Y K C U T N E K THE T S I C A M R A PH Vol. 9, No. 3 May 2014
Advocacy: Will you let these few carry all the water?
KPhA: GUARDIAN OF THE PROFESSION
More information inside and at www.kphanet.org
News & Information for Members of the Kentucky Pharmacists Association
Table of Contents
May 2014
Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 136th KPhA Annual Meeting and Convention NCPA National Legislative Conference From your Executive Director APSC 2014 Kentucky General Assembly Wrapup Technician Review May 2014 CE — Managing Drug Interactions with Warfarin March Pharmacist/Pharmacy Tech Quiz NASP Leadership Conference
2 3 4 5 6 8 9 12 13 18 19
KPhA Pharmacy Emergency Preparedness June 2014 CE — The Bare Bones of Osteoporosis June Pharmacist/Pharmacy Tech Quiz Kentucky Renaissance Pharmacy Museum KPhA New and Returning Members 2013 Government Affairs and KPPAC Contributors KPPAC/KPhA Government Affairs Contribution Forms Pharmacy Law Brief Pharmacy Policy Issues Pharmacists Mutual Cardinal Health KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted
20 21 30 31 32 34 35 36 38 40 41 42 43
Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will keep abreast of developments and maintain professional competency in my profession of pharmacy. I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.
Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.
Editorial Office: © Copyright 2014 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.
The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance. It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation. Additionally, feedback from learners will be used to improve the overall programming designed by KPERF. 2
THE KENTUCKY PHARMACIST
President’s Perspective
May 2014 sional workforce. I would concur with her feelings. I would add that, we, as professionals, need to really take very seriously our roles as mentors for these young pharmacists. We need to keep them involved in being advocates for our great profession. They enter the workforce at a very exciting time. They, not us, have the ability to determine the course of our profession. They can set the parameters for how pharmacists will be allowed to practice in the future. By keeping them involved and actively participating they — not those with no knowledge of what we do for our patients — will set the course of our profession.
PRESIDENT’S PERSPECTIVE Duane W. Parsons KPhA President 2013-2014 This has certainly been an eventful, exciting and gratifying year for me personally as well as for our great profession. Thank you so much for allowing me to serve as your President this past year.
It’s easy for us to step back and take the attitude of, “Let someone else do it. I’m too busy.” It’s just not very productive nor wholesome. We each need to be that someone else who will do it. I’ve talked a lot in my messages to you of the real strength in numbers and unity of those in our profession. NOW is a critical time for that to happen. We came within a whisker of passing our expanded Collaborative Care Agreement bill. Just a lack of bringing it to a vote by our legislators prevented that from happening. Let’s let them know that is unacceptable to us. Get out and help them understand that this is a critical issue for us. Get your friends, patients and colleagues involved.
Increasing membership in YOUR KPhA has been one of the continuing objectives for all of us. We’ve made a great start, but we can’t afford to let up our efforts. There is a very definitive contribution in the notion of strength in numbers. The more of us as pharmacists who are speaking loudly with a unified voice, the more productive our efforts will become. Mentor your colleagues. Help them understand the importance of active involvement in YOUR KPhA. I’m sure you hear all the time that involvement is critical. I Get them involved as members. would submit that it’s not only critical, but necessary. Don’t I had the opportunity in March to attend the APhA Annual wait to be called on to be involved in a KPhA Committee. Meeting in Orlando. The entire focus of the meeting was on Ask to serve. Don’t wait to be asked to serve on the KPhA attaining provider status for pharmacists with the intent to Board of Directors. Submit your name as a candidate. Don’t have pharmacists recognized and compensated by payors wait to ask your legislators to be supportive of our issues. for what we do for our patients. It’s great to know that our Seek them out. Offer your help in mentoring young pharmanational organizations are aligned with what we are doing cists about their profession and their need to be involved. here in the Commonwealth of Kentucky. We all need to Help foster the idea of pharmacy as a career choice for work hard with our legislators to increase their awareness young students. Seek out every opportunity to help others of our value to the citizens of the Commonwealth. Recogni- understand the value and importance of what you as their tion as providers within the healthcare system for pharma- pharmacist do for them on a daily basis. cists continues to be KPhA’s primary focus. That will require a concerted effort by all the pharmacists in the Com- The upcoming year can be a very productive year in setting the course for our scope of practice for years to come. Let’s monwealth. I encourage each of you to get more involved and to get our less active colleagues involved in that focus. all commit to seeing that the course will be the right one for our profession. Last year our esteemed past-president, Kim Croley, wrote about her concern for the expectations of our young stuMEMBERSHIP MATTERS!! YOUR KPhA and your profession need YOU!! dent pharmacists as they graduate and enter the profes-
Registration and schedule online at www.kphanet.org. Watch your email and social media for the latest! 3
THE KENTUCKY PHARMACIST
136th KPhA Annual Meeting and Convention
May 2014
More information online! Full schedule is posted online at www.kphanet.org Accreditation is pending for continuing education programs.
Preconference events Thursday, June 5
MTM Certification KPERF Golf Scramble
Postconference event Sunday, June 8 Friday, June 6, 2014 7 am 7:30 to 8:15 am 8:30 to 10:00 am
9:00 to 10:00 am 10:15 to 11:15 am 10:15 to 11:15 am
11:30 am to 12:30 pm 12:30 to 1:30 pm
1:40 to 2:40 pm
2:50 to 3:50 pm
4:00-5:30 pm Registration Opens Opening Breakfast Sponsored by APSC KPhA Annual Membership Meeting and Opening House of Delegates (Including recognition of outgoing members of the KPhA Board of Directors) Pharmacy Transition Services Board of Pharmacy Advisory Council Option 1. Opioid Abuse - Van Ingram(1 hour) Option 2. 2014 Update: Pharmacy Emergency Preparedness -Leah Tolliver (1 hour) KPhA Awards Luncheon Sponsored by Kroger Pharmacists Provider Status - Rebecca Snead, Executive Vice President and CEO of NASPA (1 hour) Option 1: Delta Care: A Transition of Care Program-Joan Haltom (1 hour) Option 2: CMS Medicare STAR Ratings-Cathy Hanna (1 hour) Geriatric Polypharmacy Management Principles –Demetra Antimisiaris (1 hour) Technician Option: Inventory Management 101 – Don Carpenter (1 hour)
5:30 pm 5:30 to 7:30 pm 7:00 pm 7:30 pm
Adult Immunization Training
2014 NASPA/NMA Student Pharmacist Self-Care Championship (1.5 hr) Academy of Consultant Pharmacists business meeting Opening of Hall of Exhibits Mobile Pharmacy Unit on display Financial Planning (All attendees welcome!)
Saturday, June 7, 2014 7:30 am Registration/Continental Breakfast Sponsored by Humana 8 am Reference Committee 8 to 10 am Hall of Exhibits Open 10 am to noon New Drugs: How do They Stack Up- Trish Freeman (2 hr.) 12 noon Preceptor Recognition Luncheon Sponsored by UK College of Pharmacy Technician Lunch and Academy meeting 1:10 to 2:10 pm Pharmacists Option: Pharmacy Education Update: CAPE Outcomes 2013 Anne Policastri (1 hour) Technician Option: Calculations for Technicians Don Carpenter (1 hour) 2:20 to 3:20 pm Option 1: 2014 Law Update Ralph Bouvette (1 hr) Option 2: Diabetes Update 2014Brooke Hudspeth (1 hour)
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NCPA Conference on National Legislation 3:30 to 5:15 pm
3:30 to 4:30 pm
6 pm 7 pm
May 2014
House of Delegates Closing Session (Including installation of new Officers and Directors including the new Speaker/ Vice-Speaker) Technician only: Health Literacy’s Impact on Medication Adherence and Medication Errors - Megan Reynolds (1 hour) President’s Reception Ray Wirth Banquet with “Gatsby themed” party following
The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
*New Directors of the KPhA Board of Directors will be installed at the end of the Closing House of Delegates meeting this year.
Sunday, June 8, 2014 8 am Continental Breakfast 10 am Bugs & Drugs: Melinda Joyce Noon-5 Immunization Training
KPhA and APSC visit Kentucky Delegation in Washington, DC KPhA Executive Director Robert McFalls joined KPhA and APSC Members in Washington, D.C. in early May to meet with the Kentucky congressional delegation as part of the 2014 National Community Pharmacists Association (NCPA) Conference on National Legislation and Government Affairs. The Kentucky group included James Ashby, Ralph Bouvette, Leon & Margaret Claywell, Jeffrey Danhauer, Ron Poole, Jerry and Vendonna Rickard, Larry Stovall and Timothy Young.
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THE KENTUCKY PHARMACIST
From Your Executive Director
May 2014
MESSAGE FROM YOUR
EXECUTIVE DIRECTOR Robert “Bob” McFalls How Golden is the Rule when it comes to Giving in the Political Arena? The 2014 Regular Session of the Kentucky General Assembly itself is now history. However, the legislative session didn’t end without a gasp as time expired and sine die was invoked at the stroke of midnight on April 15. Fast forward now to a 2014 election year with critical candidate choices facing Kentuckians at the federal and state levels. Like many Kentuckians, you may wonder from time to time how much your engagement means and whether your contributions are making a difference. Step back and take a deep breath. Upon reflection, we can readily see the difference that pharmacists are making in the political arena given the number of legislative successes we have enjoyed for several years now, from audit reform more recently in 2012 to being the first state to pass PBM transparency legislation in 2013. This year, we were able to work with a coalition representing cancer patients and their caregivers to obtain parity for oral chemotherapy in the bill’s first year of introduction. And we were able to get our Pharmacy Technical Advisory Committee reauthorized in terms of providing input to the Department of Medicaid.
more effective ways that we engage with them is through our conversations and financial contributions to their candidacies. Indeed, our individual and collective financial support of candidates for elected office is a critical game changer. Strategic political contributions do make an impact and they are clearly recognized by those charged with public policymaking and fundraising. In this respect, how can one best participate? Here are a few suggestions. 1. Talk with your senators and representatives at the federal and state levels. If you don’t know them, use this time to introduce yourself and let them know how and why you are concerned about your profession and the patients that you serve. Let them see your passion. Election years provide even greater access as candidates hold town hall meetings and avail themselves more to the public. They need us and our votes.
As Americans and Kentuckians, we readily acknowledge 2. Make a personal contribution to the candidate(s) of the many freedoms that we enjoy as citizens and how truly your choice. Campaigns are becoming more and more blessed we are to call this great nation and state our costly, and candidates remember those who support home. In accordance with the U.S. Constitution, WE THE them at all levels, including financially. PEOPLE have been endowed with a government of “liberty and union, now and forever” through which we are 3. Unite collectively as pharmacists and pharmacy technicians by giving to the Kentucky Pharmacy Political granted several privileges and protections, including the Action Committee (KPPAC). KPPAC regularly receives provision of justice; civil peace; a common defense; those requests for contributions from current and aspiring things of a general welfare that we cannot provide for ouroffice holders. By giving to KPPAC, you call attention selves; and, freedom. The Constitution further guarantees to the importance of pharmacy issues statewide. Conpowers that are reserved for the states from which our tributions to KPPAC must be given on an individual Kentucky constitution was developed. At the federal, state basis and cannot exceed $1,500 in a calendar year. and local levels, those whom we elect are our designated representatives who we then charge with carrying out their 4. Support the legislative advocacy work of KPhA by givduties as our elected servants to provide for our collective ing regularly to our Government Affairs Fund. These general welfare. funds are used to further the lobbying work that KPhA does throughout the year. Unlike KPPAC, donations to Election years remind us of the importance to connect and KPhA Government Affairs may be given on an individreconnect with our elected officials at all levels. One of the 6
THE KENTUCKY PHARMACIST
From Your Executive Director
May 2014
History of the KY Pharmacists Political Action Committee (KPPAC) Year
Contributions to Candidates
2013
Donations from Pharmacists $5,250 (1st quarter) $12,530
2012
$5,875
$27,021.97
2011
$12,075
$7,825
2010
$9,150
$24,362.93
2009
$8,400
$6,280.58
2008
$7,650
$17,778.27
2007
$24,800
$12,672.55
2006
$34,750
$392.96
2014
How does Pharmacist Giving compare to that of other health care professions?
$146.22
$57,000 (2013)
$8,429.19
$20,588.50 (1st quarter, 2014) $11,490.00 (1st quarter, 2014) $6,750.00 (1st quarter, 2014)
YOUR KPhA encourages you to GIVE at all levels.
Source: Kentucky Registry of Election Finance
Kentucky Physicians PAC Kentucky Optometric PAC Kentucky Dental PAC Kentucky Association of Nurse Anesthetists
KPhA Government Affairs or KPPAC, and in so doing, enlist as a vital member to impact policy decisions by voting with your dollars to impact legislative decisionmakers statewide. Since its formation in 2006, pharmacists have engaged with KPPAC through the years to varying degrees and financial commitment, as reflected in the accompa-
nying chart. ual basis or by the pharmacy/business, and there is no All of us are asked to give on an ongoing basis to a variety cap on the amount that can be contributed. of causes. Make one donation, and your mailbox is full of 5. Vote. requests from other charities. I think supporting one’s pro6. Continue to engage with your elected officials when fession is different though. You have already exhibited this they are at work and/or in session. We need their sup- level of support through your engagement and membership port, leadership and votes on critical issues facing the with YOUR KPhA. And we thank you for that. KPPAC’s profession. campaign account and KPhA’s Government Affairs work are funded with voluntary contributions from members like Each year the Kentucky Pharmacists Political Action Comyou who are true believers in what we are doing and our mittee must carefully analyze where it should allocate its legislative message. Through the years, I have been asked limited resources in terms of candidates seeking elected on more than one occasion where to find the Golden Rule office. Again, where does KPPAC raise the much-needed in the Bible. The Golden Rule is not written as a verse or funds needed to make contributions on behalf of the profespassage per se, but rather traces itself back in the Judaic sion? KPPAC relies entirely upon the goodwill of individuals Christian tradition to Hillel’s work. But its principles of caring like you who realize the value of making a difference by and doing for others are reflected in many direct ways in contributing to Pharmacists Political Action. KPPAC works the Scriptures in terms of the responsibility we have for our diligently throughout the year to grow its investment fund — neighbors. I am reminded of a short devotion from my youth that is, the KPPAC banking account — in order to support in which an individual was reflecting on the latest request s/ those candidates who support pharmacists and the profeshe had received for a gift. In first person, s/he reflects: sion of pharmacy with our key issues. KPPAC and its cam“What, giving again, I asked in dismay? Must I keep giving paign account are funded by members — like you — who and giving away?” “Oh no, said the angel, piercing me are true believers in the power of the collective voice of through; Just give until the good Lord stops giving to you.” pharmacy and what KPPAC is accomplishing. YOUR KPhA encourages you to GIVE at all levels. Get inLikewise, KPhA’s Government Affairs funds are totally devolved on the political scene by engaging with the candipendent on individuals who want to make a difference. dates, some of whom will be representing you in the KenMany of you are compelled by duty to make a real differtucky General Assembly and/or U.S. Congress in a few ence by voting with your contributions. Some of you make short months. Be golden and invest with your fellow profesyour commitment to support KPhA Government Affairs and sionals in making a financial gift. UNITED WE STAND KPPAC at the time you pay your dues. Others of you take WITH YOUR KPhA. the time to write a check or make an online contribution to 7
THE KENTUCKY PHARMACIST
APSC
May 2014
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THE KENTUCKY PHARMACIST
Summary of Pharmacy Issues
May 2014
SUMMARY OF PHARMACY ISSUES 2014 Kentucky General Assembly A Member Update from YOUR Kentucky Pharmacists Association, the Guardian of the Profession effective date was included in the legislation or the legislation contained an emergency clause which makes it effective as soon as it is signed by the Governor.
Overview: KPhA gratefully acknowledges the engagement of pharmacist members throughout the Commonwealth who made legislative advocacy a personal priority during the 2014 legislative session. Pharmacists were united in your resolve to make a difference by conducting regular telephone calls and engaging in one-on-one conversations with your state senators and representatives. From the Government Affairs Committee, Chair Richard Slone, and the entire Board of Directors: Thank you for your due diligence and commitment. Your advocacy continues to make a difference!
Pharmacy Issues
Collaborative Care Agreements: SB 76, the bill that would have made it easier for pharmacists and physicians to enter into collaborative agreements to cooperatively manage patients’ care, died in the House. The measure would have streamlined the process for establishing Collaborative Care Agreements by allowing multiple pharmacists to enter into an agreement with multiple practitioners. KPhA acknowledges and thanks our advocacy partners for The bill also proposed revising the licensing requirements this session: American Pharmacy Cooperative, Inc., Amerifor out-of-state home medical equipment dealers. can Pharmacy Services Cooperative, EPIC Pharmacies, Inc., Kentucky Independent Pharmacy Alliance, Kentucky Giving pharmacists and physicians more flexibility in ColRetail Federation, National Association of Chain Drug laborative Care Agreements was the top priority for KPhA Stores and the National Community Pharmacists Associa- and other pharmacy groups. Last year, KPhA met with the tion. Kentucky Medical Association to reach an agreement on Lawmakers went right to the wire adjourning at midnight on the language of the provision. The Association sought the the session’s final day, April 15. This year’s session was a help of Senate Health and Welfare Committee Chair Julie Denton (R-Louisville) who agreed to include the collaborabusy one for pharmacy issues. The legislature adopted several key pharmacy bills including parity for oral chemo- tive care revisions in SB 76. The bill easily cleared the Senate but stalled in the House after Representative Mary Lou therapy legislation (HB 126) and legislation to reestablish the Medicaid Technical Advisory Committee on Pharmacy Marzian (D-Louisville) added a provision to the bill in the House Health and Welfare Committee authorizing expedit(HB 286). One key KPhA measure, however, died on the ed partner therapy. The controversial amendment kept the last day of the session when the House failed to take up bill from receiving a hearing on the House floor. Denton SB 76 dealing with Collaborative Care Agreements. KPhA’s legislative team followed more than 30 pharmacy- resurrected the provisions of SB 76, as well as several othrelated bills this session and the association had significant er health care-related measures, as an amendment to an unrelated bill (HB 125) which passed the Senate. The input on many of these measures. House, however, refused to concur with those changes and The following summary provides a narrative regarding the HB 125 wound up in a free conference committee in the activity on some of the major issues affecting the pharmacy final days of the session. The committee recommended the community that were considered during this year’s legislainclusion of SB 76 in their final report. The report was tive session. The electronic version of the 2014 Pharmacy adopted by the Senate but failed to receive consideration in Legislation Summary, which can be accessed on the House on the last day of the session. www.kphanet.org under the Advocacy tab, includes links to Parity for Oral Chemotherapy Agents: Legislation to rethe legislature’s official website so you can easily access quire health insurance plans to provide the same level of the complete summaries prepared by legislative staff and all action on the measures, as well as review the full text of coverage for oral chemotherapy drugs as is provided for injected or intravenous treatments will become law. The individual bills and resolutions. Bills enacted during the issue started out as SB 148 which cleared the Senate on 2014 Session will take effect in mid-July unless a specific 9
THE KENTUCKY PHARMACIST
Summary of Pharmacy Issues
May 2014
March 20 but the bill was derailed in the House. The provisions of SB 148 were added in the Senate to HB 126, a Department of Insurance “housekeeping” measure. That bill cleared the Senate and the change was concurred in by the House. The bill was signed by the Governor on April 11. The final version of the bill establishes parity for oral chemotherapy drugs but does allow for up to a $100 copayment per 30-day supply to meet the requirement. It also delays the effective date of the provision until Jan. 1, 2015. The original bill (SB 148) was sponsored by Senator Tom Buford (R-Nicholasville). Passing oral chemotherapy parity legislation became one of KPhA’s top legislative priorities this session. The association partnered with patient advocacy organizations to promote the passage of the bill. KPhA members including Jill Rhodes, Jeff Mills and Anne Policastri - played a critical role in advocating for the legislation and provided key testimony on the measure in the Senate committee.
Greer (D-Brandenburg). Medication Synchronization: Efforts to require insurance companies to pay for pharmacy claims to “synchronize” refills to a common date were unsuccessful. HB 395, introduced by Representative Addia Wuchner (R-Burlington), initially cleared the House Banking and Insurance Committee but was later recommitted to that committee. Attempts later in the Session to revive the measure failed. The provisions of the bill ultimately wound up in a Free Conference Committee Report on HB 125. The report was passed by the Senate on the last day of the session but was never acted upon in the House.
Dextromethorphan: As in past sessions, a measure to prohibit the sale of products containing dextromethorphan to anyone under age 18 failed to win legislative approval. As introduced, HB 24 only covered products that contained dextromethorphan as the sole active ingredient but there was talk about expanding the bill’s scope to include all products containing dextromethorphan. Medicaid TechThose discussions nical Advisory University of Kentucky student pharmacists, along with Dr. Patricia Freebroke down and the Committee on man, attended a committee meeting to support the Collaborative Care bill never received a Pharmacy: HB 286 Agreement legislation during the session. hearing in the reestablishing the House Judiciary Committee. Medicaid Technical Advisory Committee on Pharmacy (TAC) passed both Houses without amendment and was signed by the Governor. It sets up a panel made up of five pharmacists appointed by the Kentucky Pharmacists Association through a nomination process involving other pharmacy groups in the Commonwealth. The committee is designed to provide input to the state Medicaid program on pharmacy issues. Most other health care provider groups have a similar group authorized by statute. Several years ago, the Medicaid Technical Advisory Committee on Drugs was dissolved in a bill reorganizing the Cabinet for Health and Family Services. At that time, state officials felt that the TAC was unnecessary because some of its functions were taken over by another advisory committee, the Drug Management Review Advisory Board (DMRAB). KPhA supported the legislation brought forward by last year’s winner of the KPhA Meritorious Service Award, Representative Jeff
Prior Authorization: Senator Tom Buford (R-Nicholasville) sought to dramatically change the way pharmacy benefit managers (PBMs) deal with the pre-authorization of drugs. Buford introduced SB 73 which would have required PBMs to notify the prescriber before a preauthorization expires or is cancelled. The measure also would have allowed prescribers to override the cancellation or expiration. The bill passed the Senate and was amended in the House Banking and Insurance Committee to require insurers to include in their “exceptions” policy, a provision to allow for an automatic 30-day extension of a prior authorization upon the request of the prescriber. The amended version of SB 73 passed the House, but the Senate never called the bill for a vote on the House amendment. A late session attempt to pass the measure as an amendment to another bill was unsuccessful. 10
THE KENTUCKY PHARMACIST
Summary of Pharmacy Issues Pharmacy Wholesalers: The bill to prohibit retail pharmacies from selling or distributing prescription drugs to pharmacy wholesalers died in the Senate. HB 325 cleared the House by a narrow margin but bogged down in the Senate. At KPhA’s request, the bill was amended in the House to exempt routine transactions between pharmacies and their wholesalers such as returns. HB 325 was an initiative of the Kentucky Board of Pharmacy. It was designed to stop the practice of small, third-party independent wholesalers obtaining drugs from pharmacies for resale. There have allegedly been problems with “gray market” drugs entering the market through these channels. Expedited Partner Therapy: HB 146, a bill to allow a practitioner to prescribe or dispense treatment for the partner of an individual with a sexually transmitted disease without actually examining the partner, died in the Senate. It narrowly passed the House but never received a hearing in the Senate Veterans, Military Affairs and Public Protection Committee. The sponsor, Representative Mary Lou Marzian (D-Louisville), later tried to revive the measure as an amendment to SB 76, but that effort was unsuccessful.
May 2014 cies, along with other Medicaid providers, are especially vulnerable under a False Claims Act. KPhA was part of a large coalition of groups that actively opposed the measure. Members of the government affairs team met with key legislative leaders in an effort to stop the legislation. Those efforts paid off as the bill never received a hearing in the House Judiciary Committee. Similar legislation was filed in past sessions but did not pass. Bio-similar Substitution: Although expected, legislation was not introduced this session to place restrictions on the substitution of bio-similar products once the FDA determines interchangeability. Bills are being pushed in other states by major manufacturers of biologics, but Kentucky was not targeted by the industry for legislative action this year. Opposing restrictions on the substitution of biosimilars was another priority of the association.
Other Issues: SB 201, a bill to require managed care organizations to make available all dosage forms of suboxone on an equal basis failed to pass. Other measures that failed to pass included a bill to require managed care organizations to file their provider network participation reHPV Vaccinations: A controversial measure to require all quirements with the Department of Insurance (HB 73) and children to be vaccinated against the human papillomavirus a proposal to require insurers to include out-of-state providvirus (HPV) by the time they enter the sixth grade failed to ers in their provider networks (HB 362). make its way into law. HB 311 would have allowed parents Also failing were two measures to legalize the medical use to opt out of the requirement for their children by filing a form with the school system. The bill passed the House but of marijuana (SB 43, HB 350). However, the legislature did, not before a floor amendment was adopted that effectively pass legislation to allow the medical use of certain deriva“gutted” the bill. The amendment made the vaccination per- tives of marijuana in limited circumstances. SB 124 restricts the use to research, compassionate use programs missive rather than mandatory. The amended bill never and in state research hospitals. The bill was signed by the received a hearing in the Senate. Governor on April 10. Also set to become law is SB 7, a bill Medical Malpractice Reform: A large coalition of health revising the rules for collaborative practice agreements becare providers and business groups including KPhA sought tween physicians and advanced practice nurse practitionthe passage of SB 119, legislation to address medical malers (APRNs). It was the first bill to pass the General Aspractice. The legislation would have established “medical sembly and was signed by Governor Beshear on February review panels” to prescreen medical malpractice claims. 13. The Governor has also signed SB 118 to allow early The panel’s decision would be nonbinding but would be refills on prescription eye drops. Additionally, it requires admissible in court. Indiana, Louisiana and several other insurers to pay for an additional bottle once every three states utilize medical review panels. The bill cleared the months under certain circumstances. It has a delayed efSenate but stalled in the House. fective date of Jan. 1, 2015. False Claims Act: House Speaker Greg Stumbo (DPrestonsburg) again filed legislation this session to create How can YOU help? the Kentucky False Claims Act. HB 335 would have al Contact your legislators. lowed private individuals (whistleblowers) to bring an action Read the KPhA Weekly Legislative Reports during the for fraud against any entity doing business with the state. session to stay abreast of the latest issues. Under the provisions of the bill, the whistleblowers would Respond to Calls for Action from YOUR KPhA be entitled to a portion of any recovery that might occur. Donate to KPhA Government Affairs and Kentucky The bill has the potential to encourage frivolous actions Pharmacists Political Advisory Committee. against entities that do business with the state. Pharma Provide input into the Government Affairs Committee 11
THE KENTUCKY PHARMACIST
Technician Review
May 2014
Technician Review From the KPhA Academy of Technicians The KPhA Pharmacy Technician Academy would like to invite any KPhA technician members to join the academy at no extra cost. By joining the Academy you are eligible to receive up to 10 hours of technician-specific CE per year provided by the Continuing Education Institute. The KPhA board members have shown strong support of the Technician Academy by approving the CE at no extra cost to the members.
put from other technicians. During the annual meeting, the Technician Academy will meet during a luncheon on Saturday, June 7 to determine how to help the technician profession as we move forward. All technicians are welcome to join us during any meeting.
The PTCB has moved forward on requiring one hour of patient safety continuing education for any technician who is eligible for recertification. They have adopted the ACPE’s The Academy has submitted a set of proposals for the fudefinition from their Policy and Procedures Manual. This is ture of the pharmacy technicians in Kentucky to the KPhA, just one example of how the national standards are changKSHP and Kentucky Board of Pharmacy Advisory Council. ing and the Technician Academy is dedicated to helping Our proposals are in accordance with the changes that are Kentucky be a leader in the Pharmacy Technician profescoming from the national level and our goal is to make Ken- sion. tucky one step ahead of the rest of the nation. The AdvisoIf you have any questions about the KPhA Pharmacy Techry Council is reviewing our proposals so they can present a nician Academy, please contact Don Carpenter at dacarfinal set of recommendations to the Board of Pharmacy. penter@st-claire.org. The Academy delegation also would like to invite all techniThank you, cians to join us at the KPhA Annual meeting. The delegates Don Carpenter, CPhT are meeting on June 5th at 6:00 pm to reorganize the reKPhA Pharmacy Technician Academy Chair sponsibilities of the delegation, and we would enjoy all in-
KPhA Member Pharmacy Technicians
FREE CE
KPhA Technician members are eligible for Free CE modeled on PTCB standards by becoming a member of the KPhA Pharmacy Technician Academy. All KPhA Technician Members are eligible for Academy Membership at no additional cost. The mission of the KPhA Academy of Pharmacy Technicians is: To unite the pharmacy technicians throughout the Commonwealth to have one voice toward the advancement of our profession. To follow what is currently happening with your profession please read our newsletter articles and become involved.
For more information contact Don Carpenter via email at dacarpenter@st-claire.org 12
THE KENTUCKY PHARMACIST
May 2014 CE — Managing Drug Interactions with Warfarin
May 2014
The Clot Thickens: Managing Drug Interactions with Warfarin By: Stacy Rowe, PharmD, MBA; Joshua Montney, PharmD, MBA, Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-14-005-H01-P&T 1.0 Contact Hour (0.1 CEU) Objectives At the conclusion of this article, the reader should be able to: 1. 2. 3. 4. 5.
Review the pharmacology of warfarin. Discuss the major mechanisms of interactions with warfarin. Describe warfarin dosing strategies for management of potential drug interactions. Discuss examples from clinical practice in managing drug interactions with warfarin. Review pertinent literature in managing drug interactions with warfarin.
KPERF offers all CE articles to members online at www.kphanet.org
endogenously occurring anticoagulant proteins S and C, resulting in a temporary hypercoaguable state. ConseWarfarin (Jantoven®, Coumadin®), the most commonly quently, for patients starting warfarin, the American College prescribed anticoagulant in the United States, is prescribed of Chest Physicians (ACCP) recommends the use of a lowfor the treatment and prevention of venous thromboembomolecular-weight heparin (LMWH) for at least five days, lism (VTE), as well as the prevention of thromboembolic and can be stopped after two consecutive therapeutic INR complications associated with atrial fibrillation, heart valve readings at least 24 hours apart.8 replacement and myocardial infarction (MI).1 The number of patients treated with warfarin has continued to increase Warfarin consists of a racemic mixture of R and S isomers, with the S isomer being two to five times more potent than as the population ages — approximately 4 million outpathe R isomer.12 The efficacy of warfarin is primarily affected tients in the U.S. are receiving long-term anticoagulation when the metabolism of S-warfarin is altered (Figure 2). with warfarin.2,3 Since it is rapidly and extensively absorbed in the gut, warFor years warfarin has been the cornerstone of anticoagu- farin has high oral bioavailability (~90 percent), and has a lation therapy; however, it has a narrow therapeutic range similar therapeutic response when compared to I.V. adminand requires frequent monitoring to avoid potential lifeistration.13,14 Warfarin is highly protein bound (97-99 perthreatening complications from both under- and overcent) and metabolized primarily in the liver by CYP450 2C9 coagulation.4-6 The aim of treatment is to prolong clotting enzymes. time to a level to prevent thrombosis but not above a level Warfarin drug interactions could occur with a very wide to cause bleeding.7 Monitoring is performed by using either range of drugs that are metabolized by CYP450 envenous or capillary blood samples, and results are reported zymes.14 For example, CYP450 inducers increase warfarin as the international normalized ratio (INR).8 The goal INR, metabolism while CYP450 inhibitors decrease warfarin mewhich is determined by the clinical indication for warfarin, is tabolism. The number of drugs reported to interact with 2.5 (range 2.0–3.0) for most indications, but a higher goal warfarin continues to expand, but most reports are of poor of 3.0 (range 2.5–3.5) is recommended for patients with quality and present potentially misleading conclusions.5 8 mechanical mitral valve placement. Reports of interactions with drugs such as azole antifungals and quinolones have remained consistent; however, Warfarin exerts its anticoagulant effect by inhibiting the synthesis of vitamin K dependent clotting factors (II, VII, IX, results suggest that co-administration with warfarin should X) produced by the liver (Figure 1). Time to full pharmaco- be closely monitored. logic effect is dependent on the elimination half-life of coManaging Interactions agulation proteins and is not present until approximately five days after initiation.9,10 Because prothrombin has an Managing warfarin drug interactions can be preemptive or elimination half-life of 60-100 hours, loading doses of war- reactive. For example, a preemptive approach includes farin are of limited value.11 Additionally, warfarin inhibits the decreasing the dose of warfarin upon initiation of the interIntroduction
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May 2014 CE — Managing Drug Interactions with Warfarin
May 2014 ups were within therapeutic range regardless of the management strategy. Antimicrobials It is hypothesized that all antibiotics may reduce vitamin K producing bacteria in the gut, thereby increasing INR, but limited data are available. For example, a 2008 study of ciprofloxacin, levofloxacin, gatifloxacin, cotrimoxazole, fluconazole, cephalexin and amoxicillin in warfarin stabilized patients showed a significant increase in bleeding episodes across all antimicrobials.4
Sulfonamides such as Bactrim® (trimethoprimsulfamethoxazole) inhibit Figure 1. Coagulation Cascade CYP2C9 and also have the acting medication and increasing INR monitoring, while a potential for protein-binding interactions. One study found reactive approach includes making dose adjustments that warfarin stabilized patients >65 years old taking a sulbased on INR response. In adjusting the dose of warfarin, fonamide were nearly three to five times more likely to be pharmacists must consider the patient’s age, illness, indicahospitalized for bleeding than those who were not exposed tion for therapy, historical response to dose adjustments to the interaction.16 and whether the patient has a higher clotting or bleeding The exact mechanism of the quinolone-warfarin interaction risk. Few would argue that managing or avoiding warfarin is unknown, but may be due to disruption of gut flora, disdrug interactions can be difficult, as all patients respond placement of warfarin from albumin and inhibition of differently to changes in therapy and often forget to report the initiation or discontinuation of medications. The follow- CYP1A2. Ciprofloxacin, norfloxacin and ofloxacin appear to 4 ing sections provide examples from clinical practice as well be the most likely to interact with warfarin. One study examined the impact of preemptive warfarin dose reduction as a review of the literature in managing commonly enon anticoagulation after initiation of Bactrim® or levofloxacountered drug interactions with warfarin. cin, and found that preemptive dose reduction with BacPrednisone trim® proved Figure 2. Warfarin Metabolism Prednisone may increase or decrease INR. The exact to be mechanism of the interaction between oral corticosteroids benefiand warfarin is unknown, but may be due to genetic deficial.17 ciencies or altered liver metabolism of warfarin by corticoPreempsteroids. tive dose A recent clinical trial investigated this interaction, using reduction preemptive (control group) and reactive (intervention group) with adjustments.15 The reactive group showed a non-significant levofloxincrease in the percentage of follow-up INRs ≥1 point over acin goal INR. Conversely, the preemptive group significantly proved less benincreased the percentage of subtherapeutic follow-up INR compared to the reactive group. Approximately ½ of follow- eficial as 14
THE KENTUCKY PHARMACIST
May 2014 CE — Managing Drug Interactions with Warfarin
May 2014
Figure 3. Managing Warfarin-Ciprofloxacin Interaction the interaction had a milder effect on INR. Figure 3 depicts an example from clinical practice. The anticoagulation providers were not informed that ciprofloxacin had been started, and monitored INR closely throughout the course of therapy. INR returned to therapeutic range without dose adjustment.
In addition to using evidence-based medicine and sound clinical judgment, it is important to look at the whole patient (i.e., age, illness, indication for therapy) in managing warfarin-drug interactions. Managing these interactions can be challenging, as all patients respond differently to changes in therapy and often forget to report the initiation or discontinuation of medications. Preemptive and/or reactive dose The interaction mechanism between tetracyclines and waradjustments often are necessary in preventing or correcting farin is unknown, but may occur through disruption of vitaa non-therapeutic INR. Pharmacists can play a key role in min K synthesis. Tetracyclines are highly protein bound, optimizing patient education and minimizing adverse efwhich also may contribute to an increase in INR via disfects associated with warfarin-drug interactions. placement of warfarin from albumin. A 2007 case report found that doxycycline can enhance the anticoagulant efReferences: fect of warfarin.18 It is important to recognize this potential 1) Ansell J, Hirsch J, Hylek E, et al. Pharmacology and interaction and obtain a complete medication profile prior to management of the vitamin K antagonists: American initiating doxycycline. Figure 4 depicts a supratherapeutic College of Chest Physicians evidence-based clinical INR as a result of doxycycline initiation. INR returned to practice guidelines (8th edition). Chest 2008;133(6 therapeutic range after preemptive and reactive intervensuppl):S160–98. tions. Note the significant drop in INR with one held dose of 2) Wysowski DK, Nourjah P, Swartz L. Bleeding complications with warfarin use: a prevalent adverse effect warfarin in combination with a dose reduction. resulting in regulatory action. Arch Intern Med 2007;167:1414–19. Conclusion 3) Garcia DA, Schwartz MJ. Warfarin therapy: tips and Once a drug interaction with warfarin has been identified, tools for better control. J Fam Pract 2011;60:70–5. pharmacists should instruct patients to inform their antico- 4) Schelleman H, Bilker WB, Brensinger CM, Han X, Kimmel SE, Hennessy S. Warfarin, fluoroquinolones, sulagulation providers. These providers must recognize the fonamides, or azole antifungals interactions and the potential of such interactions, estimate their significance risk of hospitalization for gastrointestinal bleeding. Clin and severity and make appropriate adjustments. If manPharmacol Ther. 2008;84:581-588. aged inappropriately, warfarin-drug interactions can be fa- 5) Holbrook AM, Pereira JA, Labiris R, et al. Systematic overview of warfarin and its drug and food interactions. tal. 15
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May 2014 CE — Managing Drug Interactions with Warfarin
May 2014
Figure 4. Managing Warfarin-Doxycycline Interaction Arch Intern Med. 2005; 165:1095-1106. 6) Nutescu EA, Bathija S, Sharp LK, Gerber BS, Schumock GT, Fitzgibbon ML. Anticoagulation patient selfmonitoring in the United States – considerations for clinical practice adoption. Pharmacotherapy. 2011;31 (12):1161-1174. 7) Fang MC, Chang Y, Hylek EM, et al. Advanced age, anticoagulation intensity, and risk for intracranial hemorrhage among patients taking warfarin for atrial fibrillation. Ann Intern Med. 2004; 745-752. 8) Holbrook A, Schulman S, Witt DM, et al. Evidencebased management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidencebased clinical practice guidelines. Chest 2012;141 (Suppl 2):e152S-84S. 9) Horton JD, Bushwick BM. Warfarin therapy: evolving strategies in anticoagulation. Am Fam Physician. 1999;59:635–646. 10) Hirsh J, Dalen JE, Anderson DR, Poller L, Bussey H, Ansell J, Deykin D, Brandt JT. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest. 1998;114(5 Suppl):445S– 469S. 11) Dager WE, Branch JM, King JH, White RH, Quan RS, Musallam NA, Albertson TE. Optimization of inpatient warfarin therapy: impact of daily consultation by a pharmacist-managed anticoagulation service. Ann Pharmacother. 2000;34:567–572. 12) Lara LF, Delgado LL, Frazee LA et al. A subtherapeutic international normalized ratio despite increasing doses of warfarin: could this be malabsorption? Am J Med Sci. 2000; 320:214–8.
13) Porter RS, Sawyer WT. Warfarin. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied pharmacokinetics: principles of therapeutic drug monitoring, 3rd ed. Vancouver, WA: Applied Therapeutics; 1992:31–1–46. 14) Kaminsky LS, Zhang ZY. Human P450 metabolism of warfarin. Pharmacol Ther, 1997; 73(1):67-74. 15) Dowd MB, Vavra KA, Witt DM, Delate T, Martinez K. Empiric warfarin dose adjustment with prednisone therapy. A randomized, controlled trial. J Thromb Thrombolysis. 2011 May;31(4):472-7. 16) Baillargeon J, Holmes HM, Lin YL, Raji MA, Sharma G, Kuo YF. Concurrent use of warfarin and antibiotics and the risk of bleeding in older adults. Am J Med 2012 Feb;125(2):183-9. 17) Ahmed A, Stephens JC, Kaus CA, Fay WP. Impact of preemptive warfarin dose reduction on anticoagulation after initiation of trimethoprim-sulfamethoxazole or levofloxacin. J Thromb Thrombolysis. 2008 Aug;26 (1):44-8. Epub 2007 Nov 6. 18) Hasan SA. Interactions of doxycycline and warfarin: and enhanced anticoagulant effect. Cornea 2007;26:742-3. 19) Micromedex [database]. Thomson Reuters Healthcare. Available: www.thomsonhc.com/hcs/librarian (accessed Apr 5, 2014). 20) Cook DE, Ponte CD. Suspected trimethoprim/ sulfamethoxazole-induced hypoprothrombinemia. J Fam Pract 1994;39:589-91. 21) Ellis RJ, Mayo MS, Bodensteiner DM. Ciprofloxacinwarfarin coagulopathy: a case series. Am J Hematol 2000;63:28-31. 22) Gericke KR. Possible interaction between warfarin and fluconazole. Pharmacotherapy 1993;13:508-9.
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THE KENTUCKY PHARMACIST
May 2014 CE — Managing Drug Interactions with Warfarin
May 2014
Figure 5. Summary of Clinical Trials Drug
Adjustment
Prednisone
Empiric warfarin dose adjustments are not usually necessary; however, may be required for patients receiving large bolus or pulse doses of steroids.19 Patients should return for monitoring in two to three days. It is acceptable to empirically decrease the dose of warfarin by 25 to 40 percent. 17,19,20 Patients should return for monitoring in two to three days. Most patients will have an increase in INR, but some will experience no effect. May consider empiric 10 to 30 percent warfarin dose reduction. 5,19,21 Patients should return for monitoring in two to three days. Empiric warfarin dose adjustments are not usually necessary unless the patient has other factors affecting INR (e.g., decreased appetite, fever). 19,22 Patients should return for monitoring in two to three days. Effects of fluconazole on INR are more pronounced in patients with reduced renal function due to reduced clearance of fluconazole; may consider empiric 25 to 30 percent warfarin dose reduction, with eventual reductions approaching 80 percent.19,22,23 Patients should return for monitoring in two to three days.
Bactrim® Ciprofloxacin Doxycycline Fluconazole
23) Allison EJ, McKinney TJ, Langenberg JN. Spinal epidural haematoma as a result of warfarin/fluconazole
drug interaction. Eur J Emerg Med 2002;9:175-7.
May 2014 — The Clot Thickens: Managing Drug Interactions with Warfarin 1. Which of the following CYP450 enzyme metabolizes the S isomer of warfarin? A. 3A4 B. 1A2 C. 2D6 D. 2C9
6. Which of the following is true regarding warfarin? A. Hemorrhagic complications develop in the majority of patients taking warfarin. B. Warfarin consists of a racemic mixture of isomers with equal potency. C. Warfarin is highly protein bound and interacts with many medications. 2. Which of the following is responsible for a hypercoagula- D. There are minimal food and drug interactions with warble state after warfarin initiation? farin. A. Decreased production of Von Willebrand factor B. Decreased production of protein C 7. Which of the following interactions with warfarin results C. Increased production of antithrombin in a decreased INR level? D. Increased production of fibrinogen A. Increased vitamin K intake B. Decreased vitamin K intake 3. Which of the following clotting factors are blocked by C. Initiation of ciprofloxacin warfarin? D. Initiation of fluconazole A. IIa, IX, X, XI, XII B. II, IV, V, VIII 8. According to clinical trials, empiric dose adjustments of C. II, VII, IX, X warfarin should be considered in which of the following paD. IIa, VII, X, XII tients? A. A patient receiving large bolus or pulse doses of ster4. In patients taking warfarin, how can Bactrim® affect the oids. INR level? B. A 70-year-old patient starting a course of Bactrim®. A. Increase INR C. A patient with poor renal function starting a course of B. Decrease INR fluconazole. C. No effect on INR D. Empiric dose adjustments should be considered in all D. Increase or decrease INR of these patients. 5. Which of the following medications can increase the INR level in patients taking warfarin? A. Fluconazole B. Atenolol C. Digoxin D. Lisinopril
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May 2014 CE — Managing Drug Interactions with Warfarin
May 2014
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: May 10, 2017 Successful Completion: Score of 80% will result in 1.0 contact hour or 0.1 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. May 2014 — The Clot Thickens: Managing Drug Interactions with Warfarin (1.0 contact hours) Universal Activity # 0143-0000-14-005-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B C D
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 eProfile ID #_____________________________ Birthdate ___________________(MM/DD) PHARMACISTS ANSWER SHEET May 2014 — The Clot Thickens: Managing Drug Interactions with Warfarin (1.0 contact hours) Universal Activity # 0143-0000-14-005-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B C D
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 eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
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THE KENTUCKY PHARMACIST
May 2014
Senior Care Corner
Senior Care Corner
from the KPhA Academy of Consultant Pharmacists As part of the dues for the KPhA Academy of Consultant Pharmacists, the Academy will provide five hours of Continuing Education. In consultation with KPhA staff, the Academy is exploring two options:
Academy Officers
1. Offering live activities at two regional events (possibly one in Lexington and one in Louisville) in late summer/ early fall;
Vice Chair — Joey Mattingly
Chair — Chris Miles Director of Organizational Affairs — Julie Owen
2. Developing five hours of home-study activities just for Academy members. This option would require authors to write articles and include a quiz, much like the continuing education articles in The Kentucky Pharmacist. But these articles would only be sent to Academy members.
Director of Public/Professional Affairs — Darren Parks Director of Government Affairs — Leah Tolliver
If you are interested in either of these ideas, please let Julie Owen know at Julie.Owen@pharmerica.com.
Bob & Bob visit DC for NASPA Leadership Conference KPhA PresidentElect Bob Oakley, along with KPhA Executive Director Robert McFalls, attended the 2014 NASPA Leadership Conference in early May to generate ideas to move the Association forward as Bob Oakley transitions to President in June.
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KPhA Pharmacy Emergency Preparedness
May 2014
It’s tornado season! Tornadoes are nature’s most violent storms. They come from powerful thunderstorms. They appear as a funnel, or cone-shaped cloud, with winds that can reach up to 300 miles per hour. They cause damage when they touch
down on the ground. They can damage an area one mile wide and 50 miles long. Before tornadoes hit, the wind may die down, and the air may become very still. They may also strike quickly, with little or no warning.
Before a tornado
After a tornado
Build an emergency kit. Make a family communications plan. Look for the following danger signs: dark, greenish sky large hail large, dark, low-lying cloud loud roar, like a freight train
During a tornado If you are in a building: Go to a safe room such as a basement, cellar, or lowest building level. If there is no basement, go to an inside room like a closet or hallway. Stay away from corners, windows, doors and outside walls. Do not open windows. Put on sturdy shoes. Protect your head. If you are in a trailer or mobile home: Get out immediately and go to the lowest floor of a sturdy nearby building or storm shelter. If you are outside with no shelter nearby: Get into a vehicle and buckle your seatbelt. Put your head down below the windows and cover your head with your hands and a blanket, coat or other cushion. If there is no car or shelter, try to find a ditch or area lower than the ground and lie down. You are safer in a low, flat location than under a bridge or highway overpass.
Wear sturdy shoes or boots. There may be broken glass or nails on the ground that could hurt you if you stepped on it. Never go near or touch dangling or loose power lines. They could electrocute you. Text, don’t talk. Unless there’s a life-threatening situation, if you have a cell phone, send a text so that you don’t tie up phone lines needed by emergency workers. Plus, texting may work even if cell service is down.
Visit ready.gov for more resources on preparing and surviving tornadoes and other natural disasters.
For more Emergency Preparedness Resources, visit www.kphanet.org, click on Resources and Emergency Preparedness. 20
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June 2014 CE — The Bare Bones of Osteoporosis
May 2014
The Bare Bones of Osteoporosis: Prevention, Diagnosis, and Treatment By: Elise A. Albro, PharmD, MPA, Holly L. Byrnes, PharmD, BCPS, and Sarah E. Raake, PharmD Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-14-006-H01-P&T 1.0 Contact Hours (0.10 CEUs)
KPERF offers all CE articles to members online at www.kphanet.org
Goal: To review the available therapies and current treatment guidelines for osteoporosis in males and females as well as glucocorticoid-induced disease. Objectives: At the conclusion of this lesson, the reader should be able to: 1. 2. 3. 4.
Describe the pathophysiology regarding the development of osteoporosis in various patient populations. Explain how to appropriately diagnose osteoporosis. Identify appropriate non-prescription therapies for patients with osteoporosis. Discuss the various treatment options for osteoporosis in terms of indication, mechanism of action, duration of therapy and patient counseling points. 5. Recognize therapies that are appropriate for treatment of osteoporosis in special populations. INTRODUCTION
states and medications.6-7
In 2004 the Surgeon General reported that, “by 2020 half of all Americans over 50 will have weak bones.” 1 There is also the added expectation that the number of individuals over the age of 50 years of age is projected to increase to 121.3 million by the year 2025.2 Most frequently, osteoporosis is associated with elderly white females. The risk of hip fracture in a woman is “equal to her combined risk of breast, uterine and ovarian cancer.”3 Although the incidence and risk is much higher in women, research has shown that the focus should not lie within a single gender. It is estimated that 30 percent of all hip fractures in 2005 occurred in men.2 Following hip fracture, the one year mortality rate in men is said to be 2-fold that of women.3
PATHOPHYSIOLOGY7
The aging U.S. population and data on the prevalence of osteoporosis-related fractures in males should bring to our attention the need for familiarity of both prevention and treatment of this disease for both genders. Osteoporosis: A Brief Overview Osteoporosis is a disorder of the bone characterized by weakened bone tissue, which increases an individual’s risk of fracture.4 Fractures can be due to minimal trauma and are commonly seen in the spine, hip or wrist. 5-6 Peak bone mass is typically reached by the age of 20 years old. Ensuring that children and young adults receive proper nutrients early in life promotes the formation of healthy bone, increasing their peak bone mass.7 Variability in peak bone mass is mostly attributed to genetic factors, however 20 to 40 percent can be explained by other factors such as nutrition, physical activity, smoking status, co-morbid disease
In order to understand the disease of osteoporosis, it is important to be familiar with the basic pathophysiology of the bone. Bone is comprised of both collagen and mineral components. These two components provide bone with its flexibility and rigidity, respectively. A disruption in the balance between these components compromises the quality of bone. As we age, our bones undergo continuous remodeling. This process is not fully understood but it is thought to be triggered by stress, microfractures, biofeedback systems, medications and/or disease states. The cells responsible for bone turnover are called osteoclasts and osteoblasts. Osteoclasts are responsible for resorbing old or damaged bone. Osteoblasts are responsible for the building of bone. Once bone has been rebuilt and mineralization occurs, osteoblasts undergo apoptosis and become osteocytes, which signal for the inhibition of bone formation. Younger individuals typically have greater osteoblast activity, while those who have reached their peak bone mass have equal osteoblast and osteoclast activity. Individuals with osteoporosis typically have greater osteoclast without enough osteoblast activity. RISK ANALYSIS The National Osteoporosis Foundation (NOF) recommends that men and postmenopausal women greater than 50 years of age be assessed for osteoporosis risk. 6 The WHO Fracture Risk Assessment (FRAX) Model was designed to include risk factors that increase an individual’s risk of frac-
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June 2014 CE — The Bare Bones of Osteoporosis Table 1: Risk Factors Included in the WHO Fracture Risk Assessment Tool 9 Current age Current smoking Gender Chronic glucocorticoid use
May 2014 Non-Prescription pies
Thera-
There are a variety of approaches that can be taken Low body mass (BMI) Rheumatoid arthritis to decrease fracture risk and Previous fracture Alcohol consumption (≥3 drinks/day) disease progression. NonParental hip fracture BMD of femoral neck Secondary osteoporosis (causes: type one diabetes mellitus, osteogenesis imperfecta in prescription therapy should include, but not be limited to, adults, untreated long-standing hyperthyroidism, hypogonadism or premature menopause (<45 years), chronic malnutrition or malabsorption and chronic liver disease) adequate intake of calcium and vitamin D, physical acture regardless of Bone Mineral Density (BMD) measures. 8 tivity, smoking cessation and fall prevention. Table 1 includes the factors analyzed in the FRAX CalculaADEQUATE CALCIUM AND VITAMIN D11 tion Tool. This Tool provides both the 10-year risk of any major osteoporotic fracture as well as the risk for hip frac- All individuals should be advised to intake the recommended daily allowance (RDA) of calcium and vitamin D. The ture.9 NOF states that combined supplementation can reduce DIAGNOSIS fracture risk and supports the dietary reference intakes Osteoporosis is diagnosed through the measurement of (DRIs) of calcium and vitamin D provided by the Institute of BMD or the confirmation of a vertebral or hip fracture in an Medicine (IOM).6,11 These recommendations can be found adult that is not due to major trauma (i.e. fall from high dis- in Table 3. Patients should be encouraged to obtain calcitance, car accident). The gold standard for measuring BMD um from dietary sources such as cheese, yogurt, milk, is dual-energy X-ray absorptiometry (DXA). 6-7 Peripheral spinach or fortified cereals. Excessive intake of calcium measurements, done in the forearm, heel or finger, are above 1,200 to 1,500 mg provides little benefit and is indicators of site-specific risk. These machines are often thought to increase an individual’s risk of kidney stones, used for screening in the community at health fairs. Individ- cardiovascular disease and stroke.6 Patients taking calcium uals indicated to have low BMD at these sites should be supplement products should be aware that DRIs are based referred to receive central DXA measurement, preformed upon intake of elemental calcium. Table 4 provides a list of noninvasively on the lumbar spine or hip.6-7 BMD is ex- common over-the-counter calcium products and their elepressed in terms of gram of mineral per square centimeter mental calcium content. Often, calcium supplement prodscanned (g/cm 2). In addition to BMD, an individual’s Z- ucts also contain vitamin D. Vitamin D is important for the score or T-score should be utilized to aid diagnosis. A Z- absorption of calcium. Major sources of vitamin D in the score is determined by comparing BMD to that of an age-, diet include fortified milk and cereals, salt-water fish and gender- and race-matched population. Alternatively, a T- liver. score is a comparison of BMD to a healthy, young populaPatient Counseling tion of the same gender. Based on BMD measurement at the spine, hip or forearm, the WHO has established criteria There are a variety of over-the-counter calcium products for the diagnosis of osteoporosis.10 Table 2 provides these (Table 4). When choosing a calcium supplement, it is important to note the elemental calcium content. Some condefinitions. tain a higher percentage of Table 2: WHO Definition of Osteoporosis Based on Bone Mineral Density (BMD) 10 calcium, allowing patients to Classification T-Score BMD take less of the product. The Normal T-score at -1 and above Within 1 standard deviation of a body can only absorb so young-adult reference populamuch calcium at one time; tion patients should be advised Low Bone Mass T-score between -1 and -2.5 Between 1 and 2.5 standard to divide calcium doses so (Osteopenia) deviations below that of a young-adult reference populaas not to exceed 500-600 tion mg per dose. Osteoporosis T-score at or below -2.5 2.5 standard deviations or Calcium carbonate contains more below that of a youngthe highest percentage of adult reference population elemental calcium and is Severe/Established T-score at or below -2.5 with 2.5 standard deviations or typically inexpensive. CalciOsteoporosis one or more fractures more below that of a youngum carbonate containing adult reference population 22
THE KENTUCKY PHARMACIST
June 2014 CE — The Bare Bones of Osteoporosis
May 2014
that adults engage in 150 minutes of moderate Calcium Vitamin D -intensity aerobic exerRDA (mg/day) Maximum (mg/day) RDA (IU/day) cise and perform regular Adult Women muscle-strengthening 19-50 years old 1,000 2,500 600 activities on 2 or more 51- 70 years old 1,200 2,000 600 days per week.12 Regu> 70 years old 1,200 2,000 800 lar weight-bearing aerobic exercise and muscleAdult Men strengthening activities 19-50 years old 1,000 2,500 600 can improve agility and 51- 70 years old 1,000 2,000 600 balance, reducing the > 70 years old 1,200 2,000 800 risk of falls.6 Exercise * Maximum daily intake of Vitamin D for all groups above is 4,000 units regimens should be tai35 lored to the individual’s level of ability. Table 4: Over-the-Counter Oral Calcium Products Table 3: Institute of Medicine’s Dietary Reference Intakes for Calcium and Vitamin D
Formulation Calcium carbonate
Approximate Elemental Calcium Content (%) 40
Brand Names Tums® Rolaids® Os-Cal® Caltrate 600® Florical® Maalox®
11
SMOKING CESSATION13 Research has shown that smoking is associated with reduced BMD in both males and females. Patients should be encouraged to stop smoking for the sake of bone health and overall well-being. FALL PREVENTION
Patients should be advised to make interventions in the home that may help reduce the risk of falls Calcium acetate 25 Calphron® such as installing handrails and securing loose rugs. Patients also should be advised to have reguCalcium citrate 20 Cal-Citrate® Citracal® (plus lar eye exams and report problems that impair viVitamin D) sion. Hip protectors are available for patients to wear to prevent injury to the hip upon falling. However, these products are typically ill preferred by patients. products must be taken with food to ensure absorption. If patients are unable to take their calcium with food they may Prescription Therapies consider a calcium citrate product, which contains about INDICATIONS FOR TREATMENT6 half the amount of elemental calcium as calcium carbonate The NOF recommends considering treatment in men and but does not have to be taken with food. Calcium acetate postmenopausal women 50 years of age and older who and phosphate products have the additional use for pameet one of the following three criteria: tients with phosphate irregularities. Patients with hyperphosphatemia may be indicated for calcium acetate prod- A history of a hip or vertebral fracture ucts, while patients with hypophosphatemia should consid- T-score less than or equal to -2.5 (measured at the er taking calcium phosphate. femoral neck hip or lumbar spine) Calcium phosphate
39
Posture®
Patients should know how to properly take their calcium supplements to ensure they are meeting the recommended daily intake. In addition, vitamin D consumption/ supplementation is essential for proper calcium absorption. Vitamin D can be obtained naturally in the diet or through sun exposure. Vitamin D also is available over-the-counter as ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3). These products should not be considered equivalent and patients should stick with which ever product their physician has recommended.
Low bone mass (T-score of -1.0 to -2.5) and a 10-year probability of a hip fracture ≥ 3 percent or a 10-year probability of any major osteoporotic fracture of ≥ 20 percent.
BISPHOSPHONATES
Bisphosphonates have the strongest data to support their use in the treatment of osteoporosis. There are four available agents: alendronate, ibandronate, risedronate and zoledronic acid. Bisphosphonates mimic the endogenous bone resorption inhibitor, pyrophosphate, which leads to a PHYSICAL ACTIVITY reduction in osteoclast activity.14-15 All agents in this class The Physical Activity Guidelines for Americans recommend are indicated for both prevention and treatment of osteopo23
THE KENTUCKY PHARMACIST
June 2014 CE — The Bare Bones of Osteoporosis rosis in postmenopausal women. The doses for this indication can be found in Table 5. Some of these agents also are indicated for treatment of glucocorticoid-induced disease or treatment of osteoporosis in males (see special populations section). Alendronate (Fosamax®, Binosto®)
May 2014 36-37
beyond three to five years. Duration of therapy should be decided based on individual presentation. Women, who were removed from alendronate therapy after five years and followed for an additional five years, were found to have significantly lower BMD in the hip but their risk for nonvertebral fractures was not significant. Similarly, discontinuation of zoledronic acid after three years of therapy showed only moderate decline in BMD. However, there was a reduction in the number of vertebral fractures seen.37-38 This suggests benefit in continuing therapy beyond three to five years only in women at very high risk of clinical (symptomatic) vertebral fractures.36-38
Alendronate has been found to reduce the risk of both hip and vertebral fractures by 51 percent and 55 percent respectively.16 It is available in a generic formulation, as both an oral solution and oral tablet. Consumption of the solution should be followed by 2 ounces of water. Binosto ®, an effervescent tablet, should be dissolved in 4 ounces of room temperature water. The patient should be instructed Continuation of bisphosphonate therapy beyond five years to wait ≥ 5 minutes after the effervescent effect stops, stir has been associated with an increased risk of mid-shaft long bone fractures. A small objective study examined the for 10 seconds, then drink. images of atraumatic mid-shaft fractures in individuals who Ibandronate (Boniva®) were on bisphosphonate therapy and proposed that these Oral ibandronate, compared to placebo, has been found to fractures were caused by prolonged suppression of bone reduce the risk of vertebral fractures by almost 50 per- turnover by bisphosphonates. By inhibiting osteoclast accent.17 However, its efficacy in the prevention of non- tivity, bisphosphonates “lead to the accumulation of microvertebral fractures is not as well documented. Ibandronate damage and development of hypermineralized bone.”39 is available generically as an oral tablet. It also is available It is unclear what patients should do after discontinuation as an intravenous solution for injection, which is adminisof bisphosphonate therapy. The Food and Drug Admintered no sooner than every three months. Ibandronate is istration (FDA) has considered the idea of a drug holiday, unique from the other bisphosphonates in that patients takwhere patients would discontinue bisphosphonate therapy ing the oral form should be instructed to remain upright for only to resume therapy at a later date. Currently, there is 60 minutes rather than the general 30 minute recommenno recommendation or data to support the use of drug holidation.18 days with bisphosphonate therapy. There is little evidence Risedronate (Actonel®, Atelvia®) to guide the decisions of who is indicated and what is the Risedronate has been found to reduce the risk of vertebral appropriate duration of a drug holiday.40 fractures by 41 to 49 percent and non-vertebral fractures Patient Counseling by 39 percent.19-20 It is available as an immediate release All oral bisphosphonate tablets should be administered (Actonel®) or as a delayed release tablet (Atelvia®). Unlike with 6 to 8 ounces of water. Patients should be instructed other bisphosphonate formulations, which are to be adminto refrain from eating, taking other medications or lying istered on an empty stomach, the delayed release product down for 30 minutes (60 minutes with ibandronate) after should be administered immediately after breakfast.21 administration. Side effects for oral products are similar, Zoledronic acid (Reclast®, Zometa®) including gastrointestinal disturbances, heartburn, dysphaZoledronic acid is an intravenous-only bisphosphonate. It gia, esophageal erosions and osteonecrosis of the jaw has been shown to be effective at reducing the risk of hip (BLACK BOX). Side effects with intravenous therapy infracture by 41 percent and both vertebral and non-vertebral clude flu-like symptoms, reaction at the injection site, myalfractures by 70 percent and 25 percent respectively. 22 gia and osteonecrosis of the jaw (BLACK BOX). Some patients may prefer this therapy because it is a 15 SELECTIVE ESTROGEN RECEPTOR MODULATORS minute infusion that can be given yearly or once every two (SERMs) years. Patients must be hydrated properly prior to treatment. Pre-treatment with acetaminophen to reduce the Raloxifene (Evista®) is the only agent in this class currentlikelihood of an acute reaction (flu-like symptoms) may be ly approved for prevention and treatment of postmenopausal osteoporosis. It possesses estrogen agonistic properwarranted.23 ties in the bone, which suppresses the formation of osteoDuration of Therapy clasts and promotes osteoclast apoptosis. Raloxifene has Bisphosphonate therapy should not be considered indefi- been shown to reduce the risk of vertebral fracture by 50 nite. Evidence suggests little benefit in continuing therapy percent in patients with no prior history of fracture and 30 24
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May 2014
Table 5: Dosages of Agents Approved for use in Prevention or Treatment of Osteoporosis in Females 35 Dosing for Osteoporosis in Females Bisphosphonates Alendronate (Fosamax®, Fosamax Plus D®, Binosto®) Ibandronate (Boniva®) Risedronate (Actonel®, Atelvia®) Zoledronic acid (Reclast®, Zometa®)
Prevention: 5 mg oral daily or 35 mg oral weekly Treatment: 10 mg oral daily or 70 mg oral weekly + 5,600 IU Vitamin D Prevention: 150 mg oral monthly Treatment: 150 mg oral monthly or 3 mg IV every 3 months Prevention or Treatment: 5 mg oral daily, 35 mg oral weekly (Altevia®), 75 mg on two consecutive days taken once monthly, or 150 mg monthly Prevention: 5 mg IV infusion over 15 minutes every 2 years Treatment: 5 mg IV infusion over 15 minutes yearly
Selective Estrogen Receptor Modulators (SERMs) Raloxifene (Evista®)
Prevention and Treatment of postmenopausal osteoporosis: 60 mg oral daily
Calcitonin Nasal spray (Fortical®, Miacalcin®) Intramuscular injection (Miacalcin®) Parathyroid Hormone Teriparatide (Forteo®)
Treatment of ≥5 years postmenopausal osteoporosis: 200 IU (1 spray) daily Treatment of ≥5 years postmenopausal osteoporosis: 100 IU every other day Treatment of postmenopausal osteoporosis in women at high risk of fracture: 20 mcg subcutaneous daily into thigh/ abdomen
Receptor Activator of Nuclear Factor Kappa B Ligand (RANKL) Inhibitors Denosumab (Prolia®)
Treatment of postmenopausal osteoporosis in women at high risk of fracture: 60 mg subcutaneous every 6 months
Table 6: Dosages of Agents Approved for use in Prevention or Treatment of Glucocorticoid-Induced Osteoporosis in Males and Females34-35 Dosing Bisphosphonates Alendronate (Fosamax®, Fosamax Plus D®, Binosto®) Risedronate (Actonel®, Atelvia®) Zoledronic acid (Reclast®, Zometa®)
Treatment: 5 mg oral once daily or 10 mg oral daily in postmenopausal females not on estrogen replacement therapy Prevention and Treatment: 5 mg oral daily (immediate release tablet, Actonel®) Prevention and Treatment: 5 mg IV infusion over 15 minutes yearly (Reclast®)
Parathyroid Hormone Teriparatide (Forteo®)
Treatment in men and women at high risk of fracture: 20 mcg subcutaneous daily into thigh/abdomen
percent in those with prior vertebral fracture.24 This agent is Patients can take raloxifene without regards to meals. unique in that it also is indicated for risk reduction of invaCALCITONIN sive breast cancer. Calcitonin is available as a nasal spray (Fortical®, MiacalPatient Counseling cin®) as well as a solution for injection (Miacalcin®). It has Patients should be counseled on possible anti-estrogen been shown to decrease the risk of vertebral fracture in side effects such as hot flashes, as well as arthralgia and postmenopausal women with confirmed osteoporosis by 33 flu-like symptoms. Raloxifene has a Boxed Warning for in- percent. It is indicated for the treatment of osteoporosis in creasing the risk of venous thromboembolic disease. It is women who are at least five years postmenopausal. The recommended for patients to discontinue the medication 72 manufactured products are salmon-derived and work by hours prior to long periods of immobilization (e.g. surgery). antagonizing parathyroid hormone (PTH), thereby inhibiting 25
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June 2014 CE — The Bare Bones of Osteoporosis osteoclasts.
May 2014 Denosumab (Prolia®) inhibits RANKL, which is responsible for stimulating the differentiation of hematopoietic stem cells into osteoclasts. It has been shown to reduce the risk of vertebral fractures, hip fractures and non-vertebral fractures by 68 percent, 40 percent and 20 percent respectively.27 Denosumab is given as a subcutaneous injection every six months by a healthcare professional. Hypocalcemia must be corrected prior to starting therapy. Since rapid bone loss can be seen upon discontinuation of therapy, patients who stop receiving denosumab should be placed on alternative therapy.28
Patient Counseling
Patients using the nasal spray should be instructed to store bottles that are not in use in the refrigerator. Before use, the bottle should be allowed to come to room temperature. Priming the bottle five times until a full spray is produced is required upon first use but not prior to each use. Patients should administer one spray into a single nostril once daily and the nostril used should be alternated on a daily basis. Once opened; a bottle is good for 30 days. It is important to note that patients can experience anaphylaxis from this Patient Counseling product. Other common side effects include epistaxis, rhiniCommon side effects of denosumab include nausea, vomittis, nasal irritation and taste disturbance. ing, diarrhea, back or limb pain. Less common but serious The injectable product is administered every other day eiside effects include osteonecrosis of the jaw, pancreatitis, ther intramuscularly or subcutaneously, with the subcutaskin rash and increased risk for infections (e.g. endocardineous route preferred for patients self-administering. Patis, cellulitis). tients may experience reactions at the site of injection as ESTROGEN OR HORMONE REPLACEMENT THERAPY well as some flushing, nausea or vomiting.
Estrogen replacement therapy (ERT) is approved for the prevention of osteoporosis in postmenopausal women. Women with an intact uterus should receive combination hormone replacement therapy (HRT) with both estrogen and progestin, as progestin is necessary in these patients to prevent the risk of endometrial hyperplasia. The Woman’s Health Initiative (WHO) found that hormone therapy decreased the risk of hip fractures by 34 percent and other osteoporosis-related fractures by 23 percent. This study also showed a significant increase in the risk of myocardial infarction, venous thromboembolism, stroke and breast cancer.29 Risks versus benefits should be carefully weighed in patients who are being considered for estrogen or hormone replacement therapy and osteoporosis should not be the sole indication for therapy.
PARATHYROID HOROME (PTH)
Teriparatide (Forteo®) is a recombinant parathyroid hormone analogue, which means it stimulates osteoblast function and increases intestinal and renal absorption of calcium. Teriparatide actually helps to build or rebuild bone rather than just preventing the breakdown. Upon discontinuation of teriparatide, rapid bone loss can be seen. 25 Teriparatide is likely most useful when used initially to rebuild bone in patients with low BMD. These patients are then switched to an alternate therapy to maintain bone. Teriparatide has been shown to reduce the risk of veretebral fractures by 65 percent and non-vertebral fractures by 53 percent in postmenopausal women with prior fracture history.26 Teriparatide is not currently available as a generic formulation and is only available as a solution for subcutaneous injection. Treatment duration with teriparatide should al- Special Populations ways be limited to 24 months. OSTEOPOROSIS IN MALES Patient Counseling The teriparatide solution should be stored in the refrigerator (not the freezer). Injections should be administered subcutaneously into the thigh or abdomen. First administration should occur while the patient is in a seated position in the event orthostasis occurs. Patients can experience side effects such as nausea, vomiting, headache, dizziness and leg cramps. Teriparatide has a Boxed Warning for increased risk of osteosarcoma, therefore it is important that patients with additional risk factors such as radiation exposure or other diseases of the bone (e.g. Paget’s) know they are contraindicated for this therapy.
Men are considered to have a much lower risk for osteoporosis due to larger bone size, greater peak bone mass and lower incidence of falls.30 Though the risk for falls may be considered lower in males, their mortality rate associated with fractures is twice that of women.3 Men typically present with osteoporosis due to secondary causes (e.g. medications, co-morbid conditions) and hypogonadism is the most common cause for young and middle-aged men.
It is important to be familiar with disease states which predispose males to osteoporosis such as: testosterone deficiency, type one diabetes mellitus, inflammatory bowel disease, hyperparathyroidism, chronic kidney disease, maligRECEPTOR ACTIVATOR OF NUCLEAR FACTOR KAPPA nancies, chronic obstructive pulmonary disease or stroke. B LIGAND (RANKL INHIBITOR) There also are several medications that can put males at 26
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June 2014 CE — The Bare Bones of Osteoporosis
May 2014
increased risk, including glucocorticoids, anticonvulsant CONCLUSION therapy, cytotoxic chemotherapy, antiretroviral therapy, With the advancing age of the U.S. population, osteoporoprolonged use of proton pump inhibitors and gonadotropinsis is a growing concern that does not discriminate by genreleasing hormone (GnRH) agonists or antagonists. der. Although, more prevalent in females, morbidity and Screening for osteoporosis is recommended for all men mortality in males is 2-fold higher.3 There are several treatover 70 years of age. Indications for treatment in males are ment options that exist to help mitigate the negative effects the same as those for postmenopausal females (see Indi- of the disease. It is important for pharmacists to differentications for Treatment section above).6 ate between osteoporosis in females versus osteoporosis in males, or glucocorticoid-induced disease. An under35 Treatment standing of the various treatments including how they work, Therapies indicated for the treatment of primary osteoporo- how they are administered and what adverse effects are to sis in males include bisphosphonates (alendronate and be expected can lead to selection of the best treatment for risedronate), parathyroid hormone and denosumab the individual. (Prolia®). Denosumab also has the additional indication of References: treatment of osteoporosis in males due to androgen ablation for the treatment of prostate cancer. Doses for treat- 1) US Department of Health and Human Services. Bone ment of osteoporosis in males are the same as those used Health and Osteoporosis: A Report of the Surgeon in females. General. Available at http://www.surgeongeneral.gov/ library/reports/bonehealth. Accessed Sept. 24, 2013. As mentioned previously, the most common cause of oste2) Burge R, Dawson-Hughes B, Solomon DH, Wong JB, oporosis in young and middle-aged males is hypogonadism King A, Tosteson A. Incidence of Economic Burden of or testosterone deficiency. Testosterone is indicated for the Osteoporosis-Related Fractures in the United States, treatment of hypogonadism and may benefit men with oste2005-2025. Journal of Bone and Mineral Research. oporosis secondary to this condition. However, testos2007; 22: 465-475. terone therapy alone is not indicated for the treatment of 3) National Osteoporosis Foundation. Strong Voices for osteoporosis. Strong Bones. Available at http://www.nof.org/files/nof/ GLUCOCORTICOID-INDUCED OSTEOPOROSIS public/content/file/63/upload/49.pdf. Accessed Sept. 24, 2013. “Glucocorticoids are the most common secondary cause of 4) National Osteoporosis Foundation. What is Osteoporoosteoporosis and the third most common cause of osteopo31 sis? Available at http://www.nof.org/articles/7. Acrosis overall.” Glucocorticoids cause decreased bone forcessed Sept. 24, 2013. mation through promotion of osteoblast apoptosis and in5) Barrett-Conner E. The economic and human costs of crease bone resorption by increasing RANKL, which proosteoporotic fracture. Am J Med. 1995; 98: 3S-8S. motes production of osteoclasts. They also have the ability 6) National Osteoporosis Foundation. Clinician’s Guide to to reduce estrogen and testosterone levels and cause dePrevention and Treatment of Osteoporosis. Washingcreased intestinal absorption of calcium and increased uriton, DC: National Osteoporosis Foundation; 2010. nary calcium excretion. Risk for osteoporosis with glucocorAvailable at http://nof.org/files/nof/public/content/ ticoid therapy is dose and time dependent. Bone loss is file/344/upload/159.pdf. Accessed Sept. 24, 2013. more rapid in the first few months of therapy, accounting for 7) O’Connell MB, Vondracek SF. Osteoporosis and Other 10 to 15 percent of bone lost. After the first few months, 32 Metabolic Bone Diseases. In: DiPiro JT, Talbert RL, bone loss is at a rate of 2 to 5 percent per year. Yee GC, Matzke GR, Wells BG, Posey LM, eds. PharTreatment macotherapy: A Pathophysiologic Approach. 8th ed. New York, NY: McGraw-Hill; 2011:1559-1581. All patients receiving an equivalent dose of 5 mg of predni8) Cooper C, Melton LJ. Epidemiology of osteoporosis. sone for a period of six months or greater should receive a Trends Endocrinol Metab. 1992;3(6):224-229. baseline BMD scan. These patients also should be started 9) World Health Organization Collaborating Centre for on calcium and vitamin D supplementation. Therapies apMetabolic Bone Diseases. FRAX® WHO Fracture Risk proved for the treatment of glucocorticoid-induced osteopoAssessment Tool. Calculation Tool. Available at https:// rosis include bisphosphonates (except ibandronate) and www.shef.ac.uk/FRAX/tool.aspx?country=9. Accessed parathyroid hormone (teriparatide). Table 6 shows the dosSept. 24, 2013. es for these agents as indicated for the treatment of gluco33-34 10) Kanis JA, Melton III LJ, Christiansen C, Johnston CC, corticoid-induced osteoporosis. 27
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Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res. 1994;9(8):1137-1141. Institute of Medicine of the National Academy of Sciences. Dietary reference intakes for calcium and vitamin D. 2010. Available at www.iom.edu/vitaminD. Accessed Sept. 25, 2013. U.S. Department of Health and Human Services. Physical activity guidelines for Americans. 2008. Available at www.health.gov/paguidelines. Accessed Sept. 25, 2013. Hollenbach KA, Barrett-Conner E, Edelstein SL, Holbrook T. Cigarette Smoking and Bone Mineral Density in Older Men and Women. American Journal of Public Health. 1993; 83(9): 1265-1270. O’Connell MB, Vondracek SF. Osteoporosis and Other Metabolic Bone Diseases. Bisphosphates. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York, NY: McGraw-Hill; 2011:1571 -1573. Lexi-Comp Online™, Alendronate, Hudson, Ohio: Lexi -Comp, Inc. Accessed Sept. 25, 2013 Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996; 348: 1535-1541 Chesnut III CH, Skag A, Christiansen C. et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004; 19:1241-1249. Lexi-Comp Online™, Ibandronate, Hudson, Ohio: LexiComp, Inc. Accessed Sept. 25, 2013 Harris ST, Watts NB, Genant HK. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. JAMA. 1999;282:1344-1352. Reginster J, Minnie HM, Sorensen OH, et al. Randomized trail of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int. 2000;11:83-91. Lexi-Comp Online™, Risedronate, Hudson, Ohio: Lexi -Comp, Inc. Accessed Sept. 25, 2013 Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Eng J Med. 2007;356(18):1809-1822. Lexi-Comp Online™, Zoledronic Acid, Hudson, Ohio: Lexi-Comp, Inc. Accessed Sept. 25, 2013 Ettinger B, Black DM, Mitlak BH. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year ran-
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domized clinical trial. Multiple outcomes of raloxifene evaluation (MORE) Investigators. JAMA. 1999;282 (7):637-645. Lexi-Comp Online™, Teriparatide, Hudson, Ohio: Lexi -Comp, Inc. Accessed Sept. 25, 2013 Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19): 1434-1441. Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361(8): 756-765. Lexi-Comp Online™, Denosumab, Hudson, Ohio: Lexi -Comp, Inc. Accessed Sept. 25, 2013 Rossouw JE, Anderson GL, Prentice RL, et al; Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal of results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333. Seeman E, Bianchi G, Khosla S, et al. Bone fragility in men—Where are we? Osteoporos Int 2006;17 (11):1577–1583. Mazziotti G, Angeli A, Bilezikian JP, et al. Glucocorticoid-induced osteoporosis: An update. Trends Endocrinol Metab. 2006;17(4):144–149. Jehle PM. Steroid-induced osteoporosis: how can it be avoided? Nephrol Dial Transplant. 2003;18(5): 861864. American College of Rheumatology Task Force on Osteoporosis Guidelines. Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 1996;39(11):1791–1801. Recommendations for the prevention and treatment of glucocorticoid- induced osteoporosis: 2001 update. American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis. Arthritis Rheum. 2001;44(7):1496–1503. Lexi-Comp Online™, Hudson, Ohio: Lexi-Comp, Inc. Accessed Sept. 25, 2013 Black DM, Bauer DC, Schwartz AV, Cummings SR, Rosen CJ. Continuing bisphosphonate treatment for osteoporosis—for whom and for how long? N Engl J Med.2012;366(22):2051-2053. Black DM, Schwartz AV, Ensrud KE, et al; FLEX Reasearch Group. Effects of continuing or stopping alendronate after 5 years of treatment: The Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. 2006;296(24):2927-2938. Black DM, Reid IR, Boonen S, et al. The effect of 3 versus 6 years of zoledronic acid treatment in osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res 2012;27:243-
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54. 40) Diab DL, Watts NB. Bisphosphonate drug holiday: who, when and how long. Ther Adv Musculoskelet Dis 39) Odvina CV, Levy S, Rao S, Zerwekh JE, Rao DS. Unu2013;5(3):107-11. sual mid-shaft fractures during long-term bisphosphonate therapy. Clin Endocrinol 2010;72(2):161-8.
June 2014 — The Bare Bones of Osteoporosis: Prevention, Diagnosis, and Treatment 1. What is the best approach to diagnosing a patient with osteoporosis? A. Obtain a peripheral DXA scan. B. Obtain an X-ray of the spine. C. Obtain a central DXA scan. D. Obtain serum calcium levels.
such as hot flashes. 6. Which therapy is indicated for prevention of osteoporosis? A. Denosumab B. Calcitonin C. Teriparatide D. Zoledronic acid
2. LH is a 65 year old female with a T-score of -1.7 as determined by a central DXA scan. How would you classify LH? A. Normal B. Osteopenia C. Osteoporosis D. Severe Osteoporosis
7. Treatment of postmenopausal osteoporosis with teriparatide should be limited to which duration of therapy? A. 28 days B. 12 months C. 24 months D. 5 years
3. SM is a 54 year old female who presents to your pharmacy stating that her doctor told her to start taking calcium and vitamin D. What is SM’s reference dietary intake of calcium and vitamin D? A. 1,000 mg calcium; 600 IU vitamin D B. 1,000 mg calcium; 800 IU vitamin D C. 1,200 mg calcium; 600 IU vitamin D D. 1,200 mg calcium; 800 IU vitamin D
8. Which of the following is an appropriate counseling point for a patient using calcitonin nasal spray? A. Prime the bottle prior to every use. B. Do not refrigerate bottles. C. Alternate nostrils on a daily basis. D. Each bottle is only good for 7 days.
9. Which therapy is indicated for the treatment of primary osteoporosis in males? A. Ibandronate 4. What is the mechanism of action of bisphosphonates? B. Calcitonin A. Stimulates bone formation by binding estrogen receptors. C. Raloxifene B. Decreases osteoclast maturation and lifespan. D. Denosumab C. Stimulates bone formation by increasing calcium absorption. 10. Which statement is correct regarding the mechanism by D. Increases osteoblast activity and lifespan. which glucocorticoids induce osteoporosis? A. Glucocorticoids lead to increase estrogen levels. 5. HL is a 65 year old female who has been recently diagB. Glucocorticoids increase bone resorption by increasing nosed with osteoporosis. Her doctor has written her a preRANKL. scription for alendronate 70 mg by mouth once weekly. Which C. Glucocorticoids decrease bone formation by osteoblast statement is correct regarding alendronate? production. A. It should be taken just before the patient goes to bed to D. Glucocorticoids cause increased intestinal absorption of keep her from feeling sick. calcium. B. She should take it with a full glass of water with her first bite of breakfast. C. She should avoid taking other medications for at least 30 minutes after taking. D. Taking this medication may worsen vasomotor symptoms
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June 2014 CE — The Bare Bones of Osteoporosis
May 2014
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: May 10, 2017 Successful Completion: Score of 80% will result in 1.0 contact hour or 0.10 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. June 2014 — The Bare Bones of Osteoporosis: Prevention, Diagnosis, and Treatment (1.0 contact hours) Universal Activity # 0143-0000-14-006-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B C D
9. A B C D 10. A B C D
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) PHARMACISTS ANSWER SHEET June 2014 — The Bare Bones of Osteoporosis: Prevention, Diagnosis, and Treatment (1.0 contact hours) Universal Activity # 0143-0000-14-006-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B C D
9. A B C D 10. A B C D
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
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Kentucky Renaissance Pharmacy Museum
May 2014
The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration.
Friend of the Museum $100 Proctor Society $250 Damien Society $500 Galen Society $1,000 Name______________________________________ Specify gift amount________________________ Address ____________________________________ City____________________Zip______________ Phone H____________________W________________ Email___________________________________ Employer name_____________________________________________________for possible matching gift. Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually.
Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com
For more information on the museum, see www.pharmacymuseumky.org or contact Gloria Doughty at g.doughty@twc.com or Lynn Harrelson at lharrelsonky@aol.com.
Pharmacy Time Capsules 2014 (Second Quarter) 1989 The Medicare Catastrophic Act of 1988 was resoundingly repealed after disclosures that insurance coverage could be bought on the open market for a fraction of the surtax imposed by the government, Epogen (Amgen) the first recombinant human erythropoetin product approved by the FDA for marketing. 1964 Surgeon General Luther Terry made an announcement that cigarette smoking causes lung cancer and probably heart disease.
By: Dennis B. Worthen, PhD, Cincinnati, OH
1939 Joseph Lynch, a 1927 Fordham College of Pharmacy alumni, who became a police office, was killed disarming a bomb set by Nazi saboteurs at the World’s Fair in Flushing Meadows. World War II starts, Germany invades Poland. 1914 West Virginia University establishes its College of Pharmacy. Franz Ferdinand, Archduke of Austria, and his wife are assassinated in Sarajevo by a Serbian nationalist, the justification of World War I.
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One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org
THE KENTUCKY PHARMACIST
KPhA New and Returning Members
May 2014
KPhA Welcomes New and Renewing Members March-April 2014 Frankie Abner Barbourville
Mildred Cook Tyner
Chris Harlow Louisville
Elaine Adams Crestwood
John Curry Louisville
Jordan Harp Bowling Green
Cassandra Beyerle Louisville
Judith Davenport Louisville
Julie Hawkins Pewee Valley
Stephen Blanford Louisville
Holly Divine Versailles
Jonathan Hayes Louisville
Nick Boggess Flatwoods
Kristie Doan Louisville
Joseph Hays Smiths Grove
Diana Bowles Sonora
Mellessia Driver Providence
Paula Hieneman Ashland
Michael Branstetter Glasgow
Gerald Durr Crescent Springs
Stephen Hill Stanford
Kathryn Breeze Lexington
William Farrell Ft. Mitchell
Janet Hodge Louisville
Larry Bright Campbellsville
Brooke Feltner London
Melissa Hudson Louisville
Dana Burns Florence
Jamie Ferrell Lancaster
Jennifer Ihrig Hebron
Julie Burris Louisville
Joseph Fink Lexington
Karen Jackson Paducah
Bill Burton Newburgh Ind.
Maureen Fink Lexington
Scott King Hazard
Quint Butler Munfordville
Suzanne Francis Florence
Steven King Bloomfield
James Carrico Louisville
Reed Ginn Cerulean
Darren Lacefield Bowling Green
Matt Carrico Louisville
Shirley Good Hopkinsville
Jane Lacefield Bowling Green
BC Childress Shelbyville
Karen Groce Byrdstown Tenn.
Bruce Lafferre Louisville
Andraya Clark Vine Grove
Joan Haltom Danville
Sarah Lawrence Louisville
Sharon Clouse Glasgow
George Hammons Barbourville
Thomas Lawrence Carlisle
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MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession! Michelle Loos Covington Julie Losch Bowling Green Philip Losch Bowling Green Claire Love Lexington James Marshall Leitchfield Joseph Mashni Florence Sunni Mauk Paducah John McClanahan Ashland Jack McGuire Louisville Michael McQuade Edgewood Pamela Moore Campbellsville Theresa Mullins Hindman
THE KENTUCKY PHARMACIST
KPhA New and Returning Members
May 2014
Julie Oestreich Lexington
Adam Robinson Brandenburg
Andrea Spaulding Burlington
Wendy Underwood Horse Cave
Jeffrey Osman Lexington
Barry Rose Clay City
Samuel Verenna Louisville
Julie Owen Louisville
Melody Ryan Lexington
Sally Stiltner Berea Veronica Stith Vine Grove
Angela Parrett Simpsonville
Kent Shearer Albany Catherine Shely Morehead
Chad Phelps Greensburg
J. Eddie Sutton London Neil Taylor Hardinsburg
Richard Slone Hindman
Amy Thompson Lawrenceburg
Zena Slone Hindman
Angela Tracy Louisville
Ronald Renfrow Bowling Green
Luther Smith Beattyville
Elizabeth Traxel Maysville
Felix Reynolds Lancaster
Rosemary Smith Beattyville
Steven Treadway Elizabethtown
Betty Ritchie Jeff
Edwin Snider Louisville
Michael Tucker Louisville
Stephen Pollock Prospect Myra Ray Smiths Grove
William Wagers Berea Amie Weber Florence Jack Wikas Cold Spring Samuel Willett Mayfield Carol Wills Lexington Scott Yates Russellville
Know someone who should be on this list? Ask them to join YOU in supporting YOUR KPhA!
Nominate your peers for a new feature in The Kentucky Pharmacist We are looking for members to profile in coming editions of The Kentucky Pharmacist who are making the world a better place. Do you know someone who goes above and beyond the â&#x20AC;&#x153;above and beyond the call of dutyâ&#x20AC;?? Let us know! Email Scott Sisco at ssisco@kphanet.org with a brief description of the story or to schedule a time to discuss.
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THE KENTUCKY PHARMACIST
Government Affairs/KPPAC
May 2014
2013 KPhA Government Affairs Fund Contributors KPhA Members contributed $10,170 to the Government Affairs Fund in 2013 to support the Associationâ&#x20AC;&#x2122;s lobbying efforts on YOUR behalf in Frankfort and Washington, DC. YOUR KPhA acknowledges the support from those listed below, and encourages YOU to add your name to the list for 2014!. Individuals and businesses may contribute.
Board Supporters ($1,500+)
Sliver Supporters ($499-$365)
Richard Slone Matt Carrico Leon & Margaret Claywell
Chris Killmeier
Diamond Supporters ($1,000-$1,499) Ben Scott
Gold Supporters ($999-$500) Clay Rhodes Duane Parsons George Hammons
Bronze Supporters ($364-$200) Members (No Minimum Pledge) William Conyers Kimberly Croley Leah Tolliver Joe Carr Tom Houchens
Cassandra Beyerle Randall Young Vance Smith Sandra Anderson Mary Thacker Glen Stark John Lutz Vince Peak Eugene Riley Robert Stone Pamela K. Wright CD Peterson G. Timothy Armstrong Julie Owen Patrick Noonan
Be sure to read the recap of the 2014 Kentucky General Assembly on Page 9. Groundwork was completed, but much more remains for 2015 and beyond!
2013 Kentucky Pharmacists Political Advisory Council Contributors The Kentucky Pharmacists Political Advisory Council collected $10,900 in 2013, funds which were used to support candidates in Kentucky who are friendly to pharmacy issues. The members of the KPPAC board thank the contributors and encourage YOU to add your name for 2014. Only individuals can donate up to $1,500 a year to ALL PACs. This is an election year, and candidates have already begun approaching KPPAC for support. Help KPPAC
Support the Candidates who Gold Supporters support Pharmacy in Frank- ($999-$500) fort! Sam Willett Duane Parsons Ron Poole Board Supporters William Wheeler ($1,500) George Hammons Richard & Zena Slone Matt Carrico James Carrico Silver Supporters Leon Claywell ($499-$365)
Diamond Supporters $1,000-$1,499) Patricia Thornbury Donald Riley Earnest Watts
Bronze Supporters
Tony Turner Kimberly Croley
Members (No Minimum Pledge) Ethan Klein Jacob Hutti Andrew Goble Chris Killmeier Rick Matthews Cassy Beyerle Gloria Doughty
($364-$200) Matt Martin Tom Houchens Jackson Mac Bray Crystal Keaton 34
THE KENTUCKY PHARMACIST
Government Affairs/KPPAC
May 2014
KPhA Government Affairs Contribution Name: _______________________________Pharmacy: _____________________________
Email: ______________________________________________________________ Address: _____________________________________________________________ City: ___________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs)
Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601
Kentucky Pharmacists Political Advocacy Contribution Form Name: _________________________________ Pharmacy: ___________________________ Address: _______________________ City: ________________ State: _____ Zip: ________ Phone: ________________ Fax: __--_______________ E-Mail: __________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)
Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601
CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election. Individuals may contribute no more than $1,500 per year to all PACs in the aggregate. In-kind contributions are subject to the same limits as monetary contributions.
Cash Contributions: $50 per contributor, per election. Contributions by 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)
136th KPhA Annual Meeting and Convention June 5-8, 2014 Griffin Gate Marriott, Lexington, KY 35
THE KENTUCKY PHARMACIST
Pharmacy Law Brief
May 2014
Pharmacy Law Brief: Tattoos and Piercings at Work Author: Peter P. Cohron, B.S.Pharm., J.D., Practicing pharmacist and attorney, Henderson, Ky. Question: I’m increasingly seeing applicants for positions, pharmacy students and even pharmacists, with tattoos and piercings. I’m concerned about how my more mature patients might react to that. Do such bodily embellishments fall under “Freedom of Speech” or “Freedom of Expression?” Is there some Constitutional right associated with this? If I were to hire someone with those adornments may I establish appearance standards such as covering the tattoos and removing the piercings while at work? And finally, does it make a difference whether I inform the employee of my standards and expectations before hiring or is it okay to do so after hiring? Response: For decades, employers have enjoyed an almost unfettered right to force employees to cover up any type of piercing or tattoo the employer judged offensive in the workplace. Whatever the employer considered inappropriate was simply not permitted. Employees had to find a means to cover up the offending tattoo or else be terminated.
Submit Questions: jfink@uky.edu Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information. service of the country. The right to freedom of expression exercised by protesters at the funeral service, the Court continued, may permit displays that may be abhorrent to the majority of society.
In the ensuing employment cases, courts followed the ruling in the Westboro case. Employees with a legitimate claim that their body art is an expression of deeply held beliefs may neither be terminated nor forced to hide their body art. In the most recent cases, where employers have turned back to the undue burden and financial harm tests used in such cases in the past, courts have refused to throw these defenses out, but they have substantially raised the bar for such a claim to prevail. Though courts have not stated the amount of financial harm that must be suffered before termination is permissible, courts hint that Two factors led to a resurgence of employees who have the damage must be almost disastrous. sought to have the right to be employed without having to hide their body art. The first arose out of post-9/11 cases The result of all this is that today employers must use exwhere Muslim women were being terminated for wearing treme caution in hiring and firing persons with piercings and traditional headwear. Courts unanimously supported the tattoos, as well as placing restrictions on the exposure of women, holding that the religious requirement could not be such with existing workers. Many corporate employers have successfully met this challenge with uniform dress codes factored into employment. for all employees. The second was the US Supreme Court’s 2011 decision in Snyder v Westboro Baptist Church. In this seemingly unre- Certain types of tattoos remain subject to employer related case, the court held that the Constitutional freedom of strictions. Examples include words of a sexual nature and expression trumps even the funeral of a soldier killed in the racial epithets. Art that includes nudity or graphic sexual Over time, this ability to force employees to cover up body art has been addressed in the courts, which laid down the “undue burden” or “financial harm” test. Employers were then required to show that the body art created an unfriendly or unwelcome environment that actually caused financial harm to the business, that it was an undue burden on the business to keep these employees in the workplace. Where this could be done, employees could be terminated with cause. This standard held for years, and the courts were generally favorable to employers.
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THE KENTUCKY PHARMACIST
Kelli Sheets leaves KPhA
May 2014
acts similarly may be subject to employer restrictions. So, today it is difficult to terminate an employee for body art or piercings the employer deems offensive to the customer clientele. Some constitutional rights may be contracted away if the return (in this case, employment) is satisfactory; in pre-employment interviews, make the job applicant aware of the employerâ&#x20AC;&#x2122;s policy. With existing employees, discuss the issue with the employee. Do not hesitate to speak to an employment attorney if the employee balks at your request to cover up body art or remove piercings. Currently, this issue can be a minefield.
KPhA Office Manager Kelli Sheetsâ&#x20AC;&#x2122; last day at KPhA was May 15, as she returned to a position with the state. KPhA wishes Kelli a successful future and thank her for her service to our members. We will miss her!
Are you connected to YOUR KPhA? Join us online!
Facebook.com/KyPharmAssoc
@KyPharmAssoc @KPhAGrassroots
KPhA Company Page
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THE KENTUCKY PHARMACIST
Pharmacy Policy Issues
May 2014
PHARMACY POLICY ISSUES:
Modernized Medicare DME Effects Author: Sydney M. Otis is a second year Pharm.D. student at the UK College of Pharmacy. A native from Edgewood, Ky., she obtained a B.A. in Chemistry at Eastern Kentucky University prior to beginning pharmacy school. Issue: The government’s role in health care is changing. Sometimes regulations are difficult to understand, including recent Medicare changes. How have modernized Medicare DME programs changed the way many pharmacies handle prescriptions billed to Medicare for DME? Discussion: On July 1, 2013, the Medicare DME Competitive Bidding Program enacted as part of the Medicare Modernization Act of 2003 (MMA) expanded to more regions of the country and the National Mail-Order Program took effect.1 The National Mail-Order Program requires the use of a national contracted Medicare mail-order supplier for diabetic supplies delivered to patients’ homes.2 Medicare also pays “lower, but more accurate prices for medical equipment and supplies” than under the old system.1 The specific formula used to determine the reasonable charge is outlined in 42 C.F.R. §410.152. Compared to previous billing methods, pharmacies are receiving less reimbursement. Prescriptions billed through Medicare DME have more requirements than an average prescription. The following components are needed to make a written order complete: the patient’s name, the DME ordered, prescriber’s signature and NPI number, date of the order, proper instructions and diagnosis code.3 Forgotten diagnosis codes are an inconvenience to both pharmacists who must contact the prescriber, and patients who must wait for the prescriber to send over a completed order. This causes patients to become frustrated with both the pharmacy staff and the insurance plan. Patients may be asked to keep a testing log of their blood glucose levels when maximum quantities of supplies are exceed in a given time period. These logs must be turned in to the pharmacy and added to the patient’s file. Non-insulin-dependent patients are allotted a maximum quantity of 100 test strips every 90 days whereas insulin-dependent patients are allowed to obtain a maximum quantity of 100 test strips every 30 days. 4
from the patient in order to bill a claim. A copy of the patient’s Medicare card also is required.5 A signed AOB form means the patient agrees for Medicare to pay the pharmacy based on coverage that Medicare determines.1 The pharmacy agrees to accept payment from Medicare and to bill the patient no more than 20 percent of his or her deductable.5 This form is not submitted when filing a claim with Medicare, but a pharmacy audited by Medicare must be able to present the signed AOB form. If the form is not completed correctly, Medicare can determine the claim to be an overpayment by Medicare.5 More strict Medicare laws were enacted to prevent Medicare fraud. Fraud refers to when Medicare is billed for services/supplies the patient never received.6 On the other hand, doctors or suppliers “not following good medical practices leading to unnecessary costs, improper payment or services that are not medically necessary” is referred to as Medicare abuse.6 Though Medicare DME changes might be an inconvenience, these new changes are ultimately for the overall benefit of our healthcare system. Over the past five years, Medicare has recovered about $10 billion in fraudulent charges.6 The CMS Office of Actuary has estimated a savings of $25.7 billion between 2013 and 2022 for the Medicare B program.7 Overall, this reduction has occurred without negatively affecting patients’ access to necessary supplies.7 This serves as a reminder to pharmacists of the important role we play in the healthcare system as we try to promote good health and decrease health care costs. References
Pharmacies are required to create a patient file and obtain 1. The Official U.S. Government Site for Medicare [homepage on the internet]. Baltimore: Centers for a signed and dated Assignment of Benefits (AOB) form
Have an Idea?: This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome. Please send them to jfink@uky.edu. 38
THE KENTUCKY PHARMACIST
May 2014
The Kentucky Pharmacist online
2. 3. 4. 5.
Medicare and Medicaid Services; DME Competitive dmeposcompetitivebid/. Bidding Program; [cited 2013 Oct 20]. Available from 6. Stop Medicare Fraud [homepage on Internet]. Washhttp://www.medicare.gov/what-medicare-covers/part-b/ ington DC: U.S. Department of Health & Human Serdurable-medical-equipment-bidding.html vices [cited 2013 Oct 20]. What is Medicare fraud; 42 C.F.R. ยง414.411 Available from http://www.stopmedicarefraud.gov/ aboutfraud/index.html 42 C.F.R. ยง410.38(g) 7. Competitive Bidding Update: One Year Implementahttp://www.medicare.gov/pubs/pdf/11022.pdf tion Update Centers for Medicare and Medicaid SerCenters for Medicare and Medicaid Services vices. Centers for Medicare and Medicaid Services. [homepage on Internet]. Baltimore: CMS; [updated 2012 April 17 [cited 2013 Oct 20]; Available from http:// 2013 July 3; cited 2013 Oct 20]. DMEPOS Competitive www.cms.gov/Medicare/Medicare-Fee-for-ServiceBidding; Available from http://www.cms.gov/Medicare/ Payment/DMEPOSCompetitiveBid/Downloads/ Medicare-Fee-for-Service-Payment/ Competitive-Bidding-Update-One-YearDMEPOSCompetitiveBid/index.html?redirect=/ Implementation.pdf
The Kentucky Pharmacist is online! Go to www.kphanet.org, click on Communications and then on The Kentucky Pharmacist link.
Would you rather receive the journal electronically? Email ssisco@kphanet.org to be placed on the Green list for electronic delivery. Once the journal is published, you will receive an email with a link to the online version.
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THE KENTUCKY PHARMACIST
May 2014
Pharmacists Mutual
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THE KENTUCKY PHARMACIST
Cardinal Health
May 2014
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THE KENTUCKY PHARMACIST
KPhA Board of Directors/Staff
May 2014
KPhA BOARD OF DIRECTORS
HOUSE OF DELEGATES
Kimberly Croley, Corbin kscroley@yahoo.com
Chair 606.304.1029
Cassandra Beyerle, Louisville cbeyerle01@gmail.com
Duane Parsons, Richmond dandlparsons@roadrunner.com
President 502.553.0312
Ethan Klein, Louisville kleinethan@gmail.com
Bob Oakley, Louisville Boakley@BHSI.com
President-Elect 502.897.8192
KPERF ADVISORY COUNCIL
Frankie Hammons Abner, Barbourville frankiehammons@gmail.com
Secretary 606.627.7575
Glenn Stark, Frankfort glennwstark@aol.com
Treasurer
Ann Amerson, Lexington amerson@insightbb.com
Ron Poole, Central City ron@poolespharmacycare.com
Past President
KPhA/KPERF HEADQUARTERS
Directors Heather Bryan, Mt. Washington Sullivan University hcarby8529@my.sullivan.edu Student Representative Matt Carrico, Louisville matt@boonevilledrugs.com Chris Clifton, Villa Hills chrisclifton@hotmail.com
Vice Speaker of the House
Kim Croley, Corbin kscroley@yahoo.com
1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org
Trish Freeman, Lexington trish.freeman@uky.edu Brooke Herndon, Louisville brhe226@uky.edu
Speaker of the House
University of Kentucky Student Representative
Chris Killmeier, Louisville cdkillmeier@hotmail.com Jeff Mills, Louisville* jeff.mills@nortonhealthcare.org Chris Palutis, Lexington chris@candcrx.com Richard Slone, Hindman richardkslone@msn.com Mary Thacker, Louisville mary.thacker@att.net Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee
Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org
KPhA sends email announcements weekly. If you arenâ&#x20AC;&#x2122;t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list. 42
THE KENTUCKY PHARMACIST
50 Years Ago/Frequently Called and Contacted
May 2014
50 Years Ago at KPhA SCHULTEN SUCCEEDS ARNOLD Maxwell Schulten of Louisville has been appointed Treasurer of the Kentucky Pharmaceutical Association succeeding J.P. Arnold of Franklin, who resigned. For many years, Schulten was treasurer of the old Louisville Retail Druggists Association. In 1948 he was appointed a member of the Kentucky Board of Pharmacy and served on the Board for five years, the last year serving as President. He is a graduate of the University of Kentucky College of Pharmacy, Class of 1931. He became a registered pharmacist the same year. Schulten operates a drug store at 2701 South Fourth Street in Louisville. He is the father of two sons and one daughter. Arnold resigned saying that he was going to take life easier. For many years he has served pharmacy well in Kentucky. - From The Kentucky Pharmacist, May 1964, Volume XXVII, Number 5.
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-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org
National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222
KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org. Deceased members for each year will be honored permanently at the KPhA office. 43
THE KENTUCKY PHARMACIST
May 2014
THE
Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601
Save the Date 137th KPhA Annual Meeting & Convention June 25-28, 2015 Holiday Inn University Plaza and Sloan Convention Center Bowling Green, KY For more upcoming events, visit www.kphanet.org. 44
THE KENTUCKY PHARMACIST