the kentucky pharmacist vol. 9 issue 1

2014 Kentucky

Legislative Session

Roamey and KPhA are in Frankfort,

advocating for YOU!

Vol. 9, No. 1 January 2014

TTTHEHEHE KKKENTUCKYENTUCKYENTUCKY

PPPHARMACISTHARMACISTHARMACIST

News & Information for Members of the Kentucky Pharmacists Association

Registration coming

soon at

www.kphanet.org

See Page 6 for more information

about what YOUR KPhA is doing

in the Capitol for you!

January 2014

THE KENTUCKY PHARMACIST 2

Table of Contents

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 2013 KPhA Mid-Year Conference 4 2013 Bowl of Hygeia Winners 5 From your Executive Director 6 APSC 8 2014 KPhA Professional Award Nominations 9 2014-15 KPhA Board of Directors Election Nominations 11 Saving the Bowl of Hygeia 12 January 2014 CE — 2013 HIPAA Updates 13 January Pharmacist/Pharmacy Tech Quiz 22 KPhA Emergency Preparedness Initiative 23 Technician Review 24

February 2014 CE — Making Evidence-Based Selections of Influenza Vaccines 25 February Pharmacist/Pharmacy Tech Quiz 30 Kentucky Renaissance Pharmacy Museum 31 KPhA New and Returning Members 32 Medicare Star Ratings 34 KPhA Government Affairs Contribution Form 35 Pharmacy Law Brief 36 KPhA First District Meeting 37 Pharmacy Policy Issues 38 Pharmacy Time Capsules 39 Pharmacists Mutual 40 Cardinal Health 41 KPhA Board of Directors 42 50 Years Ago/Frequently Called and Contacted 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 phar-

macy.

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 out-

comes for the patients I serve.

I will keep abreast of developments and maintain professional competency in my profession of pharmacy.

I will embrace and advocate change in the profession of pharmacy that improves patient care.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Kentucky Pharmacists Association

The mission of the Kentucky Pharmacists

Association is to promote the profession of

pharmacy, enhance the practice standards of the

profession, and demonstrate the value of pharmacist

services within the health care system.

Editorial Office:

© Copyright 2014 to the Kentucky Pharmacists Asso-ciation. The Kentucky Pharmacist is the official jour-nal of the Kentucky Pharmacists Association pub-lished bi-monthly. The Kentucky Pharmacist is dis-tributed 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 [email protected]. Website http://www.kphanet.org.

The Kentucky Pharmacy Education and Research Foun-

dation (KPERF), established in 1980 as a non-profit sub-

sidiary corporation of the Kentucky Pharmacists Associa-

tion (KPhA), fosters educational activities and research

projects in the field of pharmacy including career coun-

seling, student assistance, post-graduate education, con-

tinuing and professional development and public health

education and assistance.

It is the goal of KPERF to ensure that pharmacy in Ken-

tucky and throughout the nation may sustain the continu-

ing need for sufficient and adequately trained pharma-

cists. KPERF will provide a minimum of 15 continuing

pharmacy education hours. In addition, KPERF will pro-

vide at least three educational interventions through oth-

er mediums — such as webinars — to continuously im-

prove 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 im-

prove the overall programming designed by KPERF.

January 2014


I can hardly believe it’s al-

ready 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 pro-

viders in the health care system is generating a lot of

recognition on federal and state levels. One state, Califor-

nia, 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 Ad-

vanced Practice Pharmacist recognition, gives APPs new

authorities and provides specific requirements for pharma-

cists 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 sec-

tors of the profession working together for the singular pur-

pose of advancing the profession.

It is my belief that this success in California is just the be-

ginning 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 cen-

tered profession status.

Why is that important? More today than ever before, phar-

macists are interacting with patients, physicians and other

health care professionals in an effort to improve the quality

of life for patients. As more and more people take prescrip-

tion drugs for chronic and long term diseases, pharmacists

are being called upon increasingly to help in the manage-

ment 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 in-

teract with patients. Pharmacists have the opportunity to

supplement that health care management role by monitor-

ing and managing many long term patient disease states.

Quality of life is important to all of our patients. They al-

ready 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 over-

all health care.

The physician community in Kentucky is beginning to rec-

ognize the need for an overall “team” approach to manag-

ing the health care of their patients. That team needs to

involve pharmacists recognized as providers within the

health care system.

How do we seize the moment? We all, no matter what our

areas of practice, need to come together as a unified pro-

fession to begin dialogue with our legislators, the physi-

cians we deal with on a daily basis and our patients to ex-

press 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 hospi-

tal visits and managing drug care costs.

The work group we have established within KPhA is work-

ing 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.

2013 was a great year. Let’s all work together to make

2014 an even better year for our profession.

PRESIDENT’S

PERSPECTIVE

Duane W. Parsons

KPhA President

2013-2014

President’s Perspective

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 [email protected] 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.

January 2014


2013 KPhA Mid-Year Conference

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 Ken-

tucky Retail Federation; (left) Matt DiLoreto, senior director of state government af-

fairs for the National Community Pharmacists Association. Also speaking but not pic-

tured: 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.

January 2014


2013 Bowl of Hygeia Recipients

January 2014


From Your Executive Director

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls

With this edition of The Kentucky Pharmacist, we are happy

to report on the return of the General Assembly to Frank-

fort ,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 pharma-

cists to Frankfort, and we encourage you to visit the legisla-

ture 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!

KPhA Legislative Priorities in 2014

Pharmacists working with KPhA and our partners have

seen great legislative successes during recent legislative

sessions. I hope that you have had the opportunity to read

the Legislative Update, “KPhA in the Political Arena,” in the

last journal with respect to our overall historical progress on

a number of critical issues. Working together in 2011, we

were able to expand immunization authority for pharmacists

to administer influenza vaccines to individuals down to the

age of 9 years old. In 2012, we worked together through

KPhA to build upon the foundation for the pharmacy audit

bill that was passed in 2009 and to obtain additional protec-

tions passed in the legislature for pharmacies. We also

were successful in getting the audit legislation expanded to

cover the “new” managed care organizations serving the

Medicaid population. KPhA also has been in the forefront

on the debate over prescription drug abuse; as a result, we

were successful in our efforts to remove provisions that

would have required pharmacists to run KASPER reports

before dispensing ALL controlled substances and to obtain

a much-needed exemption for hospitals and long term care

facilities that would have required them to run KASPER

reports before administering pain medications to patients.

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 therapeu-

tic shoes for diabetics. And in 2013, YOUR KPhA led ef-

forts to pass the first PMB transparency bill in the country.

While we continue to work for compliance on this legisla-

tion, 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 legisla-

tive priorities for this year. High on our agenda is an

amendment of the Pharmacy Practice Act to allow pharma-

cists and practitioners more flexibility in entering into Col-

laborative Care Agreements. Legislation is planned to re-

vise 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

would make it easier to execute these agreements with the

result of better patient care. Current law requires that a col-

laborative care agreement be between a specific practition-

er and a specific pharmacist for a specific patient. The cur-

rent structure is very cumbersome and has proven to be an

obstacle to collaboration. I am pleased to report that the

proposal is endorsed by the Kentucky Board of Pharmacy

and is strongly supported by the Advancing Pharmacy

Practice in Kentucky Coalition. And this work is being over-

seen by KPhA through a Provider Status Work Group ap-

pointed by President Duane Parsons.

We also are pleased to report that legislation to address an

ongoing problem regarding the fitting of therapeutic shoes

by pharmacy technicians and pharmacist interns will be put

forward this session. We are working with the Prosthetic,

Orthotic and Pedorthic Association to codify in the statute

that pharmacy technicians and interns may assist pharma-

cists in the fitting of therapeutic shoes and inserts for dia-

betic patients. As you will recall, we are operating under an

agreement between the Board of Pharmacy and the Pros-

thetics, Orthotics and Pedorthics Board to allow this prac-

tice, but getting the agreement in statute will protect the

YOUR KPhA on Alert: Guardian of the Profession in Frankfort

January 2014


From Your Executive Director

Registration and

schedule will be

posted online at

www.kphanet.org.

Watch your email

and social media

for the latest!

practice in the future.

Following national trends, we expect a discussion of bio-

similar products to start on the legislative front as well. In

fact, there is a strong possibility that legislation will be in-

troduced to place restrictions on the substitution of bio-

similar products going forward, i.e., once the FDA deter-

mines interchangeability for certain products. Bills are be-

ing pushed in other states by major manufacturers of bio-

logics, and we continue to hear rumors that proposed leg-

islation 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 FDA-

approved 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 addition, we are working with the Kentucky State Pa-

tients 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.

In December, KPhA was invited to a discussion with other

health care providers and the Kentucky Chamber of Com-

merce to discuss medical malpractice issues. Subsequent-

ly, KPhA’s Board of Directors voted for KPhA to join this

new coalition which is proposing legislation to establish

“medical review panels” that would consist of a health pro-

fession’s peers to prescreen medical malpractice claims.

The panel’s decision would be nonbinding but would be

admissible in court. Indiana, Louisiana and several other

states utilize medical review panels. While this has not

been a big issue for pharmacists, being able to establish a

medical review panel could prove a useful option in the

future.

KPhA also is monitoring a medication synchronization ef-

fort 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 reim-

bursable 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-

proving access by eliminating multiple trips during the

month.

In early January, Governor Steve Beshear spoke to his

priorities of improving education and the health of Kentuck-

ians. 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 expens-

es is projected to exceed increased revenues by a signifi-

cant 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 candi-

dates for the legislature. With that in mind, don’t forget

about making a gift to your Kentucky Pharmacists PAC,

too.

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 surf-

ers also can see for themselves the issues before lawmak-

ers 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

next day’s committee meeting schedule and agendas.

However, we recognize that most of us do not have time to

keep up with this level of detail. Know that KPhA and our

Government Affairs Committee will keep you informed

through our regular communications on issues affecting

pharmacists and the profession as a whole. And, remem-

ber that you can always give your state senator and repre-

sentative feedback on issues under consideration by call-

ing the Legislative Message Line at (800) 372-7181. This is

YOUR KPhA —let’s keep our legislative momentum going

strong.

January 2014


APSC

January 2014


2014 KPhA Professional Awards

2014 KPhA Professional Awards KPhA Bowl of Hygeia Award Sponsored by APhA Foundation 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 present-ed 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 of-ficer 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 phar-macist 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

Joseph T. Elmes, Jr. 1980 H. Joe Russell 1979 Alvin R. Bertram 1978 Norman C. Horn 1977 H. Joseph Schutte 1976 D.H. "Sonny" Ralston 1975 Arthur G. Jacob 1974 James M. Brockman 1973 Richard E. Murray 1972 Randolph N. Smith 1971 Oliver E. Mayer 1970 Donald C. Morwessel 1969 James Phillip Arnold 1968 William D. Morgan 1967 Ernest M. Davis 1966 W.F. Bettinger 1965 Arvid E. Tucker 1964 Vernon B. Hager 1963 Sidney Passamaneck 1962 John H. Voige 1961 E. Crawford Meyer 1960 James J. Hamilton 1959

KPhA Distinguished Service Award Criteria- To recognize individual mem-bers who have made significant contri-butions to the Association or the pro-fession at large over an extended peri-od 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

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 previ-ous 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

January 2014



Emil Baker 1978 Robert L. Barnett 1977 Joseph L. Scanlon 1976 John B. Anneken 1975 Alvin R. Bertram 1974 Patricia A. Donahue 1973 H. Joseph Schutte 1972 Willard Alls 1971 Joe D. Taylor 1970 Richard L. Ross 1969 Ralph J. Schwartz 1968 George W. Grider 1967 Robert J. Lichtefeld 1966 E.M. Josey 1965 Julius T. Toll 1964 Charles E. Otto 1963 Charles F. Rosenberg 1962 R.N. Smith 1961 E. Crawford Meyer 1960 Charles A. Walton 1959 Ernest C. Williams 1958 George W. Grider 1957 Ray Wirth 1956 Nathan Kaplin 1955 Marion Hardesty 1954

KPhA Professional Promotion Award Criteria – To recognize individuals or organizations who have exhibited out-standing efforts to demonstrate the importance of pharmacy as a health care profession, and which promote proper application of pharmacists’ pro-fessional services. Eligibility – Open to persons or organ-izations. Previous Recipients Julie N. Burris & Walgreens Corporation 2013 SUCOP student chapter of APhA-ASP 2012 Lynne Eckmann 2011 Gloria Doughty & Lynn Harrelson 2010 Jordan Covvey 2009 Jeff Mills 2008 Trish Freeman 2007 Sherry DeCuir 2006 Pete Orzali 2005 John Armistead, Don Kupper & Willie Newby 2004 Kroger Pharmacy Mid South Division, Holly Divine, Randy Gaither, Bill Grise & Laura Jones 2003 Jefferson County Academy of Pharmacy, Ken Roberts, Ph.D 2002 Paul Easley, Bob Oakley & Michael Wyant 2001 Judy Minogue 2000

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 phar-macist’s outstanding contribution to the profession and/or community. Eligibility – The recipient must be an Active member of the Association. The recipient must be licensed to prac-tice for nine years or less. The recipi-ent must have a valid, active license to practice in Kentucky. The recipient must have demonstrated participation in a national pharmacy association, professional program(s) and/or com-munity service. Previous Recipients Brooke Hudspeth 2013 Stacy Rowe 2012 Aimee Ruder 2011 Karen Hubbs 2010 Matt Martin 2009 Tiffany Self 2008 Angela Parrett 2007 Janet Mills 2006 Alyson Schwartz 2005 Nancy Horn 2004 Jennifer O’Hearn 2003 Karen Altsman 2001 Kim Wilson 1999 Kim Harned 1998 Michael Box 1997 Dan Yeager 1996 Dan Minogue 1995 Pan Haeberlin 1994 Kim Croley 1993 Phillip Sandlin 1992 Jeffrey W. Danhauer 1991 Mark S. Edwards 1990 Susan Murray Kathman 1989 Melinda Cummins Joyce 1987

KPhA Excellence in Innovation Award Sponsored by Upsher-Smith Laboratories Criteria – To recognize a pharmacist who has demonstrated innovative pharmacy practice resulting in im-proved 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 Honor-ary 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

January 2014



Cardinal Health Generation Rx Champions Award Criteria – This award program recognizes excellence in com-munity-based prescription drug abuse prevention at state phar-macy associations. This award honors a pharmacist who has demonstrated outstanding com-mitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy com-munity. The award is also in-tended to encourage educational prevention efforts aimed at pa-tients, youth and other members of the community. In addition to the award, to honor the pharma-cist’s work to fight prescription drug abuse, APMS, state phar-macy associations and the Car-dinal Health Foundation will do-nate $500 to a charity of the award recipient’s choice. Previous Recipients Raymond Float 2013 Brian Fingerson 2012

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 phar-macy practice. The KPhA Organizational Affairs Committee is accepting nomina-tions 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 rec-

ognized pharmacy organizations in Kentucky are encouraged to submit nomina-

tions. 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

[email protected] 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.

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 Email Mail

Return form to KPhA, 1228 US 127 South, Frankfort, KY 40601, Fax 502-227-2258, or email

[email protected]. Call the KPhA Office at 502-227-2303 for more information.

For more on the awards, go to www.kphanet.org and

click on About, Professional Awards

January 2014


Bowl of Hygeia

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 Clay-

well’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

Cayce's Pharmacy, Inc.

Leon & Margaret Claywell

Brian Fingerson

Dwaine Green

George Hammons

Tom Houchens

Chris Killmeier

Matthew & Aleshea Martin

Robert McFalls

Duane Parsons

Donald Riley

Patricia Thornbury

Simon Wolf

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.

For more information on the Bowl Of Hygeia, visit:

http://www.aphafoundation.org/bowl-hygeia-award.

January 2014


Jan. 2014 CE — 2013 HIPAA Updates

2013 HIPAA Updates: Key Implications

for Your Pharmacy Organization By: Clay B. Wortham, Esq., McBrayer, McGinnis, Leslie & Kirkland, PLLC. Leah Tolliver,

Pharm.D., Director of Pharmacy Emergency Preparedness, Kentucky Pharmacists Associa-

tion.

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 nec-essary 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 communi-

cations using PHI.

KPERF offers all

CE articles to

members online at

www.kphanet.org

Introduction

In January 2013, the Department of Health and Human

Services (HHS) published a Final Rule containing numer-

ous changes to the HIPAA Privacy, Security, Breach Notifi-

cation and Enforcement Rules.1 The HIPAA updates took

effect on Sept. 23, 2013 for pharmacy covered entities

(and their business associates).2

Two of the HIPAA updates that require pharmacies to take

action now are: (i) changes to Business Associate require-

ments; and (ii) changes to the mandatory Notice of Privacy

Practices. These updates do not affect the fundamental

nature of HIPAA compliance, but they do introduce a spe-

cific "to do" list for pharmacies.

Expanded Definition of “Business Associate”

One of the important changes contained in the HIPAA up-

dates is that the definition of “Business Associate” in-

cludes:

1. Health information exchange organizations, e-

prescribing gateways, and personal health record ven-

dors that offer records on behalf of a covered entity;

2. Data transmission providers that require access to Pro-

tected Health Information (PHI) on a routine basis;

3. Business Associate “downstream” subcontractors that

create, receive, maintain or transmit PHI for the Busi-

ness Associate; and

4. Data transmission services such as digital couriers that

do not require routine access to the data continue to be

exempt from Business Associate requirements.3

Business Associate Agreements – Changes Required

Under the HIPAA updates, Business Associates must inde-

pendently comply with the HIPAA Privacy and Security

Rules.4 Further, as discussed above under the definition of

“Business Associate”, a subcontractor of a Business Asso-

ciate that handles PHI on behalf of the Business Associate

also is now considered a Business Associate.5 What does

this mean for pharmacies?

The HIPAA updates retain the requirement that a covered

entity pharmacy maintain a Business Associate Agreement

with each person that handles PHI for the pharmacy.6

Thus, a Business Associate Agreement now is required for

each entity that handles PHI for the covered entity and for

that Business Associate’s downstream subcontractors who

handle the PHI. For example, beginning on Sept. 23, 2013,

a data storage vendor of a Business Associate also will be

considered, separately, a Business Associate.

The HIPAA updates provide a “deemed compliance” period

for “BA Agreements” in place when the HIPAA updates

were published on Jan. 25, 2013.7 While new Business

Associate Agreements are required to include HIPAA up-

January 2014



dates, pharmacy covered entities are not required to incor-

porate 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

Refill Reminder FAQs

Q: What types of communications

fall within the “refill reminder” ex-

ception to marketing?

The refill reminder exception to the

definition of “marketing” encompasses

refill reminders and other communica-

tions about a drug or biologic that is

currently being prescribed for the indi-

vidual. See paragraph (2)(i) of the defi-

nition of “marketing” at 45 CFR

164.501. In addition to refill reminders

about currently prescribed drugs, the

exception encompasses communica-

tions about generic equivalents of a

drug being prescribed, adherence

communications encouraging individu-

als to take prescribed medicines as

directed and communications about

prescriptions that have lapsed within

the last 90 calendar days. Also, where

an individual is prescribed a self-

administered drug, communications

regarding all aspects of a drug delivery

system fall within the refill reminder

exception. Thus, these types of com-

munications are permitted without an

individual’s authorization, provided any

financial remuneration received from

the pharmaceutical manufacturer in

exchange for making the communica-

tion is reasonably related to the cov-

ered entity’s cost of making the com-

munication.

Q: Do communications about re-

cently-lapsed prescriptions for a

medicine fall within the “refill re-

minder” exception to marketing?

Yes, so long as the prescription lapsed

within the last 90 calendar days and

any financial remuneration received in

exchange for making the communica-

tion is reasonably related to the cov-

ered entity’s cost of making the com-

munication. Communications encour-

aging individuals to renew recently

lapsed prescriptions are consistent

with the purpose of refill reminder and

medication adherence communica-

tions, which is to encourage individuals

to continue to take their medication as

directed. However, once a prescription

has lapsed for more than 90 calendar

days, it is no longer reasonable to treat

such communications as refill remind-

ers or medication adherence communi-

cations for a currently prescribed drug

or biologic.

Q: Do communications about drug

delivery systems fall within the

“refill reminder” exception to mar-

keting?

Yes. Where an individual is prescribed

a self-administered drug or biologic,

such as insulin, communications re-

garding all aspects of a drug delivery

system, such as an insulin pump, fall

within the refill reminder exception at

paragraph (2)(i) of the definition of

“marketing” at 45 CFR 164.501, pro-

vided any financial remuneration re-

ceived in exchange for making the

communication is reasonably related to

the covered entity’s cost of making the

communication.

Q: Do communications about spe-

cific adjunctive drugs related to the

currently prescribed drug fall within

the “refill reminder” 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. An adjunctive drug that may

be used in conjunction with a currently

prescribed drug to help treat a patient’s

underlying condition or address one or

more side effects of a currently pre-

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 mar-

keting requirements. For example, a

pharmacy could send a communication

to an individual alerting the individual

to possible side effects from her cur-

rently prescribed medication, and sug-

gesting the individual go ask her doctor

about a medication to treat the side

effects if she experiences them, with-

out 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 ex-

change for making the communication.

In addition, such communications may

be made in a face-to-face encounter

with the individual, without authoriza-

tion, even if financial remuneration is

received in exchange for making the

communication.

Q: Do communications about new

formulations of a currently pre-

scribed medicine fall within the

“refill reminder” exception to mar-

keting?






164.501. However, covered entities

may communicate in a general manner

to individuals regarding the availability

of a drug with, for example, a different

dosing schedule or form, without trig-

gering the marketing requirements. For

example, a pharmacy could send an

January 2014



subcontractors to determine whether any subcontractors

handle PHI and to negotiate a Business Associate Agree-

ment appropriate for the arrangement to ensure that the

subcontractors will appropriately safeguard PHI.

New Content for BA Agreements

Specifically, in addition to existing requirements of the Pri-

vacy Rule, the HIPAA updates necessitate that Business

Associate Agreements include the following changes:

adherence communication to an indi-

vidual 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. Al-

ternatively, 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 remu-

neration in exchange for making the

communication. In addition, such com-

munications 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 encouraging

individuals to switch from a pre-

scribed medicine to an alternative

therapy fall within the “refill remind-

er” exception to marketing?






164.501. Making a communication to

an individual encouraging the individu-

al to switch from a prescribed medicine

to an alternative therapy would only be

appropriate where such communica-

tion falls within the treatment exception

to marketing at paragraph (2)(ii)(A) of

the definition and the covered entity

does not receive financial remunera-

tion in exchange for making the com-

munication; where the communication

is made in a face-to-face encounter

with the individual; or where the indi-

vidual has authorized the use or dis-

closure of his protected health infor-

mation to make such communications.

Q: Can a doctor or pharmacy be

paid by a pharmaceutical manufac-

turer to make a prescription refill

reminder without an individual’s

prior authorization under the HIPAA

Privacy Rule?

Yes, provided that any payments from

the pharmaceutical manufacturer are

reasonably related and limited to the

covered entity’s cost of making the

communication.

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 ex-

cepted communications), including

labor, materials, and supplies, as

well as capital and overhead costs.

For payments to a Business Asso-

ciate that contracts with a doctor or

pharmacy to assist in carrying out


adherence program (or to make

other excepted communications),

this means payments (either di-

rectly from the pharmaceutical

manufacturer or through the cov-

ered entity) may be only up to the

fair market value of the Business

Associate’s services.

Q: What is permitted remuneration

for purposes of the “refill reminder”

exception to marketing?

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

making the communication, if any, is

reasonably related to the covered enti-

ty’s cost of making the communication.

See paragraph (2)(i) of the definition of

“marketing” at 45 CFR 164.501. Finan-

cial remuneration means payment to a

covered entity (or Business Associate,

if applicable) from or on behalf of a

third party whose product or service is

being described. Thus, for these pur-

poses, permitted remuneration in ex-

change for making a “refill reminder”

communication is:

Non-financial or in-kind remunera-

tion, 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 de-

scribed in the communication,

such as payment from a health

plan.

Payments to a covered entity by a

pharmaceutical manufacturer or

other third party whose product is

being described in the communica-

tion that cover only the reasonable

direct and indirect costs related to


adherence program, or other ex-

cepted communications, including

labor, materials, and supplies, as

well as capital and overhead costs.

Where a covered entity enlists the

services of a Business Associate

to assist in carrying out a refill re-

minder or medication adherence

program, or to make other except-

ed 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.

January 2014



1. The Business Associate must limit its uses and disclo-

sures of PHI to meet the covered entity’s minimum nec-

essary policies and procedures (and business associ-

ates’ will want to ensure that the covered entity is re-

quired to make those policies available to the Business

Associate).

2. The business associate must implement safeguards for

electronic PHI in accordance with the HIPAA Security

Rule.

3. The Business Associate must notify the covered entity

of a security breach, including the information required

under the new Breach Reporting Rule.

Q: May a covered entity pay a Busi-

ness Associate to assist in making

a refill reminder or other communi-

cation that falls within the “refill re-

minder” exception to marketing?

Yes. The Privacy Rule permits a cov-

ered entity to engage and pay a Busi-

ness Associate to assist in making oth-

erwise permitted communications to

individuals and does not prescribe

what the covered entity itself may pay

the Business Associate for such ser-

vices. However, where financial remu-

neration is received from the pharma-

ceutical manufacturer or other third

party whose product is being described

to make such communications, there

are limits on what the Business Associ-

ate 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 re-

ceives from the third party, payments

not to exceed the fair market value of

its services.

Q: May a Business Associate be

paid by a pharmaceutical manufac-

turer to assist a covered entity in

making a refill reminder or other

communication describing the man-

ufacturer’s product that falls within

the “refill reminder” exception to

marketing?

Yes, provided any payments to the

Business Associate do not exceed the

fair market value of its services. See

paragraph (2)(i) of the definition of

“marketing” at 45 CFR 164.501. The

payments may be made by a pharma-

ceutical manufacturer through a cov-

ered entity to the Business Associate,

or directly to the Business Associate,

that is acting on behalf of the covered

entity to assist in making the refill re-

minder or other communication de-

scribing the manufacturer’s product.

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-

er?

Yes. However, in order for the refill

reminders or other program communi-

cations to fall within the “refill reminder”

exception to marketing, any financial

remuneration received by the Business

Associate from the pharmaceutical

manufacturer (either directly or through

the covered entity) must not exceed

the fair market value of the Business

Associate’s services. See paragraph

(2)(i) of the definition of “marketing” at

45 CFR 164.501. Such limitations do

not apply to what the covered entity

itself may pay the business associate

for such services when no financial

remuneration is received from the

pharmaceutical manufacturer or other


being described.

Q: We operate specialty pharmacy

programs that make pharmaceutical

manufacturer-funded communica-

tions to patients concerning their

prescribed drugs for chronic and

complex diseases that require com-

plicated therapies. Rather than en-

sure such communications meet the

conditions of the “refill reminder”



164.501 of the Privacy Rule, we have

decided to obtain authorizations

going forward for such communica-

tions from new patients as they en-

roll in the programs. For existing

patients, must we either obtain au-

thorizations by the Sept. 23, 2013

compliance date of the new provi-

sions or terminate these sponsored

communications with these pa-

tients?

No. With respect to obtaining authori-

zations from patients already enrolled

in these programs, OCR will not deter-

mine that a covered entity is in viola-

tion of the marketing provisions if it has

not obtained authorizations from all

existing patients to whom it is making

such communications by the Sept. 23,

2013 compliance date, provided the

patients from whom authorizations

have not been obtained have not opted

out or declined to receive such com-

munications and the patients’ authori-

zations are obtained at the next time

their prescriptions are renewed, but no

later than Sept. 23, 2014.

Q: If a covered entity is going to ob-

tain authorizations from patients to

make pharmaceutical manufacturer-

funded communications to the pa-

tients about currently prescribed

drugs or biologics, is the covered

entity required to obtain a new au-

thorization each time a prescription

is renewed?

No. A HIPAA authorization remains

valid until it expires or is revoked by

the individual. While a HIPAA authori-

zation must contain an expiration date

or event that relates to the individual or

the purpose of the use or disclosure,

the Privacy Rule does not otherwise

prescribe the expiration date or event

that must apply to the authorization,

January 2014



4. The Business Associate must enter into a Business

Associate Agreement with “downstream” subcontrac-

tors to which the business associate discloses PHI.

5. If the agreement delegates to the Business Associate

any of the covered entity’s HIPAA compliance obliga-

tions such as limiting disclosures of PHI or permitting

patient access to PHI, the covered entity must ensure

that the Business Associate is required to fulfill those

obligations to the same extent as the covered entity.

Breach Notification Rule

Another important change included with the HIPAA updates

is to make breach notification mandatory unless the cov-

ered entity or Business Associate determines that there is a

“low probability that the protected health information has

been compromised based on a risk assessment” of the fol-

lowing factors:

1. Nature and extent of PHI involved;

2. The unauthorized person who used the PHI or to whom the disclosure was made;

3. Whether the PHI actually was acquired or viewed; and

4. The extent to which the risk to the PHI has been miti-gated.

9

which may vary based on the circum-

stances. For example, in the case of

communications to individuals con-

cerning 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 communica-

tions 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 phar-

maceutical manufacturer. The authori-

zation 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 in-

cludes stating in the authorization that

the covered entity is receiving financial

remuneration from one or more phar-

maceutical manufacturers to make the

communications, and that the individu-

al may revoke the authorization in writ-

ing at any time he or she wishes to

stop receiving the communications.

Q: Are communications about gov-

ernment programs or government-

sponsored programs “marketing”

under the HIPAA Privacy Rule?

No. Communications about govern-

ment and government-sponsored pro-

grams do not fall within the definition of

“marketing,” as there is no commercial

component to communications about

benefits available through public pro-

grams. Therefore, a covered entity is

permitted to use and disclose protect-

ed health information to communicate

with individuals about eligibility for

such programs as Medicare, Medicaid,

or the State Children’s Health Insur-

ance Program (SCHIP). Similarly, gov-

ernment-mandated communications

are not considered marketing under

the Privacy Rule as such communica-

tions also are not commercial in na-

ture.

Q: Are pharmaceutical manufacturer

-funded communications to patients

concerning a prescribed drug con-

sidered marketing under the Privacy

Rule if they are required by a Risk

Evaluation and Mitigation Strategy

(REMS)?

No. If the Food and Drug Administra-

tion (FDA) determines that a particular

drug can only be approved with addi-

tional measures, beyond labeling, to

mitigate a serious risk posed by the

drug, and one or more of those

measures take the form of patient

communications about the drug, then

such communications are not market-

ing, even if the communication is fund-

ed by the drug manufacturer. Govern-

ment-mandated communications to

individuals are not considered market-

ing under the Privacy Rule, even if

such communications are paid for by a


being described. As with communica-

tions to individuals concerning govern-

ment and government-sponsored pro-

grams, government-mandated commu-

nications to individuals are not com-

mercial in nature. Thus, a covered enti-

ty may use or disclose an individual’s

protected health information without

the individual’s authorization to send

the individual educational or other in-

formation 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 indi-

vidual’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

services do not require individual au-

thorization, even if such communica-

tions are subsidized by the third party

whose product or service is being de-

scribed. See 45 CFR 164.508(a)(3)(i)

(A). Thus, a pharmacy or other cov-

ered entity may discuss with, or hand

printed information to, an individual

about particular medicines in a face-to-

face encounter, without triggering the

individual authorization requirements

of the HIPAA Privacy Rule. However,

face-to-face communications do not

include communications over the tele-

phone or by e-mail or mail.

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 pur-

poses without the patient’s authorization.10

Also, a PHI

may not be used for fundraising purposes unless a state-

ment 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.

Fundraising

The HIPAA updates permit a covered entity to use PHI to

raise funds for its own benefit, or the benefit of an institu-

tionally related foundation, but not to benefit a third party.12

PHI that may be used for fundraising activities includes the

department of service, treating physician and outcome.13

The covered entity’s Notice of Privacy Practices must con-

tain opt-out language that is clear and conspicuous.14

The

covered entity cannot condition treatment on not opting

out.15

Prohibition on Marketing with PHI

Generally, use or disclosure of PHI to encourage the pur-

chase or use of a product or service is considered

“marketing” and requires written patient authorization if the

covered entity is paid for the use or disclosure.16

The

HIPAA updates provide an exception for paid PHI market-

ing communications about a drug or biologic that the pa-

tient is already taking, including refill reminders, if the pay-

ment for the communication is reasonably related to the

cost of making the communication.17

(See Refill Reminder FAQs)

Sale of PHI

Authorization is generally required, with notice that disclo-

sure of PHI is in exchange for payment; it includes nonfi-

nancial benefits.

1. Exceptions

a. Public health.

b. Research purposes – remuneration must be rea-

sonably related to the cost of preparing and

transmitting information (can include indirect

costs but cannot make a profit).

c. Treatment and payment – disclosure of PHI to

receive payment is not a “sale” of PHI.

d. Corporate transactions.

e. Disclosures to Business Associates.

f. Disclosures to the individual.

g. Disclosures required by law.

h. Other disclosures permitted by the rules, provid-

ed remuneration is related to cost of making the

disclosure.

Refill Reminder Exception

HIPAA’s “refill reminder” exception to the patient authoriza-

tion requirement for paid marketing communications is

very important for pharmacies and pharmaceutical manu-

facturers. There are two components to determining

whether a communication falls within the refill reminder

exception to marketing. The first is whether the communi-

cation is about a currently prescribed drug or biologic.18

The second is whether the communication involves finan-

cial remuneration and, if it does, whether the financial re-

muneration is reasonably related to the covered entity’s

(pharmacy) cost of making the communication. Below is

guidance on each of these aspects of the exception.

1. Is the Communication about a Currently Prescribed

Drug or Biologic?

WITHIN EXCEPTION

• Refill reminders.

• Communications about generic equivalents of a drug be-

ing prescribed.

• Communications about a recently (within 90 calendar

days) lapsed prescription.

• Adherence communications encouraging individuals to

take prescribed medicines as directed.

• Where an individual is prescribed a self-administered

drug, communications regarding all aspects of a drug de-

livery system.

NOT WITHIN EXCEPTION

• Communications about specific new formulations of a

currently prescribed medicine.

• Communications about specific adjunctive drugs related

to the currently prescribed medicine.

• Communications encouraging an individual to switch from

a prescribed medicine to an alternative medicine.

2. Is There Financial Remuneration, and If So, Is It Rea-

sonably Related to the Cost of the Communication?

WITHIN EXCEPTION

• Communication does not involve remuneration.

• Communication involves only non-financial or in-kind re-

muneration, such as supplies, computers or other materi-

als.

January 2014



• Communication involves only payment from a party other

than the third party (or other than on behalf of the third par-

ty) whose product or service is being described in the com-

munication.

• 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 medica-

tion adherence program, or other excepted communica-

tions, 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 Busi-

ness 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.

NOT WITHIN EXCEPTION

• Communication involves financial remuneration other than

as described above.

Examples of Permitted Communications

• A pharmacy administers a medication adherence program

that involves mailing refill reminders and adherence com-

munications to patients about their currently prescribed

drugs even though the pharmacy receives financial remu-

neration from the pharmaceutical manufacturers, provided

the financial remuneration covers only the pharmacy’s rea-

sonable direct and indirect costs associated with the pro-

gram.

• A pharmacy mails its diabetic patients information con-

cerning the diabetic pumps used to administer their insulin

even though the pharmacy is paid by the manufacturer of

the pumps, provided the payment covers only the reasona-

ble direct and indirect costs associated with the communi-

cations.

• A pharmacy hires a Business Associate to assist in ad-

ministering a medication adherence program that involves

mailing adherence communications to patients about their

currently prescribed drugs, even though the Business As-

sociate is paid by the pharmaceutical manufacturers, pro-

vided the payment does not exceed the fair market value of

the Business Associate’s services.

Other Marketing Exceptions Continue to Apply

Other paid “marketing” communications to encourage the

purchase or use of a product or service that are not exempt

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 communica-

tions 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 indi-

vidual 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

readily producible.21

If not readily producible, the individual

has the right to a hard copy.22

If the designated record set

is maintained in electronic format, the individual has the

right to an electronic copy.23

Right of Access: Copy to Third Party

The individual may designate a third party to receive a

copy.24

The patient’s request must be in writing (full authori-

zation is optional).25

It must clearly identify the designated

person, where to send the copy and who is making the re-

quest.26

Full authorization is required if it is a third-party

request.27

Restriction for Out-of-Pocket Services

A covered entity must agree to an individual’s request to

restrict disclosure to a health plan if the disclosure:

1. Is for payment or health care operations and not other-

wise required by law; and

2. Pertains solely to health care paid for out-of-pocket.28

Notice of Privacy Practices (Summary)

1. Prohibition on sale of PHI.

2. Duty to notify affected individuals of a breach of unse-

cured PHI.

3. Right to opt out of fundraising (if applicable).

4. Right to restrict disclosure of PHI when paid out of

pocket.

5. Limit on use of genetic information (certain health plans

only).

January 2014


HIPAA Risk Analysis – An Important Annual Event

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 vulnera-

bilities 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

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 secu-

rity issues that can be mitigated with policies/procedures

and staff training. Ideally, a covered entity or Business As-

sociate will adopt policies and procedures tailored to miti-

gate 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 be-

cause failure to maintain an updated risk analysis is a

HIPAA violation and likely one of the first items a compli-

ance 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 imple-

ment 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 viola-

tions due to willful neglect and may proceed to penalty

without seeking informal resolution (e.g., settlement).

Conclusion

The HIPAA updates usher in extensive changes to the

HIPAA landscape. Pharmacies should work swiftly to im-

plement these changes in order to ensure compliance by

the deadline. The risk of ignoring HIPAA responsibilities is

a significant financial gamble.

References

1. 78 Fed. Reg. 5565 (Jan. 25, 2013).

2. 78 Fed. Reg. 5565, 5566.

3. 45 C.F.R. § 160.103.

4. 45 C.F.R. § 164.300.

5. 45 C.F.R. § 160.103.

6. 45 C.F.R. § 164.502(e)(2).

7. 45 C.F.R. § 164.532(e).

8. 45 C.F.R. § 164.532.

9. 45 C.F.R. § 164.402(2).

10. 45 C.F.R. § 164.508(a).

11. 45 C.F.R. § 164.514(f)(2).

12. 45 C.F.R. § 164.514(f).

13. 45 C.F.R. § 164.514(f)(1).

14. 45 C.F.R. § 164.514(f)(2).

15. 45 C.F.R. § 164.514(f)(2)(iii).

16. 45 C.F.R. §§ 164.501; 164.508.

17. 45 C.F.R. § 164.501.

18. Id.

19. 45 C.F.R. § 164.508(a)(3)(i)(A).

20. 45 C.F.R. § 164.508(a)(3)(i)(B).

21. 45 C.F.R. § 164.524(c).

22. 45 C.F.R. § 164.524(c)(2)(i).

23. 45 C.F.R. § 164.524(c)(2)(ii).

24. 45 C.F.R. § 164.524(c)(3)(ii).

25. 45 C.F.R. §§ 164.524(c)(3)(ii); 160.502(a)(i).

26. 45 C.F.R. § 164.524(c)(3)(ii).

27. 45 C.F.R. § 164.502(a)(iv).

28. 45 C.F.R. § 164.522(a)(1)(vi).

29. 45 C.F.R. § 164.308(a)(ii)(A).

30. 45 C.F.R. § 164.308(a)(ii)(B).

31. HHS Guidance on Risk Analysis Requirements under the HIPAA Security Rule, p. 1 (July 2010)

32. Id.

33. Id.

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 subcontrac-tors). 5. Train staff on new provisions. 6. Don’t delay.


January 2014


34. 45 C.F.R. § 160.404(b)(2)(i)(B).

35. 45 C.F.R. § 160.401.

Additional References

1. Morrone JE, Levitt JE. Federal Government Issues

Guidance on Refill Reminders Under New HIPAA Om-

nibus Rule. Frier Levitt PBM Audit Lawyers Blog Octo-

ber 9, 2013.

2. HHS.gov. Health Information Privacy. The HIPAA priva-

cy Rule and Refill Reminders and Other Communica-

tions about a Drug or Biologic Currently being Pre-

scribed for the Individual. September 19, 2013.

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. 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 noti-fied.

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 No-tification 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 pur-poses 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.

6. The HIPAA Refill Reminder Exception involves paid mar-keting communication. Which of the following communica-tions 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. 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 authori-zation to use PHI. A. True B. False 8. HIPAA requires covered entities and BAs to conduct peri-odic 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 poli-

cies and procedures. C. If the subcontractor agreement is in place, the BA is not

liable for the subcontractor if the subcontractor is non-compliant 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 recom-mended 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 de-

velop new subcontractor agreements.


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.

The Kentucky Pharmacy Education & Research Foundation is

accredited by The Accreditation Council for Pharmacy

Education as a provider of continuing Pharmacy education.

Quizzes submitted without NABP eProfile

ID # and Birthdate cannot be accepted.

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 7. A B 9. A B C D 2. A B 4. A B C D 6. A B C D 8. 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)

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 7. A B 9. A B C D 2. A B 4. A B C D 6. A B C D 8. 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 _________________________________


January 2014


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

Roamey Visits western Kentucky

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

[email protected], fax to 502-227-2258 or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601.

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 Emergen-

cy Preparedness Leah Tolliver and Director of Communi-

cations 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.

January 2014


Technician Review

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.

KPhA Member Pharmacy Technicians

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 [email protected]

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 phar-

macists be more proactive and hands-on in the care of our

patients.

Our proposals are circulating through various state organi-

zations 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 reflec-

tion of the national changes that are forthcoming. To be

more involved, join the KPhA Pharmacy Technician Acade-

my by contacting Don Carpenter at dacarpenter@st-

claire.org.

January 2014


Feb. 2014 CE — Influenza Vaccines

Making Evidence-Based Selections of Influenza Vaccines By: BC Childress, PharmD, BCACP, FASCP, Director of the InterNational Center for Advanced Pharmacy Ser-vices (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

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 intra-

dermal injections and intranasal sprays. The variety of op-

tions can lead to new questions. Which option is best? Is

one superior to another? This article aims to guide phar-

macists, pharmacy technicians and other health care pro-

fessionals in making evidence-based selections of influen-

za vaccines for their patients.

Innate vs Adaptive Immunity

First, it is important to review how the immune system

works. Innate immunity is the body’s first line of defense

against foreign invaders. Skin provides the largest physical

barrier, while cilia and mucous line the airways and respira-

tory tract to defend against inhaled organisms. When in-

vaders make it past these physical barricades, the body

deploys the innate immune system.

Innate immunity consists of various leukocytes, including

monocytes/macrophages, neutrophils, basophils, eosino-

phils and mast cells. Some of these cells secrete inflamma-

tory chemicals to trigger a greater immune response. Oth-

ers, such as macrophages, act as phagocytes and destroy

the invading pathogens on their own. As this innate immun-

ity is hard at work, the chemicals released trigger the adap-

tive immune system to join the fight. While innate immunity

is fast at recognizing and fighting pathogens that have en-

tered the body, the adaptive immune system is more effec-

tive due to memory and specificity. This system “adapts” to

fight specific pathogens, becoming more efficient with sub-

sequent infections.1,2

One very important type of cell involved in immune re-

sponse 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 numer-

ous receptors and are able to rapidly recognize and pro-

cess 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.

For immunizations to work well, both the innate and adap-

tive immune systems need to be involved. When adminis-

tered, flu vaccines elicit the creation of antibodies by the

adaptive immune system. During the two to three weeks

following immunization, these antibody levels increase and

prepare for a subsequent invasion by the real flu virus.

Consequently, the body’s immune system rapidly mobilizes

to fight the infection effectively.4

Difference in Vaccine Delivery

Does the route of vaccine administration make a differ-

ence? 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 immuni-

ty will migrate to the muscle and activate the adaptive im-

munity, but the memory of the specific pathogen (via anti-

body development) occurs in the bloodstream. Interesting-

ly, influenza infection does not begin in the bloodstream,

but rather in the respiratory tract.

January 2014



Research is not conclusive, but this could explain why flu

vaccines are not always effective — even against matched

strains. The CDC estimates that general flu vaccine effec-

tiveness is between 45-55 percent annually.4,6

This means

that 45-55 individuals out of every 100 who receive a flu

vaccine are still susceptible to infection even when the

strains are properly matched to the vaccine. So how can flu

vaccine efficacy be improved?

One solution is to strengthen the immune response to a

vaccine. This may be accomplished utilizing alternative

routes of vaccine delivery. There are three different routes

of flu vaccine administration today.7 (See Table 1.) Since

the intradermal and intranasal vaccines were released,

there have been multiple studies comparing their effective-

ness to the traditional intramuscular injection. Results pub-

lished by the CDC have shown that in a head-to-head com-

parison, the intranasal vaccine produced an 85 percent

effective rate as opposed to 71 percent by the intramuscu-

lar.8 Such discrepancies were even greater in children.

9,10

Similar studies have demonstrated superiority with intrader-

mal vaccine delivery. One study used an intradermal dose

1/5 that of the intramuscular influenza vaccine, and found

that even a significantly smaller dose of vaccine was able

to produce a stronger immune response. These research-

ers also hypothesized that this response may be due in part

to the dense population of dendritic cells in the skin (See

Table 2 for a summary of delivery comparisons).

Differences in Vaccine Composition

Vaccine delivery is not the only piece to this puzzle. One

must also consider the composition of the vaccine. For the

2013-2014 flu season, there

were 13 different flu vaccine

formulations on the market.7

While many of these vac-

cines may look the same to

a patient, there are vast dif-

ferences in their indications,

contraindications and effica-

cy. Table 3 summarizes the

current vaccines on the mar-

ket. Figure 1 provides an

algorithm for deciding which

flu vaccine to use.

Although many of these vac-

cines may look alike, there

are stark contrasts. Some of

these vaccines protect

against four strains of influ-

enza, while others protect against three. One vaccine con-

tains four times the amount of other intramuscular agents.13

As previously discussed, research continues to show that

intradermal vaccines and live intranasal vaccines are more

effective at soliciting an immune response than traditional

trivalent inactivated intramuscular vaccines.

Conclusion

Preventing influenza outbreaks is no simple task. It starts

with increasing rates of immunization and advocating for

early vaccination. Over the past several years, vaccines

have become available in August, long before the first flu

epidemic makes the news. Nonetheless, many wait until

the virus is rampant before taking action. Pharmacists and

technicians can play a vital role here by advocating for im-

munization as soon as vaccines are available. Choosing

the most appropriate vaccine also can be difficult. Even

though the CDC does not recommend one vaccine over

another, its data say otherwise. Their lack of opinion is

most likely an effort to avoid endorsing a certain brand or

company.

Research is still forthcoming, but most evidence shows that

vaccine development is progressing to provide better solu-

tions to fighting annual influenza epidemics. As a general

rule, live-virus vaccines and intradermal vaccines produce

the strongest immune response. Vaccines with four strains

Table 1. Routes of influenza vaccine delivery.7

Vaccine Name Route of Administration

Flumist (LAIV) Intranasal

Fluzone (TIV) Intradermal

All other flu vaccines (QIV/TIV)

Intramuscular

Table 2. Comparative vaccine efficacy based on delivery mechanism

Study: Intramuscular vs Intradermal11

Vaccine Intradermal Intramuscular

Seroconversion rate 78 percent 66 percent

Study: Intramuscular vs Intradermal12

Vaccine Intradermal Intramuscular

Seroconversion rate 85 percent 79 percent

Study: Intramuscular vs Intranasal8,9

Vaccine Intranasal Intramuscular

Protective efficacy 85 percent 71 percent

Study: Intramuscular vs Intranasal10

Vaccine Intranasal Intramuscular

Relative efficacy to intramuscular 27 percent (more effective) --

January 2014



Table 3. Flu vaccines available for 2013-2014 season.7

Vaccine Composition Delivery

Route Restrictions Notes

FluMist Quadrivalent - LAIV Intranasal Ages 2-49 only Not for persons with chronic disease

Fluarix QIV Intramuscular (IM)

Ages 3+

FluLaval QIV IM Ages 3+

Fluzone QIV IM 6 months +

Afluria TIV IM Ages 9 + Linked to fever in children under 9

Fluarix TIV IM Ages 3+

Flucelvax TIV IM Ages 18+, contraindicated in severe egg allergy

Cell culture-based vaccine

FluLaval TIV IM Ages 3+

Fluvirin TIV IM Ages 4+

Fluzone TIV IM 6 months +

Fluzone ID TIV Intradermal (ID)

Ages 18-64 More common reactions at injection site

Fluzone HD

TIV IM Ages 65+ Contains 4X as much inactivated vaccine as standard injections

Flublok Trivalent recombinant IM Ages 18-49 Completely egg-free

of the flu virus (quadrivalent vaccines) will provide greater

protection than trivalent vaccines. The most recent evi-

dence and sufficient knowledge of the immune system will

allow pharmacists to continue to play a major role in advo-

cating for immunizations, determining the most appropriate

vaccine and ensuring proper administration of annual vac-

cines. Technicians also can encourage vaccination in their

patient interactions and help dispel myths and rumors that

frustrate the efforts of health care providers to keep pa-

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

Prevention. Available at: http://www.cdc.gov/flu/

professionals/vaccination/effectivenessqa.htm. Ac-

cessed on: January 9, 2014.

5. Chaplin DD. Overview of the human immune re-

sponse. J Allergy Clin Immunol 2006;117:S430–S435.

6. Key facts about seasonal flu vaccine. Centers for Dis-

ease Control and Prevention. Available at: http://

www.cdc.gov/flu/protect/keyfacts.htm. Accessed on

January 9, 2014.

7. Flu vaccines 2013-2014. Pharmacist’s Letter/

Prescriber’s Letter Detail Document #291001. Octo-

ber 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 atten-

uated versus inactivated influenza vaccine in infants

and young children.

January 2014



11. Kenney RT; Frech SA; Muenz LR; Villar CP; Glenn

GM. Dose sparing with intradermal injection of influen-

za vaccine. N Eng J Med 2004;351:2295-301.

12. Canadian National Advisory Committee on Immuniza-

tion. Reccomendations on the use of intradermal triva-

lent inactivated influenza vaccine (TIV-ID). Canada

Communicable Disease Report 2011;37(ACS-4):1481-

8531. Available at: http://www.phac-aspc.gc.ca/

publicat/ccdr-rmtc/11vol37/acs-dcc-4/index-eng.php.

Accessed on: January 9, 2014.

13. Lowes R. Fluzone high-dose foils flu better in seniors,

says maker. Medscape Medical News, 2013. Availa-

ble at: http://www.medscape.com/viewarticle/813203.

Accessed on: January 9, 2014.

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 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 de-

stroy invading pathogens. C. Macrophages never have to rest between infections. D. A & B 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

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 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) 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 fac-tor, 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)

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.

The Kentucky Pharmacy Education & Research Foundation is

accredited by The Accreditation Council for Pharmacy

Education as a provider of continuing Pharmacy education.

Quizzes submitted without NABP eProfile

ID # and Birthdate cannot be accepted.


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 7. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________


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 7. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________


January 2014


The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's

leading preservation organization for pharmacy.

While contributions of any size are greatly appreciated, the following levels of annual giving have been established

for your consideration.

Friend of the Museum $100 Proctor Society $250

Damien Society $500 Galen Society $1,000

Name______________________________________ Specify gift amount________________________

Address ____________________________________ City____________________Zip______________

Phone H____________________W________________ Email___________________________________

Employer name_____________________________________________________for possible matching gift.

Tributes in honor or memory of_____________________________________________________

Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax

deductible contributions will be mailed to you annually.

Questions: Contact Lynn Harrelson @ 502-425-8642 or [email protected]

USP label standard update

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 injecta-

ble 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 life-

threatening situations — are obvious and clear. The stand-

ards were established by the U.S. Pharmacopeial Conven-

tion (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 stand-

ards and related programs that help ensure the quality,

safety and benefit of medicines and foods.

In short, this USP standard states that warning messages –

for example, “Warning – Paralyzing Agent” or “Dilute Be-

fore 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, in-

cluding 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 state-

ments are immediately apparent.

With the new USP labeling standard, if a healthcare provid-

er 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.

- Thanks to USP for providing this update.

When a Small Reminder Makes a Big Difference

January 2014


KPhA New and Returning Members

KPhA Welcomes New and Renewing Members

November-December 2013

John Anneken

Edgewood

Paul Arthur

Huntington, W.V.

Emily Balenovich

Corbin

Ellen Barger

Mount Washington

Ronald Barned

Glasgow

Walter Bauman

Lancaster

Thomas Beringer

Sparta

Kaleb Blair

Ermine

Renee' Blair

London

Wendell Boggs

Jenkins

Brenda Brewer

Stanton

William Broughton

Shepherdsville

Charles Bryant

Cave City

Jimmy Buchanan

Prospect

William Clark

Owensboro

Heather Clayton

Elkton

Robert Clement

Cadiz

Bonnie Collins

Paris

George Combs

Louisville

Matt Cull

Owenton

Dan Daffron

Monticello

Pamela Decker-Meadows

Cynthiana

Eldon Depew

London

Walter Doll

Lexington

Ben Duvall

Big Clifty

Paul Easley

Fisherville

Anna Eiler

Shepherdsville

Suzanne Epley

Russellville

Nikita Evans

South Shore

Rebecca Farney

Fort Thomas

Andy France

Dry Ridge

Virginia France

Dry Ridge

Tom Frazer

Sturgis

Kristen Fugate

Krypton

Randy Gaither

Louisville

Malcolm Geoghegan

Frankfort

Eric Gibbs

Corbin

Paula Gibson

Manchester

Mary Gilvin

Mt. Sterling

Susan Girdler

Somerset

Amy Glaser

Alexandria

Norris Glenn

Salem

Rosemary Goble

Inez

Michael Goeing

Melvin

April Golden

Corbin

William Grise

Richmond

Gina Guarino

Louisville

Tina Hall

Greenup

Gary Hamm

Elizabethtown

Catherine Hance

Louisville

Amanda Harding

Louisville

Marla Helton

Frenchburg

Robin Hipps

New Albany, Ind.

Celina Howell

Pikeville

Melissa Hudson

Villa Hills

David Hume

Louisville

Bernard Hyman

Louisville

Jane Ingram

Morehead

Kyla James

Sellersburg, Ind.

Joseph Johnson

Lebanon

Frederick Johnston

Georgetown

Linda Johnston

Georgetown

Robin Justice

Pikeville

Diane Kelly

Evarts

January 2014


KPhA New and Returning Members

Melissa Kennon

Lexington

Ethan Klein

Louisville

Dhaval Kotak

Radcliff

Amanda Leathers

Lebanon

Sheila Lee

Louisville

Martin Likins

Greenville

Michael Lin

Louisville

James Litmer

Edgewood

Robert Little

Berea

Jimmie Lockhart

Lexington

Calvin Manis

Barbourville

Arthur Marinaro

Lexington

Jonathan Marquess

Acworth, Ga.

Nancy Matyunas

Louisville

James Maze

Salt Lick

Thomas McCurry

Harlan

Clarence McGaughey

Russell

Clayton McKinney

Shelbyville

Michael McWilliams

Louisville

Parvin Mischel

Kathleen, Ga.

Megan Morgan

Manchester

Wayne Morris

Frankfort

Freddie Norris

Glasgow

Robert Oakley

Louisville

Jennifer O'Hearn

Louisville

Charles Oliver

Glasgow

Angela Onkst

Louisville

Yvonne Parmley

Florence

Kenneth Parsons

Louisville

Sam Pilotte

Prospect

Anne Policastri

Georgetown

Andrea Potter-Adams

Isom

Sharon Ran

Villa Hills

Jeanne Richardson

Memphis, Tenn.

Vendonna Rickard

Madisonville

Mary Roberts

Robinson Creek

Kristie Robertson

Louisville

Lynda Romeo

Louisville

Michael Russell

Murray

Nicholas Schwartz

Florence

James Shackleford

London

Michael Sheets

Fisherville

Angela Shoulders

Bowling Green

JD Shoulders

Bowling Green

Jennifer Shown

Cadiz

Joe Simmons

Glasgow

Sharon Small

Louisville

Jamie Smith

Booneville

Jessica Smith

Booneville

John Smith

Beattyville

Lois Smith

Blackey

Quincy Stephenson

Providence

Misty Stutz

Crestwood

William Sutherland

Louisville

Stephanie Sutphin

Lexington

Christina Taylor

Shepherdsville

Fred Toncray

Maysville

David Triplett

Louisville

Sheryl Turley

Horse Cave

G Steven Underwood

Louisville

Gabe Van Lahr

Webster

Frank Vice

Flemingsburg

Susan Weaks

Paducah

Tyler Whisman

Florence

Amy Wilder

Booneville

Brenda Wilson

Danville

Randy Windham

London

Laban Young

Huntington, W.V.

January 2014


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 [email protected] with a brief description of the story or

to schedule a time to discuss.

Medicare Star Ratings

By: Elliott M. Sogol, PhD, RPh, FAPhA

Vice President Professional Relations, Pharmacy Quality

Solutions

Did you know that your pharmacy is being evaluated by

Medicare prescription drug plans? If not, read on… The

Centers for Medicare & Medicaid Services (CMS) is evalu-

ating all Part D prescription drug plans using a Star Rating

system for several years. Medicare prescription drug plans

receive a summary “star rating” on quality that is based on

their performance across 15 individual

measures. Five measures are specifically relat-

ed to medication management and use. Be-

cause CMS more heavily weighs these 5

measures than other measures, they account

for nearly half of the plan’s Part D summary

rating. These measures are:

2 measures of medication safety

High risk medications in the elderly

Appropriate treatment of blood pressure in

persons with diabetes

3 measures of medication adherence

Oral diabetes medications

Cholesterol medication (statins)

Blood pressure (renin-angiotensin system antagonists)

CMS also evaluates prescription drug plans on “display

measures” which includes metrics on drug-drug interac-

tions, excessive doses of oral diabetes medications and

the use of atypical antipsychotics in nursing home patients.

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 ex-

pected that this CMR measure will be added to the Star

measure set in the next round of ratings.

The Part D plans are now evaluating their pharmacy net-

works on these CMS star ratings measures. Some plans

also are creating incentives for pharmacies to improve per-

formance on these measures while others are planning to

re-formulate their preferred networks with phar-

macies that perform well on the star measures.

The implications for community pharmacy is

significant!

What can you do? Pharmacies can learn how

they are performing on the star measures by

subscribing to a new program named EQuIPP.

The EQuIPP program is a web-based platform

to which health plans submit their prescription

claims data for benchmarking. EQuIPP also

calculates the star measures for each pharma-

cy and makes this information available to the

pharmacies via a secure website. EQuIPP is a

service offered by Pharmacy Quality Solutions

(PQS), a company owned by Pharmacy Quality Alliance

(PQA), a non-profit that develops medication performance

measures used by CMS for the STAR ratings process. A

growing number of Medicare plans are participating in

EQuIPP including Humana, Wellcare, Coventry, and Cigna

-HealthSpring. For more information, visit

www.EQuIPP.org.

- Special thanks to the Pharmacists Society of the State of

New York, where this article was originally published.

Medicare Star Ratings: What it means for your pharmacy

Want to know

more? YOUR KPhA

is planning a CE on

Medicare Star

Ratings for the

136th Annual

Meeting

in June 2014.

Watch

www.kphanet.org

for more

information.

January 2014


Roamey in Mayfield

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

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 [email protected], and we’ll

check his schedule!

@KyPharmAssoc

@KPhAGrassroots

Facebook.com/KyPharmAssoc

KPhA Company Page Are you connected

to KPhA?

Join us online!

January 2014


Pharmacy Law Brief

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 Associ-ation 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 or-

der to communicate her expertise to patients. But I’m won-

dering whether there are legal implications of this; for ex-

ample, might the law hold her to a higher standard of per-

formance because she holds herself out as having special-

ized expertise?

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 exami-

nations to earn their various academic degrees and, if

“board certified,” passed some form of examination created

by those already in the specialty to establish their abilities in

a certain area of practice.

But let’s differentiate some of those wall displays. An aca-

demic degree is evidence of achievement in the academic

realm but that is separate from licensure. It is the latter that

authorizes one to engage in the practice of a profession.

This authority to confer the lawful ability to practice a pro-

fession rests with the states. When the legislature defines

the “scope of practice” for a profession in a “practice act” it

establishes the parameters of professional activity.

Basic licensure authorizes the practitioner to perform all

manner of professional activities that fall within that scope

of practice. It is noteworthy, however, that some profession-

als decide to limit their activities to a subset of what the li-

censure confers, e.g., “practice limited to obstetrics” or

“practice limited to children.”

Finally, it also is possible that when a health professional is

granted privileges by the board of directors of a hospital,

the institution may limit the types of procedures that individ-

ual is authorized to perform within that setting, e.g., may

deliver babies but may not do open heart surgery.

With all that as background, what are the legal implications

of holding yourself out as a specialist? Focusing on the im-

plications during a lawsuit alleging professional negligence,

known colloquially as a malpractice case, the law first looks

at whether some legal duty was owed to the patient and,

secondarily, whether that duty was breached. Where does

that legal duty originate? The law expects that one will per-

form at the level of a reasonable and prudent practitioner

possessing the expertise of one engaging in that type of

practice. So, the performance of a family medicine special-

ist would be evaluated in light of the performance of profes-

sional peers in that specialty, just as a neurosurgeon would

have his or her performance measured against a standard

created by others in that specialty.

And that’s where all those diplomas and certificates be-

come relevant. Those documents, along with the decision

of the practitioner to define the activities in which he or she

will engage, define the area in which the professional’s per-

formance will be measured against those of peers, individu-

als with the same training and experience as the defendant

in the lawsuit. Becoming board certified is a voluntary un-

dertaking, these days involving not only written examina-

tions but also simulations to assess expertise.

A final note about terminology also is important. A physician

seeking to become board certified usually must first com-

plete a post-M.D. residency program. One who has com-

pleted that residency training receives a certificate, not an

academic degree, and the certificate holder who has yet to

take and pass the examination is said to be “board eligible,”

not board certified.

Submit Questions: [email protected]

Disclaimer: The information in this column is intended

for educational use and to stimulate professional discus-

sion 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 ade-

quately and fully address the multifaceted and often com-

plex issues that arise in the course of professional prac-

tice. It is always the best advice for a pharmacist to seek

counsel from an attorney who can become thoroughly fa-

miliar with the intricacies of a specific situation, and render

advice in accordance with the full information.

January 2014


KPhA First District Meeting

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 Prepared-

ness Leah Tolliver represented KPhA at the meet-

ing. Tolliver presented a continuing education pro-

gram on pharmacy emergency preparedness. Spe-

cial 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!

January 2014


Pharmacy Policy Issues

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 pa-

tients 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 re-

sponsibility for their recommendations and actions. Pharmacists play a particularly crucial role in preventing and reduc-

ing 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 er-

rors 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 en-

acting legislation regarding medication safety, particularly

by passing the Healthcare and Research Quality Act of

1999, and establishing the Agency for Healthcare Re-

search and Quality.

Despite major progress in the field, the respective roles of

each health care professional in medication safety pro-

grams 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 medica-

tion error prevention. They concluded that the physician

should take the lead on medication safety processes, in

collaboration with other healthcare professionals.3

Though the AMA claims physicians should be the leaders

on medication error prevention, the American Nurses Asso-

ciation has established numerous guidelines by which to

standardize medication distribution and place the nurse’s

role at the forefront given their ubiquity throughout the pro-

cess.4

The American Pharmacists Association (APhA) also sets

its professionals at the forefront of medication safety strate-

gies. 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 phar-

macists to take the lead on collaboration with physicians.5

Though organizational standards are in conflict, studies

have demonstrated that the most effective medication safe-

ty programs involve strict and clear cooperation among

pharmacists and other health care professionals in the hos-

pital. One multicenter study showed as much as a 67 per-

cent decline in adverse drug events after implementing a

medication safety regimen in which roles for nurses, phar-

macists 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

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 medi-

cation errors and better outcomes for hospitals and pa-

tients. 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 phar-

macy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions

regarding topics for consideration are welcome. Please send them to [email protected].

January 2014


Pharmacy Time Capsules

Pharmacy Time Capsules 2014 First Quarter

1989 — 25 Years Ago

The second Pharmacy in the 21st Century (P21) confer-

ence held in Williamsburg. The concept of pharmaceutical

care was formally introduced by Hepler and Strand and

enthusiastically accepted.


The survey, Mirror to Hospital Pharmacy, published. Data

included that less than 40 percent of all hospitals employed

approximately 2,000 full-time pharmacists.


Western Massachusetts School of Pharmacy opened in

Willimansett, Mass., although never accredited.


The federal Harrison Narcotic Act passed to regulate and

tax the importation, production and distribution of narcotics.


Walden University (Meharry Pharmaceutical College)

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

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 collab-

orative interprofessional teams.

References

1. Brushwood DB, Simonsmeier LM. Riff v. Morgan Phar-

macy: A legal mandate for patient-oriented pharmacy

practice. Am Pharmacy 1987 (Mar.); NS27:68-69.

2. Riff v. Morgan Pharmacy, 508 A.2d 1247 (Pa. Super.

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.

4. American Nurses Association, Medication Errors and

Syringe Safety Are Top Concerns for Nurses Accord-

ing to New National Study, News Release (Silver

Spring, MD, June 18, 2007),

http://www.nursingworld.org/

FunctionalMenuCategories/MediaResources/

PressReleases/2007/SyringeSafetyStudy.pdf.

5. Baker KR. Risk management from a collaborative per-

spective. J Am Pharm Assoc 2003 (Sept-Oct); 43(5

Supp. 1):S54-5.

6. Khoo AL, et al., A multicenter, multidisciplinary, high-

alert medication collaborative to improve patient safety:

The Singapore experience. Joint Commission Journal

on Quality and Patient Safety/Joint Commission Re-

sources 2013 (May); 39:205–212.

7. Leikola S, et al., Comprehensive medication review:

Development of a collaborative procedure. Internation-

al Journal of Clinical Pharmacy 2012 (Aug.); 34:510–

514.

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.

January 2014


Pharmacists Mutual

January 2014


Cardinal Health

January 2014


KPhA BOARD OF DIRECTORS

Kimberly Croley, Corbin Chair

[email protected] 606.304.1029

Duane Parsons, Richmond President


Bob Oakley, Louisville President-Elect


Frankie Hammons Abner, Barbourville Secretary


Glenn Stark, Frankfort Treasurer

[email protected]

Ron Poole, Central City Past President

[email protected]

Directors

Heather Bryan, Mt. Washington Sullivan University

[email protected] Student Representative

Matt Carrico, Louisville

[email protected]

Chris Clifton, Villa Hills

[email protected]

Trish Freeman, Lexington

[email protected]

Brooke Herndon, Louisville University of Kentucky

[email protected] Student Representative

Chris Killmeir, Louisville

[email protected]

Jeff Mills, Louisville*

[email protected]

Chris Palutis, Lexington

[email protected]

Richard Slone, Hindman

[email protected]

Mary Thacker, Louisville

[email protected]

Sam Willett, Mayfield

[email protected]

* At-Large Member to Executive Committee

HOUSE OF DELEGATES

Cassandra Beyerle, Louisville Speaker of the House

[email protected]

Ethan Klein, Louisville Vice Speaker of the House

[email protected]

KPERF ADVISORY COUNCIL

Kim Croley, Corbin

[email protected]

Ann Amerson, Lexington

[email protected]

KPhA/KPERF HEADQUARTERS

1228 US 127 South, Frankfort, KY 40601

502.227.2303 (Phone) 502.227.2258 (Fax)

www.kphanet.org

www.facebook.com/KyPharmAssoc

www.twitter.com/KyPharmAssoc

www.twitter.com/KPhAGrassroots

www.youtube.com/KyPharmAssoc

Robert McFalls, M.Div.

Executive Director

[email protected]

Scott Sisco, MA

Director of Communications & Continuing Education

[email protected]

Kelli Sheets

Office Manager

[email protected]

Leah Tolliver, PharmD

Director of Pharmacy Emergency Preparedness

[email protected]

KPhA Board of Directors/Staff

KPhA sends email announcements

weekly. If you aren’t receiving: eNews,

Legislative Updates, Grassroots Alerts

and other important announcements,

send your email address to

[email protected] to get on the list.

January 2014


Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org [email protected]

American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 [email protected]

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

Frequently Called and Contacted

50 Years Ago/Frequently Called and Contacted

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to

[email protected]. Deceased members for each year will be honored permanently

at the KPhA office.

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.

January 2014


THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601

For more upcoming events, visit www.kphanet.org.

Save the Date 137th KPhA Annual

Meeting & Convention

June 25-28, 2015

Holiday Inn University Plaza and Sloan

Convention Center Bowling Green, KY

the kentucky pharmacist vol. 9 issue 1

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