Y K C U T N E K THE T S I C A M R A PH Vol. 9, No. 1 January 2014
2014 Kentucky Legislative Session Roamey and KPhA are in Frankfort, advocating for YOU! See Page 6 for more information about what YOUR KPhA is doing in the Capitol for you!
Registration coming soon at www.kphanet.org News & Information for Members of the Kentucky Pharmacists Association
Table of Contents
January 2014
Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 2013 KPhA Mid-Year Conference 2013 Bowl of Hygeia Winners From your Executive Director APSC 2014 KPhA Professional Award Nominations 2014-15 KPhA Board of Directors Election Nominations Saving the Bowl of Hygeia January 2014 CE — 2013 HIPAA Updates January Pharmacist/Pharmacy Tech Quiz KPhA Emergency Preparedness Initiative Technician Review
2 3 4 5 6 8 9 11 12 13 22 23 24
February 2014 CE — Making Evidence-Based Selections of Influenza Vaccines February Pharmacist/Pharmacy Tech Quiz Kentucky Renaissance Pharmacy Museum KPhA New and Returning Members Medicare Star Ratings KPhA Government Affairs Contribution Form Pharmacy Law Brief KPhA First District Meeting Pharmacy Policy Issues Pharmacy Time Capsules Pharmacists Mutual Cardinal Health KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted
25 30 31 32 34 35 36 37 38 39 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. The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance.
Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.
Editorial Office:
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.
© 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.
2
THE KENTUCKY PHARMACIST
President’s Perspective
January 2014 health care professionals in an effort to improve the quality of life for patients. As more and more people take prescription drugs for chronic and long term diseases, pharmacists are being called upon increasingly to help in the management of these conditions. The current changes in health care will only exacerbate the necessity for pharmacists to step up their roles in managing patient health care. There is concern within the physician community that these changes will greatly reduce the amount of time they will have to interact with patients. Pharmacists have the opportunity to supplement that health care management role by monitoring and managing many long term patient disease states. Quality of life is important to all of our patients. They already see us as teachers and cheerleaders, as well as health consultants for the correct administration of their prescription medications. It’s a logical step for pharmacists to become more involved in the management of their overall health care.
PRESIDENT’S PERSPECTIVE Duane W. Parsons KPhA President 2013-2014 I can hardly believe it’s already 2014! Seems like the years just keep losing days, weeks and months as we get older! I hope all of you had a great year in 2013. Now let’s make 2014 one of the best years ever for our profession. It seems like we are right there poised to do just that. The opportunity to gain recognition of pharmacists as providers in the health care system is generating a lot of recognition on federal and state levels. One state, California, has already granted provider status to pharmacists by law. That law went into effect on Jan., 1, 2014. It not only declares pharmacists as health care providers, but gives new authorities to all licensed pharmacists, creates an Advanced Practice Pharmacist recognition, gives APPs new authorities and provides specific requirements for pharmacists seeking APP status. It, however, does not address payment for these new authorities. To get to this point in California required a unified effort from all the various sectors of the profession working together for the singular purpose of advancing the profession.
The physician community in Kentucky is beginning to recognize the need for an overall “team” approach to managing the health care of their patients. That team needs to involve pharmacists recognized as providers within the health care system.
It is my belief that this success in California is just the beginning for recognition of provider status for pharmacists in all states. It opens the door for changes in federal statutes necessary for pharmacy to be recognized as a knowledge centered profession instead of our currently product centered profession status.
The work group we have established within KPhA is working tirelessly to expand our roles as providers, but this group alone cannot get us to where we need to be. We all need to get involved. In a time when health care is evolving rapidly, much is still left to be done regarding the evolution of our roles as pharmacists.
Why is that important? More today than ever before, pharmacists are interacting with patients, physicians and other
2013 was a great year. Let’s all work together to make 2014 an even better year for our profession.
How do we seize the moment? We all, no matter what our areas of practice, need to come together as a unified profession to begin dialogue with our legislators, the physicians we deal with on a daily basis and our patients to express our willingness to be a valued provider within the health care team. Each of us needs to be involved. We play a vital role in keeping constituents, patients and individuals healthy and safe, as well as lowering the numbers of hospital visits and managing drug care costs.
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. 3
THE KENTUCKY PHARMACIST
2013 KPhA Mid-Year Conference
January 2014 Marriott Griffin Gate Resort Lexington, KY November 15-16, 2013 More than 300 student pharmacists, pharmacists, and pharmacy technicians came together to learn about KPhA’s Legislative Priorities and the legislative process on a Federal and State level.
Speakers on Friday, November 15 included (top left) Van Ingram, executive director of the Kentucky Office of Drug Control Policy; Jill Lee, Office of Inspector General; Joel Thornbury, president of the Kentucky Board of Pharmacy; Sen. Julie Denton; (top right) Trish Freeman, Associate Professor and Director, Professional Practice Programs and UK; Jan Gould, senior vice president—Government Affairs at Kentucky Retail Federation; (left) Matt DiLoreto, senior director of state government affairs for the National Community Pharmacists Association. Also speaking but not pictured: Carrie Banahan, Executive Director, Kentucky Health Benefit Exchange; Mike Burleson, Executive Director, Kentucky Board of Pharmacy. Speakers on Saturday included Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness; and Christopher Shaughnessy, with McBrayer, McGinnis, Leslie & Kirkland, PLLC.
This group is ready to immunize, thanks to Cathy Hanna, Director of Research and Education for APSC. They stayed until late Saturday afternoon learning all about the vaccination process for pharmacists, and practicing on each other. They joined 37 other pharmacists in being trained at KPhA immunization training events in 2013.
4
THE KENTUCKY PHARMACIST
2013 Bowl of Hygeia Recipients
January 2014
5
THE KENTUCKY PHARMACIST
From Your Executive Director
January 2014
MESSAGE FROM YOUR
EXECUTIVE DIRECTOR Robert “Bob” McFalls YOUR KPhA on Alert: Guardian of the Profession in Frankfort With this edition of The Kentucky Pharmacist, we are happy to report on the return of the General Assembly to Frankfort ,which began its regular session in early January. The 2014 legislative session will run for 60 days and end no later than April 15, 2014. YOUR KPhA welcomes pharmacists to Frankfort, and we encourage you to visit the legislature and to participate in your government in action. For those unable to make the trip to Frankfort, we will continue to keep you informed about legislative issues affecting the profession through weekly Legislative Updates and to ask for your active engagement on issues as communicated through our Grassroots Alerts. We would like to ask that you make sure that your email address is up-to-date on your membership profile (www.kphanet.org) or by calling the office. KPhA will continue to work hard to maintain your trust as YOUR Guardian of the Profession in Frankfort!
The Association has worked diligently for the past two years to address problems associated with legislation that impacted pharmacies with respect to the fitting of therapeutic shoes for diabetics. And in 2013, YOUR KPhA led efforts to pass the first PMB transparency bill in the country. While we continue to work for compliance on this legislation, it addressed the issue of MAC pricing and provided pharmacists with a way to counter the aggressive pricing practices of PBMs.
Building on our track record, we are working on our legislative priorities for this year. High on our agenda is an amendment of the Pharmacy Practice Act to allow pharmacists and practitioners more flexibility in entering into Collaborative Care Agreements. Legislation is planned to revise the existing collaborative care agreement language to allow multiple practitioners to enter into an agreement with multiple pharmacists for all of their patients. The change KPhA Legislative Priorities in 2014 would make it easier to execute these agreements with the Pharmacists working with KPhA and our partners have result of better patient care. Current law requires that a colseen great legislative successes during recent legislative laborative care agreement be between a specific practitionsessions. I hope that you have had the opportunity to read er and a specific pharmacist for a specific patient. The curthe Legislative Update, “KPhA in the Political Arena,” in the rent structure is very cumbersome and has proven to be an last journal with respect to our overall historical progress on obstacle to collaboration. I am pleased to report that the a number of critical issues. Working together in 2011, we proposal is endorsed by the Kentucky Board of Pharmacy were able to expand immunization authority for pharmacists and is strongly supported by the Advancing Pharmacy to administer influenza vaccines to individuals down to the Practice in Kentucky Coalition. And this work is being overage of 9 years old. In 2012, we worked together through seen by KPhA through a Provider Status Work Group apKPhA to build upon the foundation for the pharmacy audit pointed by President Duane Parsons. bill that was passed in 2009 and to obtain additional protections passed in the legislature for pharmacies. We also We also are pleased to report that legislation to address an were successful in getting the audit legislation expanded to ongoing problem regarding the fitting of therapeutic shoes cover the “new” managed care organizations serving the by pharmacy technicians and pharmacist interns will be put Medicaid population. KPhA also has been in the forefront forward this session. We are working with the Prosthetic, on the debate over prescription drug abuse; as a result, we Orthotic and Pedorthic Association to codify in the statute were successful in our efforts to remove provisions that that pharmacy technicians and interns may assist pharmawould have required pharmacists to run KASPER reports cists in the fitting of therapeutic shoes and inserts for diabefore dispensing ALL controlled substances and to obtain betic patients. As you will recall, we are operating under an a much-needed exemption for hospitals and long term care agreement between the Board of Pharmacy and the Prosfacilities that would have required them to run KASPER thetics, Orthotics and Pedorthics Board to allow this pracreports before administering pain medications to patients. tice, but getting the agreement in statute will protect the 6
THE KENTUCKY PHARMACIST
From Your Executive Director
January 2014
practice in the future.
proving access by eliminating multiple trips during the month.
Following national trends, we expect a discussion of biosimilar products to start on the legislative front as well. In fact, there is a strong possibility that legislation will be introduced to place restrictions on the substitution of biosimilar products going forward, i.e., once the FDA determines interchangeability for certain products. Bills are being pushed in other states by major manufacturers of biologics, and we continue to hear rumors that proposed legislation is in the works for the 2014 Kentucky legislative session. Typically, these bills place additional requirements on pharmacists in order to substitute these products. KPhA will oppose any restrictions on the substitution of FDAapproved biosimilars that place additional burdens on pharmacists and are contrary to the intent of the existing generic drug law. Similarly, KPhA will continue to oppose efforts to restrict generic substitution for tamper-resistant opioids in terms of patient access.
In early January, Governor Steve Beshear spoke to his priorities of improving education and the health of Kentuckians. The passage of a biennial budget will be the major issue facing lawmakers this year. The state’s fiscal outlook remains bleak. Although revenues are anticipated to see modest growth over the next two years, growth in expenses is projected to exceed increased revenues by a significant margin. We all recognize that the legislature’s plate is full. However, it is imperative that we continue to advocate our positions and to advance the profession. We know that you will continue to keep us posted on the challenges that you are facing and the opportunities that you are seeing. BEING INVOLVED IN YOUR KPhA IS CRITICAL TO OUR COLLECTIVE SUCCESS. Thank you for that engagement and for your contributions to the KPhA Government Affairs Fund. This is an election year, and we will be called upon more than ever to engage with elected officials and candidates for the legislature. With that in mind, don’t forget about making a gift to your Kentucky Pharmacists PAC, too.
In addition, we are working with the Kentucky State Patients Equal Access Coalition, a patient-centered coalition that is seeking parity for oral chemotherapy drugs. For those therapies for which an oral drug is available and has proven to be equally effective, KPhA believes that patient access and choice are critical decision points. At this point in time, 27 states have enacted oral chemotherapy access laws, and Kentucky is one of 12 that will be considering it in this legislative session. There is a grassroots effort for a parallel approach for federal legislation as well.
For the ardent advocates, the Kentucky Legislature Web Page (www.lrc.ky.gov) is updated on a daily basis and is a great resource for the latest legislative updates. Web surfers also can see for themselves the issues before lawmakers by browsing through bill summaries, amendments and resolutions. The website is regularly updated to indicate each bill’s status in the legislative process, as well as the In December, KPhA was invited to a discussion with other next day’s committee meeting schedule and agendas. health care providers and the Kentucky Chamber of ComHowever, we recognize that most of us do not have time to merce to discuss medical malpractice issues. Subsequentkeep up with this level of detail. Know that KPhA and our ly, KPhA’s Board of Directors voted for KPhA to join this Government Affairs Committee will keep you informed new coalition which is proposing legislation to establish through our regular communications on issues affecting “medical review panels” that would consist of a health propharmacists and the profession as a whole. And, rememfession’s peers to prescreen medical malpractice claims. ber that you can always give your state senator and repreThe panel’s decision would be nonbinding but would be sentative feedback on issues under consideration by calladmissible in court. Indiana, Louisiana and several other ing the Legislative Message Line at (800) 372-7181. This is states utilize medical review panels. While this has not YOUR KPhA —let’s keep our legislative momentum going been a big issue for pharmacists, being able to establish a strong. medical review panel could prove a useful option in the future.
Registration and schedule will be posted online at www.kphanet.org.
KPhA also is monitoring a medication synchronization effort being reviewed by NCPA, NASPA and other national organizations and by Pfizer to allow for prescriptions to be reimbursed under a “true up” philosophy to a common date (vs. a partial-fill approach in the past). The legislation would specify that a prescription benefit would be reimbursable in order to get the patient’s prescription supply synchronized. The advantage would be to increase patient compliance in terms of medication adherence while im-
Watch your email and social media for the latest! 7
THE KENTUCKY PHARMACIST
APSC
January 2014
8
THE KENTUCKY PHARMACIST
2014 KPhA Professional Awards
January 2014
2014 KPhA Professional Awards Joseph T. Elmes, Jr. KPhA Bowl of Hygeia Award Sponsored by APhA Foundation H. Joe Russell Alvin R. Bertram and NASPA Criteria – To recognize an individual who has demonstrated outstanding community service in pharmacy. Eligibility – The recipient must be an Active or Honorary Life member of the Association. The recipient must be a pharmacist with a current valid license to practice in Kentucky. The recipient must be living, awards are not presented posthumously. The recipient has not previously received the award and is not currently serving nor has he/she served within the past two years on the selection committee or as an officer of the Association in other than ex -officio capacity. The recipient has compiled an outstanding record of community service that apart from his/ her specific identifications as a pharmacist reflects well on the profession. Previous Recipients Leon Claywell 2013 George F. Hammons 2012 William I. McMakin, III 2011 Kim Croley 2010 Patricia Thornbury 2009 Dave Peterson 2008 Charles Fletcher 2007 Gloria Doughty 2006 Larry Hadley 2005 Harold Cooley 2004 Brian Fingerson 2003 Simon Wolf 2002 Richard Ross 2001 Tom Houchens 2000 Phil Losch 1999 Lucy Easley 1998 Nick Schwartz 1997 Michael Cayce 1996 Bill Borders 1995 Gerald Deom 1994 Kenneth Calvert 1993 Joseph G. Bessler 1992 Michel A. Burleson 1991 Lynn Harrelson 1990 William A. Conyers, Jr. 1989 Daniel R. Kovar, Jr. 1988 Martin W. Nie 1987 Ralph Schwartz 1986 Dwaine K. Green 1985 W. Vance Smith 1984 Richard L. Roeding 1983 William J. Farrell, Sr. 1982 Joseph L. Scanlon 1981
Norman C. Horn H. Joseph Schutte D.H. "Sonny" Ralston Arthur G. Jacob James M. Brockman Richard E. Murray Randolph N. Smith Oliver E. Mayer Donald C. Morwessel James Phillip Arnold William D. Morgan Ernest M. Davis W.F. Bettinger Arvid E. Tucker Vernon B. Hager Sidney Passamaneck John H. Voige E. Crawford Meyer James J. Hamilton
1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959
KPhA Distinguished Service Award Criteria- To recognize individual members who have made significant contributions to the Association or the profession at large over an extended period of time. Eligibility – Only Active or Honorary Life members of the Association shall be eligible for the award. No individual shall be a recipient of the award more than once. Previous Recipients Catherine Hanna 2013 Glenn Stark 2012 Kenneth Roberts 2011 Ann Amerson & Lynn Harrelson 2010 Larry Hadley 2009 Dwaine Green 2008 John Brislin 2007 Donnie Riley 2005 Gloria Doughty 2004 Coleman Friedman 2003 Joe Fink III 2002 Melinda Joyce 2002 David Jaquith 1999 R. Paul Easley & Jeff Osman 1998 Ralph Bouvette 1997 Pat Chadwell 1996 Jordan Cohen and Marty Nie 1995 Mike Montgomery 1994 Richard Ross 1993 Thomas Weisert 1991 R. David Cobb 1990 9
Joseph Bessler & Arthur Jacob 1989 Paul E. Davis 1988 Norman Horn & Robert E. Lee Sandlin 1987 Joseph V. Swintosky 1986 J.H. (Jack) Voige 1985 Charles T. Lesshafft, Jr. 1984 Jerry Budde 1983 William H. Nie 1982 R.N. (Randy) Smith 1981
KPhA Pharmacist of the Year Award Criteria – To recognize a pharmacist for outstanding professional activities undertaken during the current or previous calendar year, which resulted in demonstrable benefit to the profession of pharmacy. Eligibility – Only Active or Honorary Life members of the Association shall be eligible for nominations and receipt of this award. Previous Recipients Trish Freeman 2013 Alyson Schwartz 2012 William Grise 2011 Holly Byrnes 2010 Dave Sallengs 2009 Kelly Smith 2008 Joseph Bickett 2007 Paul Easley 2006 John Anneken 2005 Kim Croley 2004 Ralph Bouvette 2003 David Jaquith 2001 Melinda Joyce 1999 Michael Wyant 1998 Phil Losch 1997 Tom Houchens & Bob Kuhn 1996 Don Ruwe 1995 Mark Edwards 1994 C. Dave Peterson 1993 Brian Fingerson 1992 Martin W. Nie 1991 Judy Minogue 1990 Paul Ruwe 1989 Joseph L. Fink III 1988 Steven R. Adams 1987 William J. Farrell 1986 Harold G. Becker 1985 Dwaine K. Green 1984 R. David Cobb 1983 Richard E. Murray 1982 Richard Rolfsen 1981 Gloria H. Doughty 1980 Joseph G. Bessler 1979
THE KENTUCKY PHARMACIST
2014 KPhA Professional Awards Emil Baker Robert L. Barnett Joseph L. Scanlon John B. Anneken Alvin R. Bertram Patricia A. Donahue H. Joseph Schutte Willard Alls Joe D. Taylor Richard L. Ross Ralph J. Schwartz George W. Grider Robert J. Lichtefeld E.M. Josey Julius T. Toll Charles E. Otto Charles F. Rosenberg R.N. Smith E. Crawford Meyer Charles A. Walton Ernest C. Williams George W. Grider Ray Wirth Nathan Kaplin Marion Hardesty
1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954
January 2014 Ralph Bouvette 1999 Rodger Smith, Barbara Woerner, Mary Ann Wyant, & Rick Vissing1998 Larry Spears 1997 John B. Anneken 1996 Phil Losch 1995 Jordan Cohen 1994 Judy Minogue 1994 Kentucky Academy of Student of Pharmacy 1993 Celeste Flick & Clarence Sullivan III 1988 William H. Nie 1987 Student Kentucky APhA 1986 Northern KY Pharmacists Association 1986
KPhA Distinguished Young Pharmacist Award sponsored by Pharmacists Mutual Insurance Company
Criteria – To recognize a young pharmacist’s outstanding contribution to the profession and/or community. Eligibility – The recipient must be an Active member of the Association. KPhA Professional Promotion The recipient must be licensed to pracAward tice for nine years or less. The recipiCriteria – To recognize individuals or ent must have a valid, active license to organizations who have exhibited out- practice in Kentucky. The recipient standing efforts to demonstrate the must have demonstrated participation importance of pharmacy as a health in a national pharmacy association, care profession, and which promote professional program(s) and/or comproper application of pharmacists’ pro- munity service. fessional services. Previous Recipients Eligibility – Open to persons or organ- Brooke Hudspeth 2013 izations. Stacy Rowe 2012 Previous Recipients Aimee Ruder 2011 Julie N. Burris & Karen Hubbs 2010 Walgreens Corporation 2013 Matt Martin 2009 SUCOP student chapter of APhA-ASP Tiffany Self 2008 2012 Angela Parrett 2007 Lynne Eckmann 2011 Janet Mills 2006 Gloria Doughty & Alyson Schwartz 2005 Lynn Harrelson 2010 Nancy Horn 2004 Jordan Covvey 2009 Jennifer O’Hearn 2003 Jeff Mills 2008 Karen Altsman 2001 Trish Freeman 2007 Kim Wilson 1999 Sherry DeCuir 2006 Kim Harned 1998 Pete Orzali 2005 Michael Box 1997 John Armistead, Don Kupper Dan Yeager 1996 & Willie Newby 2004 Dan Minogue 1995 Kroger Pharmacy Mid South Division, Pan Haeberlin 1994 Holly Divine, Randy Gaither, Bill Grise Kim Croley 1993 & Laura Jones 2003 Phillip Sandlin 1992 Jefferson County Academy of Jeffrey W. Danhauer 1991 Pharmacy, Ken Roberts, Ph.D 2002 Mark S. Edwards 1990 Paul Easley, Bob Oakley Susan Murray Kathman 1989 & Michael Wyant 2001 Melinda Cummins Joyce 1987 Judy Minogue 2000
10
KPhA Excellence in Innovation Award Sponsored by UpsherSmith Laboratories Criteria – To recognize a pharmacist who has demonstrated innovative pharmacy practice resulting in improved patient care in the previous year or over an extended period of time. Eligibility – A recipient must be a pharmacist who is an Active or Honorary Life member of the Association. A recipient may receive the award more than once. Previous Recipients Buddy Wheeler 2013 Lynn Harrelson 2012 James Nash & BC Childress 2011 Lynne Eckmann & Cathy Hanna 2010 Ann Albrecht 2008 Lisa Short 2005 Holly Divine, Amy Nicholas 2004 Judy Minogue 2003 Trish Freeman 2002 Mary Ann Wyant 2001 Joyce Korfhage Rhea 2000 Cathy Edwards 1999 Celeste Flick 1998 Jeanne Zeis 1997 Dave Wren 1996 Preston Art 1995 W. Michael Leake 1994
KPhA Technician of the Year Award Criteria – To recognize a Certified Pharmacy Technician for outstanding professional activities. Eligibility – Only active Pharmacy Technician members of KPhA shall be eligible for nomination and receipt of this award. Leslie Lochner & Robin Lillpop 2013 Patricia Robinson 2012 Jessica Salmons 2011 Gwen Otter 2010 Lisa Sawvel 2008 Margaret Sinkhorn 2007 Charlotte Bowling 2006 Mary Jane Wathen 2005 Kent Williams 2004 Tammy Newsome 2003 Frank Ray 2002 Jane Woerner 2001
Come see who wins at the 136th KPhA Annual Meeting and Convention June 5-8, 2014 in Lexington THE KENTUCKY PHARMACIST
2014 KPhA Professional Awards
January 2014
2014 KPhA Board of Directors Election Paper Ballot Request Form The 2014 KPhA Board of Directors Election will be held online at www.kphanet.org. You will need to log in to the site to cast your vote. Paper ballots will be available, but ONLY upon request through this form.
Name:
Email:
Address: City, State Zip: Fax number: Preferred Method to Receive Ballot: (Circle one)
Fax
Return form to KPhA, 1228 US 127 South, Frankfort, KY 40601, Fax 502-227-2258, or email ssisco@kphanet.org. Call the KPhA Office at 502-227-2303 for more information. Cardinal Health Generation Rx Champions Award Criteria – This award program recognizes excellence in community-based prescription drug abuse prevention at state pharmacy associations. This award honors a pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy community. The award is also intended to encourage educational prevention efforts aimed at patients, youth and other members of the community. In addition to the award, to honor the pharmacist’s work to fight prescription drug abuse, APMS, state pharmacy associations and the Cardinal Health Foundation will donate $500 to a charity of the award recipient’s choice. Previous Recipients Raymond Float 2013 Brian Fingerson 2012
For more on the awards, go to www.kphanet.org and click on About, Professional Awards
2014 KPhA Professional Awards The Kentucky Pharmacists Association annually recognizes individuals from across the Commonwealth that exhibit exceptional service to patients and their community, continuously promote the profession of pharmacy, and demonstrate innovative pharmacy practice. The KPhA Organizational Affairs Committee is accepting nominations for the professional awards below: Bowl of Hygeia
Distinguished Service Award
Pharmacist of the Year
Professional Promotion Award
Young Pharmacist of the Year
Excellence in Innovation Award
Technician of the Year
Cardinal Health Generation Rx Champion
To nominate an individual, please submit a letter of nomination including the award information and the nominee’s accomplishments with regard to the award criteria. Multiple letters of support are accepted and highly encouraged. Individuals and recognized pharmacy organizations in Kentucky are encouraged to submit nominations. Individual nominators need not be a member of the Association; however, pharmacist and technician nominees must be a member of KPhA. Nominations: Nominations may be submitted electronically to Scott Sisco at ssisco@kphanet.org or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March 31, 2014. The KPhA President, President-Elect, and the Chairman of the Board, participating in any voting for awards shall not be eligible for nomination or selection for any award. Conferral of any of the awards of the Association shall be at the discretion of the Organizational Affairs Committee and is not mandatory on an annual basis.
11
THE KENTUCKY PHARMACIST
Bowl of Hygeia
January 2014
Vote for Kentucky to be #1! Vote with your contribution for Kentucky to be #1 with the “Bowl of Hygeia State Association Challenge 2.0.” Every dollar you donate will double as a result of our 2013 Bowl of Hygeia recipient Leon Claywell’s pledge to match donations up to $5,000. You can help Kentucky earn Leon’s Pledge! The APhA Foundation will award cash prizes to the state raising the most funds for the Bowl of Hygeia Endowment. The Endowment is at 75 percent of its goal. To qualify for Kentucky’s “win,” your donation has to be received by the APhA Foundation no later than March 15, 2014. To contribute, go to http://www.aphafoundation.org/kentucky-pharmacists-association-bowl-hygeia-team .
Kentucky Contributors as of January 1, 2014 $3,860 total contributions
Cassandra Beyerle
Chris Killmeier
Cayce's Pharmacy, Inc.
Matthew & Aleshea Martin
Leon & Margaret Claywell
Robert McFalls
Brian Fingerson
Duane Parsons
Dwaine Green
Donald Riley
George Hammons
Patricia Thornbury
Tom Houchens
Simon Wolf
For more information on the Bowl Of Hygeia, visit: http://www.aphafoundation.org/bowl-hygeia-award.
Donate online to the KPhA Government Affairs Fund! Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org and click on the Advocacy tab for more information about the KPhA Government Affairs fund and the donation form or see Page 35 to send your check directly to KPhA. 12
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates
January 2014
2013 HIPAA Updates: Key Implications KPERF offers all for Your Pharmacy Organization CE articles to By: Clay B. Wortham, Esq., McBrayer, McGinnis, Leslie & Kirkland, PLLC. Leah Tolliver, Pharm.D., Director of Pharmacy Emergency Preparedness, Kentucky Pharmacists Association.
members online at www.kphanet.org
The authors do not have financial relationships with anyone that could be perceived as real or apparent conflicts of interest affecting the subject matter of this article. Universal Activity # 0143-0000-14-001-H03-P&T 1.5 Contact Hours (0.15 CEU) Goal To ensure that pharmacists are aware of the changes to the new HIPAA rules that impact their business and to make necessary changes according to the deadlines outlined in the Final Rule. Objectives At the conclusion of this article, the reader should be able to: 1. Describe important clarifications regarding coverage of HIPAA to Business Associates and contractors. 2. Identify key new changes to the data breach notification standard. 3. Prepared to operationalize key patient rights, such as access to electronic data, and authorizations for paid communications using PHI. ness Associate; and
Introduction
In January 2013, the Department of Health and Human 4. Data transmission services such as digital couriers that Services (HHS) published a Final Rule containing numerdo not require routine access to the data continue to be ous changes to the HIPAA Privacy, Security, Breach Notifiexempt from Business Associate requirements.3 cation and Enforcement Rules.1 The HIPAA updates took Business Associate Agreements – Changes Required effect on Sept. 23, 2013 for pharmacy covered entities Under the HIPAA updates, Business Associates must inde(and their business associates).2 pendently comply with the HIPAA Privacy and Security Two of the HIPAA updates that require pharmacies to take Rules.4 Further, as discussed above under the definition of action now are: (i) changes to Business Associate require- “Business Associate”, a subcontractor of a Business Assoments; and (ii) changes to the mandatory Notice of Privacy ciate that handles PHI on behalf of the Business Associate Practices. These updates do not affect the fundamental also is now considered a Business Associate.5 What does nature of HIPAA compliance, but they do introduce a spe- this mean for pharmacies? cific "to do" list for pharmacies. The HIPAA updates retain the requirement that a covered Expanded Definition of “Business Associate” entity pharmacy maintain a Business Associate Agreement 6 One of the important changes contained in the HIPAA up- with each person that handles PHI for the pharmacy. dates is that the definition of “Business Associate” in- Thus, a Business Associate Agreement now is required for each entity that handles PHI for the covered entity and for cludes: that Business Associate’s downstream subcontractors who 1. Health information exchange organizations, ehandle the PHI. For example, beginning on Sept. 23, 2013, prescribing gateways, and personal health record vena data storage vendor of a Business Associate also will be dors that offer records on behalf of a covered entity; considered, separately, a Business Associate. 2. Data transmission providers that require access to ProThe HIPAA updates provide a “deemed compliance” period tected Health Information (PHI) on a routine basis; for “BA Agreements” in place when the HIPAA updates 3. Business Associate “downstream” subcontractors that were published on Jan. 25, 2013.7 While new Business create, receive, maintain or transmit PHI for the Busi- Associate Agreements are required to include HIPAA up13
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates
January 2014
aging individuals to renew recently lapsed prescriptions are consistent Q: What types of communications with the purpose of refill reminder and fall within the “refill reminder” exmedication adherence communicaception to marketing? tions, which is to encourage individuals to continue to take their medication as The refill reminder exception to the definition of “marketing” encompasses directed. However, once a prescription refill reminders and other communica- has lapsed for more than 90 calendar days, it is no longer reasonable to treat tions about a drug or biologic that is currently being prescribed for the indi- such communications as refill remindvidual. See paragraph (2)(i) of the defi- ers or medication adherence communications for a currently prescribed drug nition of “marketing” at 45 CFR 164.501. In addition to refill reminders or biologic. about currently prescribed drugs, the Q: Do communications about drug exception encompasses communicadelivery systems fall within the tions about generic equivalents of a “refill reminder” exception to mardrug being prescribed, adherence keting? communications encouraging individuYes. Where an individual is prescribed als to take prescribed medicines as a self-administered drug or biologic, directed and communications about such as insulin, communications represcriptions that have lapsed within garding all aspects of a drug delivery the last 90 calendar days. Also, where system, such as an insulin pump, fall an individual is prescribed a selfwithin the refill reminder exception at administered drug, communications paragraph (2)(i) of the definition of regarding all aspects of a drug delivery “marketing” at 45 CFR 164.501, prosystem fall within the refill reminder vided any financial remuneration reexception. Thus, these types of comceived in exchange for making the munications are permitted without an communication is reasonably related to individual’s authorization, provided any the covered entity’s cost of making the financial remuneration received from communication. the pharmaceutical manufacturer in exchange for making the communica- Q: Do communications about spetion is reasonably related to the covcific adjunctive drugs related to the ered entity’s cost of making the comcurrently prescribed drug fall within munication. the “refill reminder” exception to marketing? Q: Do communications about re-
Refill Reminder FAQs
scribed drug does not fall within this category. However, covered entities may communicate in a general manner to individuals regarding the availability of adjunctive drugs related to the drug that is currently being prescribed to the individual without triggering the marketing requirements. For example, a pharmacy could send a communication to an individual alerting the individual to possible side effects from her currently prescribed medication, and suggesting the individual go ask her doctor about a medication to treat the side effects if she experiences them, without naming a particular medication. Alternatively, communications about adjunctive drugs may fall within the treatment exception to marketing at paragraph (2)(ii)(A) of the definition, provided the covered entity does not receive financial remuneration in exchange for making the communication. In addition, such communications may be made in a face-to-face encounter with the individual, without authorization, even if financial remuneration is received in exchange for making the communication. Q: Do communications about new formulations of a currently prescribed medicine fall within the “refill reminder” exception to marketing?
No, only communications about drugs or biologics currently prescribed to the cently-lapsed prescriptions for a No, only communications about drugs individual fall within the refill reminder medicine fall within the “refill reor biologics currently prescribed to the exception at paragraph (2)(i) of the minder” exception to marketing? individual fall within the refill reminder definition of “marketing” at 45 CFR Yes, so long as the prescription lapsed exception at paragraph (2)(i) of the 164.501. However, covered entities definition of “marketing” at 45 CFR within the last 90 calendar days and may communicate in a general manner any financial remuneration received in 164.501. An adjunctive drug that may to individuals regarding the availability exchange for making the communica- be used in conjunction with a currently of a drug with, for example, a different prescribed drug to help treat a patient’s dosing schedule or form, without trigtion is reasonably related to the covunderlying condition or address one or gering the marketing requirements. For ered entity’s cost of making the commore side effects of a currently premunication. Communications encourexample, a pharmacy could send an dates, pharmacy covered entities are not required to incorporate the HIPAA updates into BA Agreements in effect on Jan. 25, 2013, until the earlier of (i) Sept. 22, 2014, or (ii) when the BAA is otherwise amended or renewed.8
Notwithstanding the deemed compliance period, pharmacy covered entities and their Business Associates should act swiftly to update their agreements for the HIPAA updates, and existing Business Associates should evaluate their 14
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates adherence communication to an individual that also informs the individual about the availability of a product with a more convenient dosing schedule or in a liquid instead of pill format, without naming the particular medication. Alternatively, communications about specific new formulations of a drug may fall within the treatment exception to marketing at paragraph (2)(ii)(A) of the definition, provided the covered entity does not receive financial remuneration in exchange for making the communication. In addition, such communications may be made in a face-toface encounter with the individual, without authorization, even if financial remuneration is received in exchange for making the communication.
mation to make such communications. making the communication, if any, is reasonably related to the covered entiQ: Can a doctor or pharmacy be ty’s cost of making the communication. paid by a pharmaceutical manufacSee paragraph (2)(i) of the definition of turer to make a prescription refill “marketing” at 45 CFR 164.501. Finanreminder without an individual’s cial remuneration means payment to a prior authorization under the HIPAA covered entity (or Business Associate, Privacy Rule? if applicable) from or on behalf of a Yes, provided that any payments from third party whose product or service is the pharmaceutical manufacturer are being described. Thus, for these purreasonably related and limited to the poses, permitted remuneration in excovered entity’s cost of making the change for making a “refill reminder” communication. communication is:
For payments to the doctor or pharmacy, this means payments may cover only the reasonable direct and indirect costs related to the refill reminder or medication adherence program (or other excepted communications), including labor, materials, and supplies, as well as capital and overhead costs. For payments to a Business Associate that contracts with a doctor or pharmacy to assist in carrying out the refill reminder or medication adherence program (or to make other excepted communications), this means payments (either directly from the pharmaceutical manufacturer or through the covered entity) may be only up to the fair market value of the Business Associate’s services.
Non-financial or in-kind remuneration, such as supplies, computers or other materials. Payment from a party other than the third party (or other than on behalf of the third party) whose product or service is being described in the communication, such as payment from a health plan.
Q: What is permitted remuneration for purposes of the “refill reminder” exception to marketing?
Where a covered entity enlists the services of a Business Associate to assist in carrying out a refill reminder or medication adherence program, or to make other excepted communications, the Business Associate may be paid by the third party (either directly or through the covered entity) only up to the fair market value of its services.
Q: Do communications encouraging individuals to switch from a prescribed medicine to an alternative therapy fall within the “refill remind- er” exception to marketing? No, only communications about drugs or biologics currently prescribed to the individual fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501. Making a communication to an individual encouraging the individual to switch from a prescribed medicine to an alternative therapy would only be appropriate where such communication falls within the treatment exception to marketing at paragraph (2)(ii)(A) of the definition and the covered entity does not receive financial remuneration in exchange for making the communication; where the communication is made in a face-to-face encounter with the individual; or where the individual has authorized the use or disclosure of his protected health infor-
January 2014
The Privacy Rule excepts from the definition of “marketing” refill reminders and other communications about a drug or biologic that is currently being prescribed for the individual, provided that financial remuneration received by the covered entity in exchange for
Payments to a covered entity by a pharmaceutical manufacturer or other third party whose product is being described in the communication that cover only the reasonable direct and indirect costs related to the refill reminder or medication adherence program, or other excepted communications, including labor, materials, and supplies, as well as capital and overhead costs.
subcontractors to determine whether any subcontractors New Content for BA Agreements handle PHI and to negotiate a Business Associate AgreeSpecifically, in addition to existing requirements of the Priment appropriate for the arrangement to ensure that the vacy Rule, the HIPAA updates necessitate that Business subcontractors will appropriately safeguard PHI. Associate Agreements include the following changes: 15
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates Q: May a covered entity pay a Business Associate to assist in making a refill reminder or other communication that falls within the “refill reminder” exception to marketing?
January 2014
or directly to the Business Associate, that is acting on behalf of the covered entity to assist in making the refill reminder or other communication describing the manufacturer’s product.
Yes. The Privacy Rule permits a covered entity to engage and pay a Business Associate to assist in making otherwise permitted communications to individuals and does not prescribe what the covered entity itself may pay the Business Associate for such services. However, where financial remuneration is received from the pharmaceutical manufacturer or other third party whose product is being described to make such communications, there are limits on what the Business Associate may be paid from that financial remuneration. In particular, a Business Associate only may receive, whether directly from the third party or through the covered entity from the financial remuneration the covered entity receives from the third party, payments not to exceed the fair market value of its services.
going forward for such communications from new patients as they enroll in the programs. For existing patients, must we either obtain authorizations by the Sept. 23, 2013 compliance date of the new provisions or terminate these sponsored communications with these patients?
Q: May a covered entity contract with a Business Associate to assist in administering a refill reminder or medication adherence program paid for by a pharmaceutical manufactur- No. With respect to obtaining authorizations from patients already enrolled er? in these programs, OCR will not deterYes. However, in order for the refill mine that a covered entity is in violareminders or other program communition of the marketing provisions if it has cations to fall within the “refill reminder” not obtained authorizations from all exception to marketing, any financial existing patients to whom it is making remuneration received by the Business such communications by the Sept. 23, Associate from the pharmaceutical 2013 compliance date, provided the manufacturer (either directly or through patients from whom authorizations the covered entity) must not exceed have not been obtained have not opted the fair market value of the Business out or declined to receive such comAssociate’s services. See paragraph munications and the patients’ authori(2)(i) of the definition of “marketing” at zations are obtained at the next time 45 CFR 164.501. Such limitations do their prescriptions are renewed, but no not apply to what the covered entity later than Sept. 23, 2014. itself may pay the business associate for such services when no financial Q: If a covered entity is going to obremuneration is received from the tain authorizations from patients to pharmaceutical manufacturer or other Q: May a Business Associate be make pharmaceutical manufacturerpaid by a pharmaceutical manufac- third party whose product or service is funded communications to the pabeing described. turer to assist a covered entity in tients about currently prescribed making a refill reminder or other drugs or biologics, is the covered Q: We operate specialty pharmacy communication describing the manentity required to obtain a new auprograms that make pharmaceutical ufacturer’s product that falls within thorization each time a prescription manufacturer-funded communicathe “refill reminder” exception to is renewed? tions to patients concerning their marketing? No. A HIPAA authorization remains prescribed drugs for chronic and Yes, provided any payments to the complex diseases that require com- valid until it expires or is revoked by Business Associate do not exceed the plicated therapies. Rather than enthe individual. While a HIPAA authorifair market value of its services. See sure such communications meet the zation must contain an expiration date paragraph (2)(i) of the definition of or event that relates to the individual or conditions of the “refill reminder” “marketing” at 45 CFR 164.501. The the purpose of the use or disclosure, exception at paragraph (2)(i) of the payments may be made by a pharma- definition of “marketing” at 45 CFR the Privacy Rule does not otherwise ceutical manufacturer through a cov164.501 of the Privacy Rule, we have prescribe the expiration date or event ered entity to the Business Associate, decided to obtain authorizations that must apply to the authorization, 1. The Business Associate must limit its uses and disclo- 2. The business associate must implement safeguards for sures of PHI to meet the covered entity’s minimum necelectronic PHI in accordance with the HIPAA Security essary policies and procedures (and business associRule. ates’ will want to ensure that the covered entity is re- 3. The Business Associate must notify the covered entity quired to make those policies available to the Business of a security breach, including the information required Associate). under the new Breach Reporting Rule. 16
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates which may vary based on the circumstances. For example, in the case of communications to individuals concerning currently prescribed drugs, a HIPAA authorization could expire at the time, or within a specified period of time after, a prescription expires or is no longer valid; or at the time a patient opts out of receiving such communications from the covered entity or opts out of participating in the prescription drug adherence or education program. Further, the scope of the authorization need not be limited to communications related to a single drug or biologic or the drugs or biologics of only one pharmaceutical manufacturer. The authorization must adequately describe the intended purposes of the requested uses and disclosures and otherwise contain the elements and statements of a valid authorization under 45 CFR 164.508. For these purposes, this includes stating in the authorization that the covered entity is receiving financial remuneration from one or more pharmaceutical manufacturers to make the communications, and that the individual may revoke the authorization in writing at any time he or she wishes to stop receiving the communications.
January 2014
“marketing,” as there is no commercial component to communications about benefits available through public programs. Therefore, a covered entity is permitted to use and disclose protected health information to communicate with individuals about eligibility for such programs as Medicare, Medicaid, or the State Children’s Health Insurance Program (SCHIP). Similarly, government-mandated communications are not considered marketing under the Privacy Rule as such communications also are not commercial in nature. Q: Are pharmaceutical manufacturer -funded communications to patients concerning a prescribed drug considered marketing under the Privacy Rule if they are required by a Risk Evaluation and Mitigation Strategy (REMS)?
being described. As with communications to individuals concerning government and government-sponsored programs, government-mandated communications to individuals are not commercial in nature. Thus, a covered entity may use or disclose an individual’s protected health information without the individual’s authorization to send the individual educational or other information concerning a prescribed drug that is required by a REMS, even if the communication is funded by the drug manufacturer. Q: Must a pharmacy obtain an individual’s written authorization prior to discussing with the individual an alternative medication to the one prescribed to the individual in a face -to-face encounter?
No. Face-to-face communications with an individual about specific products or No. If the Food and Drug Administraservices do not require individual aution (FDA) determines that a particular thorization, even if such communicadrug can only be approved with additions are subsidized by the third party tional measures, beyond labeling, to whose product or service is being demitigate a serious risk posed by the scribed. See 45 CFR 164.508(a)(3)(i) drug, and one or more of those (A). Thus, a pharmacy or other covmeasures take the form of patient ered entity may discuss with, or hand communications about the drug, then printed information to, an individual such communications are not market- about particular medicines in a face-toQ: Are communications about goving, even if the communication is fund- face encounter, without triggering the ernment programs or governmented by the drug manufacturer. Govern- individual authorization requirements sponsored programs “marketing” ment-mandated communications to of the HIPAA Privacy Rule. However, under the HIPAA Privacy Rule? individuals are not considered market- face-to-face communications do not No. Communications about governing under the Privacy Rule, even if include communications over the telement and government-sponsored pro- such communications are paid for by a phone or by e-mail or mail. grams do not fall within the definition of third party whose product or service is 4. The Business Associate must enter into a Business is to make breach notification mandatory unless the covAssociate Agreement with “downstream” subcontrac- ered entity or Business Associate determines that there is a tors to which the business associate discloses PHI. “low probability that the protected health information has 5. If the agreement delegates to the Business Associate been compromised based on a risk assessment” of the folany of the covered entity’s HIPAA compliance obliga- lowing factors: tions such as limiting disclosures of PHI or permitting 1. Nature and extent of PHI involved; patient access to PHI, the covered entity must ensure 2. The unauthorized person who used the PHI or to whom that the Business Associate is required to fulfill those the disclosure was made; obligations to the same extent as the covered entity. 3. Whether the PHI actually was acquired or viewed; and Breach Notification Rule 4. The extent to which the risk to the PHI has been mitigated.9 Another important change included with the HIPAA updates 17
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates
January 2014
Changes to Notice of Privacy Practices The HIPAA updates necessitate important additions to a pharmacy’s Notice of Privacy Practices to be provided to pharmacy patients after Sept. 23, 2013. Key changes for the required Notice of Privacy Practices include advising patients that PHI will not be sold or used for marketing purposes without the patient’s authorization.10 Also, a PHI may not be used for fundraising purposes unless a statement to that affect is included in the Notice of Privacy Practices.11 Another significant change for the Notice is to inform patients that they will receive a breach notification in the event their PHI is compromised as provided in the Breach Notification Rule.
e. f. g. h.
Disclosures to Business Associates. Disclosures to the individual. Disclosures required by law. Other disclosures permitted by the rules, provided remuneration is related to cost of making the disclosure.
Refill Reminder Exception
HIPAA’s “refill reminder” exception to the patient authorization requirement for paid marketing communications is very important for pharmacies and pharmaceutical manufacturers. There are two components to determining whether a communication falls within the refill reminder exception to marketing. The first is whether the communication is about a currently prescribed drug or biologic. 18 Fundraising The second is whether the communication involves finanThe HIPAA updates permit a covered entity to use PHI to cial remuneration and, if it does, whether the financial reraise funds for its own benefit, or the benefit of an institu12 muneration is reasonably related to the covered entity’s tionally related foundation, but not to benefit a third party. (pharmacy) cost of making the communication. Below is PHI that may be used for fundraising activities includes the guidance on each of these aspects of the exception. 13 department of service, treating physician and outcome. The covered entity’s Notice of Privacy Practices must con- 1. Is the Communication about a Currently Prescribed tain opt-out language that is clear and conspicuous.14 The Drug or Biologic? covered entity cannot condition treatment on not opting WITHIN EXCEPTION out.15 • Refill reminders. Prohibition on Marketing with PHI • Communications about generic equivalents of a drug beGenerally, use or disclosure of PHI to encourage the puring prescribed. chase or use of a product or service is considered • Communications about a recently (within 90 calendar “marketing” and requires written patient authorization if the days) lapsed prescription. covered entity is paid for the use or disclosure.16 The • Adherence communications encouraging individuals to HIPAA updates provide an exception for paid PHI market- take prescribed medicines as directed. ing communications about a drug or biologic that the pa• Where an individual is prescribed a self-administered tient is already taking, including refill reminders, if the pay- drug, communications regarding all aspects of a drug dement for the communication is reasonably related to the livery system. cost of making the communication.17 NOT WITHIN EXCEPTION (See Refill Reminder FAQs) • Communications about specific new formulations of a currently prescribed medicine. Sale of PHI • Communications about specific adjunctive drugs related Authorization is generally required, with notice that discloto the currently prescribed medicine. sure of PHI is in exchange for payment; it includes nonfi• Communications encouraging an individual to switch from nancial benefits. a prescribed medicine to an alternative medicine. 1. Exceptions 2. Is There Financial Remuneration, and If So, Is It Reaa. Public health. sonably Related to the Cost of the Communication? b. Research purposes – remuneration must be reasonably related to the cost of preparing and WITHIN EXCEPTION transmitting information (can include indirect • Communication does not involve remuneration. costs but cannot make a profit). • Communication involves only non-financial or in-kind rec. Treatment and payment – disclosure of PHI to muneration, such as supplies, computers or other materireceive payment is not a “sale” of PHI. als. d. Corporate transactions. 18
THE KENTUCKY PHARMACIST
January 2014
Jan. 2014 CE — 2013 HIPAA Updates • Communication involves only payment from a party other than the third party (or other than on behalf of the third party) whose product or service is being described in the communication. • Remuneration involves payments to the covered entity by a pharmaceutical manufacturer or other third party whose product is being described that cover the reasonable direct and indirect costs related to the refill reminder or medication adherence program, or other excepted communications, including labor, materials and supplies, as well as capital and overhead costs. • Remuneration involves payments to a Business Associate assisting a covered entity in carrying out a refill reminder or medication adherence program, or to make other excepted communications, up to the fair market value of the Business Associate’s services. The payments may be made by a third party whose product is being described directly to the Business Associate or through the covered entity to the Business Associate.
under the “refill reminder exception” may continue to be exempt from patient authorization requirements under the following long-standing marketing exemptions:
The communications are made face-to-face at the pharmacy or other setting. Face-to-face communications do not include communications by telephone or sent by mail or e-mail.19
The communication is a promotional gift of nominal value provided by the covered entity.20
Written authorization has been obtained from the individual to make the communications.
The communications fall within another exception to the definition of marketing and do not involve financial remuneration.
Increased Patient Rights Right of Access: Electronic Copy
The individual continues to have the right to a copy of their designated record set in the requested form and format, if • Communication involves financial remuneration other than readily producible.21 If not readily producible, the individual as described above. has the right to a hard copy.22 If the designated record set is maintained in electronic format, the individual has the Examples of Permitted Communications right to an electronic copy.23 • A pharmacy administers a medication adherence program that involves mailing refill reminders and adherence com- Right of Access: Copy to Third Party munications to patients about their currently prescribed The individual may designate a third party to receive a drugs even though the pharmacy receives financial remucopy.24 The patient’s request must be in writing (full authorineration from the pharmaceutical manufacturers, provided zation is optional).25 It must clearly identify the designated the financial remuneration covers only the pharmacy’s reaperson, where to send the copy and who is making the resonable direct and indirect costs associated with the proquest.26 Full authorization is required if it is a third-party gram. request.27 • A pharmacy mails its diabetic patients information concerning the diabetic pumps used to administer their insulin Restriction for Out-of-Pocket Services even though the pharmacy is paid by the manufacturer of A covered entity must agree to an individual’s request to the pumps, provided the payment covers only the reasona- restrict disclosure to a health plan if the disclosure: ble direct and indirect costs associated with the communi1. Is for payment or health care operations and not othercations. wise required by law; and • A pharmacy hires a Business Associate to assist in ad- 2. Pertains solely to health care paid for out-of-pocket.28 ministering a medication adherence program that involves Notice of Privacy Practices (Summary) mailing adherence communications to patients about their currently prescribed drugs, even though the Business As- 1. Prohibition on sale of PHI. sociate is paid by the pharmaceutical manufacturers, pro- 2. Duty to notify affected individuals of a breach of unsecured PHI. vided the payment does not exceed the fair market value of 3. Right to opt out of fundraising (if applicable). the Business Associate’s services. 4. Right to restrict disclosure of PHI when paid out of Other Marketing Exceptions Continue to Apply pocket. Other paid “marketing” communications to encourage the 5. Limit on use of genetic information (certain health plans purchase or use of a product or service that are not exempt only). NOT WITHIN EXCEPTION
19
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates
January 2014
HIPAA Risk Analysis – An Important Annual Event
Action Items 1. Revisit policies, procedures and training. A. Opportunity for a HIPAA compliance “tune-up.” 2. Revisit breach notification process. 3. Start using up those old notices of privacy practices. 4. Inventory BAs and update BAAs (including subcontractors). 5. Train staff on new provisions. 6. Don’t delay.
The HIPAA updates retain the Security Rule requirement for covered entities and business associates to conduct a periodic risk analysis to identify potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by the Covered Entity or Business Associate.29 Covered Entities and Business Associates are required to implement security measures to reduce risks identified by the Risk Analysis.30 A vulnerability is a flaw or weakness in system security.31 A threat is an event that can trigger a “vulnerability.”32 A risk combines the likelihood that a threat will trigger vulnerability with the magnitude of the negative impact of such an event on the CE/BA (e.g., if vulnerability is likely to be triggered with the result being a $1 million fine, the risk is substantial).33
The HIPAA updates usher in extensive changes to the HIPAA landscape. Pharmacies should work swiftly to implement these changes in order to ensure compliance by the deadline. The risk of ignoring HIPAA responsibilities is a significant financial gamble. References
Examples include: Vulnerabilities: Doors unlocked Data not backed up Weak passwords Threats: Natural (e.g., storms, earthquakes) Human (e.g., thieves, hackers) Environmental (e.g., power failure) A HIPAA Risk Analysis examines administrative, physical and technical safeguards for ePHI. It helps to identify security issues that can be mitigated with policies/procedures and staff training. Ideally, a covered entity or Business Associate will adopt policies and procedures tailored to mitigate identified vulnerabilities, threats and risks. Don’t forget to document training! Maintaining an up-to-date risk analysis is important for pharmacy Covered Entities and Business Associates because failure to maintain an updated risk analysis is a HIPAA violation and likely one of the first items a compliance auditor will review. HIPAA penalties are serious, up to $1.5 million per violation.34 Enforcement New Focus on Willful Neglect Willful neglect is conscious, intentional failure or reckless indifference.35 It may include failure to develop or implement policies and procedures/train staff. Office of Civil Rights (OCR) have said that they will investigate all cases of possible willful neglect, will impose penalty on all violations due to willful neglect and may proceed to penalty without seeking informal resolution (e.g., settlement). Conclusion
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31.
78 Fed. Reg. 5565 (Jan. 25, 2013). 78 Fed. Reg. 5565, 5566. 45 C.F.R. § 160.103. 45 C.F.R. § 164.300. 45 C.F.R. § 160.103. 45 C.F.R. § 164.502(e)(2). 45 C.F.R. § 164.532(e). 45 C.F.R. § 164.532. 45 C.F.R. § 164.402(2). 45 C.F.R. § 164.508(a). 45 C.F.R. § 164.514(f)(2). 45 C.F.R. § 164.514(f). 45 C.F.R. § 164.514(f)(1). 45 C.F.R. § 164.514(f)(2). 45 C.F.R. § 164.514(f)(2)(iii). 45 C.F.R. §§ 164.501; 164.508. 45 C.F.R. § 164.501. Id. 45 C.F.R. § 164.508(a)(3)(i)(A). 45 C.F.R. § 164.508(a)(3)(i)(B). 45 C.F.R. § 164.524(c). 45 C.F.R. § 164.524(c)(2)(i). 45 C.F.R. § 164.524(c)(2)(ii). 45 C.F.R. § 164.524(c)(3)(ii). 45 C.F.R. §§ 164.524(c)(3)(ii); 160.502(a)(i). 45 C.F.R. § 164.524(c)(3)(ii). 45 C.F.R. § 164.502(a)(iv). 45 C.F.R. § 164.522(a)(1)(vi). 45 C.F.R. § 164.308(a)(ii)(A). 45 C.F.R. § 164.308(a)(ii)(B). HHS Guidance on Risk Analysis Requirements under the HIPAA Security Rule, p. 1 (July 2010) 32. Id. 33. Id.
20
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates
January 2014
34. 45 C.F.R. § 160.404(b)(2)(i)(B). 35. 45 C.F.R. § 160.401. Additional References
ber 9, 2013. 2. HHS.gov. Health Information Privacy. The HIPAA privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently being Prescribed for the Individual. September 19, 2013.
1. Morrone JE, Levitt JE. Federal Government Issues Guidance on Refill Reminders Under New HIPAA Omnibus Rule. Frier Levitt PBM Audit Lawyers Blog Octo-
January 2014 — 2013 HIPAA Updates: Key Implications for Your Pharmacy Organization 1. One of the most important changes to the HIPAA Final Rule that impact pharmacists is: A. Risk Assessment. B. Subcontractor Agreements. C. Notice of Privacy Practices. D. Enforcement Rules.
6. The HIPAA Refill Reminder Exception involves paid marketing communication. Which of the following communications is not within exception of the Refill Reminder? A. Communication is about a currently prescribed drug or biologic. B. The communication involves financial remuneration. C. The message encourages the patient to switch from a prescribed medication to an alternative medication. D. Communication involves a promotional gift of nominal value provided by the covered entity.
2. All Business Associate (BA) Agreements must be updated by Sept. 23, 2013. A. True B. False 3. Clarifications to the definition of the Business Associate under the Final Rule includes all of the following except: A. Health information exchange organizations, e-prescribing gateways and covered entities’ personal heath record vendors. B. Data transmission providers that require access to PHI on a routine basis. C. Subcontractors that handle PHI on behalf of the BA. D. Digital couriers that only require access to PHI on a rare basis. 4. Which of the following statements is incorrect about the Breach Notification Rule: A. It is not necessary to notify the patient in the event their PHI is compromised, as long as their pharmacy is notified. B. The Business Associate is required to notify the covered entity of a security breach. C. One of the risk assessment factors under the Breach Notification Rule is the nature and extent of PHI involved. D. Subcontractors are required to notify the covered entity of a security breach. 5. Changes to the pharmacy’s Notice of Privacy Practices includes: A. Allowing for the sale of PHI under all conditions. B. Informing patients they will receive a breach notification in the event their PHI is compromised only if they request the pharmacy to notify them. C. Disallowing use of PHI for marketing or fundraising purposes unless a statement to that affect is included in the Notice of Privacy Practices. D. Letting patients know to call their pharmacy if they think their PHI was used inappropriately.
7. Financial remuneration that is reasonably related to the covered entity’s cost of making the communication within the refill reminder exception does not require a patient’s authorization to use PHI. A. True B. False 8. HIPAA requires covered entities and BAs to conduct periodic risk assessments to identify all of the following except: A. Vulnerabilities. B. Threats. C. Compromise. D. Risks. 9. Enforcement includes a new focus on willful neglect of compliance with HIPAA policies. All of the following are true about enforcement and willful neglect except: A. Willful neglect means reckless indifference. B. Willful neglect means failure to develop or implement policies and procedures. C. If the subcontractor agreement is in place, the BA is not liable for the subcontractor if the subcontractor is noncompliant with the HIPAA Rules. D. State attorneys general can prosecute for covered entities and BA for HIPAA violations. 10. In preparation for the new changes to the HIPAA Rules effective Sept. 23, 2013, the following action steps are recommended for pharmacies except: A. Revisit policies and procedures and update manuals. B. Initiate employee training on the new Rules. C. Discard old Notice of Privacy Practices forms now and begin distributing new forms immediately. D. Update current Business Associate Agreements and develop new subcontractor agreements.
21
THE KENTUCKY PHARMACIST
Jan. 2014 CE — 2013 HIPAA Updates
January 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: January 29, 2017 Successful Completion: Score of 80% will result in 1.5 contact hour or 0.15 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. January 2014 — 2013 HIPAA Updates: Key Implications for Your Pharmacy Organization (1.5 contact hours) Universal Activity # 0143-0000-14-001-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B 4. A B C D 6. A B C D
7. A B 8. A B C D
9. A B C D 10. A B C D
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No 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 January 2014 — 2013 HIPAA Updates: Key Implications for Your Pharmacy Organization (1.5 contact hours) Universal Activity # 0143-0000-14-001-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B 4. A B C D 6. A B C D
7. A B 8. A B C D
9. A B C D 10. A B C D
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.
22
Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.
THE KENTUCKY PHARMACIST
Roamey Visits western Kentucky
January 2014 Roamey visits western Kentucky Roamey, the KPhA Membership Matters Gnome, made his way to Paducah and Mayfield in November, and brought along KPhA President Duane Parsons, Executive Director Robert McFalls, Director of Pharmacy Emergency Preparedness Leah Tolliver and Director of Communications and CE Scott Sisco. Roamey is pictured here with the staff of Strawberry Hills Pharmacy in Paducah. To see more pictures of Roamey on his travels around the state, Like us on Facebook (KyPharmAssoc) or check out the Gallery on www.kphanet.org.
KPhA Pharmacy Emergency Preparedness Initiative Interest Form Name: ______________________
Status (Pharmacist, Technician, Other): ___________________
Email: ______________________________ Phone: ___________________________ For Pharmacists: Interest in serving as a volunteer: Yes____ No _____ If yes, please go to KHELPS link on KPhA Website to register (www.kphanet.org under Resources) Please send this information to Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness via email at ltolliver@kphanet.org, fax to 502-227-2258 or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601.
Pharmacy Health Screening Provide state of the art health screenings to help improve YOUR patients’ health and your bottom line. Schedule a Health Screening Day at your pharmacy to offer YOUR patients a service to improve their health and potentially catch dangerous issues early! The health screenings offer multiple advantages for your business including immediate profit from the screening process and the early recognition of diseases that are usually treated with medications as well as increase the health and longevity of your patients. The process is a partnership between the Kentucky Pharmacists Association and Xcel Diagnostics and YOUR pharmacy to bring state of the art health screenings to your patients. The net profit is divided among the partners, including your pharmacy.
Call Xcel Diagnostics today to schedule your screening day. (606) 218-5483 23
THE KENTUCKY PHARMACIST
Technician Review
January 2014
Technician Review From the KPhA Academy of Technicians The KPhA Pharmacy Technician Academy members hope that everyone had a great holiday season. As we begin 2014, we remain steadfast in our goals of advancing the pharmacy technician profession, and our hope is that every technician will join the Academy and help us reach them. This year will bring with it many changes in the healthcare profession, and no one group of providers can handle the entire patient care. We have an opportunity as pharmacy technicians to embrace these changes and help the pharmacists be more proactive and hands-on in the care of our patients. Our proposals are circulating through various state organizations and committees for review and discussion. We
hope to see some movement in 2014 that will establish the pharmacy technician as a career that will grow and evolve to accommodate the future needs of our profession. With the review of national standards by ASHP and PTCB, we will see some changes take effect in 2014. PTCB will roll out their back-ground check initiative during 2014. The national organizations are looking at the evolution of the pharmacy technician and the modifications necessary to advance the pharmacy profession. Our goals are a reflection of the national changes that are forthcoming. To be more involved, join the KPhA Pharmacy Technician Academy by contacting Don Carpenter at dacarpenter@stclaire.org.
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 24
THE KENTUCKY PHARMACIST
Feb. 2014 CE — Influenza Vaccines
January 2014
Making Evidence-Based Selections of Influenza Vaccines By: BC Childress, PharmD, BCACP, FASCP, Director of the InterNational Center for Advanced Pharmacy Services (INCAPS) & Josh Montney, PharmD, PGY-1 Pharmacy Practice Resident at INCAPS, Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-14-002-H01-P&T 1.0 Contact Hours (0.1 CEUs) Objectives: At the conclusion of this lesson, the reader should be able to: 1. Distinguish between the innate and adaptive immune systems.* 2. Describe how flu vaccines work with the body’s immune system.* 3. Discuss the differences in flu vaccine composition.* 4. Discuss the differences in flu vaccine routes of administration.* 5. Select the most effective flu vaccine for a patient. *Technician Objectives
KPERF offers all CE articles to members online at www.kphanet.org
Background
sequent infections.1,2
Years ago, intramuscular influenza vaccines were the only option available to those who wanted to arm themselves against the flu. Today there are alternatives, including intradermal injections and intranasal sprays. The variety of options can lead to new questions. Which option is best? Is one superior to another? This article aims to guide pharmacists, pharmacy technicians and other health care professionals in making evidence-based selections of influenza vaccines for their patients.
One very important type of cell involved in immune response is the dendritic cell, found primarily in the skin. For years, little was known about this type of cell. However, according to recent research, dendritic cells have numerous receptors and are able to rapidly recognize and process invading organisms.3 This means that cells in the skin can begin to activate the adaptive immune system before a pathogen ever reaches the bloodstream.
Innate immunity consists of various leukocytes, including monocytes/macrophages, neutrophils, basophils, eosinophils and mast cells. Some of these cells secrete inflammatory chemicals to trigger a greater immune response. Others, such as macrophages, act as phagocytes and destroy the invading pathogens on their own. As this innate immunity is hard at work, the chemicals released trigger the adaptive immune system to join the fight. While innate immunity is fast at recognizing and fighting pathogens that have entered the body, the adaptive immune system is more effective due to memory and specificity. This system “adapts” to fight specific pathogens, becoming more efficient with sub-
Does the route of vaccine administration make a difference? A closer look at the immune system reveals that it does. Most cells of the immune system are found in the bloodstream, but they also are able to migrate into tissues to fight infection.5 Dendritic cells, however, are predominant in the skin.3 Vaccines that are administered intramuscularly bypass these cells. Other cells involved with innate immunity will migrate to the muscle and activate the adaptive immunity, but the memory of the specific pathogen (via antibody development) occurs in the bloodstream. Interestingly, influenza infection does not begin in the bloodstream, but rather in the respiratory tract.
For immunizations to work well, both the innate and adaptive immune systems need to be involved. When adminisInnate vs Adaptive Immunity tered, flu vaccines elicit the creation of antibodies by the First, it is important to review how the immune system adaptive immune system. During the two to three weeks works. Innate immunity is the body’s first line of defense following immunization, these antibody levels increase and against foreign invaders. Skin provides the largest physical prepare for a subsequent invasion by the real flu virus. barrier, while cilia and mucous line the airways and respiraConsequently, the body’s immune system rapidly mobilizes tory tract to defend against inhaled organisms. When into fight the infection effectively.4 vaders make it past these physical barricades, the body deploys the innate immune system. Difference in Vaccine Delivery
25
THE KENTUCKY PHARMACIST
Feb. 2014 CE — Influenza Vaccines Table 1. Routes of influenza vaccine delivery.7
January 2014
Vaccine Name
Route of Administration
to the dense population of dendritic cells in the skin (See Table 2 for a summary of delivery comparisons).
Flumist (LAIV)
Intranasal
Differences in Vaccine Composition
Fluzone (TIV) All other flu vaccines (QIV/TIV)
Intradermal
Vaccine delivery is not the only piece to this puzzle. One must also consider the composition of the vaccine. For the Intramuscular 2013-2014 flu season, there were 13 different flu vaccine Table 2. Comparative vaccine efficacy based on delivery mechanism formulations on the market.7 Study: Intramuscular vs Intradermal11 While many of these vacVaccine Intradermal Intramuscular cines may look the same to a patient, there are vast difSeroconversion rate 78 percent 66 percent ferences in their indications, Study: Intramuscular vs Intradermal12 contraindications and efficaVaccine Intradermal Intramuscular cy. Table 3 summarizes the current vaccines on the marSeroconversion rate 85 percent 79 percent ket. Figure 1 provides an Study: Intramuscular vs Intranasal8,9 algorithm for deciding which Vaccine Intranasal Intramuscular flu vaccine to use. Protective efficacy 85 percent 71 percent Although many of these vac10 Study: Intramuscular vs Intranasal cines may look alike, there are stark contrasts. Some of Vaccine Intranasal Intramuscular these vaccines protect Relative efficacy to intramuscular 27 percent (more effective) -against four strains of influenza, while others protect against three. One vaccine conResearch is not conclusive, but this could explain why flu tains four times the amount of other intramuscular agents.13 vaccines are not always effective — even against matched As previously discussed, research continues to show that strains. The CDC estimates that general flu vaccine effecintradermal vaccines and live intranasal vaccines are more tiveness is between 45-55 percent annually.4,6 This means effective at soliciting an immune response than traditional that 45-55 individuals out of every 100 who receive a flu trivalent inactivated intramuscular vaccines. vaccine are still susceptible to infection even when the strains are properly matched to the vaccine. So how can flu Conclusion vaccine efficacy be improved? Preventing influenza outbreaks is no simple task. It starts with increasing rates of immunization and advocating for One solution is to strengthen the immune response to a early vaccination. Over the past several years, vaccines vaccine. This may be accomplished utilizing alternative routes of vaccine delivery. There are three different routes have become available in August, long before the first flu epidemic makes the news. Nonetheless, many wait until of flu vaccine administration today.7 (See Table 1.) Since the virus is rampant before taking action. Pharmacists and the intradermal and intranasal vaccines were released, there have been multiple studies comparing their effective- technicians can play a vital role here by advocating for imness to the traditional intramuscular injection. Results pub- munization as soon as vaccines are available. Choosing lished by the CDC have shown that in a head-to-head com- the most appropriate vaccine also can be difficult. Even though the CDC does not recommend one vaccine over parison, the intranasal vaccine produced an 85 percent effective rate as opposed to 71 percent by the intramuscu- another, its data say otherwise. Their lack of opinion is most likely an effort to avoid endorsing a certain brand or lar.8 Such discrepancies were even greater in children.9,10 company. Similar studies have demonstrated superiority with intradermal vaccine delivery. One study used an intradermal dose Research is still forthcoming, but most evidence shows that 1/5 that of the intramuscular influenza vaccine, and found vaccine development is progressing to provide better soluthat even a significantly smaller dose of vaccine was able tions to fighting annual influenza epidemics. As a general to produce a stronger immune response. These researchrule, live-virus vaccines and intradermal vaccines produce ers also hypothesized that this response may be due in part the strongest immune response. Vaccines with four strains 26
THE KENTUCKY PHARMACIST
Feb. 2014 CE — Influenza Vaccines
January 2014
Table 3. Flu vaccines available for 2013-2014 season.7 Delivery Vaccine Composition Restrictions Route
Notes Not for persons with chronic disease
FluMist
Quadrivalent - LAIV
Intranasal
Ages 2-49 only
Fluarix
QIV
Intramuscular (IM)
Ages 3+
FluLaval
QIV
IM
Ages 3+
Fluzone
QIV
IM
6 months +
Afluria
TIV
IM
Ages 9 +
Fluarix
TIV
IM
Ages 3+
Flucelvax
TIV
IM
Ages 18+, contraindicated in severe egg allergy
FluLaval
TIV
IM
Ages 3+
Fluvirin
TIV
IM
Ages 4+
Fluzone
TIV
IM
6 months +
Fluzone ID
TIV
Intradermal (ID)
Ages 18-64
Fluzone HD
TIV
IM
Ages 65+
Flublok
Trivalent recombinant
IM
Ages 18-49
Linked to fever in children under 9
Cell culture-based vaccine
More common reactions at injection site Contains 4X as much inactivated vaccine as standard injections Completely egg-free
of the flu virus (quadrivalent vaccines) will provide greater Prevention. Available at: http://www.cdc.gov/flu/ protection than trivalent vaccines. The most recent eviprofessionals/vaccination/effectivenessqa.htm. Acdence and sufficient knowledge of the immune system will cessed on: January 9, 2014. allow pharmacists to continue to play a major role in advo5. Chaplin DD. Overview of the human immune recating for immunizations, determining the most appropriate sponse. J Allergy Clin Immunol 2006;117:S430–S435. vaccine and ensuring proper administration of annual vaccines. Technicians also can encourage vaccination in their 6. Key facts about seasonal flu vaccine. Centers for Disease Control and Prevention. Available at: http:// patient interactions and help dispel myths and rumors that www.cdc.gov/flu/protect/keyfacts.htm. Accessed on frustrate the efforts of health care providers to keep paJanuary 9, 2014. tients healthy. References 1. Hall PD, Pilch N, Atchley DH. Chapter 95. Function and Evaluation of the Immune System. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 8e. New York: McGraw-Hill; 2011. http:// accesspharmacy.mhmedical.com/content.aspx? bookid=462&Sectionid=41100874. Accessed January 10, 2014. 2. Delves PJ, Roitt IM. The immune system, first of two parts. N Engl J Med 2000;343:37–49. 3. Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature 1998;392:245–252. 4. Flu vaccine effectiveness: questions and answers for health professionals. Centers for Disease Control and
7. Flu vaccines 2013-2014. Pharmacist’s Letter/ Prescriber’s Letter Detail Document #291001. October 2013. Available at: www.pharmacistsletter.com. Accessed on January 9, 2014. 8. Treanor JJ; Kotloff K; Betts RF et al. Evaluation of trivalent, live, cold-adapted (AIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection an d illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), and B viruses. Vaccine 1999; 18:899-906. 9. Jain VK; Rivera L; Zaman K; et al. Vaccine prevention of mild and moderate-to-severe influenza in children. N Engl J Med 2013; 369:2481-91. 10. Belshe RB; Edwards KM; Vesikari T; et al. Live attenuated versus inactivated influenza vaccine in infants and young children. 27
THE KENTUCKY PHARMACIST
Feb. 2014 CE — Influenza Vaccines
January 2014
11. Kenney RT; Frech SA; Muenz LR; Villar CP; Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Eng J Med 2004;351:2295-301.
8531. Available at: http://www.phac-aspc.gc.ca/ publicat/ccdr-rmtc/11vol37/acs-dcc-4/index-eng.php. Accessed on: January 9, 2014.
12. Canadian National Advisory Committee on Immuniza- 13. Lowes R. Fluzone high-dose foils flu better in seniors, tion. Reccomendations on the use of intradermal trivasays maker. Medscape Medical News, 2013. Availalent inactivated influenza vaccine (TIV-ID). Canada ble at: http://www.medscape.com/viewarticle/813203. Communicable Disease Report 2011;37(ACS-4):1481Accessed on: January 9, 2014.
28
THE KENTUCKY PHARMACIST
Feb. 2014 CE — Influenza Vaccines
January 2014
February 2014 — Making Evidence Based Selections of Influenza Vaccines 1. Which of the following cells of the innate immune system plays an important role in activating adaptive immunity? A. Macrophages B. Dendritic cells C. Neutrophils D. Eosinophils
5. Which route of flu vaccine administration generally leads to higher rates of antibodies and higher vaccine efficacy? A. Intramuscular injection B. Intradermal injection C. Oral capsule D. None of the above
2. Why is the adaptive immune system so effective at fighting infections? A. It remembers invading pathogens to fight them better each subsequent infection. B. Antibodies are developed to specifically target and destroy invading pathogens. C. Macrophages never have to rest between infections. D. A & B
6. If a patient has a severe egg allergy, which vaccine is the best to use? A. FluMist (LAIV) B. Fluzone High Dose (TIV) C. Flublok (Recombinant TIV) D. Fluzone intradermal (TIV)
3. Which of the following flu vaccines is most effective at activating both innate and adaptive immune responses? A. Intradermal flu vaccine B. Intranasal flu vaccine C. Intramuscular flu vaccine D. All of the above are equally effective 4. Which of the following flu vaccines protects against 4 strains of flu virus? A. FluMist (LAIV) (QIV) B. Fluzone (Q(V) C. Afluria (TIV) D. A & B
7. If a patient is completely healthy, 18 years old, and afraid of needles, which vaccine would be best to use? A. FluMist (LAIV) B. Fluzone High Dose (TIV) C. Flublok (Recombinant TIV) D. Fluzone intradermal (TIV) 8. Your pharmacy is ordering vaccines for the upcoming flu season. Flumist (LAIV), Fluzone Intradermal and Fluzone High Dose have already been ordered. If cost is not a factor, which of the following intramuscular vaccines would be best to complete this order? A. Afluria (TIV) B. Fluarix (TIV) C. Fluzone (QIV) D. Fluvirin (TIV)
29
THE KENTUCKY PHARMACIST
Feb. 2014 CE — Influenza Vaccines
January 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: January 30, 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. February 2014 — Making Evidence Based Selections of Influenza Vaccines (1.0 contact hours) Universal Activity # 0143-0000-14-002-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 February 2014 — Making Evidence Based Selections of Influenza Vaccines (1.0 contact hours) Universal Activity # 0143-0000-14-002-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.
30
Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.
THE KENTUCKY PHARMACIST
USP label standard update
January 2014
When a Small Reminder Makes a Big Difference Have you ever had one of those little warning icons light up on your car’s dash and you don’t know what it means? You know that some signals require attention right away and others can wait. The thing is, most of the time you have to look up the icon to make that decision. When it comes to medicines and people’s lives, there is no substitute for being clear about a warning, and for injectable drugs the stakes are particularly high. Beginning Dec. 1, 2013, manufacturers of injectable drugs will have to comply with new labeling standards that help ensure that important warnings — warnings that can help prevent lifethreatening situations — are obvious and clear. The standards were established by the U.S. Pharmacopeial Convention (USP). USP is a scientific nonprofit organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. USP's mission is to improve global health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods.
for example, “Warning – Paralyzing Agent” or “Dilute Before Using” – are the only markings that should appear on ferrules and cap overseals of injectable drugs. The ferrules and cap overseals must remain clear of any markings, including logos, except for markings intended to prevent an imminent life-threatening situation. The standard goes on to say that warnings must be printed in contrasting color and clearly visible under ordinary conditions of use. Finally, products that do not require cautionary statements should be free of information, so that those with cautionary statements are immediately apparent. With the new USP labeling standard, if a healthcare provider sees a warning on a ferrule or cap overseal, he or she will know immediately that it is a vital, possibly life-saving piece of information that must be observed and acted upon before administering the drug to the patient. Warning messages on ferrules and cap overseals may go a very long way to helping practitioners protect their patients from harm.
In short, this USP standard states that warning messages – - Thanks to USP for providing this update. 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
31
THE KENTUCKY PHARMACIST
KPhA New and Returning Members
January 2014
KPhA Welcomes New and Renewing Members November-December 2013 John Anneken Edgewood
Robert Clement Cadiz
Tom Frazer Sturgis
Gary Hamm Elizabethtown
Paul Arthur Huntington, W.V.
Bonnie Collins Paris
Kristen Fugate Krypton
Catherine Hance Louisville
Emily Balenovich Corbin
George Combs Louisville
Randy Gaither Louisville
Amanda Harding Louisville
Ellen Barger Mount Washington
Matt Cull Owenton
Malcolm Geoghegan Frankfort
Marla Helton Frenchburg
Ronald Barned Glasgow
Dan Daffron Monticello
Eric Gibbs Corbin
Robin Hipps New Albany, Ind.
Walter Bauman Lancaster
Pamela Decker-Meadows Cynthiana
Paula Gibson Manchester
Celina Howell Pikeville
Thomas Beringer Sparta
Eldon Depew London
Mary Gilvin Mt. Sterling
Melissa Hudson Villa Hills
Kaleb Blair Ermine
Walter Doll Lexington
Susan Girdler Somerset
David Hume Louisville
Renee' Blair London
Ben Duvall Big Clifty
Amy Glaser Alexandria
Bernard Hyman Louisville
Wendell Boggs Jenkins
Paul Easley Fisherville
Norris Glenn Salem
Jane Ingram Morehead
Brenda Brewer Stanton
Anna Eiler Shepherdsville
Rosemary Goble Inez
Kyla James Sellersburg, Ind.
William Broughton Shepherdsville
Suzanne Epley Russellville
Michael Goeing Melvin
Joseph Johnson Lebanon
Charles Bryant Cave City
Nikita Evans South Shore
April Golden Corbin
Frederick Johnston Georgetown
Jimmy Buchanan Prospect
Rebecca Farney Fort Thomas
William Grise Richmond
Linda Johnston Georgetown
William Clark Owensboro
Andy France Dry Ridge
Gina Guarino Louisville
Robin Justice Pikeville
Heather Clayton Elkton
Virginia France Dry Ridge
Tina Hall Greenup
Diane Kelly Evarts
32
THE KENTUCKY PHARMACIST
KPhA New and Returning Members
January 2014
Melissa Kennon Lexington
Clayton McKinney Shelbyville
Vendonna Rickard Madisonville
Quincy Stephenson Providence
Ethan Klein Louisville
Michael McWilliams Louisville
Mary Roberts Robinson Creek
Misty Stutz Crestwood
Dhaval Kotak Radcliff
Parvin Mischel Kathleen, Ga.
Kristie Robertson Louisville
William Sutherland Louisville
Amanda Leathers Lebanon
Megan Morgan Manchester
Lynda Romeo Louisville
Stephanie Sutphin Lexington
Sheila Lee Louisville
Wayne Morris Frankfort
Michael Russell Murray
Christina Taylor Shepherdsville
Martin Likins Greenville
Freddie Norris Glasgow
Nicholas Schwartz Florence
Fred Toncray Maysville
Michael Lin Louisville
Robert Oakley Louisville
James Shackleford London
David Triplett Louisville
James Litmer Edgewood
Jennifer O'Hearn Louisville
Michael Sheets Fisherville
Sheryl Turley Horse Cave
Robert Little Berea
Charles Oliver Glasgow
Angela Shoulders Bowling Green
G Steven Underwood Louisville
Jimmie Lockhart Lexington
Angela Onkst Louisville
JD Shoulders Bowling Green
Gabe Van Lahr Webster
Calvin Manis Barbourville
Yvonne Parmley Florence
Jennifer Shown Cadiz
Frank Vice Flemingsburg
Arthur Marinaro Lexington
Kenneth Parsons Louisville
Joe Simmons Glasgow
Susan Weaks Paducah
Jonathan Marquess Acworth, Ga.
Sam Pilotte Prospect
Sharon Small Louisville
Tyler Whisman Florence
Nancy Matyunas Louisville
Anne Policastri Georgetown
Jamie Smith Booneville
Amy Wilder Booneville
James Maze Salt Lick
Andrea Potter-Adams Isom
Jessica Smith Booneville
Brenda Wilson Danville
Thomas McCurry Harlan
Sharon Ran Villa Hills
John Smith Beattyville
Randy Windham London
Clarence McGaughey Russell
Jeanne Richardson Memphis, Tenn.
Lois Smith Blackey
Laban Young Huntington, W.V.
33
THE KENTUCKY PHARMACIST
Medicare Star Ratings
January 2014
Medicare Star Ratings: What it means for your pharmacy By: Elliott M. Sogol, PhD, RPh, FAPhA Vice President Professional Relations, Pharmacy Quality Solutions
During this past year, CMS also began evaluating MTM programs by measuring the “Comprehensive Medication Review (CMR) completion rate” for all drug plans. It is expected that this CMR measure will be added to the Star measure set in the next round of ratings.
Did you know that your pharmacy is being evaluated by Medicare prescription drug plans? If not, read on… The The Part D plans are now evaluating their pharmacy netCenters for Medicare & Medicaid Services (CMS) is evaluworks on these CMS star ratings measures. Some plans ating all Part D prescription drug plans using a Star Rating also are creating incentives for pharmacies to improve persystem for several years. Medicare prescription drug plans formance on these measures while others are planning to receive a summary “star rating” on quality that is based on re-formulate their preferred networks with phartheir performance across 15 individual Want to know macies that perform well on the star measures. measures. Five measures are specifically relat- more? YOUR KPhA The implications for community pharmacy is ed to medication management and use. Beis planning a CE on significant! cause CMS more heavily weighs these 5 Medicare Star What can you do? Pharmacies can learn how measures than other measures, they account Ratings for the they are performing on the star measures by for nearly half of the plan’s Part D summary 136th Annual subscribing to a new program named EQuIPP. rating. These measures are: Meeting The EQuIPP program is a web-based platform in June 2014. 2 measures of medication safety to which health plans submit their prescription Watch claims data for benchmarking. EQuIPP also High risk medications in the elderly www.kphanet.org calculates the star measures for each pharma Appropriate treatment of blood pressure in for more cy and makes this information available to the persons with diabetes information. pharmacies via a secure website. EQuIPP is a service offered by Pharmacy Quality Solutions 3 measures of medication adherence (PQS), a company owned by Pharmacy Quality Alliance Oral diabetes medications (PQA), a non-profit that develops medication performance measures used by CMS for the STAR ratings process. A Cholesterol medication (statins) growing number of Medicare plans are participating in Blood pressure (renin-angiotensin system antagonists) EQuIPP including Humana, Wellcare, Coventry, and Cigna -HealthSpring. For more information, visit CMS also evaluates prescription drug plans on “display www.EQuIPP.org. measures” which includes metrics on drug-drug interactions, excessive doses of oral diabetes medications and - Special thanks to the Pharmacists Society of the State of the use of atypical antipsychotics in nursing home patients. New York, where this article was originally published.
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 “above and beyond the call of duty”? Let us know! Email Scott Sisco at ssisco@kphanet.org with a brief description of the story or to schedule a time to discuss. 34
THE KENTUCKY PHARMACIST
Roamey in Mayfield
January 2014
Roamey in Mayfield While in Mayfield, Roamey visited Stone’s Drug and Home Medical. Where will Roamey show up next? If you want to host Roamey for an event or a tour of your practice site, email Scott Sisco at ssisco@kphanet.org, and we’ll check his schedule!
@KyPharmAssoc @KPhAGrassroots
Are you connected to KPhA? Join us online!
KPhA Company Page
Facebook.com/KyPharmAssoc
Donate online to the Kentucky Pharmacists Political Advocacy Council! Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form.
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) Credit Card (AMEX; Discover; MasterCard; VISA) Account #: _______________________________________ Expiration date: _______ CVV: ______________ Billing address (if different from above) ___________________________________________________________________________________
Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601
35
THE KENTUCKY PHARMACIST
Pharmacy Law Brief
January 2014
Pharmacy Law Brief: Implications of Being a Specialist Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I recently had occasion to visit my personal physician and while being taken back to the examination room as well as while sitting there I noticed all the diplomas and certificates she displays. I assume these are up in order to communicate her expertise to patients. But I’m wondering whether there are legal implications of this; for example, might the law hold her to a higher standard of performance because she holds herself out as having specialized expertise?
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.
Response: The experience you report is something we likely all share. Displaying such diplomas and certificates is one way professionals communicate to others evidence of their documented expertise. They passed numerous examinations to earn their various academic degrees and, if “board certified,” passed some form of examination created at whether some legal duty was owed to the patient and, by those already in the specialty to establish their abilities in secondarily, whether that duty was breached. Where does a certain area of practice. that legal duty originate? The law expects that one will perBut let’s differentiate some of those wall displays. An acaform at the level of a reasonable and prudent practitioner demic degree is evidence of achievement in the academic possessing the expertise of one engaging in that type of realm but that is separate from licensure. It is the latter that practice. So, the performance of a family medicine specialauthorizes one to engage in the practice of a profession. ist would be evaluated in light of the performance of profesThis authority to confer the lawful ability to practice a prosional peers in that specialty, just as a neurosurgeon would fession rests with the states. When the legislature defines have his or her performance measured against a standard the “scope of practice” for a profession in a “practice act” it created by others in that specialty. establishes the parameters of professional activity. And that’s where all those diplomas and certificates beBasic licensure authorizes the practitioner to perform all come relevant. Those documents, along with the decision manner of professional activities that fall within that scope of the practitioner to define the activities in which he or she of practice. It is noteworthy, however, that some profession- will engage, define the area in which the professional’s perals decide to limit their activities to a subset of what the liformance will be measured against those of peers, individucensure confers, e.g., “practice limited to obstetrics” or als with the same training and experience as the defendant “practice limited to children.” in the lawsuit. Becoming board certified is a voluntary unFinally, it also is possible that when a health professional is dertaking, these days involving not only written examinations but also simulations to assess expertise. granted privileges by the board of directors of a hospital,
the institution may limit the types of procedures that individ- A final note about terminology also is important. A physician ual is authorized to perform within that setting, e.g., may seeking to become board certified usually must first comdeliver babies but may not do open heart surgery. plete a post-M.D. residency program. One who has comWith all that as background, what are the legal implications pleted that residency training receives a certificate, not an of holding yourself out as a specialist? Focusing on the im- academic degree, and the certificate holder who has yet to plications during a lawsuit alleging professional negligence, take and pass the examination is said to be “board eligible,” known colloquially as a malpractice case, the law first looks not board certified.
36
THE KENTUCKY PHARMACIST
KPhA First District Meeting
January 2014
KPhA First District meeting draws a large crowd KPhA First District members organized a meeting in late November and more than 30 pharmacists and pharmacy technicians attended. KPhA President Duane Parsons, Executive Director Robert McFalls, Director of Communications and CE Scott Sisco and Director of Pharmacy Emergency Preparedness Leah Tolliver represented KPhA at the meeting. Tolliver presented a continuing education program on pharmacy emergency preparedness. Special thanks to Rick Sutton, Sam Willett and Fran Sherrill for hosting and planning the meeting and coordinating area pharmacy visits.
Registration and schedule information will be at www.kphanet.org soon! Mark your calendar now!
37
THE KENTUCKY PHARMACIST
Pharmacy Policy Issues
January 2014
PHARMACY POLICY ISSUES: Effectively utilizing pharmacists in interprofessional teams to reduce hospital medication errors Author: Ashley Irene Michnick, a first professional year student at the University of Kentucky College of Pharmacy, also is interested in pursuing a Master of Science in Pharmaceutical Outcomes and Policy. Ashley completed her Bachelor of Arts degree with Honors in Public Policy Analysis and Biological Sciences at The University of Chicago in June 2013. She is a native of West Chicago, Illinois. Issue: “Fallibility is a condition of the human existence. ... Each [member of the medical community] has an affirmative duty to be, to a limited extent, his brother’s keeper. ... It is not for the judiciary to dismantle the safety net and leave patients at the peril of one man’s human frailty.”1 Legal issues surrounding cases of medication errors have consistently shown that health care providers must take responsibility for their recommendations and actions. Pharmacists play a particularly crucial role in preventing and reducing medication errors in hospitals, yet professional standard-setting organizations offer conflicting responsibilities for key steps in the medication safety process. How can pharmacists act in the most effective manner to reduce medication errors in a complex healthcare system with many providers? Discussion: Beginning as early as 1975, organizations around the country began to focus vast amounts of effort on reducing medication errors. As time passed, courts found pharmacists and physicians jointly responsible for medication safety, as in the 1986 case of Riff v Morgan Pharmacy 2 and Congress took a more active role by enacting legislation regarding medication safety, particularly by passing the Healthcare and Research Quality Act of 1999, and establishing the Agency for Healthcare Research and Quality.
The American Pharmacists Association (APhA) also sets its professionals at the forefront of medication safety strategies. In order to reduce medication errors, APhA stresses collaboration and communication, both with physicians and patients. At the Annual Meeting and Exposition in 2003, pharmacist-lawyer Kenneth Baker of the APhA urged pharmacists to take the lead on collaboration with physicians. 5
Despite major progress in the field, the respective roles of each health care professional in medication safety programs are not clear in hospitals. In 2007, the American Medical Association (AMA) convened a panel of physicians and pharmacists to discuss the physician’s role in medication error prevention. They concluded that the physician should take the lead on medication safety processes, in collaboration with other healthcare professionals.3
Though organizational standards are in conflict, studies have demonstrated that the most effective medication safety programs involve strict and clear cooperation among pharmacists and other health care professionals in the hospital. One multicenter study showed as much as a 67 percent decline in adverse drug events after implementing a medication safety regimen in which roles for nurses, pharmacists and physicians were clearly delineated.6 Another study demonstrated that the “case conference between the pharmacist and these other health care professionals is an essential aspect” of the medication safety regime.7
Though the AMA claims physicians should be the leaders on medication error prevention, the American Nurses Association has established numerous guidelines by which to standardize medication distribution and place the nurse’s role at the forefront given their ubiquity throughout the process.4
Even without universally consistent recommendations, pharmacists can take the initiative to institute collaborative medication safety programs in hospitals. Utilizing each health care professional in concord results in fewer medication errors and better outcomes for hospitals and patients. Evidence has demonstrated that pharmacist recom-
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
January 2014
Pharmacy Time Capsules mendations are accepted and improve patient and hospital outcomes.8 As the drug knowledge expert on any team, pharmacists can positively impact hospitals’ medication safety programs if they take the initiative to institute collab5. orative interprofessional teams. References
http://www.nursingworld.org/ FunctionalMenuCategories/MediaResources/ PressReleases/2007/SyringeSafetyStudy.pdf. Baker KR. Risk management from a collaborative perspective. J Am Pharm Assoc 2003 (Sept-Oct); 43(5 Supp. 1):S54-5.
1. Brushwood DB, Simonsmeier LM. Riff v. Morgan Phar- 6. Khoo AL, et al., A multicenter, multidisciplinary, highmacy: A legal mandate for patient-oriented pharmacy alert medication collaborative to improve patient safety: practice. Am Pharmacy 1987 (Mar.); NS27:68-69. The Singapore experience. Joint Commission Journal on Quality and Patient Safety/Joint Commission Re2. Riff v. Morgan Pharmacy, 508 A.2d 1247 (Pa. Super. sources 2013 (May); 39:205–212. 1986). 3. American Medical Association, “The Physician’s Role in Medication Reconciliation: Issues, Strategies and Safety Principles,” 2007, http://www.ama-assn.org/ resources/doc/cqi/med-rec-monograph.pdf.
7. Leikola S, et al., Comprehensive medication review: Development of a collaborative procedure. International Journal of Clinical Pharmacy 2012 (Aug.); 34:510– 514.
4. American Nurses Association, Medication Errors and Syringe Safety Are Top Concerns for Nurses According to New National Study, News Release (Silver Spring, MD, June 18, 2007),
8. Moczygemba LR, et al., Integration of collaborative medication therapy management in a safety net patient -centered medical home,” J Am Pharm Assoc. 2011 (Apr.); 51:167–172.
Pharmacy Time Capsules 2014 First Quarter 1989 — 25 Years Ago The second Pharmacy in the 21st Century (P21) conference held in Williamsburg. The concept of pharmaceutical care was formally introduced by Hepler and Strand and enthusiastically accepted. 1964 — 50 Years Ago The survey, Mirror to Hospital Pharmacy, published. Data included that less than 40 percent of all hospitals employed approximately 2,000 full-time pharmacists. 1939 — 75 Years Ago Western Massachusetts School of Pharmacy opened in Willimansett, Mass., although never accredited. 1914 — 100 Years Ago
1889 — 125 Years Ago
The federal Harrison Narcotic Act passed to regulate and Walden University (Meharry Pharmaceutical College) tax the importation, production and distribution of narcotics. opened in Nashville. By: Dennis B. Worthen, PhD, Cincinnati, OH 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
39
THE KENTUCKY PHARMACIST
January 2014
Pharmacists Mutual
40
THE KENTUCKY PHARMACIST
Cardinal Health
January 2014
41
THE KENTUCKY PHARMACIST
KPhA Board of Directors/Staff
January 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 Killmeir, Louisville cdkillmeier@hotmail.com Jeff Mills, Louisville* jeff.mills@nortonhealthcare.org Chris Palutis, Lexington chris@candcrx.com
Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org
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
KPhA sends email announcements weekly. If you aren’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
January 2014
50 Years Ago at KPhA NOT THE BEST GRAND OPENING Ross Melton, R.Ph., Mt. Sterling, formerly with Begley Drug Company in that city, has opened Ross Drugs, Inc., in Mt. Sterling. On the Opening day Melton’s store was robbed, including cash and an undetermined amount of cigars. - From The Kentucky Pharmacist, January 1964, Volume XXVII, Number 1.
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
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 Pharmacy Technician Certification www.aphanet.org Board 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.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 ksheets@kphanet.org. Deceased members for each year will be honored permanently at the KPhA office. 43
THE KENTUCKY PHARMACIST
January 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