October 2012 Florida Pharmacy Journal by Florida Pharmacy Today

The Official Publication Of The Florida Pharmacy Association OCT. 2012

October is American Pharmacists Month

Pharmacy Time Capsule 2012 ■■

1987

1937

Twenty-five years ago:

Seventy-five year ago

Clinical Sciences Section formed within the American Pharmaceutical (now Pharmacists) Association Academy of Pharmaceutical Research and Science.

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Over 100 people were poisoned by S. E. Massengill Company’s Elixir of Sulfanilamide . This led to 1938 legislation requiring proof of safety as a condition for marketing. Loronzo L. Skaggs opened the first store of a new chain chain of self-service drugstores in the Midwest. Original name was “Pay-Less” later changed to Osco Drug.

1962

1912

Fifty years ago

One hundred years ago

Legislation introduced (unsuccessfully) to allow the FDA to inspect pharmacy prescription files. Paul Parker at the University of Kentucky established first formalized Drug Information Service. Merrell removes Mer-29 (triparanol) from market for adverse eye events.

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International Pharmaceutical Federation (FIP) established as an international federation of national pharmacy organizations. The Journal of the American Medical Association (JAMA) reports the first diagnosis of death by heart attack

By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, 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

florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers 5 President’s Viewpoint 7 Executive Insight 25 Buyer’s Guide

VOL. 75 | NO. 10 OCTOBER 2012 the official publication of the florida pharmacy association

Features

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Celebrating American Pharmacists Month First Universal Standards Guiding Content, Appearance of Prescription Container Labels to Promote Patient Understanding of Medication Instructions The Florida Pharmacy Association 2012 Resolutions

THE POWER TO HELP YOU SUCCEED - HCC - Since 1989 -

OCTOBER 2012

FPA Calendar 2012-13

November 2-3

FPA Budget and Finance Committee and Board of Directors Meeting and council meetings Orlando FPA office closed for Veterans Day

JANUARY 1 New Year’s Day FPA Office Closed 26-27 FPA Clinical Consultant Conference 31

Last day to submit election ballots FEBRUARY

15-17 NASPA and ASPL Fall Meeting Tucsan, Arizona

6-7

15-17 ASCP Annual Meeting National Harbor, Maryland

Board of Pharmacy Meeting St. Augustine

Deadline for submitting awards nominations

22-23 Thanksgiving - FPA Office Closed

MARCH

DECEMBER Sarasota Law Conference, Hyatt Regency Sarasota

1-4

3-4

Budget and Finance Committee

6-9

ASCP Fall Meeting

23-24 FPA Committee and Council Meetings Orlando

1-2

11-12 Florida Board of Pharmacy Meeting Tallahassee

APhA Annual Meeting Los Angeles, California

12-13 Legislative Days and Health Fair Deadline to submit resolutions

24-25 Christmas Holiday, FPA Office Closed

For a complete calendar of events go to www.pharmview.com CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours LIVE Continuing Education as part of the required 30 hours general education needed every license renewal period. Pharmacists should have satisfied all continuing education requirements for this biennial period by September 30, 2013 or prior to licensure renewal. Technicians will need to renew their registration by December 31, 2012. *For Pharmacy Technician Certification Board Application, Exam Information and Study materials, please contact the FPA office. For More Information on CE Programs or Events: Contact the Florida Pharmacy Association at (850) 222-2400 or visit our Web site at www.pharmview.com

Mission Statements: of the Florida Pharmacy Today Journal

The Florida Pharmacy Today Journal is a peer reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.

of the Florida Pharmacy Today Board of Directors

The mission of the Florida Pharmacy Today Board of Directors is to serve in an advisory capacity to the managing editor and executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the

Journal in its goal of self-support.

Advertisers EPC...................................................................... 10 FRIED.................................................................. 10 Healthcare consultants..................... 3 Kahan SHIR, P.L............................................. 9 PPSC.................................................................... 10 Rx Relief............................................................. 9

CONTACTS FPA — Michael Jackson (850) 222-2400 FSHP — Michael McQuone (850) 906-9333 U/F — Dan Robinson (352) 273-6240 FAMU — Leola Cleveland (850) 599-3301 NSU — Carsten Evans (954) 262-1300 DISCLAIMER Articles in this publication are designed to provide accurate and authoritative information with respect to the subject matter covered. This information is provided with the understanding that neither Florida Pharmacy Today nor the Florida Pharmacy Association are engaged in rendering legal or other professional services through this publication. If expert assistance or legal advice is required, the services of a competent professional should be sought. The use of all medications or other pharmaceutical products should be used according to the recommendations of the manufacturers. Information provided by

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Flor i d a P h a r m a c y T o d a Y

E-mail your suggestions/ideas to dave@fiorecommunications.com

The President’s Viewpoint GUEST COLUMNIST Don Bergemann, RPh, MBA

Membership – No Easy Answers

s many of you may know, FPA membership has been flat for a number of years. I first started looking at this back in 2007 when I was running for the FPA presidency. My focus at that time, since the vast majority of pharmacists were employees, was the psycho-demographics of the employee pharmacist. That is, what makes them tick? We conducted two employee pharmacist summits during my year as president in an attempt to ascertain some answers. While our sample size was too small to draw any meaningful conclusions, we were able to determine that membership was a multi-faceted issue. Those factors included demographics, geography, cultural, and generational. At that time we did not recognize how significant the generational factors were. Over the next few years the Organizational Affairs Council conducted a number of surveys and revamped membership applications. However, these were always done in addition to their other responsibilities and did not yield any meaningful results. Thus, in August 2010, I suggested to the Budget & Finance Committee that it was time to give membership the attention it deserved by creating a standing membership council. The Board of Directors subsequently approved the recommendation of the Budget & Finance Committee. During the last FPA annual meeting the final approval of the constitution and bylaw language was approved and that standing membership council came into being. Current FPA President Goar Alvarez asked me to serve as the initial chair. In preparing for this challenge, I started reviewing the current thinking and trends related to association mem-

bership. I came across two thought provoking books – Remembership by Kyle Sexton and The End of Membership As We Know It by Sarah Sladek - that reinforced my belief that there are no easy answers and that also brought to light how significant the generational factors really are. What the Membership Council is attempting to do is to identify what need or want the FPA can address for each

What the Membership Council is attempting to do is to identify what need or want the FPA can address for each target market that is so meaningful that an individual will consider joining rather than choosing to remain a nonmember. target market that is so meaningful that an individual will consider joining rather than choosing to remain a nonmember. The three target markets that are proving to be particularly challenging are the employee pharmacists, the generation X pharmacists, and the generation Y pharmacists. Allow me to delineate some of key

Don Bergemann, RPh, MBA Membership Council Chair

generational issues, extracted from the above books, that must be taken into account. First are comparative issues for three different generations followed by membership related issues. Comparative Issues Baby Boomers ■■ ■■

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Born: 1945-1964 Communication Styles: Prefer detailed dialogue in-person or via phone; appreciate meetings Why They Join: Opportunities to lead and leave a legacy Volunteer Styles: Want to lead; like to manage others; like to hold meetings and discuss strategies Turn-offs: People suggesting they try something new

Generation X ■■ ■■

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Born: 1965-1981 Communication Styles: Prefer clear, concise communication – not overexplaining, clichés, or corporate jargon; prefer e-mail Why They Join: Opportunities to OCTOBER 2012

FPA Staff

Executive Vice President/CEO Michael Jackson (850) 222-2400, ext. 200

Director of Continuing Education Tian Merren-Owens, ext. 120 Controller Wanda Hall, ext. 211

Educational Services Office Assistant Stacey Brooks, ext. 210 Coordinator of Membership Christopher Heil, ext. 110

Florida Pharmacy Today Board Chair............................................. Jennifer Pytlarz, Brandon Vice Chair...................Don Bergemann, Tarpon Springs Treasurer...............................Stephen Grabowski, Tampa Secretary.........................Stuart Ulrich, Boynton Beach Member..................................... Joseph Koptowsky, Miami Member..............................Rebecca Poston, Tallahassee Member.............................. Carol Motycka, St. Augustine Member....................................Cristina Medina, Hollywood Member................................. Norman Tomaka, Melbourne Member..............................Verender Gail Brown, Orlando Executive Editor.........Michael Jackson, Tallahassee Managing Editor.........................Dave Fiore, Tallahassee

This is a peer reviewed publication. ©2012, FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/ publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board. FLORIDA PHARMACY TODAY, Annual subscription - United States and foreign, Individual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax. Florida Pharmacy Association

610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web 6 Address: | Florhttp://www.pharmview.com ida Pharmacy TodaY

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further their careers Volunteer Styles: Want autonomy; hate being micromanaged or anything that wastes their time Turn-Offs: Chaos, distrust, loyalty that goes unrewarded

Generation Y ■■ ■■

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Born: 1982-1995 Communication Styles: Prefer frequent feedback and problem solving via technology instead of phone calls or meetings Why They Join: Opportunities to learn from others Volunteer Styles: Want structure; expect immediate feedback and increasing responsibility Turn-Offs: Dismissing their ideas because of their lack of experience

Member Related Issues ■■ From now until 2030, every eight seconds someone will turn 65. This shift in human capital – the largest shift in our country’s history – poses the greatest threat to associations because most associations remain entirely governed and supported by the Baby Boomer generation, and few have or are developing strategies to cushion themselves from this massive exodus of board members, committee chairs, and dedicated volunteers. ■■ Members of all ages are likely questioning the value of membership in your association, but the youngest will continue to pose this question for the next 18-20 years. They demand a return on investment unlike any other generation that has come before them. ■■ Generations X and Y will not respond to the recruiting efforts of the past. An entirely new approach new approach is required. Everything about the membership association has to change. ■■ There are two types of members: givers and takers. Givers, tend to be Boomers, willingly to pay their dues, volunteer their time, and give of their resources. Takers, who tend to be from younger generations, say, “I will show up if you can show me value.”

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Generational differences aren’t a matter of right and wrong. What one generation prefers isn’t better than what another generation prefers, but there are clearly differences in each generation’s preferences. Not right. Not wrong. Just different. Generations X and Y need to feel a secure relationship and a sense of ownership in your association before they join. In contrast, most baby boomers will join an association because they feel it’s the right thing to do and they work at the belonging piece after the fact. However, your association will struggle to recruit and retain younger members if they don’t feel like they belong in your association. Building trust is done in steps and over time. It’s not an immediate reaction, and neither is a sense of belonging. Different generations have different expectations of association membership. Their values are different, which means the benefits each generation perceives as valuable are also different. Your association must address the wants and needs of the under 45 crowd because these people could not care less about your association’s history, insurance discounts, or annual conference. Your association needs to know what younger generations do care about because without them your association will struggle to survive.

Yes, the FPA as an association needs to ‘Get Out of the Box’ regarding membership. We need your input and ideas as to what those key needs or wants for generation X and Y pharmacists and/or employee pharmacists may be. Please send your comments to me at don@bceinfo.com. n

Executive Insight Michael Jackson, BPharm, EVP & CEO, Florida Pharmacy Association by michael jackson, RPh

Medicare Audits Impacting Pharmacy Reimbursements

embers, this is one of those messages to you that may stir some controversy even within our own society. It is a story that has to be told because many of you are already living this reality. For some it is a minor irritation, but for others these kinds of situations can be a career-and business-changing nightmare of epic proportions. What I am referring to is simply the notion that there is a reasonable expectation that services provided by pharmacist members will be paid for. Many of us who practiced community pharmacy in the 1970s and 1980s remember when we cared for patients and were paid for those services. We also got to keep what we were paid. There was no such thing as fraud or abuse. We also had what I would consider to be a healthy relationship with the patients that visit our pharmacies. We are now living in a different world where a third-party program is paying on behalf of the patient. In 1990, over 63% of all prescriptions were paid for with cash. In 2007, the percentage of cash prescriptions dropped to only a little over 10%. What is truly interesting and deserving of considerable economic research is that the costs related to prescription drugs have climbed dramatically during that same time period. The third-party payer system is designed to give another entity the opportunity to scrutinize the value and validity of what you are providing to consumers. I used to believe that when you adjudicate a prescription drug claim that you were going to get reimbursed, and that was the end of the story. Well, the reality now is that a pa-

tient can visit a physician for an illness. The prescribing practitioner licensed by a state medical board will issue a valid prescription to correct the patientâ&#x20AC;&#x2122;s medical problem. The pharmacy will be presented with that prescription

In 1990, over 63% of all prescriptions were paid for with cash. In 2007, the percentage of cash prescriptions dropped to only a little over 10%. What is truly interesting and deserving of considerable economic research is that the costs related to prescription drugs have climbed dramatically during that same time period. for filling. The pharmacist will select the proper drug that was purchased through a licensed wholesaler. The pharmacy will have records of that purchase. The pharmacy staff will prepare the medication for dispensing, adjudicate the claim through the insurance plan claims processor and counsel the

Michael Jackson, B.Pharm

patient. The patient will sign for and begin taking the medications. If taken properly, the patient will either get better or their disease will be properly managed. Here is where the controversy begins and why I believe that change and reform is sorely needed. In consideration of all the services that you have provided above your integrity and honesty will be called into question. You have absolutely no say in that matter because your pharmacy is forced to agree to the terms and conditions of whatever thirdparty contract that you have signed. You have to prove that whatever you are billing the third party plan for, you have proper invoices showing what you purchased. You have to demonstrate to auditors that your records are not only to the standards required by Florida and Federal laws but also consistent with the obscure language that is published in your provider agreements OCTOBER 2012 |

2012 FPA Board of Directors The Florida Pharmacy Association gratefully acknowledges the hard work and dedication of the following members of the FPA leadership who work deligently all year long on behalf of our members.

Bob Parrado.............................................................................. Chairman of the Board Goar Alvarez ................................................................................................FPA President Terry Gubbins............................................................................................ President Elect Betty Harris ............................................................................................................Treasurer Eric Alvarez.................................................Speaker of the House of Delegates Gary Koesten.................................Vice Speaker of the House of Delegates Preston McDonald, Director............................................................................ Region 1 Michael Hebb, Director ......................................................................................Region 2 Eva Sunell, Director ..............................................................................................Region 3 Raul N. Correa, Director ...................................................................................Region 4 Jeffery Parrado, Director ...............................................................................Region 5 Scott Tomerlin, Director.....................................................................................Region 6 Paul Rohrbaugh, Director.................................................................................. Region 7 Raul Gallo, Director.................................................................................................Region 8 Paul Elias, Director.................................................................................................Region 9 Constance Hogrefe.................................................................President Elect FSHP Michael Jackson........................................Executive Vice President and CEO

Florida Pharmacy Today Journal Board Chair......................................................Jennifer Pytlarz, jlc_rxdoc@hotmail.com Vice Chair......................................................... Don Bergemann, don@bceinfo.com Treasurer....................Stephen Grabowski, sgrabowski@seniormmc.com Secretary...................................................................Stuart Ulrich, Stuarx@aol.com Member.................................................Joseph Koptowsky, docjik1215@aol.com Member........................Rebecca Poston, rebecca_poston@doh.state.fl.us Member....................................................... Carol Motycka, motycka@cop.ufl.edu Member........................................................Cristina Medina, cmmedina@cvs.com Member................................................................Norman Tomaka, FLRX9@aol.com Member................... Verender Gail Brown, brownvgrx4304@hotmail.com Executive Editor................Michael Jackson, mjackson@pharmview.com Managing Editor...................Dave Fiore, dave@fiorecommunications.com

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Flor i d a P h a r m a c y T o d a Y

or in the Medicare or Medicaid policy manual. For example, take a look at this Florida Medicaid policy: Diverted Pharmaceuticals Program Requirements All Medicaid pharmacy providers will be required to perform the following functions when dispensing prescription drugs (tablets and capsules, excluding nitroglycerin containing products or medication that is required by the manufacturer to be dispensed in the manufacturer‘s original packaging) to a Medicaid patient: Remove from original container and place in pharmacy vial; Prescription drugs that are in the dosage form of any of the following: creams, ointments, ophthalmics, inhalers, topical patches, otics, reconstituted medications, and injectables: Inscribe an “M” on the outside of the original manufacturer‘s packaging by using an indelible marker and ensuring that the “M” is clearly visible or remove the manufacturer label To ensure compliance, the Agency may conduct audits. Findings from an initial audit will be shared with the pharmacy during the audit and the pharmacy will receive additional instruction of dispensing requirements. Pharmacies having deficiencies greater than 10.0% in a first re-audit shall be fined in the amount of $1,000 per violation. Pharmacies that have deficiencies of greater than 10.0% in a second re-audit may either be fined up to $5,000 per violation pursuant to Section 409.913, F.S., or terminated from the Medicaid Program. Failure to comply with the dispensing requirements will result in sanctions as allowed in section 409.913, Florida Statutes, or Chapter 59G, Florida Administrative Code. While it is clear that the above policy is designed to stop patients who obtain Medicaid prescriptions and then “wholesale” them on the street back to health care providers, the penalties for pharmacies that do not comply are more severe than those for prescription dispensing errors. Termination from the Medicaid program could create an avalanche effect as new plans that you sign up for may ask if you had been terminated from the Medicaid or Medicare

program. That may be a basis for denying you as a provider. What can be done about this? Many of our members have attended our educational programs and read our articles in the Journal and Stat News and have benefitted by preparing their pharmacies for successful audits. FPA member Paul Finkel of North Miami Beach has shared with us the value of the tips provided by the FPA. Most of the audits in his pharmacy have resulted in minimal recoupment of dollars received. This is likely due to a comprehensive program of service documentation and recordkeeping consistent with pharmacy policies. Still, there is rarely a day that goes by when both member and nonmember pharmacists and pharmacy owners call the FPA office to discuss the aggressive auditing practices of the PBM industry. As an association we agree that audits of pharmacy services are necessary to verify services provided. Our concerns are primarily over how inconsistent audits are being conducted and the tech-

niques being used to extort money back from a provider that simply had recordkeeping errors. Of course, there may be those rare instances when a pharmacy provider is intentionally doing things that they have no business doing. There are remedies for that kind of behavior such as recoupment of funds received fraudulently and filing complaints to the Board of Pharmacy, Better Business Bureau or other similar agencies. If a PBM auditor assesses a finding of guilt and recommends money being taken back from a pharmacy provider because the DEA license number was on the back side of a prescription instead of the front (or face) of the prescription, is this intent to defraud a payer? Should an audit penalty or finding of guilt be more burdensome than Board of Pharmacy discipline? The FPA is a firm believer that there needs to be clear standards to deal with this kind of activity. In 2004, the FPA advocated for and was successful in getting auditing standards into the

Medicaid fee for service program. For the past several years we have worked to get bills filed and heard in both the Florida Senate and House of Representatives to expand these Medicaid auditing standards to other health plans. We can be successful with this project, but to do so means that every reader of this article will need to get engaged on this issue. We are in an election season, and state political candidates are robocalling your home telephones and visiting your churches. Help us to educate current and future members of the Florida House and Senate on pharmacy audits. You should also consider becoming actively involved in our legislative action network and place on your calendar March 12-13, 2013. That is the date of our scheduled Legislative Days and Health Fair at the Florida Capitol. Remember this quote from a Florida pharmacy school educator: “FAILURE TO GET INVOLVED IN PUBLIC POLICY MAKING EMPOWER OTHERS TO DETERMINE YOUR FUTURE.” n

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Celebrating American Pharmacists Month Source: American Pharmacists Association Pharmacists are experts in helping patients get the most out of today’s complicated medications. They are an integrated member of the health care team and are directly involved in patient care. Pharmacists advise patients and health care providers on the selection, dosages, interactions, and side effects of medications. Pharmacists have a significant role in assessing medication management in patients, and in referring patients to physicians, as they are often the first point-of-contact for patients with health inquiries. They have a passion for the profession and a strong commitment to patient safety. American Pharmacists Month (APhM) is celebrated annually during October. APhM is a time to recognize pharmacists for the vital contributions they make to health care in the United States through improved medication use and advanced patient care. It serves to promote pharmacists as the medication experts and an integral part of the health care team. APhM aims to educate the public, policymakers, and other health care professionals about the role pharmacists play in the reduction of overall health care costs and the safe and effective management of medications. APhM is a time to Educate your patients, Motivate your staff, and Engage and Inspire your community to “Know Your PHARMACIST, Know Your MEDICINE.” American Pharmacists Month Objectives ■■ To recognize the vital contributions pharmacists make to health care in the United States ■■ To enhance the image of pharmacists as the medication experts and an integral part of the health care team. ■■ To educate the public, policy makers, pharmacists and other health care professionals about the role pharmacists play in reducing health care costs and the safe and effective management of medications. ■■ To promote the importance of “Know Your Pharmacist, Know Your Medicine” in the safe and effective use of medications.

Important Questions to Talk Over with Your Patients Answers patients need, but may not know how or who to ask. 1. Do you have any allergies? 2. Do you know the name of the drug they were prescribed or what it looks like? 3. Do you know what this medication is for and why it was prescribed? 4. Do you know how and when to take this medication? 5. Do you know how long to take this medication for? 6. Do you know what will happen if he/she does not take this medication as prescribed? 7. Do you know when to expect the medication to work or that he/she will notice results? 8. Do you know what side effects to expect? 9. What other medications are you taking, including over-the-counter, prescription, vitamins and herbal supplements? o Are there any interactions with this new medication the patient needs to be aware of? o Did they advise their healthcare provider that they were taking these? 10. Do you know what to do if he/she has a problem with this medication? 11. How do you plan to pay for the medication? Insurance, cash, other? 12. Do you know that taking this medication means they need not take another older medication? 13. Are you aware of the possible interactions with food, alcohol or physical activities? 14. Are you aware that there may be pregnancy or breast-feeding implications for this medication? 15. Are you aware of the regular tests required with taking this medication, such as blood work, bone density scans, etc? 16. Were you informed of the benefits AND the risks of taking this medication, or given an alternative choice? 17. Are you aware of the proper storage and disposal for this medication? 18. Have you created a complete medication list? o Does it include their vaccinations? o Do you carry it with you?

19. Are you up to date on their immunization status? 20. Do you know my first name or the names of the other pharmacists here? o Is this the only pharmacy you are using? OCTOBER 2012 |

r e First Universal Standards Guiding Content, Appearance n i a t n o C d n r of Prescription Container Labels to Promote Patient o a i d t n p i a t of Medication Instructions cr Understanding S w th Ne

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ber of the USP as the degree to which people can obNomenclature, tain, process and understand the basic 2013 1 0 Safety and Lahealth information and services they 5 ate: 0 d l beling Expert need to make appropriate health del i F Committee, the cisions. According to IOM, 77 million G 4 group of indeAmericans have limited health literacy, 875 ing n r E o R X9 O pendent experts and a majority of Americans have difm H ED n the ure. i t responsible for ficulty understanding and using curJAN e l tab d press 1 e the new stanrently available health information and k o I Ta gh blo G M 0 dard. “With an services. 5 i IL e) R for h U 0 I aging and inElements of the new USP standards, 3 d : Qt y ROD rothiazi J di2014 creasingly D / 1 / contained in General Chapter <17> PreY 5 H ith chlo Exp: o m r S verse populascription Container Labeling, of the Unitd e (hy r e et r. 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P ardrug hownmedication instructions, which is d S in more than one million adverse their label specify patient name, drug n . l a t e lab ing s ered abelUnited t events per yearinin States, absolutely essential to preventing poname Lthe n r e c e s (spell out full nonproprietary ntn linebrand name) and strength, and onta released atietoday e C p e new istandards by the tentially dangerous mistakes and helpand n a o r w i t fo pt e be t sclear ions ize) directions for use in simple lanrescrPharmacopeial Convention (USP) ing to ensure patient health and spacsafee PU.S. gurat n h i e t fi t o i n m p h o c w fro sible of the ty.” guage. Less critical information (e.g., uate ll pos for the first time provide a universal Adeq (25–30% e the ect a z i t approach to the format, appearance, Studies have found that 46 perpharmacy name, drug quantity) should m i x n er H of te ly. Mori r innot ordsupersede n o t content and language of instructions cent of patients misunderstood one critical information and x e tal te e contain n t o n i z i r for medicines in containers dispensed more dosage instructions should be placed away from dosing inn thprescripHor o turon lack p t is particulartext. nt (b variability in d cy f i by pharmacists. Wide tion labels. The problem structions. e r o e p s n t I arma r as ine ) h l r d t p d n n , . a u o g o labels exists itobe re prescription ly troublesome intopatients with lownor -c container t (e. escri t ons High te backgr r e c t p e n , s r o i c prescriptions, marginal literacy (one study ayreadability. mbeImprove uish s for n wh individual tical showed oacross C day ed aw the ne nu e placLabels isting and s criwere on o i s d t h e c o pharmacies, retail chains states. patients with low literacy 34 times L p t should be designed and fort e r a b ce di ion e and prescripatdi(e.g., so they are easy to read. Tyould onmatted h as specific m m e spa l suprovide h s r c t a s i o n The USP standards more likely to misinterpret ) f h . i J W e cy in , etc instruct e lab toporganize amein arma labels in a thhow g rerectiononon tion warning labels),nand patients pography should be optimized by ush s D dosin e label). te rsu manner that a e i m v v o r e h f e r t “patient-centered” best receiving multiple medications that are ing high contrast print; adequate white f b us om o or ab t t e t o a b flects how most patients seek out and scheduled for administration using unspace between lines of text (i.e., 25-30 c r trun mation r Nevemedication understand instructions. necessarily complex, non-standardized percent of the point size); simple uno f n pt ical i 10for n “Lack standards latime periods. However, even patients condensed familiar fonts (Times RoE cofrituniversal a h t aller ntent conm s beling on dispensed prescription with adequate literacy often misunderman or Arial are specifically recome al co o typ criticfor tainers is aNrootescause patient misstand common prescription directions mended); and large font size (e.g., e s lud nd , incand F for l non-adherence e l understanding, and warnings. minimum 12-point Times Roman or b i poss se t) r said e v e medication errors,” Joanne G. The USP effort to create these new 11-point Arial) for critical information. u When rpose for age Schwartzberg,eM.D., director, aging standards developed from an Institute Older adults, in particular, have diffiu th p G and community health for the Amerof Medicine (IOM)-led initiative to imculty reading small print. ican Medical Association and a memprove health literacy, which is defined 12

Flor i d a P h a r m a c y T o d a Y

Give explicit instructions. Instructions for use should clearly separate the dose itself from the timing of each dose. Do not use alphabetic characters for numbers. For example, write, “Take 2 tablets in the morning and 2 tablets in the evening” rather than “Take 2 tablets twice daily.” Dosing intervals such as “twice daily,” “3 times daily,” or hourly intervals such as “every 12 hours” should be avoided because such instructions are implicit rather than explicit, may involve numeracy skills, and patient interpretation may vary from prescriber intent. Although instructions worded in terms of specific hourly times (e.g., 8 a.m. and 10 p.m.) may be assumed to be more easily understood, in actual use they are less readily understood and may present greater adherence issues due to individual lifestyle patterns (e.g., shift work) than general timeframes such as “in the morning” or “after breakfast.” Ambiguous directions such as “take as directed” should be avoided without clear supplemental information. Include purpose for use. If the purpose of the medication is included on the prescription, it should be included on the label unless a patient prefers that it not appear. Confidentiality and FDA approval for intended use (i.e., labeled vs. off-label use) may cause some to constrain its inclusion on labels. Current evidence supports inclusion of purpose-for-use language in clear, simple terms, e.g., “for high blood pressure” rather than “for hypertension.” Address limited English proficiency. Whenever possible, the directions for use on a prescription container label should be provided in the patient’s preferred language. The drug name shall be in English as well so that emergency personnel can have quick access to the information. Translations should be produced using a high-quality translation process; an example is provided in the standard.

Address visual impairment. Provide alternative access for visually impaired patients (e.g., tactile, auditory, or enhanced visual systems that may employ advanced mechanics or assistive technology). “Patients’ best—and often only— source of information regarding the medications they have been prescribed is on the prescription container label,” Dr. Schwartzberg noted. Although other written information and oral counseling may be available, the prescription container label must fulfill the professional obligations of the prescriber and pharmacist. These include giving the patient the most essential information needed to understand how to safely and appropriately use the medication and to adhere to the prescribed medication regimen. USP issued a draft version of this standard for public review and comment by all interested stakeholders— including healthcare practitioners, retailers, software vendors, consumers and others—in December 2011. The final standard will be published in November 2012, and incorporates multiple additions based on comments received, including more detail on producing high-quality translations, the visual impairment section, and the direction to include both brand and nonproprietary names on labels. Enforcement of the standard will be the decision of individual state boards of pharmacy, which may choose to adopt it into their regulations—similar to USP standards for sterile and nonsterile pharmaceutical compounding, both of which are widely recognized by states. At its 2012 annual meeting, the National Association of Boards of Pharmacy passed a resolution supporting state boards in requiring a standardized prescription container label.

Adopt-A-Student Adopt-A-Student COR R EC T ION: I n t he September 2012 issue of Florida Pharmacy Today, we published an incorrect list of contributors to the Adopt-A-Student program. Our apologies for the mistake. Below is the correct list. ■■ Paul Ackerman ■■ Terry Gubbins ■■ Betty Harris ■■ Ed Hamilton ■■ Michael Mone ■■ Jim and Pat Powers ■■ Robert Renna ■■ Robert Thomas ■■ Norman Tomaka ■■ Theresa Tolle ■■ Broward County Pharmacy Association ■■ Jim Powers ■■ Fritz Hayes ■■ William Riffee ■■ Ed Hamilton ■■ Marilyn Underberg ■■ Alachua County Association ■■ Al Tower ■■ Alexis Jurick ■■ Norman Tomaka ■■ Betty Harris ■■ Michael Mone ■■ Caridad Ferree ■■ Wayne Cheatum ■■ Reginal Harris ■■ Kathy Petsos ■■ Paul Delisser ■■ David Mackarcy ■■ Bob Parrado ■■ Elizabeth Lessmann ■■ Kerry Rambaran ■■ Chen Ganzer ■■ Karen Whalen ■■ Dade County Pharmacy Association ■■ Ramy Gabriel

OCTOBER 2012

SAMPLE PRESCIRPTION CONTAINER LABELING

U S P FA C T S H EE T

Examples of Prescription Container Labels That Comply with New Standard

RX98754

B C D E F

RX98754

Fill date: 05-01-2013

JOHN DOE Take 1 tablet in the morning for high blood pressure. HYDRODIURIL 50MG (hydrochlorothiazide)

JANE DOE Take 1 tablet in the morning for high blood pressure. HYDRODIURIL 50MG (hydrochlorothiazide)

Prescriber: Dr. Jane Smith 2 refills before 04/01/2014

Main Pharmacy 301-555-1234

Qty: 30 Exp: 5/1/2014

Main Pharmacy 301-555-1234

123 Main Street Yourtown, USA 54321

Label using approved Arial font

Qty: 30 Exp: 5/1/2014 123 Main Street Yourtown, USA 54321

G H I J

Label using approved Times Roman font

Sample labels showing key elements from the Prescription Container Labeling standard. Please note that the labels shown are examples and do not reflect all possible configurations for a patient-centered label. Shown at actual size.

Highlighting, bolding, and other typographical cues should preserve readability

Critical information and instructions should be emphasized (minimum 12 pt font): • Patient name • Drug name and strength (brand and generic name spelled out) • Instructions in simple language (sentence case) • Purpose for use

USP Headquarters Maryland, USA

Europe/Middle East/Africa Basel, Switzerland

High-contrast print (black print on white background)

Adequate white space between lines of text (25–30% of the point size)

White space to distinguish sections on the label such as directions for use versus pharmacy information

Horizontal text only. Minimize the need to turn the container in order to read lines of text.

Never truncate or abbreviate critical information

No type smaller than 10 pt for less-critical content

Less critical content (e.g., pharmacy name and phone number, prescriber name, etc.) should be placed away from dosing instructions (e.g., at the bottom of the label).

Whenever possible, include the purpose for use

USP–India Private Ltd. Hyderabad, India

USP–China Shanghai, China

USP–Brazil São Paulo, Brazil ISO 9001:2008 Certified

Flor i d a P h a r m a c y T o d a Y

CHAPTER 17 PRESCIRPTION LABEL STANDARDS Apparatus / 〈17〉 Prescription Container Labeling 1

USP 36 Add the following: ▲

〈17〉 PRESCRIPTION CONTAINER LABELING INTRODUCTION

Medication misuse has resulted in more than 1 million adverse drug events per year in the United States. Patients’ best source (and often only source) of information regarding the medications they have been prescribed is on the prescription container label. Although other written information and oral counseling sometimes may be available, the prescription container label must fulfill the professional obligations of the prescriber and pharmacist. These obligations include giving the patient the most essential information needed to understand how to safely and appropriately use the medication and to adhere to the prescribed medication regimen. Inadequate understanding of prescription directions for use and auxiliary information on dispensed containers is widespread. Studies have found that 46% of patients misunderstood one or more dosage instructions, and 56% misunderstood one or more auxiliary warnings. The problem of misunderstanding is particularly troublesome in patients with low or marginal literacy and in patients receiving multiple medications that are scheduled for administration using unnecessarily complex, nonstandardized time periods. In one study, patients with low literacy were 34 times more likely to misinterpret prescription medication warning labels. However, even patients with adequate literacy often misunderstand common prescription directions and warnings. In addition, there is great variability in the actual auxiliary warning and supplemental instructional information applied by individual practitioners to the same prescription. The specific evidence to support a given auxiliary statement often is unclear, and patients often ignore such information. The essential need for, and benefit of, auxiliary label information (both text and icons) in improving patient understanding about safe and appropriate use of their medications vs. explicit simplified language alone require further study. Lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, nonadherence, and medication errors. On May 18, 2007, the USP Safe Medication Use Expert Committee established an Advisory Panel to: 1) determine optimal prescription label content and format to promote safe medication use by critically reviewing factors that promote or distract from patient understanding of prescription medication instructions and 2) create universal prescription label standards for format/appearance and content/language. In November 2009, the Health Literacy and Prescription Container Labeling Advisory Panel presented its recommendations to the Safe Medication Use Expert Committee, which then requested that USP develop patient-centered label standards for the format, appearance, content, and language of prescription medication instructions to promote patient understanding. These recommendations form the basis of this general chapter. Note—These standards do not apply when a prescription drug will be administered to a patient by licensed personnel who are acting within their scope of practice.

PRESCRIPTION CONTAINER LABEL STANDARDS TO PROMOTE PATIENT UNDERSTANDING Organize the prescription label in a patient-centered manner: Information shall be organized in a way that best reflects how most patients seek out and understand medication instructions. Prescription container labeling should feature only the most important patient information needed for safe and effective understanding and use. Emphasize instructions and other information important to patients: Prominently display information that is critical for patients’ safe and effective use of the medicine. At the top of the label specify the patient’s name, drug name (spell out full generic and brand name) and strength, and explicit clear directions for use in simple language. The prescription directions should follow a standard format so the patient can expect that each element will be in a regimented order each time a prescription is received. Other less critical but important content (e.g., pharmacy name and phone number, prescriber name, fill date, refill information, expiration date, prescription number, drug quantity, physical description, and evidence-based auxiliary information) should not supersede critical patient information. Such less critical information should be placed away from dosing instructions (e.g., at the bottom of the label or in another less prominent location) because it distracts patients, which can impair their recognition and understanding. Simplify language: Language on the label should be clear, simplified, concise, and familiar, and should be used in a standardized manner. Only common terms and sentences should be used. Do not use unfamiliar words (including Latin terms) or medical jargon. Use of readability formulas and software is not recommended to simplify short excerpts of text like those on prescription labels. Instead, use simplified, standardized sentences that have been developed to ensure ease of understanding the instructions correctly (by seeking feedback from samples of diverse consumers). Give explicit instructions: Instructions for use (i.e., the SIG or signatur) should clearly separate the dose itself from the timing of each dose in order to explicitly convey the number of dosage units to be taken and when (e.g., specific time periods each day such as morning, noon, evening, and bedtime). Instructions shall include specifics on time periods. Do not use alphabetic characters for numbers. For example, write “Take 2 tablets in the morning and 2 tablets in the evening” rather than “Take two tablets twice daily”). Whenever available, use standardized directions (e.g., write “Take 1 tablet in the morning and 1 tablet in the evening” if the prescription reads b.i.d.). Vague instructions based on dosing intervals such as twice daily or 3 times daily, or hourly intervals such as every 12 hours, generally should be avoided because such instructions are implicit rather than explicit, they may involve numeracy skills, and patient interpretation may vary from prescriber intent. Although instructions that use specific hourly times (e.g., 8 a.m. and 10 p.m.) may seem to be more easily understood than implicit vague instructions, recommending dosing by precise hours of the day is less readily understood and may present greater adherence issues due to individual lifestyle patterns, e.g., shift work, than more general time frames such as in the morning, in the evening, after breakfast, with lunch, or at bedtime. Consistent use of the same terms should help avoid patient confusion. Ambiguous directions such as “take as directed” should be avoided unless clear and unambiguous supplemental instructions and counseling are provided (e.g., directions for use that will not fit on the prescription container label). A clear statement referring the patient to such supplemental materials should be included on the container label. OCTOBER 2012

CHAPTER 17 PRESCIRPTION LABEL STANDARDS

continued

2 〈17〉 Prescription Container Labeling / Apparatus Include purpose for use: If the purpose of the medication is included on the prescription, it should be included on the prescription container label unless the patient prefers that it not appear. Always ask patients their preference when prescriptions are submitted for filling. Confidentiality and FDA approval for intended use (e.g., labeled vs. off-label use) may limit inclusion of the purpose on labels. Current evidence supports inclusion of purpose-for-use language in clear, simple terms (e.g., “for high blood pressure” rather than “for hypertension”). Limit auxiliary information: Auxiliary information on the prescription container label should be evidence-based in simple explicit language that is minimized to avoid distracting patients with nonessential information. Most patients, particularly those with low literacy, pay little attention to auxiliary information. The information should be presented in a standardized manner and should be critical for patient understanding and safe medication use (e.g., warnings and critical administration alerts). Icons are frequently misunderstood by patients. In addition, icons that provide abstract imagery for messages that are difficult to visually depict may be ineffective at improving understanding compared with simplified text alone. Use only icons for which there is adequate evidence, through consumer testing, that they improve patient understanding about correct use. Evidencebased auxiliary information, both text and icons, should be standardized so that it is applied consistently and does not depend on individual practitioner choice. Address limited English proficiency: Whenever possible, the directions for use on a prescription container label should be provided in the patient’s preferred language. Otherwise there is a risk of misinterpretation of instructions by patients with limited English proficiency, which could lead to medication errors and adverse health outcomes. Additionally, whenever possible, directions for use should appear in English as well, to facilitate counseling; the drug name shall be in English so that emergency personnel and other intermediaries can have quick access to the information. Translations of prescription medication labels should be produced using a high-quality translation process. An example of a high-quality translation process is: • Translation by a trained translator who is a native speaker of the target language • Review of the translation by a second trained translator and reconciliation of any differences • Review of the translation by a pharmacist who is a native speaker of the target language and reconciliation of any differences • Testing of comprehension with target audience If a high-quality translation process cannot be provided, labels should be printed in English and trained interpreter services used whenever possible to ensure patient comprehension. The use of computer-generated translations should be limited to programs with demonstrated quality because dosage instructions can be inconsistent and potentially hazard-

Flor i d a P h a r m a c y T o d a Y

USP 36 ous. Standardized translated instructions and technology advances are needed to ensure the accuracy and safety of prescription container labeling for patients with low English proficiency. Improve readability: Labels should be designed and formatted so they are easy to read. Currently no strong evidence supports the superiority in legibility of serif vs. sans serif typefaces, so simple uncondensed fonts of either type can be used. Optimize typography by using the following techniques: • High-contrast print (e.g., black print on white background). • Simple, uncondensed familiar fonts with sufficient space within letters and between letters (e.g., Times Roman or Arial). • Sentence case (i.e., punctuated like a sentence in English: initial capital followed by lower-case words except proper nouns). • Large font size (e.g., minimum 12-point Times Roman or 11-point Arial) for critical information. Note that point size is not the actual size of the letter, so 2 fonts with the same nominal point size can have different actual letter sizes. X-height, the height of the lower-case x in typeface, has been used as a more accurate indicator of apparent size than point size. For example, for a given point size, the x-height and apparent size of Arial are actually bigger than those for Times Roman. Do not use type smaller than 10-point Times Roman or equivalent size of another font. Older adults, in particular, have difficulty reading small print. • Adequate white space between lines of text (25%–30% of the point size). • White space to distinguish sections on the label such as directions for use vs. pharmacy information. • Horizontal text only. Other measures that can also improve readability: • If possible, minimize the need to turn the container in order to read lines of text. • Never truncate or abbreviate critical information. • Highlighting, bolding, and other typographical cues should preserve readability (e.g., high-contrast print and light color for highlighting) and should emphasize patient-centric information or information that facilitates adherence (e.g., refill ordering). • Limit the number of colors used for highlighting (e.g., no more than one or two). • Use of separate lines to distinguish when each dose should be taken. Address visual impairment: • Provide alternative access for visually impaired patients (e.g., tactile, auditory, or enhanced visual systems that may employ advanced mechanics of assistive technology). ▲ USP36

MEMBERSHIP MATTERS! Email Network Hotline Receive up-to-date and up-to-the-minute information on Legislative Developments, Board of Pharmacy changes and other topics affecting the profession of pharmacy. Call FPA Member Services at (850) 2222400 ext. 110 – cheil@pharmview.com.

Florida Pharmacy Association

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In keeping with a tradition of offering our members real benefits, the Florida Pharmacy (FPA) is Association 1. Standing in front of the new Foundation exhibit Coupon Atlantic proud to announce (l-r) Pat Powers, EVP; Trustees Paul Ackerman, Gary Redemption Center Koesten and Todd Schmidt. Receive payment in 25 working days of the introduction of coupon’s face value plus a rebate of 1/6 sponsored Discount 2. Pat Powers dropped in the last ticket before the based on store volume. Call Meredith drawing with Al Tower (center) and Kencents Norfleet Benefits Program. McCord (800) 223-0398. doing a whole lotta shakin’. These vendors are Dee Dee and Charlie Stidham, Lake Placid, bought Florida Commerce dedicated3. to providing their brick for The Walkway of Recognition with a “Go Federal Credit Union an excellent value to Gators!” engraving. The chief objective of a credit union is not all FPA members and generating profits for stockholders, but to 4. Trustee Rod Presnell with his three grandsons at the associates. To take service to its member. The memIce Cream Social looking over the flavorsprovide of ice cream bers benefit by getting attractive returns on advantage benefits andof toppings. Decisions! Decisions! savings, loans made at fair rates of interest contact the vendors 5. The Ice Cream Social sponsored by Walgreens is plus enhanced and expanded services. This directly at the always a hitnumbers with the crowd. The Walgreens gang (l-r)one of the best deals around. is probably Keri Kratofil, Philip, Trustee Terry Gubbins and listed below andJeenu identify Call (850) 488-0035. Lince Jacob having fun dishing up the ice cream along yourself as a FPA with some laughs. Collection Services member and have your For past due accounts call I. C. System, Inc. membership ID number Call (800) 328-9595. handy.

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grams

 Monthly Issues of the Florida Pharmacy

Today Journal

Rental Car Discounts Now when you rent from Hertz, or Avis you can take advantage of special savings through either the Hertz Member Benefit Program or with an Avis member savings card. Florida Pharmacy Association members receive a discount off Hertz Daily Member Benefit Rates, Hertz U.S. Standard Rates; and Hertz U.S. Leisure Rates. Avis will be providing to members a discount off of weekly rates and a free weekend day for qualified rentals. You’ll be quoted the best rate for your rental needs at the time of reservation. See the FPA web site for more details or call the FPA office. Pharmacy Resource Materials FPA provides the most recent and relevant resources necessary to meet your professional needs. This includes the Continuous Quality Improvement Manual, Controlled Substance Inventory Booklets and Pharmacy Signs. We also have available a fraud, waste and abuse manual which includes a section on Board of Pharmacy required procedures for handling fraudulent prescriptions. Please call FPA Members Services for more information: 850222-2400 ext. 110. FPA Website Visit our FPA Website at ww.pharmview.com. The site, launched in December 2004 and revised in October 2008 and in July 2012, includes a members only section. The website offers a secure server so that you can register for CE programs, renew your membership or purchase resources materials with your credit card.

Is your technician enrolled in the FPA employer based technician training program? If so encourage them to consider becoming certified through the Pharmacy Technician Certification Board (PTCB) when they finish the program. For more information, contact the FPA at (850) 222-2400 or visit the PTCB website at www.ptcb.org.

OCTOBER 2012

The Florida Pharmacy Association 2010-2012 Resolutions Update Presented to the House of Delegates Greetings members of the Florida Pharmacy Association As you can appreciate, many resolutions have been addressed, many resolutions have been referred, and many resolutions are being worked on as I write this yearly report. The FPA has compiled 2010, 2011 and 2012 resolutions and Mr. Jackson and staff have provided me with the necessary background data to present this report. I will humbly attempt to inform you of any updates, since the FPA relies mostly on reports from the Committee Chairs and these reports are not always available in a timely fashion. Through direct orders of President Goar Alvarez, I have taken up the task of visiting with Committees and observing how these resolutions that were referred are being addressed. I am very impressed with our Committees and Chairs. The have a very strong sense of success and the Committee members are very motivated and emulate the Chairs’ leadership example. All our Committees are “cog” in a wheel of “evolution” to bring about change to our profession. This has been a very constructive year so far, and we are only halfway through. We have a fantastic team led by our Directors of the House and Gary Koesten as our incoming Speaker for 2013-2014. As many of you know, I try to communicate as often as possible with all of you, and I will wait until after our Board of Directors quarterly meeting to give you updates about issues, problems and decisions to resolve. I want to thank you for the honor of being your Speaker for 2012-2013 and look forward to a productive House of Delegates meeting during Convention. 2012-2013 House of Delegates Board of Directors Dr. Eric M. Alvarez.............................................................................................................................................Speaker of the House Mr. Gary G. Koesten.......................................................................................................................................................... Vice Speaker Suzanne Wise.........................................................................................Chairman of the House of Delegates Board of Directors Michael A. Mone’......................................................................................................................................................... Parliamentarian Terry V. Gubbins.........................................................................................................................................................................Director David Mackarey..........................................................................................................................................................................Director Kimberly Murray........................................................................................................................................................................Director Robert J. Renna............................................................................................................................................................................Director Mr. Michael A Jackson............................................................................................................................................................Secretary Regards to all, Eric Alvarez, Pharm.D. 2012-2013 Speaker of the House of Delegates

Flor i d a P h a r m a c y T o d a Y

2010- 2012 List of Resolutions 2010 Resolutions 2010-1 – Pharmacist Only Responsibilities Be it resolved that the Florida Pharmacy Association review and expand the definition of the Pharmacists’ role in health care, looking toward expansion of pharmacist-only responsibilities. Be it further resolved that regular and periodic progress reports be given to the leadership of the Florida Pharmacy Association with the understanding that the purpose would be to retain pharmacists’ privileges and to attempt to gain ground, legislatively, to solidify these privileges under the control of the pharmacist only. Action: Motion to refer to Professional Affairs Council Motion passed Professional Affairs Council members Eric Alvarez and Kathy Petsos appeared before the Florida Board of Pharmacy in October asking that consideration be given to revision of rules related to drug therapy management. 2010-2 Minor Infractions – Statute of Limitations and Expunging of Infractions Be it resolved that the Florida Pharmacy Association introduce legislation that allows the Board of Pharmacy to establish time limits (i.e. statute of limitations) for minor infractions of the Rules and Regulations pertaining to the practice of pharmacy and that do not cause patient harm, to a set time period such that a pharmacist or technician can request that their licensure record can be expunged of these minor infractions. Be it further resolved that the Florida Pharmacy Association support Board of Pharmacy efforts to categorize

pharmacist infractions into Minor and Major Categories, and that infractions in the Minor Category do not cause patient harm. Be it further resolved that the Florida Pharmacy Association supports a statute of limitations on Minor infractions such that they can be expunged from the public pharmacists’ or technician’s record upon request. The ability to expunge should be allowed to be requested for any minor infractions cited prior to this process. Be it further resolved that the Florida Pharmacy Association support the ability of the pharmacist or pharmacy technician to petition the state board of pharmacy to apply the statute of limitation on any citation received for a minor infractions and that they can have their record expunged. Motion to amend Amendment accepted Resolution passed as amended Referred to Legislative Committee who discussed this issue at their July 2010 meeting in Orlando. Recommendation to the Board of Directors as part of the 2010, 2011, 2012 and 2013 legislative advocacy programs to look for opportunities to expunge disciplinary records for minor violations through relying on the FPA lobbyist to assess the viability of successful advocacy of this program. Legislative consultant suggests that such a campaign would be challenging as Florida is considered an open records state and operates in the sunshine. Consumers will take issue with efforts to seal disciplinary records. No opportunities have been presented so far. Health profession associations have met with the Division of Medical Quality Assurance asking that they look at this option to help with disciplinary caseload relief. Also referred to the Professional Affairs Council Additional consideration suggested adding more minor violations to the list of those that can be adjudicated by citation rather than full discipline.

2010 – 7 Advocating for Student Immunizing Therefore it be resolved that the FPA supports the necessary legislative and regulatory changes to permit intern pharmacists to provide immunization services supervised by certified immunizing pharmacists. Motion to end debate passed. Resolution carried unanimously. Referred to the Legislative Affairs Committee who discussed this issue at their July 2010 meeting. The committee is recommending to the FPA Board of Directors that this issue be placed as the primary advocacy goal for 2011. The FPA Board of Directors met in August and approved the plan as the number one priority for the 2011 legislative session. Bills have been filed in both the 2011 House and Senate. These bills however are not moving and meeting with considerable resistance from the legislators friendly to the medical associations. The Senate bill passed one committee, however the House version was defeated in a Health Committee. Discussions continued during the 2012 legislative session, however again the bill sponsors again were not willing to allow language onto the bill (HB509) that would have allowed pharmacy interns to immunize patients. 2010 – 10 Pharmacist Authority to Prescribe Vitamins Be it resolved that the FPA see legislative authorization to broaden the pharmacist prescribing act to include vitamins, minerals, homeopathic, antioxidants, amino acids, medicinal foods and whole food supplements. And be it further resolved that the FPA support legislation to broaden the role of the pharmacist to provide nutritional counseling. Motion to waive rules on introduction carried. OCTOBER 2012

Resolution passes. This issue was referred to the Legislative Committee who discussed this at their July 2010 meeting. The Committee is recommending to the FPA Board of Directors that we should monitor for opportunities to revise the Self Care Consultant Act which would allow the prescribing of vitamins, minerals etc. by pharmacists if the federal laws change. The Committee is also recommending that the Association work with the naturopathic associations. The Board of Directors is recommending that we monitor this issue for opportunities. Action on this issue will depend upon how quickly other more pressing issues can be resolved. No opportunities were found during the 2010, 2011 or 2012 legislative session. There were no related bills that could be amended in any of these legislative sessions. 2010-11 – Introductory Pharmacy Practice Experience (IPPE) Standard Competencies Be it resolved by the House of Delegates of FPA that this collaborative effort will be accomplished through an FPA mediated panel consisting of FPA facilitators (one from the Professional Affairs Council and one from the Educational Affairs Council), experiential faculty member and dean (or representative) from each college of pharmacy, two preceptors from different practice settings and three student pharmacists. And be it further resolved that these competencies should reflect the professional knowledge and skills necessary for entry into advanced pharmacy practice experiences (APPEs). Motion to suspend rules for purposes of hearing the resolution Motion to suspend the rules passes. Motion to call question made, and carries. Resolution passes unanimously. 20

Flor i d a P h a r m a c y T o d a Y

Referred to the Professional Affairs Council 2010-13 Jurisdiction & Regulation of Pharmacies, Pharmacists & Pharmaceuticals Under the Florida Department of Health Be it resolved by the house of delegates of the FPA that the FPA advocate for and support the regulation and oversight of pharmacists, pharmacies, dispensing practitioners and prescription drugs by the Florida Department of Health. Motion to suspend rules for purposes of hearing resolution Motion to suspend the rules passes Resolution passed unanimously Referred to the Legislative Committee Considerable dialogue has occurred at the Florida Capitol suggesting a massive revamping of the Florida Department of Health. One proposal sought to create a massive Florida Department of Health and Human Services housing a number of Florida public health agencies. A large number of divisions with the Department are being eliminated or merged with other areas. We are continuing to monitor these efforts. The Department of Health has fully transferred the oversight of Florida Statutes 499 over to the Department of Business and Professional Regulations as directed by the Florida legislature. A total rewrite of the rules has also been implemented. There does not seem to be any effort to reverse that action. Florida statutes 499 govern prescription drugs and wholesaling. The Florida Board of Pharmacy was at one time under the auspices of the Department of Business and Professional Regulation.

2011 Resolutions 2011-3 – Information on the Prescription Be it resolved that the FPA pursue the change of this FS to remove the wording “on the Face of the

Prescription.” Substitute resolution presented by sponsor Resolution adopted with no objection Referred to Governmental Affairs This issue was also discussed with the Florida Board of Pharmacy. No opportunity for a bill yet. 2011-4 – Electronically Signed Prescriptions F.S. 456.42 Be it resolved that the FPA educate both the prescriber and the pharmacist that these electronically generated and signed prescriptions must be transmitted to the pharmacy or hand signed by the prescriber, for them to be valid. Resolution adopted with no objection Referred to Public Affairs Articles have been written by Michael Jackson in the Florida Dental Association Journal and also Florida Pharmacy Today. Jackson has also discussed these issues with advocates of the Florida Osteopathic Medical Association and Florida Medical Association. This is also subject matter at nearly every Florida Pharmacy Association law conference. 2011-5 – Pharmacist to Intern Ratio Be it resolved that the Florida Pharmacy Association work with the Florida Board of Pharmacy to change the rule to remove a preceptor to intern ratio. Rules of the House suspended to consider this item of new business Motion to table until the afternoon session Second session of the House convenes Motion to amend Motion to refer to the Professional Affairs Council Motion to refer adopted 2011-6 – Encouraging the Use of NPI Numbers Be it resolved that the FPA

seek legislation that payment for medications be composed of three components: professional fee, dispensing fee and cost of the medication and, Be it further resolved that the FPA seek legislation that adds a professional fee for prescription medications dispensed and, Be it further resolved that the professional fee be associated with and payable to the pharmacist’s NPI number. Motion to suspend the rules of the House Rules of the House suspended Resolution adopted and referred to the Governmental Affairs Committee Governmental Affairs Committee discussed this issue at their July 2012 meeting and has submitted a recommendation to the Board of Directors to pursue if an opportunity presents as part of the FPA 2012 legislative action plan. 2011-7 – Third Party Prescription Signature Requirements Be it resolved that the Florida Pharmacy Association mount an educational campaign aimed at reinforcing the legal requirements of a prescription, sharing anecdotal events from those who have been subject to a third party audit, and otherwise educating pharmacists as to the alternatives available to convert illegal invalid prescriptions into legal valid prescriptions, Further be it resolved that the Florida Pharmacy Association generate educational letters regarding the legal requirements of a prescription to physicians and that these letters be made available to members of the Florida Pharmacy Association. Motion to suspend the rules of the House Rules of the House suspended Question called to end debate

Resolution adopted Referred to the Public Affairs Council This issue is also subject matter for FPA law conferences and has been the subject of numerous discussions with the Florida physician associations. Educational letters have not been developed yet.

2012 Resolutions 2012-1 – Seat Past Presidents as Delegates Be it resolved the FPA House of Delegates seat by House rule FPA past presidents, who are members in good standing of the FPA and who for whatever reason are not seated as unit association or organization delegates, as ex-officio delegates, And be it further resolved that ex-officio delegates will be entitled to vote and will not be counted in defining the number needed for a quorum.

ownership or direct or indirect affiliation with pharmacies and/or act as dispensing practitioners which when the prescribing practitioner is likely to receive direct or indirect economic incentives or is inherently conflicted in his or her obligation to provide patients with independent quality care by virtue of the prescribers’ obligations to its affiliated business partners to maximize profits. Motion to accept the amendment Amendment adopted Resolution passes as amended This resolution was reviewed by the FPA Board of Directors. The FPA Board of Directors did not approve this resolution and instead referred it to the House of Delegates Board of Directors to clarify the resolution’s intent. This policy statement implementation will be delayed until a response is received from the House Board of Directors.

Resolutions passes House to develop rules on seating of past presidents Approved by the FPA Board of Directors 2012-3 – Community Pharmacy Accreditation Be it resolved that the Florida Pharmacy Association support voluntary participation in community pharmacy accreditation programs. Passed as amended Information published in the August 2012 Issue of Florida Pharmacy Today Approved by the FPA Board of Directors 2012-4 – Limitation and Reversal of Physician Scope of Practice Expansion Into Dispensing Therefore be it resolved that the FPA actively support any legislation that would prohibit or limit prescribing practitioners’ direct or indirect OCTOBER 2012

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APhA Foundation and NASPA Bowl of Hygeia Awarded to a pharmacist for outstanding community service above and beyond professional duties. The use of the following selection criteria is required: ■■ The recipient must be a Florida licensed pharmacist and a member of FPA. ■■           ■■ T recipient has not previously received the award. ■■                 on its award committee or an officer of the association in other than an ex officio capacity. ■■   has compiled an outstanding record of community service, which, apart from his/her specific identification as a pharmacist, reflects well on the profession. James H. Beal Award Awarded to the "Pharmacist of the Year." The criteria established for this award is that the recipient be a Florida registered pharmacist and a member of FPA, who has rendered outstanding service to pharmacy within the past five years. Criteria: ■■   must be a Florida registered pharmacist and a member of the FPA. ■■   has rendered outstanding service to pharmacy within the past five years. Technician of the Year Award Awarded annually to a Florida pharmacy technician who is recognized for his/her outstanding performance and achievement during his/her career. Criteria: ■■ Candidate must be a member of the Florida Pharmacy Association for at least 2 years. ■■ Candidate must have demonstrated contributions and dedication to the advancement of pharmacy technician practice.

Flor i d a P h a r m a c y T o d a Y

N o m i n a t i on s ■■ Candidate must have demonstrated

contributions to the Florida Pharmacy Association and/or other pharmacy organizations. ■■ Candidate must have demonstrated commitment to community service. ■■ Candidate is not a past recipient of this award. R.Q. Richards Award This award is based on outstanding achievement in the field of pharmaceutical public relations in Florida. Criteria: ■■  recipient must be a Florida registered pharmacist and a member of the FPA. ■■   has displayed outstanding achievement in the field of pharmaceutical public relations in Florida. Frank Toback/AZO Consultant Pharmacist Award Criteria: ■■ Candidate must be an FPA member, registered with the Florida Board of Pharmacy as a consultant pharmacist in good standing. ■■ Candidate should be selected based on their outstanding achievements in the field of consultant pharmacy. DCPA Sidney Simkowitz Pharmacy Involvement Award Presented annually to a Florida pharmacist who has been active at the local and state pharmacy association level in advancement of the profession of pharmacy in Florida. Criteria: ■■ A minimum of five years of active involvement in and contributions to the local association and FPA. ■■ Candidate must have held office at local level pharmacy association. ■■ Member in good standing for a period of at least five years in the FPA and must have served as a member or chairman of a committee of the association. ■■ Candidate must have been actively involved in a project that has or could potentially be of benefit to members of the profession.

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Pharmacists Mutual Companies Distinguished Young Pharmacist Award Awarded to a young pharmacist for their involvement and dedication to the practice of pharmacy. Criteria: ■■ Licensed to practice for nine (9) years or less. ■■ Licensed to practice in the state in which selected. ■■ Participation in national pharmacy association, professional programs, and/or community service. IPA Roman Maximo Corrons Inspiration & Motivation Award Interamerican Pharmacists Association created this award to honor the memory of Roman M. Corrons who inspired and motivated countless pharmacists to participate actively and aspire to take on leadership roles in their profession. Roman was always there with guidance and support that motivated pharmacists and encouraged visionary leadership, approachable active membership and succession planning. This award recognizes the motivators among us who inspire others to continue to advance the profession. Criteria: ■■ The recipient must be a Florida Licensed Pharmacist and a member of the FPA. ■■ Candidate should motivate others to excel within the profession by encouraging them to be leaders. ■■ Candidate is not necessarily an association officer, but guides, supports and/or inspires others. A brief description on the candidate’s motivational/inspirational skills must accompany the nomination. The Jean Lamberti Mentorship Award The Jean Lamberti Mentorship Award was established in 1998 to honor those pharmacists who have taken time to share their knowledge and experience with pharmacist candidates. The award is named in honor of long time FPA member Jean Lamberti for her effort in working with pharmacy stu-

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dents. Criteria ■■ The recipient must be an FPA member. ■■ The recipient must serve as a role model for the profession of pharmacy. Upsher Smith Excellence in Innovation Award Awarded to honor practicing pharmacists who have demonstrated innovation in pharmacy practice that has resulted in improved patient care. Criteria: ■■ The recipient has demonstrated innovative pharmacy practice resulting in improved patient care. ■■ The recipient should be a practicing pharmacist within the geographic area represented by the presenting Association. Qualified Nominee: A pharmacist prac-

ticing within the geographic area represented by the presenting Association. Cardinal Generation Rx Award The Cardinal Health Generation Rx Champions Award recognizes a pharmacist who has demonstrated excellence in community-based prescription drug abuse prevention. The award is intended to recognize outstanding efforts within the pharmacy community to raise awareness of this serious public health problem. It is also intended to encourage educational prevention efforts aimed at patients, youth and other members of the community. The nominee must be a pharmacist who is a member of the state association. Self-nominations are allowed. Applications will be evaluated based upon the

following criteria: ■■ Commitment to community-based educational prevention efforts aimed at prescription drug abuse ■■ Involvement of other community groups in the planning and implementation of prevention programs ■■ Innovation and creativity in the creation and implementation of prevention activities ■■ Scope/magnitude of prescription drug abuse efforts Demonstrated impact of prescription drug abuse prevention efforts

Deadline FOR NOMINATIONS: February 28, 2013 F P A A W ARD S N O MINA T I O N F O RM I am pleased to submit the following nomination:

Nominated by:

Name:

Address:

Date Submitted: Signature:

For the following Award: (Nomination Deadline February 28, 2013)  APhA Foundation and NASPA Bowl of Hygeia  James H. Beal Award

Please describe briefly below the nominee's accomplishments, indicating why you feel he or she should receive this award. (Attach additional sheets if necessary.)

 R.Q. Richards Award  Frank Toback/AZO Consultant Pharmacist Award  DCPA Sydney Simkowitz Award  Pharmacists Mutual Co. Distinguished Young Pharmacist Award  Academy of Pharmacy Practice Practitioner Merit Award  The Jean Lamberti Mentorship Award  IPA Roman Maximo Corrons Inspiration & Motivation Award  Upsher Smith Excellence in Innovation Award  Technician of the Year Award  Cardinal Generation Rx Award Mail nominatons to: Annual Awards, Florida Pharmacy Association, 610 N. Adams St., Tallahassee, FL 32301 (850) 222-2400 FAX (850) 561-6758 DEADLINE FOR NOMINATIONS IS FEBRUARY 28, 2013

OCTOBER 2012

CALL FOR RESOLUTIONS TO THE 2013 HOUSE OF DELEGATES The House of Delegates Board of Directors will meet in March 2013 to review and approve resolutions for the Annual Meeting. The deadline for submitting resolutions is March 15, 2013! PLEASE NOTE THIS DEADLINE. The following information will be needed when submitting resolutions: 1. Name of organization: The name of the organization submitting the resolutions(s); 2. Name and telephone number of individuals: A contact in the event clarification Or further information is needed; 3. Problem: A statement of the problem addressed by the resolution; 4. Intent: A statement of what passage of the resolution will accomplish; 5. Resolution Format: (please type and use double spacing) Title of Resolution Name of Organization Whereas

, and

Whereas

Therefore be it Resolved (that the FPA or Subdivision of FPA)

Contact name and phone #: Problem: Intent:

Return this form to: Membership Coordinator, Florida Pharmacy Association, 610 North Adams Street, Tallahassee, Florida 32301 or fax (850) 561-6758

Flor i d a P h a r m a c y T o d a Y

Buyer’s Guide florida PHARMACY TODAY

ADVERTISERS: This is a special section designed to give your company more exposure and to act as an easy reference for the pharmacist.

PHARMACY RESOURCES Abbott Diabetes Care Hernan Castellon (305) 220-0414 PPSC Retail Pharmacy Purchasing Program (888) 778-9909

PHARMACY CONSULTANTS HCC Pharmacy Business Solutions Dean Pedalino (800) 642-1652 Mobile: (727) 460-1855 Empire Pharmacy Consultants Michael Chen PharmD., CPh President/CEO (786) 556-7825 Mobile (305) 374-1029 Office

PHarmaceutical WHOLESALER McKesson Drug Company Jim Springer (800) 804-4590 FAX: (863) 616-2953

TEMPORARY PHARMACISTs – STAFFING HealthCare Consultants Pharmacy Staffing Bob Miller (800) 642-1652 Empire Pharmacy Consultants Michael Chen PharmD., CPh President/CEO (305) 374-1029 Office Rx Relief (800) RXRELIEF

LEGAL ASSISTANCE Kahan ◆ Shir, P.L. Brian A. Kahan, R.Ph., and Attorney at Law (561) 999-5999 Fried Law Office, P.A. Dennis A. Fried, M.D., J.D. (407) 476-1427

FREQUENTLY CALLED NUMBERS AHCA MEDICAID PHARMACY SERVICES 2727 Mahan Drive Tallahassee, FL 32308 (850) 487-4441 www.fdhc.state.fl.us/medicaid/ pharmacy AMERICAN PHARMACISTS ASSOCIATION (APhA) Washington, D.C. (800) 237-2742 www.pharmacist.com AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS Bethesda, MD (301) 657-3000 www.ashp.com/main.htm Drug Information Center Palm Beach Atlantic University (561) 803-2728 druginfocenter@pba.edu FLORIDA BOARD OF PHARMACY 4052 Bald Cypress Way Bin #C04 Tallahassee, FL 32399-3254 (850) 245-4292 www.doh.state.fl.us/mqa FLORIDA POISON INFORMATION CENTER NETWORK (800) 222-1222 www.fpicn.org National Community Pharmacists Association 100 Daingerfield Road Alexandria, VA 22314 703.683.8200 703.683.3619 fax info@ncpanet.org Recovering Pharmacists Network of Florida (407) 257-6606 “Pharmacists Helping Pharmacists”

Advertising in Florida Pharmacy Today Display Advertising: please call (850) 264-5111 for a media kit and rate sheet. Buyers’ Guide: A signed insertion of at least 3X per year, 1/3 page or larger display ad, earns a placement in the Buyers’ Guide. A screened ad is furnished at additional cost to the advertiser. Professional Referral Ads: FPA Members: $50 per 50 words; Non‑members: $100 per 50 words; No discounts for advertising agencies. All Professional Referral ads must be paid in advance, at the time of ad receipt.

OCTOBER 2012