THE KENTUCKY PHARMACIST Vol. 12, No. 4 July/August 2017 News & Informat ion for Members of the Kentucky Pharmacists Ass ociation
In this Issue: President’s Perspective Annual Meeting Highlights The Campaign for Pharmacy’s Future Continuing Education Articles
View more photos inside
KPhA President Christopher Harlow and Emily Blaiklock
Embracing the Next Generation of Pharmacy
Table of Contents
July/August 2017
Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 139th KPhA Annual Meeting and Convention Awards Message from your Executive Director 139th KPhA Annual Meeting and Convention Photos Summary from House of Delegates Meeting 2017 KPERF Golf Scramble 2017 Self Care Challenge July 2017 CE: Weighing the Pros and Cons… July Pharmacist/Pharmacy Tech Quiz Answer Sheet The Campaign for Kentucky’s Pharmacy Future August 2017 CE: Polycystic Ovarian Syndrome... August Pharmacist/Pharmacy Tech Quiz Answer Sheet
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Lessons Learned from a Pilot Project KPhA Welcomes New and Renewing Members Thank You to Our Sponsors 139th KPhA Annual Meeting and Convention Photos Pharmacy Policy Issues Pharmacy Law Brief Pharmacists Mutual Cardinal Health KPhA Board of Directors/KPERF Board of Directors 50 Years Ago/Frequently Called and Contacted/KPhA Staff
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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 Vision — We are a unified pharmacy profession empowered to maximize patient and public health as fully integrated members of the healthcare team. Mission — The mission of KPhA is to advocate for and advance the profession through an engaged membership.
Editorial Office: © Copyright 2017 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. Publisher: Mark Glasper Managing Editor: Sarah Brandenburg Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email info@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.
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THE KENTUCKY PHARMACIST
President’s Perspective
July/August 2017 ally. I take great pride in being a pharmacist. And I take great pride in each and every one of you as Pharmacists, as health care providers in academia, in hospitals, in community or wherever you practice.
PRESIDENT’S PERSPECTIVE
All of you are my family. The mission of KPhA is to advance and advocate for the profession of pharmacy through an engaged membership. But, how did we get there? Why did we choose this as our mission?
Chris Harlow KPhA President 2017-2018
All of us in the room believe in the future for our profession. So how do we move from being considered the “most under-utilized profession in the United States” to realizing our full potential? Each of us together has the power to change this. By believing in what we can do, we can inspire others to follow us!
Adapted from President Harlow’s speech during the Ray Wirth Banquet, June 24, 2017
This room tonight holds some of the most passionate individuals I have ever met. And as the leaders of this profession it is our continuing responsibility to share this passion and inspire others that they too have a stake in the future of our profession, and they have an important contribution to make. So, it is our responsibility, it is MY responsibility to continue to inspire them to believe that although as individuals we can achieve much, that as a team we become greater than the sum of our parts.
Thank you to Trish, Sam, KPhA Board of Directors, Past Presidents, Membership, Staff and the Sponsors of this evening. This is truly one of the proudest moments of my life. I have dedicated my life to this profession and I take the oath of the office with humility and gratitude. Believing:
We set the standards for our practice. We guide the policy and progress our practice forward. None of us want another profession or agency telling us what they think pharmacists can or cannot do. So, our challenge is communicating this with our members and future members.
When making the decision to run for President of KPhA, I did not hesitate. I decided to run because I believe that each and every pharmacist has a purpose and a role in our profession and that the best way to promote ourselves as individual pharmacists is by promoting the profession itself. And that happens here, every day amongst the members of OUR Kentucky Pharmacists Association.
Another one of our challenges, I believe, is the messaging. At KPhA, as with other state pharmacy associations, we struggle with relevance. Why do all pharmacists need their state pharmacy association? What do we have to offer? How do we cross those generational divides? These questions are questions I hope our Board, with the help of everyone in this room, can begin to find answers to. And begin to implement initiatives to increase membership.
We work together every day to promote our profession, and in doing so, improve ourselves, improve those who we work around and improve the lives of those entrusted in our care.
We make a daily commitment, both to our peers and our patients, to represent ourselves with honesty, integrity and respect for the vows we recite in the Oath of the Pharmacist. And through this, A fun fact, I am the first millennial President of KPhA. I recently we make a commitment to our profession and pharmacy organiza- attended the National Alliance of State Pharmacy Associations tions. Leadership Conference. We spent a lot of time talking about how we as associations can be more relevant to the millennial generaHowever, engaging others to join us in our state organization retion. mains one of our biggest challenges. I struggle with understanding why every pharmacist in Kentucky doesn’t belong to our organiza- But, I’m not convinced that any one group should necessarily be tion, and why they don’t see the value of their own contribution. treated differently than the other. We just need to recognize how So, as the leaders of our profession who sit in this room, I believe we can best use the assets of each of our members. What are our that it is our responsibility to support them and teach them that needs and what can the member offer? Is it time, a certain skillset, everyone in the field of pharmacy has a contribution that can imknowledge, networking…People just want to feel valued. I feel prove our profession. And that they are valued. And it is important that KPhA does value its membership, but do our members feel to teach them how much the organization can help them to be appreciated? better than they believe they can be. Our new and emerging pharmacists are going through life cycle So, as every President before me, it remains my mission to enchanges (graduating, marriage, buying a house, having children, gage Kentucky pharmacists. To engage them as individuals and becoming managers for the first time). We as an association need show them that there is strength in numbers. That our state organ- to be there for them when they go through these transitions. Perization can help them with a future that can offer opportunities and haps we can help lead them on their individual journey by making exciting challenges. them see, although they are new to the profession, they are valued and that they have contributions to make. Belonging:
Continued on Page 7
For me, being a member of KPhA is what defines me profession-
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KPhA Professional Awards
July/August 2017 KPhA Distinguished Young Pharmacist of the Year, sponsored by Pharmacists Mutual Insurance Frankie Abner Presented by Bruce Lafferre from Pharmacists Mutual
KPhA Professional Promotion Award Members of Rho Chi Chapter at UK College of Pharmacy, presented by Chris Clifton and Trish Freeman KPhA Excellence in Innovation Award sponsored by Upsher-Smith Laboratories, Inc. awarded to Melanie Dicks, Holly Divine (not pictured) and Tera McIntosh, presented by Chris Clifton and Trish Freeman
KPhA Meritorious Service Award KPhA Technician of the Year Ella Louise Johnson presented by Trish Freeman and Chris Clifton 4
Sen. Julie Raque Adams presented by Trish Freeman and Chris Clifton
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KPhA Professional Awards
July/August 2017 Bowl of Hygeia Award sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations with support from Boehringer Ingelheim .
Melody Ryan pictured with Sam Willett and Trish Freeman
KPhA Distinguished Service Award
Bob Oakley pictured with Trish Freeman and Chris Clifton
KPhA Pharmacist of the Year Award Sam Willett pictured with Trish Freeman and Chris Palutis
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Message from Your Executive Director
July/August 2017
MESSAGE FROM YOUR NEW EXECUTIVE DIRECTOR
Mark Glasper 139th KPhA Annual Meeting and Convention and look forward to meeting more of you at other meetings during the upcoming year. And, you're always welcome to visit KPhA headquarters. My door is always open, so please know that you can contact me anytime with your questions, comments or concerns. I look forward to hearing from you!
Greetings KPhA Members! I truly appreciate the confidence your Board of Directors has in my abilities as your new Executive Director. I was impressed with the entire search process led by KPhA President and Chair of the Search Committee Trish Freeman. She, members of the Search Committee and your Board of Directors led an effective and efficient executive search which typically demands expertise and expensive support from outside counsel.
Best regards, Mark Glasper Executive Director Biography
Mark A. Glasper is an experienced association management executive. He previously served in Executive Director positions with the Opticians Association of Ohio and the Ohio Society of Association Executives. Prior to his execuAs your new Executive Director, I have much that I want to tive positions, Glasper also served as Director of Communiaccomplish: cations with the Ohio Restaurant Association and Director of Marketing Communications at The American Ceramic Soci Growing the Association; ety. Improving member satisfaction; He is a graduate of The Ohio State University with a Bachelor of Arts degree and a major in Public Relations from the Raising awareness of the Association and the profesSchool of Journalism. Glasper has served as an adjunct sion. professor in the Department of Communication at Capital My experience in these areas translates into immediate val- University and as an adjunct instructor at the Columbus ue for KPhA because I've accomplished these goals at other State Community College Center for Workforce Developassociations. Please know that I will be a respectful steward ment. He is a member of the American Society of Associaof your association, thinking strategically, working collabora- tion Executives and a Past President-for-a-Day of the Natively and managing professionally. tional Baseball Hall of Fame. Glasper currently resides in Powell, Ohio, with his wife, Rita, I look forward to working with your Board of Directors on behalf of the entire KPhA membership as we implement our and son, Austin, with plans to relocate to the Frankfort, Ky., area in the near future. Strategic Plan. I enjoyed meeting many members at the
The Campaign for Kentucky’s Pharmacy Future Leave a legacy by participating in the campaign to replace OUR KPERF/KPhA Headquarters! Learn more about options for payment and levels of recognition at http://www.kypharmacyfuture.net/ or call 502-227-2303. 6
THE KENTUCKY PHARMACIST
President’s Perspective
July/August 2017 for this profession will set the stage for his leadership in OUR KPhA. He comes to us with experience and energy that we need to move our profession forward. I thank him for his willingness to move to Kentucky and become a part of our profession.
Continued from Page 3 So, we need not expect too much from them during their time of transition from student to pharmacist but rather accommodate them, support them and be ready for when they can make their contributions.
So, how will my leadership be different? Well, hopefully not too different. I am following one of the greatest individuals in the world of pharmacy, Dr. Trish Freeman. But, my leadership will focus on the task at hand, and that is to achieve the goals of the KPhA strategic plan. That plan has set the stage for us for the following years, and it won’t be just another document sitting on the shelf. This strategic plan sets a path for engaging, supporting, advancing and advocating.
I am confident that anyone who enters into this profession truly believes in the impact they can make in Healthcare as a pharmacist. And I am confident of the future leaders in our association. KPhA has existed since 1879. Every generation brings something unique, it is our role to help them find that. Looking to the future:
I can promise you I will lead with honesty, integrity and dignity. As I now want to take a moment to recognize our incoming Executive one of my greatest mentors, Dr. Anne Policastri, once said “I want to leave this profession in a better place than I started.” I too Director, Mark Glasper. As I look at the task ahead of me this year, I am thrilled to get to be a part of the learning experience for promise the same. Thank you. Mark. He is new to pharmacy, and I hope my passion and desire
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APSC
July/August 2017
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Ways to Get Involved
July/August 2017
Pharmacist, pharmacy technician and student pharmacist recruitment is still underway for the Kentucky Pharmacists Association emergency preparedness program! Pharmacy professionals play a critical part in responding to emergency events such as a natural disaster or infectious disease outbreak. You may sign up as a volunteer on the KPhA website, completing a volunteer form below or simply sending an email directly to jjaggers@kphanet.org. Please join the emergency preparedness program and help to recruit other volunteers! We need all of you! For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative, contact KPhA at 502-227-2303 or by email at jjaggers@kphanet.org.
For more resources, visit YOUR www.kphanet.org and click on Resources—Emergency Preparedness.
KPhA Pharmacy Emergency Preparedness Volunteer Form Name: __________________
____
Status (Pharmacist, Technician, Student): ___________________
Mailing Address: ________________________________________City: __________________ State: _________ Zip: ___________ Email: _______________________________________ Phone: ________________________ County:
_______
T-Shirt size: ______________
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 KPhA via email at jjaggers@kphanet.org, fax to 502-227-2258 or mail at KPhA, 96 C Michael Davenport Blvd., Frankfort, KY 40601.
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, 96 C Michael Davenport Blvd., Frankfort, KY 40601
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139th KPhA Annual Meeting and Convention
July/August 2017
139th KPhA Annual Meeting and Convention
KPhA Past Presidents pass the ceremonial gavel.
Sam Willett addresses the Ray Wirth Banquet Attendees.
Above: Chris Harlow addresses The House of Delegates. Below: Mark Glasper mingles with members.
Above: Chris Palutis receives recognition of service as KPhA Treasurer. Below: KPhA Staff, Angela Gibson, Scott Scisco, Liz Ramey at the Ray Wirth Banquet.
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139th KPhA Annual Meeting and Convention
July/August 2017
139th KPhA Annual Meeting and Convention
Trish Freeman addresses attendees during a session.
Don McGuire of Pharmacists Mutual speaks to attendees.
Joe Carr engages during a session.
Ralph Bouvette presents updates to Kentucky law and the legislature. 11
Melanie Dicks receives the KPhA Excellence in Innovation Award at Friday’s luncheon.
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2017 KPhA House of Delegates Meeting Summary
July/August 2017
Summary from House of Delegates Meetings at 139th KPhA Annual Meeting and Convention Lance Murphy, PharmD—2017 Speaker Cassy Hobbs—Chair of the Reference Committee Joe Fink, PharmD—Parliamentarian
4. KPhA urges prescribing pharmacists to coordinate care with patients’ other health care providers through appropriate documentation, communication, and referral.
At the 2017 KPhA House of Delegates members from throughout the Commonwealth gathered to discuss, debate and make recommendations to not only shape OUR KPhA, but also to push forward OUR beloved profession.
5. KPhA advocates that medications and services associated with prescribing by pharmacists must be covered and compensated in the same manner as for other prescribers.
Speaker Lance Murphy convened the Opening Session on the KPhA House of Delegates on Friday, June 23, 2017 at 7:50 a.m. Delegates were slated in accordance with the updated KPhA Bylaws, and annual reports of the association were presented.
6. KPhA supports the right of patients to receive pharmacistprescribed medications at the pharmacy of their choice. Pharmacists’ Role within Value-Based Payment Models
President Freeman introduced a resolution to honor Sam Willett’s work as the Interim Executive Director from MarchAugust 2017 with an Honorary KPhA Membership. Motion was made by Joe Carr to accept the Resolution, seconded by Kim Croley. Motion carried. Appreciation awards were presented to the outgoing KPhA Board members. Chair Chris Clifton, Director Matt Foltz, Director Katherine Kenney, Kevin Chen, Richard Slone, Jessika Chinn, and Lance Murphy.
1. KPhA supports value-based payment models that include pharmacists as essential health care team members and that promote coordinated care, improved health outcomes, and lower total costs of health care. 2. KPhA encourages the development and implementation of meaningful, consistent process-based and outcomesbased quality measures that allow attribution of pharmacist impact within value-based payment models. 3. KPhA advocates for mechanisms that recognize and compensate pharmacists for their contributions toward meeting goals of quality and total costs of care in valuebased payment models, separate and distinct from the full product and dispensing cost reimbursement.
Nominations were requested for Vice-Speaker; Joe Carr was nominated. There were not additional nominations. Kim Croley presented to the House recommendations for the changes to mirror some of the changes that were adopted at the APhA House of Delegates earlier in 2017. Those recommendations were moved to be reviewed at the Reference Committee. Cassy Hobbs presented the Reference Committee recommendations. The reference committee makes the motion to adopt the following: Patient Access to Pharmacist-Prescribed Medications 1. KPhA asserts that pharmacists’ patient care services and related prescribing by pharmacists help improve patient access to care, patient outcomes, and community health, and they align with coordinated, team-based care. 2. KPhA supports increased patient access to care through pharmacist prescriptive authority models. 3. KPhA opposes requirements and restrictions that impede patient access to pharmacist-prescribed medications and related services. 12
4. KPhA advocates that pharmacists must have real-time access to and exchange of electronic health record data within value-based payment models in order to achieve optimal health and medication-related outcomes. 5. KPhA supports education, training, and resources that help pharmacists transform and integrate their practices with value-based payment models and programs. Pharmacy Performance Networks 1. KPhA supports performance networks that improve patient care and health outcomes, reduce costs, use pharmacists as an integral part of the health care team, and include evidence-based quality measures. 2. KPhA urges collaboration between pharmacists and payers to develop distinct, transparent, fair, and equitable payment strategies for achieving performance measures associated with providing pharmacists’ patient care services that are separate from the reimbursement methods used for product fulfillment.
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2017 KPhA House of Delegates Meeting Summary
July/August 2017
3. KPhA advocates for prospective notification of evidencebased quality measures that will be used by a performance network to assess provider and practice performance. Furthermore, updates on provider and practice performance against these measures should be provided in a timely and regular manner.
(a) Successful completion of an accredited or stateapproved education and training program
KPhA urges pharmacists to expand patient access to secure, convenient, and ecologically responsible drug disposal options, in accordance with the Secure and Responsible Drug Disposal Act of 2010, by implementing disposal programs they deem appropriate for their individual practice sites, patient care settings, and business models in an effort to reduce the amount of dispensed but unused prescription drug product available for diversion and misuse.
Motion carried.
(b) Certification by the Pharmacy Technician Certification Board (PTCB).
2. KPhA supports state board of pharmacy regulations that require pharmacy technicians to meet minimum standards 4. KPhA supports pharmacists’ professional autonomy to of education, training, certification, and recertification. KPhA determine processes that improve performance on evidence encourages state boards of pharmacy to develop a phase-in -based quality measures. process for current pharmacy technicians. KPhA also enAdopted New Business Items courages boards of pharmacy to delineate between pharmacy technicians and student pharmacists for the purposes The following items of New Business were adopted by the of education, training, certification, and recertification. 2017 KPhA House of Delegates and are now official KPhA policy. 3. KPhA recognizes the important contribution and role of pharmacy technicians in assisting pharmacists and student Equal Rights and Opportunities for Pharmacy Personnel pharmacists with the delivery of patient care. (modifies original policy language of 2012, 1989 Equal Opportunity for Pharmacists) 4. KPhA supports the development of resources and programs that promote the recruitment and retention of qualiKPhA reaffirms its unequivocal support of equal opportunified pharmacy technicians. ties for employment and advancement, compensation, and organizational leadership positions. KPhA opposes discrimi- 5. KPhA supports the development of continuing pharmacy nation based on gender, gender identity or expression, race, education programs that enhance and support the contincolor, religion, national origin, age, disability, genetic inforued professional development of pharmacy technicians. mation, sexual orientation, or any other category protected 6. KPhA encourages the development of compensation by federal or state law. models for pharmacy technicians that promote sustainable Drug Disposal Program Involvement career opportunities.
Indication on Prescription Labels and Medication Safety KPhA supports pharmacists’ authority to include a medication’s purpose on prescription labels, on the basis of professional knowledge, judgment, and patient preference, using vocabulary that is appropriate for their unique practice sites and that addresses the needs of their specific patient populations. Motion carried.
The reference committee made the motion to move forward with the KPhA Ambassador program as presented. Motion carried. Speaker Lance Murphy received the tabulated votes for the 2017-2018 Vice Speaker of the House. Tyler Stevens will be the KPhA Vice Speaker of the House. There were open comments from delegates. Ron Poole spoke on the issues and changes facing pharmacists in the statewide changes of protocols at this time. Chris Palutis was installed as the 2017-2018 President Elect. Motion was made by Kim Croley, seconded by Ron Poole, to adjourn the 2017 House of Delegates Meeting. Motion carried.
The reference committee made the motion to refer the following statements to the KPhA Board of Directors, Professional Affairs and Technician Academy for review and revision in the coming year.
The 2017 House of Delegates, once again, was a time for discussion and debate. This is when we decide the next steps of our KPhA and look forward to more involvement and discussion in the House as we advance our profession. Pharmacy Technician Education, Training, and Develop- Speak up to become involved, serve on a committee, become a delegate in the House and voice our stance. Thank ment you to all members who have the desire and willingness to 1. KPhA supports the following minimum requirements for serve not only our patients, but our profession as well. all new pharmacy technicians: 13
THE KENTUCKY PHARMACIST
2017 KPERF Golf Scramble
July/August 2017
2017 KPERF Golf Scramble
Chris Clifton presents the award for First Place— Rick Dunn, Andy Romero, Ben Graves, Chris Palutis.
Chris Clifton presents the award for Second Place — Chris Germann, Pat Mattingly.
Chris Clifton presents the award for Last Place—Clark Kebodeaux, Chris Killmeier, Mike Burleson.
Chris Clifton presents the award for Longest Drive—Ben Graves.
Special Thanks to Our Hole Sponsors!
Chris Clifton presents the award for Closest to the Pin—Chris Anderson.
Ad-Venture Promotions
Flexible Pharmacy Services
Republic Bank & Trust
Bingham Greenebaum Doll LLP
Fred's Inc.
George Hammons, Frankie Abner & Tom Houchens
Rx Discount Pharmacy
St. Matthews Community Pharmacy
Stites & Harbison, PLLC
Sullivan University College of Pharmacy
Joel Thornbury
Walgreens
Booneville Discount Drug
C&C Pharmacy
Harrod & Associates
Compliant Pharmacy Alliance
Medica Pharmacy & Wellness Center
The Clifton Family
Pharmacists Mutual
Duncan Prescription Center
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Poole's Pharmacy Care
THE KENTUCKY PHARMACIST
2017 Self Care Challenge
July/August 2017
2017 Self Care Challenge
Jody Jaggers leads the annual Self Care Challenge.
Pharmacists and students participate in the Self Care Challenge.
Kevin Chen and students participate in the Self Care Challenge.
Pharmacists and students collaborate to answer a question.
Kaitlyn Musick and Emily Duncan answer a question that leads their team to winning the challenge.
The winning team consisted of Spencer Tungate, Kaitlyn Musick, Shirin Bigdeliazari, Emily Duncan and Matthew Wesling.
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July 2017 CE
July/August 2017
Weighing the Pros and Cons of Obesity Therapy By: Lourdes Cross, PharmD, BCACP, Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-17-007-H01-P&T 1 Contact Hours (0.1 CEU) Expires 7/3/2020
Goal: To aid pharmacists and pharmacy technicians in understanding of current recommendations for treatment of obesity and to assist with appropriate use of medications for specific patients. Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1. 2. 3. 4.
Describe the epidemiology and economic impact of obesity; Discuss current obesity treatment recommendations; Compare and contrast pharmacologic options for the management of obesity; and, List medications that may cause weight gain as a side effect.
Introduction Current National Health and Nutrition Examination Survey data on the prevalence of obesity indicate that approximately 36.5 percent of adults and 17 percent of children and adolescents in the United States are obese.1 According to The State of Obesity: Better Policies for a Healthier America published in September 2016, Kentucky has the fifth highest adult obesity rate in the nation at 33.2 percent.2 Compared with average weight individuals, obese patients incur 46 percent increased inpatient costs, 27 percent more physician visits and outpatient costs and 80 percent increased spending on prescription medications.3 The estimated annual medical costs in the U.S. for people who are obese is approximately $1,429 (42 percent) higher than those of normal weight.4 In response to the rise of obesity-related health conditions, the U.S. Department of Health and Human Services set a national target to reduce the adult obesity rate to 30.5 percent by 2020.5
KPERF offers all CE articles to members online at www.kphanet.org
of comorbid conditions.8 Complications of obesity include type 2 diabetes, hypertension, dyslipidemia, atherosclerotic cardiovascular disease, osteoarthritis, gallbladder disease, gout and cancers (colorectal, prostate and breast).9 For every 5-unit increase in BMI above 25 kg/m 2, overall mortality increases by 29 percent, vascular mortality by 41 percent and diabetes-related mortality by 210 percent. Modest weight loss (5 to 10 percent) has been shown to produce significant improvements in many conditions.10 Treatment Guidelines
The goal of therapy is to prevent or reduce the complications of obesity and improve quality of life. According to guidelines released by the American College of Cardiology, the American Heart Association and The Obesity Society in 2013, weight loss should be encouraged for overweight and obese individuals with at least 1 comorbidity. One of those comorbidities can be an elevated waist circumference (>35 inches in women and >40 inches in Pharmacists and pharmacy technicians have the oppormen). Other examples of comorbid conditions include type tunity to educate people on the importance of maintaining 2 diabetes, dyslipidemia, hypertension and obstructive a healthy weight and present strategies to achieve weight sleep apnea. A lower calorie diet and increased physical loss goals. Pharmacy technicians play a vital role in patient activity should be recommended to all patients with a BMI safety by ensuring that the correct medication is dis≥25 kg/m2, especially as an adjunct to pharmacotherapy.8 pensed, assessing patient understanding of their medica- In January 2015, the Endocrine Society released additional tions and triaging patients to the pharmacist. guidelines on the pharmacological management of obesity. Patients with a BMI ≥30 kg/m 2 or ≥27 kg/m2 in the presObesity Overview ence of an obesity-related comorbidity who are unable to In June 2013, the American Medical Association officially lose weight or sustain weight loss with comprehensive liferecognized obesity as a disease.6 Obesity is defined as an style modification may benefit from pharmacologic therapy. excessively high amount of body fat or adipose tissue in Evaluation for bariatric surgery is recommended if BMI ≥40 relation to lean body mass.7 Body mass index (BMI), which kg/m2 or ≥35 kg/m2 with an obesity-related comorbidity.11 is weight in kilograms divided by height in meters squared, Nonpharmacologic Therapy is used to identify obesity. Individuals with a BMI of 25 to 2 29.9 kg/m are classified as overweight, while adults with a Overweight and obese individuals should participate for at BMI of ≥30 kg/m2 are considered obese. Severe obesity is least 6 months in a comprehensive lifestyle program that classified as a BMI ≥40 kg/m 2 or ≥35 kg/m2 in the presence assists with adherence to a lower calorie diet and in16
THE KENTUCKY PHARMACIST
July 2017 CE Drug Phentermine (Adipex-P®, Lomaira®, generic) Diethylpropion (generic) Benzphetamine (Regimex®, generic) Phendimetrazine (generic)
Orlistat (Xenical®, AlliÒ [OTC]) Lorcaserin (Belviq®, Belviq XRÒ) Naltrexone/ bupropion ER (Contrave®)
July/August 2017 Usual Adult Dose Phentermine (excluding Lomaira): 15 to 37.5 mg PO daily in one to two divided doses Lomaira: 8 mg PO three times daily 30 minutes before meals Only indicated for short-term use (12 weeks) Immediate-release: 25 mg PO three times daily Extended-release: 75 mg PO once daily at midmorning Only indicated for short-term use (12 weeks) 25 to 50 mg PO once daily. May increase to 25 to 50 mg one to three times daily if needed. Only indicated for short-term use (12 weeks) Immediate-release: 35 mg PO two or three times daily, 1 hour before meals Extended-release: 105 mg PO once daily 30 to 60 minutes before morning meal Only indicated for short-term use (12 weeks) Xenical: 120 mg PO three times daily with each main meal containing fat Alli: 60 mg PO three times daily with each main meal containing fat Belviq: 10 mg PO twice daily Belviq XR: 20 mg PO once daily
ment of obesity for 13 years. Today, there are four additional medications with an FDA-approved indication for long-term weight loss: lorcaserin (Belviq), naltrexone and bupropion extended-release (Contrave), phentermine and topiramate extendedrelease (Qsymia) and liraglutide (Saxenda). In order for medications to achieve FDA approval for long-term weight loss, the outcomes must show a statistically significant difference in mean weight loss between the drug and placebo groups of ≥5 percent for at least one year. In addition, the proportion of subjects who lose at least 5 percent of baseline body weight must be 35 percent or more and approximately double the proportion in the placebo group.12
Efficacy and safety of weight loss medications should be assessed at Titrate up to 2 tablets* PO twice daily least monthly for the first 3 months, Titration schedule: then every 3 months at a minimum. Week 1: 1 tablet every morning When weight loss medications reach Week 2: 1 tablet twice daily Week 3: 2 tablets every morning and 1 tablet their maximal therapeutic effect, every evening weight loss plateaus. The standard of Week 4: 2 tablets twice daily care is to continue treatment as long *1 tablet = naltrexone 8 mg/bupropion 90 mg as patients are receiving benefits. For Phentermine/ Initially phentermine 3.75 mg/topiramate 23 mg most weight loss medications, if body topiramate ER PO once daily. Titrate gradually up to phenter(Qsymia®) mine 15 mg/topiramate 92 mg once daily if weight does not decrease by more needed. than 5 percent after 12 weeks of maxLiraglutide 0.6 mg subq once daily for 1 week. Increase by imum-dose therapy or if there are is(Saxenda®) 0.6 mg daily at weekly intervals to a target dose sues with safety or tolerability, the of 3 mg once daily. medication should be discontinued. Much as antihypertensive agents lower blood pressure to a creased physical activity. The best outcomes occur with new steady state with blood pressure returning to baseline frequent face-to-face visits (16 visits per year on average). levels upon discontinuation, weight is expected to increase A reduced calorie intake, such as 1,200 to 1,500 kcal/day when a weight loss medication is stopped in the absence of for women and 1,500 to 1,800 kcal/day for men, is recomlifestyle modification. It is not known whether individuals mended for weight loss. In addition, moderate-intensity who fail one therapy will experience better results with anphysical activity should be performed for at least 30 other medication.11 minutes for 5 to 7 days per week. A 5 to 7 percent reducSympathomimetics tion in body weight over 6 months is a reasonable goal for most patients. Furthermore, weight loss should generally Due to their potential for abuse, sympathomimetics are only occur at a rate of 1 to 1.5 pounds per week. Patients who approved for short-term duration (up to 12 weeks). Phenare unable to achieve weight loss goals with diet and exertermine, a schedule IV sympathomimetic amine, has been cise alone may be candidates for pharmacologic therapy.8 available in the U.S. since 1959. Other central nervous system stimulants include diethylpropion (C-IV), benzphetaPharmacotherapy mine (C-III) and phendimetrazine (C-III). SympathomimetMedications amplify the effect of the behavioral changes to ics suppress appetite by modulating catecholamines in the consume fewer calories and should be used as adjuncts to satiety centers of the hypothalamus. lifestyle change therapy. Approved in 1999, orlistat The recommended dose of phentermine (excluding Lo(Xenical) was the only medication indicated by the US maira) is 15 to 37.5 mg daily in 1 to 2 divided doses.13 LoFood and Drug Administration (FDA) for chronic manage17
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maira, approved in September 2016, is an 8 mg tablet given 3 times a day 30 minutes before meals.14 The recommended dose of diethylpropion is 25 mg 3 times daily for the immediate-release formulation and 75 mg once daily at midmorning for the extended-release formulation.15 The starting dose for benzphetamine is 25 to 50 mg once daily and may be increased to 25 to 50 mg 1 to 3 times daily. 16 The dose for phendimetrazine immediate-release is 35 mg 2 or 3 times daily 1 hour before meals and for extendedrelease is 105 mg once daily 30 to 60 minutes before the morning meal.17 Regimens should be individualized to achieve adequate response with the lowest effective dose. In one 36-week trial, phentermine led to a net weight loss of 7.4 kg compared to placebo.18
two or more hours before or after orlistat or at bedtime. For patients taking warfarin, a decrease in vitamin K may necessitate a reduction in the dose of warfarin. Although orlistat is minimally absorbed, weight-loss therapy is not recommended for pregnant or lactating women.19
Orlistat
Adverse effects are generally mild and include headache, fatigue, dizziness, constipation, dry mouth and nausea. It should be avoided or used cautiously with other serotonergic agents (eg, selective serotonin reuptake inhibitors, tricyclic antidepressants, triptans) due to the theoretical potential for serotonin syndrome. It is a schedule IV drug that may cause psychic dependence or euphoria at higher than recommended doses.22
Lorcaserin
Lorcaserin (Belviq) is a selective serotonin (5-HT)2c agonist that stimulates the appetite center of the brain and increases satiety. Unlike prior serotonin agonists that were used off-label for weight loss, selective activation reduces the risk of hallucinations through 5-HT2a receptors and cardiovascular side effects such as pulmonary hypertension through 5-HT2b activation. The initial recommended dose is or 20 Side effects include increased heart rate or blood pressure, 10 mg twice daily (immediate-release formulation) 22 mg once daily (extended-release formulation). dry mouth, constipation, and nervousness. Sympathomimetics are contraindicated in patients with a history of car- Weight should be evaluated after 12 weeks of treatment diovascular disease (eg, heart failure, stroke, uncontrolled with lorcaserin. If patients do not lose at least 5 percent of hypertension), hyperthyroidism, glaucoma and drug abuse. initial body weight, then the medication should be disconThey should not be used during or within 14 days following tinued due to low likelihood of further weight loss. In the monoamine oxidase inhibitor therapy. Late evening admin- BLOOM trial, patients on lorcaserin experienced an averistration should be avoided to reduce the possibility of inage 8 percent weight loss after 1 year of treatment. More somnia. Patients may experience non-life-threatening with- than 10 percent weight was lost in 36.2 percent of patients drawal symptoms (eg, extreme fatigue, depression) if abin the lorcaserin group compared to 13.6 percent in the ruptly discontinued, especially with high doses.13 placebo group.23 Orlistat is available over-the-counter (Alli) and by prescription (Xenical). Orlistat inhibits gastrointestinal lipase, the enzyme that hydrolyzes dietary triglycerides into free fatty acids. Xenical is prescribed as 120 mg three times a day during or up to 1 hour after each main meal containing fat.19 Alternatively, Alli is dosed at 60 mg three times a day with meals.20 The dose should be skipped if a meal is missed or contains no fat. Orlistat should be discontinued if weight loss is less than 5 percent of body weight at 3 months or if safety or tolerability issues arise. In the XENDOS trial, weight loss in the orlistat group after 1 year (10.6 kg) and 4 years (5.8 kg) significantly exceeded placebo (6.2 and 3.0 kg, respectively). Of orlistat-treated patients, 52 percent compared with 34 percent of patients on placebo completed treatment. Moreover, risk of progression to type 2 diabetes was reduced by 37 percent in the orlistat group.21 Unpleasant gastrointestinal effects may limit the use of orlistat. The predominant side effects include cramps, flatulence, fecal incontinence and oily spotting. These effects occur at a frequency rate of 15 to 30 percent, usually upon therapy initiation. Distributing daily intake of carbohydrates, fat (approximately 30 percent of daily calories) and protein over three main meals can help minimize these unpleasant side effects. Orlistat has been shown to decrease the absorption of fat-soluble vitamins (A, D, E, and K) and betacarotene. Patients should be advised to take a multivitamin
Naltrexone/bupropion ER The exact mechanism of naltrexone/bupropion extendedrelease (ER) is not entirely understood, but it is believed to effect the regulation of appetite by the hypothalamus. It also may modulate the mesolimbic reward pathways, thereby affecting goal-oriented behaviors. It is recommended to titrate the naltrexone 8 mg/bupropion 90 mg tablet weekly to the maximum of 2 tablets twice daily. However, if the patient experiences nausea, the dose should not be titrated further until tolerated. Titrating the dose according to product labeling may minimize the risk of seizures.24 The response should be evaluated after 12 weeks on the target dose. Therefore, this is usually 16 weeks after initiation of therapy, accounting for the titration schedule. Treatment should be discontinued if patients do not lose 5 percent of baseline body weight.24 In clinical trials, weight loss in the naltrexone/bupropion ER group was approximately 8.2 percent of baseline body weight compared to 1.4 percent with placebo after one year of therapy.25 18
THE KENTUCKY PHARMACIST
July 2017 CE Adverse effects include nausea, headache and constipation. Most side effects occur within a few days or weeks of therapy and resolve soon thereafter. The combination agent may increase blood pressure (1-2 mmHg on average) and heart rate. Contraindications include uncontrolled hypertension, a history of seizures, an eating disorder, use of other bupropion-containing products, chronic opioid use and administration within 14 days of taking monamine oxidase inhibitors. Bupropion can lead to new or worsening depression or suicidal thoughts, more often in patients younger than 24 years.24
July/August 2017
macy certification and a patient medication guide that discusses important safety information. If discontinuation is necessary, patients treated with the highest dose (15 mg/92 mg) should gradually discontinue therapy (eg, one dose every other day for at least one week) to avoid precipitating a seizure, even in patients without a history of epilepsy.27 Liraglutide
Liraglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist that was originally indicated for the treatment of type 2 diabetes. In 2014, it was approved in a higher dose Phentermine/topiramate ER as a medication for weight loss. Its mechanism involves the Phentermine as a single agent is approved as a short-term reduction of appetite and energy intake through direct stimadjunct therapy for weight loss, but the combination agent ulation of the appetite center of the brain. Liraglutide is adof phentermine and topiramate extended-release may be ministered once daily as a subcutaneous injection in the used long-term for weight management. It is a schedule IV abdomen, thigh or upper arm. The recommended starting medication based on the abuse potential of phentermine. dose is 0.6 mg once daily for one week. The dose can be The exact mechanism of topiramate in the management of increased by 0.6 mg daily at weekly intervals to a target weight loss is unknown. Animal studies suggest that topir- dose of 3 mg once daily. If the patient experiences nausea, amate may reduce caloric intake and increase energy exthe dose should not be titrated further until tolerated. Dispenditure.26 The recommended dosage is phentermine continue treatment if the 3 mg daily dose is not tolerated as 3.75 mg/topiramate 23 mg once daily in the morning for two efficacy has not been established at lower doses.29 weeks, followed by 7.5 mg/46 mg daily. Evaluate responsIf patients do not achieve at least 4 percent weight loss es after 12 weeks on this dose. If the patient has not lost at after 16 weeks of treatment, liraglutide should be discontinleast 3 percent of baseline body weight, discontinue the ued. In clinical trials, treatment with liraglutide led to apagent or escalate the dose to phentermine 11.25 mg/ proximately 9 percent weight loss after one year of treattopiramate 69 mg daily for 14 days, followed by 15 mg/92 ment compared to 3 percent with placebo. A total of 63.2 mg daily. If 5 pecent of baseline body weight has not been percent of the patients in the liraglutide group as compared lost after 12 weeks on phentermine 15 mg/topiramate 92 with 27.1 percent in the placebo group lost at least 5 permg daily, discontinue therapy.27 cent of their weight, and 33.1 percent and 10.6 percent, Although topiramate leads to relatively little weight loss by respectively, lost more than 10 percent of their weight.30 itself, its combination with phentermine has been shown to cause impressive weight loss. In the SEQUEL trial, patients Unpleasant gastrointestinal side effects (nausea, vomiting) and the need for daily injection may limit the use of liragtreated with the combination agent lost an average of 10 percent body weight compared to less than 2 percent in the lutide in some patients. Patients on this medication should placebo group. Moreover, the treatment group experienced be monitored for signs of pancreatitis, such as severe abdominal pain, back pain, nausea or vomiting. Studies in a reduction in blood pressure, lipid and glucose measureanimals have shown an increased risk of medullary thyroid ments. Progression to type 2 diabetes was reduced by 76 carcinoma, but it is not known if this is true for humans. In percent in patients on the high dose combination regimen patients with type 2 diabetes, other antidiabetic medica28 compared to placebo. tions (eg, sulfonylureas, insulin) should be adjusted as As with all sympathomimetics, it is important to monitor needed to prevent hypoglycemia.29 heart rate and blood pressure in patients taking phentermine/topiramate ER. Administration in the morning should Drug-Induced Weight Gain be recommended to avoid insomnia. Topiramate is contra- If possible, the use of medications that may result in weight indicated during pregnancy due to an increased risk of oro- gain in overweight and obese patients should be avoided. facial clefts in infants exposed during the first trimester of Patients with diabetes can gain as much as 10 kg in three pregnancy. Women of childbearing age should have a to six months after starting treatment with insulin, sulfonylupregnancy test before starting this drug and monthly there- reas and thiazolidinediones.11 In patients with type 2 diabeafter. This combination also should be used cautiously in tes who are overweight or obese, antidiabetic agents that patients with a history of renal stones.27 have been shown to promote weight loss or mitigate weight Phentermine/topiramate ER may only be dispensed by cer- gain (eg, GLP-1 agonists, sodium-glucose cotransporter 2 tified pharmacies under the Risk Evaluation and Mitigation inhibitors, metformin, pramlintide) should be considered. Antidepressants vary with respect to long-term weight gain. Strategy. This program includes prescriber training, phar19
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Paroxetine is considered to be the selective serotonin Practice Guidelines and The Obesity Society. J Am reuptake inhibitor with the highest long-term increase in Coll Cardiol. 2014; 63:2985-3023. body weight. Other agents associated with weight gain in9. The National Heart, Lung, and Blood Institute and the clude amitriptyline and mirtazapine. Fluoxetine and serNorth American Association for the Study of Obesity. traline are associated with weight loss and weight neutrality The Practical Guide: Identification, Evaluation, and and may be appropriate alternative agents in a patient who Treatment of Overweight and Obesity in Adults. Be31 is overweight or obese. Of the atypical antipsychotics, thesda, MD: National Institutes of Health; 2000. NIH clozapine and olanzapine cause the highest incidence of Publication No. 00-4084. weight gain, whereas aripiprazole and ziprasidone typically 10. Prospective Studies Collaboration, Whitlock G, Lewingcause minimal changes in weight.32 ton S, et al. Body-mass index and cause-specific morConclusion tality in 900 000 adults: collaborative analyses of 57 Obesity is a chronic disease that should be managed approspective studies. Lancet. 2009;373(9669):1083-96. propriately to lower the risk of serious health conditions. 11. Apovian CM, Aronne LJ, Bessesen DH, et al. PharmaThe degree of weight loss includes benefits such as imcological management of obesity: an endocrine society proving blood pressure, lowering serum lipid concentraclinical practice guideline. J Clin Endocrinol Metab. tions, increasing insulin sensitivity and decreasing hyper2015;100(2):342-62. glycemia. Weight loss medications are indicated as an adjunct to a reduced-calorie diet and increased physical activ- 12. Center for Drug Evaluation and Research. Guidance for Industry: Developing Products for Weight Manageity. Things to consider when selecting drug therapy are effiment. Rockville, MD: FDA; 2007. cacy, the potential for abuse and side effects. Pharmacists and pharmacy technicians are well positioned to assist pa- 13. Adipex-P [package insert]. Sellersville, PA: TEVA Phartients in achieving weight loss goals. maceuticals; 2012. References 1.
2.
3.
4.
14. Lomaira [package insert]. Newtown, PA: KVK-Tech, Inc; 2016. Ogden CL, Carroll MD, Kit BK, Fryar CD. Prevalence of obesity in the United States, 2011-2014. NCHS Data 15. Diethylpropion [package insert]. Philadelphia, PA: LanBrief. 2015;219:1-8. nett Company, Inc; 2016 Trust for America’s Health, The Robert Wood Johnson 16. Benzphetamine [package insert]. Coral Springs, FL: Foundation. The state of obesity: better policies for a Boca Pharmacal, LLC; 2013. healthier America. http://stateofobesity.org/files/ 17. Phendimetrazine [package insert]. Newtown, PA: KVKstateofobesity2016.pdf. Accessed Feb. 2, 2017. Tech, Inc: 2015. Stunkard AJ and Wadden TA. Obesity: Theory and 18. Munro JF, MacCuish AC, Wilson EM, Duncan LJ. Therapy. Second Ed. New York, NY: Raven Press, Comparison of continuous and intermittent anorectic 1993. therapy in obesity. Br Med J. 1968;1(5588):352-4. Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. An19. Xenical [package insert]. South San Francisco, CA: nual medical spending attributable to obesity: payerGenentech USA Inc; 2016. and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. 20. Alli [package insert]. Moon Township, PA: Glax-
5. Healthy People 2020. Nutrition and Weight Status. http://www.healthypeople.gov/2020/ topicsobjectives2020/objectiveslist.aspx?topicId=29. Accessed Feb. 5, 2017. 6. American Medical Association. Policy H-440.842. Recognition of Obesity as a Disease; 2013.
oSmithKline; 2015. 21. Torgerson JS, Hauptman J, Boldrin MN, Sjöström L. XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care. 2004;27 (1):155-61.
7. Allison DB, Downey M, Atkinson RL, et al. Obesity as a 22. Belviq (lorcaserin) [package insert]. Zofingen, Switzerdisease: a white paper on evidence and arguments land: Arena Pharmaceuticals GmbH; 2016. commissioned by the Council of the Obesity Society. Obesity (Silver Spring). 2008;16: 1161–1177. 23. Smith SR, Weissman NJ, Anderson CM, et al; Behavioral Modification and Lorcaserin for Overweight and 8. 2013 AHA/ACC/TOS Guideline for the Management of Obesity Management (BLOOM) Study Group. MultiOverweight and Obesity in Adults: A Report of the center, placebo-controlled trial of lorcaserin for weight American College of Cardiology/AHA Task Force on 20
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management. N Engl J Med. 2010;363(3):245-256.
trolled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebocontrolled, phase 3 extension study. Am J Clin Nutr. 2012;95(2):297-308.
24. Contrave [package insert]. La Jolla, CA: Orexigen Therapeutics Inc; 2014. 25. Apovian CM, Aronne L, Rubino D, et al. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013;21(5):935-943. 26. Allison DB, Gadde KM, Garvey WT, et al. Controlledrelease phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity (Silver Spring). 2012;20:330-342. 27. Qsymia [package insert]. Mountain View, CA: Vivus Inc; 2014. 28. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with con-
29. Saxenda [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2016. 30. Pi-Sunyer X, Astrup A, Fujioka K, et al; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015;373(1):1122. 31. Serretti A, Mandelli L. Antidepressants and body weight: a comprehensive review and meta-analysis. J Clin Psychiatry. 2010;71: 1259-1272. 32. Maayan L,Correll CU. Weight gain and metabolic risks associated with antipsychotic medications in children
July 2017 — Weighing the Pros and Cons of Obesity Therapy 1. How much higher is the estimated annual medical costs for U.S. adults who are obese compared to those of normal weight? A. 26 percent B. 33 percent C. 42 percent D. 60 percent 2. Pharmacologic therapy should be added in addition to comprehensive lifestyle modification when BMI ≥_____ kg/m2 or ≥_____ kg/m2 with at least one weight-related condition. A. 27; 25 B. 30; 27 C. 35; 30 D. 40; 35
6. What is the mechanism of action for lorcaserin? A. Carbonic anhydrase inhibitor B. Gastrointestinal lipase inhibitor C. Selective 5-HT2c receptor agonist D. Sympathomimetic amine 7. Which of the following is a common adverse effect of liraglutide? A. Bradycardia B. Insomnia C. Nausea D. Seizures
8. Abrupt withdrawal of phentermine/topiramate ER may cause: A. Hypotension B. Fecal incontinence 3. Lorcaserin should be discontinued if body weight does C. Seizures not decrease by more than _____ percent after _____ D. Tachycardia weeks of maximum-dose therapy. A. 5; 6 9. Phentermine/topiramate ER is contraindicated in all of B. 5; 12 the following conditions EXCEPT: C. 10; 6 A. Diabetes D. 10; 12 B. Glaucoma C. Hyperthyroidism 4. Most medications for obesity target appetite D. Pregnancy mechanisms EXCEPT: A. Liraglutide 10. Which medication(s) is/are classified as a controlled B. Lorcaserin substance? C. Orlistat A. Belviq D. Phentermine B. Contrave C. Qsymia 5. What is a counseling point of orlistat? D. A and B A. Monitor blood pressure E. A and C B. Take a multivitamin once daily at bedtime C. Use cautiously with other serotonergic agents 11. Which medication is most likely to cause weight D. Watch for cognitive impairment gain? A. Fluoxetine Save a stamp and submit your quiz online! B. Pramlintide C. Olanzapine www.surveymonkey.com/r/JulyCE2017 D. Sertraline 21
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July/August 2017
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, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: July 3, 2020 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. July 2017 — Weighing the Pros and Cons of Obesity Therapy (1.0 contact hour) Universal Activity # 0143-0000-17-007-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C 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 11. A B C D 10. A B C D E
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved 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 2017 — Weighing the Pros and Cons of Obesity Therapy (1.0 contact hour) Universal Activity # 0143-0000-17-007-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C 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 11. A B C D 10. A B C D E
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved 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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Save a stamp and submit your quiz online! www.surveymonkey.com/r/JulyCE2017
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Campaign for Kentucky’s Pharmacy Future
July/August 2017
The Campaign for Kentucky’s Pharmacy Future Donation Levels for Building Fund Campaign
KPhA and KPERF
Diamond Bowl of Hygeia Platinum Bowl of Hygeia Gold Bowl of Hygeia Silver Bowl of Hygeia Bronze Bowl of Hygeia E.M. Josey Memorial Cornerstones Builders
$100,000+ $75,000-$99,999 $50,000-$74,999 $25,000-$49,999 $10,000-$24,999 $5,000-$9,999 $2,500-$4,999 $1,000-$2,499
Pledges can be paid over 5 years. Gifts made to KPERF are tax deductible to the extent allowable by law. http://www.kypharmacyfuture.net/ or call 502-227-2303
Join the Committee of 100! Each contributor who pledges at least $5,000 over the next 5 years will be counted among the Committee of 100. Add your name to the list today by calling 502-227-2303 or log on to http://www.kypharmacyfuture.net/ Contributions are tax deductible. 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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Continuing Education Article Guidelines
July/August 2017
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. Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred). Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not pertinent to technicians, that needs to be stated clearly at the beginning of the article. Article should begin with the goal or goals of the overall program – usually a few sentences. Include 3 to 5 objectives using SMART and measurable verbs. Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.
Include a quiz over the material. Usually between 10 to 12 multiple choice questions. Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.
When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.
Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles. Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.
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Campaign for Kentucky’s Pharmacy Future
July/August 2017
The Campaign for Kentucky’s Pharmacy Future
Online donations accepted at kypharmacyfuture.net Donations to the KPERF/KPhA Building Fund are tax deductible! Leave a legacy by participating in the campaign to replace OUR KPERF/KPhA Headquarters! Learn more about options for payment and levels of recognition at kypharmacyfuture.net or call 502-227-2303.
Memorialize your Donation through the History of Pharmacy in Print Program! Pick out your print and we will display the framed print, along with a plaque with the recognition you request, in the KPhA Headquarters building. All donations of $1,000 or more are eligible.
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August 2017 CE
July/August 2017
Polycystic Ovarian Syndrome: Approaches to Treatment By: Emily Smith, PharmD and Maria Masood, PharmD Candidate; Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-17-008-H01-P&T 1.5 Contact Hour (0.15 CEUs) Expires 7/3/2020
KPERF offers all CE articles to members online at www.kphanet.org
Pharmacist Learning Objectives At the conclusion of this Knowledge-based article, the reader should be able to:
1. Describe the clinical signs and symptoms and diagnostic criteria for polycystic ovarian syndrome (PCOS); 2. Discuss the role of lifestyle modifications in PCOS; and, 3. Explain the role of oral contraceptives, clomiphene, gonadotropin, metformin, spironolactone, flutamide and thiazolidinediones in the treatment of PCOS. Pharmacy Technician Learning Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. Recognize the signs and symptoms of polycystic ovarian syndrome (PCOS); 2. Identify goals of treatment for PCOS; and, 3. List common medications and their use in the treatment of PCOS. Polycystic ovarian syndrome (PCOS) affects between 5 and 10 percent of women of childbearing age.1 It is caused by an imbalance of hormones creating problems in the ovaries. Complications of the disease include irregular menstrual periods, development of cysts in the ovaries, hirsutism, acne, weight gain and infertility.2 Despite the common diagnosis in women, PCOS can be a daunting diagnosis and with many medication options, difficult to treat. Pharmacists and pharmacy technicians can play a role in the treatment of PCOS by being the medication experts and guiding appropriate treatment of the disease. Pathophysiology There are many components that play a role in PCOS and the exact mechanism behind the disease is not fully understood. Obesity, family history of type 2 diabetes, PCOS insulin resistance genes and other factors are believed to be causes of PCOS.3 These risk factors can lead to insulin resistance and hyperinsulinemia, which in turn cause the pituitary gland to increase production of luteinizing hormone (LH) and the ovaries to increase production of testosterone.3 This increase in LH and testosterone lead to some of the signs and symptoms of PCOS as mentioned above. Although obesity, family history of type 2 diabetes and PCOS insulin resistance genes are thought to be major contributors to the development of PCOS, it is important to remember there are other potential risk factor as PCOS is a complex, multi-factor disease state (see Figure 1).
sis and management of PCOS. Although guideline criteria for diagnosis tend to be similar, there are some differences. Table 1 summarizes guideline recommendations for the diagnosis of PCOS. Note that polycystic ovaries are not necessary to diagnose PCOS, as some patients may not have ovarian cysts at time of diagnosis. It is also important to remember there are other diagnoses that need to be excluded before making the diagnosis of PCOS. These include thyroid disease, prolactin excess, non-classical congenital adrenal hyperplasia, Cushing’s disease, acromegaly, androgen secreting tumor, primary ovarian insufficiency, pregnancy and functional hypothalamic amenorrhea. Management of PCOS Treatment regimens for the management of PCOS are generally individualized based on patient symptoms (hirsutism, oligomenorrhea, infertility, obesity, glucose intolerance, etc.) and desired outcomes. The 2013 Endocrine Society PCOS guidelines are the most recent guidelines and will be the referenced guidelines for the remainder of this article. Goals of treatment in PCOS can be found in table 2.6 Lifestyle Modifications
The mainstay of therapy for all patients diagnosed with PCOS is lifestyle modifications. Diet and exercise management as part of a weight-loss strategy has been shown to improve ovulation, insulin sensitivity and hyperandrogenism. In an evaluation of six clinical trials, total testosterone, hirsutism, weight, waist circumference, fasting insulin and Criteria for Diagnosis oral glucose tolerance test all improved significantly with Several organizations have published guidelines on diagno- lifestyle modifications alone in PCOS.7 26
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Figure 1
Table 1 – Diagnosis Criteria Rotterdam Consensus Criteria4 Published: 2004 Includes two of the following: Clinical and/or biochemical hyperandrogenism Oligo-ovulation or anovulation Polycystic ovaries
Androgen Excess & PCOS Society5 Endocrine Society2 Published: 2006 Published: 2013 Includes all of the following: Includes two of the following: Clinical and/or biochemical hyClinical and/or biochemical perandrogenism hyperandrogenism Ovarian dysfunction and/or poly- Ovulatory dysfunction cystic ovaries Polycystic ovaries
Also, for patients pursuing pregnancy, even a modest weight loss of 5-10 percent has shown improvement in ovulation. In the OWL-PCOS study, patients completed a 16week pretreatment lifestyle intervention followed by clomiphene treatment (discussed below) and experienced a 62 percent rate of ovulation and 25 percent rate of live births.8 These rates are higher compared to 45 percent rate of ovulation and 10.2 percent live birth rate in the PPCOS II trial in which clomiphene was used alone.9 As health care professionals, it is vitally important to encourage these lifestyle modifications to our patients with PCOS. Hormonal Contraceptives Oral contraceptives, patches or vaginal rings are recommended as first line therapy for menstrual irregularities and hirsutism/acne related to PCOS.2 The progestin in hormonal contraceptives suppress LH levels, therefore decreasing androgen production.2 The choice of contraception is not well studied. There is some evidence using extendedcycle hormonal contraception over cyclic-cycle to prevent rebound ovarian function during the pill-free interval. Also, androgens with less androgenic properties such as desogestrel, norgestimate, drospirenone and dienogest may be considered.2,10 Unfortunately, there is no clear evidence to support their benefit. When considering hormonal contraceptives in patients it is important to keep in mind contraindications (age, smoking status, elevated blood pressure, etc.) and conception/family planning preferences. Metformin Metformin has several potential benefits in the treatment of PCOS symptoms and complications. Metformin has been
shown to improve infertility, menstrual irregularities and metabolic abnormalities.10 The dosing recommendations per Lexicomp are based on intended use. For anovulatory infertility metformin immediate release (IR) 1,000 to 2,000 mg per day in two to three divided doses or metformin extended release (ER) 1,000 mg twice daily is recommended. If the intended use of metformin is for menstrual irregularities, it can be dosed with IR at 500 mg two or three times daily, up to 1,000 mg twice daily. Increasing insulin sensitivity due to metformin will decrease circulating androgen concentrations. Metformin also may be used in combination with clomiphene, especially in women who are obese, to increase rates of ovulation and live birth. However, metformin alone has not been shown to increase ovulation.10,11,12 It is important to note that despite the possible benefits, guidelines only recommend metformin for PCOS in patients with type 2 diabetes or impaired glucose tolerance who fail lifestyle modifications, or for patients with menstrual irregularity who cannot take or do not tolerate hormonal contraceptives.2 Clomiphene Clomiphene is recommended first-line for the treatment of anovulatory infertility in PCOS patients.2 Initial dosing is 50 mg once daily for five days beginning on the fifth day of cycle.13 It is very well studied and has been shown to improve pregnancy rates versus metformin alone and provides comparable rates of pregnancy to injectable gonadotropins.14,15 This medication should be used for five days at a time starting between day two and day five of menses.13 Approximately 60 percent to 85 perent of patients using clomiphene will ovulate, but only 50 percent will conceive.
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Table 2 – Goals of Treatment 1) Improvement of hyperandrogenic symptoms (acne, hirsutism) 2) Management of underlying metabolic abnormalities 3) Prevention of endometrial hyperplasia and carcinoma 4) Contraception, if no desire to become pregnant 5) Ovulation induction for those pursing pregnancy Antiandrogens Antiandrogens such as flutamide and finasteride may be considered to target hirsutism in patients with severe hirsutism or contraindications to hormonal contraceptives.2 Flutamide works by inhibiting androgen uptake and binding of androgen in target tissues. It is dosed at 250 mg twice daily.16 Finasteride is a type II 5-alpha reductase inhibitor,
thus decreasing serum dihydrotestosterone concentration and is dosed at 2.5 to 5 mg daily. These agents are poorly studied and have only shown mild effectiveness in hirsutism.17 These agents generally should not be used alone, but in combination with contraceptives due to the teratogenic nature. Aromatase Inhibitors Letrozole works to treat infertility by inhibiting aromatase therefore inhibiting the conversion of androgens to estrogens. This is useful in PCOS because decreased estrogen leads to increased FSH and thereby increasing ovulation. It is the most studied aromatase inhibitor for this use and is recommended as a first line option.2 Use on cycle days three to seven at a dose of 2.5 to 7.5 mg daily is recommended and it may be used up to five treatment cycles.18 Studies in clomiphene resistant patients have shown letrozole to be as effective for inducing ovulation and achieving
Table 3 – Summary of Treatment Options in PCOS Drug
Place in Therapy
Dosing
Adverse Effects
Hormonal Contraceptives
Menstrual irregularities, hirsutism, acne
Varies by product
Metformin24
Infertility, menstrual irregularities, metabolic abnormalities
Anovulatory infertility IR: 1,000 to 2,000 mg/day in 2 to 3 divided doses ER: 1,000 mg twice daily Menstrual irregularities IR: 500 mg two or three times daily, up to 1,000 mg twice daily Initial course 50 mg once daily for 5 days beginning on 5th day of cycle
Clomiphene15
Infertility
Flutamide16
Hirsutism
250 mg twice daily
Finasteride25
Hirsutism
2.5 to 5 mg daily
Letrozole17
Infertility
2.5 to 7.5 mg daily on cycle days 3 to 7 (up to 5 treatment cycles)
Thiazolidinediones26,27
Infertility, menstrual irregularities, metabolic abnormalities
Pioglitazone 15 to 30 mg once daily
Spironolactone22
Acne, Hirsutism
Rosiglitazone Initial: 4 mg once daily as single dose or divided dose twice daily Target: 4 mg twice daily Acne 50 to 200 mg once daily Hirsutism 50 to 200 mg daily in 1 to 2 divided doses 28
Intermenstrual spotting, nausea, breast tenderness, headache, weight gain, mood changes, decreased libido Note: Metformin should be initiated at lower doses and gradually increased over 1-2 weeks to target dose to minimize adverse effects Diarrhea, nausea, vomiting, flatulence Ovary enlargement, hot flash, headache, bloating, nausea, vomiting, visual disturbance, breast discomfort *Increase chance of multiple births Hot flash, diarrhea, vomiting, breast tenderness Orthostatic hypotension, dizziness, decrease libido, weakness Edema, headache, fatigue, night sweats, constipation, dyspnea Edema, hypoglycemia, upper respiratory infections, weight gain
Drowsiness, headache, lethargy, abdominal cramps, diarrhea, nausea, vomiting, hyperkalemia
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Thiazolidinediones
7. This class of medications work to target infertility, menstrual irregularities and metabolic abnormalities associated with PCOS. They can be combined with clomiphene for infertili- 8. ty, but are second-line to metformin due to side effects. Refer to Table 3 for agents and dosing. Studies have shown in women with impaired glucose tolerance, thiazolidinediones can decrease the risk of progression to diabetes.21,22 Despite the potential benefits, the guidelines rec9. ommend against the use of these medications for PCOS.2 Spironolactone
10. The main uses of spironolactone in PCOS are for the treatment of hirsutism and acne in patients with severe hirsutism or contraindications to hormonal contraception.2 It 11. works by blocking the effects of aldosterone.23 The recommended dosing for both acne and hirsutism is 50 to 200 mg daily.23 If used alone, spironolactone can cause menstrual 12. irregularities so it is recommended to use in combination with a combined hormonal contraceptive (not drospirenonecontaining). It is important to counsel patients that the full effect for hirsutism may take six months or more.10 13. Conclusion Polycystic ovarian syndrome is a complex disease with multiple factors playing a role. Some patients may experience different symptoms than others and therefore, treatment should be individualized. Several medications have been studied to help with the symptoms and complications of PCOS and several guidelines exist. As pharmacists and pharmacy technicians, it is our role to be familiar with the uses of these medications in PCOS in order to maximize our patients’ outcomes in PCOS.
14.
15.
16.
References 1. McPhee SJ, Papadakis M. Polycystic ovarian syndrome. In: Current Medical Diagnosis and Treatment 2010. 49th ed. McGraw-Hill Medical; 2009: 690. 2. Legro RS, Arslanian SA, Ehrmann, et al. Diagnosis and treatment of polycystic ovary syndrome: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(12):4565-4592. 3. Tsilchorozidou T, Overton C, Conway GS. The pathophysiology of polycystic ovary syndrome. Clin Endocrinol. 2004;60(1). 4. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2003: 81;19-25. 5. Azziz R, Carmina E, Dewailly D, et al. The androgen excess and PCOS society criteria for polycystic ovarian syndrome: the complete task force report. Fertil Steril. 2009:91;456-88. 6. Barbieri RL, Ehrmann DA. Treatment of polycystic ova-
17.
18.
19.
20.
21.
22.
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ry syndrome in adults. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Accessed on Dec. 12, 2016. Moran LF, Hutchinson SK, Norman RJ, et al. Lifestyle changes in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2011;(2):CD007506. Legre RS, Dodson WC, Kris-Etherton PM, et al. Treatment of hyperandrogenism versus insulin resistance in infertile polycystic ovary syndrome (PCOS) women (OWL-PCOS). Endocrinol Metab. 2015;100(11):404858. Legro RS, Kenselman AR, Brzyski RG, et al. The pregnancy in polycystic ovary syndrome II trial (PPCOS II). Contemp Clin Trials. 2012;33(3):470-481. American College of Obstetrics and Gynecologists. ACOG Practice Bulletin No. 108. Polycystic ovary syndrome. Obstet Gynecol 2009;114:936-49. Vause TD, Cheung AP, Sierra S, et al. Ovulation induction in polycystic ovary syndrome. J Obstet Gynaecol Can 2010;32:495-502. Practice committee of the American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women: a committee opinion. Fert Steril 2013;100:3418. Clomiphene. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016. Vause TD, Cheung AP, Sierra S, et al. Ovulation induction in polycystic ovary syndrome. J Obstet Gynaecol Can 2010;32:495-502. Practice committee of the American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women: a committee opinion. Fert Steril 2013;100:3418. Flutamide. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016. Swiglo BA, Cosma M, Flynn DN, et al. Clinical review: Antiandrogens for the treatment of hirsutism. J Clin Endocrinol Metab. 2008;93(4):1153-60. Letrozole. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016. Abu Hashim H, Shokeir T, Badawy A. Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome. Fertil Steril. 2010;94(4):1405-9. Kamath MS, Aleyamma TK, Chandy A, et al. Aromatase inhibitors in women with clomiphene citrate reistance. Fertl Steril. 2010;94(7):2857-9. Glueck CJ, Moreira A, Goldenberg N, et al. Pioglitazone and metformin in obese women with polycystic ovary syndrome not optimally responsive to metformin. Hum Reprod 2003:18;1618-25 Ota H, Goto T, Yoshioka T, Ohyama N. Successful
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pregnancies treated with pioglitazone in infertile patients with polycystic ovary syndrome. Fertil Steril 2008:90:709-13. 23. Spironolactone. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016. 24. Metformin. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016.
25. Finasteride. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016. 26. Pioglitazone. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016. 27. Rosiglitazone. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http:// online.lexi.com. Accessed Dec. 13, 2016.
PHARMACY TECHNICIAN QUIZ August 2017 — Polycystic Ovarian Syndrome: Approaches to Treatment—TECH QUIZ 1. The following is a sign/symptom of PCOS. A. Irregular menstrual periods B. Cysts in the ovaries C. Acne D. All of the above
6. The following are goals of treatment in PCOS: A. Improvement of hyperandrogenic symptoms (acne, hirsutism). B. Prevention of endometrial hyperplasia and carcinoma. C. Ovulation induction for those pursing pregnancy. D. All of the above.
2. What is(are) risk factor(s) for developing PCOS? A. Obesity B. Family history of type two diabetes C. PCOS insulin resistance genes D. All of the above
7. Hormonal contraceptives come in many dosage forms (pill, patch, ring, etc.) and may help with menstrual irregularities and hirsutism/acne related to PCOS. A. True B. False
3. A key sign/symptom of PCOS is _________. A. Hyperandrogenism B. High levels of estrogen C. Regular ovulation D. Weight loss
8. The following is an example of an antiandrogen medication that may help with hirsutism: A. Flutamide. B. Letrozole. C. Clomiphene. D. Metformin.
4. Which treatment should be the mainstay of therapy for PCOS and can help patients improve ovulation, insulin sensitivity and hyperandrogenism? A. Hormonal contraceptives B. Metformin C. Lifestyle modifications D. Clomiphene
9. RL is a patient coming in to your pharmacy to drop off two new prescriptions, metformin and clomiphene. She is obese and you notice she has been on clomiphene before, but not metformin. What might RL be using this combination of medications for? A. Acne B. Hirsutism C. Infertility D. Nothing related to PCOS
5. Spironolactone is recommended for what complication(s) related to PCOS? A. Acne/hirsutism B. Infertility C. Menstrual irregularities D. Metabolic complications (obesity, diabetes, hyperlipidemia, etc.)
10. Which medication used for infertility may increase the chance of multiple births? A. Metformin B. Letrozole C. Clomiphene D. Thiazolidinediones
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PHARMACIST QUIZ August 2017 — Polycystic Ovarian Syndrome: Approaches to Treatment—RPh QUIZ 1. Which hormones are elevated in PCOS? A. Luteinizing hormone and estrogen B. Estrogen and testosterone C. Glucagon and testosterone D. Luteinizing hormone and testosterone
6. A patient comes to the pharmacy to fill a prescription for clomiphene. Which of the following would be an appropriate counseling point for this patient? A. This medication should be taken every day for one 28 day cycle B. Start this medication on day 14 of your cycle C. This medication increases the chance of multiple births D. This medication will help treat acne and hirsutism
2. What is/are risk factor(s) for developing PCOS? A. Obesity B. Family history of type two diabetes C. PCOS insulin resistance genes D. All of the above
7. Another patient at your pharmacy has failed metformin and clomiphene for infertility and asks you if there is an alternative. Which medication would be the most 3. SM is a 37 year old, female patient. She has a high appropriate alternative? androgen level, complains of facial hair and is found A. Flutamide to have polycystic ovaries. According to the Endocrine B. Thiazolidinediones Society guidelines published in 2013, this patient C. Letrozole would be diagnosed with PCOS. D. Spironolactone A. True B. False 8. It is important to monitor which lab parameter for a patient starting spironolactone? 4. Pre-treatment lifestyle modifications in patients diA. Sodium agnosed with PCOS have shown an increase in ovula- B. Potassium tion compared with clomiphene alone. C. Triglycerides A. True D. Magnesium B. False 9. It is recommended a patient on flutamide or finaster5. ________ is/are recommended first line for menstru- ide for hirsutism should be on what other medication? al irregularities and hirsutism/acne related to PCOS. A. Metformin A. Metformin B. Letrozole B. Hormonal contraceptives C. Clomiphene C. Antiandrogens (i.e. flutamide, finasteride) D. Hormonal contraception D. Spironolactone 10. Metformin alone has been shown to increase ovulation in women with PCOS. A. True B. False
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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, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: July 3, 2020 Successful Completion: Score of 80% will result in 1.5 contact hours or .15 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. August 2017 — Polycystic Ovarian Syndrome: Approaches to Treatment(1.5 contact hour) Universal Activity # 0143-0000-17-008-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B 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 Achieved 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 2017 — Polycystic Ovarian Syndrome: Approaches to Treatment(1.5 contact hour) Universal Activity # 0143-0000-17-008-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B 5. A B C D 2. A B C D 4. A B 6. A BC D
7. A B C D 8. A B C D
9. A B C D 10. A B
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved 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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Lessons Learned from a Pilot Project
July/August 2017
Increasing HPV Vaccination through Community Pharmacy Partnerships: Lessons Learned from a Pilot Project Authors: Robin Vanderpool, DrPH1; Meagan Pilar, MPH1*; Jennifer Barker, Pharm D2; Patricia R. Freeman, PhD3 1 University of Kentucky College of Public Health, Lexington, 2Total Care Pharmacy, Morehead, 3University of Kentucky College of Pharmacy *Corresponding Author: 151 Washington Avenue, 336 Bowman Hall, Lexington, KY 40506, Meagan.pilar@uky.edu, 859-257-8911 Goals of the overall program
while adolescent males’ vaccine initiation rates were lower at 50 percent.4 However, series completion rates for both groups of adolescents are even lower than the initiation rates: only 42 percent of females and 28 percent of males received all three vaccine doses in 2015.4 These statistics indicate that HPV vaccination rates are still well below Healthy People 2020 national goal of 80 percent.4 In Kentucky, however, the HPV vaccination rates are notably lower than national estimates. For example, in 2015, 57 percent adolescent females in Kentucky received one dose of HPV vaccine, compared to only 35 percent of adolescent males. 4 Similarly, HPV series completion rates differ greatly between sexes, with only 36 percent and 17 percent of Kentucky females and males, respectively, receiving all three doses in 2015.4
Pharmacies are important venues that can be used to increase human papillomavirus (HPV) vaccination rates. As such, the University of Kentucky (UK), a collaborating center of the Cancer Prevention and Control Research Network’s (CPCRN) HPV Vaccination Workgroup, received pilot funding from the American Cancer Society (ACS) to implement a HPV vaccination pharmacy project from February-September 2016. The primary goal was to increase HPV vaccine initiation and completion rates through the implementation and evaluation of a pharmacy-based vaccination program. Project Objectives: 1. Create additional HPV vaccination opportunities within a community featuring collaboration between a community pharmacy and local public health department. 2. Utilize, and tailor as necessary, existing education materials, tools and resources, including those developed by national health organizations (e.g., Centers for Disease Control and Prevention [CDC], ACS), in delivery of HPV vaccination services and parental/adolescent/ provider education. Introduction Human papillomavirus (HPV) is the most common sexually transmitted infection, with 14 million new infections occurring among women and men in the United States each year.1 HPV is responsible for approximately 39,800 cases of cancer annually, including virtually all cases of cervical cancer.2 The HPV vaccine – which prevents HPV infection and subsequent HPV-related cancer – is recommended for adolescents beginning at 11 years of age. Over the past decade, various iterations of the HPV immunization guidelines called for a 3-dose series in all age groups. However, these were updated in October 2016 and currently, for males and females ages 9-14, HPV vaccination consists of two doses over the course of six months, while older adolescents and young adults ages 15-26 years require three doses.3 In 2015, approximately 63 percent of adolescent females in the U.S. received one dose of HPV vaccine,
A unique opportunity to increase HPV vaccination rates focuses on increasing accessibility to the vaccine in community settings. The 2012-2013 President’s Cancer Panel Report5 specifically addressed the need to increase the availability of HPV vaccination for adolescents and young adults by offering immunizations outside of primary care in “alternative settings” such as community pharmacies. According to the report, pharmacies provide a convenient option for many, as evidenced by their efficiency in administering yearly influenza vaccines,6-10 and research suggests that nearly one-third of parents would be willing to have their child(ren) receive HPV vaccination in a pharmacy setting.11 However, many state-level policies constrain pharmacists from fully delivering HPV vaccination. For example, nearly 40 percent of pharmacists surveyed reported that they were unable to administer the HPV vaccine to 12year old girls, while another 24 percent were required to have a physician’s prescription to administer the vaccine.5 These restrictions limit the potential impact pharmacies could have on increasing HPV vaccination among community constiuents.12,13 The desire to increase HPV vaccination through implementation of immunization services in alternative settings prompted a group of University of Kentucky (UK) College of Public Health investigators participating in the Centers for Disease Control and Prevention-(CDC) funded Cancer
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Lessons Learned from a Pilot Project
July/August 2017
Prevention Control Research Network (CPCRN) to apply for funding from the American Cancer Society (ACS) to implement a pilot pharmacy-located HPV vaccination project. The project was conducted in collaboration with the UK College of Pharmacy and Total Care Pharmacy (TCP) in Morehead. This academic-community partnership allowed researchers to better meet the needs of the community, while also pooling resources and experience.14 For example, UK collaborators were able to offer program evaluation and technical assistance, while TCP leaders provided extensive insight into the target community and administration of the HPV vaccine.
UK team members were actively involved in adapting existing educational materials and marketing the project throughout Morehead and Rowan County. The UK team printed HPV vaccine-related posters and handouts produced by the CDC for providers, parents, adolescents and young adults and delivered them to TCP and student health services at Morehead State University (MSU). Between July and September, the team explored a variety of advertising mediums, including newspapers, radio stations, direct mailings, electronic billboards and face-to-face interactions, which were used to promote the availability of HPV vaccination at TCP.
Methods
Results: Process
In January 2016, UK researchers and TCP leadership met to discuss the project, including the HPV vaccination protocol, data collection, clarifying roles and responsibilities and identifying areas where investigators could be of assistance such as offering continuing education (CE) programming for pharmacy staff, advising on a reminder system and a tracking database and promoting HPV vaccination in the community by branding existing CDC educational materials with TCP information. Discussion also included the possibility of enrolling in the Kentucky Department for Public Health’s Vaccines for Children (VFC) program.15 Ultimately, TCP leadership decided not to pursue the VFC program, due to staff time constraints and facility limitations; however, the remainder of activities were implemented and are described herein.
For advertising purposes, the research staff printed, stamped and delivered 430+ envelopes to TCP, which contained a Frequently Asked Questions factsheet regarding HPV vaccination from the Immunization Action Coalition (IAC), as well as information about receiving the vaccine through TCP. Pharmacy staff addressed the envelopes and mailed them to age-eligible clients. In addition, UK collaborators scheduled a series of 30-second ads to air in fall 2016 on several local radio stations (WIVY, WQHY and WMKY) for a total of 237 ads. Four bi-weekly ads, designed by Research Communication Office at the UK Markey Cancer Center, also were printed in a local newspaper, along with an ad in a local community magazine. Finally, researchers coordinated IAC flyer and CDC poster distribution with community programs, including a back-to-school middle school event with 100+ families and student health services at MSU.
UK collaborators offered a CE session for TCP pharmacists, which focused specifically on HPV vaccination, in March 2016. The session included best practices, current guidelines and strategies to increase HPV vaccine uptake. In addition to CE credit, this training helped to ensure TCP pharmacists were up-to-date regarding current practices and recommendations related to HPV vaccination. With assistance from UK team members, TCP developed a reminder system for HPV vaccine doses 2 and 3. TCP documented patients’ receipt of HPV vaccination and provided record of the immunization to the patient's healthcare provider by fax or electronic method upon request. TCP also maintained a patient log using REDCap software, which was designed by UK to track each vaccination. Data entry included the following: date, name, sex, age, race/ethnicity, county of residence, insurance status, HPV dose number, patient reaction (if any) and pharmacist initials. In June 2016, TCP partnered with Gateway District Health Department to approve the HPV vaccination protocol and process for administering the vaccines under the protocol. The process involved TCP staff identifying age-eligible patients, contacting patients with reminders for subsequent doses, administering HPV vaccinations under the approved protocol and tracking each vaccination in the data log. Before administering the vaccination, patients or their legal guardians completed a screening questionnaire and signed an authorization form.
Results: Outcome Ultimately, three patients received a vaccine dose, and eight others scheduled appointments during the course of this project. Unfortunately, three interested patients were turned away because their insurers did not cover the vaccine in a pharmacy setting. However, the project had an impact on the community in terms of education about the HPV vaccine. In March 2016, four staff members attended the CE training session at TCP; when completing evaluation forms, staff members rated the session’s speakers, learning objectives and content with the highest scores (“excellent”). This CE was used to springboard an HPV vaccination-specific presentation at the 2016 Kentucky Pharmacists Association meeting attended by 25 pharmacists and 11 Doctor of Pharmacy students from UK. A similar CE presentation also was delivered to approximately 75 people who attended Northeast Kentucky Area Health Education Center’s Immunizations Conference in September 2016.16 Discussion Despite few administrations of the HPV vaccine in the pharmacy site, the team learned valuable lessons from this pilot project, which inform and guide future implementation of similar initiatives. Challenges included vaccine payment at pharmacies. For example, more work is needed to help pharma-
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THE KENTUCKY PHARMACIST
Lessons Learned from a Pilot Project
July/August 2017
cies enroll in the VFC program and manage the related requirements. It should be noted, however, that even if the pharmacy had participated in the VFC program, additional Medicaid policy changes are needed to ensure payment of the associated vaccine administration fee. Future conversations with payers about reimbursing pharmacies for delivering HPV vaccination – and subsequent changes in policy – would be useful. Similarly, understanding pharmacies’ capacity to participate in quality improvement projects and new vaccination initiatives is needed to maximize their involvement and buy-in. Since the end of this project, new legislation was passed in Kentucky allowing pharmacists to administer all age-appropriate vaccines via prescriber protocol down to age 9. This new policy in particular may remove barriers to pharmacies providing HPV vaccination given that the recommended age for completion of the HPV vaccine series is 1112 years.
community pharmacies located throughout Kentucky. Funding: American Cancer Society National HPV Vaccination Roundtable References 1. Centers for Disease Control and Prevention. Genital HPV Infection – Fact Sheet. http://www.cdc.gov/std/HPV/ STDFact-HPV.htm#a7 2. Centers for Disease Control and Prevention. HPV and Cancer. http://www.cdc.gov/cancer/hpv/statistics/ cases.htm
3. Meites E, Kempe A, Markowitz LE, Use of a 2-dose schedule for Human Papillomavirus vaccination – Updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Morta Wkly Rep 2016;65:1405-1408. DOI: http://dx.doi.org/10.15585/ mmwr.mm6533a4 In the process of developing a protocol and gathering promotional materials for recruitment, investigators easily found 4. Reagan-Steiner S, Yankey D, Jeyarajah J, et al. Nationhelpful educational materials about HPV vaccination for a al, regional, state, and selected local area vaccination range of target populations, including practitioners, parents, coverage among adolescents aged 13-17 years – United young adults and adolescents. The team used posters and States, 2015. MMWR Morb Morta Wkly Rep 2016;65:850 flyers available on the CDC website for commercial printing -858. DOI: http//dx.doi.org/10.15585.mmwr.mm6533a4 for display throughout the community. One improvement that 5. Accelerating HPV Vaccine Uptake: Urgency for Action to could be made to the available materials focused on HPV Prevent Cancer. A Report to the President of the United vaccination would be an increased availability of versions in States from the President’s Cancer Panel. Bethesda, various languages or the ability to tailor the materials to inMD: National Cancer Institute; 2014. clude pictures of local youth and community providers. 6. Rothholz M, Tan LL. Promoting the immunization neighThrough this academic-community collaboration, new partborhood: benefits and challenges of pharmacies as addinerships were formed between UK Colleges of Public Health tional locations for HPV vaccination. Hum Vaccin Immuand Pharmacy, TCP and Gateway District Health Departnother. 2016; 12(6):1646-8. doi: ment, which could be beneficial for future “scaled-up” inter10.1080/21645515.2016.1175892. ventions in eastern Kentucky pharmacies. The program also provided CE for TCP staff members, as well as pharmacists 7. Goad JA, Taitel MS, Fensterheim LE, Cannon AE. Vacand students across Kentucky regarding best practices and cinations administered during off-clinic hours at a nationways to increase uptake of HPV vaccination. Finally, through al community pharmacy: implications for increasing paadvertising efforts and community engagement, this program tient access and convenience. Ann Fam Med. 2013; 11 raised awareness regarding the benefits and current recom(5):429-36. doi: 10.1370/afm.1542. mendations for vaccinating adolescents against HPV. 8. Brewer NT, Chung JK, Baker HM, Rothholz MC, Smith Conclusion JS. Pharmacist authority to provide HPV vaccine: novel partners in cervical cancer prevention. Gynecol OnDelivery of the HPV vaccine using pharmacy-public health col. 2014; 132 Suppl 1:S3-8. doi: 10.1016/ partnerships is a promising model for the improvement of j.ygyno.2013.12.020. immunization rates through the use of alternative settings. Preliminary public reactions were positive, recognizing the convenience presented by longer business hours and the walk-in availability of HPV vaccination in pharmacies. Pharmacists were eager and competent vaccine providers, with the largest barrier encountered during the payment process. Lessons learned will be used to inform future collaborative opportunities to increase HPV vaccination rates. Additionally, we would pursue possible expansion of the pilot project, for instance to the five additional TCP pharmacy sites, or other
9. Skiles MP, Cai J, English A, Ford CA. Retail pharmacies and adolescent vaccination--an exploration of current issues. J Adolesc Health. 2011; 48(6):630-2. doi: 10.1016/j.jadohealth.2010.09.003. 10. Trogdon JG, Shafer PR, Shah PD, Calo WA. Are state laws granting pharmacists authority to vaccinate associated with HPV vaccination rates among adolescents? Vaccine. 2016; 34(38):4514-9. doi: 10.1016/ j.vaccine.2016.07.056. 35
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Lessons Learned from a Pilot Project
July/August 2017
11. William A. Calo, Melissa B. Gilkey, et al. (2017). Parents' willingness to get human papillomavirus vaccination for their adolescent children at a pharmacy. Preventive Medicine, 99, 251-256, ISSN 0091-7435, https://doi.org/10.1016/j.ypmed.2017.02.003.
1178222617692538. http:// doi.org/10.1177/1178222617692538 14. Lesser, J., & Oscos-Sanchez, M.A. (2007). Community -academic research partnerships with vulnerable populations, Annual Review of Nursing Research, 25(1), 317–337
12. Rothholz M, Tan LL. Promoting the immunization neighborhood: Benefits and challenges of pharmacies 15. Health Care Professionals: Vaccines for Children. as additional locations for HPV vaccination Hum Vaccin (2017). Retrieved May 11, 2017, from http:// Immunother. 2016; 12(6):1646-8. doi: chfs.ky.gov/dph/epi/Health Care Professionals.htm 10.1080/21645515.2016.1175892. 16. Calendar: Immunizations Conference (2016). Northeast 13. Islam, J. Y., Gruber, J. F., Lockhart, A., et al. (2017). Kentucky Area Health Education Center. Retrieved Opportunities and challenges of adolescent and adult May 2017. http://www.neahec.org/calendar.aspx? vaccination administration within pharmacies in the eventid=765 United States. Biomedical Informatics Insights, 9,
The Campaign for Kentucky’s Pharmacy Future
Make your donation online at http://www.kypharmacyfuture.net/ Are you connected to YOUR KPhA? Join us online! Facebook.com/KyPharmAssoc Facebook.com/ KPhA Company Page @KyPharmAssoc @KPhAGrassroots
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THE KENTUCKY PHARMACIST
July/August 2017
NEW in 2017!
Two of the six editions of The Kentucky Pharmacist will be published online only. To access the online version, go to www.kphanet.org, click on Communications and then on The Kentucky Pharmacist link. Continuing Education articles are available to KPhA Members electronically under the Education tab on the KPERF CE Articles page (log-in required).
The March/April and November/December editions will be electronic only. Would you rather receive all of the journals electronically? Email info@kphanet.org to be placed on the KPhA Green List for electronic delivery. Once the journal is published online, you will receive an email with a link to the online version. Contact KPhA at info@kphanet.org or call the KPhA Headquarters at 502-227-2303 with questions.
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THE KENTUCKY PHARMACIST
July/August 2017
KPhA New and Returning Members
KPhA Welcomes New and Renewing Members May-June 2017
Cathy A Adams Pineville
Cindy Ann Biecker Edgewood
John C Cerrito Louisville
John Adams Lebanon
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Margaret Christopher Winchester
Sandra Foster Anderson Monticello
Raymond J Bishop Louisville
Heather Clayton Elkton
Heather Anderson Louisville
Kara G Blevins Catlettsburg
Chris Clifton Villa Hills
Michael Andrews Almo
Nick Boggess Flatwoods
Katy Clifton Villa Hils
Danielle Jon Ayres Nicholasville
Kenneth M Boggs Hazard
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Karen L Baisch Louisville
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Elizabeth Ashley Coomes Bardstown
Jason K Baker Louisville
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Paul M Cooper Morehead
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David E Bowman Columbia
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Benjamin Brown Louisville
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Daniel Beebe Cincinnati, Ohio
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Martina Bennett London
Joseph Ryne Carroll Salyersville
Jeffrey W Danhauer Owensboro
William J Bentley South Shore
John E Carver Louisville
Alan Daniels Georgetown
Robert Michael Bero New Bern, N.C.
Terry W. Case Georgetown
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R Michael Cayce Hopkinsville
Steven Dawson McDowell
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Amy Beth Delcourt Minford, Ohio
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MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession! Seth Herbert DePasquale Lexington Leah Hill DeVaughn Richmond Dave Dickerson Morehead Jackie Dickerson-Galer Inez Steve Doom Elizabethtown Barry L. Eadens Bowling Green Kevin Emberton Edmonton Ashley Current Eschenbach Louisville John B Evans Eddyville Jamie Lee Ferrell Winchester Jaime Janielle Fields Hindman Timothy Lee Finley Florence Alan Flener Glasgow Celeste C Flick Crestview Hills Sophia June Foree Sulphur
THE KENTUCKY PHARMACIST
July/August 2017
KPhA New and Returning Members Sarah Foree Sulphur
Jimmi Hatton-Kolpek Lexington
Charles Preston Kluesner London
Judith Zax Minogue Louisville
Cathy N Francisco Pikeville
Melodie Hawkins Mt Sterling
Sarah M. Lawrence Louisville
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Patricia Freeman Lexington
J Gregg Henry Greenville
Thomas Lawrence Carlisle
Jeffrey Bernard Moore Middlesboro
Aaron Michael Gilbert Butler
Kirstyn Michelle Hill Lexington
Tim S. Lawson Corbin
Sonya Muncy Russell
Michelle Elizabeth Gilbert Butler
Dana N. Ho Louisville
William M. Leake Danville
Erica Christine Neff Florence
Thomas P Glover Providence
Cassandra Hobbs Louisville
Kenneth Wayne Lipscomb London
Brad Newcomb Paducah
Ben W Gower Henderson
Tom Houchens London
Andrew Logsdon Barlow
Chasity Brooke Nichols London
Dwaine K Green The Villages, Fla.
Jan Houchens London
Claire W. Love Lexington
Frank Nicks Bowling Green
Kyle Lee Griffin LaGrange
Reymonda Gail Howard London
Robert T Lucas Flatwoods
John F. Nie Independence
Monte J Gross Stanton
Jennifer Ihrig Hebron
Tara Anderson Mains Morehead
Miley Girgis Nikirk Lexington
Jill Elizabeth Grutza Maysville
John Inabnitt Somerset
Thomas Charles Mason Fairfield, Ohio
Jean Oldham Lexington
Don Gubser Melbourne
Karen Jackson Paducah
Kelly Maston Woodburn
David Wayne O'Quinn West Liberty
Tyler D Guess Marion
Barbara L Jolly Louisville
Sunni Mauk Paducah
Jamie Otte Florence
Larry Hadley Frankfort
Daniel L. Jones Paducah
George McDannold Eminence
Staci Overby Paducah
Ryan Haggard Richmond
Melinda Joyce Bowling Green
John McFarland London
Richard E. Parsons Lexington
Jeffrey W Hall Lexington
Clark Kebodeaux Lexington
Brittany Kidwell McIntyre Bardstown
Brookes Pickard Louisville
Kelsey Hall Louisville
Debra H. Kelley Nicholasville
Brandy McQuitty Bethel, Ohio
Michael Pipkin Gilbertsville
Catherine Hanna Lexington
Angela Parrett Kennedy Simpsonville
Lynita McWaters Paducah
Andrew Plott Lexington
Kathy Hardy Smiths Grove
Ann J Keown Scottsville
Mark Meador Scottsville
Aric P Polston Bowling Green
Kyle Harris London
Brian K. Key Pineville
Laurie Meeks Lexington
Haley Poston East Bernstadt
Clara J Hartgrove Martin
Patricia Kinney Erlanger
Linda Menner Henderson
Amanda Powers Boaz
John D Milam Lexington
Elizabeth A. Prather Florence
Christopher Matthew Miller Louisville
John T Price Louisvillle
Dan Minogue Louisville
Joshua Seth Profitt Lexington
KPhA Honorary Life Members Ralph Bouvette, Leon Claywell, R. David Cobb, Gloria Doughty, Ann Amerson Mazone, Kenneth Roberts, Sam Willett
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THE KENTUCKY PHARMACIST
KPhA New and Returning Members
July/August 2017
Andrew Rich Lexington
Shanna Spalding Louisville
Natalie Marie Weber Lexington
Betty Ritchie Jeff
Katherine Spencer Louisville
Matthew A Westling Lexington
Marcella Robinson Paducah
Julie Kay Spivey Lexington
Tonya Westmoreland Lowmansville
Alyson Claywell Roby Bardstown
Scott Stephens Cynthiana
Rodney Whittington Princeton
Frank Romanelli Lexington
Dan Stevenson Vanceburg
Gary Wientjes Lexington
Barry Rose Clay City
Christopher Scott Stovall London
Charlsie Williams Murray
Richard Ross Louisville
Jacquelyn Strickland Hopkinsville
Tori Marissa Williams Lexington
Thomas Runge Union
Anna Studtmann Lexington
Clyde J. Wilson Danville
Doug Russell Louisville
David Bradley Stultz Greenup
James Blake Wiseman Benton
Jessica L Salmons Hazard
Brianna Katherine Sullivan Lexington
Reginald David Woolf South Fulton, Tenn.
Joanna H Sames Shelbyville
Gene Thompson Lexington
Whitney Wright Dixon
Denise Schickling Villa Hills
Judy B Thompson Argillite
Delaney Wright Independence
Lisa Schwartz Crestview Hills
Clint Adam Tilford West Paducah
Michael B Wyant Finchville
William J. Sewell Utica
Kathryn Nicole Trueblood Madison, Ind.
Jeanne Zeis Covington
Mohammed Shailuddin Brentwood, Tenn.
Clifford P Tsuboi Lexington
Frances Sherrill Paducah
Shelby Spencer Tungate Campbellsville
Rayean Sifri Cincinnati, Ohio
Jason Underwood Shelbyville
John Simkins Somerset
Sarah B Vickey Wilmore
Lisa Smith Dry Ridge
William Wagers Berea
Ronald Smith Hazard
Joseph L Wagner Louisville
Marla Rae Smoot Crittenden
Earnest J. Watts Cornettsville
Know someone who should be on this list? Ask them to join YOU in supporting OUR KPhA!
http://www.kypharmacyfuture.net/ 40
THE KENTUCKY PHARMACIST
139th KPhA Annual Meeting and Convention
July/August 2017
KPhA Would Like to Thank Our 2017 Sponsors Event Sponsors
KPERF Golf Hole Sponsors
American Pharmacy Services Corporation Jefferson County Academy of Pharmacists KPhA Past Presidents Kroger Corporation—Mid-South Division Northern Kentucky Pharmacists Association Novo Nordisk Pharmacists Mutual Co. Insurance Sullivan University College of Pharmacy Transaction Data Systems Inc. (Rx30) University of Kentucky College of Pharmacy
Annual Meeting Supporters Rx Systems, Inc. Kroger—Cincinnati Division KDPH-Diabetes Prevention & Control and Heart Disease & Stroke Programs
Sponsoring Pharmacy’s Future Cardinal Health Customers in Kentucky C&C Pharmacy ( Chris Palutis) Matt Carrico Jessika Chilton Chinn Brian Fingerson Trish Freeman Humana McKesson Corporation
Miami-Luken National Association of Chain Drug Stores Duane Parsons Richard & Zena Slone Wellcare Sam Willett
Ad-Venture Promotions Bingham Greenebaum Doll LLP Booneville Discount Drug Friend of the C&C Pharmacy Compliant Pharmacy Alliance Profession Compliant The Clifton Family Pharmacy Alliance Duncan Prescription Center Flexible Pharmacy Services Fred’s Pharmacies George Hammons, Frankie Abner & Tom Houchens Harrod & Associates Medica Pharmacy and Wellness Center Pharmacists Mutual Co. Insurance Poole’s Pharmacy Care Republic Bank & Trust Rx Discount Pharmacy St. Matthews Community Pharmacy Stites & Harbison, PLLC Sullivan University College of Pharmacy Joel Thornbury
Government Affairs Program Support American Pharmacy Cooperative, Inc.
… and our 2017 Exhibitors
Adapt Pharmaceuticals Allergan Amarin Pharmaceuticals American Pharmacy Cooperative, Inc. AmerisourceBergen American Pharmacy Services Corp. Anthem Medicaid Cardinal Health Compliant Pharmacy Alliance Computer Rx EPIC Pharmacies, Inc. Fred’s Pharmacy GeriMed
HD Smith Ideal Protein of America Inventory IQ Kentucky Cabinet for Health & Family Services (KASPER) Kentucky Dept. for Public Health— Immunization Kentucky Health Information Exchange Kentucky Renaissance Pharmacy Museum KOWA Pharmaceuticals McKesson Pharmaceutical Merck Miami Luken
Pfizer Pharmacists Mutual Companies Purdue Pharma QS/1 Retractable Technologies Inc. Samuels Products, Inc. Scrub World Smith Drug Company SUCOP Student Organizations Two Dimensional Instruments LLC UK COP Experiential Ed/ CAPP UK Student Organizations Union Springs Integrative Medicine Walgreens
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THE KENTUCKY PHARMACIST
139th KPhA Annual Meeting and Convention
July/August 2017
Thank you to the outgoing Board members.
Members participate in a continuing education session.
Members take notes in a continuing education session.
Sam Willett networks with conference attendees.
Save the Date! 140th KPhA Annual Meeting & Convention June 14-17, 2018 Covington
Students pose for a photo.
Clark Kebeaux presents a continuing education session.
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THE KENTUCKY PHARMACIST
139th KPhA Annual Meeting and Convention
July/August 2017
Mark Glasper networks with members.
Chris Palutis engages with an exhibitor.
Thank you to our exhibitors and sponsors!
An exhibitor connects with conference attendees.
The exhibit hall bustles with activity. 43
THE KENTUCKY PHARMACIST
Pharmacy Policy Issues
July/August 2017
PHARMACY POLICY ISSUES: The Implications of Electronic Prescribing for Pharmacy Practice
Author: Kelsey L. Dieters is a PY3 student in the PharmD program at the University of Kentucky College of Pharmacy. A native of Shelby Township, Mich., she completed her pre-professional studies at The Ohio State University and UK. Issue: During my time in the profession, I’ve witnessed the tremendous impact of information technology resources on the day-to-day operations within a pharmacy. Availability of computers has eased the impact of preparing more prescriptions while at the same time assuring that the medication will assist the patient’s overall health condition. Now we’re receiving prescriptions that the prescriber has transmitted electronically. What are some of the implications of this innovation? Discussion: Pharmacy is an everThese limitations can lead to paHave an Idea? changing profession that continues to tient frustration and prolonged This column is designed to push the boundaries in order to optiwaiting times following arrival at address timely and practical mize patient care. Throughout the the pharmacy. issues of interest to pharmacists, years, the invention of technology has Although challenges are evident, pharmacy interns and pharmacy greatly impacted the practice of phare-prescribing has certainly benetechnicians with the goal being to macy. As computers became more fited the practice of pharmacy. By encourage thought, reflection and advanced with secure databases, eliminating the potential threat of exchange among practitioners. electronic prescriptions evolved as the misreading a prescription due to Suggestions regarding topics for last type of accepted prescription form illegible handwriting or creating a consideration are welcome. Please to date. Electronic prescribing, or etranscription error when a presend them to jfink@uky.edu. prescribing, has become even more scription has arrived via commonplace in pharmacies today voicemail, e-prescribing serves as with the usage of iPads by prescribers. a means to reduce medication Although e-prescribing has provided many benefits to the errors. Even though errors can still occur, e-prescribing practice of pharmacy, what challenges has it imposed helps patients to receive their medication more quickly upon pharmacy staff? Have both patients and pharmacy due to the fact that it allows prescribers to send prescripstaff taken this once seen luxury for granted in our current tions directly to the patient’s pharmacy. Not only does this technology driven, fast-paced society? save time, it is more convenient for patients, especially for Theoretically, e-prescribing is the quickest way for pharthose who are unable to drive or are very ill. Furthermore, macies to receive a prescription, but prescriptions do not electronic prescription orders are an asset to both patients always come through with ease. For example, confusing and pharmacists because they eliminate the potential of instructions or discrepancies between the quantity and misplacing the hardcopy prescription and assist with day supply are frequently seen in the community setting. recordkeeping requirements, respectively. As a result, a pharmacy staff member has to call the preUltimately, the utilization of technology and development scriber’s office to clarify the prescription order. Additionalof e-prescribing allows prescribers and pharmacists to ly, electronic prescriptions for Schedule II controlled subuse their time more efficiently. Although some drawbacks stances pose specific challenges under federal regulaare evident, e-prescribing has beneficially impacted phartions. These include the inability to fix data entry errors macy practice. The assistance of technology has led to even after clarification from a prescriber or to transfer preimproved patient safety, medication adherence and overscriptions. A practicing community pharmacist referenced all quality of care. It truly is an exciting time to see how this drawback specifically when the pharmacy is out of technological advancements play a role in pharmacy stock of a medication and the patient needs the medicapractice. How will technology continue to evolve and imtion the same day. Since pharmacists are not permitted to pact patient care? What implications will it have on pharprint the electronic C-II prescription to give to the patient, macy staff and patients? With both technology and the the prescriber would have to be contacted in order to profession of pharmacy continually changing, the possibilsend a new C–II prescription to a different pharmacy. ities are endless!
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THE KENTUCKY PHARMACIST
139th KPhA Annual Meeting and Convention
July/August 2017
New Board Members Past President Representative Jessika Chinn, UK Student Rep Jaclyn Ochsner, Sullivan Student Rep Nathan Hughes, Director Richard Slone and Director Angela Brunemann.
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THE KENTUCKY PHARMACIST
Pharmacy Law Brief
July/August 2017
Pharmacy Law Brief: Denial of Coverage for Experimental or Investigational Therapy Author: Joseph L. Fink III, B.S. Pharm., J.D., Professor of Pharmacy Law and Policy and KPhA Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy
Question: I had a patient come in to tell me that her insurance company was declining to cover or pay for a certain therapy she was receiving because it deemed that therapeutic approach to be experimental rather than established. How can an insurance company do that? Does she have any recourse? Response: Insurance contracts between the insurer and the insured nearly always include a set of provisions designated “Exclusions.” In this section of the written agreement, the policy specifies those instances where the coverage will not apply. This is seen with one’s homeowner’s policy (e.g., does not apply to cover flood damage) or automobile policy (e.g., no coverage if the vehicle is rented to others or used to carry persons for a charge). Even traditional indemnity health insurance policies typically had provisions excluding from coverage treatment that is “investigative in nature.” What recourse exists if a patient needs a form of therapy deemed experimental or investigational by the insurer or health care plan? Does the patient have a legal basis to challenge a decision if coverage is denied? Katherine Benesch, writing in a publication of the Health Law Section of the American Bar Association, pointed out that indeed a patient in such a situation may have, at least theoretically, expanded options compared to the situation, say, at the middle of the last century: In the past, these issues (of legal liability) were straightforward. There were two parties to choose from – the doctor and the hospital, and liability sounded in (was based on) tort. Courts today are finding liability on the part of individual physicians, both as employees and as independent contractors, hospitals, HMO’s, and IPA’s. In fact, some courts are beginning to find liability against insurance carriers and utilization review organizations whose decisions have been found to interfere with medical decision-making which caused injury to the patient. (Parenthetical statements added for clarity)1 The basis for a claim against the plan used to be able to be rooted in a number of legal theories, with negligence being the most common. However, an additional theory comes from a federal statute known as the Employee Retirement Income Security Act (ERISA). This statute directs that an administrator of an employer-sponsored health insurance plan is to act solely in the interest of the employ-
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.
ee enrollees and beneficiaries, and to discharge responsibilities with prudence.2 If the plan administrator breaches the fiduciary duty owed the beneficiary the individual covered under the plan can bring a civil suit under ERISA. 3 Some treatments commonly accepted in the medical community may, nonetheless, be regarded as experimental or investigational by certain managed care plans. Under this latter approach, the plan may cover only a portion, or perhaps even none, of the expense for that treatment or procedure, invoking the exclusion clause in the policy to deny coverage. Moreover, therapeutic measures accepted as eligible for coverage under the insurance scheme may later be considered ineligible for coverage. An example of this was seen with the position of Medicare covering and then excluding lung reduction surgery for treatment of emphysema.4 Later reversing position again, the Centers for Medicare and Medicaid Services revisited and revised that position.5 Cases involving denial of coverage for experimental or investigative therapies were at one point very prevalent and prominent. They were highly celebrated in the media, for both lay and professional audiences, but especially for the public because of the David versus Goliath implications. But the clamor has diminished because of a U.S. Supreme Court ruling about cases alleging denial of claims or denial of coverage. The decision in the case of Aetna Health, Inc. v. Davila is a stringent decision from the U.S. Supreme Court on the issue of whether beneficiaries of employer-sponsored health plans may sue for damages under state law for injuries allegedly sustained as a result of the plan’s coverage decisions.6 The Court ruled that ERISA provides the exclusive remedy. If a state-level statute purports to duplicate,
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THE KENTUCKY PHARMACIST
Pharmacy Law Brief
July/August 2017
supplement or supplant the remedies under ERISA it is of no effect. Such lawsuits can be complex and there are now attorneys and law firms that focus their practices in that area. If the patient with whom you spoke has her health insurance coverage through an employer-sponsored plan she may wish to consult an attorney with such expertise.
2.
29 U.S.C. §1104(a)(1).
3.
29 U.S.C. §1132(a)(2).
4. Associated Press. Medicare stops funding emphysema surgery, February 3, 1996.
References:
5. CMS Manual (online), Publication 100-03, Section 240.1.
1. Benesch K. Managed care liability: An expansion of familiar theories. The Health Lawyer 1996-97;9:8.
6. Aetna Health, Inc. fka Aetna U.S. Healthcare Inc. v. Davila, 542 U.S. 200 (2004).
Donors to the Campaign for Kentucky’s Pharmacy Future as of July 1, 2017
Anonymous Jeff Arnold Ray Bishop Lanny Branstetter William R. Brown Fred Carrico Matt Carrico Jessika Chinn Margaret Christopher J. Leon & Margaret Claywell Chris & Katy Clifton Kim Croley C. Michael Davenport Marshall Davis David Dubrock James & Debra Dunaway Paul Easley Ashley Eschenbach First District Brian Fingerson Renie & Joseph L. Fink III Matt Foltz Tim Ford Andrew & Virginia France Thomas Roe Frazer Trish Freeman Angela Gibson Robert Goforth Cynthia Gray Kelsey L. Hall George & Burnetta Hammons
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Cathy Hance Christopher Harlow Josiah Jaggers JCAP KPhA First District Michael & Lee Ann Keller Don & Vicki Kupper Phil & Julie Losch Claire Love Joe Mashni Wayne Morris Bob Oakley Chris & Consuelo Palutis Duane Parsons Pharmacists Month Ron & Lisa Poole Elizabeth Ramey Donnie Riley Richard Ross Melody Ryan Richard & Zena Slone Kelly Smith Jo Anne Taheri Leah Tolliver Robert & Jason Wallace Lewis & Kim Wilkerson Sam Willett Jacob & Carol Wishnia Michael & Mary Ann Wyant
THE KENTUCKY PHARMACIST
July/August 2017
Pharmacists Mutual
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THE KENTUCKY PHARMACIST
Cardinal Health
July/August 2017
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THE KENTUCKY PHARMACIST
KPhA Board of Directors/KPERF Board of Directors
KPhA BOARD OF DIRECTORS Trish Freeman, Lexington trish.freeman@uky.edu
Chair
Chris Harlow, Louisville cpharlow@gmail.com
July/August 2017
KPERF BOARD OF DIRECTORS Bob Oakley, Louisville rsoakley21@gmail.com
Chair
President
Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu
Secretary
Chris Palutis, Lexington chris@candcrx.com
President-Elect
Duane Parsons, Richmond dandlparsons@roadrunner.com
Treasurer
Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com
Secretary
Chris Harlow, Louisville cpharlow@gmail.com
President
Duane Parsons, Richmond dandlparsons@roadrunner.com
Treasurer
Paul Easley, Louisville rpeasley@bellsouth.net
Jessika Chinn, Beaver Dam jessikachilton@ymail.com
Past President Representative
Melinda Joyce, Bowling Green MBJoyce@chc.net
Directors
Sarah Lawrence, Louisville slawrence@sullivan.edu
Angela Brunemann, Union Angbrunie@gmail.com
Kelly Smith, Lexington ksmit1@email.uky.edu
Matt Carrico, Louisville* matt@boonevilledrugs.com
KPERF ADVISORY COUNCIL
Jaclyn Ochsner, Lexington jaclyn.Ochsner@uky.edu
University of Kentucky Student Representative
Matt Carrico, Louisville matt@boonevilledrugs.com
Chad Corum, Manchester pharmdky21@gmail.com
Kim Croley, Corbin kscroley@yahoo.com
Cassy Hobbs, Louisville cbeyerle01@gmail.com
Kimberly Daugherty, Louisville kdaugherty@sullivan.edu
Nathan Hughes, Louisville Sullivan University nhughe1030@my.sullivan.edu Student Representative
Mary Thacker, Louisville mary.thacker@att.net
Chris Killmeier, Louisville cdkillmeier@hotmail.com
KPhA/KPERF HEADQUARTERS
96 C Michael Davenport Blvd., 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
Don Kupper, Louisville donku.ulh@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield willettsam@bellsouth.net *At-Large Member to Executive Committee
HOUSE OF DELEGATES Amanda Jett, Louisville ajett@sullivan.edu
Tyler Stephens, Lexington stevens.tyler@uky.edu
Speaker of the House Vice Speaker of the House
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July/August 2017
50 Years Ago at KPhA FROM KENTUCKY AT A GLANCE Dr. Joseph V. Swintosky, Dean of the University of Kentucky College of Pharmacy and President of the APhA Academy of Pharmaceutical Sciences, will take part in the VIII Scientific Congress of the Polish Pharmaceutical Society. Dr. Swintosky will present a scientific paper at one of the August 2426 session in Lublin, Poland. He will also confer with leading pharmaceutical scientists in several other countries - From The Kentucky Pharmacist, August 1967, Volume XXX, Number 8.
Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd. 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 Kentucky Regional Poison Center (800) 222-1222 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 SUCOP 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu
KPhA Staff
Classifieds
Mark Glasper Executive Director mglasper@kphanet.org
Parata Max for sale. Contact Larry Hadley at 502-330-4398
Sarah Brandenburg Director of Communications & Continuing Education sbrandenburg@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Pharmacy Emergency Preparedness jjaggers@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org
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. 51
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The Kentucky Pharmacist 96 C Michael Davenport Blvd. Frankfort, KY 40601
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