Y K C U T N E K THE T S I C A M R A PH Vol. 10, No. 2 March/April 2015
2015 Legislative Session Wins
CCA Bill Signed
Medication Synch Signed
Repeal of HIV CE Requirement Signed
Increased patient access to Naloxone through pharmacists
More work to do
PBM Transparency
Involvement in medical marijuana discussions
Register Now! www.kphanet.org Membership Matters in YOUR KPhA News & Information for Members of the Kentucky Pharmacists Association
Table of Contents
March/April 2015 2015 KPERF Golf Scramble March 2015 CE — Cholesterol Guidelines March Pharmacist/Pharmacy Tech Quiz Kentucky Renaissance Pharmacy Museum KPhA New and Returning Members Pharmacy Law Brief Pharmacy Policy Issues Pharmacists Mutual Cardinal Health KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted
Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 137th KPhA Annual Meeting & Convention From your Executive Director APSC 2015 KPhA Board of Directors Election Feb. 2015 CE — Pneumococcal Vaccination February Pharmacist/Pharmacy Tech Quiz KPhA Emergency Preparedness: Winter Storms Response Technician Review
2 3 4 6 8 9 12 18 19 20
21 22 30 31 32 36 38 40 41 42 43
Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will keep abreast of developments and maintain professional competency in my profession of pharmacy. I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.
Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.
Editorial Office: © Copyright 2015 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.
The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance. It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation. Additionally, feedback from learners will be used to improve the overall programming designed by KPERF. 2
THE KENTUCKY PHARMACIST
President’s Perspective
March/April 2015
What is Leadership? PRESIDENT’S PERSPECTIVE
KPhA, and Jan Gould from the Kentucky Retail Federation, help to close the deal with successful legislative efforts; however, it cannot happen without the hard work of the leaders before them.
Robert Oakley
Rebuilding for the Future Leadership
KPhA President 2014-2015
In previous columns, I have discussed my goal of starting a fund to “rebuild for the future” to make sure that KPhA has sufficient funds to maintain adequate office space to meet our needs for the future. I have proceeded slowly in this Every organization such as project because I want to make sure that we have done our YOUR KPhA needs leaderdue diligence to determine what the exact needs will be for ship to thrive and survive. the future. At the last Board meeting, the Board showed But what is leadership? I true leadership by requesting Bob McFalls and I to consider think all of us have a differall potential opportunities in regards to the current KPhA ent concept or idea as to building. These options include the cost of repair of the curwhat leadership is and what it takes to be a leader. The standard definition from the dictionary would describe lead- rent building versus potential replacement of the building. ership as: “1. Condition of being a leader, 2. Ability to lead, KPhA is fortunate that our past leaders of the association 3. Guidance or direction.” When I speak of leadership, I am had the foresight to buy the land on which the current not referring to myself as President of KPhA. I am speaking KPhA building was built. Given the location, the property may be of greater value than the current building. My goal of the many examples of leadership that I see each and is to complete this review and have the options and their every day as I interact with the many active members of costs available for presentation to the House of Delegates YOUR KPhA. These would include the members of the KPhA Board, KPhA Committee members and the Commit- in June for your discussion, review and approval. tee Chairs, members who choose to get involved by conFuture Leaders tacting their state and federal representatives to advance I was fortunate to have been invited to participate in the the legislative agenda of the profession, and the future November Leadership seminar at SUCOP. The event was leaders of the profession and KPhA. This is by no means co-sponsored by KPhA and JCAP. It was organized by the an exhaustive list of the leaders I have seen, but they are meant to serve as a sample. I will try to tie it all together in new pharmacy leadership society at SUCOP, Phi Lambda Sigma. It was very impressive to see so many students the following paragraphs. choose to spend their Saturday attending a leadership Legislative Leadership seminar. Chris Harlow (JCAP President, KPhA Vice Speaker of the House) was the keynote speaker. He gave a fanDuring this year’s Kentucky Legislative Session, HB 377 tastic talk on “The Role of Leadership in the Advancement (Collaborative Care Agreement) and SB 44 (Medication Synchronization) were passed by both houses of the legis- of Your Pharmacy Career.” I think following his talk, Chris has a big Twitter following from SUCOP students. The next lature and signed into law by the governor. These did not speaker was Beth Hicks, a counselor from Assumption happen on their own. It happened by the hard work and leadership shown by many KPhA members. The leadership High School. She administered the Myers Briggs Personalito make these happen starts with the KPhA members who ty style test to the group. It made for very interesting dishave made donations to the Government Affairs Committee cussions. The concluding remarks were by SUCOP Dean (GAC) and to KPPAC. Next, it is the members who lead by Cindy Stowe who spoke on “Day to Day Leadership.” All speakers were well received by the students. personally contacting their Senators and Representatives to urge their support of these important pieces of legislation. The work of the GAC under the leadership of Richard Slone is the next key piece of the legislative process. The leadership of Bob McFalls, Executive Director of YOUR
In my welcoming remarks, I shared my thoughts on how
Continued on Page 7 3
THE KENTUCKY PHARMACIST
137th KPhA Annual Meeting & Convention
March/April 2015
Registration Form Please print the following information and check the applicable boxes.
All meals are included for registrants except for Ray Wirth Banquet. Tickets will be provided for Ray Wirth Banquet at registration table. KPhA made this change to improve the accuracy of ordering meals for the event. If you require special assistance or special diet, please call us at (502) 227-2303 or email ssisco@kphanet.org. First Name
Middle Initial
Last Name
PREFERRED BADGE NAME
Preferred Street Address
City
State
Daytime Telephone Number
Preferred Email Address
Zip Code
Business Affiliation
Pre-Conference Event Registration (NOT included in registration fees) MTM Certification program on 6/25/2015 registration is available at http://pages.sullivan.edu/wellness/mtm-certificate-training6-25-15.aspx Registration is open to all KPhA members. If you are not a current member, log in at www.kphanet.org, call 502-227-2303, or include membership with your registration. Membership rates: Pharmacists $225, Joint Members $335, Associate Members $225, Senior Pharmacist $150, Retired $120, Joint Retired $180, Technician $50, New Practitioner First year $70, New Practitioner Second Year $140. Single Day Registration Select Day: Friday – Saturday - Sunday
Full Registration Before June 10 Pharmacist Member Technician Member Resident Student Registration Total
$ 200.00 $ 28.00 $ 88.00 $ 8.00
After June 10 $ $ $ $
250.00 35.00 110.00 10.00
Before June 10 $ 100.00 $ 24.00 $ 60.00
Ray Wirth Banquet
After June 10 $ 125.00 $ 30.00 $ 75.00
$25.00 $25.00 $25.00 $5.00
Meal Events: Please indicate the total number that will be attending each meal event. Day Fri, June 26 Sat, June 27 Sat, June 27
Meal Event
Self
KPhA Award Luncheon Preceptor Recognition Luncheon Ray Wirth Banquet
Guest(s) Name
@ $30 ea. @ $30 ea. @ $50 ea.
Total for Additional Guest(s) Meals Check Payment: Payable to KPhA and mail to KPhA, 1228 US 127 South, Frankfort KY 40601 Credit Card Payment: Log onto www.kphanet.org and register online, or call 502-227-2303 to pay over the phone.
# Guest(s)
$
Overnight Accommodations: KPhA Members will want to stay at the Holiday Inn University Plaza Hotel during the KPhA Annual Meeting at a reduced rate of $129/night for single and double occupancy. Overnight accommodations can be made by through a link at http://www.kphanet.org/?page=AnnualMeeting. The Group Code is KPA. Lodging rate includes wireless internet access.
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THE KENTUCKY PHARMACIST
137th KPhA Annual Meeting & Convention
March/April 2015
CE Topics
Addiction and the Interesting New Substances of Abuse
Diabetes Update
Naloxone Update
Good Quality Supplements
Continuity of Operations Plan for Disaster Response
News Drugs
Law Update
Patient Safely for Technicians
And an updated, interactive Preceptor training program
And much more!
Come join the fun! 5
THE KENTUCKY PHARMACIST
From Your Executive Director
March/April 2015
MESSAGE FROM YOUR
EXECUTIVE DIRECTOR Robert “Bob” McFalls After a challenging season of cold, ice and snow, isn’t it great to welcome Spring and embrace the warmth of the new season? Who knew that Kentuckians would make national news — not once but twice — due to the two record snowfalls that covered the span of the entire Commonwealth? These winter storms led the governor to issue states of emergency each time. In conjunction with YOUR KPhA’s partnership with the Department for Public Health, Emergency Preparedness Branch, association staff were very involved in monitoring the impact that these storms had on the state with respect to patient access for needed prescriptions. And, the two storms could not have varied more in terms of their longevity. The February 16th Winter Storm was followed by a chilly forecast that kept us surrounded by snow and ice for days on end. True to form, in randomly checking with pharmacies from one end of the state to the other, and in monitoring Facebook posts, it was reassuring to see that pharmacists had found a way to open their doors to assure patients had access to needed medications. Patients can always count on their pharmacists and their technicians! However, there was a concern. Many patients had prescriptions that had expired and could not get in touch with their family physicians due to office closings. YOUR KPhA staff escalated this concern with state officials on Day 1 and requested consideration for a statewide declaration for emergency prescription refills the afternoon the storm hit. As you will recall, within 24 hours, Governor Steve Beshear issued an executive order to allow pharmacists to “dispense emergency refills of up to a 30 day supply of any non-scheduled medication for residents of any county of the Commonwealth.” That initial Emergency Order, signed on February 17, was for one week and, due to continuing poor weather conditions, was subsequently extended by Governor Beshear for an additional week, i.e., from February 24 until March 3.
To view the whole emergency order, visit http://www.kphanet.org/?page=33
lowing a devastating ice storm in the winter of 2009. That effort culminated in the passage of our current legislation that gives pharmacists additional tools in order to serve their patients during natural and man-made disasters. The law allows the Governor to grant expanded Interesting enough, I was contacted by a couple of other powers to pharmacists in the event of a declared state of state pharmacy associations who inquired about our legisla- emergency. It has been invoked a few times since 2010 — tion. KPhA began setting the stage for legislation to grant including the 2012 tornadic disaster that impacted West expanded powers to pharmacists during emergencies folLiberty and other affected communities — and has dramati6
THE KENTUCKY PHARMACIST
From Your Executive Director
March/April 2015
cally helped pharmacists meet patient needs during disasters. YOUR KPhA has had the occasion to ask Governor Beshear to invoke the emergency legislation twice now, since expanding our Emergency Preparedness partnership with KDPH. Other states are interested in learning about the history of our legislation, and one state executive expressed concern about how patients could easily slip through the cracks and possibly die without the protections that our legislation provides. Saving one individual is what it is all about, and assuring ongoing access to needed medications is both responsible and compassionate health policy.
in Space movie of, "Warning! Warning!", and "Danger, Will Robinson!" Let us consider ourselves blessed that keen minds had the forethought to bring forward this legislation to make sure that patient needs can be met, and that their emotional well-being is kept in check when their pharmacist is able to reassure them that a plan was in place and their medication can be filled “right here, right now.” The weather was enough to worry about — kudos to all of you who were able to intervene and soften the warning light by removing the danger of even one patient not being able to keep his or her medication therapy in check. This legislation should be a source of pride for all of us — and more importantly — for the patients who count on you everyday.
I am a fan of classic lines from movies. Like me, you may recall those oft-repeated lines of the Robot in the 1998 Lost
Continued from Page 3
Watch your inbox for the link to vote in the 2015 KPhA Board of Directors election!
you become a leader. I think you become a leader by choosing to get involved whether in your work setting or in your professional associations. Once you get involved, you choose to stay involved. Please note that you are a leader by choosing to become active in YOUR profession, not by any title or office that you hold. There is certainly more to it than that, but I think that is how most leaders get started. Leaders choose to take action to move their career and profession forward; they do not sit back and wait for someone to do the work for them. If you allow someone else to do all the work, you might not be pleased with the results. I think all of us become leaders through the choices we make, the people that we work with and the impact they have on us, and how we deal with the “opportunities” that we encounter every day.
If you would rather have a paper ballot, see the request form on page 43.
Summary fession to better serve our patients. I also think that leadership is shown by those who are able to give back to the profession by their decision to get involved and stay involved.
I would like to give my personal thanks to all of the hard work shown by the current and future leaders of YOUR KPhA. It is through the work of all of our leaders that we continue to grow as an organization and advance our pro-
The Kentucky Pharmacist is online! Go to www.kphanet.org, click on Communications and then on The Kentucky Pharmacist link.
Would you rather receive the journal electronically? Email ssisco@kphanet.org to be placed on the Green list for electronic delivery. Once the journal is published, you will receive an email with a link to the online version.
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THE KENTUCKY PHARMACIST
APSC
March/April 2015
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THE KENTUCKY PHARMACIST
2015 KPhA Board Election
March/April 2015
2015 KPhA Board of Directors Election Candidates quest to be recognized as providers of care. Individually and collectively, we have provided efficient and effective Patricia (Trish) Rippetoe Freeman, RPh, PhD care to our patients and have improved medication use outcomes, yet as a profession we have gone unrecognized Dr. Trish Freeman is a long-standing member of the Kentucky Pharmacists Association, having served on both the much of the time for these contributions. As your PresidentElect, I will utilize my passion and expertise to advocate for Professional Affairs and Public Affairs committees numerous times, and, most recently, as a member of the Board of advanced pharmacy practice, including the achievement of provider status, within Kentucky. I look forward to the opDirectors between 2010 and 2014. Currently, she repreportunity to serve you, YOUR KPhA and the profession sents the KPhA as its delegate to the United States Pharshould I be elected.” macopeia and recently served as a Kentucky delegate at the 2015 APhA Annual Meeting. Dr. Freeman received a Treasurer bachelor of pharmacy degree and a Ph.D. degree from the University of Kentucky, and completed postdoctoral fellow- Chris Palutis ships at the University of Vermont College of Medicine and I am currently finishing my first term as a member of the the UK College of Medicine. Board of Directors. This has been an extremely rewarding Dr. Freeman holds several positions in the College of Phar- as well as a fantastic learning experience. With that said, I macy at the University of Kentucky, including Director of desire to be elected to return to the Board in the role of the Center for the Advancement of Pharmacy Practice Treasurer. Since my involvement with KPhA two years ago, (CAPP); Clinical Associate Professor in the Pharmacy I have become increasingly passionate regarding our proPractice and Science Department, and Faculty Associate in fession. I am not afraid of debate and voicing not only my the Institute for Pharmaceutical Outcomes and Policy opinion, but the logic behind my opinion as it relates to is(IPOP). As director of CAPP, she has worked to advance sues that will inevitably affect how we practice pharmacy. pharmacy practice in Kentucky by establishing the Advanc- Examples of such issues are the Collaborative Care Agreeing Pharmacy Practice Coalition, which includes pharmament, Pharmacists given “Provider Status” and on a procists from all major pharmacy organizations in the state posed board of pharmacy regulation dealing with mandato(including YOUR KPhA) working together to advance prac- ry counseling. I vow to represent every one of you with as tice goals, including revision of our collaborative care stat- much earnest as I would represent myself in any situation. I ute and achieving provider status for pharmacists. Dr. have vast experience in fiduciary responsibility. My experiFreeman, in collaboration with faculty colleagues in IPOP, ence over the last 20 years with two Fortune 500 compahas made significant contributions to drug abuse policy nies exposed me to sole responsibility for annual budgets research, including evaluating the impact of KASPER, and of more than three quarters of a billion dollars. Also, owning more recently, Kentucky House Bill 1, on prescription drug my own pharmacy now for six years has given me even abuse and diversion and the impact of pseudoephedrine further intimate knowledge and importance of proper finanprecursor laws on methamphetamine production and cial budgeting, reporting, as well as transparency. I believe abuse. Dr. Freeman is also a part-time clinical pharmacist my track record of financial success and integrity within the at the Frankfort Regional Medical Center, Frankfort, Ky., corporate environment as well as my own pharmacy will where she just completed her 20th year of service. prove critical to my success as Treasurer for KPhA.
President-Elect
In her spare time, Dr. Freeman enjoys cooking, spending If elected. I will evaluate the current programs in place to time with her husband, Ken and children, Kenneth, Mary identify areas of opportunity to improve our financial posiand Edward, and advocating for the rights of deaf and hard tion in order to help KPhA provide the highest level of serof hearing children. vice and/or offerings to its members and the pharmacy in“Now is a critical time for our profession as we continue our dustry as a whole. This can be attained by utilizing in9
THE KENTUCKY PHARMACIST
2015 KPhA Board Election
March/April 2015
house resources, as well as using the large number of locations in our group as leverage. Secondly, my goals will involve looking ahead at how the profession is evolving to ensure we are positioned in a way that will allow us to stay current and even ahead of the ever-changing pharmacy industry. Thank you in advance for your consideration.
Director Cassandra Beyerle I am very interested in serving on the KPhA Board of Directors. After serving in the capacity of Vice and then Speaker of the House I feel I have a good understanding of the requirements for KPhA Board service. I am excited about the prospect of representing fellow pharmacists through the role of KPhA Board member. Service to the profession is something that I cherish and find important to personal growth as well as growth of the profession.
Our profession has always been one of the most trusted, yet remains underutilized in the health care system. However, we are at an exciting time where we can control our destiny and our future roles in health care. Nothing would make me more proud than to be able to serve our profession again and help pave the way for all pharmacists.
Ray Bishop I am presently serving a one-year term as Past-President on the KPhA Board of Directors. I have recently retired from community practice of over 40 years. I was Director of Pharmacy at the previous Taylor Drug Stores which was purchased by Rite Aid from which I retired. I have always been active with pharmacy associations having served as President of both the Jefferson County Academy of Pharmacy and the Kentucky Pharmacists Association. I also am presently serving as Secretary/Treasurer of the Veterans Drug Club in Louisville. I have really enjoyed participating as a member of the Board of Directors and wish to continue if it is the wish of the membership. I feel I have a lot of experience to offer and am excited about the direction the Association is leading our members. I would appreciate your consideration to continue this great experience. Matt Carrico
my time on the board, I have taken full advantage of the opportunity to professionally network and make friendships with pharmacists, in all fields, throughout the state. I also have taken part in many aspects of furthering our profession such as: testifying before a Senate subcommittee on behalf of SB 107 in 2013, serving on the Government Affairs Committee, assuming the role of Chair for the Kentucky Pharmacists Political Advocacy Council (KPPAC), serving on the KPERF board, becoming a pharmacy district coordinator for Owsley and Lee counties through the KPhA Emergency Preparedness program, meeting with state legislators to discuss upcoming pharmacy bills, and becoming an active member of APhA and NCPA.
Chad Corum I am writing this statement with the most sincere intentions to hopefully join KPhA's Board of Directors. I have an extreme passion for the profession of pharmacy, and I am eager to serve with an organization that I know shares my same passion of not only wanting to protect the profession, but also to advance it. I currently practice in Manchester, Ky., as an independent pharmacist/owner at Corum Family Pharmacy. I graduated from the University of KY College of Pharmacy in 2012 and soon thereafter returned to my hometown to open my own store in May of 2013.The business is doing well thus far so I can now refocus some of my efforts from being an owner I have a much deeper insight now as to the challenges we face as a profession, as well as the opportunities we have to capitalize upon. I have been involved with KPhA in the past to some capacity (i.e. New Practitioner Committee, KPhA ambassador initiative) but I had to pull away in a sense to focus on getting my business off the ground. I see my business as a resource to help facilitate my desire to get involved and as we approach our two year anniversary, I am now better poised to get involved again. I have nothing but praise for the work this organization puts into our profession; I simply want to join in and do my part to give back, not just for myself but for all pharmacists and student pharmacists alike.
I was born and raised in Louisville, Ky. From 2006 to 2010 I attended pharmacy school at the University of Charleston (WV). During my last two summers, I interned at Walgreens corporate offices in Chicago learning about the business of pharmacy. Upon graduating, I began working as a staff pharmacist for Walgreens in Louisville at Algonquin Parkway and a part time pharmacist for my father’s pharmacy (Booneville Discount Drug) in Booneville, Ky. In 2012 I made the difficult career decision to leave Walgreens and work full time in the Here are some of my accomplishments while at UK: wild and wonderful world of independent pharmacy. Now, I am happily a co-owner and PIC for Booneville Discount Drug. Elected as Class President For the last three years, I have had the pleasure of serving as Received the "Outstanding Graduating Man" award at a director on the board of KPhA. This has proven to be one of graduation the most fulfilling experiences in my short career thus far. In Recipient of the Student Enhancement Scholarship 10
THE KENTUCKY PHARMACIST
2015 KPhA Board Election
March/April 2015
Received the KY Bluegrass Pharmacist Award as a freshmen Co-Chair of the KAPS Professional Development Committee (KY Alliance of Pharmacy Students) Core representative for the College of Pharmacy Interprofessional Leadership Legacy Program Elected as a member of PLS (Phi Lambda Sigma) honor society Elected into Kappa-Psi Professional Pharmaceutical Fraternity Asked to be a member of the College of Pharmacy Honor Code Committee as well as the University of KY Health Care Colleges Honor Code Committee Asked to be one of two student members for the College of Pharmacy Curricular Review Committee- also served on this committee in 2013 as a new practitioner
the movement for 2013 Senate Bill 107, which required PBM transparency. It would be my honor to serve you for the next three years on the Board of Directors as we work to implement the amendment to the Collaborative Care Agreements in Kentucky and obtain Provider Status nationally. If there is going to be growth, it is of the utmost importance to inspire young practitioners to be more involved in shaping our profession. Our organization has done great things in the past, but this new involvement could be the perfect spark that we need. This will be my goal as a Director. I will show no hesitancy in leading the surge for changes we seek while bringing the next generation of pharmacists to the table to “Be the Change!” I thank you for your consideration. Sam Willett
I appreciate in advance your consideration of my application I grew up in the small town of Fancy Farm, did my underand I would be honored if given the opportunity to help bet- graduate studies at UK and I graduated from University of Oklahoma College of Pharmacy in 1977 and have practiced ter serve my Profession. pharmacy in Kentucky (Mayfield) since then. I currently own Ethan Klein and operate two pharmacies in Mayfield. I am seeking reelection for the Board of Directors of KPhA. I have served on With practical experience in multiple practice site settings the board for nine years and am also a member of the Budgand two years of experience as a KPhA officer, I feel well et and Audit Committee. suited to step into a KPhA Director position. Following my PGY1 hospital residency in Northern Chicago, I moved to Louisville and began work in a community setting while I established myself in Kentucky. After practicing with Rite Aid nearly three years and experiencing the challenges and excitement of community pharmacy, I've found my niche. Looking at the external pressors facing the profession and the mounting pressures put on pharmacists within the practice setting, we need a voice an organization to galvanize all pharmacists into action and effect change. KPhA is the organization to benefit pharmacists and the profession of pharmacy, and I want to help facilitate that achievement. Serving as Vice-Speaker of the House of Delegates last year and Speaker of the House this year, I feel more confident in my abilities to contribute towards the growth of the profession and organization. KPhA is moving forward and growing. We need board members involved in the profession that are self motivated, and I would appreciate your support.
As pharmacists we face challenges every day, from provider status, preferred networks, reimbursement, DIR fees, closed network and mail order to name a few. I have always said that we have had to, adapt, overcome and make do. Overcoming some of these challenges seems to get more difficult all the time but we must not give up. Working together and through our KPhA, hopefully we can meet and beat these challenges. I would appreciate you vote and will work hard for you and the profession the next three years. Thank you.
2015 KPhA Board of Directors Election Paper Ballot Request Form
Lance Murphy I am a Staff Pharmacist with Walgreens in La Grange, NewPractitioner, and a 2014 graduate from Sullivan University College of Pharmacy. During my years at SUCOP, I made it a point to be as involved as possible and had the chance to serve on KPhA’s Board of Directors as SUCOP's Student Representative. I had the privilege of witnessing and participating in 11
See page 43 for the complete form, or call 502-227-2303 to request your paper ballot. Paper ballots must be received in the KPhA office no later than May 20, 2015 to be valid. THE KENTUCKY PHARMACIST
Feb. 2015 CE — Pneumococcal Vaccination
March/April 2015
Pneumococcal Vaccination: New Guidelines and Recommendations By: Eric Coons, PharmD, Kristin Carbrey, PharmD, Kris Harrell, PharmD, and Deborah Minor, PharmD; The University of Mississippi Medical Center, Departments of Pharmacy and Medicine Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared. This activity may appear in other state pharmacy association journals. There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-9999-15-002-H04-P&T 1.5 Contact Hours (1.5 CEU)
KPERF offers all CE articles to members online at www.kphanet.org
Goal: The purpose of this review is to increase the awareness and understanding of current recommendations for pneumococcal vaccination, as well as highlight recent changes in Medicare coverage. Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. Provide recommendations for pneumococcal vaccination in children and adults, including recent changes and updates. 2. Identify persons who are considered “high-risk” for pneumococcal disease and describe criteria for vaccination with PCV13 and/or PPSV23. 3. Explain recent changes in Medicare coverage for pneumococcal vaccination. and otitis media in infants and children. The most commonly reported adverse effects for all age groups include injecStreptococcus pneumoniae (pneumococcus) commonly tion site swelling and tenderness, irritability, decreased apcauses infections such as bacteremia, pneumonia, menin- petite, sleep disturbances and fever. Contraindications to gitis and middle ear infections in young children, certain PCV13 include those who have had an anaphylactic reachigh-risk patients and the elderly. Though the bacterium tion to diphtheria-toxoid containing vaccine and hypersensihas more than 90 serotypes, and most cause disease, 62 tivity to any vaccine component. While not a contraindicapercent of invasive pneumococcal disease worldwide is tion, caution should be used when administering the vaccaused by the 10 most common types. Vaccination against cine in the presence of moderate or severe acute illness, the most common Streptococcus pneumoniae strains pro- with or without fever.3 A polysaccharide vaccine, licensed in tects persons against severe illness and medical conditions 1977, was the first pneumococcal vaccine. In 1983, the 23that may result in hospitalization, serious lifelong complica- Valent Pneumococcal Polysaccharide Vaccine (PPSV23 or tions (e.g., seizures, blindness and paralysis) or even Pneumovax 23®) was approved and replaced the original death. While vaccination does not guarantee prevention of 14-valent vaccine. PPSV23 shares 12 serotypes with infection, it significantly reduces the incidence of severe PCV13 as well as 11 additional serotypes (1-5, 6B, 7F, 8, illness, especially in high-risk populations.1,2 9N, 9V, 10A, 11A, 12F, 14 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F) of pneumococcal bacteria. PPSV23 is There are primarily two different types of pneumococcal vaccines used in the United States, a conjugate and a poly- recommended for use in specific groups of high-risk chilsaccharide. The 13-Valent Pneumococcal Conjugate Vac- dren and adults, and all of those 65 years and older. Adcine (PCV13 or Prevnar 13®) protects against 13 serotypes verse effects with PPSV23 are similar to that of PCV13 and include injection site tenderness and swelling, fatigue, (1-5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F) of pneumococcal bacteria and is the newest formulation. This vaccine headache, muscle and joint pain, decreased appetite, chills and rash. The only contraindication for PPSV23 is a prior is recommended as a part of the routine immunization 4 schedule for infants and young children, specific groups of severe allergic reaction to any component of the vaccine. high-risk children and adults and all of those 65 years and Guidelines for pneumococcal and other vaccinations are older. In 2010, PCV13 replaced the 7-Valent Conjugate adopted and published by the Center for Disease Control Vaccine (PCV7) for prevention of pneumococcal disease and Prevention (CDC) after extensive review and recomIntroduction
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THE KENTUCKY PHARMACIST
Feb. 2015 CE — Pneumococcal Vaccination
March/April 2015
Table 1 Pneumococcal Vaccination: CDC Recommendations in High Risk Patients, Ages 6-64 Years Risk Group
Immunocompetent Persons
Underlying Medical Condition
PCV13 Recommended
Chronic heart disease† Chronic lung disease
Immunocompromised Persons
Recommended
Revaccination ≥ 5 years after first dose
§
Diabetes mellitus
Persons with Functional or Anatomic Asplenia
PPSV23
CSF leaks
Cochlear implants Alcoholism Chronic liver disease Cigarette smoking Sickle cell disease/other hemoglobinopathies Congenital or acquired asplenia Congenital or acquired immunodeficiencies¶ HIV infection Chronic renal failure
Nephrotic syndrome Leukemia
Lymphoma Hodgkin disease Generalized malignancy Iatrogenic immunosuppression‡ Solid organ transplant
Multiple myeloma Including congestive heart failure and cardiomyopathies § Including chronic obstructive pulmonary disease, emphysema, and asthma ¶ Includes B-(humoral) or T-lymphocyte deficiency, complement deficiencies (particularly C1, C2, C3, and C4 deficiencies), and phagocytic disorders (excluding chronic granulomatous disease) ‡ Diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids and radiation therapy †
mendations from the federal Advisory Committee on Immunization Practices (ACIP). Recommendations for vaccination in children and adolescents are made upon conferral with the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and the American College of Obstetrics and Gynecology (ACOG). Recommendations for adults are harmonized with input from AAFP, ACOG and the American College of Physicians (ACP). If and when recommendations are accepted, they are then disseminated by the CDC (http:// www.cdc.gov/vaccines). Over the past several years, ACIP has modified pneumococcal vaccination recommendations for a wide range of individuals, based on age and other medical conditions. As a result of these changes, as well as the evolving structure
of third party coverage and payment, including the Centers for Medicaid and Medicare Services (CMS), confusion has likely occurred among both providers and patients. Patient inquiries also have been spurred by the increase in direct to consumer advertising, which ideally may be an effective target for improving vaccination rates. The purpose of this review is to summarize and increase the awareness and understanding of the most recent ACIP and CDC recommendations for pneumococcal vaccination in persons 6 years of age and older, and highlight changes in Medicare coverage. Recommendations for PCV13 in children aged 2 months to 59 months are not discussed, as immunizations are typically administered per routine schedules and wellchild visits. Current CDC vaccine schedules and information (Vaccine Information Statements, VIS) always
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THE KENTUCKY PHARMACIST
Feb. 2015 CE — Pneumococcal Vaccination
March/April 2015
Table 2 Pneumococcal Vaccination: Summary of CDC Recommendations, Ages 6-64 Years Pneumococcal vaccine-naïve If both PCV13 and PPSV23 are indicated: Administer PCV13 first (do not give if previously given) Administer PPSV23 ≥ 8 weeks after PCV13 administration If PPSV23 is indicated and PCV13 is not, administer PPSV23 If a second PPSV23 dose is indicated, administer ≥ 8 weeks after PCV13 and ≥ 5 years after the first PPSV23 Previously received PPSV23 If indicated, and not previously received, administer PCV13 ≥ 1 year after most recent PPSV23 administration If a second PPSV23 dose is indicated, administer ≥ 8 weeks after PCV13 and ≥ 5 years after the first PPSV23 should be reviewed prior to vaccine administration. Federal law requires that healthcare staff provide a VIS that explains both the benefits and risks to a vaccine recipient, a parent or legal representative before each dose of certain vaccines. These are available at http://www.cdc.gov/ vaccines. Pneumococcal Vaccination in Persons Aged 6-18 Years From 2007-2009, 49 percent of invasive pneumococcal disease in immunocompromised children aged 6-18 years was caused by serotypes contained within PCV13, and an additional 23 percent by serotypes included within PPSV23.1 Given the high burden of IPD caused by serotypes in PPSV23 but not in PCV13, use of both PCV13 and PPSV23 might provide broader protection. Per initial recommendations from 1997, children aged 6-18 years with certain underlying medical conditions should receive one dose of PPSV23 (Table 1).1,5,6 In 2010, after the approval of PCV13, ACIP and CDC added recommendations for PCV13 vaccination for persons with specific underlying medical conditions, as with PPSV23, which placed them at high risk for pneumococcal disease. High-risk individuals are defined as those who are considered immunocompetent but have underlying medical conditions, those with functional or anatomic asplenia and those with immunocompromising conditions. These guidelines were updated in 2013 to a Category A recommendation. Though there is serotype overlap in vaccine coverage, vaccination with both preparations is recommended because of the broader protection offered and differences in specific immune response elicited by the polysaccharide and conjugate preparations.1 In contrast to the recommendations for infants and young children, routine use of PCV13 is not recommended for healthy children aged > 5 years.5 In January 2013, the Food and Drug Administration (FDA) approved PCV13 in healthy children aged 6-17 years for prevention of invasive pneumococcal disease, though ACIP currently has no recommendations for use in this age group. ACIP recommen-
dations for vaccination with PCV13 and PPSV23 in children aged 6-18 years are summarized below and in Tables 1 and 2.5,6 All children aged 6-18 years with qualifying medical conditions who are pneumococcal vaccine-naïve, and for whom both PCV13 and PPSV23 are indicated, should first receive vaccination with PCV13, followed ≥ 8 weeks later by PPSV23. Children who meet criteria for PCV13 administration (and have no history of PCV13 administration) should be given PCV13 even if they have previously received PPSV23 or other formulations (i.e., PCV7) of pneumococcal vaccine. When indicated and if the opportunity exists, PCV13 should always be administered before a recommended dose of PPSV23. For some children, as with younger adults, only PPSV23 is recommended.6 All children aged 6-18 years who have received PPSV23 and are PCV13 naïve, should be vaccinated with PCV13, if indicated, ≥ 1 year after PPSV23 vaccination. If a second vaccination with PPSV23 is recommended (e.g., immunocompromised, functional or anatomic asplenia), administer ≥ 5 years after the first PPSV23 vaccination, and ≥ 8 weeks after PCV13. Only two vaccinations with PPSV23 should occur before age 65.1 Pneumococcal Vaccination in Patients Aged 19-64 Years with Underlying Medical Conditions In 2010, 50 percent of invasive pneumococcal disease cases among immunocompromised adults were caused by serotypes contained by PCV13, and an additional 21 percent were caused by serotypes contained only in PPSV23. 7 Initial vaccination with PPSV23 is recommended for a variety of immunocompetent persons with underlying medical conditions, those with functional or anatomic asplenia, and immunocompromised persons.7 Additionally, it is recommended that patients at especially high risk (e.g., immunocompromised, functional or anatomic asplenia) receive a second vaccination with PPSV23 ≥ 5 years after the first.2,7 In 2012, ACIP and CDC added recommendations for rou-
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THE KENTUCKY PHARMACIST
Feb. 2015 CE — Pneumococcal Vaccination
Table 3 Pneumococcal Vaccination: CDC Recommendations, Aged ≥ 65 Years Pneumococcal vaccine-naïve Administer PCV13 at age ≥ 65 years Administer PPSV23 6-12 months after PCV13 administration** Previously received PPSV23 at age ≥ 65 years Administer PCV13 ≥ 1 year after PPSV23 administration Previously received PPSV23 at < 65 years, now ≥ 65 years If not previously received, administer PCV13 ≥ 1 year after PPSV23 administration Administer PPSV23 6-12 months after PCV13 administration** and ≥ 5 years after the most recent dose of PPSV23 **can administer PPSV23 later than 6-12 months after PCV13 if window is missed, preferably at next visit; minimum acceptable interval between PCV13 and PPSV23 administration is 8 weeks; if given within 8 weeks of each other, doses do not need to be repeated.
March/April 2015 though there were no ACIP or CDC recommendations at that time. The 2012 ACIP recommendations regarding the use of PCV13 in adults aged ≥ 19 years with specific underlying medical conditions also included recommendations for vaccine administration in the population aged ≥ 65 years.8 In 2013, over 13,500 cases of invasive pneumococcal disease occurred among adults aged 65 years and older. Approximately 20-25 percent of invasive pneumococcal disease and 10 percent of community-acquired pneumonia cases in this population were caused by PCV13 serotypes. On Aug. 13, 2014, following favorable data from randomized clinical trials in older adults, ACIP made recommendations for use of PCV13 along with PPSV23 in all patients aged ≥ 65 years. Providing both vaccines offers the opportunity for a higher immune response and broader coverage. CDC has plans to assess and evaluate the impact of this recommendation on the burden of invasive pneumococcal disease in 2018.8 The current recommendations were published by the CDC in September 2014, and are summarized below and in Table 3.8
All patients aged ≥ 65 years who are pneumococcal vaccine-naïve should be vaccinated with PCV13, then vaccinated with PPSV23 six to 12 months later. Again, as with other age groups, PCV13 should be administered before PPSV23. In immunogenicity studies, subjects receiving tine vaccination with PCV13 in adults aged ≥ 19 years with PCV13 as the initial dose, followed by PPSV23, elicited a underlying medical conditions. PCV13 is specifically recom- higher functional antibody response than the converse regimended in immunocompromised persons, those with coch- men, regardless of the initial immune response. In all caslear implants or cerebrospinal fluid (CSF) leaks, or function- es, the minimum acceptable time between these vaccinations is eight weeks. If the designated window is missed, al or anatomic asplenia.7 patients may receive the PPSV23 vaccine at a later date.8 All persons aged 19-64 years who are pneumococcal vacAll patients who received PPSV23 at age ≥ 65 years, but cine-naïve, and for whom both PCV13 and PPSV23 are are PCV13-naïve, should be vaccinated with PCV13 ≥ 1 recommended, should be vaccinated first with PCV13 followed ≥ 8 weeks later by PPSV23. All persons aged 19-64 year after PPSV23 administration. Additional PPSV23 vacyears who have received only PPSV23 in the past, and for cination is not required after PCV13 vaccination. All patients aged ≥ 65 years who received their last PPSV23 vacwhom PCV13 is indicated, should be vaccinated with PCV13 ≥ 1 year after the most recent PPSV23 vaccination. cination at < 65 years and are PCV13-naïve, should reIf a second vaccination with PPSV23 is recommended, ad- ceive PCV13 ≥ 1 year after the most recent PPSV23 vacminister ≥ 5 years after the first vaccination and ≥ 8 weeks cination. PPSV23 should then be administered at least six after PCV13. No revaccination with PCV13 is currently rec- to 12 months after PCV13 vaccination, provided it has been ≥ 5 years since the most recent PPSV23 vaccination. If ommended, regardless of underlying medical conditions. Recommendations regarding use of PPSV23 and PCV13 in patients aged ≥ 65 years have received PCV13 at any age, those aged 19-64 years with underlying medical conditions and PPSV23 at age < 65 years, they should be revaccinated with PPSV23 (≥ 5 years after the most recent vaccinaare summarized in Tables 1 and 2.7 tion).8 Again, patients who previously received PCV13 Pneumococcal Vaccination in Persons Aged ≥ 65 Years should not be revaccinated.8 In 2010, ACIP updated recommendations for PPSV23 vaccination in those aged ≥ 65 years. In December 2011, the FDA approved PCV13 for use in patients aged ≥ 50 years,
As vaccination history can be difficult to obtain, per Medicare suggestions, it is acceptable to rely on the patient’s verbal history to determine prior vaccination status. Those 15
THE KENTUCKY PHARMACIST
Feb. 2015 CE — Pneumococcal Vaccination
March/April 2015
administering the pneumococcal vaccine should not require the patient to present a record in order to receive the vaccine, nor should they feel compelled to review the patient’s complete medical record if it is unavailable. Health care providers should use clinical judgment and available resources to assess vaccination appropriateness.9-12
tions. It is imperative to increase awareness of these changes amongst providers and individuals who may benefit from the recommended vaccinations.
Pharmacists and pharmacy technicians are a valuable resource for obtaining vaccination information and among the most accessible members of the health care community. Through increasing awareness of the need for vaccination, Medicare Part B Coverage of Pneumococcal Vaccines obtaining and reviewing patient histories and identifying On Feb. 2, 2015, CMS implemented Medicare Part B covthose who qualify for vaccination, as well as administering erage changes to reflect the updated CDC recommendavaccinations, both pharmacists and pharmacy technicians tions for pneumococcal vaccination.9 Effective for dates of can target community health, effectively improving vaccinaservice on or after Sept. 19, 2014, an initial pneumococcal tion rates and overall patient care. While vaccination does vaccine may be administered to all Medicare beneficiaries not guarantee prevention of infection, it significantly reducwho have never received a pneumococcal vaccine under es the incidence of severe illness, especially in high-risk Medicare Part B. A different, second pneumococcal vacpopulations. Most importantly, pharmacists and pharmacy cine may be administered 1 year after the first vaccine (i.e., technicians are in a unique position to positively impact the 11 full months following administration of the last pneumocare and management of patients at multiple levels and coccal vaccine).10-12 throughout the health care system. Both the pneumococcal vaccine and its administration are References covered under Medicare Part B.10-12 1. Centers for Disease Control and Prevention (CDC). A beneficiary may receive the vaccine upon request, withUse of 13-valent pneumococcal conjugate vaccine and out a physician’s order and without physician supervision.10 23-valent pneumococcal polysaccharide vaccine There is no coinsurance or co-payment applied to this benamong children aged 6-18 years with immunocompro11 efit, or deductible required. The pneumococcal vaccine is mising conditions: recommendations of the Advisory excluded from Part D coverage. Prior to this change in poliCommittee on Immunization Practices (ACIP). MMWR cy, the pneumococcal vaccine was covered by Medicare Morb Mortal Wkly Rep. 2013 Jun 28;62(25):521-4. once in a beneficiary’s lifetime, with revaccinations covered only for those at highest risk if five years had passed since 2. Centers for Disease Control and Prevention (CDC). the last vaccination or if the beneficiary’s vaccination histoUpdated recommendations for prevention of invasive ry was unknown.10-12 pneumococcal disease among adults using the 23valent pneumococcal polysaccharide vaccine It is important that providers recognize the lack of agree(PPSV23). MMWR Morb Mortal Wkly Rep. 2010 Sep ment between CMS payment schedules and CDC guide3;59(34):1102-6. lines. Even in instances where CDC recommends PPSV23 administration as early as six months after PCV13, provid- 3. PREVNAR 13 (Pneumococcal 13-valent Conjugate ers should wait at least 11 full months between vaccinaVaccine [Diphtheria CRM197 Protein]) [package insert]. tions to ensure CMS payment. Philadelphia, PA: Pfizer Inc; 2007. Pneumococcal vaccines are covered by most private health 4. PNEUMOVAX 23 (pneumococcal vaccine polyvalent) insurance plans and wellness programs. If there are ques[package insert]. Whitehouse Station, NJ: Merck & Co, tions regarding coverage, cost or in-network vaccine proInc; 2011. viders, individuals should check with their insurance 5. Centers for Disease Control and Prevention (CDC). provider. Prevention of pneumococcal disease among infants and children-use of 13-valent pneumococcal conjugate Conclusion vaccine and 23-valent pneumococcal polysaccharide Vaccination is identified as a leading health indicator by the vaccine-recommendations of the Advisory Committee Healthy People 2020 health objectives. Over the past five on Immunization Practices (ACIP). MMWR Recomm years pneumococcal vaccination recommendations and Rep. 2010 Dec 10;59(RR-11):1-18. guidelines for both children and adults have changed significantly. Recent recommendations affecting persons 65 and 6. Committee on Infectious Diseases. Immunization for older also have led to corresponding changes in Medicare Streptococcus pneumoniae infections in high-risk chilcoverage and reimbursement for pneumococcal vaccinadren. Pediatrics. 2014 Dec;134(6):1230-3. 16
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Feb. 2015 CE — Pneumococcal Vaccination 7. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012 Oct 12;61(40):816-9.
March/April 2015 10. Centers for Medicare and Medicaid Services. Modifications to Medicare Part B coverage of Pneumococcal vaccinations. CMS Manual System. 2014 Dec 31; Pub 100-02 Medicare Benefit Policy. Transmittal 202. Available from: http://www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/Downloads/ R202BP.pdf
8. Centers for Disease Control and Prevention (CDC). 11. Immunizations [Internet]. Baltimore (MD): Centers for Use of 13-valent pneumococcal conjugate vaccine and Medicare and Medicaid Services; [updated 2014 Dec 23-valent pneumococcal polysaccharide vaccine 15; cited 2015 Feb 8]. Available from: http:// among adults aged ≥65 years: recommendations of the www.cms.gov/Medicare/Prevention/Immunizations/ Advisory Committee on Immunization Practices (ACIP). index.html?redirect=/immunizations/. MMWR Morb Mortal Wkly Rep. 2014 Sep 19;63 12. Pneumococcal vaccinations update from CMS (37):822-5. [Internet]. Baltimore (MD): Centers for Medicare and 9. Centers for Medicare and Medicaid Services. ModificaMedicaid Services; [updated 2015 Jan 29; cited 2015 tions to Medicare Part B coverage of Pneumococcal Feb 8]. Available from: http://www.cms.gov/Medicare/ vaccination. MLN Matters. 2014 Dec 31; Article Prevention/PrevntionGenInfo/Health-Observance#MM9051. Available from: http://www.cms.gov/ Mesages-New-Items/2015-01-29-Pneumococcal.html. Outreach-and-Education/Medicare-Learning-NetworkMLN/MLNMattersArticles/Downloads/MM9051.pdf
February 2015 — Pneumococcal Vaccination: New Guidelines and Recommendations 1. An anaphylactic reaction to a diphtheria-toxoid containing vaccine is a contraindication for use of: A. PCV13. B. PPSV23.
6. If recommended, revaccination with PPSV23 should be provided 5 years after the initial vaccination. A. True B. False
2. A healthy 7 year old who has completed early childhood immunizations should receive PCV13. A. True B. False
7. A 67 year old received PPSV23 three years ago. When is revaccination with PPSV23 recommended? A. He should not receive revaccination B. At least 5 years after his last vaccination C. Now, as he is > 65 years old
3. A 10 year old develops leukemia. Which pneumococcal vaccination course is recommended for administration? A. PCV13 if not previously received, followed by PPSV23, followed by revaccination with PPSV23 B. PPSV23, followed by PCV13 C. PCV13, followed by PPSV23, followed by revaccination with PCV13 D. PCV13 only, followed by PCV23 4. A 35 year old develops congestive heart failure. He has no other known high-risk medical conditions. What pneumococcal vaccination course is recommended for administration? A. PCV13, followed by PPSV23 B. PPSV23 only C. PCV13, followed by PPSV23 D. PCV13 only
8. Individuals > 65 years of age should be vaccinated with PCV13 if they have not received previous vaccination? A. True B. False 9. A 65 year old patient is pneumococcal vaccine-naïve. What is the recommended vaccination administration course? A. PCV13 only B. PPSV23, followed by PCV13 C. PCV13, followed by PPSV23 D. Administer PPSV23 only 10. An order from a licensed physician is not required for Medicare Part B coverage of pneumococcal vaccine. A. True B. False
5. Per CDC recommendations, which of the following conditions would not meet criteria for revaccination with PPSV23 prior to age 65 years? A. Leukemia B. Functional asplenia C. HIV D. Chronic lung disease
Send Potential CE topics to Scott Sisco at ssisco@kphanet.org
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THE KENTUCKY PHARMACIST
Feb. 2015 CE — Pneumococcal Vaccination
March/April 2015
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: April 9, 2018 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. February 2015 — Pneumococcal Vaccination: New Guidelines and Recommendations (1.5 contact hours) Universal Activity # 0143-9999-15-002-H04-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B 3. A B C D 5. A B C D 2. A B 4. A B C D 6. A B
7. A B C 8. A B
9. A B C D 10. A B C D
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET February 2015 — Pneumococcal Vaccination: New Guidelines and Recommendations (1.5 contact hours) Universal Activity # 0143-9999-15-002-H04-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B 3. A B C D 5. A B C D 2. A B 4. A B C D 6. A B
7. A B C 8. A B
9. A B C D 10. A B C D
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
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Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.
THE KENTUCKY PHARMACIST
KPhA Pharmacy Emergency Preparedness
March/April 2015
YOUR KPhA responds to winter storms Based on the difficulty in providing medications without causing a delay in the patient’s care, and in consultation with YOUR KPhA, Governor Steve Beshear issued an Executive Order (EO) on February 17, allowing a one-time, In February, Kentucky experienced one of the worst snow 30 day refill of non-controlled medications. The EO was in storms accompanied by freezing temperatures in several place for one week and subsequently extended for a secyears. Leah Tolliver, KPhA Director of Pharmacy Emerond week, expiring on March 3. During the two week time gency Preparedness, attended daily conference calls with period, KPhA worked with you to track the number of prethe Kentucky Department for Public Health (KDPH) Emer- scriptions and medications refilled by pharmacies. KPhA gency Preparedness Branch, the Kentucky Hospital Asso- reported to KDPH that the pharmacies and their patients ciation and representatives from the 15 regions – including relied heavily on the EO to obtain their medications during the local health departments and emergency management the storm. After the event, KPhA conducted a statewide services. Dr. Tolliver worked very closely with Executive survey with the following results being reported: Director Bob McFalls and Scott Sisco, Director of Commu 19 pharmacies reported being impacted by the winter nications & CE, in conducting outreach and coordinating storm. timely communications with community pharmacies during The average number of prescriptions filled during the this event. two weeks the Executive Order was in place ranged KDPH activated the State Health Operations Center to a between 15 and 20. This equates to some 380 preLevel 2 priority as a result of the statewide weather condiscriptions being filled under the authority of the Executions. During each call, the regional preparedness coorditive Order during a two week period. nator updated the attendees on the status of the counties within their respective region. The primary issues included The primary medications filled under the Executive setting up shelters — also called warming centers — for Order included insulin, inhalers and maintenance medindividuals needing protection from the freezing temperaications. tures, experiencing electrical outages and/or lacking an The roof of Village Pharmacy, located in Beattyville and adequate water supply. KDPH warned the public about owned by Rosemary and Luther Smith, collapsed under possible carbon monoxide poisoning. Emergency phone the weight of the snow. Familiar with the KPhA emergency numbers were provided to the public for reporting weather preparedness program, Rosemary called KPhA Executive issues in which they needed assistance. KDPH and KPhA Director Bob McFalls for consultation. Bob and Leah, in provided links to their websites with the contents for emerconjunction with KDPH, worked together to develop a temgency supply kits as well as resources in the state that porary solution for Rosemary to continue pharmacy operacould provide emergency services. tions. Bob and Leah worked with Rosemary throughout the The following are issues the pharmacies and their custom- week, to ensure she received the assistance needed to ers faced during the winter storm: continue operations. The pharmacy’s computer operating system was salvaged, but none of the inventory could be Many businesses were unable to open due to treachrecovered. It was considered adulterated by the Board of erous driving conditions and freezing temperatures. Pharmacy; therefore, the drug inventory was sent to a re Physician offices were closed so pharmacies were turns company for destruction. Rosemary and her staff unable to reach physicians in order to fill prescriptions moved their records and operating system into another for their patients. pharmacy she owns in Beattyville. They are currently operating out of this pharmacy, until the building can be rebuilt. Patients were not always able to travel to their pharmacy to pick up medications.
Some pharmacies were unable to deliver medications to their patients.
The pharmacy had an inadequate number of employees to fill prescriptions.
For more Emergency Preparedness Resources, visit www.kphanet.org, click on Resources and Emergency Preparedness.
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THE KENTUCKY PHARMACIST
Technician Review
March/April 2015
Technician Review From the KPhA Academy of Technicians Your KPhA Pharmacy Technician Academy continues to work for all pharmacy technicians by attempting to help guide the future of our profession. The Academy is always seeking new members to join and strengthen our voice and provide new insights. The Academy is meeting with the Kentucky Board of Pharmacyâ&#x20AC;&#x2122;s Advisory Council to participate in discussions about the technician profession. The Academy has requested a reduced KPhA membership fee for students actively enrolled in a pharmacy technician program from the KPhA Board. Membership to the Academy is free for any KPhA-member technician.
ence before, now would be a great time. You will have a chance to attend several continuing education sessions and network with other technicians from different areas. KPhA has reduced the registration rates for the Annual meeting. The full registration rates for early birds are $28 and $35 for any registrants after June 10th. We hope to see you there.
The KPhA Annual Meeting and Convention is June 25th through 28th in Bowling Green and all required continuing education sections will be available during the seminar. If you have not had an opportunity to attend a KPhA confer-
If you have any questions about the KPhA Pharmacy Technician Academy please contact Don Carpenter at dacarpenter@st-claire.org.
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THE KENTUCKY PHARMACIST
2015 KPERF Golf Scramble
March/April 2015
Register Now! www.kphanet.org 21
THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines
March/April 2015
Update on the 2013 ACC/AHA Cholesterol Guidelines By: Kayla N. Kreft, PharmD candidate, Kathleen D. Faulkenberg, PharmD, Stacy A. Taylor, PharmD, MHA, BCPS University of Kentucky College of Pharmacy
KPERF offers all CE articles to members online at www.kphanet.org
There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-15-004-H01-P&T 1.5 Contact Hours (1.5 CEU) Goal: To assist pharmacists and pharmacy technicians in understanding how the new cholesterol guidelines will impact cholesterol management in the patients they serve. Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. Differentiate the major recommendations in the 2013 ACC/AHA cholesterol guidelines as compared to the 2002 ATP III guidelines. 2. Provide recommendations regarding treatment-limiting adverse effects of statin therapy to ensure safety and efficacy. 3. Explain the recommended lifestyle management guidelines that pertain to lowering blood cholesterol. 4. Describe the cardiovascular outcomes observed following the release and implementation of the 2013 ACC/AHA guidelines. guidelines evaluated the use of fixed doses of statin theraIntroduction py, the new guidelines correspondingly emphasize treating The 2013 American College of Cardiology/American Heart with evidence-based fixed statin doses regardless of the Association (ACC/AHA) Guidelines on the Treatment of resultant LDL-C level attained. The major differences beBlood Cholesterol1 supersede the 2002 National Cholestertween the ol Education 2013 ACC/ Program Adult Table 1: Classification of Recommendations AHA and the Class of Class I Class IIa Class IIb Treatment 2002 NCEP Panel III (ATP Recommendation Benefit >>> Risk Benefit >> Risk Benefit ≥ Risk ATPIII III) guidelines.2 Level of Evidence Level A Level B Level C guidelines The guidelines Data from multiple Data from single Data from consensus can be found were created RCTs or RCT or opinions of experts, in Table 2. by systematimeta-analyses nonrandomized case studies, or cally reviewing The evistudies standard of care available evidence from dence from randomized controlled trails (RCTs), reviews large clinical trials supported the use of statins to treat and meta-analyses that examined atherosclerotic cardioblood cholesterol levels among four statin benefit groups to vascular disease (ASCVD) outcomes. Recommendations reduce ASCVD. The groups are as follows: are classified according to the level of evidence and class Group 1: Clinical ASCVD of recommendation as described in Table 1. Group 2: Primary Elevations of LDL-C ≥190mg/dL The 2013 guidelines represent a major shift in clinical practice with the new guidelines focusing on treating popula Group 3: Diabetics 40 to 75 years of age with LDL-C 70 tions who are likely to benefit from statin use in the preven-189mg/dL tion of ASCVD. When applied to the U.S. population, statin Group 4: Estimated 10-year ASCVD risk of ≥7.5 peruse now will be recommended in 56.6 percent of Americent without diabetes or clinical ASCVD cans as compared to 42.0 percent under the ATP III guidelines.3 The 2013 guidelines additionally do not recommend The strongest available evidence from RCTs support statin therapy over any other cholesterol lowering medications; treating to a specific low-density lipoprotein cholesterol therefore, the new guidelines focus exclusively on the use (LDL-C) goal. Since the RCTs reviewed to create the new 22
THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines
March/April 2015
Table 2: Differences Between 2013 ACC/AHA and 2002 NCEP ATP III Primary Focus Other Major Differences
2002 NCEP ATP III Guidelines
2013 ACC/AHA Guidelines
Targeted LDL goals for prevention of coronary heart disease
Lipid management to as primary and secondary prevention of ASCVD
Therapy guided on coronary heart disease risk factors to target LDL goals
Framingham Risk Score to estimate coronary heart disease risk
Recommendations for the detection, evaluation and treatment of lipid disorders
Fixed dose statin therapy as supported by RCT
RCT identified patients who would benefit most from cholesterol lowering statin therapy
Pooled cohort ASCVD risk calculator
Does not provide comprehensive recommendations for the treatment of hyperlipidemia
NCEP= National cholesterol education program, ATP=Adult treatment panel, ACC= American College of Cardiology, HAH= American Heart Association, LDL= Low-density lipoprotein, ASCVD= Atherosclerotic cardiovascular disease, RTC=Randomized control trial of statin therapy. However, it is worthwhile to note that the new guidelines evaluated trials published through 2011 and additional data have already and will continue to be published that may influence treatment decisions beyond statins. One such example are data from the IMPROVE-IT trial4 which demonstrate a beneficial effect of adding ezetimibe to statin therapy in the prevention of ASCVD events among patients who have experienced an acute coronary syndrome. Additionally, there are two populations in whom statin therapy has shown no benefit: NYHA Class II-IV heart failure and long-term hemodialysis patients. The ACC/AHA guidelines do not provide recommendations and clinicians will need to consult other references to guide treatment among these patients. As previously mentioned, the new guidelines recommend initiating fixed, evidence-based statin doses based on treatment indication and can be categorized into high-intensity, moderate-intensity or low-intensity dosing strategies. By definition, high-intensity statin therapy lowers LDL-C by approximately ≥50 percent and moderate-intensity statin therapy lowers LDL-C by approximately 30 - <50 percent. Table 3 provides the intensity classification of statins at various doses, the approximate expected LDL-C reduction and the recommended intensity strategy for each statin benefit group. Specific treatment recommendations are discussed further in the following paragraphs for each statin benefit group.
sumed to be of atherosclerotic origin. Patients ≤ 75 years of age should receive high-intensity statin therapy (I,A). Moderate-intensity is recommended as second-line in patients intolerant to the common adverse effects of high-intensity statin therapy or in whom it is contraindicated (I,A). Patients greater than 75 years of age who are already receiving statin therapy should continue their current statin therapy (IIa,B). In patients greater than 75 who have not yet initiated statin therapy, it is reasonable to begin moderate to high -intensity statin along after evaluating the risks, benefits and patient preferences. Statin Benefit Group 2: Primary Elevations of LDL–C ≥190 mg/dL The second statin benefit group is for primary prevention among patients ≥21 years of age with an LDL-C of ≥190mg/dL. These patients, as well as patients with triglycerides ≥500mg/dL, should be evaluated for secondary causes of hyperlipidemia (Table 4) prior to initiating statin therapy (I,B). High-intensity statin therapy or the maximum tolerated statin therapy is recommended for this patient population unless contraindicated (I,B). In this group, it is expert opinion to consider an LDL-C reduction of at least 50 percent as a treatment goal and either intensify statin therapy (IIa,B) or consider adding a nonstatin drug to achieve this goal (IIb,C). Statin Benefit Group 3: Diabetics 40 to 75 years of age with LDL-C 70-189 mg/dL
Statin Benefit Group 1: Clinical ASCVD
The third statin benefit group is for primary prevention The first statin benefit group is for secondary prevention among patients between the ages of 40-75 with diabetes among patients >21 years of age with clinical ASCVD. Clin- and an LDL-C of 70-189mg/dL. For diabetic patients with a ical ASCVD is defined as acute coronary syndromes, histo- higher LDL-C, the guidelines for statin benefit group 2 ry of myocardial infarction (MI), stable or unstable angina, should be followed. At a minimum, patients in group 3 coronary or other arterial revascularization, stroke, transishould have a moderate-intensity statin initiated or continent ischemic attack (TIA) or peripheral arterial disease pre- ued (IA). To further delineate therapy, the patient’s 10-year 23
THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines ASCVD risk should be calculated using the Pooled Cohort Equations. Highintensity statin therapy is recommended for patients with an estimated 10-year risk ≥7.5 percent (IIa,B).
March/April 2015
Table 3: Intensities of Statin Therapies Medications HighIntensity Statin Therapy
Approximate LDL-C Reduction ≥50 percent
Group 1 Patients <75 years of age
Group 2 Patients 21-75 years of age
Group 3 Patients with ≥7.5% 10-year risk
Group 4 Group 3 patients with <7.5% 10-year risk
Simvastatin 20-40 mg§
Group 4 Patients
Pravastatin 40 (80) mg
Those in a high-intensity statin benefit group who are intolerant to high-intensity
Those in a moderate or high-intensity statin benefit group who are intolerant to those intensities
Atorvastatin (40*) 80 mg Rosuvastatin 20 (40) mg
Statin Benefit Group 4: Estimated 10-year ASCVD risk of 7.5 percent or higher The last statin benefit group includes patients aged 4075 years with an LDL-C of 70-189mg/dL without clinical ASCVD or diabetes with an estimated 10-year ASCVD risk of ≥7.5 percent. It’s recommended that patients within this group receive moderate- to high-intensity statin therapy (I,A). Before initiating therapy, it is expert opinion to discuss this decision with the patient weighing the risks and benefits and taking the patient’s personal preferences into account (IIa,C). Patients falling in this age and LDL-C category who have a lower estimated 10-year ASCVD risk of 5 percent to <7.5 percent, therapy with a moderateintensity statin may be offered (IIa,B).
ModerateIntensity Statin Therapy
Statin Benefit Groups
Atorvastatin 10 (20) mg Rosuvastatin (5) 10 mg
30 percent to <50 percent
Lovastatin 40mg Fluvastatin 40 mg bid Fluvastatin XL 80 mg LowIntensity Statin Therapy
Pitavastatin 2-4 mg Pravastatin 10-20 mg Lovastatin 20mg Simvastatin 10mg Fluvastatin 20-40 mg
<30 percent
Pitavastatin 1 mg Bolded statins and doses demonstrated a reduction in major cardiovascular events in RCTs and meta-analyses. Un-bolded statins are FDA approved doses that yield a similar LCL-C reduction but were not evaluated in the reviewed RCTs. *Atorvastatin 80 mg is preferred but 40mg is supported by evidence from 1 RCT and can be used as an alternative for intolerance of 80mg. §Simvastatin 80mg was evaluated in RCTs but is not recommended by the FDA due to increased risk of myopathy. units or ≥75 percentile for age, sex, and ethnicity (For additional information, see http://www.mesa-nhlbi.org/ CACReference.aspx)
Patients Falling Outside the Above Groups
For patients who do not fall into one of the above catego Ankle-Brachial Index (ABI) <0.9 ries but have additional risk factors, statin therapy should be considered (IIb,C). According to the guidelines, the addi- Lifetime risk of ASCVD tional ASCVD risk factors may include: Estimating ASCVD Risk Primary LDL–C >160 mg/dL or other evidence of geThe ACC/AHA also released guidelines on the assessment netic hyperlipidemias of cardiovascular risk in 2013.5 It is recommended in these guidelines to use the race- and sex-specific Pooled Cohort Family history of premature ASCVD with onset <55 Equations to predict the 10-year risk for a first hard ASCVD years in a first degree male or <65 years in a first deevent in non-Hispanic African Americans and non-Hispanic gree female relative Whites aged 40-79 years of age (I,B). For other populations High sensitivity-C-Reactive protein >2 mg/L these calculations may underestimate the 10-year risk; however, use of the sex-specific Pooled Cohort Equations Coronary Artery Calcium (CAC) score ≥300 Agatston 24
THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines Table 4: Secondary Causes of Elevated LDL-C Diet Elevated LDL-C
Elevated Triglycerides
Saturated or trans fats Weight gain Anorexia Weight gain Very low-fat diets High intake of refined carbohydrates Excessive alcohol intake
March/April 2015 Drugs
Diseases
Diuretics Cyclosporine Glucocorticoids Amiodarone Oral estrogens Glucocorticoids Bile acid sequestrants Protease inhibitors Retinoic acid Anabolic steroids Sirolimus Raloxifene Tamoxifen Beta blockers (not carvedilol) Thiazides
may be used (IIb,C). Spreadsheets and web-based calculators can be found at http://my.americanheart.org/ cvriskcalculator and http://www.cardiosource.org/ scienceand-quality/practice-guidelines-and-qualitystandards/2013-prevention-guideline-tools.aspx. The American Heart Association website offers a free downloadable “CV Risk Calculator” app that is useful for clinical practice and easy to use. For a full explanation of how the risk calculations were created and the data to support their use, please see the guidelines. Safety Concerns with Statins Emphasis should be placed on empowering the patient to invest in his or her healthcare. The first step is education on appropriate medication use, adverse effects and when to contact a physician. Some of the common side effects include fatigue, nausea, diarrhea, dyspepsia, nasopharyngitis, arthralgias and myalgias.6 Statins have a low incidence of severe side effects with a rate of occurrence of less than 2 percent. These effects include myopathies, hepatotoxicity/increased serum transaminases, new onset diabetes and confusion/cognitive dysfunction. Most of the severe adverse effects are manageable if they are detected early; therefore, all patients should be counseled on how to recognize these symptoms. Due to potentially severe complications associated with statin therapy, the guidelines have made several safety recommendations as described below.
Biliary obstruction Nephrotic syndrome
Nephrotic syndrome Chronic renal failure Lipodystrophies
Disorders and altered states of metabolism Hypothyroidism Obesity Pregnancy
Diabetes (poorly controlled) Hypothyroidism Obesity Pregnancy
be used instead (I,B). These predisposing characteristics are as follows:
Multiple or serious comorbidities, including impaired renal or hepatic function
History of previous statin intolerance or muscle disorders
Unexplained ALT elevations >3 times the upper limit of normal
Patient characteristics or concomitant use of drugs affecting statin metabolism
Age >75
However, patients with a history of hemorrhagic stroke or Asian ancestry may be considered for higher statin intensities than recommended due to higher risk of ASCVD that may outweigh the risk of adverse effects (I,B).
Randomized controlled trials report the incidence of statin myopathy from 1.5-5 percent.7 Women, elderly and patients with statin intolerance were often excluded from the RCTs, which may underrepresent the incidence of myopathies reported within these trials.8 It is reasonable to measure a baseline CK in patients that are believed to be at an increased risk for adverse muscle events such as women and the elderly (IIa,C). Also, it is reasonable to measure CK during statin therapy in patients with alarming muscle symptoms such as pain, tenderness, stiffness, cramping, For patients in whom high-intensity statin therapy is recom- weakness or generalized fatigue (IIa,C). If severe muscle mended who have characteristics predisposing them to symptoms occur with therapy, statin therapy should be disadverse effects, moderate-intensity statin therapy should continued and the patient should be evaluated for rhabdo25
THE KENTUCKY PHARMACIST
March 2015 CEâ&#x20AC;&#x201D;Cholesterol Guidelines
March/April 2015
myolysis by measuring CK, creatinine and myoglobinuria in a urinalysis (IIa,B). If mild to moderate symptoms arise, discontinue therapy and evaluate for other potential causes of the symptoms. If symptoms resolve, the patient can be started on a lower dose of the original statin or on a low dose of a different statin that can be titrated as tolerated (IIa,B). If symptoms persist after two months off statin therapy, it is important to evaluate the patient for other causes (IIa,B).
mend that patients who develop confusion or memory impairment while on statin therapy be evaluated for nonstatin contributors such as other medications, systemic issues or neuropsychiatric causes in addition to evaluating the statin drug therapy (IIb,C).
There are currently conflicting data on the relationship between statins and glucose metabolism. Some data have shown statin use to lead to a higher incidence of new-onset diabetes while other data have not. It also is not currently known whether this is potentially a medication-specific consideration or one that applies to the entire statin class. 6 The 2013 guidelines state that future research is needed to evaluate the incidence, pathophysiology, clinical course and clinical outcomes of possible statin-associated newonset diabetes. Based on this, the guidelines recommend patients should be screened for new-onset diabetes mellitus while on statin therapy using the current diabetes screening guidelines (I,B).
increased half-life.
Finally, attention should be paid to drug-drug interactions with statin therapy. Many statins have potential to interact with other medications due to their metabolism through CYP3A4 leading to an increased risk for adverse effects. Due to the potential for statin-induced hepatotoxicity and For example in 2011, the FDA released a safety announcetransaminitis, a baseline alanine aminotransferase (ALT) ment recommending that simvastatin 80mg should be limshould be measured (I,B). Periodic monitoring is not neces- ited to patients who have been taking the dose for at least sary, but should 12 months withTable 5: Statin Pharmacokinetics be measured as out evidence of clinically indicat- Statin Hepatic Metabolism Hydrophilic Active metabolites myopathy due to ed in patients the increased Atorvastatin CYP3A4 No Yes showing sympincidence of myoRosuvastatin CYP2C9 (minor) Yes Yes (minor) toms of hepatopathy (4.9 out of CYP3A4 (minor) toxicity. Persis100,000 people Simvastatin CYP3A4 No Yes tent levels greatcompared to 4.4 Pravastatin CYP3A4 (minor) Yes No er than three with other doses times the upper and statin theraLovastatin CYP3A4 No Yes limit of normal pies).10 It also Fluvastatin CYP2C9 (minor) No Yes (do not circulate should be evalurequired a label CYP2D6 (minor) systemically) ated and a dechange for the CYP3A4 (minor) crease in dose addition of severPitavastatin None No No or discontinuaal new contraindi9 tion of the medication should be considered. Patients also cations and dose limitations with certain medications that should be counseled on and evaluated for symptoms of are known CYP3A4 inhibitors. hepatotoxicity (unusual fatigue or weakness, loss of appe- Table 5 outlines some of the pharmacokinetic parameters tite, abdominal pain, dark-colored urine or yellowing of the that are important to consider. Route of hepatic metaboskin or sclera). However, slight transaminitis after initiating lism, lipophilicity and active metabolites can increase the statin therapy is normal and also may be an indicator of risk of adverse effects due to drug-drug interactions, inpatient compliance. creased penetration of the skeletal muscle membrane and Treatment Goals for Statin Therapy
The 2013 ACC/AHA guidelines do not support the use of specific LDL-C or non-HDL-C targets as treatment goals. As discussed earlier, the RCTs reviewed to create the guidelines evaluated fixed statin doses as opposed to LDL-C targeted therapy. Therefore, the guidelines recommend treating with evidence-based statin doses which demonstrated a decrease in ASCVD events in clinical trials. Although there has been a shift in treatment guidelines, there is still a role for follow-up lipid monitoring. For instance, lipid monitoring can be used to monitor therapeutic response and adherence to medication by comparing follow-up values to expected In reviewing RCTs, the expert panel concluded there was a LDL-C percent decreases (IIa,B). For high-intensity statin lack of evidence that statins contributed to cognitive chang- therapy, LDL-C is generally expected to decrease by â&#x2030;Ľ50 es or risk of dementia. Therefore, the guidelines recompercent from baseline. For moderate-intensity therapy, LDL26
THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines
March/April 2015
C is generally expected to decrease by 30 percent to <50 percent from baseline. The guidelines specify that these monitoring parameters are not to be used as “performance standards.” Recommendations are to obtain an initial fasting lipid panel which includes total cholesterol, triglycerides, HDL-C and calculated LDL-C. A follow-up fasting lipid panel should be performed within four to 12 weeks after initiation or dose adjustment (I,A). Subsequent fasting lipid panels should be assessed every three to 12 months (I,A).
ucts, poultry, fish, legumes, non-tropical vegetable oils and nuts (I,A). Diets also should limit the intake of sweets, sugar-sweetened beverages and red meats (I,A). The diet plan should be adapted to the patient-specific calorie requirements, personal and cultural food preferences and nutrition therapy for other medical conditions such as diabetes mellitus (I,A). A good way to help patients achieve dietary goals is to recommend following approved dietary plans such as the Dash diet, the USDA Food Pattern or the AHA Diet and provide patients the appropriate resources to do so (I,A). A If the patient has an inadequate LDL-C reduction response, key component of the diet plan is to reduce the percent of it is recommended to reinforce medication adherence, incalories from saturated and trans fat to 5-6 percent (I,A). tensive lifestyle changes and exclude secondary causes of hyperlipidemia (Table 4) (I,A). Patients who are tolerating The lifestyle management guidelines also address physical high-intensity statin therapy and still having an inadequate activity. It is recommended to advise patients to engage in response may receive an additional nonstatin cholesterol40 minutes of moderate-to-vigorous aerobic physical activilowering medication with preference given to those medica- ty three to four times a week to reduce LDL-C and nontions that have been shown to reduce ASCVD events in HDL-C (IIa,A). As always, it is important to remember the RCTs (IIb,C). For these patients, the benefits from ASCVD five A’s when counseling patients on lifestyle modifications risk reduction should outweigh the risks of potential ad(Assess, Advise, Agree, Assist, Arrange).12 Even in short verse effects (IIb,C). Higher-risk patients where this may be interactions, it is possible to identify some patient barriers the case include patients with clinical ASCVD who are <75 to adopting lifestyle modifications and suggest simple mitiyears of age, patients with baseline LDL-C of ≥190mg/dL gation strategies. and patients with diabetes mellitus who are 40 to 75 years Outcomes Since the New Guidelines were Published of age (IIb,C). In patients who are statin intolerant, a nonPencina, et al released an article in 2014 in the New Engstatin cholesterol lowering medication shown in RCTs to reduce ASCVD events may be used instead (IIa,B). On the land Journal of Medicine that estimated the new guidelines other hand, some patients may respond exceedingly well to would increase the number of Americans eligible for statin statin therapy. The guidelines recommend considering de- therapy from 43.2 million under the ATP III guidelines to 56 3 creasing the dose of statin therapy if the LDL-C falls below million under the 2013 guidelines. Due to the major clinical shift recommended by the 2013 guidelines, it is important 40mg/dL in two consecutive lipid assessments (IIb,C). to know that the studied outcomes since their release are For patients not eligible for statin therapy, it is important to positive. Johnson and Dowe evaluated statin eligibility with monitor for any new diagnoses or changes in ASCVD risk the 2002 ATP III guidelines as compared to the new ACC/ factors at periodic follow-up visits. In patients with an LDLAHA guidelines in patients with a high atherosclerotic C of 70-180mg/dL without diabetes mellitus or clinical plaque burden.13 They reported an increase in the number ASCVD, a 10-year ASCVD risk should be calculated every of patients appropriately assigned to statin therapy with the four to six years. 2013 guidelines as compared to the 2002 ATP III guidelines. Johnson and Dowe hypothesize that the new guideLifestyle Modifications lines are more accurate at identifying patients who need The AHA/ACC also released lifestyle management guidestatin therapy by relying on proven risk factors rather than lines in 2013.11 These guidelines include specific diet and focusing on an LDL target since there are no data demonexercise recommendations for blood cholesterol and blood strating a direct correlation between plaque burden and pressure management. This section will only address the LDL cholesterol numbers. This finding was confirmed by lifestyle modification recommendations that directly relate Pursnani and colleagues who also concluded the 2013 ACto blood cholesterol management. As seen in the treatment C/AHA guidelines were better at identifying patients with algorithm and throughout the ACC/AHA blood cholesterol atherosclerosis than either the 2004 NCEP ATP III guideguidelines, lifestyle management is a key component in the line update or the 2011 European Society of Cardiology/ treatment and prevention of ASCVD. European Atherosclerosis Society (ESC/EAS) guidelines.14 The lifestyle management guidelines suggest that patients Conclusion consume a diet that emphasizes the intake of vegetables, fruits and whole grains and also includes low-fat dairy prod- In closing, there are some significant shifts in blood choles27
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March 2015 CE—Cholesterol Guidelines
March/April 2015
terol treatment recommendations between the 2002 ATP III 5. guidelines and the 2013 ACC/AHA guidelines. As opposed to a primary focus on LDL-C levels, the new guidelines support using statins for four major groups of patients with characteristics that are known to be associated with a high risk for ASCVD events. These four statin benefit groups are: 6. Group 1: Clinical ASCVD
Group 2: Primary Elevations of LDL-C ≥190mg/dL
Group 3: Diabetics 40 to 75 years of age with LDL-C 70-189mg/dL
Group 4: Estimated 10-year ASCVD risk of ≥7.5 percent without diabetes or clinical ASCVD
Bays H. Statin safety: an overview and assessment of the data--2005. The American journal of cardiology. 2006;97(8a):6c-26c.
8.
Bitzur R, Cohen H, Kamari Y, Harats D. Intolerance to statins: mechanisms and management. Diabetes care. 2013;36 Suppl 2:S325-330.
References Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of 12. Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S1-45.
2.
Third Report of the National Cholesterol Education 13. Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-3421.
3.
Pencina MJ, Navar-Boggan AM, D'Agostino RB, Sr., et al. Application of new cholesterol guidelines to a population-based sample. The New England journal of medicine. 2014;370(15):1422-1431.
4.
Online.lexi.com. Lexicomp Online Login. 2015; https://online.lexi.com/lco/action/home. Accessed April 1, 2015.
7.
Due to the evidence and proven effectiveness of statin therapy, the statins serve as the mainstay of blood cholesterol 9. management in the new guidelines with all other agents being relegated to second-line therapy for patients who are statin-intolerant. Statins should now be dosed at high, moderate or low intensity dosing based on patient indication 10. and no longer require dosing to reach specific target LDL-C levels. The 2013 ACC/AHA guidelines reviewed data published through 2011. New data will continue to be published, augmenting current evidence and helping guide clinician decision-making in the management of blood choles11. terol.
1.
Goff DC, Jr., Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S49-73.
14.
Spinar J, Spinarova L, Vitovec J. [IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (studie IMPROVE-IT)]. Vnitrni lekarstvi. 2014;60(12):1095-1101.
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Black DM. A general assessment of the safety of HMG CoA reductase inhibitors (statins). Current atherosclerosis reports. 2002;4(1):34-41. fda.gov. FDA Drug Safety Communication: New Retractions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury. http://www.fda.gov/Drugs/DrugSafety/ ucm256581.htm. Accessed April 1, 2015. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S76-99. Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based approach. American journal of preventive medicine. 2002;22(4):267-284. Johnson KM, Dowe DA. Accuracy of statin assignment using the 2013 AHA/ACC Cholesterol Guideline versus the 2001 NCEP ATP III guideline: correlation with atherosclerotic plaque imaging. Journal of the American College of Cardiology. 2014;64 (9):910-919. Pursnani A, Mayrhofer T, Ferencik M, Hoffmann U. The 2013 ACC/AHA cardiovascular prevention guidelines improve alignment of statin therapy with coronary atherosclerosis as detected by coronary computed tomography angiography. Atherosclerosis. 2014;237(1):314-318.
THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines
March/April 2015
March 2015 — Update on the 2013 ACC/AHA Cholesterol Guidelines 1. Which of the following is not classified as clinical ASCVD? A. Stable angina B. Myocardial infarction C. Uncontrolled hypertension D. Transient ischemic attack 2. What is the appropriate treatment choice for a 50 year old diabetic with an LDL-C of 154mg/dL and an 8.3 percent 10-year estimated risk? A. Atorvastatin 10mg twice daily B. Rosuvastatin 20mg once daily C. Simvastatin 80mg once daily D. Gemfibrozil 600mg twice daily 3. At what calculated LDL should all patients over 21 receive a high-intensity statin? A. LDL-C ≥190mg/dL B. LDL-C of >170mg/dL C. LDL-C of ≥170mg/dL D. LDL-C of >190mg/dL 4. At what estimated 10-year risk score should a 65 year old patient without clinical ASCVD or diabetes and an LDL-C of 130mg/dL be initiated on statin therapy? A. ≥8.5 precent B. ≥5 percent C. ≥7.5 percent D. ≥10 percent 5. What baseline labs should be obtained in all patients initiating statin therapy? A. CK and fasting lipid panel B. ALT, CK, and fasting lipid panel C. ALT and CK D. ALT and fasting lipid panel 6. Which of the following is not a severe adverse effect associated with statin therapy? A. Nasopharyngitis B. Rhabdomyolysis C. Transaminitis D. Cognitive dysfunction
8. Which of the following is the most accurate statement regarding treatment goals with statin therapy? A. Since no recommendation was made about target blood cholesterol goals, the target goals from ATPIII guidelines should still be used. B. A patient should be treated with cholesterol-lowering medications until the appropriate percent decrease in LDL -C is achieved since that is the performance standard. C. A patient should be treated according to the treatment algorithm using LDL-C percent decrease as a monitoring technique for assessing therapeutic response and patient adherence. D. A patient should be treated according to the treatment algorithm and no attention should be given to percent LDL-C decrease, as it is not useful in monitoring therapy. 9. What percent of calories from the patient’s daily intake should consist of saturated and trans fat in order to manage blood cholesterol? A. <5 percent B. 6 percent - 8 percent C. 3 percent - 5 percent D. 5 percent - 6 percent 10. Which of the following is the most accurate statement regarding the role of lifestyle modifications in the management and treatment of blood cholesterol and ASCVD risk reduction? A. Lifestyle modifications are very efficacious and should be continuously monitored in order to achieve proper ASCVD risk reduction. B. Lifestyle modifications are very efficacious but patients hardly ever adhere to them so their role is somewhat limited part of the treatment plan. C. Lifestyle modifications are not very efficacious but should be adhered to in order to achieve proper health. D. Lifestyle modifications are not very efficacious and should not be included in the treatment plan.
Send Potential CE topics to Scott Sisco at ssisco@kphanet.org
7. What is the approximate percent decrease in LDL-C with high-intensity statin therapy on average? A. ≥60 percent B. ≥50 percent C. ≥40 percent D. ≥30 percent
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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THE KENTUCKY PHARMACIST
March 2015 CE—Cholesterol Guidelines
March/April 2015
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: April 24, 2018 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. March 2015 — Update on the 2013 ACC/AHA Cholesterol Guidelines (1.5 contact hours) Universal Activity # 0143-0000-15-004-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 10. A B C D
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET March 2015 — Update on the 2013 ACC/AHA Cholesterol Guidelines (1.5 contact hours) Universal Activity # 0143-0000-15-004-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 10. A B C D
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
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Quizzes submitted without NABP eProfile ID # and Birthdate will not be accepted.
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Kentucky Renaissance Pharmacy Museum
March/April 2015
The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration.
Friend of the Museum $100 Proctor Society $250 Damien Society $500 Galen Society $1,000 Name______________________________________ Specify gift amount________________________ Address ____________________________________ City____________________Zip______________ Phone H____________________W________________ Email___________________________________ Employer name_____________________________________________________for possible matching gift. Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually.
Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com
For more information on the museum, see www.pharmacymuseumky.org or contact Gloria Doughty at g.doughty@twc.com or Lynn Harrelson at lharrelsonky@aol.com. Pharmacists Mutual Insurance offers Medicare Surety Bond In 2009 the Centers for Medicare and Medicaid Services (CMS) implemented Surety Bond Requirements for suppliers of Durable Medical Equipment, Prosthetics and Supplies (CMS-6006-F). This ruling requires that each existing supplier must have a $50,000 surety bond to CMS.
To see if you qualify for a $250 Medicare Surety Bond, or would like information regarding our other products, please contact us:
Pharmacists Mutual Insurance Company, through its subsidiary PMC Advantage Insurance Services, Inc. d/b/ a Pharmacists Insurance Agency (in California), led the way to meet this requirement by negotiating the price of the bond from $1,500 down to $250 for qualifying risks.
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Call 800.247.5930 Extension 4260 E-mail medbond@phmic.com Contact a Pharmacists Mutual Field Representative or Sales Associate http://www.phmic.com/phmc/ services/ibs/Pages/Home.aspx In Kentucky, contact Bruce Lafferre at 800.247.5930 ext. 7132 or 502.551.4815 or Tracy Curtis at 800.247.5930 ext. 7103 or 270.799.8756.
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KPhA New and Returning Members
March/April 2015
KPhA Welcomes New and Renewing Members January-February 2015 Ann Abbott Louisville
Larry Bright Campbellsville
Tom Clarke Lexington
Demetra Antimisiaris Prospect
Stephen Britt Louisville
William Conyers Glasgow
Doug Antle Louisville
Emily Brooks Berea
Chad Corum Manchester
Tim Armstrong Mount Washington
William Broughton Shepherdsville
Terry Coyle Campbellsville
Maryann Awosika Cold Spring
Elois Broughton Shepherdsville
Tonya Crutchfield Annville
Karen Baisch Louisville
Amy Brown Greenup
Helen Danser Tyner
Nathan Bales Frankfort
Clyde Brown Mayfield
Joey Darling Wheelersburg, Ohio
Ellen Barger Mount Washington
Amanda Burton Danville
Amy Delcourt Greenup
Cathy Barker Flatwoods
Donell Busroe Harlan
Eldon Depew London
Loary Bartlett Owensboro
Misty Camp Horse Branch
Glenn Downs Lexington
Andy France Covington
Mary Beimesch Hebron
Mark Capps Burkesville
Paul Elmes Sarasota, Fla.
Clarence Francis Maysville
Michelle Bell Burkesville
Israel Cardenas Louisville
Catherine Elmes Sarasota, Fla.
Kristen Fugate-Oliver Krypton
Marguerite Bertram Albany
Shelia Carrico Lawrenceburg
Kay Embrey Brandenburg
Lynn Fuller Versailles
Stephen Blanford Louisville
Kyle Carver Alexandria
Tony Esterly La Grange
John Fuller Versailles
Gregory Blank Edgewood
Timothy Castagno Louisville
Lauren Esterly La Grange
Bernard Fussenegger Louisville
Charles Boggs Dandridge, Tenn.
Aimee Chambers Somerset
Rebecca Farney Fort Thomas
Patty Gayheart Hindman
Virginia Bohmer Cincinnati, Ohio
Carolyn Chou Louisville
David Figg Beaver Dam
April Golden Corbin
Samantha Bradstreet Campbellsville
Carrie Christofield Ft Mitchell
Kevin Fosso Carlisle
Stephen Goodlett Lexington
Erika Branham Versailles
Leanne Clark Richmond
Virginia E. France Covington
Lisa Goodlett Springfield
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MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession!
THE KENTUCKY PHARMACIST
KPhA New and Returning Members
March/April 2015
Charles Gore Russell Springs
Tawnya Hunt Greenup
Burnice Napier Hazard
Andrew Rudd Floyds Knobs
Cynthia Gray La Grange
John Inabnitt Somerset
Sherry Neely Tyner
Thomas Russell Independence
Bernard Gregorowicz Louisville
Jane Ingram West Liberty
Anna New Owenton
Melody Ryan Lexington
William Grise Richmond
Karen Jackson Paducah
Karl O'Dell Flatwoods
Larry Schaefer Madisonville
Dale Gunkel Madisonville
H. Dale Johnson Corbin
Kathy O'Dell Ashland
Jim Scott Earlington
Ryan Haggard Irvine
Daniel Johnson Hagerhill
Beth Parks Coralville, Iowa
Catherine Shely Morehead
Brandon Hale Murray
Robert Kidwell Crestwood
Darren Parks Louisville
Roberta Sloan Lexington
Deborah Harden Campbellsville
Christopher Killmeier Louisville
Himati Patel Louisville
Sheel Slone Lexington
David Harris Mayfield
David Kramp Elmwood Place, Ohio
George Patterson Gilbertsville
Richard Slone Jr. Lexington
Henry Harris Louisville
Cheryl Little Staffordsville
Charles Peterson Rineyville
Rosemary Smith Beattyville
Dale Heise Harrodsburg
Julie Losch Bowling Green
Lance Piecoro Louisville
Luther Smith Beattyville
Jolinda Henry Lexington
Philip Losch Bowling Green
Bruce Polly Lexington
Justin Smith Williamsburg
Larry Hill Williamsburg
Craig Martin Georgetown
Sarah Raake Palmyra, Ind.
Vance Smith Harrodsburg
Kristina Hinkle Heidrick
James Maze Salt Lick
James Raasch Villa Hills
Andrea Spaulding Burlington
James Hinkle Heidrick
Okey Mbadike Louisville
Nancy Rath Louisville
R. James Spencer Beaver Dam
Susan Hogsten Flatwoods
Catherine Mcclish Louisville
Jill Rhodes Louisville
Kathryn Stoltz Louisville
Barry Horne Danville
Pam Montgomery Lawrenceburg
James Clay Rhodes Louisville
David Strunk Lexington
Melissa Hudson Louisville
Pamela Moore Campbellsville
Adam Robinson Brandenburg
Mykel Tidwell Mayfield
Brooke Hudspeth Lexington
Charles Moore Wentzville, Mo.
Scott Ross Hopkinsville
Angela Tracy Louisville
David Hume Louisville
Ronald Moreland Falmouth
Angela Rudd Floyds Knobs
Tiffany Trombley Quincy
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THE KENTUCKY PHARMACIST
KPhA New and Returning Members
March/April 2015
Michael Tucker Louisville
Rodney Ward Louisa
Kerri Woods Hamilton, N.Y.
Jane Yeager Lexington
John Turpin Harrogate, Tenn.
Amanda Ward Louisa
Grady Wright Georgetown
Dan Yeager Lexington
Terry Vest Russell
Ashley Wellman Argillite
William Wagers Berea
Sandy Wethington Liberty
Joseph Wagner Louisville
Beverly White Williamsburg
Julie Walker West Paducah
Paul Williams Hardinsburg
Know someone who should be on this list? Ask them to join YOU in supporting YOUR KPhA!
KPhA Honorary Life Members Ralph Bouvette
Leon Claywell
Kenneth Roberts
Gloria Doughty
Ann Amerson Stewart
KPhA Headquarters Rebuilding Campaign Watch eNews and subsequent editions of
The Kentucky Pharmacist for more information on ways YOU can help rebuild YOUR KPhA Headquarters!
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THE KENTUCKY PHARMACIST
KPhA New and Returning Members
March/April 2015
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.
Register Now! www.kphanet.org
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THE KENTUCKY PHARMACIST
Pharmacy Law Brief
March/April 2015
Pharmacy Law Brief: Criminal Liability of Pharmacists Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I heard something about a pharmacist in Texas or Oklahoma being convicted and sentenced to prison for some incident that occurred in his pharmacy. I hope that is an unusual occurrence that a pharmacist is sent to prison. What’s the story behind that? I’ve heard pharmacists be concerned about malpractice liability but this is an entirely different ballgame. Response: Your question came in some time ago and, unfortunately, there have been pharmacists in the news with criminal charges since the case you cite of James Ersland, the Oklahoma pharmacist who was convicted of first-degree murder for shooting a would-be robber at his pharmacy during 2009. He is serving a life sentence while pursuing appeals. That case followed the filing of criminal charges of reckless homicide (reduced to involuntary manslaughter) against former pharmacist Eric Cropp for the 2006 death of two year old Emily Jerry in Ohio. That unfortunate incident occurred when hypertonic sodium chloride solution was used to deliver the medication. And we need not go into the more recently filed criminal charges against a number of pharmacists in Massachusetts arising from the New England Compounding Center incidents.
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.
stop. He bumps into the person next to him, perhaps somewhat forcefully, constituting the possible criminal act of battery (offensive touching without consent) but there was no mens rea; it was an accident. There are generally considered to be two major categories of criminal offenses:
A felony (an offense with a penalty including incarceration for one year or more); and A misdemeanor (an offense with a penalty including incarceration of up to one year).
The above cases have received widespread notice among pharmacists because they are different from the traditional Serious criminal offenses in Kentucky are further divided matters that brought a small portion of the profession in into classifications of felonies: contact with the criminal justice system, i.e,, diversion of A Capital Offense – punishable with death, imprisonment for life without parole controlled substances for personal use or sale. 25 years to life in prison, or 20-50 years imprisonment To begin we need to differentiate criminal law from civil law. A Class A Felony – life in prison or 20-25 years incarThe former represents a wrong against all of society for ceration breaking a law enacted by the legislature, meaning that A Class B Felony – 10-20 years incarceration something is a crime only if the legislature says it is. Civil law, on the other hand, deals with relationships between A Class C Felony – 5-10 year in prison individuals within society, e.g., think of a contract dispute or A Class D Felony – 1-5 years in prison a negligence claim – all of society is not involved. We should mention in passing, however, that one factual situation can give rise to both criminal and civil legal actions – remember O.J. Simpson’s legal travails with escaping criminal charges and the civil trial where he lost. Generally speaking commission of a crime involves two elements: the doing of a criminal act (actus rea) and accompany criminal intent (mens rea). It may help to think of them as the “guilty act” and the “guilty mind.” Think of a person standing on a crowded bus that makes a sudden
All this background brings us to a consideration of interplay of the criminal law with the law in Kentucky related to licensure of pharmacists. The provisions in K.R.S. 315.121 are applicable: Grounds for acting against licensee – Notification to board of conviction required – Petition for reinstatement -- Expungement (1) The board may refuse to issue or renew a license, permit, or certificate to, or may suspend, temporarily suspend,
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THE KENTUCKY PHARMACIST
Pharmacy Law Brief
March/April 2015
revoke, fine, place on probation, reprimand, reasonably restrict, or take any combination of these actions against any licensee, permit holder, or certificate holder for the following reasons: (c) Being convicted of, or entering an â&#x20AC;&#x153;Alfordâ&#x20AC;? plea or plea of nolo contendere to, irrespective of an order granting probation or suspending imposition of any sentence imposed following the conviction or entry of such plea, one (1) or more of the following: 1. A felony; 2. An act involving moral turpitude or gross immorality; or, 3. A violation of the pharmacy, drug, or home medical equipment laws, rules, or administrative regulations of this state, any other state, or the federal government.
One hope is that a pharmacist never gets entangled with the criminal justice system. But should that occur or perhaps to a neighbor, relative or coworker, a sound recommendation is to work with an attorney who works in that area of the law on a frequent basis. With these high stakes, both in terms of possible incarceration and implications for licensure status not to mention the embarrassment attendant with such a turn of events, it may be a good idea to look beyond the attorney who handled the closing on the sale of your home or who drafted your will. Having an experienced criminal defense attorney at your side can have a number of possible benefits.
Are you connected to YOUR KPhA? Join us online!
Facebook.com/KyPharmAssoc
@KyPharmAssoc @KPhAGrassroots
KPhA Company Page
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THE KENTUCKY PHARMACIST
Pharmacy Policy Issues
March/April 2015
PHARMACY POLICY ISSUES: The Impact of Kentucky Medicaid Expansion Author: Devin Pence is a third professional year Pharm.D. student at the University of Kentucky College of Pharmacy and also is pursuing a Master of Business Administration degree at the Gatton College of Business and Economics. A native of Leitchfield, Ky., he completed his pre-pharmacy coursework at the University of Louisville. Issue: The Affordable Care Act has granted states the opportunity to expand Medicaid to cover all adults up to 138 percent of the federal poverty level (FPL). As of October 2014, Kentucky was one of 27 states to accept the expansion. 1 What benefits will the Medicaid expansion have on the citizens of our state? Discussion: While the Affordable Care Act brought with it many implications, one significant opportunity that it created was the option for states to expand their Medicaid programs. The act has given states the option to expand Medicaid eligibility for adults up to 138 percent of FPL: this significantly increases the number of Medicaid eligible Americans who did not meet the former criteria due to the lower cut-off at 100 percent of FPL, or other factors such as not having children. In 2014, 27 states, including Kentucky, and the District of Columbia have opted for the expansion. In our state, the additional coverage has the opportunity to cut the number of uninsured nearly in half, as approximately 308,000 Kentuckians without coverage fall below the new 138 percent of FPL cutoff. Thousands of Kentuckians are now able to afford the care that they previously did not have access to, which will lead to improved healthcare outcomes throughout the state. In addition to the positive effects Medicaid expansion will have on health outcomes for Kentucky, the decision to expand also is a beneficial move financially for the state. For the first three years, the federal government will be fully funding the program expansion. The support of the federal government will then gradually fall to cover only 90 percent of the cost by the year 2020. However, during this time period new jobs will be created and less local funding will be required for services that will now be covered under the Medicaid expansion. A study conducted by the University of Louisville estimates that the expansion would have a $15.9 billion impact on the stateâ&#x20AC;&#x2122;s economy over the years 2014-2020 through the creation of 17,000 new jobs, newly generated tax revenue, and an increase in healthcare spending. To further justify the stateâ&#x20AC;&#x2122;s decision to expand coverage, failing to accept the expansion would have had an estimated negative financial impact of $38.9 million on Kentucky through increased penalties for businesses, decreased hospital funding for indignant care and having to subsidize the other states that did elect for the expansion. 2 While dissenters may quickly assume the expansion may be costly to the state, it is actually a positive economic op-
Have an Idea?: This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome. Please send them to jfink@uky.edu. portunity that will lead to more jobs and increased revenue for the state. The expansion of Medicaid is on track to help millions of people; but there is a concern as to whether supply will keep up with demand. According to a recent study conducted by PerryUndem, on behalf of the Medicaid and CHIP Payment and Access Commission, new Medicaid beneficiaries throughout the country enjoyed the new coverage and even felt as if their health had improved since enrolling in Medicaid. However, some have had difficulties finding a primary care provider to accept them.3 While Kentucky specifically was not included in the study, it is clear that similar issues could be occurring in our state, especially in rural, medically underserved areas. This primary care shortage makes it difficult for the flood of new beneficiaries to receive the care they are now eligible for. Pharmacists can view this shortage as an opportunity, and could even relay these concerns to legislators in support of healthcare provider status for pharmacists. Despite the Medicaid expansion being in its early stages, positive predictions and observations have already been made concerning the impact this will have on the country. The expansion grants millions of Americans access to healthcare who previously have been unable to afford the medical treatment they need. Also, the states that have chosen to undergo the expansion will reap many economic benefits throughout the life of the project. However, steps may need to be taken in the future to increase primary care access to accommodate the increased need for healthcare:
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THE KENTUCKY PHARMACIST
March/April 2015
Pharmacy Policy Issues
a role that pharmacists may be able to fill one day in the 2. United States. Commonwealth of Kentucky. Governor's near future. Office. Kentucky.gov. N.p., 2014. Web. 17 Oct. 2014. <http://governor.ky.gov/healthierky/medicaid/ Citations Pages/default.aspx>. 1. A 50-State Look at Medicaid Expansion: 2014. Families 3. Early Experiences of New Medicaid Enrollees. PerryUnUSA. N.p., Sept. 2014. Web. 17 Oct. 2014. <http:// dem, Sept. 2014. Web. 17 Oct. 2014. familiesusa.org/product/50-state-look-medicaidexpansion-2014>.
Kentucky Pharmacists Political Advocacy Contribution Form Name: _________________________________ Pharmacy: ___________________________ Address: _______________________ City: ________________ State: _____ Zip: ________ Phone: ________________ Fax: __--_______________ E-Mail: __________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)
Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601
CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election. Individuals may contribute no more than $1,500 per year to all PACs in the aggregate. In-kind contributions are subject to the same limits as monetary contributions.
Cash Contributions: $50 per contributor, per election. Contributions by cashierâ&#x20AC;&#x2122;s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election. (This information is in accordance with KRS 121. 150)
KPhA Government Affairs Contribution Name: _______________________________Pharmacy: _____________________________
Email: ______________________________________________________________ Address: _____________________________________________________________ City: ___________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs)
Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601
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THE KENTUCKY PHARMACIST
March/April 2015
Pharmacists Mutual
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THE KENTUCKY PHARMACIST
Cardinal Health
March/April 2015
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THE KENTUCKY PHARMACIST
KPhA Board of Directors/Staff
March/April 2015
KPhA BOARD OF DIRECTORS
HOUSE OF DELEGATES
Duane Parsons, Richmond dandlparsons@roadrunner.com
Chair 502.553.0312
Ethan Klein, Louisville kleinethan@gmail.com
Speaker of the House
Bob Oakley, Louisville Boakley@BHSI.com
President
Chris Harlow, Louisville cpharlow@gmail.com
Vice Speaker of the House
Chris Clifton, Villa Hills chrisclifton@hotmail.com
President-Elect
KPERF ADVISORY COUNCIL
Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com
Secretary
Matt Carrico, Louisville matt@boonevilledrugs.com
Glenn Stark, Frankfort glennwstark@aol.com
Treasurer
Kim Croley, Corbin kscroley@yahoo.com
Raymond J. Bishop raybishop13@gmail.com
Past President Representative
Kimberly Daugherty, Louisville kdaugherty@sullivan.edu
Directors
Mary Thacker, Louisville mary.thacker@att.net
Matt Carrico, Louisville* matt@boonevilledrugs.com
KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc
Tony Esterly, Louisville tonye50@hotmail.com Matt Foltz, Villa Hills mfoltz@gomedcare.com Chris Killmeier, Louisville cdkillmeier@hotmail.com Mallory Megee, Nicholasville mallory.megee@uky.edu
University of Kentucky Student Representative
Jeff Mills, Louisville jeff.mills@nortonhealthcare.org
Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org
Chris Palutis, Lexington chris@candcrx.com Christian Polen cpolen7392@my.sullivan.edu
Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org
Sullivan University Student Representative
Richard Slone, Hindman richardkslone@msn.com Mary Thacker, Louisville mary.thacker@att.net Sam Willett, Mayfield duncancenter@bellsouth.net
Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org
* At-Large Member to Executive Committee
KPhA sends email announcements weekly. If you arenâ&#x20AC;&#x2122;t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list. 42
THE KENTUCKY PHARMACIST
50 Years Ago/Frequently Called and Contacted
March/April 2015
50 Years Ago at KPhA COLEMAN FRIEDMAN MAN-OF-THE-YEAR Coleman Friedman was named 1964 Man-of-the-Year at the meeting of the Jefferson County Academy of Pharmacy in March, 1965. Coleman was very active in the Diabetic Detection Drive and other civic affairs. He is a member of the Kentucky Board of Pharmacy. A plaque expressing the appreciation of the Academy was presented to Coleman by Bill Walker, 1964 President of the Academy. - From The Kentucky Pharmacist, April 1965, Volume XXVIII, Number 4.
Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org
Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org
National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222
2015 KPhA Board of Directors Election Paper Ballot Request Form The 2015 KPhA Board of Directors Election will be held online at www.kphanet.org. You will need to log in to the site to cast your vote. Paper ballots will be available, but ONLY upon request through this form.
Name:
Email:
Address: City, State Zip: Fax number: Preferred Method to Receive Ballot: (Circle one)
Fax
Return form to KPhA, 1228 US 127 South, Frankfort, KY 40601, Fax 502-227-2258, or email ssisco@kphanet.org. Call the KPhA Office at 502-227-2303 for more information.
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THE KENTUCKY PHARMACIST
March/April 2015
THE
Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601
Register Now! June 25-28, 2015 Holiday Inn University Plaza and Sloan Convention Center Bowling Green, KY www.kphanet.org
Show your Pharmacist Pride with a KPhA Roamey Window Cling ($5) or your own personalized Roamey ($25)!
2015 KPhA Legislative Conference November 13-14, 2015 Hyatt Regency Lexington
All proceeds benefit the KPhA Building Fund Available at the KPhA Online Store www.kphanet.org, click on About Tab, Online Store
For more upcoming events, visit www.kphanet.org. 44
THE KENTUCKY PHARMACIST