georgia pharmacy journal - january 2014
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January 2014VOLUME 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
Call for G
PhA Award
Nominations
Page 6
Editor: Jim [email protected]
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 ARtwORkThose 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 [email protected].
SUBSCRIPtIONS ANd CHANGE Of AddRESSThe 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.
AdVERtISINGAdvertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at [email protected].
GPhA Headquarters50 Lenox Pointe, NE
Atlanta, Georgia 30324t 404-231-5074 f 404-237-8435
gpha.org
January 2014
1The Georgia Pharmacy Journal
ContentsMessage from Pamala Marquess .................
Message from Jim Bracewell .........................
Welcome New Members.................................
Member News ..................................................
2
43
5
.........................................
1213
Georgia Board of Pharmacy Bracewell Sworn In ........................................................
Legislative Updates ........................................................
GPhA 2014 Legislative Review .................12
11
PharmPac Supporters .................................18Continuing Education ................................21
Meet the Georgia Pharmacist Legislators
GPhA Board of Directors .........................28
Editor: Jim [email protected]
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 ARtwORkThose 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 [email protected].
SUBSCRIPtIONS ANd CHANGE Of AddRESSThe 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.
AdVERtISINGAdvertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at [email protected].
GPhA Headquarters50 Lenox Pointe, NE
Atlanta, Georgia 30324t 404-231-5074 f 404-237-8435
gpha.org
January 2014
1The Georgia Pharmacy Journal
ContentsMessage from Pamala Marquess .................
Message from Jim Bracewell .........................
Welcome New Members.................................
Member News ..................................................
2
43
5
.........................................
1213
Georgia Board of Pharmacy Bracewell Sworn In ........................................................
Legislative Updates ........................................................
GPhA 2014 Legislative Review .................12
11
PharmPac Supporters .................................18Continuing Education ................................21
Meet the Georgia Pharmacist Legislators
GPhA Board of Directors .........................28
Pamala MarquessGPhA President
Th e Georgia Pharmacy Journal2
MESSAGE from Pamala MarquessProvider Status’ First Hand
It 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 wind-ing down toward the end of the year, it will be considering legislation that could help phar-macy increase access to cost-saving Medication Th erapy 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 oth-ers were not introduced or withdrawn when the bill came to vote. Why is this important?
“Th e Pharmacists of America made their fi rst stand for provider status this day on Cap-itol Hill,” stated APhA’s EVP and CEO Tom Menighan. “Th e 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, We’ve only just begun. Just getting pharmacists as providers mentioned at the Congressional level, let alone introduced into the amendment record, is a signifi cant accomplishment.
We know that our patients need our services, and we need provider status to be in a position to help. For this to happen, we need to continue to communi-cate the message on a state and national level to our representatives.
Th e Georgia Pharmacy Association will be supporting this eff ort in our 2014 legislative session. I applaud APhA for their leadership on Provider Status and support this endeavor. Pharmacists are an integral member on every
health care team and should be recognized as such. I am confi dent 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. Th ere 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 prog-ress to increase patient access to pharmacists as providers of patient care services in 2014!
Pamala S. Marquess
Th e GPhA will be supporting the Provider
Status eff ort in our 2014
legislative session.
WELCOME
Th e 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 develop-ment partner as you address your future in pharmacy. Professional networking, skills training and continuing pharmacy education are key benefi ts 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.
New Members
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!
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 ASSOCIATION
Your Voice in Pharmacy
Pam
Pharmacists
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
WELCOME
� e 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 develop-ment partner as you address your future in pharmacy. Professional networking, skills training and continuing pharmacy education are key bene� ts 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.
New Members
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!
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 ASSOCIATION
Your Voice in Pharmacy
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
he currently serves on the Board of Trustees.
Dr. Marquess shares own-ership of six pharmacies with his wife and current GPhA President Dr. Pam Marquess, Pharm.D., who will now ac-cept full management respon-sibilities for the pharmacies
while he concentrates his efforts on lead-ing the clinical services team at ACPI.
ACPI has announced a renewed commitment to providing the support, knowledge, and the leadership necessary to ensure success in patient care and ad-ministering quality clinical services. n
Jim Bracewell Executive Vice President
5The Georgia Pharmacy Journal The Georgia Pharmacy Journal
If 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 mem-ber 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 num-ber one premiere service of the Georgia Pharmacy Association.
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 quote from his father – “What a country!”
Many pundits like to negatively label associations as “those powerful special interest groups”, as though uniting for a common cause is detrimental to our form of government. The late United States Supreme Court Justice Thurgood Marshall said: “Millions of Americans speaking in unison is not a corruption of the democratic political process, it is the democratic political process.”
Where would our country be without such associations as the NAACP, the NRA, the Tea Party, and the Sierra Club? With each group I named, you may 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 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 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 respon-sibility for the governance of their profession through membership and involvement in the Georgia Pharmacy Association.
Jim
Advocacy: The Role of Associations
4
M E M B E R N E W S
State representative Bruce Broad-rick (Class of ’76) was the recipient of the University of Georgia College of Phar-macy 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 phar-macy 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 Com-mittees. He is a member of the College of Pharmacy President’s Club and estab-lished the Broadrick Family Endowed Student Scholarship in 2006.
Throughout his career, Rep. Broad-rick has served on numerous boards, in-cluding the Northwest Georgia Health-care Partnership, Georgia Partnership for Caring, Medical Advisory Commit-tee for the State Board of Workers Com-pensation, and Whitfield County Board of Health. He has also received numer-ous service and leadership awards for his positive impact on the pharmacy profes-sion.
The Georgia Pharmacy Association would like to congratulate Bruce on his outstanding career, his service to the community, and his unwavering com-mitment to the pharmacy profession. n
Broadrick Receives Distinguished Alumni AwardSince 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 ACPIDr. Jonathan Marquess,
Pharm.D., has joined ACPI as Vice President of Professional Affairs.
Dr. Marquess is a Mercer University graduate and is ac-tively involved in local, state, and national professional organizations including the Georgia Pharmacy Association where he served as President in 2005 and was named the Innovative Pharmacist of the Year in 2008.
In addition to membership in the GPhA, Dr. Marquess is a member of the American Pharmacy Association where
“Resolve today to be an active advocate for
your profession through the con-tribution of your time, talent and resources to that common cause of advocacy.”
Dr. Jonathan Marquess, Pharm.D.
he currently serves on the Board of Trustees.
Dr. Marquess shares own-ership of six pharmacies with his wife and current GPhA President Dr. Pam Marquess, Pharm.D., who will now ac-cept full management respon-sibilities for the pharmacies
while he concentrates his efforts on lead-ing the clinical services team at ACPI.
ACPI has announced a renewed commitment to providing the support, knowledge, and the leadership necessary to ensure success in patient care and ad-ministering quality clinical services. n
Jim Bracewell Executive Vice President
5The Georgia Pharmacy Journal The Georgia Pharmacy Journal
If 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 mem-ber 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 num-ber one premiere service of the Georgia Pharmacy Association.
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 quote from his father – “What a country!”
Many pundits like to negatively label associations as “those powerful special interest groups”, as though uniting for a common cause is detrimental to our form of government. The late United States Supreme Court Justice Thurgood Marshall said: “Millions of Americans speaking in unison is not a corruption of the democratic political process, it is the democratic political process.”
Where would our country be without such associations as the NAACP, the NRA, the Tea Party, and the Sierra Club? With each group I named, you may 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 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 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 respon-sibility for the governance of their profession through membership and involvement in the Georgia Pharmacy Association.
Jim
Advocacy: The Role of Associations
4
M E M B E R N E W S
State representative Bruce Broad-rick (Class of ’76) was the recipient of the University of Georgia College of Phar-macy 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 phar-macy 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 Com-mittees. He is a member of the College of Pharmacy President’s Club and estab-lished the Broadrick Family Endowed Student Scholarship in 2006.
Throughout his career, Rep. Broad-rick has served on numerous boards, in-cluding the Northwest Georgia Health-care Partnership, Georgia Partnership for Caring, Medical Advisory Commit-tee for the State Board of Workers Com-pensation, and Whitfield County Board of Health. He has also received numer-ous service and leadership awards for his positive impact on the pharmacy profes-sion.
The Georgia Pharmacy Association would like to congratulate Bruce on his outstanding career, his service to the community, and his unwavering com-mitment to the pharmacy profession. n
Broadrick Receives Distinguished Alumni AwardSince 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 ACPIDr. Jonathan Marquess,
Pharm.D., has joined ACPI as Vice President of Professional Affairs.
Dr. Marquess is a Mercer University graduate and is ac-tively involved in local, state, and national professional organizations including the Georgia Pharmacy Association where he served as President in 2005 and was named the Innovative Pharmacist of the Year in 2008.
In addition to membership in the GPhA, Dr. Marquess is a member of the American Pharmacy Association where
“Resolve today to be an active advocate for
your profession through the con-tribution of your time, talent and resources to that common cause of advocacy.”
Dr. Jonathan Marquess, Pharm.D.
Th e Georgia Pharmacy Journal6
M E M B E R N E W SM E M B E R N E W S
Call for GPhA Awards!The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 139th Annu-al 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 sub-mitting 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 pharma-cy associations. Selection Criteria: 1) Th e nominee must be a licensed Georgia pharmacist; 2) Th e Award is not made posthumously; 3) Th e nominee is not a previous recipient of the Award; 4) Th e nominee is not currently serving nor has served within the immediate past two years as an offi cer of GPhA other than ex-of-
fi cio capacity or its awards committee; 5) Th e nominee has an outstanding record of service to the community which refl ects will on the profession.
Distinguished Young Pharmacist Created in 1987 to recognize the achieve-ments of young pharmacists in the profes-sion, the Award has quickly become one of the GPhA’s most prestigious awards. Th e purpose of the Award is two-fold: 1) To encourage new phar-macists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the phar-macy profession. Selection Criteria: 1) Th e 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 phar-macy association programs or activities and community service projects.
2014 Awards Nomination FormBowl of Hygeia Distinguished Young Pharmacist Innovative Pharmacy Practice Generation Rx Champions
Nominee’s Full Name Nickname Home Address City State Zip Practice Site Work Address City State Zip College/School of Pharmacy List of professional activities, state/national pharmacy organization affi liations, and/or local civic church activities:
Supporting Information:
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.
Innovative Pharmacy Practice Th is Award is presented annually to a prac-ticing pharmacist who has demonstrated innovative pharmacy practice which has resulted in improved patient care. Selection Criteria: 1) Th e 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 AwardTh is award is presented annually to a phar-macist who has demonstrated work with prescription drug abuse. Th is 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 eff ort to reduce prescription drug abuse;2) Nominee must be a licensed Georgia Pharmacist; 3) Nominee must be a member of the Geor-gia Pharmacy Association in the year of the selection.
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 Speaker & Author PharmPAC Supporter PharmPAC Supporter Creating Real Financial Planning for over 20 Years
1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455
[email protected] www.fnaplanners.com
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.
Th e Georgia Pharmacy Journal
The Academy of Employee Phar-macists (AEP) is holding a networking dinner on Tuesday, February 4 for phar-macists and technicians.
Th e networking dinner will be held at Maggiano’s Little Italy Restaurant, lo-cated at 4400 Ashford Dunwoody Road NE in Atlanta. Th e networking social be-gins at 6:30 pm and dinner will be served starting at 7 pm. Th e networking dinner is sponsored by Janssen Pharmaceu-tical and there is no charge to GPhA members.
Dr. Th omas M. Flood, MD, FACE, will be the guest speaker. Dr. Flood is a Physi-cian with Georgia Center for Diabetes in Atlanta. His topic will be INVOKANA: Changing Paradigms in T2DM Manage-ment. “Th is 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 fi rst 60 pharmacists/technicians that sign up.
If you have any questions or need more information, contact Sharon Ze-rillo, AEP Chairman, at 770-301-5375 or email Sharon at [email protected]. n
Academy of Employee Pharmacists (AEP)To Hold Networking Dinner
About AEPTh e GPhA Academy of Employee
Pharmacists (AEP) represents pharma-cists that are employed in various prac-tice settings throughout the profession and is one of GPhA’s oldest academies.
Employee pharmacists have unique issues and needs and AEP serves to ar-ticulate 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 Phar-macists and Th e Georgia Pharmacy As-sociation. n
Special Thanks to:
Th e Georgia Pharmacy Journal6
M E M B E R N E W SM E M B E R N E W S
Call for GPhA Awards!The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 139th Annu-al 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 sub-mitting 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 pharma-cy associations. Selection Criteria: 1) Th e nominee must be a licensed Georgia pharmacist; 2) Th e Award is not made posthumously; 3) Th e nominee is not a previous recipient of the Award; 4) Th e nominee is not currently serving nor has served within the immediate past two years as an offi cer of GPhA other than ex-of-
fi cio capacity or its awards committee; 5) Th e nominee has an outstanding record of service to the community which refl ects will on the profession.
Distinguished Young Pharmacist Created in 1987 to recognize the achieve-ments of young pharmacists in the profes-sion, the Award has quickly become one of the GPhA’s most prestigious awards. Th e purpose of the Award is two-fold: 1) To encourage new phar-macists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the phar-macy profession. Selection Criteria: 1) Th e 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 phar-macy association programs or activities and community service projects.
2014 Awards Nomination FormBowl of Hygeia Distinguished Young Pharmacist Innovative Pharmacy Practice Generation Rx Champions
Nominee’s Full Name Nickname Home Address City State Zip Practice Site Work Address City State Zip College/School of Pharmacy List of professional activities, state/national pharmacy organization affi liations, and/or local civic church activities:
Supporting Information:
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.
Innovative Pharmacy Practice Th is Award is presented annually to a prac-ticing pharmacist who has demonstrated innovative pharmacy practice which has resulted in improved patient care. Selection Criteria: 1) Th e 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 AwardTh is award is presented annually to a phar-macist who has demonstrated work with prescription drug abuse. Th is 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 eff ort to reduce prescription drug abuse;2) Nominee must be a licensed Georgia Pharmacist; 3) Nominee must be a member of the Geor-gia Pharmacy Association in the year of the selection.
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 Speaker & Author PharmPAC Supporter PharmPAC Supporter Creating Real Financial Planning for over 20 Years
1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455
[email protected] www.fnaplanners.com
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.
Th e Georgia Pharmacy Journal
The Academy of Employee Phar-macists (AEP) is holding a networking dinner on Tuesday, February 4 for phar-macists and technicians.
Th e networking dinner will be held at Maggiano’s Little Italy Restaurant, lo-cated at 4400 Ashford Dunwoody Road NE in Atlanta. Th e networking social be-gins at 6:30 pm and dinner will be served starting at 7 pm. Th e networking dinner is sponsored by Janssen Pharmaceu-tical and there is no charge to GPhA members.
Dr. Th omas M. Flood, MD, FACE, will be the guest speaker. Dr. Flood is a Physi-cian with Georgia Center for Diabetes in Atlanta. His topic will be INVOKANA: Changing Paradigms in T2DM Manage-ment. “Th is 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 fi rst 60 pharmacists/technicians that sign up.
If you have any questions or need more information, contact Sharon Ze-rillo, AEP Chairman, at 770-301-5375 or email Sharon at [email protected]. n
Academy of Employee Pharmacists (AEP)To Hold Networking Dinner
About AEPTh e GPhA Academy of Employee
Pharmacists (AEP) represents pharma-cists that are employed in various prac-tice settings throughout the profession and is one of GPhA’s oldest academies.
Employee pharmacists have unique issues and needs and AEP serves to ar-ticulate 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 Phar-macists and Th e Georgia Pharmacy As-sociation. n
Special Thanks to:
wish to pay the LTC pre-miums out of your busi-ness, depending on how you fi le your taxes.
Resolution in the New Year can take many forms, maybe the time is right to schedule an LTC consultative engagement
with the Long Term Care Planning Team at the GPHA. n
Give RuthAnn McGehee a call at 404-419-8173 or email at [email protected] to set up a no-obligation Long Term Care consult. We look forward to helping you however we can.
M E M B E R N E W S
In past articles we have discussed how important it is to become edu-cated on Long Term Care on what it is and more importantly - isn’t. While it is true that there are essentially three Ba-sic Components to eff ective Long Term Care Learning (1. Education, 2. Under-writing 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 eff ective LTC education is un-derstanding what the daily or monthly associated Long Term Care costs are in
Ruth Ann McGehee Manager of Insurance Services, GPHA
Compounding Labs
Pharmacy Planning & Design
Patient Consultation
Areas
Stocking Lozier Distributor
Full of line Pharmacy Fixtures
Custom Wood Work
Professional Installation and Delivery
9517 Monroe Road, Suite A • Charlotte, NC 28270
1-800-321-4344www �� .displayoptions.com
Rx Planning st
Speciali
Roland Thomas
experience in over 2,000
.pharmacies
Division of Display Options, Inc.
www.displayoptions.com
Long Term Care Planning:How much of the Daily or Monthly risk do you want to take on?
your area where you live or where you are planning to live or get care should you need it. Th e costs for this care can range in Atlanta right at or around $250 per day.$250 per day is:• $7,500 per month• $90,000 per year
With eff ective Long Term Care Plan-ning, you can remove a large measure of this exposure; exposure that can af-fect your family and fi nances. You may wish to take on only part of the daily or monthly costs associated with Long Term Care for your area. Th ere may po-tentially be favorable tax treatment if you
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.
REAL SOLUTIONS. CONSERVATIVE PRINCIPLES.
There is not a singlePharmacist 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.
SUPPORT BUDDY CARTER R.Ph FOR CONGRESS
PAID FOR BY BUDDY CARTER FOR CONGRESSCARLTON HODGES, TREASURER
wish to pay the LTC pre-miums out of your busi-ness, depending on how you fi le your taxes.
Resolution in the New Year can take many forms, maybe the time is right to schedule an LTC consultative engagement
with the Long Term Care Planning Team at the GPHA. n
Give RuthAnn McGehee a call at 404-419-8173 or email at [email protected] to set up a no-obligation Long Term Care consult. We look forward to helping you however we can.
M E M B E R N E W S
In past articles we have discussed how important it is to become edu-cated on Long Term Care on what it is and more importantly - isn’t. While it is true that there are essentially three Ba-sic Components to eff ective Long Term Care Learning (1. Education, 2. Under-writing 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 eff ective LTC education is un-derstanding what the daily or monthly associated Long Term Care costs are in
Ruth Ann McGehee Manager of Insurance Services, GPHA
Compounding Labs
Pharmacy Planning & Design
Patient Consultation
Areas
Stocking Lozier Distributor
Full of line Pharmacy Fixtures
Custom Wood Work
Professional Installation and Delivery
9517 Monroe Road, Suite A • Charlotte, NC 28270
1-800-321-4344www �� .displayoptions.com
Rx Planning st
Speciali
Roland Thomas
experience in over 2,000
.pharmacies
Division of Display Options, Inc.
www.displayoptions.com
Long Term Care Planning:How much of the Daily or Monthly risk do you want to take on?
your area where you live or where you are planning to live or get care should you need it. Th e costs for this care can range in Atlanta right at or around $250 per day.$250 per day is:• $7,500 per month• $90,000 per year
With eff ective Long Term Care Plan-ning, you can remove a large measure of this exposure; exposure that can af-fect your family and fi nances. You may wish to take on only part of the daily or monthly costs associated with Long Term Care for your area. Th ere may po-tentially be favorable tax treatment if you
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.
REAL SOLUTIONS. CONSERVATIVE PRINCIPLES.
There is not a singlePharmacist 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.
SUPPORT BUDDY CARTER R.Ph FOR CONGRESS
PAID FOR BY BUDDY CARTER FOR CONGRESSCARLTON HODGES, TREASURER
11Th e Georgia Pharmacy Journal
Representative Bruce Broadrick(R) Dalton, GA - District 4• 404-656-0202• [email protected] • Sworn In January 14, 2013 • Occupation - Pharmacist
Representative Buddy Harden (R) Cordele, GA - District 148• 404-656-0188• [email protected]• Sworn In January 12, 2009• Occupation - Pharmacist
Representative Ron Stephens (R) Savannah, GA - District 164• 404-656-5115• [email protected]• Sworn In July 20, 1997 • Occupation - Pharmacist
Representative Butch Parrish (R) Swainsboro, GA - District 158• 404-463-2247• [email protected]• Sworn In January 14, 1985 • Occupation - Pharmacist
Senator Buddy Carter (R) Chief Deputy Whip - District 1• 404-656-5109• [email protected]• Elected November 22, 2009• Occupation - Pharmacist
Cordially Invited! You are
50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.orgTHE GEORGIA PHARMACY ASSOCIATION
RSVP
www.gpha.org
To the Georgia Reception at the APhA Annual Meeting
Question: Who is the advocacy voice for pharmacy in Georgia?
Answer: Th e Georgia Pharmacy Association seeks to be the Advocacy Voice for pharmacy in Georgia, at the State House, the Board of Phar-macy, 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 pharma-cist in the Georgia General Assembly with the election of Neal Florence of Lafayette, GA to House District 2.
Question: Th is 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 Dis-trict 1 of Georgia.
Question: If you care about the future of the profession of pharmacy, where will you be on Th ursday, February 27, 2014?
Answer: You will be joining us at the Geor-gia State Capitol for VIP Day. Th is is your chance to voice your support for pharmacy. It’s FREE but you must RSVP at www.gpha.org
Meet the Georgia Pharmacist Legislators
About Advocacy
The Georgia Pharmacy Association main-tains a strong presence on the political scene, not only during the legislative session but also throughout the year. Th e GPhA stays abreast of current issues that could impact the profes-sion of pharmacy. Th e association also works to build relationships with policy makers on a state and national level.
11Th e Georgia Pharmacy Journal
Representative Bruce Broadrick(R) Dalton, GA - District 4• 404-656-0202• [email protected] • Sworn In January 14, 2013 • Occupation - Pharmacist
Representative Buddy Harden (R) Cordele, GA - District 148• 404-656-0188• [email protected]• Sworn In January 12, 2009• Occupation - Pharmacist
Representative Ron Stephens (R) Savannah, GA - District 164• 404-656-5115• [email protected]• Sworn In July 20, 1997 • Occupation - Pharmacist
Representative Butch Parrish (R) Swainsboro, GA - District 158• 404-463-2247• [email protected]• Sworn In January 14, 1985 • Occupation - Pharmacist
Senator Buddy Carter (R) Chief Deputy Whip - District 1• 404-656-5109• [email protected]• Elected November 22, 2009• Occupation - Pharmacist
Cordially Invited! You are
50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.orgTHE GEORGIA PHARMACY ASSOCIATION
RSVP
www.gpha.org
To the Georgia Reception at the APhA Annual Meeting
Question: Who is the advocacy voice for pharmacy in Georgia?
Answer: Th e Georgia Pharmacy Association seeks to be the Advocacy Voice for pharmacy in Georgia, at the State House, the Board of Phar-macy, 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 pharma-cist in the Georgia General Assembly with the election of Neal Florence of Lafayette, GA to House District 2.
Question: Th is 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 Dis-trict 1 of Georgia.
Question: If you care about the future of the profession of pharmacy, where will you be on Th ursday, February 27, 2014?
Answer: You will be joining us at the Geor-gia State Capitol for VIP Day. Th is is your chance to voice your support for pharmacy. It’s FREE but you must RSVP at www.gpha.org
Meet the Georgia Pharmacist Legislators
About Advocacy
The Georgia Pharmacy Association main-tains a strong presence on the political scene, not only during the legislative session but also throughout the year. Th e GPhA stays abreast of current issues that could impact the profes-sion of pharmacy. Th e association also works to build relationships with policy makers on a state and national level.
The CMS STAR Ratings - How Quality Ratings Impact Community Pharmacy
The Georgia Pharmacy Journal12 13The Georgia Pharmacy Journal
Health care reform is constantly changing and today is no different. As an example, our colleagues in health-system practice are very accustomed to being measured and accredited on a number of key metrics.
Today, community-based pharmacy quality measure-ment and accreditation is on the horizon. In fact, the Center for Pharmacy Prac-tice Accreditation (CPPA) and URAC published stan-dards for community phar-macy practice in early 2013. Community-based phar-macy practice is starting to shift to not just a culture of cost effectiveness, but also one of quality outcomes and patient–centered care
A facet of accreditation implies mea-surements. However, even before com-munity pharmacy accreditation discus-sions began, the Centers of Medicare & Medicaid Services (CMS) were measur-ing health plans; who in return are measur-ing community phar-macies. This has been on-going for several years. Prescription drug plans receive a summary “STAR rating” on quality measures based on prescription adjudi-cation.
For 2014 the STAR ratings for Medi-care Part D plans are based on fifteen individual measures with five measures specific to medication management and use, yet these five account for nearly half
of the plan’s Part D sum-mary rating as they carry a triple weighting in the CMS summary score. These measures are:• Two measures of medica-tion safety.• High-risk medications in the elderly.• Medications that should be either limited in expo-sure to the elderly or not prescribed at all.• Appropriate treatment of blood pressure in persons with diabetes.• Protection of organs – specifically the kidney (patients on insulin are included in this metric).
• Three measures of medication adher-ence.• Oral diabetes medications.• Patients on insulin are excluded from this metric as it is difficult to track. adherence if a patient is provided leeway
to adjust dosing.• Cholesterol medica-tion (statins).• Focuses on appro-priate treatment and adherence.• Blood pressure.
• Appropriate adherence focusing on renin-angiotensin system antagonists (RASA).
CMS also evaluates prescription drug plans on “display measures” which in-clude metrics on drug-drug interac-tions, excessive doses of oral diabetes medications and the use of atypical an-tipsychotics in nursing home patients.
Starting in 2014 , CMS will also begin evaluating MTM programs by measur-ing the “Comprehensive Medication Review (CMR) completion rate” for all drug plans. It is expected that this CMR measure will be added to the STAR rat-ing measure set in the next round of ad-ditions and deletions. The metric is be-ing used to determine how many eligible patients (by percentage) are actually re-ceiving 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 pharma-cies to see their STAR ratings. EQuIPP is a service offered by Pharmacy Quali-ty 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-sys-tems 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, FAPhAis Vice President Professional Relations,Pharmacy Quality Solutions.John A. Galdo, Pharm.D., BCPS isClinical 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.
By Elliott M. Sogol, PhD, RPh, FAPhA and John A. Galdo, Pharm.D., BCPS
John A. Galdo, Pharm.D., BCPS
Elliott M. Sogol, PhD, RPh, FAPhA
For 2014 the STAR ratings are based on
fifteen individual measures.
Bracewell Sworn In
Jim Bracewell, Executive Vice President of the Georgia Pharmacy Associa-tion, 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 As-sociations Executives and was named Association Executive of the Year.
Currently Jim serves on the Mercer University Board of Visitors in the Col-lege 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
L E G I S L A T I V E U P D A T E S
Georgia Board of Pharmacy GPhA 2014 Legislative Review
The 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 elect-ed 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 legis-lative team will have their hands full next session working on MAC pricing, more immunizat ions by pharmacists under physician protocol, and beginning to lay 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 ex-pected from the PBMs that benefit fi-nancially 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 legis-lation 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 mem-bers 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 Associ-ation. Email Andy at [email protected].
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.
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 ap-plicants, and regulates the practice of licensees throughout the state. Board meet-ings 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
By Andy Freeman
We will remain vigilant
in our efforts to defeat harmful
legislation.
The CMS STAR Ratings - How Quality Ratings Impact Community Pharmacy
The Georgia Pharmacy Journal12 13The Georgia Pharmacy Journal
Health care reform is constantly changing and today is no different. As an example, our colleagues in health-system practice are very accustomed to being measured and accredited on a number of key metrics.
Today, community-based pharmacy quality measure-ment and accreditation is on the horizon. In fact, the Center for Pharmacy Prac-tice Accreditation (CPPA) and URAC published stan-dards for community phar-macy practice in early 2013. Community-based phar-macy practice is starting to shift to not just a culture of cost effectiveness, but also one of quality outcomes and patient–centered care
A facet of accreditation implies mea-surements. However, even before com-munity pharmacy accreditation discus-sions began, the Centers of Medicare & Medicaid Services (CMS) were measur-ing health plans; who in return are measur-ing community phar-macies. This has been on-going for several years. Prescription drug plans receive a summary “STAR rating” on quality measures based on prescription adjudi-cation.
For 2014 the STAR ratings for Medi-care Part D plans are based on fifteen individual measures with five measures specific to medication management and use, yet these five account for nearly half
of the plan’s Part D sum-mary rating as they carry a triple weighting in the CMS summary score. These measures are:• Two measures of medica-tion safety.• High-risk medications in the elderly.• Medications that should be either limited in expo-sure to the elderly or not prescribed at all.• Appropriate treatment of blood pressure in persons with diabetes.• Protection of organs – specifically the kidney (patients on insulin are included in this metric).
• Three measures of medication adher-ence.• Oral diabetes medications.• Patients on insulin are excluded from this metric as it is difficult to track. adherence if a patient is provided leeway
to adjust dosing.• Cholesterol medica-tion (statins).• Focuses on appro-priate treatment and adherence.• Blood pressure.
• Appropriate adherence focusing on renin-angiotensin system antagonists (RASA).
CMS also evaluates prescription drug plans on “display measures” which in-clude metrics on drug-drug interac-tions, excessive doses of oral diabetes medications and the use of atypical an-tipsychotics in nursing home patients.
Starting in 2014 , CMS will also begin evaluating MTM programs by measur-ing the “Comprehensive Medication Review (CMR) completion rate” for all drug plans. It is expected that this CMR measure will be added to the STAR rat-ing measure set in the next round of ad-ditions and deletions. The metric is be-ing used to determine how many eligible patients (by percentage) are actually re-ceiving 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 pharma-cies to see their STAR ratings. EQuIPP is a service offered by Pharmacy Quali-ty 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-sys-tems 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, FAPhAis Vice President Professional Relations,Pharmacy Quality Solutions.John A. Galdo, Pharm.D., BCPS isClinical 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.
By Elliott M. Sogol, PhD, RPh, FAPhA and John A. Galdo, Pharm.D., BCPS
John A. Galdo, Pharm.D., BCPS
Elliott M. Sogol, PhD, RPh, FAPhA
For 2014 the STAR ratings are based on
fifteen individual measures.
Bracewell Sworn In
Jim Bracewell, Executive Vice President of the Georgia Pharmacy Associa-tion, 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 As-sociations Executives and was named Association Executive of the Year.
Currently Jim serves on the Mercer University Board of Visitors in the Col-lege 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
L E G I S L A T I V E U P D A T E S
Georgia Board of Pharmacy GPhA 2014 Legislative Review
The 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 elect-ed 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 legis-lative team will have their hands full next session working on MAC pricing, more immunizat ions by pharmacists under physician protocol, and beginning to lay 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 ex-pected from the PBMs that benefit fi-nancially 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 legis-lation 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 mem-bers 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 Associ-ation. Email Andy at [email protected].
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.
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 ap-plicants, and regulates the practice of licensees throughout the state. Board meet-ings 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
By Andy Freeman
We will remain vigilant
in our efforts to defeat harmful
legislation.
The Georgia Pharmacy Journal14
L E G I S L A T I V E U P D A T E S
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 im-plemented that advice by showing up to demonstrate their support for Congress-man Doug Collins at an event in his hon-or on the evening of November 25th.
Governor Deal attended the event in addition to special guest Republican Ma-jority Leader Eric Cantor, who came to express his support for the work of Doug Collins in the US Congress.
Georgia Pharmacy Association Exec-utive Vice President Jim Bracewell not-ed, “This is political advocacy at its best. When constituents let their Represen-tative 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
Gainesville Pharmacists Take Active Role Honoring Congressman Doug Collins“This is political advocacy at its best.”
Amy and Laird Miller poise with Geor-gia’s First Lady Sandra Deal at the special event honoring Ninth District Congressman Doug Collins.
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 pharma-cists from the Washington, DC-metro area performed free health screenings on Capitol Hill. The screenings, includ-ing 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 ser-vices; 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 Journal14
L E G I S L A T I V E U P D A T E SL E G I S L A T I V E U P D A T E S
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 im-plemented that advice by showing up to demonstrate their support for Congress-man Doug Collins at an event in his hon-or on the evening of November 25th.
Governor Deal attended the event in addition to special guest Republican Ma-jority Leader Eric Cantor, who came to express his support for the work of Doug Collins in the US Congress.
Georgia Pharmacy Association Exec-utive Vice President Jim Bracewell not-ed, “This is political advocacy at its best. When constituents let their Represen-tative 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
Gainesville Pharmacists Take Active Role Honoring Congressman Doug Collins“This is political advocacy at its best.”
Amy and Laird Miller poise with Geor-gia’s First Lady Sandra Deal at the special event honoring Ninth District Congressman Doug Collins.
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.
Pharmacists Perform Health Screenings on Capitol Hill
WASHINGTON, DC – More than 75 pharmacists and student pharma-cists from the Washington, DC-metro area performed free health screenings on Capitol Hill. The screenings, includ-ing 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 ser-vices; 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,
Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA. “Pharma-cists are the most accessi-ble health care provider, with pharmacy locations in almost every commu-nity in America. Phar-macists demonstrated knowledge and training, combined with this ac-cessibility, makes them a valuable member of a patient’s health care team. APhA thanks all of the pharmacists and student pharmacists who par-ticipated in yesterday’s health fair and demon-strated the services they provide every day and their value as health care providers.”
The Hill health fair was hosted by the Congressional Community Pharmacy
Caucus, the American Pharmacists Associ-ation, the American Society of Health-Sys-tem Pharmacists, the National Association of Chain Drug Stores and the National Com-munity Pharmacists Association. Several Washington DC-area pharmacies and schools of pharmacy provid-ed invaluable time and support to showcase the services pharmacists are providing in their com-munities.
“Our community pharmacists play a crit-ical role in our health
care system,” said Rep. Austin Scott (R-GA), co-chair of the Congressional Com-munity Pharmacy Caucus. “For many
in rural towns and cities in Georgia and across the country, community pharma-cies not only provide lifesaving prescrip-tions, 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 crit-ical role in keeping Americans healthy,” commented Rep. Peter Welch (D-VT), co-chair of the Congressional Commu-nity 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 in-valuable services they provide every day in rural America.”
The Hill health fair was a visual lobby-ing effort for the ongoing provider status campaign. n
“Our community pharmacists play a
critical role in our health care system,” said Rep. Austin Scott (R-GA), co-chair of the Con-
gressional Community Pharmacy Caucus.
The Georgia Pharmacy Journal16
L E G I S L A T I V E U P D A T E S
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 Hernan-dez, 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 Phar-macist (APP) recognition, gives new authorities to APPs, and specifies re-quirements for pharmacists seeking rec-ognition as APPs.
“We appreciate the Governor’s signa-ture on this landmark legislation,” Jon R. Roth, CAE, CEO of the California Phar-macists 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 leg-islation will help ensure that the millions of new patients receiving insurance will be able to access health care services through their local pharmacist.”
Unified PridePharmacists from many areas of prac-
tice came together in support of this im-portant 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 tire-lessly in support of the legislation.” Al-varez is Assistant Dean of Experiential Education and Continuing Professional Development at Chapman University’s
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 pa-tients will rise significantly,” said APhA Trustee Michael A. Pavlovich, PharmD, owner of Westcliff Compounding Phar-macy in Newport Beach, CA.
Future ProspectsAs pharmacists in California look for-
ward 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 neces-sary to move us from a product-centered profession to a knowledge-centered pro-fession.”
“APhA could not be more excited with the progress on provider status being made at the state level. These state suc-cesses are incredibly valuable to pharma-cy’s pursuit of coverage of pharmacists’
patient care services across the country,” said Stacie Maass, BSPharm, JD, APhA Senior Vice President of Pharmacy Prac-tice and Government Affairs. “Califor-nia’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 evolv-ing rapidly, much remains to be done re-garding 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.
California Provider Status Bill Becomes Law
The legislation goes into effect this month and hopefully will serve as a model for other states.
Helpful ResourcesAPhA 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 sup-ported by the Community Pharmacy Foundation, all 51 of these four-page re-sources are available at www.pharmacist.com/mtm-state-advocacy-fact-sheets.
SAVE THIS DATE ON YOUR CALENDAR Thursday, February 27, 2014
VIP DAY Voice In Pharmacy
At The State Capitol
No cost to you to participate. Huge cost to your career not to be there.
50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.orgTHE GEORGIA PHARMACY ASSOCIATION
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
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.
Register Online at www.gpha.org
The Georgia Pharmacy Journal16
L E G I S L A T I V E U P D A T E S
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 Hernan-dez, 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 Phar-macist (APP) recognition, gives new authorities to APPs, and specifies re-quirements for pharmacists seeking rec-ognition as APPs.
“We appreciate the Governor’s signa-ture on this landmark legislation,” Jon R. Roth, CAE, CEO of the California Phar-macists 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 leg-islation will help ensure that the millions of new patients receiving insurance will be able to access health care services through their local pharmacist.”
Unified PridePharmacists from many areas of prac-
tice came together in support of this im-portant 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 tire-lessly in support of the legislation.” Al-varez is Assistant Dean of Experiential Education and Continuing Professional Development at Chapman University’s
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 pa-tients will rise significantly,” said APhA Trustee Michael A. Pavlovich, PharmD, owner of Westcliff Compounding Phar-macy in Newport Beach, CA.
Future ProspectsAs pharmacists in California look for-
ward 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 neces-sary to move us from a product-centered profession to a knowledge-centered pro-fession.”
“APhA could not be more excited with the progress on provider status being made at the state level. These state suc-cesses are incredibly valuable to pharma-cy’s pursuit of coverage of pharmacists’
patient care services across the country,” said Stacie Maass, BSPharm, JD, APhA Senior Vice President of Pharmacy Prac-tice and Government Affairs. “Califor-nia’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 evolv-ing rapidly, much remains to be done re-garding 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.
California Provider Status Bill Becomes Law
The legislation goes into effect this month and hopefully will serve as a model for other states.
Helpful ResourcesAPhA 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 sup-ported by the Community Pharmacy Foundation, all 51 of these four-page re-sources are available at www.pharmacist.com/mtm-state-advocacy-fact-sheets.
SAVE THIS DATE ON YOUR CALENDAR Thursday, February 27, 2014
VIP DAY Voice In Pharmacy
At The State Capitol
No cost to you to participate. Huge cost to your career not to be there.
50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.orgTHE GEORGIA PHARMACY ASSOCIATION
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
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.
Register Online at www.gpha.org
The Georgia Pharmacy Journal18
Thanks to All Our Supporters Highlight denotes new and increased contributors.
NOTICE: Contact Andy Freeman, GPhA Director of Govern-ment Affairs, to update your support or if any information is incorrect. [email protected] 404-419-8118
Diamond Level$4,800 minimum pledge*Scott Meeks, R.Ph.*Fred Sharpe, R.Ph
Titanium Level$2,400 minimum pledge*Ralph Balchin, R.Ph. T.M. Bridges, R.Ph. 12/14*Ben Cravey, R.Ph.*Michael Farmer, R.Ph.*David Graves, R.Ph.*Raymond Hickman, R.Ph.Ted Hunt, R.Ph. 1/14*Robert Ledbetter, R.Ph.*Brandall Lovvorn, Pharm.D. *Marvin McCord, R.Ph.Loren Pierce, R.Ph. 12/13*Jeff Sikes, R.Ph.*Danny Smith, R.Ph.*Dean Stone, R.Ph.*Tommy Whitworth, R.Ph.
Platinum Level$1,200 minimum pledgeJim Bracewell 9/14Thomas Bryan, Jr. 12/14*Larry Braden, R.Ph.*William Cagle, R.Ph.*Hugh Chancy, R.Ph.*Keith Chapman, R.Ph.*Dale Coker, R.Ph.*Billy Conley, R.Ph.*Al Dixon Jr., R.Ph.*Ashley Dukes, R.Ph.*Jack Dunn Jr., R.Ph.
*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. 6/14Henry Wilson, Pharm.D. 11/14
Gold Level$600 minimum pledgeJames Bartling, Pharm.D. 6/14*William Brewster, R.Ph.*Liza Chapman, Pharm.D.Carter Clements, Pharm. D. 12/14 *Mahlon Davidson, R.Ph.*Angela DeLay, R.Ph.*Benjamin Dupree, Sr., R.Ph
*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.TLance 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.
Silver Level$300 minimum pledge*Renee Adamson, Pharm.D.Larry Batten, R. Ph. 11/14Lance Boles, R.Ph. 8/14Laura Coker, Pharm D 6/14Patrick Cook, Pharm.D. 1/14*Ed Dozier, R.Ph.*Greg Drake, R. Ph.*Terry Dunn, R.Ph.*Marshall Frost, Pharm.D.*Amanda Gaddy, R. Ph.*Johnathan Hamrick, Pharm.D.*Willie Latch, R.Ph
*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. 6/14Steve Wilson, Pharm.D. 7/14*William Wolfe, R.Ph.*Sharon Zerillo, R.Ph.
Bronze Level$150 minimum pledgeMonica Ali-Warren, R.Ph. 6/14*Shane Bentley, Student *Robert Bowles*Rabun Deckle, R. Ph.Ashley Faulk, Pharm.D. 4/14James Fetterman, Jr., Pharm.D. 4/14Charles Gass, R.Ph. 1/14*Larry Harkleroad, R.Ph.Winton Harris Jr., R.Ph. 6/14*Amy Grimsley, Pharm. D*Thomas Jeter, R.Ph. *Henry Josey, R.Ph*Brenton Lake, R.Ph.*Tracie Lunde, Pharm.D.*Michael Lewis, Pharm.D.Max Mason, R.Ph. 6/14
*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.PhDon 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.
MembersNo minimum pledgeClaude Bates, R.Ph 6/14Winston Brock, R.Ph. 6/14David Carver, R.Ph. 6/14Marshall Curtis, R.Ph. 6/14Donley Dawson, Pharm.D. 12/14John Drew, R.Ph. 6/14James England, R.Ph. 6/14Martin Grizzard, R.Ph. 12/14Christopher Gurley, R. Ph 6/14Marsha Kapiloff, R.Ph. 6/14Charles Kovarik, R. Ph. 6/14Carroll Lowery, R.Ph. 6/14Ralph Marett, R.Ph. 6/14Kenneth McCarthy, R.Ph. 6/14Whitney Pickett, R.Ph. 11/14
*Denotes a monthly sustaining PAC member. (Month/Year) Denotes most recent contribution.
19The Georgia Pharmacy Journal
PharmPac Board of Directors Eddie Madden, ChairmanDean Stone, Region 1Keith Dupree, Region 2Judson Mullican, Region 3Bill McLeer, Region 4Mahlon Davidson, Region 5Mike McGee, Region 6Jim McWilliams, Region 7T.M. Bridges, Region 9Mark Parris, Region 9Chris Thurmond, Region 10Stewart Flanagin, Region 11Henry Josey, Region 12Pam Marquess, Ex-OfficioJim Bracewell, Ex-Officio
Michael Reagan, R. Ph 6/14Ola Reffell, R.Ph. 6/14Leonard Reynolds, R.Ph. 6/14Victor Serafy, R.Ph. 6/14Terry Shaw, Pharm.D. 5/14Harry Shurley, R.Ph 6/14Amanda Stankiewicz, Student 6/14Benjamin Stanley, R.Ph 6/14Krista Stone, R.Ph 6/14John Thomas, R.Ph. 11/14William Thompson, R.Ph. 6/14Carey Vaughan, Pharm.D. 6/14Jonathon Williams R.Ph 8/14
The Georgia Pharmacy Journal18
Thanks to All Our Supporters Highlight denotes new and increased contributors.
NOTICE: Contact Andy Freeman, GPhA Director of Govern-ment Affairs, to update your support or if any information is incorrect. [email protected] 404-419-8118
Diamond Level$4,800 minimum pledge*Scott Meeks, R.Ph.*Fred Sharpe, R.Ph
Titanium Level$2,400 minimum pledge*Ralph Balchin, R.Ph. T.M. Bridges, R.Ph. 12/14*Ben Cravey, R.Ph.*Michael Farmer, R.Ph.*David Graves, R.Ph.*Raymond Hickman, R.Ph.Ted Hunt, R.Ph. 1/14*Robert Ledbetter, R.Ph.*Brandall Lovvorn, Pharm.D. *Marvin McCord, R.Ph.Loren Pierce, R.Ph. 12/13*Jeff Sikes, R.Ph.*Danny Smith, R.Ph.*Dean Stone, R.Ph.*Tommy Whitworth, R.Ph.
Platinum Level$1,200 minimum pledgeJim Bracewell 9/14Thomas Bryan, Jr. 12/14*Larry Braden, R.Ph.*William Cagle, R.Ph.*Hugh Chancy, R.Ph.*Keith Chapman, R.Ph.*Dale Coker, R.Ph.*Billy Conley, R.Ph.*Al Dixon Jr., R.Ph.*Ashley Dukes, R.Ph.*Jack Dunn Jr., R.Ph.
*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. 6/14Henry Wilson, Pharm.D. 11/14
Gold Level$600 minimum pledgeJames Bartling, Pharm.D. 6/14*William Brewster, R.Ph.*Liza Chapman, Pharm.D.Carter Clements, Pharm. D. 12/14 *Mahlon Davidson, R.Ph.*Angela DeLay, R.Ph.*Benjamin Dupree, Sr., R.Ph
*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.TLance 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.
Silver Level$300 minimum pledge*Renee Adamson, Pharm.D.Larry Batten, R. Ph. 11/14Lance Boles, R.Ph. 8/14Laura Coker, Pharm D 6/14Patrick Cook, Pharm.D. 1/14*Ed Dozier, R.Ph.*Greg Drake, R. Ph.*Terry Dunn, R.Ph.*Marshall Frost, Pharm.D.*Amanda Gaddy, R. Ph.*Johnathan Hamrick, Pharm.D.*Willie Latch, R.Ph
*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. 6/14Steve Wilson, Pharm.D. 7/14*William Wolfe, R.Ph.*Sharon Zerillo, R.Ph.
Bronze Level$150 minimum pledgeMonica Ali-Warren, R.Ph. 6/14*Shane Bentley, Student *Robert Bowles*Rabun Deckle, R. Ph.Ashley Faulk, Pharm.D. 4/14James Fetterman, Jr., Pharm.D. 4/14Charles Gass, R.Ph. 1/14*Larry Harkleroad, R.Ph.Winton Harris Jr., R.Ph. 6/14*Amy Grimsley, Pharm. D*Thomas Jeter, R.Ph. *Henry Josey, R.Ph*Brenton Lake, R.Ph.*Tracie Lunde, Pharm.D.*Michael Lewis, Pharm.D.Max Mason, R.Ph. 6/14
*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.PhDon 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.
MembersNo minimum pledgeClaude Bates, R.Ph 6/14Winston Brock, R.Ph. 6/14David Carver, R.Ph. 6/14Marshall Curtis, R.Ph. 6/14Donley Dawson, Pharm.D. 12/14John Drew, R.Ph. 6/14James England, R.Ph. 6/14Martin Grizzard, R.Ph. 12/14Christopher Gurley, R. Ph 6/14Marsha Kapiloff, R.Ph. 6/14Charles Kovarik, R. Ph. 6/14Carroll Lowery, R.Ph. 6/14Ralph Marett, R.Ph. 6/14Kenneth McCarthy, R.Ph. 6/14Whitney Pickett, R.Ph. 11/14
*Denotes a monthly sustaining PAC member. (Month/Year) Denotes most recent contribution.
19The Georgia Pharmacy Journal
PharmPac Board of Directors Eddie Madden, ChairmanDean Stone, Region 1Keith Dupree, Region 2Judson Mullican, Region 3Bill McLeer, Region 4Mahlon Davidson, Region 5Mike McGee, Region 6Jim McWilliams, Region 7T.M. Bridges, Region 9Mark Parris, Region 9Chris Thurmond, Region 10Stewart Flanagin, Region 11Henry Josey, Region 12Pam Marquess, Ex-OfficioJim Bracewell, Ex-Officio
Michael Reagan, R. Ph 6/14Ola Reffell, R.Ph. 6/14Leonard Reynolds, R.Ph. 6/14Victor Serafy, R.Ph. 6/14Terry Shaw, Pharm.D. 5/14Harry Shurley, R.Ph 6/14Amanda Stankiewicz, Student 6/14Benjamin Stanley, R.Ph 6/14Krista Stone, R.Ph 6/14John Thomas, R.Ph. 11/14William Thompson, R.Ph. 6/14Carey Vaughan, Pharm.D. 6/14Jonathon Williams R.Ph 8/14
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21Th e Georgia Pharmacy Journal
Mona T. Thompson, R.Ph., PharmD
continuing educat ion for pharmacists
FDA Safety Warnings and Prescribing Updates: Zolpidem, Valproate, Ketoconazole, and Acetaminophen
Volume XXXI, No. 11
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 is-sued over the past several months regarding zolpidem-containing products, valproate use in pregnan-cy, ketoconazole and acetamino-phen.
Objectives. At the completion of this activity, the participant will be able to:
1. demonstrate an understand-ing of the safety warnings and associated prescribing changes, if applicable, issued for each of the entities discussed;
2. identify the patient popula-tion 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.
Zolpidem-Containing Medications Zolpidem is a sedative-hypnotic medication used for the treat-ment of insomnia. In 2011, ap-proximately nine million patients received zolpidem products from U.S. outpatient retail pharmacies, of which over half were dispensed
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 extended-release (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 caution-ary statement that the higher dose can increase the risk of next-day impairment of driving and other activities that require full alert-ness. Because labeling for Inter-mezzo 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 indi-cated that individuals with zolpi-dem 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 per-cent of women and 25 percent of men had zolpidem blood concentra-tions exceeding 50 ng/mL, approxi-mately 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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21Th e Georgia Pharmacy Journal
Mona T. Thompson, R.Ph., PharmD
continuing educat ion for pharmacists
FDA Safety Warnings and Prescribing Updates: Zolpidem, Valproate, Ketoconazole, and Acetaminophen
Volume XXXI, No. 11
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 is-sued over the past several months regarding zolpidem-containing products, valproate use in pregnan-cy, ketoconazole and acetamino-phen.
Objectives. At the completion of this activity, the participant will be able to:
1. demonstrate an understand-ing of the safety warnings and associated prescribing changes, if applicable, issued for each of the entities discussed;
2. identify the patient popula-tion 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.
Zolpidem-Containing Medications Zolpidem is a sedative-hypnotic medication used for the treat-ment of insomnia. In 2011, ap-proximately nine million patients received zolpidem products from U.S. outpatient retail pharmacies, of which over half were dispensed
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 extended-release (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 caution-ary statement that the higher dose can increase the risk of next-day impairment of driving and other activities that require full alert-ness. Because labeling for Inter-mezzo 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 indi-cated that individuals with zolpi-dem 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 per-cent of women and 25 percent of men had zolpidem blood concentra-tions exceeding 50 ng/mL, approxi-mately 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-
The Georgia Pharmacy Journal22 23The Georgia Pharmacy Journal
creased age may slow the metabo-lism 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 gener-ics), in women, and the elderly. The pharmacokinetic trials con-ducted 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 increas-es the risk of such behaviors.
An article published in 2011 in the Journal of Clinical Sleep Medi-cine by Poceta examined a series of clinical and legal cases follow-ing the ingestion of zolpidem. The author described cases of zolpidem-associated complex behaviors including daytime automatisms and sleep-related parasomnia,
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
and concluded that risk factors for these behaviors include concomi-tant 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. Pa-rasomnias are sleep disorders that involve abnormal and unnatural movements, behaviors, emotions, perceptions, and dreams that oc-cur 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 com-plex sleep-related behaviors and next morning impairment.
The zolpidem drug label car-ries other noteworthy precautions. Since it is a CNS depressant, its effect can be additive when used concurrently with other CNS de-pressants 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 re-ported in patients treated with sed-ative-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 depres-sion 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. Zol-pidem 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 profession-als 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. Stron-ger warnings about use during pregnancy will be added to the drug labels and valproate’s preg-nancy 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
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 ineffec-tive. Pregnancy category X means that adequate well-controlled or observational studies in animals or pregnant women have demon-strated positive evidence of fetal abnormalities or risks. The use of category X agents is contraindicat-ed 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 addi-tion, 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 pro-spective, observational study that involved children of women who were taking one of four anti-epileptic drugs as monotherapy: lamotrigine, carbamazepine, phe-nytoin, or valproate products. The study compared results of IQ tests of six-year-olds who had been ex-posed to one of these antiepileptic drugs in utero. Children exposed to valproate products during preg-nancy 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 respec-tively. Additionally, the mean IQs were higher in groups whose moth-ers reported periconceptional folate use. However, the authors warn that these findings should be inter-preted 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-
tic drugs throughout their pregnan-cies, and it is unknown if the tim-ing 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., Depa-kote, 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 gamma-aminobutyric acid (GABA) levels in the brain. Divalproex sodium is approved for use in simple and complex absence seizures, complex partial epileptic seizure, manic bi-polar I disorder, and prophylaxis of migraines. Off label, these agents may also be prescribed for alcohol withdrawal syndrome, mainte-nance of bipolar I and II disorder, chronic headache disorder, post-traumatic 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 he-reditary mitochondrial disease are at a higher risk of developing fatal hepatotoxicity. Use may be contra-indicated in these populations.
In addition to impaired cogni-tive development during prenatal exposure, valproate products may produce major congenital mal-formations such as neural tube defects (i.e., spina bifida). Life-threatening pancreatitis has also been reported in adults and chil-dren taking these agents.
Affected patients should be ad-vised 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 profes-sional 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 ef-fective birth control, if they are not pregnant but of child bearing age. Folic acid supplementation before conception and during early preg-nancy 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 preg-nant women in the United States and Canada at Massachusetts General Hospital in Boston, Mas-sachusetts. The major objective of the registry is to obtain and pub-lish 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 news-letter summarizing these findings, as well as additional information for providers and patients, can be found on their website at www.aed-pregnancyregistry.org. The regis-try 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)
The Georgia Pharmacy Journal22 23The Georgia Pharmacy Journal
creased age may slow the metabo-lism 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 gener-ics), in women, and the elderly. The pharmacokinetic trials con-ducted 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 increas-es the risk of such behaviors.
An article published in 2011 in the Journal of Clinical Sleep Medi-cine by Poceta examined a series of clinical and legal cases follow-ing the ingestion of zolpidem. The author described cases of zolpidem-associated complex behaviors including daytime automatisms and sleep-related parasomnia,
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
and concluded that risk factors for these behaviors include concomi-tant 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. Pa-rasomnias are sleep disorders that involve abnormal and unnatural movements, behaviors, emotions, perceptions, and dreams that oc-cur 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 com-plex sleep-related behaviors and next morning impairment.
The zolpidem drug label car-ries other noteworthy precautions. Since it is a CNS depressant, its effect can be additive when used concurrently with other CNS de-pressants 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 re-ported in patients treated with sed-ative-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 depres-sion 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. Zol-pidem 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 profession-als 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. Stron-ger warnings about use during pregnancy will be added to the drug labels and valproate’s preg-nancy 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
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 ineffec-tive. Pregnancy category X means that adequate well-controlled or observational studies in animals or pregnant women have demon-strated positive evidence of fetal abnormalities or risks. The use of category X agents is contraindicat-ed 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 addi-tion, 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 pro-spective, observational study that involved children of women who were taking one of four anti-epileptic drugs as monotherapy: lamotrigine, carbamazepine, phe-nytoin, or valproate products. The study compared results of IQ tests of six-year-olds who had been ex-posed to one of these antiepileptic drugs in utero. Children exposed to valproate products during preg-nancy 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 respec-tively. Additionally, the mean IQs were higher in groups whose moth-ers reported periconceptional folate use. However, the authors warn that these findings should be inter-preted 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-
tic drugs throughout their pregnan-cies, and it is unknown if the tim-ing 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., Depa-kote, 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 gamma-aminobutyric acid (GABA) levels in the brain. Divalproex sodium is approved for use in simple and complex absence seizures, complex partial epileptic seizure, manic bi-polar I disorder, and prophylaxis of migraines. Off label, these agents may also be prescribed for alcohol withdrawal syndrome, mainte-nance of bipolar I and II disorder, chronic headache disorder, post-traumatic 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 he-reditary mitochondrial disease are at a higher risk of developing fatal hepatotoxicity. Use may be contra-indicated in these populations.
In addition to impaired cogni-tive development during prenatal exposure, valproate products may produce major congenital mal-formations such as neural tube defects (i.e., spina bifida). Life-threatening pancreatitis has also been reported in adults and chil-dren taking these agents.
Affected patients should be ad-vised 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 profes-sional 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 ef-fective birth control, if they are not pregnant but of child bearing age. Folic acid supplementation before conception and during early preg-nancy 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 preg-nant women in the United States and Canada at Massachusetts General Hospital in Boston, Mas-sachusetts. The major objective of the registry is to obtain and pub-lish 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 news-letter summarizing these findings, as well as additional information for providers and patients, can be found on their website at www.aed-pregnancyregistry.org. The regis-try 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)
The Georgia Pharmacy Journal24 25The Georgia Pharmacy Journal
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 formu-lation 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 Medi-cines 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 ef-fect 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 pos-sible to identify measures to reduce the risk. Topical formulations of ketoconazole such as creams, oint-ments, and shampoo can continue to be used as the amount of drug absorbed throughout the body is
low. Liver damage with ketocon-
azole is documented for patients receiving high doses for short pe-riods 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 some-times reversible upon discontinu-ation. 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 treat-ment and monitored routinely (i.e., weekly), as well as at the first signs
Table 2Selected Drugs with Plasma Concentrations Altered by Nizoral®*
Systemic exposure to these drugs is Alprazolam, midazolam, HMG-CoA reductase inhibitors increased significantly by ketoconazole: triazolam (lovastatin, simvastatin) Cisapride Nisoldipine Dofetilide PimozideConcomitant use is contraindicated. Eplerenone Quinidine Ergot alkaloids Systemic exposure to these drugs is increased Alfentanil, fentanyl, sufentanil Indinavir, saquinavir by ketoconazole: Amlodipine, felodipine, Methylprednisolone nicardipine, nifedipine RifabutinCareful monitoring, with possible adjustment Bosentan Sildenafil in dosing, is recommended. Buspirone Sirolimus (not recommended) Busulfan Tacrolimus Carbamazepine Telithromycin Cilostazol Tolterodine Cyclosporine Trimetrexate Digoxin Verapamil Docetaxel, paclitaxel Vinca alkaloids Oral anticoagulants
*This list is not all-inclusive. From Nizoral package insert.
Table 3Selected Drugs that may Alter Plasma Concentrations of Nizoral®*
Systemic exposure to ketoconazole is Carbamazepine Nevirapine significantly reduced by these drugs and Gastric acid suppressants Phenytoin concomitant use is not recommended. (antacids, antimuscarinics, Rifampin, rifabutin, isoniazid histamine H2 blockers, proton pump inhibitors, sucralfate)
Systemic exposure to ketoconazole is Ritonavirincreased significantly by this drug: Dose reduction of ketoconazole should be considered.
*This list is not all-inclusive. From Nizoral package insert.
or symptoms of possible hepatotox-icity. Signs and symptoms of hepa-totoxicity include anorexia, nausea, vomiting, fatigue, jaundice, abdom-inal 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 se-vere liver injury with ketoconazole, the drug safety communication identified that the antifungal is as-sociated with adrenal insufficiency. Adrenal insufficiency is a decreased ability of the adrenal glands to pro-duce corticosteroids. Health care professionals are advised to moni-tor adrenal function in patients taking ketoconazole tablets who have existing adrenal insufficiency or in patients experiencing extend-ed periods of stress (i.e., following major surgery or increased stays in intensive care settings).
Lastly, the warning brings attention to the many drug interac-tions that are possible with keto-conazole 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 cur-rent drug label includes a black box warning indicating that keto-conazole is contraindicated with dofetilide, quinidine, pimozide, and cisapride. These combinations can cause elevated plasma concentra-tions of these drugs which may re-sult in further QT prolongation and possibly life-threatening ventricu-lar dysrhythmias such as torsades de pointes. Co-administration of ketoconazole tablets with oral midazolam, oral triazolam, or al-prazolam is also contraindicated as it has resulted in elevated plasma concentrations of these drugs and may potentiate or prolong the sedative and hypnotic effects espe-cially with repeated dosing. Other contraindicated agents include the CYP3A4 metabolized HMG-CoA re-ductase inhibitors simvastatin and lovastatin, as well as nisoldipine, eplerenone, and ergot alkaloids.
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, keto-conazole 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 myco-ses when alternative antifungal therapies are not available. Indica-tions for which the risk of ketocon-azole therapy outweighs the benefit have been removed from the label. Therefore, the use of ketoconazole in Candida and dermatophyte in-fections 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 re-ports from office-based physicians indicated that the most common diagnosis associated with use in recent years have included superfi-cial skin and nail fungal infections. Ultimately, oral ketoconazole can now only be prescribed for the fol-lowing infections: blastomycosis, coccidioidomycosis, histoplasmo-sis, chromomycosis, and paracoc-cidioidomycosis 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 acet-aminophen 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 gener-alized 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 4Summary of Nizoral®
Medication Guide
•Nizoral (ketoconazole) tablets can cause serious side effects, including:Liver Problems. A healthcare pro-vider 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, yel-lowing 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: blastomy-cosis, coccidioidomycosis, histoplas-mosis, chromomycosis, and paracoc-cidioidomycosis. •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 insuf-ficiency; (3) are pregnant or plan to become pregnant; (4) are breastfeed-ing or plan to breastfeed. •Patients should avoid drinking alco-hol while taking Nizoral tablets.
mucosal surfaces such as eyes, oral cavity, upper airway or esophagus, gastrointestinal tract, or anogeni-tal 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
The Georgia Pharmacy Journal24 25The Georgia Pharmacy Journal
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 formu-lation 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 Medi-cines 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 ef-fect 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 pos-sible to identify measures to reduce the risk. Topical formulations of ketoconazole such as creams, oint-ments, and shampoo can continue to be used as the amount of drug absorbed throughout the body is
low. Liver damage with ketocon-
azole is documented for patients receiving high doses for short pe-riods 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 some-times reversible upon discontinu-ation. 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 treat-ment and monitored routinely (i.e., weekly), as well as at the first signs
Table 2Selected Drugs with Plasma Concentrations Altered by Nizoral®*
Systemic exposure to these drugs is Alprazolam, midazolam, HMG-CoA reductase inhibitors increased significantly by ketoconazole: triazolam (lovastatin, simvastatin) Cisapride Nisoldipine Dofetilide PimozideConcomitant use is contraindicated. Eplerenone Quinidine Ergot alkaloids Systemic exposure to these drugs is increased Alfentanil, fentanyl, sufentanil Indinavir, saquinavir by ketoconazole: Amlodipine, felodipine, Methylprednisolone nicardipine, nifedipine RifabutinCareful monitoring, with possible adjustment Bosentan Sildenafil in dosing, is recommended. Buspirone Sirolimus (not recommended) Busulfan Tacrolimus Carbamazepine Telithromycin Cilostazol Tolterodine Cyclosporine Trimetrexate Digoxin Verapamil Docetaxel, paclitaxel Vinca alkaloids Oral anticoagulants
*This list is not all-inclusive. From Nizoral package insert.
Table 3Selected Drugs that may Alter Plasma Concentrations of Nizoral®*
Systemic exposure to ketoconazole is Carbamazepine Nevirapine significantly reduced by these drugs and Gastric acid suppressants Phenytoin concomitant use is not recommended. (antacids, antimuscarinics, Rifampin, rifabutin, isoniazid histamine H2 blockers, proton pump inhibitors, sucralfate)
Systemic exposure to ketoconazole is Ritonavirincreased significantly by this drug: Dose reduction of ketoconazole should be considered.
*This list is not all-inclusive. From Nizoral package insert.
or symptoms of possible hepatotox-icity. Signs and symptoms of hepa-totoxicity include anorexia, nausea, vomiting, fatigue, jaundice, abdom-inal 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 se-vere liver injury with ketoconazole, the drug safety communication identified that the antifungal is as-sociated with adrenal insufficiency. Adrenal insufficiency is a decreased ability of the adrenal glands to pro-duce corticosteroids. Health care professionals are advised to moni-tor adrenal function in patients taking ketoconazole tablets who have existing adrenal insufficiency or in patients experiencing extend-ed periods of stress (i.e., following major surgery or increased stays in intensive care settings).
Lastly, the warning brings attention to the many drug interac-tions that are possible with keto-conazole 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 cur-rent drug label includes a black box warning indicating that keto-conazole is contraindicated with dofetilide, quinidine, pimozide, and cisapride. These combinations can cause elevated plasma concentra-tions of these drugs which may re-sult in further QT prolongation and possibly life-threatening ventricu-lar dysrhythmias such as torsades de pointes. Co-administration of ketoconazole tablets with oral midazolam, oral triazolam, or al-prazolam is also contraindicated as it has resulted in elevated plasma concentrations of these drugs and may potentiate or prolong the sedative and hypnotic effects espe-cially with repeated dosing. Other contraindicated agents include the CYP3A4 metabolized HMG-CoA re-ductase inhibitors simvastatin and lovastatin, as well as nisoldipine, eplerenone, and ergot alkaloids.
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, keto-conazole 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 myco-ses when alternative antifungal therapies are not available. Indica-tions for which the risk of ketocon-azole therapy outweighs the benefit have been removed from the label. Therefore, the use of ketoconazole in Candida and dermatophyte in-fections 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 re-ports from office-based physicians indicated that the most common diagnosis associated with use in recent years have included superfi-cial skin and nail fungal infections. Ultimately, oral ketoconazole can now only be prescribed for the fol-lowing infections: blastomycosis, coccidioidomycosis, histoplasmo-sis, chromomycosis, and paracoc-cidioidomycosis 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 acet-aminophen 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 gener-alized 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 4Summary of Nizoral®
Medication Guide
•Nizoral (ketoconazole) tablets can cause serious side effects, including:Liver Problems. A healthcare pro-vider 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, yel-lowing 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: blastomy-cosis, coccidioidomycosis, histoplas-mosis, chromomycosis, and paracoc-cidioidomycosis. •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 insuf-ficiency; (3) are pregnant or plan to become pregnant; (4) are breastfeed-ing or plan to breastfeed. •Patients should avoid drinking alco-hol while taking Nizoral tablets.
mucosal surfaces such as eyes, oral cavity, upper airway or esophagus, gastrointestinal tract, or anogeni-tal 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
27The Georgia Pharmacy Journal The Georgia Pharmacy Journal26
Program 0129-0000-13-011-H05-PRelease date: 11-15-13
Expiration date: 11-15-16CE Hours: 1.5 (0.15 CEU)
The author, the Ohio Pharmacists Founda-tion and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the infor-mation contained herein. Bibliography for additional reading and inquiry is available upon request.
This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.
The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
epidermal detachment affecting more than 30 percent of the body surface area. The cutaneous erup-tion is usually preceded by nonspe-cific symptoms of fever and fatigue occurring one to 14 days before the skin lesion. Cough may be present and fever may be high during the active stages of the disease.
AGEP is a rare, acute skin eruption characterized by the development of numerous nonfol-licular sterile pustules on a back-ground of edematous erythema. In about 90 percent of cases, it is caused by drugs but there have been isolated reports linked to viral, bacterial, or parasitic in-fections. The eruption develops within hours or days after drug exposure and resolves spontane-ously in one to two weeks after drug discontinuation.
While it is rare for these reac-tions to occur, the data collected by FDA does indicate that an associa-tion has been found. The review of medical literature conducted by FDA found three cases of confirmed serious skin reaction with acet-aminophen following a positive re-challenge, as well as 26 other cases where acetaminophen was the only drug used prior to the reaction or hypersensitivity was demonstrated by skin testing or other means. The majority of these patients were hospitalized with no deaths report-ed in the literature, and the cases resolved upon discontinuation of the drug. Furthermore, a search of the FDA Adverse Event Reporting System (FAERS) from 1969 to 2012 identified 91 cases of SJS/TEN and 16 cases of AGEP which resulted in 67 hospitalizations and 12 deaths. The cases were ranked as either possible or probable in conjunc-tion with acetaminophen use. FDA reviewed five SJS/TEN case-control studies and one of AGEP indicat-ing that risks of SJS/TEN may be increased with the use of ac-etaminophen and were generally independent of the effects of other drugs. FDA noted that all but two of these case control studies failed to address the possible presence of protopathic bias. Protopathic
bias occurs when a pharmaceuti-cal agent is inadvertently pre-scribed for an early manifestation of a disease that has not yet been diagnostically detected. In this instance, protopathic bias refers to a false increase in the risk of SJS/TENS attributed to acetaminophen when used to treat fever because fever is also an early symptom of SJS/TEN. In one of the studies that did control for protopathic bias, acetaminophen was still associated with SJS/TEN.
FDA states that it is difficult to determine how frequently serious skin reactions occur with acet-aminophen due to the widespread use, difference in usage among individuals, and the fact that the medication has been available for so long. FDA is requiring that a warning be added to the labels of acetaminophen-containing pre-scription drugs and requesting the same from manufacturers of OTC acetaminophen drug products.
While health care profession-als should be aware of this risk, they should recall that it is rare and consider other drugs that carry the same warnings in their label. Drugs that are most com-monly associated with SJS include anticonvulsants such as phenytoin, phenobarbital, carbamazepine, lamotrigine, and valproic acid; sul-fonamides; penicillins; nonsteroidal anti-inflammatory drugs (NSAIDs); allopurinol; and tetracyclines. Drugs that are rarely associated with SJS include: leflunomide, venlafaxine, furosemide, nevirap-ine, and following vaccination from smallpox and chickenpox. SJS has also occurred rarely following cer-tain fungal and protozoal infections and in children with Epstein-Barr virus and enterovirus infections. Overall incidence of SJS is 0.1 to 0.7 cases per 100,000 per year. It occurs mainly in children and young adults, affecting males two times more than females.
AGEP is most often caused by antibiotics such as aminopenicillins and macrolides, calcium chan-nel blockers, and antimalarials. Among many other drugs, aspirin
and NSAIDs such as celecoxib, etodolac, and ibuprofen have been linked. The estimated incidence is one to five cases per million per year. While it can occur at any age, AGEP most often affects adults with a slight female predominance.
AGEP symptoms include red-dening of the skin, rash, blisters, and detachment of the upper surface of the skin. During the acute phase, fever and leukocyto-sis can occur. Those who experi-ence symptoms are advised to stop taking the drug and seek medical attention right away. It is impor-tant for patients to understand that these reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Individuals who have experienced a serious skin reaction with ac-etaminophen should not take the medication again.
SummaryThe safety information and pre-scribing updates discussed in this lesson provide a detailed review of FDA drug safety communications recently issued for zolpidem-con-taining products, valproate use in pregnancy, ketoconazole, and ace-taminophen. The updated product leaflets should be consulted for full prescribing information.
continuing educat ion quiz FDA Safety Warnings and Prescribing Updates: Zolpidem, Valproate, Ketoconazole, and Acetaminophen
Program 0129-0000-13-011-H05-P0.15 CEUPlease print.
Name________________________________________________
Address_____________________________________________
City, State, Zip______________________________________
Email_______________________________________________
NABP e-Profile ID____________Birthdate_________ (MMDD)
Return quiz and payment (check or money order) to Correspondence Course, OPA,
2674 Federated Blvd, Columbus, OH 43235-4990
Completely fill in the lettered box corresponding to your answer.1. [a] [b] [c] [d] 6. [a] [b] 11. [a] [b] [c] [d] 2. [a] [b] [c] [d] 7. [a] [b] [c] [d] 12. [a] [b] 3. [a] [b] [c] [d] 8. [a] [b] [c] [d] 13. [a] [b] [c] [d] 4. [a] [b] 9. [a] [b] [c] 14. [a] [b] [c] [d] 5. [a] [b] [c] [d] 10. [a] [b] [c] [d] 15. [a] [b]
I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.
1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor)2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________3. Was the content balanced and without commercial bias? yes no4. Did the program meet your educational/practice needs? yes no5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.
1. The recommended initial dose of extended-release zolpidem for women is now: a. 5 mg. c. 10 mg. b. 6.25 mg. d. 12.5 mg. 2. Data suggests that the risk for next-morning impair-ment is greatest in patients taking which of the following formulations of zolpidem? a. Immediate-release c. Sublingual b. Oral spray d. Extended-release
3. Zolpidem’s effects can be additive with all of the fol-lowing drugs EXCEPT: a. alcohol. c. tricyclic antidepressants. b. benzodiazepines. d. ketoconazole. 4. Zolpidem should not be taken if fewer than how many hours of sleep are anticipated? a. 5 to 6 hours b. 7 to 8 hours 5. The pregnancy category for valproate products pre-scribed for migraines is now: a. Category X. c. Category C. b. Category D. d. Category B.
6. It has been confirmed that the timing of exposure to valproate during pregnancy affects the severity of cogni-tive effects in children. a. True b. False 7. The label of valproate products carries a black box warning for the risk of: a. renal toxicity. c. hepatotoxicity. b. respiratory depression. d. adrenal insufficiency.
8. The major objective of the North American Antiepi-leptic Drug Pregnancy Registry is to publish information on the frequency of: a. major malformations in babies. b. colonic obstruction. c. fistulas and perianal disease. d. small bowel obstruction.
9. Liver damage with ketoconazole is documented in patients receiving all of the following EXCEPT: a. low doses for short periods of time. b. low doses for long periods of time. c. high doses for short periods of time.
10. In addition to severe liver injury, ketoconazole is associated with: a. renal toxicity. c. pancreatitis. b. respiratory depression. d. adrenal insufficiency.
11. All of the following medications are contraindicated with ketoconazole EXCEPT: a. alprazolam. c. carbamazepine. b. dofetilide. d. simvastatin.
12. Ketoconazole is appropriate therapy for fungal infec-tions of the skin or nails. a. True b. False 13. Patients taking ketoconazole should be advised to avoid: a. alcohol. c. caffeine. b. acetaminophen. d. NSAIDs.
14. Rare but serious skin reactions associated with acet-aminophen use include all of the following EXCEPT: a. AGEP. c. TEN. b. SJS. d. LDE.
15. The estimated incidence of acute generalized exan-thematous pustulosis is: a. 0.1 to 0.7 cases per 100,000 per year. b. 1 to 5 cases per million per year.
To receive CE credit, your quiz must be received no later than Novem-ber 15, 2016. A passing grade of 80% must be attained. CE credit for successfully completed quizzes will be uploaded to the CPE Monitor. CE statements of credit will not be mailed, but can be printed from the CPE Monitor website. Send inquiries to [email protected].
november 2013
27The Georgia Pharmacy Journal The Georgia Pharmacy Journal26
Program 0129-0000-13-011-H05-PRelease date: 11-15-13
Expiration date: 11-15-16CE Hours: 1.5 (0.15 CEU)
The author, the Ohio Pharmacists Founda-tion and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the infor-mation contained herein. Bibliography for additional reading and inquiry is available upon request.
This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.
The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
epidermal detachment affecting more than 30 percent of the body surface area. The cutaneous erup-tion is usually preceded by nonspe-cific symptoms of fever and fatigue occurring one to 14 days before the skin lesion. Cough may be present and fever may be high during the active stages of the disease.
AGEP is a rare, acute skin eruption characterized by the development of numerous nonfol-licular sterile pustules on a back-ground of edematous erythema. In about 90 percent of cases, it is caused by drugs but there have been isolated reports linked to viral, bacterial, or parasitic in-fections. The eruption develops within hours or days after drug exposure and resolves spontane-ously in one to two weeks after drug discontinuation.
While it is rare for these reac-tions to occur, the data collected by FDA does indicate that an associa-tion has been found. The review of medical literature conducted by FDA found three cases of confirmed serious skin reaction with acet-aminophen following a positive re-challenge, as well as 26 other cases where acetaminophen was the only drug used prior to the reaction or hypersensitivity was demonstrated by skin testing or other means. The majority of these patients were hospitalized with no deaths report-ed in the literature, and the cases resolved upon discontinuation of the drug. Furthermore, a search of the FDA Adverse Event Reporting System (FAERS) from 1969 to 2012 identified 91 cases of SJS/TEN and 16 cases of AGEP which resulted in 67 hospitalizations and 12 deaths. The cases were ranked as either possible or probable in conjunc-tion with acetaminophen use. FDA reviewed five SJS/TEN case-control studies and one of AGEP indicat-ing that risks of SJS/TEN may be increased with the use of ac-etaminophen and were generally independent of the effects of other drugs. FDA noted that all but two of these case control studies failed to address the possible presence of protopathic bias. Protopathic
bias occurs when a pharmaceuti-cal agent is inadvertently pre-scribed for an early manifestation of a disease that has not yet been diagnostically detected. In this instance, protopathic bias refers to a false increase in the risk of SJS/TENS attributed to acetaminophen when used to treat fever because fever is also an early symptom of SJS/TEN. In one of the studies that did control for protopathic bias, acetaminophen was still associated with SJS/TEN.
FDA states that it is difficult to determine how frequently serious skin reactions occur with acet-aminophen due to the widespread use, difference in usage among individuals, and the fact that the medication has been available for so long. FDA is requiring that a warning be added to the labels of acetaminophen-containing pre-scription drugs and requesting the same from manufacturers of OTC acetaminophen drug products.
While health care profession-als should be aware of this risk, they should recall that it is rare and consider other drugs that carry the same warnings in their label. Drugs that are most com-monly associated with SJS include anticonvulsants such as phenytoin, phenobarbital, carbamazepine, lamotrigine, and valproic acid; sul-fonamides; penicillins; nonsteroidal anti-inflammatory drugs (NSAIDs); allopurinol; and tetracyclines. Drugs that are rarely associated with SJS include: leflunomide, venlafaxine, furosemide, nevirap-ine, and following vaccination from smallpox and chickenpox. SJS has also occurred rarely following cer-tain fungal and protozoal infections and in children with Epstein-Barr virus and enterovirus infections. Overall incidence of SJS is 0.1 to 0.7 cases per 100,000 per year. It occurs mainly in children and young adults, affecting males two times more than females.
AGEP is most often caused by antibiotics such as aminopenicillins and macrolides, calcium chan-nel blockers, and antimalarials. Among many other drugs, aspirin
and NSAIDs such as celecoxib, etodolac, and ibuprofen have been linked. The estimated incidence is one to five cases per million per year. While it can occur at any age, AGEP most often affects adults with a slight female predominance.
AGEP symptoms include red-dening of the skin, rash, blisters, and detachment of the upper surface of the skin. During the acute phase, fever and leukocyto-sis can occur. Those who experi-ence symptoms are advised to stop taking the drug and seek medical attention right away. It is impor-tant for patients to understand that these reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Individuals who have experienced a serious skin reaction with ac-etaminophen should not take the medication again.
SummaryThe safety information and pre-scribing updates discussed in this lesson provide a detailed review of FDA drug safety communications recently issued for zolpidem-con-taining products, valproate use in pregnancy, ketoconazole, and ace-taminophen. The updated product leaflets should be consulted for full prescribing information.
continuing educat ion quiz FDA Safety Warnings and Prescribing Updates: Zolpidem, Valproate, Ketoconazole, and Acetaminophen
Program 0129-0000-13-011-H05-P0.15 CEUPlease print.
Name________________________________________________
Address_____________________________________________
City, State, Zip______________________________________
Email_______________________________________________
NABP e-Profile ID____________Birthdate_________ (MMDD)
Return quiz and payment (check or money order) to Correspondence Course, OPA,
2674 Federated Blvd, Columbus, OH 43235-4990
Completely fill in the lettered box corresponding to your answer.1. [a] [b] [c] [d] 6. [a] [b] 11. [a] [b] [c] [d] 2. [a] [b] [c] [d] 7. [a] [b] [c] [d] 12. [a] [b] 3. [a] [b] [c] [d] 8. [a] [b] [c] [d] 13. [a] [b] [c] [d] 4. [a] [b] 9. [a] [b] [c] 14. [a] [b] [c] [d] 5. [a] [b] [c] [d] 10. [a] [b] [c] [d] 15. [a] [b]
I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.
1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor)2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________3. Was the content balanced and without commercial bias? yes no4. Did the program meet your educational/practice needs? yes no5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.
1. The recommended initial dose of extended-release zolpidem for women is now: a. 5 mg. c. 10 mg. b. 6.25 mg. d. 12.5 mg. 2. Data suggests that the risk for next-morning impair-ment is greatest in patients taking which of the following formulations of zolpidem? a. Immediate-release c. Sublingual b. Oral spray d. Extended-release
3. Zolpidem’s effects can be additive with all of the fol-lowing drugs EXCEPT: a. alcohol. c. tricyclic antidepressants. b. benzodiazepines. d. ketoconazole. 4. Zolpidem should not be taken if fewer than how many hours of sleep are anticipated? a. 5 to 6 hours b. 7 to 8 hours 5. The pregnancy category for valproate products pre-scribed for migraines is now: a. Category X. c. Category C. b. Category D. d. Category B.
6. It has been confirmed that the timing of exposure to valproate during pregnancy affects the severity of cogni-tive effects in children. a. True b. False 7. The label of valproate products carries a black box warning for the risk of: a. renal toxicity. c. hepatotoxicity. b. respiratory depression. d. adrenal insufficiency.
8. The major objective of the North American Antiepi-leptic Drug Pregnancy Registry is to publish information on the frequency of: a. major malformations in babies. b. colonic obstruction. c. fistulas and perianal disease. d. small bowel obstruction.
9. Liver damage with ketoconazole is documented in patients receiving all of the following EXCEPT: a. low doses for short periods of time. b. low doses for long periods of time. c. high doses for short periods of time.
10. In addition to severe liver injury, ketoconazole is associated with: a. renal toxicity. c. pancreatitis. b. respiratory depression. d. adrenal insufficiency.
11. All of the following medications are contraindicated with ketoconazole EXCEPT: a. alprazolam. c. carbamazepine. b. dofetilide. d. simvastatin.
12. Ketoconazole is appropriate therapy for fungal infec-tions of the skin or nails. a. True b. False 13. Patients taking ketoconazole should be advised to avoid: a. alcohol. c. caffeine. b. acetaminophen. d. NSAIDs.
14. Rare but serious skin reactions associated with acet-aminophen use include all of the following EXCEPT: a. AGEP. c. TEN. b. SJS. d. LDE.
15. The estimated incidence of acute generalized exan-thematous pustulosis is: a. 0.1 to 0.7 cases per 100,000 per year. b. 1 to 5 cases per million per year.
To receive CE credit, your quiz must be received no later than Novem-ber 15, 2016. A passing grade of 80% must be attained. CE credit for successfully completed quizzes will be uploaded to the CPE Monitor. CE statements of credit will not be mailed, but can be printed from the CPE Monitor website. Send inquiries to [email protected].
november 2013
Name PositionRobert M. Hatton Chair of the BoardPamala S. Marquess PresidentRobert B. Moody President-ElectThomas H. Whitworth First Vice PresidentLance P. Boles Second Vice PresidentLiza Chapman State At LargeTerry Forshee State At LargeDavid Graves State At LargeJoshua D. Kinsey State At LargeEddie Madden State At LargeLaird Miller State At LargeChris Thurmond State At Large Krista Stone 1st Region PresidentEd S. Dozier 2nd Region PresidentRenee D. Adamson 3rd Region PresidentNicholas O. Bland 4th Region PresidentShelby Biagi 5th Region PresidentSherri S. Moody 6th Region PresidentTyler Mayotte 7th Region PresidentMichael Lewis 8th Region PresidentAmanda Westbrooks 9th Region President Flynn Warren 10th Region PresidentKalen Manasco 11th Region President Ken Von Eiland 12th Region PresidentTed Hunt ACP ChairSharon B. Zerillo AEP ChairJohn Drew AHP ChairDrew Miller AIP ChairMichelle Hunt APT ChairLeah Stowers ASA ChairJohn T. Sherrer Foundation ChairAl McConnell Board of Pharmacy ChairMegan Freeman GSHP PresidentAmy C. Grimsley Mercer Faculty RepresentativeRusty Fetterman South Faculty RepresentativeLindsey Welch UGA Faculty RepresentativeTyler Bryant ASP, Mercer University Tiffany Galloway ASP, South University Jessica Kupstas ASP, UGA Jim Bracewell Executive Vice President
2013-2014 BOARD OF DIRECTORS
Melvin M. Goldstein, P.C.AT T O R N E Y AT L AW___
248 Roswell StreetMarietta, Georgia 30060
Telephone 770/427-7004Fax 770/426-9584
www.melvinmgoldstein.com
n Private practitioner with an emphasis on representing healthcare professionals in administrative cases as well as other legal matters
n Former Assistant Attorney General for the State of Georgia and Counsel for professional licensing boards including the Georgia Board of Pharmacy and the Georgia Drugs and Narcotics Agency
n Former Administrative Law Judge for the Office of State Administrative Hearings
28
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Address:______________________________________________________________________________
E-mail Address (Please Print):_____________________________________________________________
Will you be joining us for lunch (12-1pm)? Yes_____ No_____; # of additional Staff/Guests:____________
Names of Staff/Guests: ___________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
PLEASE FAX
BACK TO (404) 237-8435
THE GEORGIA PHARMACY ASSOCIATION
Name PositionRobert M. Hatton Chair of the BoardPamala S. Marquess PresidentRobert B. Moody President-ElectThomas H. Whitworth First Vice PresidentLance P. Boles Second Vice PresidentLiza Chapman State At LargeTerry Forshee State At LargeDavid Graves State At LargeJoshua D. Kinsey State At LargeEddie Madden State At LargeLaird Miller State At LargeChris Thurmond State At Large Krista Stone 1st Region PresidentEd S. Dozier 2nd Region PresidentRenee D. Adamson 3rd Region PresidentNicholas O. Bland 4th Region PresidentShelby Biagi 5th Region PresidentSherri S. Moody 6th Region PresidentTyler Mayotte 7th Region PresidentMichael Lewis 8th Region PresidentAmanda Westbrooks 9th Region President Flynn Warren 10th Region PresidentKalen Manasco 11th Region President Ken Von Eiland 12th Region PresidentTed Hunt ACP ChairSharon B. Zerillo AEP ChairJohn Drew AHP ChairDrew Miller AIP ChairMichelle Hunt APT ChairLeah Stowers ASA ChairJohn T. Sherrer Foundation ChairAl McConnell Board of Pharmacy ChairMegan Freeman GSHP PresidentAmy C. Grimsley Mercer Faculty RepresentativeRusty Fetterman South Faculty RepresentativeLindsey Welch UGA Faculty RepresentativeTyler Bryant ASP, Mercer University Tiffany Galloway ASP, South University Jessica Kupstas ASP, UGA Jim Bracewell Executive Vice President
2013-2014 BOARD OF DIRECTORS
Melvin M. Goldstein, P.C.AT T O R N E Y AT L AW___
248 Roswell StreetMarietta, Georgia 30060
Telephone 770/427-7004Fax 770/426-9584
www.melvinmgoldstein.com
n Private practitioner with an emphasis on representing healthcare professionals in administrative cases as well as other legal matters
n Former Assistant Attorney General for the State of Georgia and Counsel for professional licensing boards including the Georgia Board of Pharmacy and the Georgia Drugs and Narcotics Agency
n Former Administrative Law Judge for the Office of State Administrative Hearings
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Continental Breakfast & Lunch Provided
SAVE THE DATE
Network with Colleagues
Meet with Partners
Exciting Continuing Education Programs
SHOW YOUR SUPPORT
ATTEND THIS YEAR’S AIP SPRING MEETING
AIP Spring Meeting Sunday, March 30, 2014
Macon Marriott & Centreplex Macon, GA
Registration: (For Planning Purposes Please Fill Out and Return )
Member’s Name:_______________________________________ Nickname________________________
Pharmacy Name:_______________________________________________________________________
Address:______________________________________________________________________________
E-mail Address (Please Print):_____________________________________________________________
Will you be joining us for lunch (12-1pm)? Yes_____ No_____; # of additional Staff/Guests:____________
Names of Staff/Guests: ___________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
PLEASE FAX
BACK TO (404) 237-8435
THE GEORGIA PHARMACY ASSOCIATION
50 Lenox Pointe, NE Atlanta, GA 30324
It’s more than just investing.
Please contact us today to start exploring your options.
Harris Gignilliat, CRPS®
Vice President–Wealth Management3455 Peachtree Road NE, Suite 1700 Atlanta, GA [email protected]
Visit us online:ubs.com/team/wile
Member benefits include
– Complimentary financial planning (a $5k–$10k value)
– Brand new 401(k) retirement savings plan designed exclusively for GPhA members at a group discount rate
– Advisory and investment program offered at group discount rate
– Retirement planning guidance, including a retirement income replacement system
– Lending capabilities with competitive interest rates
– Free access to UBS global investment research
Chartered Retirement Plans SpecialistSM and CRPS® are registered service marks of the College for Financial Planning®. Neither UBS Financial Services Inc. nor any of its employees provides legal or tax advice. You should consult with your personal legal or tax advisor regarding your personal circumstances. As a firm providing wealth management services to clients, we offer both investment advisory and brokerage services. These services are separate and distinct, differ in material ways and are governed by different laws and separate contracts. For more information on the distinctions between our brokerage and investment advisory services, please speak with your Financial Advisor, the Wile Consulting Group, or visit our website at ubs.com/workingwithus. Financial Planning services are provided in our capacity as a registered investment adviser. As a firm providing wealth management services to clients in the U.S., we offer both investment advisory and brokerage services. These services are separate and distinct, differ in material ways and are governed by different laws and separate contracts. ©UBS 2013. All rights reserved. UBS Financial Services Inc. is a subsidiary of UBS AG. Member SIPC. 7.00_8.5x8_AX0313_WilE 0313150 exp3/22/15
We’re pleased to partner with GPhA to bring our comprehensive services to members as the endorsed wealth management provider for the association. Through the UBS/Georgia Pharmacy relationship, GPhA members have exclusive access to financial services resources through the Wile Consulting Group. This group relationship enables members to leverage the vast scale of products and services at UBS. We distinguish ourselves with a robust service model, comprehensive benefits, diligent research, quality performance and competitive pricing.
Created
03/13/13
Last revision
March 26, 2013 4:04 PM
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Ed Wile named to Barron’s Top 1,000 Financial Advisors for 2013 and the Wile Consulting Group named one of the top 100 Retirement Plan Advisors for 2013 by Planadvisor.
THE GEORGIA PHARMACY ASSOCIATION