Y K C U T N E K E H T T S I C A M PHAR Vol. 7, No. 5 September 2012
Planning Retreat 2012 Where do we want to be and how do we get there? Find out: Pages 55--7
MARK YOUR CALENDAR: 2012 KPhA Mid-Year Conference on Legislative Priorities & Emergency Preparedness November 30-December 1 * Embassy Suites Lexington News & Information for Members of the Kentucky Pharmacists Association
Table of Contents
September 2012 October CE— Hypertension and Obesity October Pharmacist/Pharmacy Tech Quiz Medicare Surety Bond Information Pharmacy Law Brief New Members of KPhA Continuing Education Article Guidelines KPhA Mid-Year Conference Senior Care Corner RxTM Staff Changes Pharmacy Policy Issues Pharmacists Mutual KPhA Social Networking Connections KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted
Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective Pharmacists Running for KY House Message From Your Executive Director Strategic Planning Report KPhA Committees 2012-13 Supreme Court upholds ACA September CE—The Advancement of Pipeline Drugs September Pharmacist/Pharmacy Tech Quiz Bowl of Hygeia Million Hearts Team Up. Pressure Down. Leadership Development of Students
2 3 4 5-6 7 8-9 10-11 12-17 18 19 20-21 22-25
26-33 34 35 36 37 38 39 40 41 42-43 44 45 46 47
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.
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.
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.
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.
Editorial Office: © Copyright 2012 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bimonthly. 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.
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President’s Perspective
President’s Perspective
September 2012 ren Lentz; as well as two members of the Kentucky Retail Federation, Jan Gould and Gay Dwyer. Representing APSC were Executive Vice President Ralph Bouvette and Vice President for Professional Affairs Cathy Hanna. Quite a stellar group I would say!
The group gave Commissioner Kissner information on a number of topics affecting pharmacy practice and Kimberly Sasser overall patient care as it relates to the Department of Medicaid. We gave many specific examples where Croley pharmacies have been denied payment for legitimate KPhA President claims. We discussed the recent snafu over patients 2012-2013 being locked in to pharmacies they did not normally use. We also focused on the overall added value of pharmacists and pharmacy-based services to Medicaid beneficiaries who are recognized as being complex patients for whom to provide care. The Commissioner took lots of notes and asked probing questions As we continue our journey thru “Relevance and Re- to extract further information. I certainly hope our lationships”, I wanted to share with you some of the “Relevance and Relationships” pays off here! opportunities I have been given to represent KPhA on The second opportunity was at the UKCOP White your behalf. The two opportunities I have chosen to Coat Ceremony held Friday, August 17 at the Sintell you about are very different in many respects but gletary Center. I had never been to this Ceremony, both share the ability to show the importance of but it was quite lovely and very meaningful to the stu“Relevance and Relationships.” dent pharmacists and pharmacists in attendance. Here, I was given two minutes to discuss “what it takes to be a good pharmacist.” As you can imagine, I was quite dismayed at the two-minute time frame because I love to talk! However, I managed to narrow the answer to the question down to three things (well maybe four). You need a “good mind, good mouth, good mentor” and a good (comfortable) pair of shoes. As I pointed out to those in attendance, the student pharmacists all have “good minds” or they would not have the grade point average to get in to pharmacy school. I told them that if they were shy or introverted to come see me! and I would help them develop a “good mouth” to talk to their patients. I told them to choose wisely for rotations and find “good mentors” to help them grow in their pharmacy careers and never forget the comfortable shoes! I think we can all see Bob McFalls, Leon Claywell, Richard Slone and I at- the “Relevance and Relationships” involved here tended this meeting; along with several members of for our new student pharmacists. Never forget we KIPA, including board members Rosemary and Luwere all there once and make sure to be a “good ther Smith, Jason Wallace, Rob Warford, Michael and mentor” to the student pharmacists you are lucky Elizabeth Berry, Jerry Rickard and EPIC lobbyist Ka- enough to be around! The first opportunity involved a group of pharmacists meeting with our new Commissioner of Medicaid, Lawrence Kissner. KPhA and other pharmacy groups spent countless hours working with the previous Secretary, Janie Miller, and Commissioner Neville Wise. By building our relationships with these individuals with mutual respect and always being forthright and forthcoming in our meetings, we were able to accomplish many items that improved patient care in Kentucky. It can be very difficult to start over with this relationship building when the decision makers at the top change just when opportunities to make a difference arise. At this point, the relevance that we have offered to the prior decision makers definitely gives us a jumping off point with the new people.
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Pharmacists running for Legislature
September 2012
Pharmacists running for House seats Kelly Whitaker (D-Lowes), a pharmacist and Graves County School Board Member, is running for state representative from Kentucky's 2nd District. The 2nd House District includes Graves County and the southern portion of McCracken County.
sentative Fred Nesler who announced he would not seek reelection in late December 2011. Whitaker’s contact information is: Kelly Whitaker, PharmD, CDE 270-674-5292 whitaker4rep@gmail.com
Whitaker is seeking to succeed Repre-
SUPPORT YOUR PHARMACIST CANDIDATES! GET INVOLVED! Earlington Mayor Mike Seiber (DEarlington) filed to run for the 10th District (Hopkins County) seat now held by Repr. Ben Waide (R-Madisonville).
Seiber's contact information is:
Seiber 2012 Campaign 101 W. Highland Park Earlington KY 42410 Seiber sold his pharmacy a few years PHONE: (270) 871-3530 ago and now works for Walgreens. He is E-mail: info@Seiber2012.com a member of KPhA and APhA.
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THE KENTUCKY PHARMACIST
From Your Executive Director
September 2012
MESSAGE FROM YOUR
EXECUTIVE DIRECTOR Robert “Bob” McFalls UNITED We Stand: A Call to Action in THIS Election Year Much has been happening at the Association as evidenced throughout the pages of your journal. Directors conducted a Strategic Board Retreat in August. Board and staff are busily planning this fall’s Mid-Year Conference on Legislative Priorities and Emergency Preparedness for November 30 & December 1. And, we are looking forward to launching our new web site and membership enhancements this fall. It’s an exciting time to be engaged with Your KPhA!
KPhA and KPPAC exist to support and represent the interests of pharmacists and pharmacy technicians at the state Capitol through membership service, legislative advocacy, political engagement It also is an election year which provides a perfect and financial contriopportunity to get involved and to make a differbutions. KPhA also seeks to increase the political ence. Our state motto speaks volumes in this reawareness of our members with discussion and eduspect, and I have always admired and appreciated it cation at our Mid-Year Conference and through other for this reason. As we know, Kentucky was originally a means. Thus, for our Election 2012 Call to Action in part of Virginia and then later formed from its territory Unity, I would like to offer these thoughts: as the first of seven states when we became the 15th Unite by getting involved with the election of your state on June 1, 1792. Some six months later, the state senator and representative. They are seekfirst Kentucky General Assembly adopted an official ing contributions now and are likely having town seal. Likewise, we can trace the origin for the concept hall meetings. Attend. Participate. Give. Become of strength in unity to one of Aesop’s fables in which Acquainted/Reacquainted. he teaches his sons that sticks in a bundle, when bound together, are not easily broken, but such a task is achievable when done one by one. Aesop’s moral thus being, “Union gives strength.” Most historians believe that the patriotism of Kentucky's first governor, Isaac Shelby—who made my native Lincoln County his home—was the inspiration for the state's choice of our motto, "United We Stand, Divided We Fall." Shelby, a hero of the Revolutionary War for his victory at the Battle of Kings Mountain, was fond of "The Liberty Song," written in 1768 by John Dickinson. The chorus of the song includes, They join in hand, brave Americans all, By uniting we stand, by dividing we fall. Our common roots as Kentuckians call our patriotism into action as we seek how we can unite and become stronger together. 5
Unite by supporting our Government Affairs work. Your donations provide additional financial support for the work of your KPhA staff and lobbyists on legislative issues that affect pharmacists and pharmacy. (For convenience, see Page 40 for a contribution form.) Unite by participating in the work of your KY Pharmacists Political Action Council which was formed in 2010. Your financial support is crucial in this election year, as every candidate has made an appeal to KPPAC for a financial contribution. KPPAC reported at the 2012 KPhA Annual Meeting that $15,931 had been distributed to candidates for state legislative office. Since that time, an additional $19,000 has been contributed by
THE KENTUCKY PHARMACIST
From Your Executive Director
September 2012
KPPAC, and as you might surmise, the KPPAC fund balance is running low. KPPAC is funded by voluntary individual contributions from KPhA members like you. (For convenience, see Page 43 for a contribution form.)
By contributing to KPPAC, individual pharmacist/pharmacy contributions are reinforced when KPPAC is also able to support candidates who support our issues. KPPAC strives:
To promote and strive for the improvement of government by encouraging and stimulating pharmacists and others to take a more active and effective part in governmental affairs.
To encourage pharmacists and others to understand the nature and actions of their government, as to political issues, and as to records, officeholders and candidates for elective office.
Contributing to KPhA Government Affairs and KPPAC demonstrates your additional support for your professional association and our collective advocacy efforts as KPhA members and staff.
Support your PHARMACIST CANDIDATES for the General Assembly in this year’s election. We are fortunate to have two qualified candidates running to represent our profession in the General Assembly. Let’s unite and support them in their aim for state legislative service. It would be great to have representation once again in the legislature from the “inside out” to work alongside our other champions of pharmacists/pharmacy. See Page 4 for more information on our pharmacist candidates for the House of Representatives.
In closing, I want to encourage everyone to remain focused on the opportunities that our strength represents when we work together in a way that undergirds all pharmacists and pharmacy issues. As we reembrace the words of our foremothers and forefathers, United We Stand, Divided We Fall, let’s do our part individually and collectively to make a difference for our profession.
To assist pharmacists and others in organizing themselves for more effective political action and in carrying out their civic responsibilities.
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KPhA Strategic Plan 2012-2015
September 2012
Strategic Planning 2012—2015 Report from the Board Planning Retreat, August 18, 2012 scan of its strengths, weaknesses, opportunities, and challenges; to identify strategic goals and next steps so KPhA can become a stronger membership Association; and, to create and define an action plan and timetable.
Overview: The Kentucky Pharmacists Association was founded in 1879 and the IRS has designated the Association as a 501(c)(6) tax exempt organization. Our programs and services include legislative advocacy, member communications, continuing education, an annual meeting, medication therapy management through Rx Therapy Management, LLC, KY Pharmacy Education & Research Foundation and the KY Pharmacists PAC. The Board of Directors recently conducted a Retreat with the goal of initiating a Strategic Planning process. Once developed, the new plan will guide KPhA for the next three years.
The following Directors and staff participated: Kim Croley, President; Duane Parsons, President-Elect; Lewis Wilkerson, Chairman; Cassandra Beyerle; Matt Carrico; Matt Martin; Joey Mattingly; Jeff Mills; Lance Murphy; Richard Slone; Leah Tolliver; Molly Trent; Sam Willett; ED Robert McFalls; Kelli Sheets and Scott Sisco. Participating from RxTM were Chris Harlow and Christine Richardson. Participants in the Retreat focused their energy on four critical areas and have developed draft goals by each focus area as delineated below.
The theme of the August Board Retreat was Relevance and Relationships defined by President Croley as “the quintessential ingredients to successfully keeping KPhA strong, vibrant, and meaningful to our membership and providing the key to our movement towards advancing the practice in new and innovative ways.” This theme was built upon three goals in terms of identifying ways KPhA can become stronger and more effective by conducting a new environmental
After reviewing the S.W.O.T. Analysis and discussing in small groups, the Board drafted four strategic goals as the first step of the KPhA Strategic Plan. Goals may be equated with the “core competencies” of the Association.
Strategic Goals
Provider Status Strategic Goal: Achieve Provider Status to foster expanded patient access to pharmacists’ services and receive reimbursement for those services through Education, Legislation and Promotion by July 1, 2015. Note: This Strategic Initiative has been designed to dovetail with the work of the Advancing Pharmacy Practice in KY Coalition.
Membership Engagement and Relevance Strategic Goal: Activate a new Membership Engagement Committee to increase membership involvement with the concurrent goal of increasing membership by 20 percent by 2015.
Legislative Advocacy and Grassroots Development Strategic Goal: Engage members understanding and increase involvement in the legislative process, advocacy and government relations.
Doing Business Better: Improving Utilization of our Infrastructure Strategic Goal: Revitalize the Association’s infrastructure to support our work with membership service, district associations, academies, KPERF, Rx Therapy Management and other defined partnerships and emerging relationships.
Next Steps: The KPhA Strategic Plan is a work in progress, and we are doing this with our collective expertise and not hiring an independent facilitator. Board and staff are working to outline a draft plan and would love to hear from you with your feedback. To this end, watch for an announcement in eNews and a posting of the draft plan itself on our website for YOUR review and feedback. 7
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KPhA Committees 2012-13
September 2012
KPhA Committees 2012-13 Executive Committee Lewis Wilkerson – Chair – rphs2@aol.com Kim Croley – kscroley@yahoo.com Duane Parsons – dandlparsons@roadrunner.com Glenn Stark – glennwstark@aol.com Frankie Abner – frankiehammons@gmail.com Trish Freeman – trish.freeman@uky.edu
Clay Rhodes – crhodes1@humana.com Organizational Affairs Joey Mattingly – Chair – joeymattingly@gmail.com Matt Martin – Vice-Chair – matt67martin@hotmail.com Joel Thornbury – jthorn6@gmail.com Vince Peak – vlpeak@insightbb.com BC Childress – bchildress@sullivan.edu Ralph Bouvette – Bouvette@apscnet.com Linda Menner – mennerl@bellsouth.net Leah Tolliver – leahtolliver@tollivergroup.net Judy Minogue – judy@lourx.com Matt Harman – UK COP student – mdhstx138@uky.edu Brent Simpkins – UKCOP – basimp4@uky.edu Shane Fogle – fogleshane@bellsouth.net
Past Presidents Donnie Riley – Chair – rileyd@ggclinic.com Leon Claywell – Vice-Chair – claywell24@gmail.com Lynn Harrelson – Lharrelsonky@aol.com George Hammons – kpp@windstream.net Larry Hadley – larry.hadley@hotmail.com Melinda Joyce – mbjoyce@mcbg.org Dwaine Green – dgree1@uky.edu Joe Carr – carrcjoe@aol.com Ron Poole – ron@poolespharmacycare.org Richard Slone – richardkslone@msn.com Johnny B. Anneken – jbanneken@aol.com Jessika Chinn – jessikachilton@ymail.com Joel Thornbury – jthorn6@gmail.com Greg Naseman – gregrph@isightbb.com
Professional Affairs/Public Affairs Jeff Mills – Chair – Jeff.Mills@nortonhealthcare.org Anne Policastri – Vice-chair – apoli2@email.uky.edu Allison Cubit – arcubit@yahoo.com Terry Vest – terry_vest@yahoo.com
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KPhA Committees 2012-13
September 2012
Holly Divine – hsdivi1@email.uky.edu Molly Trent – UKCOP- mjtren2@uky.edu Zach Thompson – UKCOP – rzthomp07@uky.edu Candace Robinson – Candace.robinson@nortonhealthcare.org Amy Larkin – alarkin@ceconcepts.net Cathy Hanna – channa@apscnet.com Greg Baker – greg.baker@walgreens.com Chris Harlow – cpharlow@gmail.com Misty Stutz – mstutz@sullivan.edu
Kim Croley – kscroley@yahoo.com Joe Carr – carrcjoe@aol.com George Hammons – kpp@windstream.net Kelley Ratermann – UK COP student – klrater200@uky.edu New Practitioner Bobby Bero – Co-Chair – bero@alumni.unc.edu Amanda Burton – Co-Chair – amandastarkburton@gmail.com Joey Mattingly – joeymattingly@gmail.com Chris Clifton – chrisclifton@hotmail.com Amanda Jett – SUCOP student – AJETT1706@my.sullivan.edu Alex Flannery – alex.flannery@uky.edu Lindsey Flanders – Lindseyk45@hotmail.com Danielle L. Waymeyer – UKCOP – d.waymeyer@uky.edu
Ad Hoc Committees Budget & Audit Glenn Starks – Chair – glennwstark@aol.com Duane Parsons – dandlparsons@roadrunner.com Sam Willett – duncancenter@bellsouth.net Frankie Abner – frankiehammons@gmail.com Lewis Wilkerson – rphs2@aol.com Kim Croley – kscroley@yahoo.com
Membership Benjamin Mudd – bpmu222@gmail.com Duane Parsons — dandlparsons@roadrunner.com Ashley Lanham – UKCOP – ashley.lanham@uky.edu Amanda Ward – AmandaPreston@hotmail.com Ellen Barger – medicarxshep@gmail.com Kim Croley – kscroley@yahoo.com Matt Carrico – rxcarricojr@gmail.com
Contract Review Trish Freeman – Chair – trish.freeman@uky.edu Ralph Bouvette – Bouvette@apscnet.com Anne Policastri – apoli2@uky.edu Government Affairs Richard Slone – Chair – richardkslone@msn.com Leon Claywell – claywell24@gmail.com Steve Hill – stevehill@alltell.net David Roy – UKCOP – djroy2@uky.edu Jessica Stokes – UKCOP- jessica.stokes@uky.edu Kelly Whitaker – whitaker97@hotmail.com Leah Tolliver – leahtolliver@tollivergroup.net Larry Hadley – larry.hadley@hotmail.com Matt Foltz – mfoltz@gomedcare.com Chris Killmeier – cdkillmeier@gmail.com Anne Policastri – apoli2@email.uky.edu Craig Martin – cmart2@email.uky.edu Jill Rhodes – Jillrh@ulh.org Barry Eadens – Beadens@BHSI.com
Emergency Preparedness Len Gore – Chair – lenkaragore@aol.com Lewis Wilkerson – rphs2@aol.com Kim Croley – kscroley@yahoo.com Brandy Trice – btrice@brtc.net Gary Sullivan – gwsullivan@chc.net Lynn Harrelson – lharrelsonky@aol.com Health Information Technology Larry Blandford – Chair – blandford@thehobartgroup.com Barry Eadens – Beadens@BHSI.com Patricia Robinson – Tech – patricia.robinson@ky.gov *We are looking for at least one technician member to serve on each committee except Past President's, Budget and Audit, New Practitioner and Contract Review. We also are looking for at least one student member for each committee except for Past President's, Budget and Audit and Contract Review.
Policy Review Tyler Whisman – Chair – tyler.whisman@gmail.com Matt Martin – Vice-Chair – matt67martin@hotmail.com Frankie Abner – frankiehammons@gmail.com 9
THE KENTUCKY PHARMACIST
hubonpolicyandadvocacy
September 2012
hubonpolicyandadvocacy Supreme Court upholds ACA
Leaving the pharmacy-friendly provisions of the health care reform law intact, the U.S. Supreme Court on June 28 upheld the Affordable Care Act (ACA) in a complicated 5–4 decision.
Ruling ACA constitutional in one part and unconstitutional in another part, the court upheld the “individual mandate” as a tax but not under the Commerce Clause, and limited the law’s expansion of Medicaid so that states can’t be penalized to the full extent of their Medicaid funding for not complying with this expansion. “APhA views the Supreme Court ruling as an important opportunity for pharmacists to help patients with their medications,” said Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, APhA Executive Vice President and CEO, on June 28. “Today’s ruling means that important elements of the law will stand, including closure of the doughnut hole and opportunities for pharmacist inclusion as members of the health care team in medical homes and accountable care organizations. We will continue to look for every opportunity to collaborate with our health care colleagues to improve patient care.” Pharmacy-related topics Over three days of oral arguments on ACA on March 26–28, the Supreme Court faced four main issues, including the Anti-Injunction Act, the individual mandate, its “severability” from the rest of the law, and the expansion of Medicaid. The cases Services, et al. (severability); Department of Health and Human Services, et al., v Florida, et al. (individual mandate, AntiInjunction Act), and Florida, et al., v Department of Health and Human Services, et al. (severability, Medicaid expansion).
Integrated care models such as accountable care organizations, medical homes and independence at home
Other hospital pharmacy–related provisions (see page HSE 3; available at www.pharmacytoday.org)
Health spending accounts and OTCs
Biosimilars
Fraud, waste and abuse
Electronic health record incentives and eprescribing
Chief Justice John G. Roberts, Jr. delivered the opinion of the court, joined by Justices Ruth Bader Ginsburg, Stephen G. Breyer, Sonia Sotomayor and Elena Kagan. Ginsburg filed a partially concurring opinion. Justice Anthony M. Kennedy authored the dissenting opinion, joined by Justices Antonin Scalia, Clarence Thomas and Samuel Anthony Alito, Jr. Thomas filed an additional dissenting opinion. Federal, state implementation Now that ACA has been upheld, APhA will be especially focused on how CMS and other federal agencies interpret the law. “The devil is always in the details in these matters,” said Brian Gallagher, BSPharm, JD, APhA’s Senior Vice President of Government Affairs, reflecting on his days as a legislator in West Virginia. “With ACA now set to proceed toward implementation of the individual mandate in 2014, APhA will engage our members in reviewing and seeking needed changes in regulations as they are developed, and we will work with our colleagues in state pharmacy associations as exchanges are developed.”
“If the court had gotten into a severability analysis, that’s where issues and provisions that affect pharmacy could have gotten very complicated,” noted Jay Campbell, BSPharm, JD, Executive Director of the North Carolina Board of Pharmacy. Pharmacy-related topics in ACA include the following:
Medication therapy management (MTM) opportunities in the unfunded MTM grant program, improvements to Part D MTM, the funded Center for Medicare and Medicaid Innovation, essential health benefits, medical loss ratio and the PatientCentered Outcomes Research Institute
The states will need to carefully evaluate the opportunities under ACA, according to Rebecca P. Snead,
Medicare Part D Coverage Gap Discount Program (the gradual closing of the doughnut hole) 10
THE KENTUCKY PHARMACIST
hubonpolicyandadvocacy
September 2012
BSPharm, Executive Vice President & CEO, National Alliance of State Pharmacy Associations. “They will be faced with making tough decisions due to existing financial constraints,” Snead said. “I believe it will be critical that state pharmacy associations receive the pharmacy profession’s support in working with state agencies to ensure access to pharmacist-provided patient care services.”
Hospitals now may be in a bind, Gallagher added. They’d cut a deal to support health care reform expecting that having more Medicaid-covered patients would offset current costs in uncompensated care for uninsured patients as well as decreased reimbursement under ACA. “As states seek ways to pay for the potential expansion of Medicaid, pharmacies may see a greater push towards lower reimbursement methodologies,” said Lee Rosebush, PharmD, JD, MBA, MS, Associate in Morgan Lewis’s FDA and Healthcare Practice. “Pharmacies should pay close attention to state Medicaid agency actions.”
Looking ahead: States Many states may choose to develop their insurance exchange by 2014 rather than let the federal government set it up for them. While the majority of states have not authorized the creation of exchanges, now that the high court has ruled and the states already in are sharing work product, “a lot of states will be prepared with their insurance exchanges on time,” Gallagher said.
Looking ahead: Nation In the wake of the Supreme Court upholding ACA, the health care reform debate rages on. The pace of ACA implementation will continue and may even pick up, Gallagher said, with more monies for grants from the CMS Center for Medicare and Medicaid Innovation and additional initiatives. “You go back to what the administration’s been trying to do, which is embed a bunch of this stuff,” he added. “It’s not going to be as simple as just repealing everything. Some [provisions] are popular.”
Editor’s Note: Kentucky Governor Steve Beshear issued an executive order July 17 creating a health exchange in the Commonwealth. According to the order, it should be operational January 1, 2014 and Carrie Banahan was named director. Banaham had been executive director of the Kentucky Office of Health Policy. Under ACA, the exchanges are required to create plans that have a set of essential health benefits including medications and that correspond to tiers with varying levels of coverage. “If the level of medication coverage and/or [MTM] is covered differently in the different tiers, then pharmacists will probably have a role like they have in Part D with explaining to people which tier [is] the best tier for them given their medical history,” Gallagher added. It’s less clear whether states will take the option to expand their Medicaid eligibility by 2014 to cover people younger than 65 years with incomes below 133% of the federal poverty level. As Today went to press, six governors had announced their intention to opt out. “There are states that have now an incentive to not opt in to the Medicaid match and cover these newly covered lives,” Gallagher said. “You’ll still be in a situation where patients can’t get their medications because they’re not going to be covered by Medicaid.”
ACA being upheld is “a great opportunity for pharmacists to further demonstrate their value as key members of the health care team,” said Laura Carpenter, BSPharm, JD, LLM, of Carpenter Law Firm PC. “Pharmacists must be informed and understand the complexities of the law as they impact the practice of pharmacy.” —Diana Yap With reporting from L. Michael Posey, BSPharm, MA; Amy K. Erickson, MA; and Corrie Whitmer
Reprinted with permission from the Hub on Policy and Advocacy column in the August 2012 issue of Pharmacy Today (www.pharmacytoday.org). For more information about the Affordable Care Act and pharmacy’s role in shaping the outcomes of this law, access the Government Affairs section of APhA’s website, www.pharmacist.com. Copyright © 2011, American Pharmacists Association. All rights reserved.
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Sept. 2012– Advancement of Pipeline Drugs
September 2012
The Advancement of Pipeline Drugs in 2012 By: Rachel Tafel, Pharm D. Candidate, Sullivan University College of Pharmacy Julie N. Bosler, Pharm.D., Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-12-009-H04-P&T 1 Contact Hour (0.1 CEUs)
KPERF offers all CE articles to members online at www.kphanet.org
OBJECTIVES: At the conclusion of this lesson, the reader should be able to:
Outline the process for FDA new drug approvals.
List both trade and generic names for New Molecular Entities (NMEs) approved from January 2012 thru April 2012.
Name the indication, administration route, dosage form, dosage and side effects of each NME.
State significant black box warnings, contraindications, necessary dosing adjustments and drug interactions for each NME.
BACKGROUND The Food and Drug Administration (FDA) released a statement in November 2011 that over the past 12 months the U.S. FDA had approved 35 new medications.1 The approval rate was among the highest on record, exceeded only by 37 approvals in 2009. The 35 approved medications have studies indicating increased survival and quality of life for disease states such as hepatitis C, lupus, Hodgkin’s lymphoma and late-stage prostate cancer. The FDA has attempted to expedite such new drug approvals by creating more flexible clinical trial requirements, while maintaining safety standards. Industries are working feverishly to market drugs for oncology, rare disease states and second-line therapies for chronic disease states. Industries who wish to market a new drug for U.S. consumption have to prove the drug’s efficacy and safety to the FDA. New Drug Applications (NDAs) are completed by the applicant and include drug name, indication, ingredients, strength, dosage form and route of administration.2 The application also should contain clinical trial information, stability testing, pharmacokinetic studies, side effects, toxicology and labeling information. The application provides comprehensive drug information with the goal of showing that the drug’s benefits outweigh its risks. The FDA aims to reduce the time it takes for drugs to be approved to less than six months in order to more efficiently pro-
vide the best possible treatment options to individuals who suffer from acute or chronic diseases.1 The collaborated effort of the FDA and pharmaceutical manufacturers has increased new drug approvals over the past few years. New drug products are marketed through commercial advertizing and drug representatives. It is important for physicians, practitioners and pharmacists in particular to become familiar with these newly approved drugs in order to provide the best, most current treatment options to patients. Since January 2012, 11 New Molecular Entities (NMEs) have been approved with indications spanning from an erythopoiesis-stimulating agent (ESA) to a drug used for erectile dysfunction.3 NEWLY APPROVED DRUGS FOR 2012 (Jan. 1 – May 1, 2012)3 VORAXAZE® (glucarpidase) Glucarpidase is a carboxypeptidase enzyme FDA approved Jan. 17, 2012 that is used to treat toxic methotrexate levels (>1µmol/L).4 Patients receiving a methotrexate chemotherapy regimen with renal impairment have difficulty clearing the drug which can result in extensive stomatitis, kidney/liver damage, intestinal destruction, skin rashes and reduced blood cell counts. The drug lowers methotrexate levels by converting the entity to glutamate and 4-deoxy-4amino-N 10-methylpteroic acid (DAMPA) which can
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Sept. 2012– Advancement of Pipeline Drugs
September 2012
be eliminated hepatically.5 It should be given at a dose of 50 units/kg reconstituted in 1mL normal saline and administered intravenously over five minutes; the line should be flushed before and after administration. Leucovorin rescue treatment should be continued but should not be given within two hours of glucarpidase administration.5 Hypotension, flushing, headache, nausea and vomiting were reported side effects of glucarpidase. DAMPA levels can cause falsely high readings of methotrexate levels within 48 hours of administration; therefore, use DNA chromatographic method for accurate readings.5 PICATO® (ingenol mebutate) Ingenol mebutate gel was approved Jan. 23, 2012 for actinitic keratosis as the first topical that can be used for as little as two to three consecutive days.6 Actinic keratosis is a precancerous condition caused by ongoing sun exposure that has potential to progress to squamous cell carcinoma.7 The mechanism of which the gel induces cell death is unknown. The 0.015 percent strength is approved for use once daily on the face and scalp for three consecutive days, and the 0.05 percent strength is approved for use once daily on the trunk and extremities for two consecutive days. The drug is not systemically absorbed, but patients with pre-existing eye/skin disorders should take extra precaution. The lesion site may crust, become red, flake, form a pustule or become painful throughout the days of administration. Pharmacists should counsel patients to apply gel from the single-use tube to affected area and allow drying for 15 minutes. Patients should wash their hands immediately after administration, avoiding any ophthalmic contact. The gel can be washed off six hours after administration with mild soap. 6
hypertensive crisis, uncontrolled or worsening hypertension, hemorrhage, proteinuria or concomitant use with CYP3A4/5 inhibitors. Axtinib must be adjusted with hepatic impairment and discontinued 24 hours before surgery. Liver function testing, INR, clotting signs, blood pressure and urinalyses should be conducted to monitor side effects. Trademark chemotherapy side effects of nausea, vomiting, hypothyroidism, redness on hands and feet, diarrhea, fatigue and stomatitits have been frequently reported.9 Close monitoring of blood cell counts and patient counseling on side effects are essential for patients receiving this drug. ERIVEDGE® (vismodegib)
Vismodegib, manufactured by Genentech, was approved Jan. 30, 2012 for the treatment of adults with metastatic basal cell carcinoma, locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery or radiation.10,11 This is the first FDA-approved drug for advanced stages of the most common skin cancer.10 Visomodegib is an oral capsule designed to selectively inhibit abnormal signaling of the Hedgehog pathway. This pathway is a molecular driver of basal cell carcinoma by increasing cell growth and decreasing cell repair. The capsule is available in 150 mg strength dosed once daily with or without food. Safety and efficacy in renal/hepatic impaired patients havenot been established, nor has safety in adults over 65 years of age. The drug has few interactions but does carry a black box warning for embryo-fetal death and severe birth defects. Due to its high teratogenicity, monitoring for pregnancy and using additional anti-contraceptives are important. Pharmacists should counsel patients to take a pregnancy test seven days before initiation of therapy and use extra birth control precautions for INLYTA® (axtinib) seven months after therapy discontinuation. There The tyrosine kinase-inhibitor, axtinib, was approved has been greater than 10 percent incidence of side Jan. 27, 2012 for the treatment of advanced renal cell effects reported including muscle spasms, alopecia, carcinoma for patients who have not responded to weight loss, nausea, vomiting, diarrhea, dysgeusia other types of therapy.8 Axtinib is available in a 1 mg and fatigue. The drug has a similar side effect profile and 5 mg tablet with a recommended initial dose of 5 to other antineoplastics, but it is important for pharmamg every 12 hours.8 The dose can be increased to 7 cists to counsel on its teratogenic black box warning. mg twice daily then 10 mg twice daily if previous dose KALYDECO® (ivacaftor) was well-tolerated by patient in previous two weeks. Dose interruptions or decreases are necessary with Ivacaftor was approved Jan. 31, 2012 for cystic fibro13
THE KENTUCKY PHARMACIST
Sept. 2012– Advancement of Pipeline Drugs Trade Name
®
September 2012
Generic Name
Manufacturer
Drug Class
Voraxaze
glucarpidase
BTG International, Inc
Hematologic Antidote
Picato
ingenol mebutate
LEO, Inc
Dermatologics
Inlyta
axtinib
Pfizer, Inc
Antineoplastics
Erivedge
vismodegib
Genentech, Inc
Antineoplastics
Kalydeco
ivacaftor
Vertex Pharmaceuticals, Inc
Pulmonary
Zioptan
tafluoprost
Merck, Inc
Antiglaucoma, Prostaglandin Agonist
Surfaxin
lucinactant
Discovery Laboratories
Lung Surfactant
AMYViD
florbetapir F 18
Eli Lilly, Inc
Diagnostic Imaging Agent
Omontys
peginestanide
Affymax
Hematopoietic Growth Factor
Stendra
avanafil
Vivus, Inc
Phosphodiesterase-5 Enzyme Inhibitors
Elelyso
taliglucerase alfa
Protalix/Pfizer, Inc
Enzyme Replacement Therapy
sis (CF) patients ages 6 and older with the G551D mutation.12,13 Approximately four percent of CF patients have the G551D mutation which causes an increased blockage of salt and fluid flow.12 Ivacaftor helps to unlock this block and restore function of the defective protein to improve lung function. The 150 mg tablet is to be taken with a high fat meal every 12 hours. The drug has been associated with serious drug interactions with CYP3A inhibitors and inducers; therefore, dose adjustments with drugs such as St. John’s Wort, rifampin and phenytoin will be necessary. Headache, nasal congestion, oropharyngeal pain and abdominal pain are among this drug’s side effect profile. Monitoring for elevated transaminases before treatment, three months after initiation, then annually thereafter are important considerations for physicians.12 Pharmacists should screen patients for drug interactions while using this drug. ZIOPTAN® (tafluprost ophthalmic solution) Tafluprost’s approval was announced Feb. 13, 2012 by the FDA to be the first preservative-free prostaglandin analog for open-angle glaucoma (OAG) or ocular hypertension.14,15 Tafluprost was shown to have powerful intraocular pressure (IOP) lowering ef-
fects. In clinical studies of up to two years in length, tafluprost, dosed once-daily in the night lowered IOP at three and six months by 6-8 mmHg and 5-8 mmHg respectively, from a baseline pressure of 23-26 mmHg (mmHg = millimeters of mercury, a measurement of fluid pressure in the eye).15 The prostaglandin analog is thought to increase uveoscleral outflow. The product is available in 0.0015 percent solution singleuse packs to be instilled into the conjunctival sac once daily in the evening. Dosing should not occur more than once daily as the IOP effects could be lessened over time. Changes in length, thickness and number of lashes were observed in clinical trials in addition to pigmentation changes of the iris.14 Patients with active macular edema should not use this product. SURFAXIN® (lucinactant) Lucinactant is a liquid medication approved by the FDA on March 6, 2012 for the prevention of Respiratory Distress Syndrome (RDS) within 24 hours of infant birth.16 Premature infants’ lungs do not contain enough surfactant. Without surfactant, infants have difficulty breathing and can experience low oxygen saturation. The drug works to supply surfactant and reduce pulmonary surface tension during respiration. 14
THE KENTUCKY PHARMACIST
Sept. 2012– Advancement of Pipeline Drugs
September 2012
Lucinactant is provided as an 8.5 mL suspension that is to be administered intratracheally. The suggested dosing is 5.8 mL/ kg birth weight into four aliquoted doses, with up to four doses in 48 hours, but not to exceed more than one dose in six hours.16 The doses will need to be warmed for 15 minutes on a warming block at 44°C and shaken vigorously before given as a free-flowing suspension; the suspension should appear opaque white to clear.16 The drug is contraindicated in adults and its side effects include endotracheal tube reflux or airway obstruction.
weeks or >2 g/dL in four weeks), reduce peginesatide dose by 25 percent.19 Peginesatide has a black box warning for increased risk of stroke and cardiovascular risk and should not be given when hemoglobin levels are greater than 11 g/dL. Diarrhea, dyspnea, nausea, cough, injection site reaction, headache, muscle spasms and changes in blood pressure have been observed. In addition to checking blood pressure, hemoglobin levels should be monitored every two weeks and therapy should be discontinued if there is no response.19
AMYVID® (Florbetapir F 18 Injection)
STENDRA® (avanafil)
The FDA approved Amyvid on April 10, 2012 for Positron Emission Tomography (PET) viewing of the brain in patients suspected of Alzheimer’s Disease (AD).17 The florbetapir F 18 isotope binds to the beta-amyloid plaque and can be detected by the PET scanner.17 Inject 370 MBq (10 mCi) as a single IV bolus injection in a total volume of 10 mL or less and perform the PET starting 30-50 minutes after injection. A positive scan is indicated when there is little white to gray contrast in the cerebral cortex or higher gray content in one or more areas.18 Positive scans are not a gold standard for diagnosis of AD but can be used to aid diagnosis and treatment approaches. There are minimal side effects of florbetapir F 18 except for headaches, reported in one to 10 percent of patients.18 PET scans with florbetapir F 18 will be able to show evidence of cognitive decline in patients over time.
Avanafil was approved for erectile dysfunction on April 27, 2012, expanding available treatment options for the 30 million men in the United States that suffer from this condition.21,22 The drug is a phosphodiesterase type 5 inhibitor that enhances the effects of nitrous oxide. Avanafil is available in 50 mg, 100 mg, and 200 mg tablets to be taken 30 minutes before intercourse. Therapy may be initiated with the 100 mg tablet and titrated to 200 mg or decreased to 50 mg depending on tolerability.21 Avanafil safety and efficacy in severe hepatic or renal impairment has not been established. Do not exceed 50 mg/ 24 hours if using alpha blockers; organic nitrates or CYP3A4 inhibitor concomitant use is contraindicated. The drug has minimal side effects, including headaches, flushing and nasal congestion, but hypertensive patients should be counseled on risks.21
OMONTYS® (peginesatide)
ELELYSO® (taliglucerase alfa)
Peginesatide was approved by the FDA on March 27, 2012 to treat anemia in adult dialysis patients who have chronic kidney disease (CKD).19,20 This erythropoiesis-stimulating agent (ESA) is used to promote red blood cell production to increase hemoglobin and reticulocyte counts. Peginesatide is available in various strengths within single-use vials, pre-filled syringes and multiple-dose vials. Therapy should be initiated at hemoglobin levels less than 10 g/dL at the initial treatment dose of 0.04-0.08mg/kg subcutaneously once monthly.19 There are dose conversions for patients previously receiving Aranesp and Epogen. Peginesatide offers the advantage of once monthly dosing as opposed to other agents that have weekly dosing. If hemoglobin rises rapidly ( >1 g/dL in the two
Taliglucerase alfa was approved May 1, 2012 by the FDA as an orphan drug for the rare Gaucher’s disease.23 Gaucher’s disease is found in approximately 6,000 Americans who have the genetic defect for the glucocerebrosidase enzyme used to breakdown harmful substances in the liver, spleen, bones and bone marrow.23 Patients would most likely resort to a bone marrow transplant in severe cases, but this enzyme replacement drug offers a less invasive treatment approach. Taliglucerase alfa catalyzes the hydrolysis of glucocerebroside to glucose and ceramide which results in reduced spleen and liver enlargement and increased RBCs and platelets.24 The drug is dosed as 60 units/kg IV every two weeks infused over one to two hours. There are no dose conversions that
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Sept. 2012– Advancement of Pipeline Drugs
September 2012
2. The FDA's Drug Review Process: Ensuring Drugs Are need to be made when switching from Cerezyme Safe and Effective. Food and Drug Administration Web (imiglucerase), another medication currently available site. Available at: http://www.fda.gov/drugs/ for the rare disease. Healthcare professionals should resourcesforyou/consumers/ucm143534.htm. Acobserve for allergic type reactions upon intravenous cessed May 7, 2012. administration. 3. New Drugs Approved by FDA 2012. Pharmacist’s Letter Web site. Available at: http:// The FDA has remained true to its promise to expedite pharmacistsletter.therapeuticresearch.com/pl/ drug approvals as evident by 11 drugs already apNewDrugs.aspx. Accessed May 6, 2012.
CONCLUSION
proved in the first four months of 2012. With 35 ap4. Voraxazane (glucarpidase) [package insert]. West Conprovals in 2011, the pipeline looks promising for 2012. shohocken, Pa: BTG International Inc; 2012. The 2012 approvals are on the market and available 5. FDA Approvals: Glucarpidase to Reduce Toxic Methoto consumers ahead of their deadlines, allowing patrexate Levels. Medscape Pharmacy Web site. Availatients to have the best available options for treatment ble at: http://www.medscape.org/viewarticle/757667. sooner. Accessed May 14, 2012. Drugs have been developed for rare and incurable diseases such as Gaucher’s Disease (Elelyso) and cystic fibrosis (Kalydeco) giving hope to patients who otherwise had fewer therapeutic options. With cancer rates soaring, manufacturers are pushing oncologic and hematologic drugs to increase survival rates for cancer patients refractory to first-line treatments. Drugs have been currently approved as second-line therapies for renal cell carcinoma (Inlyta) and basal cell carcinoma (Erivedge) but could have indications expanded to first-line therapies as more trial data are available. Manufacturers are pushing to produce drugs specific to patients with renal impairment to increase survival rates in CKD patients with multiple disease states.
6. Picato (ingenol mebutate) [package inset]. San Antonio, TX: LEO Pharma; 2012. 7. FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing. PR Newswire Web site. Available at: http:// www.prnewswire.com/news-releases/fda-approvespicato-ingenol-mebutate-gel-the-first-and-only-topicalactinic-keratosis-ak-therapy-with-2-or-3-consecutivedays-of-once-daily-dosing-138033448.html. Accessed May 7, 2012. 8. Nelson, Roxanne. FDA Approves Axitinib for Advanced Renal Cell Cancer (1/27/2012). Medscape Medical Web site. Available at: http:// www.medscape.com/viewarticle/757630. Accessed May 14, 2012.
Manufacturers have shifted focus from marketing chronic maintenance drugs to rarer, more plaguing conditions. While these drugs may have more convenient dosing and offer promise to minority diseases, they come with a hefty price tag. Drug manufacturers are working with insurance agencies and local governments to promote coverage of these newly approved drugs. The FDA pushing for faster drug approvals in addition to drug marketing possible at earlier dates will give consumers more choices and prevent clogs within the drug pipeline.
9. Inlyta (axitinib) [package insert]. New York, NY: Pfizer, Inc; 2012. 10. Erivedge (visodegib) [package insert]. San Francisco, CA: Genentech, Inc; 2012. 11. Nelson, Roxanne. FDA Approves Visodegib for Advanced Basal Cell Carcinoma. Medscape Medical Web site. Available at: http://www.medscape.com/ viewarticle/757707. Accessed May 7, 2012. 12. Kalydeco (ivacaftor) [package insert]. Cambridge, MA:Vertex Pharmaceuticals; 2012.
13. FDA Approves Kalydeco (VX-770) — First Drug That Targets the Underlying Cause of Cystic Fibrosis. CF 1. FDA News Release: 35 innovative new drugs approved Foundation Web site. Available at: http://www.cff.org/ in fiscal year 2011. Food and Drug Administration Web aboutCFFoundation/NewsEvents/1-31-FDA-Approvessite. Available at: http://www.fda.gov/NewsEvents/ Kalydeco.cfm. Accessed May 8, 2012. Newsroom/PressAnnouncements/ucm278383.htm. 14. FDA Approves Zioptan (tafluprost ophthalmic solution), Accessed May 8, 2012. REFERENCES
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Sept. 2012– Advancement of Pipeline Drugs Merck’s Once-Daily, Preservative-Free Ophthalmic Medication. Merck Inc, Web site. Available at: http:// www.merck.com/newsroom/news-release-archive/ prescription-medicine-news/2012_0213.html . Accessed May 14, 2012.
September 2012 ble at: http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm297464.htm. Accessed May 14, 2012. 20. Omontys (peginesatide) [package insert]. Palo Alto, CA: Affymax, Inc; 2012.
15. Zioptan (tafluprost ophthalmic solution) [package insert]. Whitehouse Station, NJ: Merck, Inc; 2012. 16. 17.
18. 19.
21. FDA approves Stendra for erectile dysfunction. FDA Drug Approval Web site. Available at: http:// Surfaxin (lucinactant) [package insert]. Warrington, PA: www.fda.gov/NewsEvents/Newsroom/ Discovery Labs Inc; 2012. PressAnnouncements/ucm302140.htm. Accessed on May 14, 2012. FDA approves imaging drug Amyvid. FDA Drug Approval Web site. Available at: http://www.fda.gov/ 22. Stendra (avanafil) [package insert]. Mountain View, NewsEvents/Newsroom/PressAnnouncements/ CA: Vivus Inc; 2012.Gaucher Disease. PubMed Health ucm299678.htm. Accessed on: May 12, 2012. Web site. Available at: http://www.ncbi.nlm.nih.gov/ pubmedhealth/PMH0001590/. Accessed May 14, Amyvid (Florbetapir F 18 Injection) [package insert]. 2012. Philadelphia, PA: Avid Radiopharmaceuticals; 2012. 23. Elelyso (taliglucerase alfa) [package insert]. New York, FDA approves Omontys to treat anemia in adult paNY: Pfizer Labs Inc; 2012. tients on dialysis. FDA Drug Approval Web site. AvailaSeptember 2012 — The Advancement of Pipeline Drugs in 2012
1. In order for the FDA to approve a drug _______. A. Safety and efficacy must be proved B. The drug must be cost effective C. The benefits of the drug must outweigh the risks D. A and C
5. AMYViD® binds to ______________ in PET scans to show evidence of cognitive decline. A. α- amyloid B. GABA receptors C. β-amyloid 2. Patients taking Picato® most likely have which of the D. cerebral axons following conditions? A. Acitinic keratosis 6. When is Omontys® contraindicated? B. Hyperuremia A. History of breast cancer C. Steven Johnson’s Syndrome B. Chronic kidney disease D. Cystic Fibrosis C. Hg> 11g/dL D. Folic acid deficient anemia 3. Which of the following drugs is indicated for advanced renal cell carcinoma? 7. Voraxaze® is used to decrease levels of _______ to A. Elelyso® prevent organ damage and bone marrow suppression. B. Inlyta® A. Cyclophosphamide C. Stendra® B. Etoposide D. Amyvid® C. Leucovorin D. Methotrexate 4. Which of the following drugs should be administered with a high fat meal and requires close monitoring of 8. Elelyso® is used to treat which rare condition? liver transaminases? A. Gaucher’s Disease A. Picato® B. Turner’s syndrome B. Erivedge® C. Addision’s Disease C. Elelyso® D. Cushing’s Syndrome D. Kalydeco® 17
THE KENTUCKY PHARMACIST
Sept. 2012– Advancement of Pipeline Drugs
September 2012
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Credit will be applied to your CPE Monitor Profile. Expiration Date: September 10, 2015 Successful Completion: Score of 80% will result in 1.0 contact hours or 0.1 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. September 2012 — The Advancement of Pipeline Drugs in 2012 TECHNICIANS ANSWER SHEET. Universal Activity # 0143-0000-12-009-H04-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 2. A B C D 4. A B C D 6. A B C D 8. 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 I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD) September 2012 — The Advancement of Pipeline Drugs in 2012 Universal Activity # 0143-0000-12-009-H04-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 2. A B C D 4. A B C D 6. A B C D 8. 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 Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ 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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THE KENTUCKY PHARMACIST
Bowl of Hygeia Fundraising Efforts
September 2012
Help support the Bowl of Hygeia Award! This year another 50+ Bowl of Hygeia recipients will be added to our ranks. All are dedicated pharmacists who take community service seriously and endeavor to make a difference in a way that is meaningful. Their stories are inspiring, and their attitudes are humble. All will make you proud.
sonally giving to this fund, and it’s why I think you’ll be interested to join me in making an investment in the future of the award. After all, it is the future recipients of the award that guarantee the legacy of our own awards.
The Bowl of Hygeia has a rich history within pharmacy and it represents well members of our profession. That’s why I’m excited to be helping to carry forth the Bowl of Hygeia tradition through collaboration with the Kentucky Pharmacists Association as our Association works with the “stewards” of the Bowl of Hygeia, the National Alliance of State Pharmacy Associations, the APhA Foundation and the American Pharmacists Association. Before these national Pharmacy groups assumed responsibility for the Bowl, this prestigious award was in jeopardy of being extinguished. If it were not for their agreement to carry forward the honor through a professional collaboration, 2010 would have been the last year the Bowl of Hygeia was awarded.
Online at: http://www.aphafoundation.org and choose the Bowl of Hygeia endowment button. Kentucky will get credit by your address.
Our goal is to raise $5,000 as a collective gift from members of the Kentucky Pharmacists Association. And we’re eager to show our state pride by either meeting or exceeding this goal. Won’t you please help by making a contribution? There are two ways to give:
Or, you can send your check to: AphA Foundation – Bowl of Hygeia 2215 Constitution Ave., NW Washington, DC 20037-2985 Thank you in advance for joining me in this effort. Sincerely in Service I am, George Hammons, RPh Owner/President Knox Professional Pharmacy Bowl of Hygeia Award Recipient, 2012
Given that this is an award presented at the state level, the State Pharmacy Associations — including your Kentucky Pharmacists Assocaiation — along with NASPA, are working together to help make sure this award we hold so dearly is never at risk again. In order to sustain the award, each state association is working together to build an endowment sufficient to generate dividends that will fund the program in perpetuity. The APhA Foundation, a national nonprofit 501 (c) (3), has agreed to be the home of the endowment account, and to date we are almost half way to our goal of $600,000. As a recipient of the award, I am excited to be a leader in helping the Kentucky Pharmacists Association kick off its campaign. I want to be sure the Bowl of Hygeia continues to represent the hallmark of community service in our profession. That’s why I am per-
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THE KENTUCKY PHARMACIST
Team Up. Pressure Down.
September 2012
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THE KENTUCKY PHARMACIST
Team Up. Pressure Down.
September 2012
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THE KENTUCKY PHARMACIST
Leadership Development of Students
September 2012
Leadership Development of Students through an Integrated Student Organization Structure in a College of Pharmacy By: T. Joseph Mattingly II, Joseph L. Fink III and T. David Marr Pharmacy is a profession that requires those who practice to be very well educated within their specialty. However, it is equally important for pharmacists to conduct themselves as professionals in all that they do so they can retain the trust of the public and the professionals with whom they deal on a daily basis. In addition, pharmacists are frequently called on to serve in leadership roles in several forums – professional associations, civic clubs, health-related voluntary organizations and a wide variety of other community or religious organizations.
of initiatives and programming was a bit of a challenge. The creation of an “umbrella” organization in 1999, called the Kentucky Alliance of Pharmacy Students (KAPS), has allowed students to work together on projects to advance different facets of pharmacy practice. Membership in KAPS entitles the student pharmacists to membership in the American Pharmacists Association Academy of Student Pharmacists, the American Society of Health-System Pharmacists, the National Community Pharmacists Association and the state affiliates Kentucky Pharmacists Association and the Kentucky Society of Health-System PharmaStudent organizations can play an integral role in the cists. Through this structure, students have the oppordevelopment of leadership and professionalism within tunity to participate in a wide variety of patient care pharmacy. Various national pharmacy organizations and professional outreach events in community and have acknowledged the importance of this.[1-3] Indeed, clinical settings providing them with valuable experithe American Association of Colleges of Pharmacy ence that may enhance their career path or expose has identified six tenets of student professionalism them to unexplored opportunities. that relate to leadership:[4] The Structure Altruism Duty Accountability
Honor and Integrity
Excellence
Respect for Others
Recognizing the importance of collaboration between the different pharmacy organizations and attempting to meet this challenge should be a top priority for pharmacy education programs. Indeed, the Accreditation Council for Pharmacy Education affirmatively acknowledges this and embodies the expectations in its accreditation standards for Pharm.D. degree programs. [Appendix A] An earlier report described the student organization structure in place at the University of Kentucky College of Pharmacy prior to 1999.[5] In that year, students at UKCOP developed an integrated student organizational structure to serve as what can be viewed as a joint venture to advance the profession by further developing leadership skills in future practitioners. The impetus for this development was that a vibrant, effective set of organizations existed but coordination
Initially, an assessment of the current student organizations offered helped determine the best avenue for the development of an umbrella organization. In the University of Kentucky example, KAPS membership covers the three major national associations for pharmacists and two affiliated state organization memberships. Students pay one fee to obtain a membership in KAPS and that fee is used to pay for dues to the respective associations within the metaphorical umbrella. This saves students the hassle of completing paperwork associated with joining the individual organizations, thereby lowering potential barriers to membership, and also creates exposure to different aspects of pharmacy in which the student may have originally had no interest. Once the organizations were selected to be included in the new structure, the composition of an Executive Committee was established. Equal representation from the individual associations has worked well at the University of Kentucky. The President and Presi22
THE KENTUCKY PHARMACIST
Leadership Development of Students dent-elect of each organization serve as voting members of the KAPS Executive Committee. The KAPS organization also elects a Chair, Vice-Chair, Treasurer, Recording Secretary, Corresponding Secretary and Director of Committees. Advisors to each organization within KAPS serve as ex officio non-voting members of the Executive Committee. The Constitution In order for a structure like this to work, it is important to develop an official constitution for the organization. There needs to be a document for students and advisors to consult and cite when issues arise. The KAPS constitution addresses membership issues like eligibility and voting status. It also includes officer definitions and duties, the election process and details of how to handle situations, such as when student officers are not able to complete their term of office. While such an organization is in its infancy stage, it may be a good idea to start with a simple constitution, but plans should be made for this to be a dynamic document, based on reviewing and updating the document on a regular basis. Once KAPS developed its constitution to create the broad framework for the organization, attention became focused on the bylaws which are much more operational in orientation. After those documents were in place and officers were elected, it was possible to pursue institutional recognition of KAPS as an official student organization at the University.[6] This creates opportunities to secure funding from the Student Government Association for various initiatives. Budget Operations and Guidelines
September 2012 the revenues and expenses in the KAPS budget. As a member of the umbrella organization, each represented association forfeits the ability to have an independent budget. This situation sacrifices flexibility in exchange for the advantages of participating in a much larger budget. As individual association chapters decided to restructure within one integrated organization, it was important to determine the process for financial decision making. An Additional Advantage For well over 30 years, the College of Pharmacy at the University of Kentucky has designated one hour per week when no classes are scheduled so that a college-wide convocation can be held for all to attend. Student leaders have responsibility for identifying convocation topics, identifying and inviting speakers as well as hosting them when on campus. Subjects for consideration at this forum often complement and expand classroom material. Due to the integrated nature of the KAPS approach to coordination of student organizations, no interest group or specialty is left out of such opportunities to present programming related to their interests. KAPS takes the lead on this initiative and, as in all it does, strives to be inclusive and even-handed. Other synergisms can be identified as:
Community service projects can draw upon KAPS members from all constituent organizations;
Coalescing of financial resources;
Accumulation of “KAPS points” earned through community service projects can enhance participation in those undertakings and create additional reimbursement for travel to professional meetings; and the existence of KAPS creates additional leadership development opportunities for student pharmacists.
A critical issue of concern when integrating different organizations into a new structure is the handling of fundraising and finances. The KAPS organization has The Process of Making it Work one budget and the members of the Executive Com- Having success in an umbrella organization is chalmittee vote as a board to make decisions concerning lenging in that each association has its own agenda 23
THE KENTUCKY PHARMACIST
Leadership Development of Students
September 2012
and priorities. First, it is important for each member of the Executive Committee to recognize and value the differences between the individual groups and make an effort to become more knowledgeable about all the associations represented on the coordinating Executive Committee. In order to facilitate this process, the KAPS Executive Committee meets bi-weekly to discuss agenda items and receive reports from each constituent association. A recent development has been to invite the co-chairs of one programming committee to provide an update at each meeting of the Executive Committee. This has facilitated communications as well as accountability. It is also important to have strong leadership from the Chair of the Executive Committee. The KAPS Chair at the University of Kentucky is a crucial position for success of the collaboration puzzle. This position requires a leader who can constructively deal with the priorities and egos of the different Chapter Presidents and continuously encourage a group approach to issues and challenges. One challenge noted with the position of KAPS Chair is that the importance and significance of this position has limited recognition outside of UKCOP. Chapter Presidents of the different associations, like the American Pharmacists Association and the American Society of Health-System Pharmacists, have more contact and networking opportunities with regional and national leaders in the associations. This may be something to be considered when determining the selection process of the Chair of the organization.
group provides a forum of student leaders “that acts as a voice for its student constituency.”[7] Selected Evidence of Outcomes Over the years since this integrated, coordinated structure has been in place, there have been a number of developments in the form of national recognitions and awards for the affiliated organizations and UK student pharmacists in leadership roles. Recent examples include:
2006 – UK student receives ASHP Student Leadership Award
2008 – UK students served as APhA-ASP Speaker of the House, Regional Delegate and Member-atLarge as well as an ASHP Student leadership Award
2009 – UK student receives ASHP Student Leadership Award
2011 – UK student received ASHP Student Leadership Award
2012 – UK student receives APhA National Leadership Award
2012 – UK student receives ASHP National Leadership Award
These student accomplishments reflect great credit not only on the individuals selected but on the College, the University and the Commonwealth. Conclusion
Nearly all faculty will readily acknowledge that a great deal of learning occurs outside the classroom, the Existence of this integrated organizational structure to teaching laboratory and the experiential rotation site. facilitate and enhance student leadership development To continue expanding the role of the pharmacist on is consistent with and supportive of several elements the health care team and promoting the full contribuof the current strategic plan of the College of Pharmation of pharmacists to the well-being of patients, the cy. Those specific provisions are: profession of pharmacy needs to foster leadership de Train and empower individuals to become change velopment among students and new practitioners with agents with skill sets to influence patient outcomes an emphasis on promoting collaboration. Integration of and advance the practice of pharmacy. the individual student organizations provides many Produce leaders across all areas of the pharmacy opportunities for different student leaders to work profession. These leaders will practice at the high- closely together, creating a team environment. This est level of pharmacy and have the capability of collaboration also promotes leadership development, functioning as change agents. as the leaders of the different organizations can learn from each other as they advance the profession. Additionally, the KAPS Chair serves as a member of the Student Advisory Council of the College. This Contributions to the College
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Leadership Development of Students
September 2012
References:
ed January 23, 2011, Effective February 14, 2011, 1. Anon. White Paper on Pharmacy Student Professional- Accreditation Council on Pharmacy Education (emphasis added) ism. JAPhA 2000 (Jan-Feb);40:98-102. STANDARDS FOR STUDENTS
2. Pharmacy Professionalism Toolkit for Students and Faculty Provided by the APhA-ASP/AACP Committee on Student Professionalism. (2008) Available at http:// www. pharmacist .com/ AM/Template.cfm?Section =Professionalism_ Toolkit_ for_Students_ and_Faculty&Template =/CM/ HTMLDisplay.cfm&ContentID=5415.
The purpose of the standards in this section is to ensure that the college or school has adequate resources, fair and equitable policies and procedures, and capabilities to support student admission, progression, personal and professional development, and input into programmatic quality improvement.
3. Final Report, Task Force on Preparation of Pharmacy Faculty and Students to be Citizen Leaders and Pharmacy Advocates. American Association of Colleges of Pharmacy (2010). Available at http://www.aacp.org/ governance/councilfaculties/Documents/Task%20 Force%20Advocacy%20and%20Leadership.pdf.
Standard No. 22: Student Representation and Perspectives Standard No. 22: Student Representation and Perspectives The college or school must consider student perspectives and include student representation, where appropriate, on committees, in policy-development bodies, and in assessment and evaluation activities.
4. Hammer DP, Berger BA, Beardsley RS, Easton MR. Student professionalism. Am J Pharm Educ. 2003;67 (3) Article 96. 5. Fink III JL, Giltner CL, Littrell RA. Leadership training for pharmacy students: The Kentucky story. Ky Pharm.1988(Apr);51:96-98.
Guideline 22.1 The college or school should have a student government as well as suitable committees, such as a student/faculty relations committee, to develop student leadership and professionalism, to ensure a forum for student dialogue, and to ensure adequate communication of student opinions and perspectives.
6. University of Kentucky Administrative Regulations – A.R. 4:1 Registration of Student Organizations. Available at http://www.uky.edu/regs/Administrative/ ar4.1.htm. 7. University of Kentucky College of Pharmacy Student Handbook (2011-2012), p. 38. Available at http:// pharmacy.mc.uky.edu/programs/pharmd/files/ handbook.pdf.
Standard No. 23: Professional Behavior and Harmonious Relationships
T. Joseph Mattingly, Pharm.D., M.B.A., is General Manager of the Indianapolis Hub for Alixa Rx, L.L.C. T. David Marr, a native of Greensburg, KY, is a third professional year PharmD student at the College of Pharmacy at the University of Kentucky and is also dually enrolled in the M.B.A. Program at the UK Gatton College of Business and Economics. He currently serves as Chair of KAPS. Joseph L. Fink III, B.S.Pharm., J.D., is the Kentucky Pharmacists Association Professor of Leadership and Professor of Pharmacy Law and Policy in the UK College of Pharmacy. He also serves as Faculty Advisor for KAPS, the organization described here.
Appendix A: Accreditation standards related to student leadership development
The college or school must provide an environment and culture that promotes professional behavior and harmonious relationships among students, faculty, administrators, preceptors, and staff. Faculty, administrators, preceptors, and staff must be committed to developing professionalism and fostering leadership in students and to serving as mentors and positive role models for students. Guideline 23.2 The college or school should foster and support opportunities for students to participate in student selfgovernment.
Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree (Version 2.0), Adopt-
Continued on Page 35 25
THE KENTUCKY PHARMACIST
Oct. 2012 CE—Hypertension and Obesity
September 2012
Hypertension and Obesity: Relationships and Management
KPERF offers all CE articles to members online at www.kphanet.org
By: Debbie Minor, PharmD, Grant Smith, PharmD, and Marion Wofford, MD, MPH The University of Mississippi Medical Center Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared. There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-9999-12-010-H01-P&T 1 Contact Hour (0.1 CEUs)
The goal of this article is to review the very common condition of obesity-hypertension. Objectives
1. Describe the relationships between obesity and hypertension. 2. Identify potential pathophysiologic mechanisms of obesity-hypertension. 3. Discuss nonpharmacologic and pharmacologic treatment strategies for obesity-hypertension. Hypertension is a significant public health problem in the United States and worldwide, primarily due to its place as a major modifiable risk factor for cardiovascular and kidney disease. Hypertension is typically defined as systolic blood pressure of > 140 mm Hg or diastolic blood pressure of > 90 mm Hg or taking antihypertensive medication. Blood pressure is considered to be controlled if < 140/90 mm Hg or < 130/80 mm Hg for those with diabetes or chronic kidney disease.1,2 The prevalence of hypertension does not vary significantly by gender but is significantly and independently associated with increasing age, increasing body mass index (BMI, kg/m2), being AfricanAmerican and having less education.2 Obesity is also recognized as an epidemic and independent risk factor for cardiovascular disease that is strongly associated with other risk factors.1,3,4 More than one-third of United States adults are currently obese (BMI > 30), with a prevalence in Kentucky of 30.4 percent. The prevalence of obesity (BMI > 30) has increased in all racial/ethnic, gender and age groups and more than doubled from 15 percent to over 30 percent since 1980. During this same period, the prevalence of obesity in United States children and adolescents (ages 2-19 years) has tripled to the current rate of 17 percent.5 These trends are especially alarming as children and adolescents carry the burden of obesity and its associated problems into adulthood.
The relationship between weight and blood pressure is clear. Over 70 percent of adults with hypertension are overweight or obese, with the prevalence of high blood pressure increasing progressively with increasing BMI.2,4 In the Framingham Heart Study, 70 percent of the new cases of hypertension were attributable to excess body weight and for every 10-pound weight gain, systolic blood pressure increased an average of 4.5 mm Hg.6 Obesity, specifically excess body weight, is the single most important cause of primary hypertension.1,7 The objective of identifying and treating obesityrelated hypertension is the same for all patients: to reduce the risk of cardiovascular disease and associated morbidity and mortality. This article reviews the treatment of hypertension in the obese patient from the perspective of potential mechanisms related to this association and nonpharmacologic and pharmacologic strategies that may offer benefits for this population. PATHOPHYSIOLOGY OF OBESITYHYPERTENSION Although obesity and hypertension are intimately linked, the underlying pathophysiology and mechanisms are not well defined. Sympathetic nervous system, metabolic and renal factors all contribute to increases in blood pressure.7 Studies of obesity-hypertension have demonstrated
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Oct. 2012 CEâ&#x20AC;&#x201D;Hypertension and Obesity
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sympathetic nervous system overactivity. Distribution of excess body weight influences overactivity, with increased sympathetic activity associated with increasing abdominal visceral fat.8 Potential mediators of increased sympathetic activity in obesityhypertension include hyperinsulinemia, hyperlipidemia, angiotensin II, hyperleptinemia, impaired baroreflexes and activation of chemoreceptor reflexes associated with obstructive sleep apnea (OSA). The link between hyperinsulinemia, insulin resistance and obesity-hypertension is unclear, but may be linked to leptin and its role in each of these conditions.8-10 Leptin is an adipocyte-derived hormone which decreases appetite and increases metabolism through hypothalamic signaling that ultimately increases blood pressure.10 Leptin resistance, like insulin resistance, also may play a role in obesity. In the future, a better understanding of leptin physiology may provide new therapeutic targets for obesity-hypertension.
ease prevention. A systematic team approach utilizing health care professionals and community resources when possible can assist in providing the necessary education, support and follow-up needed to achieve successful lifestyle changes.1,11
Lifestyle interventions are pivotal in the management of obesity-related hypertension and should be the foundation of treatment. Weight loss, increased physical activity and sodium restriction are recommended for all patients with hypertension and as the initial approach to treating most patients with prehypertension (systolic blood pressure 120 - 139 mm Hg or diastolic blood pressure 80 - 89 mm Hg).1 Even more farreaching than the value in the treatment of established obesity-hypertension is the potential for dis-
Successful weight reduction is achieved by losing one to two pounds per week. Diets should include approximately 500-1000 kilocalories per day less than the normal intake, and total fat should be equal to or less than 30 percent of total daily calories.3 The benefits of weight reduction are apparent but success in maintenance is difficult for many. Even modest weight reduction for overweight and obese patients should, however, be encouraged and will likely provide significant health and economic benefits.
Weight Loss Weight reduction remains the cornerstone of treatment for obesity-hypertension and is the most effective method of risk reduction, particularly if it reduces visceral or abdominal fat.4 Reduction of excess weight can be accomplished by lifestyle changes, pharmacologic interventions and surgical procedures. Several studies demonstrate that weight loss lowers blood pressure in obese subjects and may prevent hypertension even when compared to sodium reduction.
Weight reductions of as little as five to 10 percent can improve blood pressure and amplify the pharmacologic treatment for hypertension, potentially reducing the amount of medications needed to reach goals. FurActivation of the renin-angiotensin aldosterone system (RAAS) is associated with weight gain and viscer- thermore, weight reduction decreases blood volume, left ventricular mass, cardiac output, sympathetic acal adiposity and implicated in hypertension. Obese renin activity, aldosterone and plasma subjects often have increases in plasma renin activity, tivity, plasma 4 insulin. angiotensinogen, angiotensin converting enzyme (ACE) activity, angiotensin II and aldosterone levels. BMI is the most practical method for assessment and Even a five percent reduction in bodyweight decreas- classification of overweight and obesity. The waist-tohip ratio allows determination of upper and loweres these levels significantly.7 body obesity and has been shown in epidemiological Physical compression of the kidneys and changes in studies to predict correlations between obesity and renal hemodynamics caused by excess abdominal hypertension and risk for cardiovascular disease. The adiposity also are thought to play a major role in the presence of excess abdominal fat out of proportion to development of hypertension.9 In obesity, renal mechtotal body fat is an independent predictor of risk facanisms also contribute to sodium absorption and tors and disease. Waist circumference provides a blood volume expansion. simple and clinically useful measure of abdominal fat. NONPHARMACOLOGIC MANAGEMENT OF BMI and waist circumference should be measured in OBESITY-HYPERTENSION all hypertensive subjects.3
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Table: Anti-hypertensives in Obesity-Hypertension: General Targets and Potential Metabolic Effects Class Alpha Blockers
Physiological Target
Metabolic Effects
SNS
↓ Total cholesterol
↓ TPR
↓ Insulin resistance ↓ Plasma insulin
ACE Inhibitors
ARBs
RAAS
↓ Plasma leptin ↓ Insulin resistance
↓ Aldosterone
↓ Plasma leptin
Natriuresis
↓ Plasma insulin ↓ Insulin resistance
↓ TPR
↓ Plasma leptin ↓ BMI Beta-Blockers
SNS
↓ Insulin sensitivity
↓ Heart rate, cardiac output
↑ Triglycerides
↓ Renin release CCBs
↓ TPR
↓ Plasma Leptin
Natriuresis
↓ Plasma Insulin ↑ Sympathetic Activity
Diuretics
Diuresis
↓ Insulin sensitivity
Natriuresis
↑ LDL cholesterol, triglycerides (short term)
↓ Cardiac output ↓ TPR
SNS=sympathetic nervous system; TPR=total peripheral resistance; LDL=low-density lipoprotein
hypertension. Increased physical activity contributes to weight loss, singularly and when combined with Patients with obesity-hypertension should be instructdietary therapy. Adding regular physical activity to caed in the benefits of healthy dietary habits. A diet rich loric restriction can accelerate and increase overall in fresh fruits, vegetables and low fat dairy products weight loss and be beneficial for weight loss mainte(e.g., the DASH diet) lowers blood pressure indenance. Individuals who combine exercise and diet are pendent of weight reduction. Decreasing sodium inmuch less likely to regain weight.3 The combination of take also decreases blood pressure and the risk for exercise with weight reduction may have additive efcardiovascular disease in most individuals. For those fects on blood pressure reduction. Current guidelines with hypertension, it is recommended that sodium inrecommend a goal for all adults to accumulate at least take be limited to 1,500 mg per day. Although studies 30 minutes or more of moderately intense physical exploring salt sensitivity in obese hypertensive paactivity on most, and preferably, all days of the tients have not been reported, decreasing sodium inweek.11 take may contribute to improved blood pressure control.12 Obstructive Sleep Apnea Dietary Modification
Physical Activity Physical inactivity is associated with obesity-
OSA is a form of secondary hypertension associated with obesity.13 Although very common and seen in all 28
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September 2012
gender, ethnic and age groups, this life-threatening condition is often overlooked. With the increasing rates of obesity, the incidence of hypertension associated with OSA will likewise increase. The hemodynamic changes associated with OSA that result in hypertension are not clearly understood. OSA causes nocturnal surges in blood pressure and daytime hypertension. Studies show that OSA is associated with increased sympathetic nerve activity, inflammation and endothelial dysfunction. All patients with obesity-hypertension should be questioned about symptoms of OSA including snoring, choking or gasping during sleep, daytime somnolence and morning headaches. Weight reduction should be encouraged but more aggressive intervention with continuous positive airway pressure (CPAP) is often required. Treatment decreases daytime and nocturnal blood pressures.13 Management of this common disorder may reduce cardiovascular events and improve quality of life for many. PHARMACOLOGIC MANAGEMENT OF OBESITYHYPERTENSION Despite the epidemic of obesity and the well-known effects of excess weight on blood pressure, there are no specific guidelines for pharmacologic treatment of obesity-hypertension and few clinical trials designed to determine the best agents. Goals for treatment and therapeutic decisions should be based on a constellation of factors, including the actual level of blood pressure.1 Classes of antihypertensive agents differ in their metabolic effects including the potential for weight gain. The included table summarizes potential benefits and side effects of antihypertensive drugs in obesity-hypertension. Therapeutic decisions should be based on identification of known causes of high blood pressure, assessment of the presence or absence of target organ damage and cardiovascular disease, extent of the disease, response to therapy and identification of other cardiovascular risk factors or concomitant disorders that may define prognosis and guide treatment.
ume expansion and impaired urinary sodium excretion (natriuresis), diuretics should be considered in the treatment of obesity-hypertension.9 The Treatment of Obese Patients with Hypertension (TROPHY) trial was one of the few early clinical trials designed to address hypertension management in obese subjects. Comparing an ACE inhibitor to a thiazide diuretic, both agents were equally effective in lowering blood pressure although response varied with age and race. The ACE inhibitor was more effective in young and Caucasian subjects whereas the diuretic was more effective in African-Americans of all ages. Insulin and lipid profiles did not differ between the treatment groups but there was a significant increase in plasma glucose with the diuretic.14 Decreased peripheral insulin sensitivity and impaired insulin secretion occur in a dose dependent fashion with thiazides and are likely associated with potassium homeostasis. However, the link between thiazide diuretics and worsening glucose control or new onset diabetes is not consistently demonstrated in all studies.15,16 RAAS expression in adipose tissue causes different regulatory mechanisms in lean compared to obese hypertensive subjects. Many studies confirm the neutral or positive metabolic properties of ACE inhibitors and angiotensin receptor blockers (ARBs), with no associated weight gain or adverse effects on lipids or glucose.1,15-18 ARBs have also been shown to decrease mortality, reduce left ventricular mass and decrease the incidence of type 2 diabetes in patients with left ventricular hypertrophy when compared to treatment with atenolol.18 ACE inhibitors or ARBs are drugs of choice for several conditions commonly associated with obesity including congestive heart failure, chronic kidney disease, hypertension in diabetes and left ventricular hypertrophy.1
Aldosterone antagonists and renin inhibitors may have a potential role in obese subjects. Renin and aldosterone levels are elevated in obese compared to lean hypertensive patients, particularly in those with visceral adiposity.19 Resistant hypertension may be observed in patients with obesity and OSA related to Thiazide diuretics are among the most widely prestimulation of aldosterone excretion.19 Aliskiren, the scribed antihypertensive drugs worldwide and are recommended for initial therapy for most patients with first direct renin inhibitor, has been studied in obese patients with hypertension uncontrolled on thiazide hypertension.1 Given the close association with vol29
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Oct. 2012 CEâ&#x20AC;&#x201D;Hypertension and Obesity
September 2012
monotherapy.20 Comparison groups were an ARB, a non-dihydropiridine calcium channel blocker (CCB), or placebo added to hydrochlorothiazide in a dose escalation design. The aliskiren/thiazide combination had similar tolerability to the placebo group and provided similar blood pressure reductions to those with the ARB and CCB groups.20
pared valsartan and felodipine in regard to blood pressure, leptin, insulin sensitivity and norepinephrine levels. After 16 weeks, there were no significant differences in blood pressure reduction between the groups. Felodipine did increase norepinephrine but had no effect on leptin, body weight or insulin resistance.23
CCBs reduce peripheral resistance, promote water and sodium excretion and are neutral in effects on glucose and insulin. In large clinical trials there have been no differences in primary cardiac endpoints and mortality in patients treated with amlodipine compared to a diuretic, an ARB or a beta blocker.15,17-21 CCBs are potentially beneficial in obesity-hypertension.
Antiobesity Agents
Alpha-adrenergic blockers have neutral or favorable effects on insulin resistance and dyslipidemia but are no longer recommended as first line treatment for hypertension.1.15 However, alpha blockers may have a role in combination therapy. In one study, combined alpha and beta blockade reduced blood pressure significantly more in obese hypertensive patients than in lean hypertensive patients.22 Centrally acting agents such as clonidine are effective in lowering blood pressure in obesity-hypertension. These drugs inhibit the release of norepinephrine thus suppressing the sympathetic nervous system and decreasing blood volume and sodium reabsorption.9 However, the many adverse side effects such as drowsiness, sedation and dry mouth limit the use of available agents in treatment of chronic hypertension.
The National Institutes of Health, National Heart, Lung, and Blood Institutes guidelines recommend (after a six-month trial of lifestyle modification) that overweight individuals with a BMI > 27 and â&#x20AC;&#x153;concomitant obesity-related risk factors or diseasesâ&#x20AC;? or obese persons with a BMI > 30 and no concomitant disease be considered candidates for weight-loss intervention strategies, including pharmacologic treatment.3 Until recently, orlistat was the only FDAapproved agent marketed for long-term use in obesity.24 This year, two new products, Qysmia and Belviq, have been approved. The extended release combination product, Qysmia, contains topiramate and phenteramine. Belviq is the trade name for locaserin, a new agent which modulates the seratonergic system. Both are approved as an adjunct to a low calorie diet and exercise in patients with a BMI of 30 or more or those with a BMI of 27 or greater who have at least one obesity-related comorbidity such as hypertension or diabetes. The amount of attributable weight loss with these agents is modest.24 The utility and overall place in therapy of these newer agents will be determined over time. Other classes of medications not typically identified as antiobesity agents, particularly those in the antiepileptic or antidepressant classes, may be useful in the management of obesity and have implications in obesity-hypertension. Bupropion, fluoxetine, sertraline, t zonisamide and naloxone have all been used for weight loss but evidence is limited and general recommendations cannot be made for most.25
Although beta-blockers decrease mortality in patients with hypertension, there is little evidence to support their use in obesity-hypertension.1 Most beta-blockers promote weight gain, alter lipids and increase insulin levels, increasing the risk for diabetes.16,18 Particular agents, such as metoprolol or nebivolol, appear to have fewer metabolic adverse effects. Unless there are compelling indications for the use of betablockers, other agents less likely to have adverse Rimonabant and other newer classes of antiobesity metabolic effects should be considered in the treatagents that have seemed promising have most rement of hypertension, particularly in the obese pacently been denied FDA approval because of adverse tient. effects. Questions regarding optimal duration of treatLimited studies have evaluated and compared specif- ment and possible adverse events remain unanic treatments in obese hypertensives. One study com- swered for all pharmacologic treatments. Reliance on 30
THE KENTUCKY PHARMACIST
Oct. 2012 CEâ&#x20AC;&#x201D;Hypertension and Obesity antiobesity pharmacotherapeutics as a mainstay of obesity therapy is premature; no long-term data demonstrate decreases in morbidity or mortality from obesity-related conditions.25 CONCLUSIONS
September 2012 3. National Institutes of Health, National Heart, Lung, and Blood Institutes. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults-the evidence report. Obes Res 1998, 6(Suppl 2):51S-209S.
4. Poirier P, Giles TD, Bray GA, et al.: Obesity and The treatment of hypertension among obese individucardiovascular disease: pathophysiology, evaluaals is challenging for patients and health care providtion, and effect of weight loss. Circulation 2006, ers alike. The link between increasing body weight 113: 898-918. and hypertension is well established. If the prevalence of obesity continues to grow, then it should be ex5. Ogden CL, Carroll MD, Kit BK, Flegal KM: Prevapected that the prevalence of hypertension will also lence of obesity in the United States, 2009-2010. increase in all age groups. Weight loss or prevention NCHS data brief, no 82. Hyattsville, MD: National of excess weight gain is the most obvious approach to Center for Health Statistics. 2012. preventing this epidemic. 6. Garrison RJ, Kannel WB, Stokes JS, et al.: InciCurrent guidelines for the treatment of hypertension dence and precursors of hypertension in young recognize the contribution of obesity but do not make adults; the Framingham Offspring Study. Prev specific recommendations for pharmacological manMed 1987, 16:235-251. agement. The various mechanisms leading to hyper7. Hall JE. The kidney, hypertension, and obesity. tension and the metabolic abnormalities that characHypertension. 2003, 41:625-633. terize the obese patient should be taken into account 8. Esler M, Straznicky N, Eikelis N, et al.: Mechawhen selecting antihypertensive agents and making nisms of sympathetic activation in obesity-related other recommendations. Further clinical trials are hypertension. Hypertension 2006,48:787-796. needed to determine the most effective antihypertensive drugs for the obese, hypertensive patient.
9. Wofford MR, Hall JE: Pathophysiology and treatment of obesity hypertension. Curr Pharm Des Appropriate modification of lifestyle factors can direct2004, 10:3621-3637. ly influence blood pressure and cardiovascular risk. Patients should be encouraged that even modest 10. Rahmouni K, Correia MLG, Haynes WG, Mark AL: weight loss can lead to blood pressure reduction. AdObesity-associated hypertension: new insights vances in obesity management and population-based into mechanisms. Hypertension 2004, 45:9-14. strategies would greatly impact the management of 11. Lichetenstein AL, Appel LJ, Brands M, et al.: Diet obesity-hypertension. Various national initiatives are and lifestyle recommendations revision 2006:a underway and have demonstrated commitment to scientific statement form the American Heart Ascontinued efforts to influence lifestyles and help consociation Nutrition Committee. Circulation 2006, trol this public health problem. 114:82-96. References 12. Appel LJ, Brands MW, Daniels SR, et al.: Dietary 1. Chobanian AV, Bakris GL, Black HR, et al.: The approaches to prevent and treat hypertension: a seventh report of the Joint National Committee on scientific statement for the American Heart AssoPrevention, Detection, Evaluation, and Treatment ciation. Hypertension 2006, 47:296-308. of High Blood Pressure: the JNC report. JAMA 13. Wolk R, Shamsuzzaman AS, Somers VK: Obesi2003, 289:2560-2572. ty, sleep apnea, and hypertension. Hypertension 2. Ong KL, Cheung BM, Man YB, et al.: Prevalence, 2003, 42:1067-1074. awareness, treatment, and control of hypertension among United States adults 1999-2004. Hyperten- 14. Reisin E, Weir MR, Falkner B, et al., for the Treatment in Obese Patients with Hypertension sion 2007, 49(1):69-75. 31
THE KENTUCKY PHARMACIST
Oct. 2012 CE—Hypertension and Obesity (TROPHY) Study Group: Lisinopril versus hydrochlorothiazide in obese hypertensive patients: a multicenter placebo-controlled trial. Hypertension 1997, 30:140-145.
September 2012 nea. Chest 2004, 125:112-7. 20. Jordan J, Engeli S, Boye SW, et al.: Direct renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension 2007, 49:10471055.
15. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), 21. Dahlöf B, Sever PS, Poulter NR, et al., for the ASALLHAT Officers and Coordinators for the ALLCOT Investigators: Prevention of cardiovascular HAT Collaborative Research Group.: Major outevents with an antihypertensive regimen of amcomes in high-risk hypertensive patients randomlodipine adding perindopril as required versus ized to angiotensin-converting enzyme inhibitor or atenolol adding bendroflumethiazide as required, calcium channel blocker vs diuretic: the antihyperin the Anglo-Scandinavian Cardiac Outcomes Tritensive and lipid-lowering treatment to prevent al-Blood Pressure Lowering Arm (ASCOT-BPLA): heart attack trial. JAMA 2002, 288:2981-2997. a multicentre randomised controlled trial. Lancet 16. Gress TW, Neito FJ, Shahar E, et al.: Hyperten2005, 366:895-906. sion and antihypertensive therapy as risk factors 22. Wofford MR, Anderson DC, Brown CA, et al.: Antifor type 2 diabetes mellitus. Atherosclerosis Risk hypertensive effect of alpha- and beta-adrenergic in Communities Study. N Engl J Med 2000, blockade in obese and lean hypertensive subjects. 342:905-912. Am J Hypertens 2001, 14:164-168. 17. Julius S, Kjeldsen SE, Weber M, et al., for the 23. Fogari R, Derosa G, Zoppi A, et al.: Comparison VALUE trial group: Outcomes in hypertensive paof the effects of valsartan and felodipine on plastients at high cardiovascular risk treated with regima leptin and insulin sensitivity in hypertensive mens based on valsartan or amlodipine: the VALobese patients. Hypertens Res 2005, 28:209-214. UE randomised trial. Lancet 2004, 363:202224. U.S. Food and Drug Administration. July 2012. 2031. www.fda.gov. 18. Lindholm LH, Ibsen H, Borch-Johnsen K, et al.: 25. Snow V, Barry P, Fitterman N, et al. for the CliniRisk of new-onset diabetes in the losartan intercal Efficacy Assessment Subcommittee of the vention for endpoint reduction in hypertension American College of Physicians: Pharmacologic study. J Hypertens 2002, 20:1879-1886. and surgical management of obesity in primary 19. Calhoun DA, Nishizaka MK, Zaman MA, Harding care: a clinical practice guideline from the AmeriSM: Aldosterone excretion among subjects with can College of Physicians. Ann Intern Med 2005, resistant hypertension and symptoms of sleep ap142:525-541.
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September 2012
Oct. 2012 CE—Hypertension and Obesity
October 2012 — Hypertension and Obesity: Relationships and Management
1. The single most prevalent and important cause of primary hypertension is: A. High sodium intake B. Excess body weight C. Less education D. Racial background 2. The pathophysiology of hypertension is thought to be linked with: A. High plasma angiotensinogen and aldosterone B. High plasma leptin C. Physical compression of the kidneys by fat D. All of the above 3. Which of the following is the adipose-derived hormone that contributes to increases in blood pressure seen in obesity? A. Leptin B. Insulin C. Glucagon D. Aldosterone
6. Obstructive sleep apnea is associated with snoring, daytime somnolence and: A. Hypertension B. Nocturnal decreases in blood pressure 7. Classes of antihypertensive medications differ in their potential for metabolic effects. A. True B. False 8. The link between thiazide diuretics and worsening glucose control is consistently demonstrated in all studies. A. True B. False
9. Which of the following antihypertensive classes of medications may potentially increase insulin levels and promote weight gain? A. ACE inhibitors B. ARBs C. Alpha blockers 4. In obese patients with hypertension, weight loss is D. Beta blockers effective in decreasing: A. Blood volume 10. Which of the following have shown potential for B. Cardiac output aiding weight loss among obese individuals? C. Sympathetic activity A. Bupropion D. All of the above B. Topiramate C. Naloxone 5. In people with hypertension, the recommended D. All of the above daily sodium intake should be limited to no more than: A. 1,500 mg B. 2,400 mg C. 3,000 mg D. 3,500 mg
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Oct. 2012 CE—Hypertension and Obesity
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This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Credit will be applied to your CPE Monitor Profile. Expiration Date: September 10, 2015 Successful Completion: Score of 80% will result in 1.0 contact hours or 0.1 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. October 2012 — Hypertension and Obesity: Relationships and Management TECHNICIANS ANSWER SHEET. Universal Activity # 0143-9999-12-010-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D
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5. A B C D 6. A B
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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 I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
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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 Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
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Medicare Surety Bond from Pharmacists Mutual
September 2012
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 Pro Advantage 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.
Continued from Page 25 Guideline 23.3 The college or school should support students, faculty, administrators, preceptors, and staff participation in, as appropriate, local, state, and national pharmacy, scientific, and other professional organizations. Standard No. 26: Faculty and Staff Continuing Professional Development and Performance Review The college or school must have an effective continuing professional development program for full-time, part-time, and voluntary faculty and staff consistent with their responsibilities. The college or school must review the performance of faculty and staff on a regular basis. Criteria for performance review must be commensurate with the responsibilities of the faculty and staff in the professional degree program.
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.
Guideline 26.1 The college or school must have or provide support for programs and activities for faculty and preceptor continuing professional development as educators, researchers, scholars, and practitioners commensurate with their responsibilities in the program. In general, the programs and activities for full-time and part-time faculty, as well as for volunteer faculty where appropriate, should: provide strategies to develop consistent socialization, leadership, and professionalism in students throughout the curriculum ACPE Standards Appendix B - Additional Guidance on the Science Foundation for the Curriculum Practice Management development of leadership skills 35
THE KENTUCKY PHARMACIST
Pharmacy Law Brief
September 2012
Pharmacy Law Brief: Contemporary Legal Issues for Leadership in Non-Profits - I Author: Joseph L. Fink III, B.S. Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I am new to serving on the board of a non-profit community health agency in my area. During one of the meetings an experienced board member mentioned something called “fiduciary obligations” that I have in that role. We had no orientation session for new board members. What is that? Response: At the outset, it should be noted that an earlier column in this series, appearing in the November 2008 issue, was entitled “Potential Legal Exposure with Community Service as a Board Member of a Non-Profit Agency.” This installment will begin to address fiduciary obligations of board members and supplement or extend that earlier item. The specific focus of this item will be the potential for conflict of interest issues to arise.
Submit Questions: jfink@uky.edu
his or her relationship or interest and (b) not participate in any board discussion or vote, unless the organization’s board determines that the director may participate in such discussion or vote. If the board determines that the director may participate, the director may still decide that a conflict exists and that he or she should not participate in any discussion or vote. A possibly high profile issue for board members is The result of this is that if a director follows these dispotential conflict of interest. In general, a conflict of closure and recusal procedures, a party challenging a interest exists when the non-profit organization which transaction on the grounds of a conflict of interest/ the board member serves does business with: breach of fiduciary duty will face a heightened burden. a director of the organization; The best approach with potential conflict of interest is, another entity in which a director of the organiza- first, heightened awareness of the potential for the tion is also a trustee, director, officer, employee, issue to surface, and second, full and open disclosure consultant or agent; or to other members of the governing body. Then the another entity in which a director has a financial decision about how substantial the potential conflict interest (a “financial interest” can generally be de- appears to be and whether that should bar the individfined to include an ownership or investment inter- ual from participating in discussing and voting on the est in the entity with which the organization is con- matter should initially rest with the other members of tracting, or a compensation arrangement with the board, not with the individual presenting the potential conflict. such entity). To avoid even the appearance of a conflict of interest, a director may want to treat as a conflict any transaction between the organization and (i) the director’s spouse, descendants or ascendants; (ii) any entity in which such a relative is a trustee, director, officer, employee, consultant or agent or (iii) any entity in which such a relative has a financial interest.
A future installment will address other fiduciary obligations of board members.
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. If a conflict of interest is or may be present, the direc- It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar tor should (a) disclose to the board of directors or rel- with the intricacies of a specific situation, and render advice evant committee of the board the material facts as to in accordance with the full information. 36
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New Members
September 2012
KPhA Welcomes New and Returning Members January through August 2012 Daniel L. Beebe Cincinnati, OH
Jessica H. Dubree Tompkinsville, KY
Joanne Logsdon Louisville, KY
Andrea Santoro Florence, KY
Julie Nicole Bosler Louisville, KY
Justin M. Fink Fort Wright, KY
Craig Martin Lexington, KY
Keith Saylor Flat Lick, KY
Greg Browning Louisville, KY
William Jason Fugate Louisville, KY
William Joseph Merrick Louisville, KY
Anthony Schmid Grand Rapids, MI
Peggy Canler Louisville, KY
Dennis E. Gawronski Prestonsburg, KY
James Murphy Whitley City, KY
Sarah Slabaugh Louisville, KY
Thomas E. Carter Lexington, KY
Reed Ginn Cerulean, KY
Lilian Nelehi Louisville, KY
Jacquelyn Strickland Hopkinsville, KY
Rachel Carrigan Chancy Louisville, KY
Jennifer Grove Madison, IN
Christopher Noetzel Flemingsburg, KY
Mark A. Taylor Danville, KY
Lisa L. Clontz Prospect, KY
Jim D. Harned Louisville, KY
Audra Norvell Louisville, KY
Penny Taylor Lancaster, KY
Stephanie Sue Collins Corbin, KY
Michael Hitchcock Grand Rapids, MI
Stacey Oliva Louisville, KY
Carolynn Weber Fort Wright, KY
Mildred Cook Tyner, KY
Chrystyanna Hoefler Brooksville, KY
Thomas T. Ranz Louisville, KY
Charlsie Rhea Williams Murray, KY
Susan Copass Paducah, KY
Elizabeth Hubbs Harlan, KY
Denise Robinson Louisville, KY
Heather M. Wind Silver Spring, MD
Chad Corum Manchester, KY
Robert W. Hughes Lexington, KY
Patricia Robinson Whitesburg, KY
Dachea Wooten Hazard, KY
Ross Domke Redding, CA
Audrey Hurley Louisville, KY
Stacy Rowe Louisville, KY
Sue E. Wynn Whitley City, KY
Derek Downing Alexandria, KY
Sarah Lawrence Louisville, KY
Anthony E. Samaan Lexington, KY
Tina Yokley Tompkinsville, KY
Visit www.kphanet.org to download your application. Already a member? Pass it along! 37
THE KENTUCKY PHARMACIST
Continuing Education Article Guidelines
September 2012
Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to completing a continuing education article for publication in The Kentucky Pharmacist.
Include a quiz over the material. Usually between 10 to 12 multiple choice questions.
Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.
Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).
When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.
Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not pertinent to technicians, that needs to be stated clearly Articles should address topics designed to narrow at the beginning of the article. gaps between actual practice and ideal practice in Article should begin with the goal or goals of the pharmacy. Please see the KPhA website overall program – usually a few sentences. (www.kphanet.org) under the KPERF link to see preInclude 3 to 5 objectives using SMART and meas- viously published articles. urable verbs.
Articles must be submitted electronically to the KPhA director of communications and continuing education Feel free to include graphs or charts, but please submit them separately, not embedded in the text (ssisco@kphanet.org) by the 15th of the month preceding publication. of the article.
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KPhA Mid-Year Conference
September 2012
We’re Bringing it Back! 2012 KPhA MID-YEAR CONFERENCE ON LEGISLATIVE PRIORITIES & EMERGENCY PREPAREDNESS ine as we determ rd a e h e ic o v Make your the Priorities for e v ti la is g e L r ou n. lative Sessio is g e L y k c tu n 2013 Ke
November 30-December 1, 2012 Embassy Suites, Lexington Call 1-859-455-5000 or 1-800-EMBASSY to make your reservation today! KPhA rate is $109.95 before Nov. 1, 2012.
Highlights:
House of Delegates to meet to discuss and approve legislative priorities.
CE programs on KASPER, Grassroots Legislative Advocacy and Immunization.
Updates on how YOU can be involved in KPhA’s Emergency Preparedness Initiatives.
For more information, go to www.kphanet.org.
KPhA is YOUR voice in Frankfort! Help us craft the message for 2013! 39
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September 2012
Academy of Consultant Pharmacists
Senior Care Corner from the KPhA Academy of Consultant Pharmacists Submitted by Elisha Bischoff, PharmD, BCPS, Chair or the Academy of Consultant Pharmacists Particular Relevance. The section on Sedative/ Hypnotics states, “These guidelines apply to any medication that is being used to treat insomnia. InitiaI recently visited a facility that was thinking about initi- tion of medications to induce or maintain sleep should ating a resident on melatonin because the resident be preceded or accompanied by other interventions was having trouble sleeping, and they were trying to to try to improve sleep.” avoid a medication that would require dose reducConsider reviewing your residents’ medications and tions. It was my opinion that melatonin would need to ask about dose reductions on medications like melabe evaluated for gradual dose reductions (GDR) betonin, diphenhydramine and hydroxyzine if they are cause it was being used for sleep. being used for sleep. Interventions such as increasing activity, reducing caffeine and monitoring temperI referred to the State Operations Manual Appendix PP for answers. I found Table 1: Medication Issues of ature, noise and lighting should be tried. Does melatonin require a gradual dose reduction?
KPhA Government Affairs Contribution Election Year Appeal—Donate Today! Name: ______________________________________________________________
Pharmacy: ___________________________________________________________ Email: ______________________________________________________________ Address: _____________________________________________________________ City: _______________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs) Credit Card (AMEX; Discover; MasterCard; VISA) Account #: ____________________________________________________ Expiration date: _______ Address to which credit card statement is mailed (if different from above) ___________________________________________________________________________________
Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601
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RxTM and KPhA staff changes
September 2012
RxTM and KPhA say “See ya Later” to two staffers Matt Worthy, Director of Professional and Clinical Services for Rx Therapy Management, moved back to the West Coast. His last day at RxTM and KPhA was Aug. 1, 2012. He’s pictured with members of the RxTM Board of Managers BC Childress, Tera McIntosh and Chris Harlow, and KPhA Executive Director/ RxTM CEO Robert McFalls on his last day.
Darcie Nixon, Administrative Coordinator and Billing Specialist for RxTM, also has departed as her husband accepted a new position in Spokane, Wash. Her last day was August 23, 2012. Pictured with Darcie (middle) are Nancy Baldwin, McFalls, Scott Sisco, Christine Richardson, Samantha Gubser, Angela Gibson and Kelli Sheets. Special thanks to KPhA Board Chair Lewis Wilkerson for taking the photo of the staff.
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Pharmacy Policy Issues
September 2012
PHARMACY POLICY ISSUES:
What does increased transparency for drug companies mean to pharmacy? Author:
Stephen R. Polley is a third-year student pharmacist and current SSHP Chapter President at the University of Kentucky College of Pharmacy. He also is an MPA degree student in the Martin School of Public Policy and Administration at the University of Kentucky. Stephen completed his pre-professional education at the University of Kentucky and is a native of Tollesboro, Ky.
Issue:
Increasing attention has been focused on payments to prescribers by firms manufacturing, promoting and selling pharmaceuticals. Calls for disclosure of information about payments to physicians involved in promotional activities have increased substantially.
Discussion: In January 2012, the New York Times reported that the Obama administration was poised to require drug companies to disclose payments made to physicians for research, consulting and speaking as part of the new health care law. Over the years, the government has aimed to make these practices by drug companies much more transparent. The regulation stems from a public desire to know whether treatment is based on medical evidence or for other reasons such as financial incentives. PhRMA, the Pharmaceutical Researchers and Manufacturers of America, has acknowledged the poor public perception that surrounds these practices and has enacted new measures to improve this perception.
PhRMA has strengthened its Code on In- Have an Idea?: teractions with This column is designed to Healthcare Profesaddress timely and practical sionals, stating that issues of interest to promotional items pharmacists, pharmacy given to healthcare interns and pharmacy professionals are no technicians with the goal longer permissible being to encourage thought, unless they advance reflection and exchange disease or treatment among practitioners. education. Other Suggestions regarding topics items addressed in for consideration are the code include welcome. Please send them meals, business reto jfink@uky.edu. lated trips and consulting services. Another area that has greatly affected pharmacy is pharmaceutical companies sponsoring continuing education opportunities. In the past, these companies have provided a number of continuing education opportunities, but in recent years these numbers have declined due to the more stringent restrictions.
In a study published in the Journal of the American Medical Association in 2007, the authors found that over a three-year period in Minnesota, 7,290 payments were disclosed with 95 percent of these being for more than $100. Payments over the three years added up to $30.96 million. With the new regulation, each failure to disclose payment will result in a $10,000 fine up to a total of $1 million per year. While the effects of this regulation seem to target the medical profession, pharmacy has already felt and will The most recent PhRMA Code includes guidance on continue to feel the effects of the increased transpar- the criteria that must first be met and the types of ency by the drug companies. compensation appropriate to provide healthcare proIt wasn't that long ago when standing behind the fessionals who serve as speakers. PhRMA recomcounter in the pharmacy, one could observe a pletho- mends that â&#x20AC;&#x153;speakers and their materials should idenra of ink pens, counting trays and notepads branded tify the company that is sponsoring the presentation, by drug companies. Those have since disappeared as that the speaker is presenting on behalf of the compa42
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September 2012
Pharmacy Policy Issues
ny and that the speaker is presenting information that References is consistent with FDA guidelines." 1 Pear R. "Fees To Doctors By Drugs Makers To Be Disclosed." The New York Times 16 Jan. 2012: A1. PhRMA has readily accepted these conditions; however, they have noted that context must be consid- 2 Ross JR., Lackner JE, Lurie P, Wolfe S, and Krumholz ered when examining these disclosed payments as HM. Pharmaceutical company payments to physicians: interactions between drug companies and physicians Early experiences with disclosure laws in Vermont and Mincan play an important role in the improvement of care. nesota." JAMA 297.1121 Mar. (2007): 1216-25. Web. 2 Only time will tell the full impact of these newest re- Mar. 2012. quirements on pharmacists and the practice of phar- 3 "Code on Interactions with Healthcare Professionals." macy. PhRMA, Jan. 2009. Web. <http://www.phrma.org/sites/ default/files/369/phrma_marketing_code_2008-1.pdf>.
Support the Candidates who Support YOU! Make your Donation Today!
KPPAC Contribution Election Year Appealâ&#x20AC;&#x201D;Donate Today! Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)
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)
Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601
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September 2012
Pharmacists Mutual
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Connecting with KPhA
September 2012
Are you Connected to KPhA? Join us online! @KyPharmAssoc @KPhAGrassroots
Facebook.com/KyPharmAssoc
Kentucky Pharmacists Association Company Page
135th KPhA Annual Meeting June 5-8, 2013 Louisville Marriott Downtown Mark your calendars today! More details to come on www.kphanet.org and social media sites.
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KPhA Board of Directors
September 2012
KPhA BOARD OF DIRECTORS
HOUSE OF DELEGATES
Lewis Wilkerson, Frankfort rphs2@aol.com
Chairman 502.695.6920
Matt Martin, Louisville matt67martin@gmail.com
Kimberly Croley, Corbin kscroley@yahoo.com
President 606.304.1029
Cassandra Beyerle, Louisville Vice Speaker of the House cbeyerle01@gmail.com
Duane Parsons, Richmond dandlparsons@roadrunner.com
President-Elect 502.553.0312
KPERF ADVISORY COUNCIL
Frankie Hammons Abner, Barbourville frankiehammons@gmail.com
Secretary 606.627.7575
Glenn Stark, Frankfort glennwstark@aol.com
Treasurer
Donnie Riley, Russelville Past President donnierileyatclinicpharmacy@msn.com Directors Molly Trent, Georgetown mjtren2@uky.edu
Student Representative
Lance Murphy, Louisville lmurph8942@my.sullivan.edu
Student Representative
Matt Carrico, Louisville rxcarricojr@gmail.com Chris Clifton, Erlanger chrisclifton@hotmail.com Trish Freeman, Lexington* trish.freeman@uky.edu Joey Mattingly, Prospect joeymattingly@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Bob Oakley, Louisville roborx13@aol.com Richard Slone, Hindman richardkslone@msn.com Leah Tolliver, Lexington leahtolliver@tollivergroup.net Sam Willett, Mayfield duncancenter@bellsouth.net
Speaker of the House
Kim Croley, Corbin kscroley@yahoo.com Ann Amerson, Lexington amerson@insightbb.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 Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Scott Sisco, MA Director of Communications and Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Christine Richardson, PharmD Clinical Pharmacist, Interim Director of Professional & Clinical Services crichardson@kphanet.org Nancy Baldwin Receptionist/Office Assistant nbaldwin@kphanet.org Angela Gibson Administrative Coordinator & Billing Specialist (Temporary placement) agibson@kphanet.org
* At-Large Member to Executive Committee
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THE KENTUCKY PHARMACIST
50 Years Ago/Frequently Called and Contacted
September 2012
50 Years Ago at KPhA On Aug. 21, 1962, the Special Committee on Legislation met in the Frankfort offices of KPhA to begin planning for a new pharmacy law bill. The committee selected a fundraising committee. “Each member of the Committee agreed to study various pharmacy acts and make recommendations of what they thought should be considered by the full Committee.” Next meeting scheduled for Oct. 10, 1962. - From The Kentucky Pharmacist, September 1962, Volume XXV, Number 9.
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 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org Kentucky Society of Health Systems Pharmacists 1501 Twilight Trail Frankfort, KY 40601 (502) 223-5322 www.kshp.org
Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu
KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to ksheets@kphanet.org. Deceased members for each year will be honored permanently at the KPhA office. 47
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September 2012
THE
Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601
Save the Dates! KPhA Mid-Year Conference on Legislative Priorities & Emergency Preparedness November 30-December 1, 2012 Embassy Suites, Lexington 135th KPhA Annual Meeting June 5-8, 2013 Louisville Marriott Downtown Visit www.kphanet.org for more.
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