Georgia Pharmacy Journal - January 2014 by Georgia Pharmacy Association

January 2014 VOLUME 36, ISSUE 1

Meet the Georgia Pharmacist Legislators Plus:

Broadrick Receives Alumni Award The GPhA Legislative Agenda Bracewell Sworn In to The Board of Pharmacy How Quality Ratings Impact Community Pharmacy

ard w A Aons h GP inati r o ll f Nom age a C P

January 2014 Editor: Jim Bracewell jbracewell@gpha.org

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2014, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association. Articles and Artwork Those interested in writing for this publication are encouraged to request the official “GPJ Guidelines for Writers.” Artists or photographers wishing to submit artwork for use on the cover should call, write or email jbracewell@gpha.org. Subscriptions and Change of Address The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe, NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices. POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324. Advertising Advertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at jbracewell@gpha.org.

GPhA Headquarters 50 Lenox Pointe, NE Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

Contents

2 Welcome New Members................................. 3 Message from Jim Bracewell ......................... 4 Member News .................................................. 5 Message from Pamala Marquess .................

Meet the Georgia Pharmacist Legislators

.........................................

12 12 13

GPhA 2014 Legislative Review ................. Georgia Board of Pharmacy

Bracewell Sworn In ........................................................ Legislative Updates ........................................................

18 Continuing Education ................................ 21 GPhA Board of Directors ......................... 28 PharmPac Supporters .................................

gpha.org

The Georgia Pharmacy Journal

January 2014 Editor: Jim Bracewell jbracewell@gpha.org

GPhA Headquarters 50 Lenox Pointe, NE Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

Contents

Meet the Georgia Pharmacist Legislators

.........................................

12 12 13

GPhA 2014 Legislative Review ................. Georgia Board of Pharmacy

Bracewell Sworn In ........................................................ Legislative Updates ........................................................

18 Continuing Education ................................ 21 GPhA Board of Directors ......................... 28 PharmPac Supporters .................................

gpha.org

The Georgia Pharmacy Journal

MESSAGE

from Pamala Marquess

WELCOME

Provider Status’ First Hand

t is the middle of December 2013 as I am writing this article. I am contemplating the things I have been thankful for in 2013 and considering my goals for 2014, when I receive a legislative email….. ACTION ALERT!!! An early Christmas surprise! As Congress is windPamala Marquess ing down toward the end of the year, it will be considering legislation that could help pharGPhA President macy increase access to cost-saving Medication Therapy Management (MTM) services. An amendment to the Sustainable Growth Rate (SGR) doctor fi x at year’s end. I make my phone call and await the result. By the next day, it is announced that the amendment and 140 others were not introduced or withdrawn when the bill came to vote. Why is this important? “The Pharmacists of America made their first stand for provider status this day on Capitol Hill,” stated APhA’s EVP and CEO Tom Menighan. “The outcome may not have been what we wanted, but we let the United States Congress know that pharmacists are ready to perform as providers of patient care services! Today we stood up and said, The GPhA will We’ve only just begun. Just getting pharmacists as providers mentioned at be supporting the Congressional level, let alone introduced into the amendment record, is a the Provider significant accomplishment. We know that our patients need our services, and we need provider status to Status eﬀort in be in a position to help. For this to happen, we need to continue to communiour 2014 cate the message on a state and national level to our representatives. The Georgia Pharmacy Association will be supporting this effort in our legislative 2014 legislative session. I applaud APhA for their leadership on Provider Status session. and support this endeavor. Pharmacists are an integral member on every health care team and should be recognized as such. I am confident that provider status will become a reality for our profession. I am thankful for each of you and your contribution to our profession. I am hopeful in 2014 for our provider status, MAC pricing success, and immunization expansion. There is much debate to be had and I look forward to working with the stakeholders to see these issues become a standard of practice for our profession. I wish each of you a Happy New Year and I pray our profession experiences forward progress to increase patient access to pharmacists as providers of patient care services in 2014!

New Members Pharmacists

Your Voice in Pharmacy The Georgia Pharmacy Association strives to be the leading voice for pharmacy in the state of Georgia. We aggressively advocate for the profession by shaping public policy and scope of practice to enhance the value of pharmacy. We take pride in our prestigious history and value our membership for its diversity in all practice settings as well as its dedication to health care. GPhA provides its members with the resources and support needed to advance our profession. As healthcare changes, so do job responsibilities and career tracks may be refocused. GPhA is your career development partner as you address your future in pharmacy. Professional networking, skills training and continuing pharmacy education are key benefits of your GPhA membership. Whether you are a recent Pharmacy school grad or an established pharmacist, there is a place for your voice at GPhA.

Deborah Baker - Lilburn, GA Gary Beals - Lawrenceville, GA Deborah Burzotta - Alpharetta, GA Wilma Jones - Stone Mountain, GA Al McConnell - Milton, GA Vipal Patel - Lilburn, GA Diane Sanders - Tyrone, GA Ike Uzodinma - Riverdale, Ga Technician Pedro Valentin - Columbus, GA 1st Year Graduate Donley Dawson - Macon, GA

Have you considered GPhA’s new Sustaining Membership? ..........only $14.58 per month Never get another renewal notice! Visit gpha.org and sign up today!

Pam

Pamala S. Marquess

THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

The Georgia Pharmacy Journal

WELCOME New Members Pharmacists

Deborah Baker - Lilburn, GA Gary Beals - Lawrenceville, GA Deborah Burzotta - Alpharetta, GA Donley Dawson - Macon, GA Wilma Jones - Stone Mountain, GA Al McConnell - Milton, GA Vipal Patel - Lilburn, GA Diane Sanders - Tyrone, GA Ike Uzodinma - Riverdale, Ga Technician Pedro Valentin - Columbus, GA

Have you considered GPhAâ&#x20AC;&#x2122;s new Sustaining Membership? ..........only $14.58 per month Never get another renewal notice! Visit gpha.org and sign up today!

THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

M E M B E R

Advocacy: The Role of Associations

f I asked ten pharmacists what in your practice would you like to be recognized for, I think all would say taking care of my patients. If you asked any of the forty-one members of the Georgia Pharmacy Association Board of Directors what is it you want GPhA to be recognized for, I think each one would say for taking care of our members. You know how to deliver patient care. Do you know the number one way to deliver member care for the pharmacists in Georgia? ADVOCACY! In January 2010, after a lengthy meeting of a selected yet very diverse group of GPhA members, the GPhA Board adopted the group’s recommendation that Advocacy be the numJim Bracewell ber one premiere service of the Georgia Pharmacy Association. Executive Vice President In the United States, we espouse to be a government of laws. Our democracy has set up several checks and balances in our government. We have the Congress to create the law. We have the Judicial to interpret the law. We have the administrative, the President, to apply to law. We have the free press to monitor the whole process and uniquely to America we have associations to provide the common man the ability to assemble together and formulate positions and petitions to address government with our needs. It matters not the issue, social, economic, or political, our constitution grants and protects our right to assemble and address our common issues before our government. Tim Russert, the legendary host of Sunday’s “Meet The Press” liked to often repeat a great “Resolve today quote from his father – “What a country!” Many pundits like to negatively label associations as “those powerful special to be an active interest groups”, as though uniting for a common cause is detrimental to our advocate for form of government. The late United States Supreme Court Justice Thurgood your profession Marshall said: “Millions of Americans speaking in unison is not a corruption of through the con- the democratic political process, it is the democratic political process.” Where would our country be without such associations as the NAACP, the tribution of your NRA, the Tea Party, and the Sierra Club? With each group I named, you may time, talent and applaud or oppose their ideas but in what other country would those people have the protected right to assemble and petition their government on behalf of their resources to that cause? common cause In the state of Georgia, the Georgia General Assembly passes the laws that allow the practice of the profession of pharmacy in our state. The Georgia Board of advocacy.” of Pharmacy is provided the power to regulate and license the profession. But who advocates for the profession of pharmacy in Georgia before the General Assembly and the Board of Pharmacy? The Georgia Pharmacy Association does. Do you want to impact the practice of pharmacy? Do you want to assure the economic viability of your degree for the future? Do you want your profession to be valued as part of the future of healthcare delivery in our state? Then resolve today to be an active advocate for your profession through the contribution of your time, talent and resources to that common cause of advocacy. What a country! And what a privilege it is for pharmacists to be able to accept the responsibility for the governance of their profession through membership and involvement in the Georgia Pharmacy Association.

Jim

The Georgia Pharmacy Journal

N E W S

Broadrick Receives Distinguished Alumni Award Since 1976, former GPhA President and current State Representative Bruce Broadrick has served his community and the pharmacy profession with an unwavering commitment.

State Representative Bruce Broadrick (left) receives the University of Georgia College of Pharmacy Distinguished Alumnus Award.

Marquess Joins ACPI D

he currently serves on the r. Jonathan Marquess, Board of Trustees. Pharm.D., has joined ACPI as Dr. Marquess shares ownVice President of Professional ership of six pharmacies with Affairs. his wife and current GPhA Dr. Marquess is a Mercer President Dr. Pam Marquess, University graduate and is acPharm.D., who will now actively involved in local, state, Dr. Jonathan Marquess, cept full management responand national professional Pharm.D. sibilities for the pharmacies organizations including the Georgia Pharmacy Association where while he concentrates his efforts on leadhe served as President in 2005 and was ing the clinical services team at ACPI. ACPI has announced a renewed named the Innovative Pharmacist of the commitment to providing the support, Year in 2008. In addition to membership in the knowledge, and the leadership necessary GPhA, Dr. Marquess is a member of the to ensure success in patient care and adAmerican Pharmacy Association where ministering quality clinical services. n

The Georgia Pharmacy Journal

tate representative Bruce Broadrick (Class of ’76) was the recipient of the University of Georgia College of Pharmacy Distinguished Alumnus Award. Broadrick has been active serving his profession and community since he earned his pharmacy degree in 1976. He owned and operated Frank’s Pharmacy, a successful independent family pharmacy in Dalton, Georgia for more than 30 years and is currently working for Walgreens. Broadrick served as the Georgia Pharmacy Association’s President from 1995-1997. In January 2013, he began his service as a member of the Georgia House of Representatives, representing the 4th district of Georgia, including the city of Dalton and Whitfield County. He is a standing member of the Health & Human Services, Industry & Labor, and Intra-governmental Coordination Committees. He is a member of the College of Pharmacy President’s Club and established the Broadrick Family Endowed Student Scholarship in 2006. Throughout his career, Rep. Broadrick has served on numerous boards, including the Northwest Georgia Healthcare Partnership, Georgia Partnership for Caring, Medical Advisory Committee for the State Board of Workers Compensation, and Whitfield County Board of Health. He has also received numerous service and leadership awards for his positive impact on the pharmacy profession. The Georgia Pharmacy Association would like to congratulate Bruce on his outstanding career, his service to the community, and his unwavering commitment to the pharmacy profession. n

M E M B E R

Advocacy: The Role of Associations

Jim

The Georgia Pharmacy Journal

N E W S

State Representative Bruce Broadrick (left) receives the University of Georgia College of Pharmacy Distinguished Alumnus Award.

Marquess Joins ACPI D

The Georgia Pharmacy Journal

M E M B E R

N E W S

M E M B E R

Call for GPhA Awards! T

he GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 139th Annual Convention in 2014. A brief description and criteria of each award is included below. Please select the award for which you would like to nominate someone and indicate their name on the form below. Deadline for submitting the completed nomination form is March 1, 2014. Nominations will be received by the Awards Committee and an individual will be selected for presentation of the Award at GPhA’s 139th Annual Convention at the Wyndham Bay Point Resort in Panama City Beach, FL.

Bowl of Hygeia

Recognized as the most prestigious award in pharmacy, the Bowl of Hygeia is presented annually by the GPhA and all state pharmacy associations. Selection Criteria: 1) The nominee must be a licensed Georgia pharmacist; 2) The Award is not made posthumously; 3) The nominee is not a previous recipient of the Award; 4) The nominee is not currently serving nor has served within the immediate past two years as an officer of GPhA other than ex-of-

ficio capacity or its awards committee; 5) The nominee has an outstanding record of service to the community which reflects will on the profession.

Distinguished Young Pharmacist

Created in 1987 to recognize the achievements of young pharmacists in the profession, the Award has quickly become one of the GPhA’s most prestigious awards. The purpose of the Award is two-fold: 1) To encourage new pharmacists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) The nominee must have received entry degree in pharmacy less than ten years ago; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.

Innovative Pharmacy Practice

This Award is presented annually to a practicing pharmacist who has demonstrated innovative pharmacy practice which has resulted in improved patient care. Selection Criteria: 1) The nominee must have demonstrated innovative pharmacy practice which has resulted in improved patient care; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a member of the GPhA in the year of selection.

Generation Rx Champions Award

This award is presented annually to a pharmacist who has demonstrated work with prescription drug abuse. This award gives honor to the recipient with a plaque and donates $500 to the charity of the recipients choice. Selection Criteria: 1) Nominee must a have demonstrated a committed effort to reduce prescription drug abuse; 2) Nominee must be a licensed Georgia Pharmacist; 3) Nominee must be a member of the Georgia Pharmacy Association in the year of the selection.

2014 Awards Nomination Form Bowl of Hygeia

Distinguished Young Pharmacist

Innovative Pharmacy Practice

Nominee’s Full Name Home Address

Generation Rx Champions

Nickname City

State

Zip

City

State

Zip

Practice Site Work Address

College/School of Pharmacy List of professional activities, state/national pharmacy organization afﬁliations, and/or local civic church activities:

Academy of Employee Pharmacists (AEP) To Hold Networking Dinner

he Academy of Employee Pharmacists (AEP) is holding a networking dinner on Tuesday, February 4 for pharmacists and technicians. The networking dinner will be held at Maggiano’s Little Italy Restaurant, located at 4400 Ashford Dunwoody Road NE in Atlanta. The networking social begins at 6:30 pm and dinner will be served starting at 7 pm. The networking dinner is sponsored by Janssen Pharmaceutical and there is no charge to GPhA members. Dr. Thomas M. Flood, MD, FACE, will be the guest speaker. Dr. Flood is a Physician with Georgia Center for Diabetes in Atlanta. His topic will be INVOKANA: Changing Paradigms in T2DM Management. “This will be a great opportunity to meet new friends in the pharmacy profession and learn about changes in Diabetes management and other new trends in the pharmacy profession”, said Sharon Zerillo, AEP Chairman. If you would like to attend this event, please RSVP to Lauren Clayton by Tuesday, January 28 at 404-808-5664 or visit http://www.medforcereg.net/ SOMP46995. Space is limited to the first 60 pharmacists/technicians that sign up. If you have any questions or need more information, contact Sharon Zerillo, AEP Chairman, at 770-301-5375 or email Sharon at sdeason99@hotmail. com. n Special Thanks to:

Supporting Information:

N E W S

Employee pharmacists have unique issues and needs and AEP serves to articulate those needs to the GPhA Board of Directors and GPhA staff. Visit http://

www.gpha.org/aep for more information about the Academy of Employee Pharmacists and The Georgia Pharmacy Association. n

Real Financial Planning. No Generics. It means having real strategies for all your financial issues, not just insurance and investments. It means working with a real planner who is experienced with the needs of pharmacists, their families and their practices. It means working with an independent firm you can trust. For more information visit us at www.fnaplanners.com.

Michael T. Tarrant, CFP® Speaker & Author PharmPAC Supporter Creating Real Financial Planning for over 20 Years

1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455 mike@fnaplanners.com www.fnaplanners.com

About AEP

The GPhA Academy of Employee Pharmacists (AEP) represents pharmacists that are employed in various practice settings throughout the profession and is one of GPhA’s oldest academies.

Submitted By: Submit this form completed by March 1, 2014 to: GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324 or complete this form online at www.gpha.org.

The Georgia Pharmacy Journal

Registered Representative of INVEST Financial Corporation, member FINRA/SIPC. INVEST and its affiliated insurance agencies offer securities, advisory services and certain insurance products and are not affiliated with Financial Network Associates, Inc. Other advisory services are offered through Financial Network Associates, Inc.

M E M B E R

N E W S

M E M B E R

Call for GPhA Awards! T

Bowl of Hygeia

ficio capacity or its awards committee; 5) The nominee has an outstanding record of service to the community which reflects will on the profession.

Distinguished Young Pharmacist

Innovative Pharmacy Practice

Generation Rx Champions Award

2014 Awards Nomination Form Bowl of Hygeia

Distinguished Young Pharmacist

Innovative Pharmacy Practice

Nominee’s Full Name Home Address

Generation Rx Champions

Nickname City

State

Zip

City

State

Zip

Practice Site Work Address

College/School of Pharmacy List of professional activities, state/national pharmacy organization afﬁliations, and/or local civic church activities:

Academy of Employee Pharmacists (AEP) To Hold Networking Dinner

Supporting Information:

N E W S

Employee pharmacists have unique issues and needs and AEP serves to articulate those needs to the GPhA Board of Directors and GPhA staff. Visit http://

www.gpha.org/aep for more information about the Academy of Employee Pharmacists and The Georgia Pharmacy Association. n

Michael T. Tarrant, CFP® Speaker & Author PharmPAC Supporter Creating Real Financial Planning for over 20 Years

1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455 mike@fnaplanners.com www.fnaplanners.com

About AEP

The GPhA Academy of Employee Pharmacists (AEP) represents pharmacists that are employed in various practice settings throughout the profession and is one of GPhA’s oldest academies.

Submitted By: Submit this form completed by March 1, 2014 to: GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324 or complete this form online at www.gpha.org.

The Georgia Pharmacy Journal

SUPPORT BUDDY CARTER R.Ph FOR CONGRESS There is not a single Pharmacist serving in Congress. It’s time to change that. Please support Buddy Carter R.Ph for Congress. buddycarterforcongress.com/donate/ With all of the major changes taking place in the health care industry, now more than ever, we pharmacists must have our voices heard.

M E M B E R

N E W S

Long Term Care Planning:

How much of the Daily or Monthly risk do you want to take on?

n past articles we have discussed how important it is to become educated on Long Term Care on what it is and more importantly - isn’t. While it is true that there are essentially three Basic Components to effective Long Term Care Learning (1. Education, 2. Underwriting 3. Funding) it is also true that you need to consider how much of the Long Term Care daily or monthly risk/ costs you want to take on. If you do not own a Long Term Care Plan, it is likely safe to say that you are currently taking on all of the daily or monthly risk. Part of effective LTC education is understanding what the daily or monthly associated Long Term Care costs are in

wish to pay the LTC preyour area where you live or miums out of your busiwhere you are planning to ness, depending on how live or get care should you you fi le your taxes. need it. The costs for this care Resolution in the can range in Atlanta right at New Year can take many or around $250 per day. Ruth Ann McGehee forms, maybe the time is $250 per day is: Manager of Insurance right to schedule an LTC • $7,500 per month Services, GPHA consultative engagement • $90,000 per year With effective Long Term Care Plan- with the Long Term Care Planning ning, you can remove a large measure Team at the GPHA. n of this exposure; exposure that can affect your family and finances. You may Give RuthAnn McGehee a call at 404wish to take on only part of the daily 419-8173 or email at rmcgehee@gpha. or monthly costs associated with Long org to set up a no-obligation Long Term Care for your area. There may po- Term Care consult. We look forward tentially be favorable tax treatment if you to helping you however we can.

Division of Display Options, Inc.

Compounding Labs Pharmacy Planning & Design

REAL SOLUTIONS. CONSERVATIVE PRINCIPLES. Corporate contributions and contributions by foreign nationals are prohibited. Individuals may contribute a maximum of $5,200 to the campaign- $2,600 for the primary election and $2,600 for the general election. PACS may contribute $10,000 to the campaign - $5,000 for the primary election and $5,000 for the general election. Federal law requires us to use our best efforts to collect and report the name, mailing address, occupation, and name of employer of each individual whose aggregate contributions exceed $200 in an election cycle. PAID FOR BY BUDDY CARTER FOR CONGRESS CARLTON HODGES, TREASURER

Rx Planning Specialist

Patient Consultation Areas

Roland Thomas

Stocking Lozier Distributor

experience in over 2,000 pharmacies.

Full line of Pharmacy Fixtures Custom Wood Work Professional Installation and Delivery

9517 Monroe Road, Suite A • Charlotte, NC 28270

1-800-321-4344 www.displayoptions.com www � .displayoptions.com �

M E M B E R

N E W S

Long Term Care Planning:

How much of the Daily or Monthly risk do you want to take on?

Division of Display Options, Inc.

Compounding Labs Pharmacy Planning & Design

Rx Planning Specialist

Patient Consultation Areas

Roland Thomas

Stocking Lozier Distributor

experience in over 2,000 pharmacies.

Full line of Pharmacy Fixtures Custom Wood Work Professional Installation and Delivery

9517 Monroe Road, Suite A • Charlotte, NC 28270

1-800-321-4344 www.displayoptions.com www � .displayoptions.com �

You are

Cordially Invited! To the Georgia Reception at the APhA Annual Meeting

Meet the Georgia Pharmacist Legislators Representative Bruce Broadrick (R) Dalton, GA - District 4 • 404-656-0202 • bruce.broadrick@house.ga.gov • Sworn In January 14, 2013 • Occupation - Pharmacist

About

Advocacy T

Senator Buddy Carter

(R) Chief Deputy Whip - District 1 • 404-656-5109 • bcarter331@aol.com • Elected November 22, 2009 • Occupation - Pharmacist

Representative Buddy Harden (R) Cordele, GA - District 148 • 404-656-0188 • bharden@planttel.net • Sworn In January 12, 2009 • Occupation - Pharmacist

RSVP

Representative Butch Parrish (R) Swainsboro, GA - District 158 • 404-463-2247 • butch.parrish@house.ga.gov • Sworn In January 14, 1985 • Occupation - Pharmacist

www.gpha.org Representative Ron Stephens (R) Savannah, GA - District 164 • 404-656-5115 • quickrxdrugs@yahoo.com • Sworn In July 20, 1997 • Occupation - Pharmacist

THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

The Georgia Pharmacy Journal

he Georgia Pharmacy Association maintains a strong presence on the political scene, not only during the legislative session but also throughout the year. The GPhA stays abreast of current issues that could impact the profession of pharmacy. The association also works to build relationships with policy makers on a state and national level. Question: Who is the advocacy voice for pharmacy in Georgia? Answer: The Georgia Pharmacy Association seeks to be the Advocacy Voice for pharmacy in Georgia, at the State House, the Board of Pharmacy, and the US Congress. Question: What does Georgia have that no other state in the country has? Answer: FIVE pharmacists in the Georgia General Assembly and by the time you read this we may very well have our Sixth pharmacist in the Georgia General Assembly with the election of Neal Florence of Lafayette, GA to House District 2. Question: This Fall, in November 2014, what is Georgia likely to have that no other state in the country has? Answer: A pharmacist in the US Congress with the election of Buddy Carter of Pooler, GA as the Congressman from Congressional District 1 of Georgia. Question: If you care about the future of the profession of pharmacy, where will you be on Thursday, February 27, 2014? Answer: You will be joining us at the Georgia State Capitol for VIP Day. This is your chance to voice your support for pharmacy. It’s FREE but you must RSVP at www.gpha.org

You are

Cordially Invited! To the Georgia Reception at the APhA Annual Meeting

About

Advocacy T

Senator Buddy Carter

(R) Chief Deputy Whip - District 1 • 404-656-5109 • bcarter331@aol.com • Elected November 22, 2009 • Occupation - Pharmacist

Representative Buddy Harden (R) Cordele, GA - District 148 • 404-656-0188 • bharden@planttel.net • Sworn In January 12, 2009 • Occupation - Pharmacist

RSVP

Representative Butch Parrish (R) Swainsboro, GA - District 158 • 404-463-2247 • butch.parrish@house.ga.gov • Sworn In January 14, 1985 • Occupation - Pharmacist

www.gpha.org Representative Ron Stephens (R) Savannah, GA - District 164 • 404-656-5115 • quickrxdrugs@yahoo.com • Sworn In July 20, 1997 • Occupation - Pharmacist

THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

The Georgia Pharmacy Journal

L E G I S L A T I V E

Georgia Board of Pharmacy

Bracewell Sworn In

GPhA 2014 Legislative Review By Andy Freeman

Jim Bracewell, Executive Vice President of the Georgia Pharmacy Association, is congratulated by Nathan Deal as the new Consumer Member of the Georgia Board of Pharmacy.

Jim Bracewell, Executive Vice President of the Georgia Pharmacy Association, was recently sworn in as the new Consumer Member of the Georgia Board of Pharmacy. Bracewell, a native of Georgia and a graduate of Georgia State University, has served for over twenty-one years as an association executive. In addition he has served on numerous state and national boards, several national leadership positions, and as former President of the National Alliance of State Pharmacy Associations. Jim also served as President of the South Carolina Society of Associations Executives and was named Association Executive of the Year. Currently Jim serves on the Mercer University Board of Visitors in the College of Pharmacy, Chairman of Pace Alliance (an organization of nineteen states benefiting community pharmacy), and since 1993 Jim has served as a delegate to the United States Pharmacopoeia (previously representing South Carolina and currently representing Georgia). Jim and his wife, Nancy, currently reside in Atlanta. They have two sons, Ron who resides in Atlanta with wife Jamie, Michael who resides in California with wife Callie and their two daughters, and grandson Griffen Hedrick who resides in Haymarket, VA. n

About the Georgia State Board of Pharmacy The Georgia State Board of Pharmacy is an eight-member board appointed by the Governor to protect, promote and preserve the public health, safety and welfare of the citizens of Georgia. The Board is composed of seven licensed practicing pharmacists and one consumer member. They are responsible for the regulation of pharmacists and pharmacies in Georgia. The Board reviews applications, administers examinations, licenses qualified applicants, and regulates the practice of licensees throughout the state. Board meetings are open to the public and persons wishing to bring matters for the Board’s consideration should submit a written request to the office at: Georgia Board of Pharmacy, 2 Peachtree Street, NW, Atlanta, GA 30303. n

he 2014 legislative session of the Georgia General Assembly will be a short and fast paced session. Why will it be short and fast? 2014 is an election year for state legislators and statewide elected officials in Georgia. The quicker they get out of Atlanta the quicker they can get home and start campaigning for the May 20 primaries. GPhA’s legislative team will have their hands full next session We will working on MAC pricing, more remain vigilant immunizations in our efforts by pharmacists to defeat under physician harmful protocol, and beginning to lay legislation. the groundwork for getting healthcare provider status for pharmacists. Fixing the problems of MAC pricing will take up the most of our time during the session as strong opposition is expected from the PBMs that benefit financially for reimbursing pharmacies at lower prices than what prescriptions can be purchased. Besides working on MAC pricing and other pro-pharmacy legislation, every session the GPhA has to fight off legislation that is harmful to the practice of pharmacy. Next year will probably be no different but we will remain vigilant in our efforts to continue defeating harmful legislation. Weekly emails to GPhA members will continue this session informing you of what is going on at the Capitol and what you can do to help. n Andy Freeman is Director of Government Affairs at the Georgia Pharmacy Association. Email Andy at afreeman@gpha.org.

The Georgia Pharmacy Journal

U P D A T E S

The CMS STAR Ratings -

How Quality Ratings Impact Community Pharmacy By Elliott M. Sogol, PhD, RPh, FAPhA and John A. Galdo, Pharm.D., BCPS

ealth care reform is of the plan’s Part D sumconstantly changing and mary rating as they carry a today is no different. As an triple weighting in the CMS example, our colleagues in summary score. health-system practice are These measures are: very accustomed to being • Two measures of medicameasured and accredited on tion safety. a number of key metrics. • High-risk medications in Elliott M. Sogol, PhD, Today, community-based RPh, FAPhA the elderly. pharmacy quality measure• Medications that should ment and accreditation is be either limited in expoon the horizon. In fact, the sure to the elderly or not Center for Pharmacy Pracprescribed at all. tice Accreditation (CPPA) • Appropriate treatment of and URAC published stanblood pressure in persons dards for community pharwith diabetes. macy practice in early 2013. • Protection of organs – Community-based pharspecifically the kidney macy practice is starting to John A. Galdo, (patients on insulin are Pharm.D., BCPS shift to not just a culture of included in this metric). cost effectiveness, but also one of quality • Three measures of medication adheroutcomes and patient–centered care ence. A facet of accreditation implies mea- • Oral diabetes medications. surements. However, even before com- • Patients on insulin are excluded from munity pharmacy accreditation discus- this metric as it is difficult to track. sions began, the Centers of Medicare adherence if a patient is provided leeway & Medicaid Services to adjust dosing. (CMS) were measur• Cholesterol medicaing health plans; who tion (statins). in return are measur• Focuses on approing community pharpriate treatment and macies. This has been adherence. on-going for several • Blood pressure. years. Prescription drug plans receive • Appropriate adherence focusing on a summary “STAR rating” on quality renin-angiotensin system antagonists measures based on prescription adjudi- (RASA). cation. CMS also evaluates prescription drug For 2014 the STAR ratings for Medi- plans on “display measures” which incare Part D plans are based on fifteen clude metrics on drug-drug interacindividual measures with five measures tions, excessive doses of oral diabetes specific to medication management and medications and the use of atypical anuse, yet these five account for nearly half tipsychotics in nursing home patients.

For 2014 the STAR ratings are based on fifteen individual measures.

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Starting in 2014 , CMS will also begin evaluating MTM programs by measuring the “Comprehensive Medication Review (CMR) completion rate” for all drug plans. It is expected that this CMR measure will be added to the STAR rating measure set in the next round of additions and deletions. The metric is being used to determine how many eligible patients (by percentage) are actually receiving a CMR. Today the number and corresponding percentage is very low. The implication of quality metrics for community pharmacies is huge. Part D plans are now changing how they will look to pharmacies for inclusion in preferred networks and even potential changes in the level of reimbursement based on STAR ratings. Programs are available, like EQuIPP, to allow pharmacies to see their STAR ratings. EQuIPP is a service offered by Pharmacy Quality Solutions (PQS), a company owned by Pharmacy Quality Alliance (PQA), a non -profit that develops medication performance measures used by CMS for the STAR ratings process and CE City a technology based company. Ultimately, quality measures will allow us to help transition our patients from health-systems to the community, and give us the opportunity to get in front of the counter to care for our patients. n Elliott M. Sogol, PhD, RPh, FAPhA is Vice President Professional Relations, Pharmacy Quality Solutions. John A. Galdo, Pharm.D., BCPS is Clinical Pharmacy Educator at Barney’s Pharmacy, Clinical Assistant Professor at the UGA College of Pharmacy and Clinical Instructor at the GRU College of Dental Medicine.

L E G I S L A T I V E

Georgia Board of Pharmacy

Bracewell Sworn In

GPhA 2014 Legislative Review By Andy Freeman

Jim Bracewell, Executive Vice President of the Georgia Pharmacy Association, is congratulated by Nathan Deal as the new Consumer Member of the Georgia Board of Pharmacy.

The Georgia Pharmacy Journal

U P D A T E S

The CMS STAR Ratings -

How Quality Ratings Impact Community Pharmacy By Elliott M. Sogol, PhD, RPh, FAPhA and John A. Galdo, Pharm.D., BCPS

For 2014 the STAR ratings are based on fifteen individual measures.

The Georgia Pharmacy Journal

L E G I S L A T I V E

U P D A T E S

Gainesville Pharmacists Take Active Role Honoring Congressman Doug Collins “This is political advocacy at its best.”

Amy and Laird Miller poise with Georgia’s First Lady Sandra Deal at the special event honoring Ninth District Congressman Doug Collins.

It is important to stay in touch with your congressional representatives espe-

cially when you are not asking for their help. The pharmacists of Gainesville implemented that advice by showing up to demonstrate their support for Congressman Doug Collins at an event in his honor on the evening of November 25th. Governor Deal attended the event in addition to special guest Republican Majority Leader Eric Cantor, who came to express his support for the work of Doug Collins in the US Congress. Georgia Pharmacy Association Executive Vice President Jim Bracewell noted, “This is political advocacy at its best. When constituents let their Representative know how much they appreciate the Congressman’s work on their behalf. Gainesville GPhA members set a high standard for the balance of our members to emulate.” n

L-R: Ron Cain of Clermont Drug, Laird Miller of Medical Park Pharmacy, Congressman Doug Collins; Amy Miller of Lula Pharmacy, Steve Adams of Lawrence Pharmacy, and Kevin Woody of Woody's Pharmacy gathered at the event in Gainesville, Georgia honoring Congressman Collins.

Pharmacists Perform Health Screenings on Capitol Hill WASHINGTON, DC – More than 75 pharmacists and student pharmacists from the Washington, DC-metro area performed free health screenings on Capitol Hill. The screenings, including bone density, body composition, glucose, cholesterol, blood pressure and medication consultations or “Ask the Pharmacist,” were given to more than 200 members of Congress, staff, aides and the general public, in the Rayburn Foyer,

House of Representatives. The screenings were provided to demonstrate the value of pharmacist-provided patient care services; health screenings and medication services that pharmacists are already providing in their pharmacies everyday across the country. “Pharmacist-provided patient care is an important service for many people throughout the country,” stated APhA Executive Vice President and CEO,

The Georgia Pharmacy Journal

L E G I S L A T I V E

U P D A T E S

L E G I S L A T I V E

Gainesville Pharmacists Take Active Role Honoring Congressman Doug Collins “This is political advocacy at its best.”

Amy and Laird Miller poise with Georgia’s First Lady Sandra Deal at the special event honoring Ninth District Congressman Doug Collins.

It is important to stay in touch with your congressional representatives espe-

L-R: Ron Cain of Clermont Drug, Laird Miller of Medical Park Pharmacy, Congressman Doug Collins; Amy Miller of Lula Pharmacy, Steve Adam of Lawrence Pharmacy, and Kevin Woody of Woody's Pharmacy gathered at the event in Gainesville, Georgia honoring Congressman Collins.

The Georgia Pharmacy Journal

U P D A T E S

Thomas E. Menighan, Caucus, the American BSPharm, MBA, ScD Pharmacists Associ(Hon), FAPhA. “Pharmaation, the American cists are the most accessiSociety of Health-Sysble health care provider, tem Pharmacists, the with pharmacy locations National Association in almost every commuof Chain Drug Stores nity in America. Pharand the National Commacists demonstrated munity Pharmacists knowledge and training, Association. Several combined with this acWashington DC-area “Our community cessibility, makes them pharmacies and schools a valuable member of a of pharmacy providpharmacists play a patient’s health care team. critical role in our health ed invaluable time and APhA thanks all of the to showcase the care system,” said Rep. support pharmacists and student services pharmacists are Austin Scott (R-GA), pharmacists who parproviding in their comco-chair of the Conticipated in yesterday’s munities. health fair and demon“Our community gressional Community strated the services they pharmacists play a critPharmacy Caucus. provide every day and ical role in our health their value as health care providers.” care system,” said Rep. Austin Scott (RThe Hill health fair was hosted by the GA), co-chair of the Congressional ComCongressional Community Pharmacy munity Pharmacy Caucus. “For many

in rural towns and cities in Georgia and across the country, community pharmacies not only provide lifesaving prescriptions, but they also provide a number of important preventative health services for their patients. Thanks to the participating pharmacists and pharmacy students for providing these critical services and free health screenings on the hill today.” “Community pharmacies play a critical role in keeping Americans healthy,” commented Rep. Peter Welch (D-VT), co-chair of the Congressional Community Pharmacy Caucus. “By providing life-saving medicine, medical supplies and in-person counseling, these small businesses help maintain the viability of rural and small-town life. This health fair was a great way to demonstrate the invaluable services they provide every day in rural America.” The Hill health fair was a visual lobbying effort for the ongoing provider status campaign. n

L E G I S L A T I V E

U P D A T E S

California Provider Status Bill Becomes Law

For California pharmacists, the dream of being recognized as health care

providers by the state became a reality on October 1 when Gov. Jerry Brown signed SB 493 into law. State Sen. Ed Hernandez, OD, (D-24) wrote the legislation, which will go into effect January 1, 2014. Gaining provider status will expand roles for pharmacists and increase access to pharmacists’ patient care services for Californians. The new law declares pharmacists are health care providers. It gives new authorities to all licensed pharmacists, establishes an Advanced Practice Pharmacist (APP) recognition, gives new authorities to APPs, and specifies requirements for pharmacists seeking recognition as APPs. “We appreciate the Governor’s signature on this landmark legislation,” Jon R. Roth, CAE, CEO of the California Pharmacists Association, said in an October 1 statement. “With the implementation of the Affordable Care Act at a time when the number of primary care physicians continues to shrink, we believe this legislation will help ensure that the millions of new patients receiving insurance will be able to access health care services through their local pharmacist.”

Unified Pride

Pharmacists from many areas of practice came together in support of this important piece of legislation. The success of these efforts brought a sense of pride. APhA Trustee Nancy A. Alvarez, PharmD, BCPS, FAPhA, felt “pleased and proud of the efforts of the many pharmacists from various sectors of the profession in the state who worked tirelessly in support of the legislation.” Alvarez is Assistant Dean of Experiential Education and Continuing Professional Development at Chapman University’s

The legislation goes into effect this month and hopefully will serve as a model for other states. By Sara Wettergreen and Diana Yap new School of Pharmacy in Orange, CA. “You have to give tremendous credit to those who showed incredible trust in pharmacists to help create the means by which the level of care available to patients will rise significantly,” said APhA Trustee Michael A. Pavlovich, PharmD, owner of Westcliff Compounding Pharmacy in Newport Beach, CA.

Future Prospects

As pharmacists in California look forward to using their expanded roles, the state’s provider status legislation serves as a model for other states, as well as the nation. The success in the state of California, Pavlovich predicted, “will eventually lead to the changes in federal statutes necessary to move us from a product-centered profession to a knowledge-centered profession.” “APhA could not be more excited with the progress on provider status being made at the state level. These state successes are incredibly valuable to pharmacy’s pursuit of coverage of pharmacists’

patient care services across the country,” said Stacie Maass, BSPharm, JD, APhA Senior Vice President of Pharmacy Practice and Government Affairs. “California’s new law recognizes the services pharmacists are trained and qualified to provide and the importance of having pharmacists as part of the health care team. APhA is extremely appreciative of the California Pharmacists Association, California’s pharmacists, and the hard work being done by state associations and pharmacists around the country to advance our profession. You are making a difference to patients, to our health care system, and to our profession.” In a time when health care is evolving rapidly, much remains to be done regarding the concurrent evolution of the roles of the pharmacist. Provider status in California serves as a stepping stone to future efforts. Each step along the way deserves celebration. n Sara Wettergreen is an Experiential Intern at APhA. Diana Yap is Senior Assistant Editor, Pharmacy Today.

Helpful Resources APhA is developing a series of eight issue briefs on ACOs for APhA members to assist members in identifying opportunities and implementing new services. The ACO briefs are being published at www.pharmacist.com/ apha-accountable-care-organization-briefs. In coordination with NASPA, APhA also helped develop data sheets on the pharmacy environment within each state to highlight innovation, successes and changes necessary to advance pharmacists as providers. A project supported by the Community Pharmacy Foundation, all 51 of these four-page resources are available at www.pharmacist.com/mtm-state-advocacy-fact-sheets.

The Georgia Pharmacy Journal

SAVE THIS DATE ON YOUR CALENDAR Thursday, February 27, 2014

VIP DAY Voice In Pharmacy At The State Capitol

Here’s your chance to voice your support for pharmacy in Georgia. The Georgia Pharmacy Association will be holding the Voice in Pharmacy (VIP) Day on Thursday, February 27 at the Georgia State Capitol. VIP Day is an excellent way of getting to know your elected officials and having your voice count as we continue to shape public policy. Mark the date on your calendar and we’ll see you there.

Planned Activities Include: Breakfast with your invited Georgia Legislator and Presentation of the GPhA Legislator of the Year Featured Keynote Speaker: Tom Menighan, RPh Executive Vice President American Pharmacists Association No cost to you to participate. Huge cost to your career not to be there.

Register Online at www.gpha.org THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

L E G I S L A T I V E

U P D A T E S

California Provider Status Bill Becomes Law

For California pharmacists, the dream of being recognized as health care

Unified Pride

Future Prospects

The Georgia Pharmacy Journal

SAVE THIS DATE ON YOUR CALENDAR Thursday, February 27, 2014

VIP DAY Voice In Pharmacy At The State Capitol

Register Online at www.gpha.org THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

*Denotes a monthly sustaining PAC member. (Month/Year) Denotes most recent contribution.

Thanks to All Our Supporters Diamond Level

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*Neal Florence, R.Ph. *Andy Freeman *Robert Hatton, Pharm.D. Ted Hunt, R.Ph.12/14 *Ira Katz, R.Ph. Thomas Lindsay, R.Ph. 5/14 *Eddie Madden, R.Ph. *Jonathan Marquess, Pharm.D. *Pam Marquess, Pharm.D. *Kenneth McCarthy, R.Ph. *Ivey McCurdy, Pharm. D *Drew Miller, R.Ph. *Laird Miller, R.Ph. *Jay Mosley, R.Ph. *Sujal Patel, Pharm D *Mark Parris, Pharm.D. *Allen Partridge, R.Ph. Jeff Lurey, R.Ph. 4/14 *Houston Rogers, Pharm.D. Tim Short, R.Ph. 10/14 *Benjamin Stanley, Pharm.D. *Danny Toth, R.Ph. *Christopher Thurmond, Pharm.D. *Alex Tucker, Pharm.D. Lindsay Walker, R.Ph. 6/14 Henry Wilson, Pharm.D. 11/14

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*Stewart Flanagin, R.Ph. *Kevin Florence, Pharm.D. *Kerry Griffin, R.Ph. *Michael Iteogu, R.Ph. *Joshua Kinsey, Pharm.D. *Dan Kiser, R.Ph. *Allison Layne, C.Ph.T Lance LoRusso 6/14 *Sheila Miller, Pharm.D. *Robert Moody, R.Ph. *Sherri Moody, Pharm.D. *William Moye, R.Ph. *Anthony Ray, R.Ph. *Jeffrey Richardson, R.Ph. *Andy Rogers, R.Ph. Daniel Royal Jr., R.Ph.12/14 *Michael Tarrant *James Thomas, R.Ph. Zach Tomberlin, Pharm.D. 4/14 *Mark White, R.Ph. *Charles Wilson Jr., R.Ph.

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Highlight denotes new and increased contributors.

*Hilary Mbadugha, Pharm.D. *Kalen Manasco, Pharm.D. *William McLeer, R.Ph. *Sheri Mills, C.Ph.T. Albert Nichols, R.Ph. 2/14 *Richard Noell, R.Ph. *Cynthia Piela *Donald Piela, Jr. Pharm.D. Bill Prather, R.Ph. 6/14 *Kristy Pucylowski, Pharm.D. *Edward Reynolds, R.Ph. *Ashley Rickard, Pharm D. *Brian Rickard, Pharm D. Flynn Warren, R.Ph. 6/14 Steve Wilson, Pharm.D. 7/14 *William Wolfe, R.Ph. *Sharon Zerillo, R.Ph.

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*Susan McLeer, R.Ph. Judson Mullican, R.Ph. 11/14 *Natalie Nielsen, R.Ph. *Mark Niday, R. Ph. *Don Richie, R.Ph. *Amanda Paisley, Pharm.D. *Alex Pinkston IV, R.Ph Don Richie, R.Ph. 11/14 *Corey Rieck Carlos Rodriguez-Feo, R.Ph. 12/14 *Laurence Ryan, Pharm.D. *Olivia Santoso, Pharm. D. James Stowe, R.Ph. 12/14 *Dana Strickland, R.Ph. G.H. Thurmond, R.Ph. 11/14 *Tommy Tolbert, R. Ph. William Turner, R.Ph 1/14 *Austin Tull, Pharm.D.

Members

No minimum pledge Claude Bates, R.Ph 6/14 Winston Brock, R.Ph. 6/14 David Carver, R.Ph. 6/14 Marshall Curtis, R.Ph. 6/14 Donley Dawson, Pharm.D. 12/14 John Drew, R.Ph. 6/14 James England, R.Ph. 6/14 Martin Grizzard, R.Ph. 12/14 Christopher Gurley, R. Ph 6/14 Marsha Kapiloff, R.Ph. 6/14 Charles Kovarik, R. Ph. 6/14 Carroll Lowery, R.Ph. 6/14 Ralph Marett, R.Ph. 6/14 Kenneth McCarthy, R.Ph. 6/14 Whitney Pickett, R.Ph. 11/14

Michael Reagan, R. Ph 6/14 Ola Reffell, R.Ph. 6/14 Leonard Reynolds, R.Ph. 6/14 Victor Serafy, R.Ph. 6/14 Terry Shaw, Pharm.D. 5/14 Harry Shurley, R.Ph 6/14 Amanda Stankiewicz, Student 6/14 Benjamin Stanley, R.Ph 6/14 Krista Stone, R.Ph 6/14 John Thomas, R.Ph. 11/14 William Thompson, R.Ph. 6/14 Carey Vaughan, Pharm.D. 6/14 Jonathon Williams R.Ph 8/14

NOTICE:

Contact Andy Freeman, GPhA Director of Government Affairs, to update your support or if any information is incorrect. afreeman@gpha.org 404-419-8118

PharmPac Board of Directors

Eddie Madden, Chairman Dean Stone, Region 1 Keith Dupree, Region 2 Judson Mullican, Region 3 Bill McLeer, Region 4 Mahlon Davidson, Region 5 Mike McGee, Region 6 Jim McWilliams, Region 7 T.M. Bridges, Region 9 Mark Parris, Region 9 Chris Thurmond, Region 10 Stewart Flanagin, Region 11 Henry Josey, Region 12 Pam Marquess, Ex-Officio Jim Bracewell, Ex-Officio

*Denotes a monthly sustaining PAC member. (Month/Year) Denotes most recent contribution.

Thanks to All Our Supporters Diamond Level

$4,800 minimum pledge *Scott Meeks, R.Ph. *Fred Sharpe, R.Ph

Titanium Level

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NOTICE:

Contact Andy Freeman, GPhA Director of Government Affairs, to update your support or if any information is incorrect. afreeman@gpha.org 404-419-8118

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continuing education for pharmacists Volume XXXI, No. 11

d/b/a Pharmacists Insurance Agency (in California) CA License No. 0G22035

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Now more than ever, pharmacists are learning just how important it is to have not only proper insurance coverage, but the right amount of insurance. We understand the risks involved in operating a pharmacy practice and have coverage designed to ensure that you and your business are protected. We even provide policies specifically designed for practices that offer specialty services such as compounding or home medical equipment. Trust the experts - our representatives can help you determine the right coverage for you. We offer products to meet all your needs; everything from business and personal insurance to life and investments. We’re proud to be your single source for insurance protection.

FDA Safety Warnings and Prescribing Updates: Zolpidem, Valproate, Ketoconazole, and Acetaminophen Mona T. Thompson, R.Ph., PharmD

Mona T. Thompson has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide a review of select U.S. Food and Drug Administration (FDA) safety warnings and associated prescribing updates that were issued over the past several months regarding zolpidem-containing products, valproate use in pregnancy, ketoconazole and acetaminophen. Objectives. At the completion of this activity, the participant will be able to: 1. demonstrate an understanding of the safety warnings and associated prescribing changes, if applicable, issued for each of the entities discussed; 2. identify the patient population at risk for adverse events in relation to the safety warnings for the entities discussed; and 3. list fundamental patient counseling points secondary to the safety warnings and associated prescribing changes, if applicable, for the entities discussed.

Hutton Madden

800.247.5930 ext. 7149 404.375.7209

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Zolpidem-Containing Medications

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Zolpidem is a sedative-hypnotic medication used for the treatment of insomnia. In 2011, approximately nine million patients received zolpidem products from U.S. outpatient retail pharmacies, of which over half were dispensed

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to females. In January 2013, FDA notified the public that new data indicated that blood levels of zolpidem may be high enough the morning after use to impair activities that require alertness, including driving. While this specific warning focused on zolpidem-containing products such as Ambien, Ambien CR, Edluar, and Zolpimist, drowsiness the day after taking virtually any insomnia product is possible and warrants caution. FDA announced that they were requiring manufacturers to reduce the recommended dose of these agents in order to lower resulting blood levels the following morning. For over 20 years, FDA has received reports of possible driving impairment and motor vehicle accidents associated with zolpidem. However, in most cases it was difficult to determine if the driving impairment was related to zolpidem or a specific zolpidem drug level. The availability of this new data and driving simulation studies has led to the approval of new drug labels reflecting these dosing changes as of May 2013. The recommended initial dose of immediate-release products Ambien and Edluar is now 5 mg for women and either 5 mg or 10 mg for men. The recommended initial dose of zolpidem extendedrelease (Ambien CR) is 6.25 mg for women, and either 6.25 mg or 12.5 mg for men. These initial doses are expected to be effective in most patients. However, if they

are not, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release with the cautionary statement that the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness. Because labeling for Intermezzo already recommends a lower dose in women compared to men, FDA is not requiring additional changes. Table 1 lists a summary of these dosing changes. Data submitted to FDA indicated that individuals with zolpidem blood levels greater than 50 ng/mL may be impaired enough to increase the risk of a motor vehicle accident. In pharmacokinetic trials utilizing zolpidem products at the 10 mg dose, 15 percent of women and 3 percent of men had zolpidem concentrations that exceeded 50 ng/mL eight hours after dosing. Of the total 250 women and 250 men tested, three women and one man had levels exceeding 90 ng/mL. In trials involving zolpidem extended-release 12.5 mg, 33 percent of women and 25 percent of men had zolpidem blood concentrations exceeding 50 ng/mL, approximately eight hours after dosing. Eight hours following 6.25 mg extended-release doses of zolpidem, 15 percent of adult women and 5 percent of adult men had levels exceeding the proposed threshold. Ten percent of both elderly men and women were also found to have such levels, indicating that in-

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FDA Safety Warnings and Prescribing Updates: Zolpidem, Valproate, Ketoconazole, and Acetaminophen Mona T. Thompson, R.Ph., PharmD

Mona T. Thompson has no relevant financial relationships to disclose.

Hutton Madden

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800.247.5930 www.phmic.com

Zolpidem-Containing Medications

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Table 1 2013 Dosing recommendations for zolpidem* Ambien, Edluar, Zolpimist

Women: 5 mg once daily, immediately before bedtime Men: 5 or 10 mg once daily, immediately before bedtime

Ambien CR

Women: 6.25 mg once daily, immediately before bedtime Men: 6.25 or 12.5 mg once daily, immediately before bedtime

*for non-elderly adults

creased age may slow the metabolism of zolpidem. Hence, data supports that the risk for next-morning impairment is greatest in patients taking the extended-release forms of these drugs (i.e., Ambien CR and generics), in women, and the elderly. The pharmacokinetic trials conducted did not find a relationship between zolpidem blood levels and the body weight or ethnicity of the patient. FDA notes that next-morning impairment is different than complex sleep-related behaviors. Next-morning impairment occurs in patients who are awake, while complex sleep-related behaviors occur when patients get out of bed and perform activities such as sleepwalk, drive a car, or prepare and eat food while they are not fully awake and without memory of the activity. In 2007, the zolpidem label’s Warnings and Precautions section was updated to reflect the concern of complex sleep-related behaviors. The co-administration of central nervous system (CNS) depressants with zolpidem increases the risk of such behaviors. An article published in 2011 in the Journal of Clinical Sleep Medicine by Poceta examined a series of clinical and legal cases following the ingestion of zolpidem. The author described cases of zolpidemassociated complex behaviors including daytime automatisms and sleep-related parasomnia,

and concluded that risk factors for these behaviors include concomitant ingestion of other sedating drugs, a higher dose of zolpidem, a history of parasomnia, ingestion at times other than bedtime or when sleep is unlikely, poor management of pill bottles, and living alone. Parasomnias are sleep disorders that involve abnormal and unnatural movements, behaviors, emotions, perceptions, and dreams that occur while falling asleep, sleeping, between sleep stages or during arousal from sleep. Family history, sleep deprivation, fever, alcohol, and medications predispose people to parasomnia. FDA states that the new dosing recommendations are expected to decrease both complex sleep-related behaviors and next morning impairment. The zolpidem drug label carries other noteworthy precautions. Since it is a CNS depressant, its effect can be additive when used concurrently with other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, and alcohol. Sleep disturbances can present with physical and/or psychiatric disorder(s). Therefore, symptomatic treatment of insomnia should be prescribed with caution and careful evaluation as well as re-evaluation. Abnormal thinking and behavior changes have been reported in patients treated with sedative-hypnotics such as zolpidem. These changes include decreased inhibition, bizarre behavior, agita-

tion, and depersonalization. Visual and auditory hallucinations have been reported. Worsening depression and suicidal thoughts and actions have been reported in patients treated with sedative-hypnotics who are primarily depressed. Providers are cautioned to prescribe minimal tablets of zolpidem as intentional overdosage is common in this group of patients. The risk of respiratory depression when used at hypnotic doses should be considered in patients with respiratory impairment including those with sleep apnea and myasthenia gravis. Patients should be monitored for tolerance, abuse, and dependence of zolpidem. Reports of withdrawal signs and symptoms following rapid dose decrease or abrupt discontinuation have been reported. In order to reduce the risk of next-morning impairment, patients should take the lowest dose that manages their symptoms. Zolpidem should not be taken if less than seven to eight hours of sleep is anticipated. Poceta suggests instructing the patient to not only “ingest immediately prior to going to bed,” but to add that it should be taken “at your usual bedtime only.”

Valproate Sodium Use in Pregnancy

FDA alerted health care professionals and women in May 2013 that recent studies provide evidence that the anti-seizure medications, valproate sodium and related products, can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels and valproate’s pregnancy category will be changed from “D” to “X” when prescribed for migraines. However, valproate products will remain in pregnancy category “D” for treating epilepsy and manic episodes associated with bipolar disorders. Pregnancy risk category D indicates that adequate well-controlled or observational studies in pregnant women have

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demonstrated a risk to the fetus. Yet, the benefits of therapy may outweigh the potential risk such as cases where the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective. Pregnancy category X means that adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of category X agents is contraindicated in women who are or who may become pregnant. Health care professionals are advised to prescribe these products in pregnant women with epilepsy or bipolar disorders when other medications are not effective or otherwise unacceptable. In addition, for women of childbearing age who are not pregnant, valproate products should be resorted to only when the medication is considered essential and prescribed along with effective birth control. Meador et al. reported a prospective, observational study that involved children of women who were taking one of four antiepileptic drugs as monotherapy: lamotrigine, carbamazepine, phenytoin, or valproate products. The study compared results of IQ tests of six-year-olds who had been exposed to one of these antiepileptic drugs in utero. Children exposed to valproate products during pregnancy had statistically significant lower IQ scores, when compared to all other monotherapies that were studied. The mean IQ for the valproate was 97 compared to 105, 108, and 108 for carbamazepine, lamotrigine, and phenytoin respectively. Additionally, the mean IQs were higher in groups whose mothers reported periconceptional folate use. However, the authors warn that these findings should be interpreted with caution as the effect of periconceptional folate use was not a primary outcome of the study and the information for this outcome was collected retrospectively. It is important to note that the women studied were exposed to antiepilep-

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tic drugs throughout their pregnancies, and it is unknown if the timing of exposure during pregnancy may affect the severity of cognitive effects in children. Valproate products include: valproate sodium (e.g., Depacon), divalproex sodium (e.g., Depakote, Depakote CP, Depakote ER), valproic acid (e.g., Depakene and Stavzor). While the exact mechanism of action is unknown, their antiepileptic action may be attributed to increased gammaaminobutyric acid (GABA) levels in the brain. Divalproex sodium is approved for use in simple and complex absence seizures, complex partial epileptic seizure, manic bipolar I disorder, and prophylaxis of migraines. Off label, these agents may also be prescribed for alcohol withdrawal syndrome, maintenance of bipolar I and II disorder, chronic headache disorder, posttraumatic headache, and bipolar type schizoaffective disorder. The label of valproate products carries a black box warning for the risk of hepatotoxicity which usually occurs within the first six months of treatment. Liver function tests are recommended at the start of therapy and at frequent intervals, particularly during the first six months. Children younger than two years of age and patients with hereditary mitochondrial disease are at a higher risk of developing fatal hepatotoxicity. Use may be contraindicated in these populations. In addition to impaired cognitive development during prenatal exposure, valproate products may produce major congenital malformations such as neural tube defects (i.e., spina bifida). Lifethreatening pancreatitis has also been reported in adults and children taking these agents. Affected patients should be advised that taking valproate during pregnancy can decrease the child’s IQ score and a higher risk for birth defects exists. These women should speak with their health care professional immediately, but should not stop valproate treatment suddenly as this can cause serious and life-

threatening medical problems to both the mother and baby. Health care providers should counsel patients on the importance of effective birth control, if they are not pregnant but of child bearing age. Folic acid supplementation before conception and during early pregnancy has been shown to reduce the chance of neural tube defects in babies and should be routinely recommended. Additionally, health care providers can share information with their patients about the North American Antiepileptic Drug Pregnancy Registry. The registry was established in 1997 for pregnant women in the United States and Canada at Massachusetts General Hospital in Boston, Massachusetts. The major objective of the registry is to obtain and publish information on the frequency of major malformations (such as heart defects, spina bifida, and cleft lip), with the highest priority placed on new information related to the use of newer antiepileptic drugs (AEDs) marketed in the past ten years. Prior to the creation of this registry, data regarding the safety of antiepileptic drugs was conducted by manufacturers and there was no systematic method to determine whether or not specific anticonvulsants were associated with increases in malformations. As of April 2012, 8,500 women had enrolled in the registry. The registry’s most recent newsletter, published in 2012, announced new findings on the comparative safety of 11 AEDs used during pregnancy. The newsletter summarizing these findings, as well as additional information for providers and patients, can be found on their website at www.aedpregnancyregistry.org. The registry staff emphasizes a need for the largest possible sample size as they study the safety of AEDs in order to report accurate findings. Women must register themselves and can do so by calling 1.888.233.2334.

Ketoconazole

Ketoconazole (Nizoral and others)

Table 1 2013 Dosing recommendations for zolpidem* Ambien, Edluar, Zolpimist

Women: 5 mg once daily, immediately before bedtime Men: 5 or 10 mg once daily, immediately before bedtime

Ambien CR

Women: 6.25 mg once daily, immediately before bedtime Men: 6.25 or 12.5 mg once daily, immediately before bedtime

*for non-elderly adults

Valproate Sodium Use in Pregnancy

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Ketoconazole

Ketoconazole (Nizoral and others)

Table 2 Selected Drugs with Plasma Concentrations Altered by Nizoral ® * Systemic exposure to these drugs is increased significantly by ketoconazole: Concomitant use is contraindicated. Systemic exposure to these drugs is increased by ketoconazole: Careful monitoring, with possible adjustment in dosing, is recommended.

Alprazolam, midazolam, triazolam Cisapride Dofetilide Eplerenone Ergot alkaloids

HMG-CoA reductase inhibitors (lovastatin, simvastatin) Nisoldipine Pimozide Quinidine

Alfentanil, fentanyl, sufentanil Amlodipine, felodipine, nicardipine, nifedipine Bosentan Buspirone Busulfan Carbamazepine Cilostazol Cyclosporine Digoxin Docetaxel, paclitaxel Oral anticoagulants

Indinavir, saquinavir Methylprednisolone Rifabutin Sildenafil Sirolimus (not recommended) Tacrolimus Telithromycin Tolterodine Trimetrexate Verapamil Vinca alkaloids

*This list is not all-inclusive. From Nizoral package insert.

Table 3 Selected Drugs that may Alter Plasma Concentrations of Nizoral ® * Systemic exposure to ketoconazole is significantly reduced by these drugs and concomitant use is not recommended.

Carbamazepine Gastric acid suppressants (antacids, antimuscarinics, histamine H2 blockers, proton pump inhibitors, sucralfate)

Systemic exposure to ketoconazole is increased significantly by this drug: Dose reduction of ketoconazole should be considered.

Ritonavir

Nevirapine Phenytoin Rifampin, rifabutin, isoniazid

*This list is not all-inclusive. From Nizoral package insert.

is an imidazole antifungal agent that has been prescribed for the treatment of many superficial and systemic fungal infections. During 2012 alone, approximately 600,000 prescriptions for the tablet formulation were dispensed. While it has been associated with drug-induced liver injury for several years, FDA is now requiring the drug label to be updated and requesting that ketoconazole’s use be limited. The announcement came from FDA on July 26, 2013 and includes several changes following a negative risk versus benefit assessment that was conducted by the European Medicines Agency (EMA). EMA made a public announcement recommend-

ing that marketing authorization of oral ketoconazole be suspended throughout the European Union. Similar action was taken in France, also because of high liver injury associated with ketoconazole use. The foreign agencies state that while hepatitis is a known side effect of other antifungal medicines, both incidence and severity of liver injury with oral ketoconazole were higher than with other antifungals, and it does not appear to be possible to identify measures to reduce the risk. Topical formulations of ketoconazole such as creams, ointments, and shampoo can continue to be used as the amount of drug absorbed throughout the body is

low. Liver damage with ketoconazole is documented for patients receiving high doses for short periods of time or low doses for long periods of time, and may occur in those without obvious risk factors for liver disease. Hepatotoxicity associated with the agent is sometimes reversible upon discontinuation. However, damage leading to liver transplantation or death has occurred. Therefore, oral use is contraindicated in patients with acute or chronic liver disease. The new label recommends that liver function be assessed prior to treatment and monitored routinely (i.e., weekly), as well as at the first signs

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or symptoms of possible hepatotoxicity. Signs and symptoms of hepatotoxicity include anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain, or dark urine. Health care professionals should advise patients to avoid alcohol and other potentially hepatotoxic drugs while receiving ketoconazole tablets. In addition to warning of severe liver injury with ketoconazole, the drug safety communication identified that the antifungal is associated with adrenal insufficiency. Adrenal insufficiency is a decreased ability of the adrenal glands to produce corticosteroids. Health care professionals are advised to monitor adrenal function in patients taking ketoconazole tablets who have existing adrenal insufficiency or in patients experiencing extended periods of stress (i.e., following major surgery or increased stays in intensive care settings). Lastly, the warning brings attention to the many drug interactions that are possible with ketoconazole which can lead to serious and potentially life-threatening outcomes. FDA is calling for all health care professionals to assess all other concurrent medications that the patient is taking in order to minimize this risk. The current drug label includes a black box warning indicating that ketoconazole is contraindicated with dofetilide, quinidine, pimozide, and cisapride. These combinations can cause elevated plasma concentrations of these drugs which may result in further QT prolongation and possibly life-threatening ventricular dysrhythmias such as torsades de pointes. Co-administration of ketoconazole tablets with oral midazolam, oral triazolam, or alprazolam is also contraindicated as it has resulted in elevated plasma concentrations of these drugs and may potentiate or prolong the sedative and hypnotic effects especially with repeated dosing. Other contraindicated agents include the CYP3A4 metabolized HMG-CoA reductase inhibitors simvastatin and lovastatin, as well as nisoldipine, eplerenone, and ergot alkaloids.

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Careful monitoring and dosing adjustments may be required with several other commonly prescribed medications. Tables 2 and 3 include more drug interactions as detailed in the Nizoral package insert. Under the new label, ketoconazole should not be used as a first-line agent for any fungal infection and should only be used for the treatment of certain fungal infections such as endemic mycoses when alternative antifungal therapies are not available. Indications for which the risk of ketoconazole therapy outweighs the benefit have been removed from the label. Therefore, the use of ketoconazole in Candida and dermatophyte infections is no longer indicated and this oral antifungal is no longer appropriate for fungal infections of the skin or nails. This labeling change will alter prescribing as reports from office-based physicians indicated that the most common diagnosis associated with use in recent years have included superficial skin and nail fungal infections. Ultimately, oral ketoconazole can now only be prescribed for the following infections: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis in patients who have failed other therapies or who are intolerant to them. A patient Medication Guide is now required by law each time a prescription is dispensed, and is summarized in Table 4.

Acetaminophen

A new safety warning with acetaminophen has been issued. On August 1, 2013, FDA published a statement to warn the public about rare but serious skin reactions that have been reported secondary to acetaminophen use. The skin reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), and they can be fatal. Stevens-Johnson Syndrome is described as severe, widespread vesiculobullous disease of the skin with involvement of two or more

Table 4 Summary of Nizoral ® Medication Guide •Nizoral (ketoconazole) tablets can cause serious side effects, including: Liver Problems. A healthcare provider should be contacted right away if any of the following symptoms are experienced: loss of appetite or weight loss, nausea or vomiting, tired feeling, stomach pain or tenderness, dark urine or light-colored stools, yellowing of the skin or the whites of the eyes, fever or rash. QT Prolongation can occur when taken with certain medications such as dofetilide, quinidine, pimozide, and cisapride. Patients should tell a health care provider right away if the following symptoms are experienced: feeling faint, lightheaded, dizzy, or irregular or fast heart beat. •Nizoral is prescribed to treat serious fungal infections including: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. •Nizoral is not used to treat fungal nail infections. •Nizoral has not been approved for the treatment of advanced prostate cancer or Cushing’s syndrome. The safety and efficacy have not been established. •Nizoral tablets should only be used in children if prescribed by a health care provider who has determined that the benefits outweigh the risks. •Nizoral tablets should not be taken if a patient has liver problems or is taking any medications that are contraindicated with it. •Before taking Nizoral tablets, patients should tell their health care provider if they (1) have had an abnormal heart rhythm or if a family member has had congenital long QT syndrome; (2) have adrenal insufficiency; (3) are pregnant or plan to become pregnant; (4) are breastfeeding or plan to breastfeed. •Patients should avoid drinking alcohol while taking Nizoral tablets.

mucosal surfaces such as eyes, oral cavity, upper airway or esophagus, gastrointestinal tract, or anogenital mucosa. SJS results in mucosal erosions and epidermal detachment affecting less than 10 percent of the body surface area. TEN is the most extreme form of the disease with