Clements Morganfield

John Adams Lebanon

Sherry Bilyeu Russellville

Arica Collins Albany

Kasey Alford Smiths Grove

Kenneth Boggs Hazard

Elizabeth Coomes Bardstown

Christina Amburgey Nicholasville

Michael Bordes Williamsburg

Paul Cooper Morehead

Mark Antis South Portsmouth

Ralph Bouvette Frankfort

Kim Croley Corbin

Karen Arlinghaus Ft. Wright

Charlotte Bowling London

Robert Croley Corbin

Kimberly Arvin Fort Thomas

David Bowman Columbia

Heather Crump Flemingsburg

William Ashby Canton

Terry Box Cynthiana

Jeffrey Danhauer Owensboro

Rosana Aydt Villa Hills

Abigail Breit Louisville

Sharon Davidson East Bernstadt

James Ball Elizabethtown

Benjamin Brown Louisville

Steven Dawson McDowell

Christopher Barker Morehead

Kyle Bryan Lebanon Junction

Dave Dickerson Morehead

Larry Barnett South Williamson

Dianna Bryant Hartford

Jackie Dickerson-Galer Inez

Richard Baudendistel Cincinnati, Ohio

William Bucy Bowling Green

James Dixon Barbourville

Morgan Beck Madisonville

Dana Burns Covington

Steve Doom Elizabethtown

Daniel Beebe Cincinnati, Ohio

John Byassee Clinton

Elisha Dougherty Benton

Margaret Beeler Lebanon Junction

Holly Byrnes Louisville

Michael Eastridge Lebanon

Crystal Belt Annville

Joseph Carroll Salyersville

David Edmundson Bowling Green

Caleb Benningfield Bowling Green

Dave Cavanah Hopkinsville

Kevin Emberton Edmonton

William Bentley South Shore

Jessika Chinn Beaver Dam

Ashley Eschenbach Louisville

Alexander Bessler Newport

Margaret Christopher Winchester

John Evans Henderson

John Beville Shelbyville

Kenneth Clayton Elkton

Lorie Evans Garrison

44

MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession!

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.

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

July/August 2015

Aaron Gilbert Butler

J Henry Greenville

Penny Liles Vanceburg

Frank Nicks Bowling Green

Michelle Gilbert Butler

James Hicks Whitesburg

Michelle Lowe Paducah

John Nie Independence

Thomas Glover Providence

Gregory Hines Bowling Green

Robert Lucas Flatwoods

Christopher Noetzel Flemingsburg

Tamara Goff Hartford

Carolynn Horn Philpot

Thomas Mason Fairfield

David O'Quinn West Liberty

Patricia Gooch Pikeville

Jan Houchens London

Kelly Maston Woodburn

Jamie Otte Florence

Dwaine Green The Villages, Fla.

Tom Houchens London

Joey Mattingly Baltimore, Md.

Kelly Owens Phoenix, Az.

Melissa Greenlee Burlington

James Howard Fountain Run

Sunni Mauk Paducah

Paul Patrick London

Monte Gross Stanton

Reymonda Howard London

Velda McDaniel Georgetown

Kenneth Pearce Danville

Donald Gubser Independence

Mark Huffmyer Lexington

John McFarland London

Megan Pendley Lexington

Larry Hadley Frankfort

Robert Hughes Lexington

Michael McQuade Edgewood

Risa Perry Almo

Carolyn Hale Columbia

Michael Ingram Cynthiana

Lynita McWaters Paducah

Brookes Pickard Louisville

Kelsey Hall Louisville

Joseph Johnson Campbellsville

Mark Meador Scottsville

Larry Powell Richmond

William Hall Whitesburg

Daniel Jones Paducah

Anne Megibben Finchville

Amanda Powers Boaz

Joan Haltom Danville

Karen Jones Gilbertsville

John Milam Lexington

Elizabeth Prather Florence

Catherine Hanna Lexington

Kyle Katterjohn Paducah

Kelly Mink Lancaster

Timothy Quillen Greenup

Kathy Hardy Smiths Grove

Ann Keown Scottsville

Dan Minogue Louisville

Gary Rice Corbin

Lisa Hart Frankfort

Brian Key Pineville

Judith Minogue Louisville

Herbert Rice Grand Rivers

Steve Hart Frankfort

Scott King Hazard

Bernardine Miracle Whitesburg

Marcella Robinson Paducah

Clara Hartgrove Martin

Steven King Bloomfield

Jeffrey Moore Middlesboro

Alyson Roby Bardstown

Kyle Hatterick Cynthiana

Patricia Kinney Erlanger

Sonya Muncy Russell

Frank Romanelli Lexington

Melodie Hawkins Mt Sterling

Kristy Klebeck Maysville

Erica Neff Florence

Thomas Runge Union

Jonathan Hayes Prospect

Sarah Lawrence Louisville

Owen Neff Centerville, Ohio

Donald Ruwe Fort Thomas

Pamela Hays McKee

Mike Leake Danville

Brad Newcomb Paducah

Jessica Salmons Hazard

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THE KENTUCKY PHARMACIST

KPhA New and Returning Members

July/August 2015

Joanna Sames Shelbyville

Lisa Smith Dry Ridge

David Tabb Elizabethtown

Cary White Lexington

Denise Schickling Villa Hills

Michael Smithson Frankfort

Joanne Taheri Louisville

Lenville White Irvine

Lisa Schwartz Crestview Hills

Edwin Snider Louisville

Francis Thompson London

Rodney Whittington Princeton

Jan Scott Earlington

Walter Soja Taylorsville

Gene Thompson Lexington

Gary Wientjes Morehead

Kimberly Scott Frankfort

Rodney Stacey Cumberland

Leah Tolliver Lexington

Charlsie Williams Paducah

William Sewell Utica

James Stallard Neon

Jason Underwood Flemingsburg

Cindi Williams Hazard

Mohammon Shajiudoin Radcliff

Scott Stephens Cynthiana

Joseph Vennari Lexington

James Wiseman Benton

Anna Sharp Campbellsville

Dan Stevenson Portsmouth, Ohio

Brett Vickey Wilmore

Reginald Woolf South Fulton, Tenn.

Edwin Shelton Owensboro

Christopher Stovall London

Sarah Vickey Wilmore

Maribeth Wright Nicholasville

Gina Sherrow Brodhead

Jacquelyn Strickland Hopkinsville

Samuel Waddell Sitka

Whitney Wright Dixon

David Shipley Henderson

David Stultz Greenup

Jason Wallace Dry Ridge

Michael Wyant Finchville

John Simkins Somerset

J. Sutton London

Earnest Watts Cornettsville

Jeanne Zeis Covington

Alan Simon Prospect

Juliana Swiney Prospect

Catherine Webb Scottsville

KPhA Honorary Life Members Ralph Bouvette Leon Claywell R. David Cobb Gloria Doughty Bob Lichtenfeld Kenneth Roberts Ann Amerson Stewart

Know someone who should be on this list? Ask them to join YOU in supporting YOUR KPhA!

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THE KENTUCKY PHARMACIST

KPhA Emergency Preparedness

July/August 2015

KPhA participates in Kentucky SNS Drill 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 Department 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 guidelines recommend that the federal SNS assets be released within 12 hours upon being contacted by a state department 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- tion). Therefore it will take 200 hours to package and label enough medication to treat them. sponders and their families (10 day supply of medica-

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 ltolliver@kphanet.org, fax to 502-227-2258 or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601.

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Pharmacy Law Brief

July/August 2015

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 issues 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 consideration. In this installment, we will consider issues related to money and finances. Then the subsequent column will focus 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 federal laws, and the distribution and sale of marijuana is illegal, so we don’t bank the proceeds from sale of medical or recreational marijuana.” Banks reportedly will not accept deposits from firms involved with production or distribution of marijuana. Nor can credit cards be used for the transactions 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 deduction…shall be allowed for any amount paid…in carrying on any trade or business if such business…consists of trafficking on controlled substances…” [26 U.S.C. §280E – Expenditure 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

Submit Questions: jfink@uky.edu 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 educational 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 pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

“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 traditional 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 Revenue 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 provision 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 drugrelated 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 accommodation.” What about other tenants and their “right to quiet enjoyment” of the premises they leased? What about issues with commercial versus residential property? Marijuana 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?

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Pharmacy Law Brief

July/August 2015

Finally, what if the marijuana business is not as successful as the optimistic founder anticipated? Issues can arise under the federal bankruptcy laws such as a case last fall when a federal judge in Denver denied a wholesale marijuana 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 impediments 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 liquidating 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, because 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 number of additional issues arising from these developments around the country.

SAVE THE DATE Are you connected to YOUR KPhA? Join us online!

Facebook.com/KyPharmAssoc Facebook.com/ KPhANewPractitioners

@KyPharmAssoc @KPhAGrassroots

KPhA Company Page 49

THE KENTUCKY PHARMACIST

Pharmacy Policy Issues

July/August 2015

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) includes a collection of symptoms displayed as a result of Have an Idea?: neonatal drug withdrawal after intrauterine exposure to a This column is designed to address timely and practical substance during pregnancy. Infants born under these cir- issues of interest to pharmacists, pharmacy interns and cumstances have an increased risk of many complications. pharmacy technicians with the goal being to encourage This syndrome is commonly seen with exposure to opioids, thought, reflection and exchange among practitioners. but also can be caused by exposure to other drugs as well. Suggestions regarding topics for consideration are Opioid use and dependence continues to be a significant welcome. Please send them to jfink@uky.edu. public health issue and leads to many major problems in pregnancy and potentially devastating outcomes for the developing fetus.

Review Board (INTPRB) decided that the use of opioids for infants and children suffering from withdrawal did not fall In the year 2000, fewer than 30 infants were diagnosed under the Narcotic Addict Treatment Act (NATA) and was with NAS in Kentucky. For the year 2013, that number was not subject to the same rules and regulations.3 This made more than 950.1 This increasing number of infants being an exception for the treatment of infants suffering from born with NAS has had an impact on length of hospital NAS, even though current state and federal laws did not stay, overcrowding of Neonatal Intensive Care Units and allow methadone to be prescribed to treat opiate withdrawhas led to significant increase in cost for patients as well as al. It was declared that a physician treating a child with hospitals.

NAS may issue a prescription for any opioid, including DEA regulations found at 21 CFR §1306.07 “Administering methadone, based on clinical judgment, existing standards or dispensing of narcotic drugs” has had a great impact in of practice and as well as the patient’s response to therapy. terms of the management of neonatal opioid withdrawal However, despite these actions taken by the INTPRB, and treatment of NAS.2 Methadone therapy was initially many physicians do not utilize their right to do this because used as treatment in the hospital for withdrawal symptoms, they are skeptical and fearful of not complying with the and then a taper was continued upon discharge. Many phy- standards in place. sicians thought this was appropriate for newborns with What is the role of pharmacists in this issue? A project has NAS who had no other health conditions, as opposed to been initiated by the Kentucky Perinatal Quality Collaborahaving them admitted for withdrawal treatment. This treattive that was introduced in June of 2014 at the Kentucky ment significantly decreased their length of stay, reduced Pharmacists Association annual meeting. The goal of this cost to the family as well as the hospital and allowed the project is to start collecting information from hospitals in baby a safer recovery away from exposure to other illnessKentucky about the best practices for treating infants with es that could be present in the hospital. However, 21 CFR NAS in hopes of distributing the information they find to §1306.07 has set limitations on the medication treatment hospitals and maternal-infant health care providers.1 There physicians can provide to a “narcotic dependent person for may not be a clear solution yet; however, pharmacists can the purpose of maintenance or detoxification treatplay an active role in helping to work towards a standardment” (emphasis added) in these circumstances.2 ized treatment involving interventions of both medication In 2001, the Federal Interagency Narcotic Treatment Policy and non-medical treatments to improve the outcomes of 50

THE KENTUCKY PHARMACIST

July/August 2015

KPhA Government Affairs/KPPAC both mother and infants that are affected by NAS.

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.

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.

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.

2. Drug Enforcement Administration: Administering or

KPhA Government Affairs Contribution Name: _______________________________Pharmacy: _____________________________

Email: ______________________________________________________________ Address: _____________________________________________________________ City: ___________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs)

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

Kentucky Pharmacists Political Advocacy Contribution Form Name: _________________________________ Pharmacy: ___________________________ Address: _______________________ City: ________________ State: _____ Zip: ________ Phone: ________________ Fax: __--_______________ E-Mail: __________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)

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

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

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

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

Cash Contributions: $50 per contributor, per election. Contributions by cashier’s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election.

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

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July/August 2015

Pharmacists Mutual

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Cardinal Health

July/August 2015

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THE KENTUCKY PHARMACIST

KPhA Board of Directors/Staff

July/August 2015

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Bob Oakley, Louisville Boakley@BHSI.com

Chair

Chris Harlow, Louisville cpharlow@gmail.com

Chris Clifton, Villa Hills chrisclifton@hotmail.com

President

Lance Murphy, Louisville Vice Speaker of the House lancemurphy84@gmail.com

Trish Freeman trish.freeman@uky.edu

President-Elect

KPERF ADVISORY COUNCIL

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Matt Carrico, Louisville matt@boonevilledrugs.com

Chris Palutis, Lexington chris@candcrx.com

Treasurer

Kim Croley, Corbin kscroley@yahoo.com

Duane Parsons, Richmond dandlparsons@roadrunner.com

Past President Representative

Matt Carrico, Louisville* matt@boonevilledrugs.com

Mary Thacker, Louisville mary.thacker@att.net

Chad Corum pharmdky21@gmail.com

KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc

Tony Esterly, Louisville tonye50@hotmail.com Matt Foltz, Villa Hills mfoltz@gomedcare.com Chris Killmeier, Louisville cdkillmeier@hotmail.com University of Kentucky Student Representative

Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Catherine Serratore cserra4007@my.sullivan.edu

Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Christen Schenkenfelder cschenkenfelder@sullivan.edu

Directors

Kevin Mercer kevin.mercer@uky.edu

Speaker of the House

Sullivan University Student Representative

Richard Slone, Hindman richardkslone@msn.com Mary Thacker, Louisville mary.thacker@att.net Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee

Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org

KPhA sends email announcements weekly. If you arenâ&#x20AC;&#x2122;t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list.

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50 Years Ago/Frequently Called and Contacted

July/August 2015

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 industry 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 pharmacy Josey was respected and loved by all, as was shown by his many appointed offices and positions with the American 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 community, 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.

Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222

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July/August 2015

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

Show your Pharmacist Pride with a KPhA Roamey Window Cling ($5) or your own personalized Roamey ($25)!

All proceeds benefit the KPhA Building Fund Available at the KPhA Online Store www.kphanet.org, click on About Tab, Online Store

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

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