OCT. 2012

The Official PublicationOf The Florida Pharmacy Association

October is AmericanPharmacists Month

1987Twenty-five years ago:

■ Clinical Sciences Section formed within the Ameri-can Pharmaceutical (now Pharmacists) Association Academy of Pharmaceutical Research and Science.

Pharmacy Time Capsule 2012

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

1962Fifty 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.

1937Seventy-five year ago

■ Over 100 people were poisoned by S. E. Massen-gill 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.

1912One hundred years ago

■ International Pharmaceutical Federation (FIP) es-tablished 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

O C T O B E R 2 0 1 2 | 3

VOL. 75 | NO. 10OCTOBER 2012ThE OffiCiaL puBLiCaTiON Of ThEfLORida phaRmaCy assOCiaTiONP H A R M A C Y T O D A Y

florida

Departments 4 Calendar

4 advertisers

5 president’s Viewpoint

7 Executive insight

25 Buyer’s Guide

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

FeaturesCelebrating 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

1112

18

4 | f L O R 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

Mission Statements:of the florida pharmacy Today JournalThe Florida Pharmacy Today Journal is a peer reviewed journal which serves as a medium through which the Florida Phar-macy 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 execu-tive editor of the Florida Pharmacy Today Journal in the establishment and interpreta-tion of the Journal’s policies and the manage-ment 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.

AdvertisersEPC ..................................................................... 10FRIED ................................................................. 10HEALTHCARE COnSULTAnTS .................... 3KAhAn ShIR, P.L. ........................................... 9PPSC ................................................................... 10Rx RELIEF ............................................................ 9

2012-13

FPA Calendar nOvEmbEr

2-3 FPA Budget and Finance Committee and Board of Directors Meeting and council meetingsOrlando

12 FPA office closed for Veterans Day

15-17 nASPA and ASPL Fall MeetingTucsan, Arizona

15-17 ASCP Annual MeetingNational Harbor, Maryland

22-23 Thanksgiving - FPA Office Closed

dECEmbEr

1-2 Sarasota Law Conference, Hyatt Regency Sarasota

3-4 Budget and Finance Committee

6-9 ASCP Fall Meeting

11-12 Florida Board of Pharmacy Meeting Tallahassee

24-25 Christmas Holiday, FPA Office Closed

January

1 new Year’s Day FPA Office Closed

26-27 FPA Clinical Consultant Conference

31 Last day to submit election ballots

FEbruary

6-7 Board of Pharmacy Meeting St. Augustine

15 Deadline for submitting awards nominations

marCH

1-4 APhA Annual Meeting Los Angeles, California

12-13 Legislative Days and Health Fair

15 Deadline to submit resolutions

23-24 FPA Committee and Council Meetings Orlando

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

COnTaCTSFPA — Michael Jackson (850) 222-2400FSHP — Michael McQuone (850) 906-9333U/F — Dan Robinson (352) 273-6240FAMU — Leola Cleveland (850) 599-3301nSU — 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 under-standing 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

For a complete calendar of events go to www.pharmview.com

O C T O B E R 2 0 1 2 | 5

As 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 fo-cus at that time, since the vast majori-ty of pharmacists were employees, was the psycho-demographics of the em-ployee pharmacist. That is, what makes them tick?

We conducted two employee phar-macist 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-facet-ed issue. Those factors included de-mographics, geography, cultural, and generational. At that time we did not recognize how significant the genera-tional factors were.

Over the next few years the Orga-nizational 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 atten-tion it deserved by creating a standing membership council. The Board of Di-rectors subsequently approved the rec-ommendation of the Budget & Finance Committee.

During the last FPA annual meet-ing the final approval of the constitu-tion 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 pro-voking books – Remembership by Kyle Sexton and The End of Membership As We Know It by Sarah Sladek - that rein-forced 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 at-tempting 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 non-member. The three target markets that are proving to be particularly challeng-ing are the employee pharmacists, the generation x pharmacists, and the gen-eration Y pharmacists.

Allow me to delineate some of key

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 ■ Born: 1945-1964 ■ Communication Styles: Prefer de-

tailed 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 meet-ings and discuss strategies

■ Turn-offs: People suggesting they try something new

Generation X ■ Born: 1965-1981 ■ Communication Styles: Prefer clear,

concise communication – not over-explaining, clichés, or corporate jar-gon; prefer e-mail

■ Why They Join: Opportunities to

Membership – no Easy Answers

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.

The President’s ViewpointguEST COlumniST dOn bErgEmann, rPH, mba

Don Bergemann, RPh, MBAMembership Council Chair

E-mail yOur SuggESTiOnS/idEaS TO

dave@fiorecommunications.com

6 | f L O R i d a p h a R m a C y T O d a y

further their careers ■ Volunteer Styles: Want autonomy;

hate being micromanaged or any-thing that wastes their time

■ Turn-Offs: Chaos, distrust, loyalty that goes unrewarded

Generation y ■ Born: 1982-1995 ■ Communication Styles: Prefer fre-

quent feedback and problem solv-ing via technology instead of phone calls or meetings

■ Why They Join: Opportunities to learn from others

■ Volunteer Styles: Want structure; expect immediate feedback and in-creasing 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 his-tory – poses the greatest threat to associations because most associ-ations remain entirely governed and supported by the Baby Boom-er generation, and few have or are developing strategies to cushion themselves from this massive exo-dus of board members, committee chairs, and dedicated volunteers.

■ Members of all ages are likely questioning the value of member-ship in your association, but the youngest will continue to pose this question for the next 18-20 years. They demand a return on invest-ment unlike any other generation that has come before them.

■ Generations x and Y will not re-spond to the recruiting efforts of the past. An entirely new approach new approach is required. Every-thing about the membership asso-ciation 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 gen-erations, say, “I will show up if you can show me value.”

■ Generational differences aren’t a matter of right and wrong. What one generation prefers isn’t better than what another generation pre-fers, but there are clearly differ-ences in each generation’s prefer-ences. 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 asso-ciation 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 associa-tion. Building trust is done in steps and over time. It’s not an immedi-ate reaction, and neither is a sense of belonging.

■ Different generations have dif-ferent expectations of association membership. Their values are dif-ferent, which means the benefits each generation perceives as valu-able 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 associa-tion’s history, insurance discounts, or annual conference. Your associ-ation 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’ regard-ing membership. We need your input and ideas as to what those key needs or wants for generation x and Y phar-macists and/or employee pharmacists may be. Please send your comments to me at don@bceinfo.com. ■

executive Vice President/CeoMichael Jackson

(850) 222-2400, ext. 200Director of Continuing education

Tian Merren-Owens, ext. 120Controller

Wanda Hall, ext. 211 Educational Services Office Assistant

Stacey Brooks, ext. 210Coordinator of membership

Christopher Heil, ext. 110

FlOrida PHarmaCy TOday bOardChair............................................. Jennifer Pytlarz, BrandonVice Chair ..................Don Bergemann, Tarpon SpringsTreasurer ..............................Stephen Grabowski, TampaSecretary ........................Stuart Ulrich, Boynton BeachMember .................................... Joseph Koptowsky, MiamiMember .............................Rebecca Poston, TallahasseeMember ............................. Carol Motycka, St. AugustineMember ...................................Cristina Medina, HollywoodMember ................................Norman Tomaka, MelbourneMember .............................Verender Gail Brown, OrlandoExecutive Editor ........Michael Jackson, TallahasseeManaging Editor ........................Dave Fiore, Tallahassee

This is a peer reviewed publication. ©2012, FLORIDA PHARMACY JOURNAL, INC.ARTICLE ACCEPTANCE: The Florida Phar-macy 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 sub-scription - United States and foreign, Indi-vidual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax.

Florida Pharmacy association

610 N. Adams St. • Tallahassee, FL 32301850/222-2400 • FAX 850/561-6758

Web Address: http://www.pharmview.com

FPA STAFF

O C T O B E R 2 0 1 2 | 7

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.

Members, this is one of those messages to you that may stir some controversy even with-

in our own society. It is a story that has to be told because many of you are al-ready 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 reason-able expectation that services provided by pharmacist members will be paid for.

Many of us who practiced commu-nity 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 con-sider 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 interest-ing and deserving of considerable eco-nomic research is that the costs related to prescription drugs have climbed dra-matically during that same time period.

The third-party payer system is de-signed to give another entity the op-portunity 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 reim-bursed, and that was the end of the sto-ry. 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 val-id prescription to correct the patient’s medical problem. The pharmacy will be presented with that prescription

for filling. The pharmacist will select the proper drug that was purchased through a licensed wholesaler. The pharmacy will have records of that pur-chase. The pharmacy staff will prepare the medication for dispensing, adjudi-cate the claim through the insurance plan claims processor and counsel the

patient. The patient will sign for and begin taking the medications. If tak-en 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 re-form is sorely needed. In consideration of all the services that you have pro-vided above your integrity and hones-ty 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 third-party 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 Flor-ida and Federal laws but also consis-tent with the obscure language that is published in your provider agreements

Medicare Audits Impacting Pharmacy Reimbursements

Executive Insightby miCHaEl JaCkSOn, rPHmiCHaEl JaCkSOn, bPHarm, EvP & CEO, FlOrida PHarmaCy aSSOCiaTiOn

Michael Jackson, B.Pharm

8 | f L O R i d a p h a R m a C y T O d a y

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 BoardGoar Alvarez ...............................................................................................FPA PresidentTerry Gubbins ........................................................................................... President ElectBetty Harris ............................................................................................................TreasurerEric Alvarez ................................................Speaker of the House of DelegatesGary Koesten ................................Vice Speaker of the House of DelegatesPreston McDonald, Director ...........................................................................Region 1Michael Hebb, Director ......................................................................................Region 2Eva Sunell, Director .............................................................................................Region 3 Raul N. Correa, Director ...................................................................................Region 4 Jeffery Parrado, Director ..............................................................................Region 5 Scott Tomerlin, Director ....................................................................................Region 6Paul Rohrbaugh, Director ................................................................................. Region 7Raul Gallo, Director ................................................................................................Region 8Paul Elias, Director ................................................................................................Region 9Constance Hogrefe ................................................................President Elect FSHPMichael Jackson .......................................Executive Vice President and CEO

Florida Pharmacy Today Journal board

Chair......................................................Jennifer Pytlarz, jlc_rxdoc@hotmail.comVice Chair ........................................................ Don Bergemann, don@bceinfo.comTreasurer ...................Stephen Grabowski, sgrabowski@seniormmc.comSecretary ..................................................................Stuart Ulrich, Stuarx@aol.comMember ................................................Joseph Koptowsky, docjik1215@aol.comMember .......................Rebecca Poston, rebecca_poston@doh.state.fl.usMember ...................................................... Carol Motycka, motycka@cop.ufl.eduMember .......................................................Cristina Medina, cmmedina@cvs.com Member ...............................................................Norman Tomaka, FLRX9@aol.comMember ..................Verender Gail Brown, brownvgrx4304@hotmail.comExecutive Editor ...............Michael Jackson, mjackson@pharmview.comManaging Editor ..................Dave Fiore, dave@fiorecommunications.com

2012 FPa board of directors 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 follow-ing functions when dispensing prescrip-tion drugs (tablets and capsules, exclud-ing nitroglycerin containing products or medication that is required by the man-ufacturer to be dispensed in the manu-facturer‘s original packaging) to a Med-icaid patient: Remove from original container and place in pharmacy vial; Prescription drugs that are in the dos-age form of any of the following: creams, ointments, ophthalmics, inhalers, topi-cal patches, otics, reconstituted medica-tions, and injectables: Inscribe an “M” on the outside of the original manufac-turer‘s packaging by using an indelible marker and ensuring that the “M” is clearly visible or remove the manufac-turer label

To ensure compliance, the Agen-cy may conduct audits. Findings from an initial audit will be shared with the pharmacy during the audit and the pharmacy will receive additional in-struction of dispensing requirements. Pharmacies having deficiencies great-er than 10.0% in a first re-audit shall be fined in the amount of $1,000 per viola-tion. Pharmacies that have deficiencies of greater than 10.0% in a second re-au-dit may either be fined up to $5,000 per violation pursuant to Section 409.913, F.S., or terminated from the Medicaid Pro-gram.

Failure to comply with the dispens-ing requirements will result in sanc-tions as allowed in section 409.913, Flor-ida Statutes, or Chapter 59G, Florida Administrative Code.

While it is clear that the above poli-cy is designed to stop patients who ob-tain 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 dis-pensing errors. Termination from the Medicaid program could create an ava-lanche effect as new plans that you sign up for may ask if you had been termi-nated from the Medicaid or Medicare

O C T O B E R 2 0 1 2 | 9

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The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience.

program. That may be a basis for deny-ing you as a provider.

What can be done about this?Many of our members have attend-

ed our educational programs and read our articles in the Journal and Stat news and have benefitted by prepar-ing their pharmacies for successful au-dits. 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 ser-vice documentation and recordkeep-ing 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 au-dits are being conducted and the tech-

niques being used to extort money back from a provider that simply had re-cordkeeping 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 rem-edies for that kind of behavior such as recoupment of funds received fraud-ulently and filing complaints to the Board of Pharmacy, Better Business Bu-reau 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 Phar-macy 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 Represen-tatives to expand these Medicaid au-diting 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 robo- calling your home telephones and vis-iting your churches. Help us to edu-cate current and future members of the Florida House and Senate on pharma-cy audits. You should also consider be-coming actively involved in our legisla-tive 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 POLI-CY MAKInG EMPOWER OThERS TO DETERMInE YOUR FUTURE.” ■

10 | f L O R i d a p h a R m a C y T O d a y

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O C T O B E R 2 0 1 2 | 11

Pharmacists are experts in helping pa-tients get the most out of today’s compli-cated medications. They are an integrated member of the health care team and are di-rectly 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 medi-cation management in patients, and in re-ferring 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 im-proved medication use and advanced pa-tient 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 oth-er 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 commu-nity 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 pro-fessionals 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 medica-tions.

Celebrating American Pharmacists Month Source: american Pharmacists association

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?

12 | f L O R i d a p h a R m a C y T O d a y

With medication misuse resulting in more than one million adverse drug events per year in the United States, new standards released today by the U.S. Pharmacopeial Convention (USP) for the first time provide a universal approach to the format, appearance, content and language of instructions for medicines in containers dispensed by pharmacists. Wide variability in prescription container labels exists to-day across individual prescriptions, pharmacies, retail chains and states. The USP standards provide specific di-rection on how to organize labels in a “patient-centered” manner that best re-flects how most patients seek out and understand medication instructions.

“Lack of universal standards for la-beling on dispensed prescription con-tainers is a root cause for patient mis-understanding, non-adherence and medication errors,” said Joanne G. Schwartzberg, M.D., director, aging and community health for the Amer-ican Medical Association and a mem-

ber of the USP nomenclature, Safety and La-beling Expert Committee, the group of inde-pendent experts responsible for the new stan-dard. “With an aging and in-creasingly di-verse popula-tion, and people u t i l i z i n g a growing num-ber of medica-tions, the risks are more pro-nounced today than ever. These USP standards

will promote patient understanding of their medication instructions, which is absolutely essential to preventing po-tentially dangerous mistakes and help-ing to ensure patient health and safe-ty.”

Studies have found that 46 per-cent of patients misunderstood one or more dosage instructions on prescrip-tion labels. The problem is particular-ly troublesome in patients with low or marginal literacy (one study showed patients with low literacy were 34 times more likely to misinterpret prescrip-tion warning labels), and in patients re-ceiving multiple medications that are scheduled for administration using un-necessarily complex, non-standardized time periods. However, even patients with adequate literacy often misunder-stand common prescription directions and warnings.

The USP effort to create these new standards developed from an Institute of Medicine (IOM)-led initiative to im-prove health literacy, which is defined

as the degree to which people can ob-tain, process and understand the basic health information and services they need to make appropriate health de-cisions. According to IOM, 77 million Americans have limited health literacy, and a majority of Americans have dif-ficulty understanding and using cur-rently available health information and services.

Elements of the new USP standards, contained in General Chapter <17> Pre-scription Container Labeling, of the Unit-ed States Pharmacopeia and the National Formulary, include:

Emphasize instructions and other information important to patients.

Prominently display information that is critical for patients’ safe and ef-fective use of the medicine. At the top of the

label specify patient name, drug name (spell out full nonproprietary and brand name) and strength, and clear directions for use in simple lan-guage. Less critical information (e.g., pharmacy name, drug quantity) should not supersede critical information and should be placed away from dosing in-structions.

improve readability. Labels should be designed and for-

matted so they are easy to read. Ty-pography should be optimized by us-ing high contrast print; adequate white space between lines of text (i.e., 25-30 percent of the point size); simple un-condensed familiar fonts (Times Ro-man or Arial are specifically recom-mended); and large font size (e.g., minimum 12-point Times Roman or 11-point Arial) for critical information. Older adults, in particular, have diffi-culty reading small print.

First Universal Standards Guiding Content, Appearance of Prescription Container Labels to Promote Patient Understanding of Medication Instructions

JOHN DOE

Take 1 tablet in the morning

for high blood pressure.

HYDRODIURIL 50MG

(hydrochlorothiazide)

Prescriber: Dr. Jane Smith

2 refills before 04/01/2014

Qty: 30

Exp: 5/1/2014

Fill date: 05-01-2013

RX98754

USP FAC T SHEE T

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

Qty: 30

Exp: 5/1/2014

Fill date: 05-01-2013

Main Pharmacy

301-555-1234

123 Main Street

Yourtown, USA 54321

RX98754

ISO 9001:2008 Certified

USP Headquarters

Maryland, USA

Europe/Middle East/Africa

Basel, Switzerland

USP–India Private Ltd.

Hyderabad, India

USP–China

Shanghai, China

USP–Brazil

São Paulo, Brazil

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

High-contrast print (black print

on white background)

White space to distinguish sections

on the label such as directions for

use versus pharmacy information

Never truncate or abbreviate

critical information

No type smaller than 10 pt

for less-critical content

Whenever possible, include

the purpose for use

Adequate white space between lines

of text (25–30% of the point size)

Horizontal text only. Minimize the

need to turn the container in order

to read lines of text.

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).

A

C

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H

B

DJ

F

E

G

Examples of Prescription Container

Labels That Comply with New Standard

Main Pharmacy

301-555-1234

123 Main Street

Yourtown, USA 54321

A

B

C

D

E

F

G

H

J

I

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.

Label using approved Arial font

Label using approved Times Roman font

O C T O B E R 2 0 1 2 | 13

adopt-a-Student

C O R R E C T I O n : I n t h e 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

give explicit instructions. Instructions for use should clearly

separate the dose itself from the tim-ing of each dose. Do not use alphabet-ic 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.” Dos-ing intervals such as “twice daily,” “3 times daily,” or hourly intervals such as “every 12 hours” should be avoid-ed because such instructions are im-plicit rather than explicit, may involve numeracy skills, and patient interpre-tation may vary from prescriber in-tent. 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 ac-tual use they are less readily under-stood and may present greater adher-ence issues due to individual lifestyle patterns (e.g., shift work) than general timeframes such as “in the morning” or “after breakfast.” Ambiguous direc-tions 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 pa-tient prefers that it not appear. Confi-dentiality and FDA approval for in-tended 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 contain-er label should be provided in the pa-tient’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-qual-ity translation process; an example is provided in the standard.

address visual impairment. Provide alternative access for visu-

ally impaired patients (e.g., tactile, au-ditory, 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 pre-scribed is on the prescription contain-er label,” Dr. Schwartzberg noted. Al-though other written information and oral counseling may be available, the prescription container label must ful-fill the professional obligations of the prescriber and pharmacist. These in-clude giving the patient the most es-sential information needed to under-stand 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 com-ment by all interested stakeholders—including healthcare practitioners, re-tailers, software vendors, consumers and others—in December 2011. The fi-nal standard will be published in no-vember 2012, and incorporates mul-tiple additions based on comments received, including more detail on pro-ducing high-quality translations, the visual impairment section, and the di-rection to include both brand and non-proprietary 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 non-sterile 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 support-ing state boards in requiring a stan-dardized prescription container label.

adopt-a-Student

14 | f L O R i d a p h a R m a C y T O d a y

JOHN DOETake 1 tablet in the morning for high blood pressure.HYDRODIURIL 50MG (hydrochlorothiazide)Prescriber: Dr. Jane Smith 2 refills before 04/01/2014

Qty: 30 Exp: 5/1/2014

Fill date: 05-01-2013RX98754

USP FAC T SHEE T

JANE DOETake 1 tablet in the morning for high blood pressure.HYDRODIURIL 50MG (hydrochlorothiazide)Prescriber: Dr. Jane Smith 2 refills before 04/01/2014

Qty: 30 Exp: 5/1/2014

Fill date: 05-01-2013

Main Pharmacy 301-555-1234

123 Main Street Yourtown, USA 54321

RX98754

ISO 9001:2008 Certified

USP Headquarters Maryland, USA

Europe/Middle East/Africa Basel, Switzerland

USP–India Private Ltd. Hyderabad, India

USP–China Shanghai, China

USP–Brazil São Paulo, Brazil

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

High-contrast print (black print on white background)

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

Never truncate or abbreviate critical information

No type smaller than 10 pt for less-critical content

Whenever possible, include the purpose for use

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

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

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).

A C

I

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BD

J

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Examples of Prescription Container Labels That Comply with New Standard

Main Pharmacy 301-555-1234

123 Main Street Yourtown, USA 54321

A

B

C

D

E

F

G

H

J

I

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.

Label using approved Arial font Label using approved Times Roman font

SAMPLE PRESCIRPTION CONTAINER LABELING

O C T O B E R 2 0 1 2 | 15

USP 36 Apparatus / ⟨17⟩ Prescription Container Labeling 1

Add the following: PRESCRIPTION CONTAINER LABELSTANDARDS TO PROMOTE PATIENT

UNDERSTANDING� ⟨17⟩ PRESCRIPTION CONTAINERLABELING Organize the prescription label in a patient-centered

manner: Information shall be organized in a way that bestreflects how most patients seek out and understand medica-tion instructions. Prescription container labeling should fea-ture only the most important patient information needed forsafe and effective understanding and use.INTRODUCTIONEmphasize instructions and other information important

Medication misuse has resulted in more than 1 million to patients: Prominently display information that is criticaladverse drug events per year in the United States. Patients’ for patients’ safe and effective use of the medicine. At thebest source (and often only source) of information regarding top of the label specify the patient’s name, drug name (spellthe medications they have been prescribed is on the pre- out full generic and brand name) and strength, and explicitscription container label. Although other written information clear directions for use in simple language.and oral counseling sometimes may be available, the pre- The prescription directions should follow a standard for-scription container label must fulfill the professional obliga- mat so the patient can expect that each element will be in ations of the prescriber and pharmacist. These obligations in- regimented order each time a prescription is received.clude giving the patient the most essential information Other less critical but important content (e.g., pharmacyneeded to understand how to safely and appropriately use name and phone number, prescriber name, fill date, refillthe medication and to adhere to the prescribed medication information, expiration date, prescription number, drugregimen. quantity, physical description, and evidence-based auxiliary

Inadequate understanding of prescription directions for information) should not supersede critical patient informa-use and auxiliary information on dispensed containers is tion. Such less critical information should be placed awaywidespread. Studies have found that 46% of patients misun- from dosing instructions (e.g., at the bottom of the label orderstood one or more dosage instructions, and 56% misun- in another less prominent location) because it distracts pa-derstood one or more auxiliary warnings. The problem of tients, which can impair their recognition andmisunderstanding is particularly troublesome in patients understanding.with low or marginal literacy and in patients receiving multi- Simplify language: Language on the label should be clear,ple medications that are scheduled for administration using simplified, concise, and familiar, and should be used in aunnecessarily complex, nonstandardized time periods. In standardized manner. Only common terms and sentencesone study, patients with low literacy were 34 times more should be used. Do not use unfamiliar words (includinglikely to misinterpret prescription medication warning labels. Latin terms) or medical jargon.However, even patients with adequate literacy often misun- Use of readability formulas and software is not recom-derstand common prescription directions and warnings. In mended to simplify short excerpts of text like those on pre-addition, there is great variability in the actual auxiliary scription labels. Instead, use simplified, standardizedwarning and supplemental instructional information applied sentences that have been developed to ensure ease of un-by individual practitioners to the same prescription. The spe- derstanding the instructions correctly (by seeking feedbackcific evidence to support a given auxiliary statement often is from samples of diverse consumers).unclear, and patients often ignore such information. The es- Give explicit instructions: Instructions for use (i.e., thesential need for, and benefit of, auxiliary label information SIG or signatur) should clearly separate the dose itself from(both text and icons) in improving patient understanding the timing of each dose in order to explicitly convey theabout safe and appropriate use of their medications vs. ex- number of dosage units to be taken and when (e.g., specificplicit simplified language alone require further study. time periods each day such as morning, noon, evening, andLack of universal standards for labeling on dispensed pre- bedtime). Instructions shall include specifics on time peri-scription containers is a root cause for patient misunder- ods. Do not use alphabetic characters for numbers. Forstanding, nonadherence, and medication errors. On May example, write “Take 2 tablets in the morning and 2 tablets18, 2007, the USP Safe Medication Use Expert Committee in the evening” rather than “Take two tablets twice daily”).established an Advisory Panel to: 1) determine optimal pre- Whenever available, use standardized directions (e.g.,scription label content and format to promote safe medica- write “Take 1 tablet in the morning and 1 tablet in thetion use by critically reviewing factors that promote or dis- evening” if the prescription reads b.i.d.). Vague instructionstract from patient understanding of prescription medication based on dosing intervals such as twice daily or 3 timesinstructions and 2) create universal prescription label stan- daily, or hourly intervals such as every 12 hours, generallydards for format/appearance and content/language. should be avoided because such instructions are implicitIn November 2009, the Health Literacy and Prescription rather than explicit, they may involve numeracy skills, andContainer Labeling Advisory Panel presented its recommen- patient interpretation may vary from prescriber intent. Al-dations to the Safe Medication Use Expert Committee, though instructions that use specific hourly times (e.g., 8which then requested that USP develop patient-centered la- a.m. and 10 p.m.) may seem to be more easily understoodbel standards for the format, appearance, content, and lan- than implicit vague instructions, recommending dosing byguage of prescription medication instructions to promote precise hours of the day is less readily understood and maypatient understanding. These recommendations form the present greater adherence issues due to individual lifestylebasis of this general chapter. patterns, e.g., shift work, than more general time framesNote—These standards do not apply when a prescription such as in the morning, in the evening, after breakfast, withdrug will be administered to a patient by licensed personnel lunch, or at bedtime. Consistent use of the same termswho are acting within their scope of practice. should help avoid patient confusion.

Ambiguous directions such as “take as directed” shouldbe avoided unless clear and unambiguous supplemental in-structions and counseling are provided (e.g., directions foruse that will not fit on the prescription container label). Aclear statement referring the patient to such supplementalmaterials should be included on the container label.

CHAPTER 17 PRESCIRPTION LABEL STANDARDS

16 | f L O R i d a p h a R m a C y T O d a y

2 ⟨17⟩ Prescription Container Labeling / Apparatus USP 36

Include purpose for use: If the purpose of the medication ous. Standardized translated instructions and technology ad-is included on the prescription, it should be included on the vances are needed to ensure the accuracy and safety ofprescription container label unless the patient prefers that it prescription container labeling for patients with low Englishnot appear. Always ask patients their preference when pre- proficiency.scriptions are submitted for filling. Confidentiality and FDA Improve readability: Labels should be designed andapproval for intended use (e.g., labeled vs. off-label use) formatted so they are easy to read. Currently no strong evi-may limit inclusion of the purpose on labels. Current evi- dence supports the superiority in legibility of serif vs. sansdence supports inclusion of purpose-for-use language in serif typefaces, so simple uncondensed fonts of either typeclear, simple terms (e.g., “for high blood pressure” rather can be used.than “for hypertension”). Optimize typography by using the following techniques:Limit auxiliary information: Auxiliary information on the • High-contrast print (e.g., black print on whiteprescription container label should be evidence-based in background).simple explicit language that is minimized to avoid distract- • Simple, uncondensed familiar fonts with sufficient spaceing patients with nonessential information. Most patients, within letters and between letters (e.g., Times Romanparticularly those with low literacy, pay little attention to or Arial).auxiliary information. The information should be presented • Sentence case (i.e., punctuated like a sentence in En-in a standardized manner and should be critical for patient glish: initial capital followed by lower-case words ex-understanding and safe medication use (e.g., warnings and cept proper nouns).critical administration alerts). Icons are frequently misunder- • Large font size (e.g., minimum 12-point Times Romanstood by patients. In addition, icons that provide abstract or 11-point Arial) for critical information. Note thatimagery for messages that are difficult to visually depict may point size is not the actual size of the letter, so 2be ineffective at improving understanding compared with fonts with the same nominal point size can have dif-simplified text alone. Use only icons for which there is ade- ferent actual letter sizes. X-height, the height of thequate evidence, through consumer testing, that they im- lower-case x in typeface, has been used as a moreprove patient understanding about correct use. Evidence- accurate indicator of apparent size than point size.based auxiliary information, both text and icons, should be For example, for a given point size, the x-height andstandardized so that it is applied consistently and does not apparent size of Arial are actually bigger than thosedepend on individual practitioner choice. for Times Roman. Do not use type smaller than

10-point Times Roman or equivalent size of anotherAddress limited English proficiency: Whenever possible,font. Older adults, in particular, have difficulty read-the directions for use on a prescription container labeling small print.should be provided in the patient’s preferred language. Oth-

• Adequate white space between lines of text (25%–30%erwise there is a risk of misinterpretation of instructions byof the point size).patients with limited English proficiency, which could lead

• White space to distinguish sections on the label such asto medication errors and adverse health outcomes. Addi-directions for use vs. pharmacy information.tionally, whenever possible, directions for use should appear

• Horizontal text only.in English as well, to facilitate counseling; the drug nameOther measures that can also improve readability:shall be in English so that emergency personnel and other• If possible, minimize the need to turn the container inintermediaries can have quick access to the information.

order to read lines of text.Translations of prescription medication labels should be• Never truncate or abbreviate critical information.produced using a high-quality translation process. An exam-• Highlighting, bolding, and other typographical cuesple of a high-quality translation process is:

should preserve readability (e.g., high-contrast print• Translation by a trained translator who is a nativeand light color for highlighting) and should empha-speaker of the target languagesize patient-centric information or information that fa-• Review of the translation by a second trained translatorcilitates adherence (e.g., refill ordering).and reconciliation of any differences

• Limit the number of colors used for highlighting (e.g.,• Review of the translation by a pharmacist who is a na-no more than one or two).tive speaker of the target language and reconciliation

• Use of separate lines to distinguish when each doseof any differencesshould be taken.• Testing of comprehension with target audience

Address visual impairment:If a high-quality translation process cannot be provided, la-• Provide alternative access for visually impaired patientsbels should be printed in English and trained interpreter ser-

(e.g., tactile, auditory, or enhanced visual systemsvices used whenever possible to ensure patient comprehen-that may employ advanced mechanics of assistivesion. The use of computer-generated translations should betechnology).limited to programs with demonstrated quality because dos-

� USP36age instructions can be inconsistent and potentially hazard-

CHAPTER 17 PRESCIRPTION LABEL STANDARDS CONTINUED

O C T O B E R 2 0 1 2 | 17

1. Standing in front of the new Foundation exhibit (l-r) Pat Powers, EVP; Trustees Paul Ackerman, Gary Koesten and Todd Schmidt.

2. Pat Powers dropped in the last ticket before the drawing with Al Tower (center) and Ken Norfleet doing a whole lotta shakin’.

3. Dee Dee and Charlie Stidham, Lake Placid, bought their brick for The Walkway of Recognition with a “Go Gators!” engraving.

4. Trustee Rod Presnell with his three grandsons at the Ice Cream Social looking over the flavors of ice cream and toppings. Decisions! Decisions!

5. The Ice Cream Social sponsored by Walgreens is always a hit with the crowd. The Walgreens gang (l-r) Keri Kratofil, Jeenu Philip, Trustee Terry Gubbins and Lince Jacob having fun dishing up the ice cream along with some laughs.

Email network HotlineReceive up-to-date and up-to-the-minute information on Legislative Developments, Board of Pharmacy changes and other top-ics affecting the profession of pharmacy. Call FPA Member Services at (850) 222-2400 ext. 110 – cheil@pharmview.com.

Tax resourceProvides defense and protection of your assets when you are audited. Tax Resource will defend their clients for any income tax audit, Federal or State, for any tax year. Tax Resource pioneered the tax audit service business, and is the largest audit defense firm in the United States. Call (800) 92-AUDIT (800-922-8348).

atlantic Coupon redemption Center Receive payment in 25 working days of coupon’s face value plus a rebate of 1/6 cents based on store volume. Call Meredith McCord (800) 223-0398.

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Collection Services For past due accounts call I. C. System, Inc. Call (800) 328-9595.

Other member benefits ■ Discounted Continuing Education Pro-

grams■ Monthly Issues of the Florida Pharmacy

Today Journal

rental Car discountsNow 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. Flori-da 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 re-sources 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: 850-222-2400 ext. 110.

FPa Website Visit our FPA Website at ww.pharmview.com. The site, launched in December 2004 and re-vised in October 2008 and in July 2012, in-cludes 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 cred-it card.

in keeping with a tradition of offering our members real benefits, the Florida Pharmacy association (FPa) is proud to announce the introduction of sponsored discount Benefits Program. these vendors are dedicated to providing an excellent value to all FPa members and associates. to take advantage of benefits contact the vendors directly at the numbers listed below and identify yourself as a FPa member and have your membership id number handy.

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Is your technician enrolled in the FPA employer based technician training program? If so encour-age 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.

18 | f L O R i d a p h a R m a C y T O d a y

The Florida Pharmacy Association 2010-2012 Resolutions UpdatePresented to the House of delegates

Greetings members of the Florida Pharmacy AssociationAs you can appreciate, many resolutions have been addressed, many resolutions have been referred, and many resolu-tions 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 most-ly 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’ lead-ership 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 com-municate 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 HouseMr. Gary G. Koesten ......................................................................................................................................................... Vice SpeakerSuzanne Wise ........................................................................................Chairman of the House of Delegates Board of DirectorsMichael A. Mone’ ........................................................................................................................................................ ParliamentarianTerry V. Gubbins.........................................................................................................................................................................DirectorDavid Mackarey .........................................................................................................................................................................DirectorKimberly Murray .......................................................................................................................................................................DirectorRobert J. Renna ...........................................................................................................................................................................Director Mr. Michael A Jackson ...........................................................................................................................................................Secretary

Regards to all,Eric Alvarez, Pharm.D.2012-2013 Speaker of the House of Delegates

O C T O B E R 2 0 1 2 | 19

2010- 2012 LIST OF RESOLUTIONS2010 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 CouncilMotion passedProfessional 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 amendAmendment acceptedResolution passed as amendedReferred 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 CouncilAdditional 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.

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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 resolutionMotion to suspend the rules passes.Motion to call question made, and carries.Resolution passes unanimously.

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 resolutionMotion to suspend the rules passesResolution passed unanimouslyReferred to the Legislative CommitteeConsiderable 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 sponsorResolution adopted with no objectionReferred to Governmental AffairsThis 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 objectionReferred to Public AffairsArticles 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 businessMotion to table until the afternoon sessionSecond session of the House convenesMotion to amendMotion to refer to the Professional Affairs CouncilMotion to refer adopted

2011-6 – Encouraging the Use of NPI Numbers

Be it resolved that the FPA

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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 HouseRules of the House suspendedResolution adopted and referred to the Governmental Affairs CommitteeGovernmental 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 HouseRules of the House suspendedQuestion called to end debate

Resolution adoptedReferred to the Public Affairs CouncilThis 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.

Resolutions passesHouse to develop rules on seating of past presidentsApproved by the FPA Board of Directors2012-3 – 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

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 amendmentAmendment adoptedResolution passes as amendedThis 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.

22 | f L O R i d a p h a R m a C y T O d a y

aPha Foundation and naSPa bowl of Hygeia

Awarded to a pharmacist for out-standing community service above and beyond professional duties. The use of the following selection criteria is re-quired:

■ The recipient must be a Florida li-censed pharmacist and a member of FPA.

■ The recipient must be living. Awards are not presented posthumously.

■ The recipient has not previously re-ceived the award.

■ The recipient is not currently serving nor has he/she served within the immediate past 2 years on its award committee or an officer of the asso-ciation in other than an ex officio ca-pacity.

■ The recipient has compiled an out-standing record of community ser-vice, which, apart from his/her spe-cific identification as a pharmacist, reflects well on the profession.

James H. beal awardAwarded to the "Pharmacist of the

Year." The criteria established for this award is that the recipient be a Flori-da registered pharmacist and a mem-ber of FPA, who has rendered outstand-ing service to pharmacy within the past five years.Criteria:

■ The recipient must be a Florida reg-istered pharmacist and a member of the FPA.

■ The recipient has rendered outstand-ing service to pharmacy within the past five years.

Technician of the year awardAwarded annually to a Florida phar-

macy 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 techni-cian practice.

■ Candidate must have demonstrated contributions to the Florida Pharma-cy Association and/or other phar-macy organizations.

■ Candidate must have demonstrated commitment to community service.

■ Candidate is not a past recipient of this award.

r.Q. richards awardThis award is based on outstanding

achievement in the field of pharmaceu-tical public relations in Florida.Criteria:

■ The recipient must be a Florida reg-istered pharmacist and a member of the FPA.

■ The recipient has displayed out-standing achievement in the field of pharmaceutical public relations in Florida.

Frank Toback/aZO Consultant Pharmacist awardCriteria:

■ Candidate must be an FPA member, registered with the Florida Board of Pharmacy as a consultant pharma-cist 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 pe-riod 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 active-ly involved in a project that has or could potentially be of benefit to members of the profession.

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 awardInteramerican Pharmacists Associa-tion created this award to honor the memory of Roman M. Corrons who in-spired and motivated countless phar-macists to participate actively and as-pire to take on leadership roles in their profession. Roman was always there with guidance and support that moti-vated pharmacists and encouraged vi-sionary leadership, approachable active membership and succession planning. This award recognizes the motivators among us who inspire others to contin-ue to advance the profession.Criteria:

■ The recipient must be a Florida Li-censed Pharmacist and a member of the FPA.

■ Candidate should motivate others to excel within the profession by en-couraging them to be leaders.

■ Candidate is not necessarily an asso-ciation 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 experi-ence with pharmacist candidates. The award is named in honor of long time FPA member Jean Lamberti for her ef-fort in working with pharmacy stu-

C a L L f O R N O m i N a T i O N s F P a a W a r d S 2 0 1 2 - 2 0 1 3

O C T O B E R 2 0 1 2 | 23

dEadlinE FOr nOminaTiOnS: FEbruary 28, 2013

dents.Criteria

■ The recipient must be an FPA mem-ber.

■ The recipient must serve as a role model for the profession of pharmacy.

upsher Smith Excellence in innovation award

Awarded to honor practicing phar-macists who have demonstrated inno-vation in pharmacy practice that has re-sulted in improved patient care.Criteria:

■ The recipient has demonstrated inno-vative pharmacy practice resulting in improved patient care.

■ The recipient should be a practic-ing pharmacist within the geograph-ic area represented by the presenting Association.

Qualified nominee: A pharmacist prac-

ticing within the geographic area repre-sented by the presenting Association.

Cardinal generation rx awardThe Cardinal Health Generation Rx

Champions Award recognizes a phar-macist who has demonstrated excellence in community-based prescription drug abuse prevention. The award is intend-ed to recognize outstanding efforts with-in the pharmacy community to raise awareness of this serious public health problem. It is also intended to encour-age 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. Applica-tions 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 imple-mentation of prevention programs

■ Innovation and creativity in the cre-ation and implementation of preven-tion activities

■ Scope/magnitude of prescription drug abuse effortsDemonstrated impact of prescription

drug abuse prevention efforts

I AM PLEASED TO SUBMIT THE FOLLOWING NOMINATION:

Name:

Address:

FOR THE FOLLOWING AWARD:

(Nomination Deadline February 28, 2013)

APhA Foundation and NASPA Bowl of Hygeia

James H. Beal Award

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

NOMINATED BY:

Name:

Date Submitted:

Signature:

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

C a L L f O R N O m i N a T i O N s F P a a W a r d S 2 0 1 2 - 2 0 1 3

F P a a W a r d S n O m i n a T i O n F O r m

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

24 | f L O R i d a p h a R m a C y T O d a y

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 resolu-tions 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 in-

formation 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

O C T O B E R 2 0 1 2 | 25

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