November GPhA Journal 2012 by Georgia Pharmacy Association

November 2012

The Stars of the

Blue Ridge Norcross Kennesaw

Region Meetings Athens

2012

Augusta

GrifďŹ n

Macon

Savannah Dublin

Columbus

Waycross Tifton

g din r a Reg

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Endorsed by:**

November 2012 Editor: Jim Bracewell jbracewell@gpha.org The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2012, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association. ARTICLES AND ARTWORK Those interested in writing for this publication are encouraged to request the official “GPJ Guidelines for Writers.” Artists or photographers wishing to submit artwork for use on the cover should call, write or email jbracewell@gpha.org.

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SUBSCRIPTIONS AND CHANGE OF ADDRESS The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe, NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices. POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324. ADVERTISING Advertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at adefaveri@gpha.org. GPhA HEADQUARTERS 50 Lenox Pointe, NE Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

gpha.org

CONTENTS 2 4

Message From Robert Hatton.............................

Message From Jim Bracewell...............................

5 6 10 11 14 16 18 21

Welcome New GPhA Members..........

Blue Ridge Norcross

Kennesaw

Stars of the Region Meetings...............

Athens

Augusta

Grifﬁn

Macon

Savannah Dublin

Columbus

Waycross Tifton

Braden Wins NCPA Dargavel Award....................

Gay Selected Long-term Care Phamacist of the Year........................

Meningitis Outbreak........................

Call for GPhA Award Entrees............

PharmPAC Supporters........................

Continuing Education for Pharmacists....

The Georgia Pharmacy Journal

PO Box 370 • Algona Iowa 50511

The Georgia Pharmacy Journal

Endorsed by:**

Guarantee a better

Quality of Life for your family.

Life Insurance can provide for your loved ones by:

• Providing coverage for final medical and funeral expenses • Paying outstanding debts • Creating an estate for those you care about • Providing college funding

Life insurance solutions from The Pharmacists Life Insurance Company. For more information, contact your local representative:

Hutton Madden

gpha.org

CONTENTS 2 4

Message From Robert Hatton.............................

Message From Jim Bracewell...............................

5 6 10 11 14 16 18 21

Welcome New GPhA Members..........

Blue Ridge Norcross

Kennesaw

Stars of the Region Meetings...............

Athens

Augusta

Grifﬁn

Macon

Savannah Dublin

Columbus

Waycross Tifton

Braden Wins NCPA Dargavel Award....................

Gay Selected Long-term Care Phamacist of the Year........................

Meningitis Outbreak........................

Call for GPhA Award Entrees............

PharmPAC Supporters........................

Continuing Education for Pharmacists....

The Georgia Pharmacy Journal

PO Box 370 • Algona Iowa 50511

The Georgia Pharmacy Journal

MESSAGE from Robert Hatton GPhA Leadership Attends NCPA Annual Meeting

The GPhA Executive Committee attended the NCPA’s 114th Annual Meeting in

beautiful San Diego October 13-17. If you have never had the chance to attend an NCPA convention you really need to put it on the short list and make plans to do so. Robert Hatton Great programs, lots of pertinent information and cutting edge CE was just a few of GPha President the perks in attending. While there, we were able to enjoy amenities in the area such as tours of Balboa Park and Coronado Island. San Diego is definitely a city worth visiting. The NCPA leadership, including its House of Delegates, emphasized the importance of and our commitment to pursuing recognition of pharmacists as providers both federally and in states. The prevalence of 340B programs is growing and depending on how they are implemented, it can be an opportunity or a threat for community pharmacy owners. Participants that attended this NCPA Annual Meeting left with the insight “GPhA is known to determine if getting into the 340B space was right for them and if so, nationwide for how to proceed. I attended the convention I realized that we were fortunate to have its leaders and soAsmuch leadership at the national level. Past GPhA presidents John we should be Sherrer and Hugh Chancy are on the NCPA Executive Committee and proud of the represent us well. GPhA is known nationwide for its leaders and we be proud of the commitment shown by these individuals. commitment should Former GPhA Executive Vice President Larry Braden was honored by shown by these the NCPA Foundation as the winner of the John Dargavel award. See the individuals.” photo and coverage in this journal. Congratulations to Larry. We also learned that Brent Gay of Dublin, GA was awarded the Generation Rx LTC Pharmacist. Congratulations to Brent also. I would be remiss, however, if I failed to mention how much the convention made me realize how much we need people to step up to the plate and get the message out about community pharmacy. We are under constant pressure to demonstrate our relevance and prove our worth in the healthcare arena. There are many changes headed our way and we are going to have to band together and make our message clear. Talk to your local, state and national legislators, invite them to your store, and write an op-ed article for your local paper. Do whatever it takes to get the word out that community pharmacy is a viable, necessary, integrated part of the healthcare system. We all have to do our part to make sure that we are at the table when decisions affecting our future are being discussed. What I learned in San Diego is that NCPA is doing their best to represent us on the national stage, but we have to do our part back home to make it work.

The Georgia Pharmacy Journal

All Georgia Pharmacists must now present verifiable documentation. Amendments to O.C.G.A. § 50-36-1 became effective January 1, 2012.

Georgia law now requires all applicants for licensure, and all those applying for renewal of an existing license to submit secure and verifiable documentation with their application that will be reviewed by the Board. Examples of secure and verifiable documents are driver’s license, U.S. passport, or green card; however, a complete list of the approved Secure and Verifiable Documents may be found on the Professional Licensing Board’s webpage.

All Pharmacists are encouraged to submit their renewal applications early to avoid delays! Pharmacists may submit their renewal online in minutes just follow these quick and easy steps: • Visit the Georgia Online Licensing site at www.sos.ga.gov/plb (Free internet access is available at every Georgia Public Library) • Click on the License Renewal link to begin the renewal process. • Step-by-Step instructions can be found here: www.sos.ga.gov/plb/renewal_process.htm • Update address, phone number, e-mail address and answer the renewal questions. • Pay renewal fee(s) using a American Express, Mastercard, or Visa on our secure server. • Upload your secure and veriﬁable document. • Print the receipt of payment. • Verify the renewal online by the end of the next business day. • Receive the renewed license in the mail. If pharmacists choose not to renew online and would like to request a renewal form that will be mailed to your address on ﬁle with board, please call (404)463-1100. Please note that renewing by mail may take up to 4 weeks to process after the completed renewal form is received. A licensee cannot practice after their license expiration date.

AVOID ADDITIONAL DELAY & LATE FEES BY RENEWING NOW!

MESSAGE from Robert Hatton GPhA Leadership Attends NCPA Annual Meeting

The GPhA Executive Committee attended the NCPA’s 114th Annual Meeting in

The Georgia Pharmacy Journal

All Georgia Pharmacists must now present verifiable documentation. Amendments to O.C.G.A. § 50-36-1 became effective January 1, 2012.

AVOID ADDITIONAL DELAY & LATE FEES BY RENEWING NOW!

MESSAGE from Jim Bracewell GPhA Creates Pharmacy Jobs

WELCOME New GPhA Members Pharmacy School Student

In the current Presidential election the creation of jobs was a running topic at each

debate and campaign event. That caused me to think, do the pharmacists of Georgia realize that GPhA is a job creating entity for the profession of pharmacy? Jim Bracewell Executive Vice President There is no R and there is no D in GPhA but we do create pharmacy jobs in Georgia with every action we take as an association and I doubt that few of our members stop and think about the association in that manner. So let me make the case for GPhA as a job creator for the profession of pharmacy. GPhA advocates for the expansion of the pharmacist’s scope of prac“Let me make tice to allow a pharmacist to administer any immunization under the the case for prescriptive order of a physician. advocates for the expansion of the pharmacist’s scope of pracGPhA as a job ticeGPhA to allow a pharmacist to administer flu immunizations under a procreator for the tocol of a physician. GPhA advocates for payment for medication management therapy for profession of pharmacists. pharmacy.” GPhA advocates for patient’s option to use their community pharmacy verses mandated mail order prescriptions from out of state. GPhA advocates for collaborative practice agreements between pharmacists and physicians. GPhA advocates for the highest quality compounding standards for the profession to assure patients’ access to physician prescribed compounded therapy. GPhA advocates a restricted pharmacist technician ratio to assure quality pharmacy care for patients. GPhA advocates for adequate reimbursement rates from state and federal programs for pharmacy services. GPhA advocates for pharmacists’ voices at the table of all boards, commissions and committees that address healthcare in Georgia. GPhA advocates for pharmacists to service in our state general assembly to assure a voice for pharmacy in all legislation for the profession. Today there are over 13,000 pharmacists licensed in Georgia and over 10,000 of them live and practice in our state. The good health of pharmacy profession in our state is a credit to the work of the Georgia Pharmacy Association. GPhA’s job is to make Georgia the best state in the union to practice the profession of pharmacy. Your association has a history of doing just that. The future for pharmacy in Georgia is brighter today because of the work of the members of the Georgia Pharmacy Association.

Stephanie Theard, Norcross, GA Tina Simpson, Buford, GA Zachary Alexander Young, Athens, GA Riley Jonathan Luke, Athens, GA Tekia Hamilton, Savannah, GA Jennifer Huynh, Savannah, GA

New Graduate

About GPhA

The Georgia Pharmacy Association is the collective voice of the pharmacy profession, aggressively advocating for the profession in the shaping of public policy, encouraging ethical health care practices, advancing educational leadership while ensuring the profession’s future is economically prosperous. The members of GPhA would like to welcome all our new members and encourage them to take advantage of all the benefits membership offers.

Benjamin Lewis Culpepper, Pharm.D., Augusta, GA

Pharmacy Technician

Iris K. Meaders, C.Ph.T., Norcross, GA Chrissi Oneal, C.Ph.T., Dudley, GA

Active Pharmacist

Sebrena Pollard Bartlett, R.Ph., Evans, GA Darren L. Bryan, R.Ph., Dublin, GA Joanne Dora Marcone, Pharm.D., Marietta, GA Kerop B. Gourdikian, Suwanee, GA Laura Beasley Miller, Pharm.D., Dublin, GA Teri Stephens Crosby, R.Ph., Wrightsville, GA Ann Taylor McLeod, R.Ph., Tallahassee, FL Jeffrey Douglas Crisp, Pharm.D., Forest Park, GA Ray W. Crisp, R.Ph., Forest Park, GA Allyson Aaron Thomas, Pharm.D., Rocky Ford, GA

THANK YOU FOR YOUR MEMBERSHIP! Georgia Pharmacy Association 50 Lenox Pointe, NE, Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

gpha.org

The Georgia Pharmacy Journal

MESSAGE from Jim Bracewell GPhA Creates Pharmacy Jobs

WELCOME New GPhA Members Pharmacy School Student

In the current Presidential election the creation of jobs was a running topic at each

Stephanie Theard, Norcross, GA Tina Simpson, Buford, GA Zachary Alexander Young, Athens, GA Riley Jonathan Luke, Athens, GA Tekia Hamilton, Savannah, GA Jennifer Huynh, Savannah, GA

New Graduate

About GPhA

Benjamin Lewis Culpepper, Pharm.D., Augusta, GA

Pharmacy Technician

Iris K. Meaders, C.Ph.T., Norcross, GA Chrissi Oneal, C.Ph.T., Dudley, GA

Active Pharmacist

THANK YOU FOR YOUR MEMBERSHIP! Georgia Pharmacy Association 50 Lenox Pointe, NE, Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

gpha.org

The Georgia Pharmacy Journal

The Stars of the

Region Meetings

Blue Ridge

2012

Norcross Kennesaw

Athens

eorgia is the largest state east of the Mississippi River and it is never so abundantly clear to your GPhA Executive Committee as it is each fall when we travel to twelve cities across our great state. The leadership of your association still believes it is important to invest time and resources to take the GPhA story to the members in all parts of our state. Your volunteer leaders of

GPhA gave up many days this past October to meet with members in a dozen cities in Georgia. The content of the GPhA presentation at our meetings focused on

the legislative issues facing our profession. Legislative representatives were invited to speak at the meetings to hear pharmacistsâ&#x20AC;&#x2122; concerns about PBMs, illegal prescriptions, expan-

Augusta

GrifďŹ n

Macon

Savannah Dublin

Columbus

Left to right: GPhA Board Chair Jack Dunn, Region 5 President Julie Bierster, Rep. Brett Harrell, and GPhA President Elect Pam Marquess.

Left to right: GPhA 2nd VP Tommy Whitworth, Region 4 President Nic Bland, Senator Rick Jeffares, AEP Chair Sharon Zerillo, and AIP Chair Drew Miller.

Waycross Tifton

GPhA 2nd VP Tommy Whitworth presents plaque to Roy McClendon honoring his 50 years in the profession.

The Georgia Pharmacy Journal

Left to right: GPhA 1st VP Bobby Moody, GPhA President Robert Hatton, State Representative Carol Fullerton, and 2nd Region President Ed Dozier.

The Stars of the

Region Meetings

Blue Ridge

2012

Norcross Kennesaw

Athens

GPhA gave up many days this past October to meet with members in a dozen cities in Georgia. The content of the GPhA presentation at our meetings focused on

Augusta

GrifďŹ n

Macon

Savannah Dublin

Columbus

Left to right: GPhA Board Chair Jack Dunn, Region 5 President Julie Bierster, Rep. Brett Harrell, and GPhA President Elect Pam Marquess.

Left to right: GPhA 2nd VP Tommy Whitworth, Region 4 President Nic Bland, Senator Rick Jeffares, AEP Chair Sharon Zerillo, and AIP Chair Drew Miller.

Waycross Tifton

GPhA 2nd VP Tommy Whitworth presents plaque to Roy McClendon honoring his 50 years in the profession.

The Georgia Pharmacy Journal

Left to right: GPhA 1st VP Bobby Moody, GPhA President Robert Hatton, State Representative Carol Fullerton, and 2nd Region President Ed Dozier.

Region Meetings

sion of immunizations and their patients. The Association’s 2013 legislative agenda was laid out and critiqued by our members. We honored the five pharmacists that have been elected to the Georgia legislature and their role in leading the improvement for the

practice of pharmacy in our state. Each member was encouraged to speak this fall with their local House and Senate members to invite them to the pharmacy day at the capitol. Our VIP – Voice In Pharmacy day sets the tone for our clout with the Georgia General Assembly.

GPhA President elect Pam Marquess addresses Region 10 overﬂow meeting.

Region Meetings

The strength of GPhA starts in the towns and cities around the state. GPhA is a member driven association and the Association leaders are proud to have the opportunity to connect with members through these Region Meetings each October and April.

Left to right: GPhA 2nd VP Tommy Whitworth, Region 3 President Renee Adamson and GPhA Board Chair Jack Dunn.

GPhA Board Chair Jack Dunn presents to Region 3.

AIP Membership Service Representative Charles Boone mans the registration table at Region 4.

Chair of the Board of GPhA Jack Dunn speaks to the 5th Region attendees.

Region 9 members enjoy a cozy family style setting for their program.

Division of Display Options, Inc. Region 10 has a packed house for its October 30 meeting.

Chris Thurmond, GPhA Board member, urges broader support for PharmPAC.

Compounding Labs Pharmacy Planning & Design

Rx Planning Specialist

Patient Consultation Areas

Roland Thomas

Stocking Lozier Distributor

experience in over 2,000 pharmacies.

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

9517 Monroe Road, Suite A • Charlotte, NC 28270 GPhA Past Presidents Eddie Madden, Flynn Warren and Jonathan Marquess with Region 10 President Lance Boles.

GPhA 2nd VP Tommy Whitworth presents the GPhA program at Region 6.

The Georgia Pharmacy Journal

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

Region Meetings

GPhA President elect Pam Marquess addresses Region 10 overﬂow meeting.

Region Meetings

Left to right: GPhA 2nd VP Tommy Whitworth, Region 3 President Renee Adamson and GPhA Board Chair Jack Dunn.

GPhA Board Chair Jack Dunn presents to Region 3.

AIP Membership Service Representative Charles Boone mans the registration table at Region 4.

Chair of the Board of GPhA Jack Dunn speaks to the 5th Region attendees.

Region 9 members enjoy a cozy family style setting for their program.

Division of Display Options, Inc. Region 10 has a packed house for its October 30 meeting.

Chris Thurmond, GPhA Board member, urges broader support for PharmPAC.

Compounding Labs Pharmacy Planning & Design

Rx Planning Specialist

Patient Consultation Areas

Roland Thomas

Stocking Lozier Distributor

experience in over 2,000 pharmacies.

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

9517 Monroe Road, Suite A • Charlotte, NC 28270 GPhA Past Presidents Eddie Madden, Flynn Warren and Jonathan Marquess with Region 10 President Lance Boles.

GPhA 2nd VP Tommy Whitworth presents the GPhA program at Region 6.

The Georgia Pharmacy Journal

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

Braden Wins 2012 NCPA Dargavel Award San Diego, CA (October 15, 2012)

arry Braden, Atlanta-area pharmacist and President of Lacey Drug Company, was honored as the recipient of the 2012 John W. Dargavel Medal by the National Community Pharmacists Association (NCPA) Foundation during NCPA’s 114th Annual Convention and Trade Exposition held October 13-17. The McKesson Corporation sponsors the annual award that honors an individual whose contributions on behalf of independent pharmacy embody the spirit of leadership and accomplishment personified by John W. Dargavel, who was executive secretary of the National Association of Retail Druggists (NARD), now NCPA, from 1933 to 1961. In fact, the NCPA Founda- Left to right: Larry Braden, NCPA Foundation President Sharlea tion was established in 1953 to honor Leatherwood, and Senior Vice President Independent National Accounts Rex Catton Dargavel. “Larry Braden has dedicated his School of Pharmacy and became af- of the board of CPA. Braden received his pharmacy honlife’s work to independent pharma- filiated with Lacey Drug Company at cy, not just his own stores, but on the that time. He acquired an ownership or from Mercer University in 1965 interest the next and was awarded the Doctor of Scistate and national year and full own- ence degree in 2004, the first pharlevel with his work “Larry Braden has ership four years macy graduate of the University to with the Georgia dedicated his life’s later. receive that degree. He has also rePharmacy AssociaWhile practicing ceived numerous state and national tion and the Comwork to independent pharmacy full- awards, including the Bowl of Hygeia pliant Pharmacy Alliance,” said Sharlea pharmacy, not just his time for the fol- Award in 2005, the Distinguished lowing fourteen Service Award from the University Leatherwood, PD, NCPA Foundation own stores, but on the years, Braden was Of Georgia College Of Pharmacy, active in the Geor- the V. Carlton Henderson Award for President. “Braden state and national gia Pharmacy As- Outstanding Personal and Profesis a credit to his prolevel with his work sociation (GPhA) sional Achievement, and the Dean’s fession and his comserving on the Ex- Award from Mercer University. He is munity and that is with the Georgia ecutive Committee a recipient of the Georgia Pharmacy why we are proud to honor him with this Pharmacy Association when he was asked Association Meritorious Achievehis colleagues ment Award, which was renamed year’s John W. Darand the Compliant by to assume the role the Larry L. Braden Meritorious gavel Medal for his lifetime of service.” Pharmacy Alliance.” of Executive Vice Achievement Award in 1997. President. After His civic affairs include serving as Braden is a pharmacist and President of Lacey Drug retiring from GPhA in 1997, Braden a member of the Board of Trustees of Company, which operates three was instrumental in the creation of Mercer University, Chairman of the pharmacies and related businesses in Compliant Pharmacy Alliance® Co- Georgia Partnership for Caring, and the metro-Atlanta area. He began his operative (CPA), a community phar- Chairman of the Board of Trustees of career in pharmacy in 1965 following macy Group Purchasing Organiza- the United States Pharmacopoeia. graduation from Mercer University tion. He currently serves as a director 10

The Georgia Pharmacy Journal

GPhA’s Brent Gay Selected Next Generation Long-term Care Pharmacist of the Year A

quest for perfection in providServices offered include monthly indicators, resident assessment protoing medicines, consulting, and other nurse consulting by a licensed RN/ cols, unnecessary drugs protocol, and care services in a timely NHA and bi-monthly inappropriate medications for the el“Open and cost-effective manregulatory consulting derly consulting—something the faner is a hallmark of Brent by a licensed RN. Gayco cilities it serves appreciate. “Effingham Care Center is very apGay’s career as a long- communications Healthcare offers conterm care pharmacist. is one of Gay’s sultations with a geriat- preciative of the service we have reAfter purchasing what ric certified pharmacist ceived over the years from Gayco,” priorities.” would become Gayco to maintain compli- said Norma Jean Morgan, chief exHealthcare in 1993, Gay ance, and also offers in- ecutive officer of Effingham County set his goals on customer service and depth consulting that includes quality Extended Care. integrity in long-term care. Although the company provided services to just 4 extended-care facilities when purchased, it has since expanded to serve more than 50 locations that include skilled nursing, hospice, and correctional institutions. Employees of Gayco say this is beA T T O R N E___ Y AT L AW cause of the special touch Gay brings to his business and his emphasis on service and dedication to care. In 248 Roswell Street particular, Gay ensures the integrity Marietta, Georgia 30060 of his company’s services by incorporating only ethically and morally Telephone 770/427-7004 appropriate practices into its services. Fax 770/426-9584 Three care questions govern decisions at Gayco Healthcare, with pharmawww.melvinmgoldstein.com cists there constantly asking whether a treatment decision is good for the n Private practitioner with an emphasis on resident, good for the facility, and good for the pharmacy. representing healthcare professionals in “It is a real pleasure working with administrative cases as well Gayco,” Janet McKay, director of nursing at Riverview Health & Rehaas other legal matters bilitation Center, said in Gay’s nomination materials. “I have worked with n Former Assistant Attorney General for a lot of pharmacies and pharmacists the State of Georgia and Counsel for over the years. I can truly say Gayco is the most moral, ethical, and compasprofessional licensing boards including the sionate I have known.” Georgia Board of Pharmacy and the Georgia Open communication between the pharmacy and the facilities it serves is Drugs and Narcotics Agency among Gay’s priorities as a pharmacist. Its incorporation of clinical tools, n Former Administrative Law Judge for the coupled with the open communicaOffice of State Administrative Hearings tion, ensures appropriate medication regimens and positive outcomes for patients.

Melvin M. Goldstein, P.C.

The Georgia Pharmacy Journal

Braden Wins 2012 NCPA Dargavel Award San Diego, CA (October 15, 2012)

The Georgia Pharmacy Journal

GPhA’s Brent Gay Selected Next Generation Long-term Care Pharmacist of the Year A

Melvin M. Goldstein, P.C.

The Georgia Pharmacy Journal

Southeastern Girls of Indulge. Pharmacy Leadership Weekend

Board of Pharmacy Update A

s I am sure you know there is a tremendous problem with prescriptions being filled from “pill mills” or other prescribers who will sell their integrity. It has been said that for evil to triumph it is necessary that good people do nothing to oppose it. My experience is that the majority of Georgia Pharmacists are good people who try to do the right thing. If you want to keep from having a problem with GDNA or the BOP each time you fill a prescription, especially for controlled substances, ask yourself “am I doing the right thing”. We want to make you aware of an issue brought to the BOP by the Office of the Attorney General at our last meeting. Georgia law says that to give flu shots a Pharmacist must have a protocol with a Georgia licensed practitioner, which has been filed with the Georgia Composite Medical Board. As of September 19th only one (1) protocol had been filed with the Medical Board. It’s probably the responsibility of the Physician to file this protocol, but SOMEBODY needs to file it so if, god forbid, a vaccination somehow has either a real or perceived undesirable outcome, you “Georgia law the Pharmacist is covered. Remember the popular TV atsays that to give torney’s ad, “one call that’s all”. Please be aware that this is a renewal year. New Georgia flu shots a law mandates that to initiate or renew a professional liPharmacist must cense you must prove who you are. This is probably best have a protocol accomplished by faxing or E mailing a copy of your drivlicense as instructed on the BOP website along with with a Georgia er’s your application. The e-mail address is svd@sos.ga.gov, licensed fax# is 478-314-9746 . Our staff in Macon works very hard, but due practioner.” to budget and staff cuts brought on by the great recession, they find themselves between the dog and the fireplug. These staff cuts are not the fault of the BOP but simply a matter of not enough dollars. The staff that serves all of the examining boards, not just pharmacy, has been cut from approximately 140 to 87 warm bodies. So please start early and be patient. If the BOP office has your current e-mail address you have probably already received a reminder to renew. The BOP or any state board no longer sends out cards through the postal service to remind you to renew your license.

Bill Prather

Chairman of the GA Board of Pharmacy

The Georgia Pharmacy Journal

January 11- 13, 2013 Grove Park Inn, Asheville, NC Register today at www.scrx.org

Southeastern Girls of Indulge. Pharmacy Leadership Weekend

Board of Pharmacy Update A

Bill Prather

Chairman of the GA Board of Pharmacy

The Georgia Pharmacy Journal

January 11- 13, 2013 Grove Park Inn, Asheville, NC Register today at www.scrx.org

Meningitis Outbreak Tied to New England Compounding Pharmacy Three hundred and seventeen cases have been identified in seventeen states that have resulted in twenty-four deaths. One case has been reported in Georgia. How common is pharmacy compounding?

• Compounding is a traditional part of pharmacy practice. It involves the preparation of medications on prescription by physicians and other authorized prescribers who meet unique patient healthcare needs that cannot be met with commercially manufactured and marketed drug products. This might include providing different strengths, preparing a drug with different non-active excipients for which a patient may have an allergy, or creating dosage forms which are more palatable for a patient. • Of the approximately 56,000 community-based pharmacies, more than half provide some level of basic compounding services to local patients and physicians. IACP estimates that there are 7,500 pharmacies in the United States that specialize in advanced compounding services of which approximately 3,000 provide sterile compounding. It is estimated that one to three percent of all prescriptions dispensed in the United States are compounded on prescriptions for individual patients. • The value of compounding pharmacy to the healthcare system has grown recently as pharmacists have worked with local physicians, hospitals and medical clinics to address the ongoing shortage of critical man14

ufactured medications. As the number of medicines previously available through manufacturers have gone into backorder or long-term shortage status due to manufacturing problems, compounding pharmacists have been able to access the raw drug ingredients and collaborate to provide those medicines until manufacturing supply has been revived.

Is compounding pharmacy regulated?

• All compounding pharmacists and pharmacies are subject to governmental oversight by three distinct regulatory bodies: their individual State Boards of Pharmacy for adherence to practice requirements, the

Food & Drug Administration (FDA) for the integrity of the drugs and Active Pharmaceutical Ingredients (APIs) which they order, store and use; and, by the Drug Enforcement Administration (DEA) for their handling of controlled substances used in the preparation of compounded medications. • In addition to government regulation, adherence to United States Pharmacopeia USP <797> standards for the compounding of sterile medications is expected. USP <797> is a national standard for the process, testing, and verification of any medication prepared for administration to patients. These standards are included as a requirement in many state regulations in addition to being a professional standard. • The pharmacy profession has an accrediting body – the Pharmacy Compounding Accreditation Board (PCAB) – which provides an additional level of quality assurance recognition for sterile and non-sterile compounded preparations. Pharmacies with PCAB accreditation status have demonstrated that their policies and processes meet the highest possible quality standards. New England Compounding Center is not a current PCAB accredited pharmacy.

The Georgia Pharmacy Journal

o t r o w c o k H

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How do I Enroll? • Go to www.rxAlly.com/enroll. • Enter your contact information. • Select your role as “Pharmacy owner/officer”. Enter your NCPDP number. • Then, you will see another box with your affiliation(s) listed. If you have more than one affiliation, select “AIP”. • Click “submit” button. • Review and confirm your acceptance of the Pharmacy Network Agreement by checking the box at the bottom of the agreement and clicking the “confirm” button. • You will see a Network Enrollment Confirmation screen indicating that you have successfully enrolled. • Within a few days you will receive an enrollment confirmation email that includes your pharmacy name, NCPDP number and selected affiliation.

It’s good for your patients, and good for your business. Join the revolution today at www.rxAlly.com/enroll

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Is compounding pharmacy regulated?

The Georgia Pharmacy Journal

o t r o w c o k H

It’s good for your patients, and good for your business. Join the revolution today at www.rxAlly.com/enroll

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Call for GPhA Awards!

The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA

138th Annual Convention in 2013. A brief description and criteria of each award is included below. Please select the award for which you would like to nominate someone and indicate their name on the form below. Deadline for submitting the completed nomination form is March 1, 2013. Nominations will be received by the Awards Committee and an individual will be selected for presentation of the Award at GPhA’s 138th Annual Convention at the Omni Amelia Island Plantation on Amelia Island, FL.

Bowl of Hygeia Award

Recognized as the most prestigious award in pharmacy, the Bowl of Hygeia is presented annually by GPhA and all state pharmacy associations. Selection Criteria: 1) The nominee must be a licensed Georgia pharmacist; 2) The Award is not made posthumously; 3) The nominee is not a previous recipient of the Award; 4) The nominee is not currently serving nor has served within the immediate past two years as an officer of GPhA other than ex-officio capacity or its awards committee; 5) The nominee has an outstanding record of service to the community which reflects will on the profession.

Distinguished Young Pharmacist Award

Created in 1987 to recognize the achievements of young pharmacists in the profession, the Award has quickly become one of GPhA’s most prestigious awards. The purpose of the Award is two-fold: 1) The encourage new pharmacists to participate in association and community activities, and 2) To annually

recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) The nominee must have received entry degree in pharmacy less than ten years ago; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.

Distinguished Young Pharmacist

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

Generation Rx Champions Award

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

Innovative Pharmacy Practice

Nominee’s Full Name Home Address

Generation Rx Champions

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

Supporting information:

Thursday, February 14, 2013 The Georgia Railroad Freight Depot - Freight Room (Across from the Capitol Building)

65 Martin Luther King Drive, SE, Atlanta, GA 30335

- Schedule of Events -

*Note: Schedule of events is tentative. We will continue to update you as it becomes permanent.

6:00 am - Registration and Exhibit Hall Opens with Coffee 6:30 am - GPhA Attendee Orientation 7:00 am - Breakfast with Your Legislator(s) 8:00 am - Presentation of GPhA Legislator of the Year Award and Closing Remarks 9:15 am - Group Photo on the Capitol Steps 10:00 am - Tour of the Georgia Capitol Building Special GPhA Recognitions to Be Made by Georgia House and Senate Members Plan to wear white coat and make your presence known at the Capitol. Parking directions available online.

Submitted by (optional):

Submit this form completed by March 1, 2013 to: GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324 or complete this form online at www.gpha.org.

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Innovative Pharmacy Practice Award

2013 Awards Nomination Form Bowl of Hygeia

Join Us For

The Georgia Pharmacy Journal

Call for GPhA Awards!

The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA

Bowl of Hygeia Award

Distinguished Young Pharmacist Award

Distinguished Young Pharmacist

Generation Rx Champions Award

Innovative Pharmacy Practice

Nominee’s Full Name Home Address

Generation Rx Champions

Nickname City

State

Zip

Practice Site Work Address

City

State

Zip

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

Supporting information:

Thursday, February 14, 2013 The Georgia Railroad Freight Depot - Freight Room (Across from the Capitol Building)

65 Martin Luther King Drive, SE, Atlanta, GA 30335

- Schedule of Events -

*Note: Schedule of events is tentative. We will continue to update you as it becomes permanent.

Submitted by (optional):

Submit this form completed by March 1, 2013 to: GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324 or complete this form online at www.gpha.org.

VIP Day

Innovative Pharmacy Practice Award

2013 Awards Nomination Form Bowl of Hygeia

Join Us For

The Georgia Pharmacy Journal

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Association Plans Are DIFFERENT (between ordinary and extraordinary)

continuing education for pharmacists Volume XXX, No. 9

Phytosterols and Cardiovascular Health Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio and J. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio Dr. Thomas A. Gossel and Dr. J. Richard Wuest have no relevant financial relationships to disclose.

Georgia Pharmacy Association proudly sponsors Meadowbrook Insurance Group for your Worker’s Compensation insurance needs.

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Goal. The goal of this lesson is to educate pharmacists on phytosterols (plant sterols), their mechanisms of action in reducing blood cholesterol levels, and implications for their use in promoting cardiovascular health. Objectives. At the completion of this activity, the participant will be able to: 1. define the term phytosterol and list specific types; 2. explain the mechanisms of action by which phytosterols act to reduce blood levels of low-density lipoprotein cholesterol; 3. identify natural dietary sources of phytosterols; 4. select the effective dose of phytosterols for reduction of cholesterol and avoidance of adverse effects; and 5. demonstrate an understanding of information and resources to convey to patients about phytosterols. Throughout history, plants have been consumed by humans and animals. In addition to being rich in fiber and plant protein, our ancestors’ diets were also rich in phytosterols – plant-derived sterols similar to cholesterol in structure and function. Much evidence exists that reintroduction of plant foods

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Gossel

Wuest

that provide phytosterols into today’s diet can reduce the risk of cardiovascular disease (CVD) by decreasing blood cholesterol levels. The major manifestation of CVD is coronary heart disease (CHD), which remains the leading cause of death in the developed world. Atherosclerosis, which damages coronary arteries, is the primary pathology involved in CHD.

LDL-Cholesterol is a Major Cause of CHD

Sixty to 70 percent of the total cholesterol (TC) concentration in humans consists of low-density lipoprotein cholesterol (LDL-C). It is the primary atherogenic (atherosclerosis-causing) lipid and its reduction in the blood is the main target of total cholesterol-lowering strategies. Hypercholesterolemia is a prerequisite for atherogenesis. Atherosclerosis progresses rapidly when LDL-C levels are high (160 to 189 mg/dL). At very high LDL-C levels (≥190 mg/dL), individuals can develop premature CHD, even in the absence of other risk factors. Those with high LDL-

C levels can experience premature CHD when other risk factors, such as smoking, hypertension or family history, are present. This is true, even when absolute risk according to Framingham Risk Scores is <10 percent over 10 years. There is little doubt that measures to lower LDL-C in persons with elevated levels can prevent atherogenesis. Using data from a large number of cohort studies, it has been shown that the benefits of blood cholesterol reduction are related to age. A 10 percent reduction in TC concentration attained at age 40 produces a reduction in CHD of 50 percent, 40 percent at age 50, 30 percent at age 60, and 20 percent at age 70. Some benefits can be realized right away, most after two years, and full benefit after five years. The Framingham Heart Study and the Multiple Risk Factor Intervention Trial (MRFIT), along with the Lipid Research Clinical Trial, demonstrated a direct relationship between LDL-C (or TC) levels and the rate of onset of new CHD in both men and women who were previously free of the disease. A similar positive correlation can be shown for recurrent coronary events in persons with established CHD. The widespread prevalence of high LDL-C levels in persons living in the United States who consume a typical Western diet accounts in large part for their near-universal development of coronary atherosclerosis and their

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Gossel

Wuest

LDL-Cholesterol is a Major Cause of CHD

Table 1 Selected food sources and their total phytosterol content Food Sources Oils Rice bran Corn Wheat germ Flax seed Cottonseed Soybean Peanut Olive Coconut Palm

Total Sterol Content (mg/100 g) 1055 952 553 338 327 221 206 176 91 49

Vegetables Beet root Brussels sprout Cauliflower Onion Cabbage Yam

25 24 18 15 11 10

Fruits Orange Banana Apple Cherry Peach Pear

24 16 12 12 10 8

Nuts Cashew Almond Pecan Pistachio Walnut

158 143 108 108 108

Legumes Pea Kidney bean Broad bean

135 127 124

Table spreads Take ControlÂŽ spread 100 mg free sterols per tablespoon (14g) BenecolÂŽ spread 500 mg free stanols per tablespoon (14g)

high risk of developing CHD over a lifetime. This risk is reported to be 49 percent for men and 32 percent for women. Atherogenesis. The development of atherosclerosis begins in adolescence as fatty-streak lipid deposits in arterial walls, and can be identified by gross pathological examination of coronary arteries. The streaks consist mainly of cholesterol-rich macrophages. The next phase embodies formation of fibrous plaque that is characterized by a layer of scar tissue overlaying a lipid-rich core. Eventually, unstable plaque may rupture and form luminal thrombi, which are responsible for most acute coronary syndromes (unstable angina, myocardial infarction [MI], coronary death). Elevated TC and LDL-C concentrations increase atherogenesis during the teenage years, with outcomes amplified by young adulthood, perhaps 20 to 30 years before coronary artery disease manifests clinically. Approximately 19 percent of men aged 30 to 34 years will have well-developed lesions in their left anterior descending coronary arteries. The significance of this early onset of atherosclerosis becomes even more apparent from observations of Klag and coworkers who showed that 22-year-old men with blood TC concentrations >5.45 mMol/L (approximately 209 mg/ dL or higher) were 5.6 times more likely to develop coronary artery disease, six times more likely to experience an MI, and 9.6 times more likely to die during the next 40 years than men whose TC level was <4.45 mMol/L (approximately 171 mg/dL or lower). The goal of therapy for all persons with elevated LDL-C levels is best achieved through an inclusive program that coordinates certain lifestyle changes along with drug therapies. Lifestyle therapy in clinical management, termed therapeutic lifestyle changes (TLC), is a four-step process that includes (1) reduced consumption of cholesterol and saturated fats, (2) dietary options employing phytosterols along

with increased viscous fiber to enhance LDL reduction, (3) weight control, and (4) increased physical activity.

Phytosterols

Phytosterols are essential structural components of the lipid membrane of plants. Free phytosterols serve to stabilize the membranes of plant cells just as cholesterol does in animal cell membranes. In animals, cholesterol is most often the sole product of sterol synthesis. However, each plant species has its own characteristic distribution of phytosterols. More than 40 phytosterols have been identified in nature. The most abundant are beta-sitosterol (65 percent), campesterol (30 percent) and others, mainly stigmasterol, with much lower levels of brassicasterol. These compounds are structurally similar to cholesterol, but differ in their side chains. Stanols are saturated sterols; that is, they have no double bonds in the sterol ring. Stanols are less abundant in nature than sterols, comprising only about 10 percent of total dietary phytosterols, and are produced by hydrogenating sterols. Stanols are more resistant to oxidation than sterols. The designation phytosterol is a collective term inclusive of both plant sterols and plant stanols. Phytosterols are found in vegetables and vegetable oils, seeds, nuts, table spreads, and some fruits (Table 1). A major source of phytosterols is tall oil, also called liquid rosin or tallol. It is a viscous yellow-black odorous liquid which is derived from tall trees, such as pines, during the pulping process. Tall oil contains significant levels of sitosterol, campesterol, and the naturally occurring saturated (stanol) compounds, sitostanol and campestanol. Stigmasterol and other sterols are also found in lesser quantities. The phytosterols exist in nature in free, non-esterified forms. Phytosterols can be present in Western diets in amounts almost equal to dietary cholesterol, with

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intake estimated to be approximately 250 mg/dL in nonvegetarians and about 500 mg/dL in vegetarians. Animal studies over the past 80 years have demonstrated that intestinal absorption in mammals is minimal, reported to be as little as 5 percent of total dietary intake. In contrast, intestinal absorption of cholesterol equals 50 to 60 percent of intake. In populations ingesting a typical Western diet, the major blood phytosterols are campesterol (approximately 0.33 mg/dL) and sitosterol (approximately 0.25 mg/dL) with the others present at much lower concentrations. Phytosterols contribute less than 1 percent to the total blood sterol concentration, which is comprised mainly of cholesterol (about 200 mg/dL). Phytosterols are not synthesized endogenously in humans, so all that is found in blood and tissues is derived from the diet, especially enriched foods, or oral dosage forms of phytosterols. Following absorption, phytosterols circulate in lipoprotein particles in either esterified or unesterified form, are rapidly secreted into bile, stored in the gallbladder, and released intermittently into the duodenum where they are incorporated into the fecal mass. The rate of phytosterol secretion into bile is much greater than that of cholesterol. The poor solubility of natural plant sterols and stanols in water and lipids can limit their usefulness in human applications and therapeutics. This problem has been partially overcome by esterifying them with mono- or polyunsaturated fatty acids. Esterification greatly increases their lipid solubility and ease of incorporation into food products such as table spreads and salad dressings. Following passage through the stomach, the esters undergo hydrolysis within the intestinal lumen as part of the normal digestive process, releasing free compounds. Phytosterols are Hypocholesterolemic. The cholesterollowering property of phytosterols was first demonstrated in 1951

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when Peterson fed plant sterols to chicks. Shortly thereafter, Pollak showed the same effect in humans by administering crude sitosterol at a dose of 5 to 10 g/day, over a span ranging from eight days to 14 months. He later observed that sitosterol was poorly absorbed from the intestine in rabbits, and when present in excess, blocked cholesterol absorption and ultimately prevented fatty streaking in coronary arteries. Lees and Lees were among the first to speculate on the desirable therapeutic use of phytosterols. They used a preparation derived from soybean oil that consisted of 60 to 65 percent sitosterol with the remainder being mainly campesterol. Doses of 18 g/day lowered blood cholesterol, but resulted in marked increases in blood levels of the plant sterols, especially campesterol, which is better absorbed than sitosterol. In another trial, investigators showed that ingestion of capsules of sitostanol dispersed in sunflower oil, at a dose of 12.5 g/day, lowered LDL-C by 15 percent in hypercholesterolemic adults. Two weeks after cessation of sitostanol administration, blood cholesterol returned to pretreatment levels. On the basis of these reports and other data, Eli Lilly & Co. introduced the first plant sterol product, Cytellin, in the mid 1950s as a cholesterol-lowering pharmaceutical. It consisted predominately of beta-sitosterol. Due to its low water solubility and the resulting low bioavailability, a daily intake of 18 g/day of sitosterol was needed to achieve a reduction in serum cholesterol levels. Because the daily dosage was impractical, production of Cytellin was stopped. In the early 1990s, researchers succeeded in the esterification of phytosterols by developing a process which considerably improved the water solubility of phytosterols. This process made it possible to greatly expand the market for phytosterols as dietary supplements, leading to a rapidly growing worldwide market.

The result is renewed interest in plant sterols as hypocholesterolemic agents to be used alone, or as agents to supplement drug therapy or phytosterol-enriched food. Combining phytosterols with an HMG-CoA reductase inhibitor (statin), for example, provides additional benefit on reducing LDL-C levels. The results of controlled clinical trials suggest that consumption of 2 to 3 g/day of plant sterols or stanols by individuals on statin therapy may result in an additional 7 to 11 percent reduction in LDL-C, an effect comparable to doubling the statin dose. Results of well-designed clinical trials demonstrated that plantderived stanol/sterol esters at dosages of 2 to 3 g/day lower LDL-C levels by 6 to 15 percent with little or no change in HDL-C or triglyceride levels. More recently, the Third Report of the National Cholesterol Education Programâ&#x20AC;&#x2122;s Adult Treatment Panel III (NCEP:ATP III) recommended that maximal lowering of LDL-C occurs at intakes of phytosterol/stanol esters of 2 g/ day. Despite potential advantages of stanols over sterols, a rigorous comparison of the two types had not been reported at the time of publication of the NCEP:ATP III. For this reason, NCEP:ATP III did not distinguish between them. LDL-C reductions are also noted in individuals with both hypercholesterolemia and type 2 diabetes (T2DM), and in children with hypercholesterolemia. It has been proposed that phytosterol consumption of 2 g/day equivalents would reduce the risk for development of heart disease by 25 percent. Unfortunately, it is not feasible to conduct a clinical trial of adequate size and power to test this hypothesis. To test this assumption and prove effectiveness in reducing heart disease, a randomized clinical trial with CHD as the primary endpoint would be required. For such a trial to detect a 12 to 20 percent reduction in CHD incidence, 10,000 to 15,000 patients with CHD (and a greater number of persons without CHD to

Table 1 Selected food sources and their total phytosterol content Food Sources Oils Rice bran Corn Wheat germ Flax seed Cottonseed Soybean Peanut Olive Coconut Palm

Total Sterol Content (mg/100 g) 1055 952 553 338 327 221 206 176 91 49

Vegetables Beet root Brussels sprout Cauliflower Onion Cabbage Yam

25 24 18 15 11 10

Fruits Orange Banana Apple Cherry Peach Pear

24 16 12 12 10 8

Nuts Cashew Almond Pecan Pistachio Walnut

158 143 108 108 108

Legumes Pea Kidney bean Broad bean

135 127 124

Table spreads Take ControlÂŽ spread 100 mg free sterols per tablespoon (14g) BenecolÂŽ spread 500 mg free stanols per tablespoon (14g)

with increased viscous fiber to enhance LDL reduction, (3) weight control, and (4) increased physical activity.

Phytosterols

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serve as controls) would be needed. This is economically impractical, so current data must suffice.

Mechanism(s) of Hypocholesterolemic Action

Several mechanisms of action have been proposed for the cholesterollowering efficacy of phytosterols. As with cholesterol, phytosterols are incorporated into mixed micelles before they are taken up by enterocytes, cells that line the intestinal wall. Mixed micelles are mixtures of bile salts, lipids and sterols formed in the small intestine after a fat-containing meal is consumed. It is well documented that their action is primarily through reduced absorption of cholesterol as a result of its displacement from the micelles. Cholesterol displaced from the micelles is not absorbed and, thus, excreted in the feces. In response to decreased cholesterol absorption, tissue LDL-receptor expression is upregulated (more receptors are formed), which results in increased clearance of circulating LDL. Phytosterols can inhibit up to 50 percent of intestinal cholesterol absorption and increase fecal elimination of both dietary and biliary cholesterol, without causing a significant shift from larger to smaller, more atherogenic LDL particles in the blood. Phytosterols also activate the adenosine triphosphate-binding cassette A1 (ABCA1) transporter and most likely ABCG5 and ABCG8 transporters in enterocytes. ABCG5 and ABCG8 each form one-half of a transporter that is responsible for the reverse transport of cholesterol and absorbed phytosterols from enterocytes back into the intestinal lumen. Phytosterols are secreted back into the intestine by ABCG5/G8 transporters at a much greater rate than cholesterol, which results in much lower intestinal absorption of dietary phytosterols than cholesterol. Most clinical trials have investigated the effect of phytosterols ingested in two or, more commonly, three divided doses each day taken

with meals. This regimen is based on the presumption that the compounds need to be present in the intestinal lumen postprandially to compete with cholesterol within mixed micelles and inhibit its absorption, thereby achieving an optimal hypocholesterolemic effect. This hypothesis has been challenged, however. Plat and coworkers compared the effects of margarine-based stanol ester given in a single daily dose or three divided doses, and showed that the decrease in LDL-C in subjects on the single-dose regimen did not differ significantly from that in subjects on divided doses. The persistence of the single-dose hypocholesterolemic effect strongly supports the notion that stanols not only compete with cholesterol for micellar solubilization, but also have an additional, longer-lasting effect on intestinal mucosal cells.

Selected Studies that Support Phytosterolsâ&#x20AC;&#x2122; Hypocholesterolemic Activity

A number of controlled clinical trials have shown that phytosterols safely and effectively reduce blood levels of LDL-C and TC. The majority of these trials have used phytosterol-enriched food as a treatment choice. In terms of carriers, there is abundant evidence to support the beneficial LDL-C lowering efficacy of phytosterols either as plant sterols or stanols when incorporated into various foods, including yogurt, low-fat milk, orange juice, ground beef, mayonnaise, chocolate, cereal, snack bars and breads. In investigations that have compared plant sterols with plant stanols, no difference in LDL-C lowering effect has been demonstrated and the compounds can be considered to be comparable. Food Enrichment with Phytosterols. One of the bestknown studies is the year-long randomized, double-blind clinical trial undertaken by Miettinen and coworkers. One hundred-two hypercholesterolemic subjects consumed 1.8 or 2.6 g/day of sitostanol

contained in margarine; 51 others consumed margarine without sitostanol. Subjects taking the higher dose exhibited a 14 percent decrease in LDL-C after 12 months, compared with a 1 percent increase in persons using the control spread. There were no significant adverse effects. Hendriks et al evaluated the hypocholesterolemic effect of three different intake levels of esterified soybean sterols at doses of 0.83, 1.61 or 3.24 g/day incorporated into table spreads. In this randomized, double-blind, placebo-controlled trial, 100 healthy normocholesterolemic and mildly hypercholesterolemic volunteers consumed four table spreads (one of three treatment [sterol-enriched] concentrations or a control) with lunch and dinner, each for a period of 3.5 weeks. Compared to the control spread, the three relatively low dosages of phytosterols produced a significant cholesterol lowering effect in LDL-C by 6.7 to 9.9 percent and TC by 4.9 to 6.8 percent. The LDL/HDL ratio decreased by 6.5 to 7.9 percent. There was no significant difference in cholesterol lowering activity between the three dosages of phytosterols. In an extensive meta-analysis of 23 clinical trials of plant sterolenriched foods and 27 clinical trials of plant stanol-enriched foods, doses of 2 g/day of either plant sterols or stanols lowered LDL-C by about 10 percent. Higher doses did not improve the cholesterol lowering efficacy of either group. The results of numerous investigations hold that the minimum effective dose for lowering LDL-C is 0.8 g/day. It has been proposed, largely on theoretical grounds, that stanol esters derived from wood sources such as tall oil, which contain primarily sitostanol, might be more effective in inhibiting cholesterol absorption than stanol esters derived from vegetable sources, such as soybeans (up to 33 percent of which is campestanol). However, the results of three separate studies have shown that there is no significant difference in the LDL-C

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lowering effect of sitostanol esterrich versus campestanol ester-rich mixtures. Thus, the composition of stanol esters would appear to be irrelevant to their efficacy, the source being determined by market forces such as availability and cost. Direct Oral Dosing. Most reports showing LDL-C lowering activity have involved phytosterols mixed into food. The question remains whether phytosterols administered in an oral dosage form would demonstrate similar properties. Pharmaceutical dosage forms, such as tablets and capsules, can be more convenient and flexible for the recommended long-term usage than the traditional food applications. In addition, these dosage forms of phytosterols are easier to incorporate into therapeutic regimens involving statins and other hypocholesterolemic drugs. Woodgate and associates administered sitostanol ester in softgel capsules. Thirty hypercholesterolemic adults were supplemented with 1.6 g of free phytostanol equivalents as phytostanol ester (2.7 g stanol esters) or placebo, each day for 28 days in a randomized, double-blind, parallel study design. Subjects were instructed to maintain their regular eating habits and physical activity. Phytostanol supplementation resulted in a significant decrease in TC of 8 percent and LDL-C of 9 percent. In another trial, Acuff et al studied the effect of plant sterol esters in soft-gel capsules. Sixteen subjects participated in a doubleblind, placebo-controlled, sequential study with a four-week placebo phase followed by a two-week washout period and a four-week treatment phase. They were instructed to maintain their normal diet and exercise programs. Treatment consisted of doses of 1.3 g/day (equivalent to 0.8 g/day free sterol). Blood samples were collected at day 7, 21 and 28 of each phase. Primary measurements were change in blood TC, LDL-C and HDL-C between phases and within each phase. In comparison to placebo, LDL-C was significantly reduced by

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7 percent and 4 percent at week 3 and week 4, respectively; HDL was significantly increased by 9 percent at week 3 of the treatment, but not at week 4; TC was not significantly different from placebo throughout the trial period.

Safety

An important question is whether it is safe to supplement the daily diet with phytosterols. They are virtually unabsorbed, and their consumption does not produce significant adverse effects. When adverse effects occur, they are usually mild and transient. The most frequently reported are of gastrointestinal origin (nausea, indigestion, diarrhea and constipation). In one study, individuals who consumed a plant sterol-enriched table spread providing 1.6 g/day for up to one year did not report more adverse effects than those consuming a control spread. In another, persons consuming a plant stanol-enriched spread providing 1.87 to 2.6 g/day for one year did not report any adverse effects. Consumption of up to 8.6 g/day of phytosterols in margarine for three to four weeks was well tolerated by healthy men and women, and did not adversely affect intestinal bacteria or female hormone levels. The debate regarding sterol versus stanol safety is centered on their differing intestinal absorptions and resulting plasma concentrations. Beta-sitosterolemia. This is a rare autosomal inherited disorder that results from mutations in one or both of two adjacent genes, ABCG5 and ABCG8. As noted earlier, these genes encode transporters that regulate blood plant sterol levels by limiting the reverse transport of cholesterol and absorbed phytosterols from enterocytes back into the intestinal lumen. Although blood cholesterol levels may be normal or only slightly elevated, affected individuals (especially young men) are at high risk for premature atherosclerosis with CHD development, suggesting that high blood levels of phytosterols may be particularly atherogenic.

Because of concerns that increased absorption of plant sterols resulting from higher intakes may be pathogenic, some investigators have suggested that caution is needed in their recommendation. However, the degree of risk associated with high blood phytosterol levels in otherwise normal individuals is much below the risk of toxicity attained in patients with beta-sitosterolemia. Prudence dictates that persons with betasitosterolemia avoid excessive phytosterol ingestion.

Recommendations for Use of Phytosterols in Management of Hypercholesterolemia

The dosage recommendation of 0.8 to 1 g/day of free sterol and free sterol equivalents compares favorably with FDAâ&#x20AC;&#x2122;s proposed rule that recommends inclusion of 0.65 g of sterol esters per serving, twice per day, in table spreads, which is equivalent to 0.8 g/day of free sterol equivalents. On December 8, 2010, FDA recognized that the scientific literature supported expansion of the health claim to include free forms of plant sterols and stanols, and to approve of their use in a wider range of food products, including low-fat products. FDA further stated that there was sufficient evidence to recommend that the lowest effective daily intake of free phytosterols was 0.8 g/day. FDA has granted phytosterols GRAS (generally recognized as safe) status when used as food additives. The agency also tentatively approved the claim that doses of 0.8 g/day or more, expressed as the weight of free phytosterol, may reduce the risk of CHD. TLC remains the cornerstone of treatment for patients with hyperlipidemia. The most powerful LDLC lowering component of dietary therapy consists of adding phytosterols. Consumption from natural sources should be encouraged for all persons, following consultation with a clinician. Individuals who consume phytosterols regularly should also cut back on dietary fat

serve as controls) would be needed. This is economically impractical, so current data must suffice.

Mechanism(s) of Hypocholesterolemic Action

Selected Studies that Support Phytosterolsâ&#x20AC;&#x2122; Hypocholesterolemic Activity

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Safety

Recommendations for Use of Phytosterols in Management of Hypercholesterolemia

Table 2 Selected websites for additional information www.fitness.gov www. nhlbi.nih.gov/health/prof/heart/ www.nhlbi.nih.gov/hbp www.nutrition.gov

intake and increase physical activity. This same advice holds true for all individuals who consume a typical Western diet. The sooner in life that treatment is begun to lower LDL-C levels, the greater the reduction in relative risk for development of CHD. Individuals should start early in life to slow the onset of atherogenesis, and lower their LDL-C levels when they are higher than normal. Some choose to downplay the importance of data on projected expansion of longevity based on epidemiological data. Investigation with HMG-CoA reductase inhibitors (statins), which are first line pharmaceutical treatment for reduction of LDL-C in most patients, indicates that a 1 percent reduction in LDL-C reduces risk of CHD by about 1 percent. However, epidemiological studies across the globe strongly support the notion that maintaining lower blood cholesterol levels for periods beyond the duration of clinical trials yields a greater reduction in risk than is predicted from the trials, since clinical trials by their very nature are closedended. In populations that maintain very low cholesterol levels throughout life, the risk for CHD is much lower at any age than in populations that habitually maintain higher cholesterol levels. In contrast, in high-risk populations, the reduction in CHD attained with aggressive hypocholesterolemic therapy still leaves absolute CHD rates far above those in low-risk populations.

Importance of Patient Adherence to Therapy Instructions

Results from numerous studies have demonstrated that the variability in lipoprotein responsiveness to treatment is often due to poor compliance with therapy instructions. There is a strong likelihood that reported reductions in LDL-C recorded with doses of 0.8 g/ day might be greater if full compliance with phytosterol dosage and instructions were assured. In studies where subjects were monitored closely to ensure full compliance with therapy, efficacy in LDL-C lowering with a 1.5 to 2 g/day dose ranged from 12 to 16 percent. Patient counseling along with written instructions appears to have the greatest impact on improving short-term therapy adherence, but less impact on long-term regimens. A patient who admits to nonadherence with therapy means he or she is usually telling the truth. A patient who denies nonadherence with long-term therapy translates into his or her telling the truth about half the time. About one-third of patients will remain adherent with therapy just from having its importance stressed by a trusted healthcare professional. Fifteen to 25 percent will be nonadherent with therapy even with the most vigorous consultations. Interventions to improve adherence, then, are optimally aimed at the middle 50 percent of individuals who may adhere if given support and encouragement.

products containing phytosterols provides convenience in dose formulation and administration, and lower cost, compared to the use of conventional hypocholesterolemic drugs. The importance of patient adherence to dosing instructions cannot be overstated. The websites listed in Table 2 provide additional information on areas covered in this lesson. The authors, the Ohio Pharmacists Foundation and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the information 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.

Program 0129-0000-12-009-H01-P Release date: 9-15-12 Expiration date: 9-15-15

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continuing education quiz

Please print.

Phytosterols and Cardiovascular Health

Address_____________________________________________

1. Sixty to 70 percent of the total cholesterol concentration in humans consists of: a. HDL-C. c. VLDL-C. b. LDL-C. 2. The Lipid Research Clinical Trial demonstrated a direct relationship between total cholesterol (TC) levels and the rate of onset of new coronary heart disease (CHD) in: a. both men and women. c. women but not men. b. men but not women. 3. Which of the following food sources has the highest total phytosterol content? a. Banana c. Olive oil b. Cabbage d. Walnut 4. The fatty-streak lipid deposits in arterial walls consist mainly of cholesterol-rich: a. apolipoproteins. c. granulocytes. b. cytokines. d. macrophages. 5. Elevated concentrations of which of the following sets of lipids increases atherogenesis during teenage years? a. HDL-C and TC c. HDL-C and VLDL-C b. LDL-C and VLDL-C d. LDL-C and TC 6. Approximately 19 percent of men aged 30 to 34 years will have well-developed lesions in which of the following areas of their coronary arteries?

a. Left anterior ascending c. Left anterior descending b. Right posterior ascending d. Right posterior descending

7. The most abundant phytosterol in nature is: a. alpha-sitosterol. c. gamma-sitosterol. b. beta-sitosterol. d. delta-sitosterol.

Completely fill in the lettered box corresponding to your answer. 1. 2. 3. 4. 5.

Summary and Conclusion

Therapeutic lifestyle changes remain an essential modality in clinical management of hypercholesterolemia. LDL-C reduction forms the basis to effectively reduce CHD. Plant sterols and stanols are safe and effective, well-tolerated hypocholesterolemic agents. At recommended intakes, food enriched with phytosterols, or oral products containing them with at least an 0.8 g/ day equivalent dose, can help lower LDL-C without causing significant side effects. Oral administration of

[a] [a] [a] [a] [a]

[b] [b] [b] [b] [b]

[c] 6. [a] [c] 7. [a] [c] [d] 8. [a] [c] [d] 9. [a] [c] [d] 10. [a]

[b] [c] [d] [b] [c] [d] [b] [b] [c] [d] [b]

11. [a] 12. [a] 13. [a] 14. [a] 15. [a]

[b] [b] [b] [b] [b]

[c] [d] [c] [d]

[c] [d] [c]

 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  no 4. Did the program meet your educational/practice needs?  yes  no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

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Program 0129-0000-12-009-H01-P 0.15 CEU

Name________________________________________________

City, State, Zip______________________________________ Email_______________________________________________ NABP e-Profile ID*__________________________________ *Obtain NABP e-Profile number at www.MyCPEmonitor.net.

Birthdate____________

(MMDD)

Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990

8. Stanols are saturated sterols. a. True b. False 9. Following absorption, phytosterols circulate in lipoprotein particles in which of the following forms? a. Esterified c. Either esterified or unesterified b. Unesterified d. Neither esterified or unesterified 10. Combining phytosterols with an HMG-CoA reductase inhibitor (statin) provides additional benefit on reducing LDL-C levels. a. True b. False 11. Mixtures of bile salts, lipids and sterols formed in the small intestine after a fat-containing meal is consumed are known as mixed: a. stanols. c. fatty acids. b. micelles. d. chyme. 12. Phytosterols most likely activate which of the following transporters in enterocytes? a. ABCG2 c. ABCG4 b. ABCG3 d. ABCG5 13. When different intake levels of esterified soybean sterols at doses of 0.83, 1.16, or 3.24 g/day were studied, the results showed no significant difference in cholesterol lowering activity between the three dosages. a. True b. False 14. The most frequently reported adverse effects seen from the consumption of phytosterols include all of the following EXCEPT: a. constipation. c. heartburn. b. diarrhea. d. nausea. 15. FDA’s proposed rule for the dosage of sterol esters in therapy of hypercholesterolemia recommend including which of the following dosages, twice a day, in table spread? a. 0.35 g per serving. c. 1.30 g per serving. b. 0.65 g per serving.

To receive CE credit, your quiz must be received no later than September 15, 2015. A passing grade of 80% must be attained. All quizzes received after July 1, 2012 will be uploaded to the CPE Monitor Program and a statement of credit will not be mailed. Send inquiries to opa@ohiopharmacists.org.

september 2012 27

Table 2 Selected websites for additional information www.fitness.gov www. nhlbi.nih.gov/health/prof/heart/ www.nhlbi.nih.gov/hbp www.nutrition.gov

Importance of Patient Adherence to Therapy Instructions

Program 0129-0000-12-009-H01-P Release date: 9-15-12 Expiration date: 9-15-15

CE Hours: 1.5 (0.15 CEU) The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

continuing education quiz

Please print.

Phytosterols and Cardiovascular Health

Address_____________________________________________

a. Left anterior ascending c. Left anterior descending b. Right posterior ascending d. Right posterior descending

7. The most abundant phytosterol in nature is: a. alpha-sitosterol. c. gamma-sitosterol. b. beta-sitosterol. d. delta-sitosterol.

Completely fill in the lettered box corresponding to your answer. 1. 2. 3. 4. 5.

Summary and Conclusion

[a] [a] [a] [a] [a]

[b] [b] [b] [b] [b]

[c] 6. [a] [c] 7. [a] [c] [d] 8. [a] [c] [d] 9. [a] [c] [d] 10. [a]

[b] [c] [d] [b] [c] [d] [b] [b] [c] [d] [b]

11. [a] 12. [a] 13. [a] 14. [a] 15. [a]

[b] [b] [b] [b] [b]

[c] [d] [c] [d]

[c] [d] [c]

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Program 0129-0000-12-009-H01-P 0.15 CEU

Name________________________________________________

Birthdate____________

(MMDD)

Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990

september 2012 27

Georgia Pharmacy Association

2012-2013 BOARD OF DIRECTORS Name

Position

L. Jack Dunn Chairman of the Board Robert M. Hatton President Pamala S. Marquess President-Elect Robert B. Moody First Vice President Second Vice President Thomas H. Whitworth State At Large Hugh M. Chancy Liza G. Chapman State At Large State At Large Keith N. Herist Joshua D. Kinsey State At Large State At Large Tracie D. Lunde Eddie M. Madden State At Large State At Large Jonathan G. Marquess Christine Somers 1st Region President Ed S. Dozier 2nd Region President Renee D. Adamson 3rd Region President Nicholas O. Bland 4th Region President 5th Region President Julie W. Bierster Sherri S. Moody 6th Region President Amanda McCall 7th Region President Michael Lewis 8th Region President Kristy L. Pucylowski 9th Region President Lance P. Boles 10th Region President Ashley London 11th Region President Ken Von Eiland 12th Region President Thomas R. Jeter ACP Chairman Sharon B. Zerillo AEP Chairman Archie R. Thompson AHP Chairman Drew Miller AIP Chairman Linda Gail Lowney APT Chairman ASA Chairman Robert Bentley John T. Sherrer Foundation Chairman Michael E. Farmer Insurance Trust Chairman Bill Prather Georgia Board of Pharmacy Chariman Kenneth G Jozefcyk Georgia Society of Health Systems Pharmacists Amy C. Grimsley Mercer Faculty Representative Rusty Fetterman South Faculty Representative Sukhmani K. Sarao UGA Faculty Representative Negin Sovaidi Moon ASP, Mercer University TBD ASP, South University James William Spence ASP President, UGA Jim Bracewell Executive Vice President

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