The Georgia Pharmacy Journal: January 2010

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Come Experience What Others Already Know... The Insurance Trust

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Call or e-mail TODAY to schedule a time to discuss your health insurance needs.

Trevor Miller – Director of Insurance Services 404.419.8107 or email at tmiller@gpha.org Georgia Pharmacy Association Members Take Advantage of Premium Discounts Up to 30% on Individual Disability Insurance Have you protected your most valuable asset? Many people realize the need to insure personal belongings like cars and homes, but often they neglect to insure what provides their lifestyle and financial well-being - their income! The risk of disability exists and the financial impact of a long-term disability (90 days or more) can have a devastating impact on individuals, families and businesses. During the course of your career, you are 3½ times more likely to be injured and need disability coverage than you are to die. (Health Insurance Association of America, 2000) As a member of the Georgia Pharmacy Association, you can help protect your most valuable asset and receive premium discounts up to 30% on high-quality Individual Disability Income Insurance from Principal Life Insurance Company.

For more information visit www.gphainsurance.com. * Association Program subject to state approval. Policy forms HH 750, HH 702, HH 703. This is a general summary only. Additional guidelines apply. Disability insurance has limitations and exclusions. For costs and details of coverage, contact your Principal Life financial representative.

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Departments

Alaska Cruise Continuing Education at Sea FEATURE ARTICLES

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Pharmacy Technician Employment increasing up to 32 Percent by 2016 Quick Facts for Clinicians on Antiviral Treatment for 2009 H1N1 MTM Opportunities Grow in Georgia Generic Substitution in the State of Georgia Innovative Pharmacy Practice ­ The Patient Centric Model

10 New Practitioner Leadership Conference Nomination Form 16 GPhA New Members 19 GPhF Annual Fund Giving Form 20 Pharm PAC Contribution Card 23 Call for Awards Nominations 31 GPhA Board of Directors

Advertisers 2 2 5 6 12 13 14 18 20 20 21 22 24 24 32

The Insurance Trust Principal Financial Group Pharmacy Quality Commitment Pharmacists Mutual Companies Logix, Inc. Michael T. Tarrant PharmStaff AIP Melvin M. Goldstein, P.C. Toliver & Gainer Georgia’s Own Credit Union PACE Alliance GPhA Career Center MTM Toolkit The Insurance Trust

CPE Opportunity: Access to Good Quality Dietary Supplements

COLUMNS

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President’s Message Editorial

For an up­to­date calendar of events, log onto

www.gpha.org.

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PRESIDENT’S MESSAGE Eddie M. Madden, R.Ph. GPhA President

Politics 2010 This year will be a very important year to pharmacists in Georgia and to healthcare providers throughout the United States. National healthcare reform is on the forefront in Congress. Several issues are on the table in this debate. AMP is being batted around with numbers being considered that may still leave pharmacies dispensing generic drugs below acquisition cost. This will impact all community pharmacies and jeopardize the viability of pharmacy operations.

external interests will have little effect in the selection process, the Speaker’s appointment of committees and chairmen are of great concern. Hopefully a Speaker friendly to pharmacy will be chosen. We will probably not see changes to the committee structure during this session, but a new Speaker will play a significant role in the 2011 session, which will follow statewide elections of all members of the Georgia Legislature. How important are the elections of 2010? The Academy of Independent Pharmacy has recognized that it is important to the tune of committing to fund political action efforts at a quarter of a million dollars!!! With a new governor being elected, it is imperative that pharmacy in Georgia has a governor that is pharmacy friendly. AIP is asking their membership to contribute $500.00 each toward this venture. The Academy recognizes that supporting the re-election of leadership positions in the House and Senate are critical to having influence on the movement of pharmacy legislation. I would like to challenge our other academies to make a commitment to increase their support of Pharm PAC. With every seat in the legislature up for re-election and the Governor, Lieutenant Governor, Insurance Commissioner, and Secretary of State up for election, a lot of financial resources will be required.

The requirement of accreditation for pharmacies is still under consideration but the definition of how to define which pharmacies will be exempt is still being debated. NCPA is asking that the language be changed to exempt pharmacies that bill Medicare for less than five percent of their sales. As of this writing this exemption may not be signed into law before the December 31, 2009 deadline for the requirement of accreditation. Changes are coming in Georgia during 2010. The Session will bring a new Speaker, with Mark Burkhalter, Speaker Pro Tem, assuming the interim role as Speaker. After indicating that he would set a “new tone” Speaker Pro Tem Burkhalter has announced he will not be a candidate for Speaker and will call for an election when the House convenes for the 2010 Session. Election of a new Speaker is important to the political process since the Speaker is the second most powerful man in Georgia. While

The Georgia Pharmacy Journal

VIP Day at the Capitol, which is scheduled for February 17, will also provide another opportunity for

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every pharmacist in the State to become personally involved in heightening the presence of pharmacists’ stature in the Georgia Legislature. The day will begin at the Sloppy Floyd Building with a breakfast and will feature speeches from our political leaders. Afterwards, attending pharmacists and pharmacy students wearing their white coats will move to the Capitol. This is an impressive site with hundreds of white coats walking the halls of the Capitol and being in the House and Senate Galleries for recognition by the respective bodies.

to the participant. You will be able to better understand the legislative process and put faces to the names of legislators and legislative leaders. The finale will be a group photo with the Governor. Make a commitment to becoming involved and join GPhA at VIP Day on February 17. Grab your white coat and be there. Sign up is easy at www.gpha.org. Politically, 2010 will be a very busy year. As a member you can count on GPhA being involved. The political process is and always has been about grassroots involvement. That means without you, GPhA cannot be as successful as pharmacy needs to be. Make a New Year’s Resolution to do your part in making pharmacy have a better future!

VIP Day is strongly supported by the schools of pharmacy in the State. Each of the three schools has made it a priority to have their students participate. It has proven to be a very effective way of getting future pharmacists to become acquainted with Georgia’s political process and prepare them to become grassroots advocates. VIP Day has been growing in participation with practicing pharmacists. I realize that to participate means taking a day off and being in Atlanta at 7:30 a.m., but the rewards of the experience will mean a lot

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EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO

2010: To Whom Does the Future Belong? improve as a professional association. As your Executive Vice President, I took the Task Force work to the Directors of GPhA and more specifically to Director of Public Affairs, Kelly McLendon, and to Director of Government Affairs, Stuart Griffin, for their critique and input. Having almost twenty years of association work on my resume, I was able to weigh in on this project as well.

“The future does not belong to those who are content with today, apathetic toward common problems and their fellow man alike, timid and fearful in the face of bold projects and new ideas. Rather, it will belong to those who can blend passion, reason and courage in a personal commitment to the great enterprises and ideals of American society.” Senator Robert Kennedy

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t the end of January, the GPhA Board of Directors will meet in their continuing efforts to lead the Georgia Pharmacy Association to a brighter, stronger future for the benefit of the profession of pharmacy.

The GPhA Directors and I totally support and agree that Membership and Advocacy should be the two key components of any strategy for our future. If in the wisdom of the Board they adopt this plan, then the plan will be reviewed at each future Board meeting together with ongoing status reports of its progress. The plan will remain constant, but the short term objectives will need adjustment and approval to ensure that we stay focused on these two goals for the future.

I reported to you in my November 2009 article that under the leadership of GPhA President, Eddie Madden, GPhA had convened a Strategic Planning Workshop made up of a broad based group of members for a weekend in Atlanta in October. We challenged their knowledge, we challenged their passion for pharmacy and they compiled a list of desired components of a 2010 strategic plan for the consideration of the Board of Directors.

One of my favorite axioms is “The best way to predict the future is to create the future.” That is what this exercise is all about, securing a great future for the profession by building a strong professional association. The future of pharmacy in Georgia belongs to us. If you are not a member, come join us now for an exciting 2010.

The consensus report of their work found that the Georgia Pharmacy Association should strategically focus our resources in two areas, Membership and Advocacy, if GPhA is to continue to grow and

“The future does not belong to those who are content with today, apathetic toward common problems and their fellow man alike, timid and fearful in the face of bold projects and new ideas. Rather, it will belong to those who can blend passion, reason and courage in a personal commitment to the great enterprises and ideals of American society.” Senator Robert Kennedy The Georgia Pharmacy Journal

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TECHNICIAN NEWS

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PHARMACY NEWS

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MTM News

MTM Opportunities Grow in Georgia: Local pharmacists already making a difference with Outcomes® MTM services utcomes Pharmaceutical Health Care® (Outcomes) has thousands of Medication Therapy Management (MTM)-eligible patients available for local pharmacists to serve in the state of Georgia today. Some pharmacies have already started serving their patients:

TIPs to its claims platform and distributes TIPs by mail to pharmacies. Pharmacists may respond to TIPs by fax or mail before contracting and training are complete. TIPs are now in pharmacies and are a great way to get started with Outcomes MTM services!

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To join other Georgia pharmacists who have already started with the program, simply complete the following two steps:

Encounter #574111 – Cost Efficacy Management While filling a prescription for an Outcomes-covered patient at Big C Pharmacy in Thomaston, GA, Outcomes Personal Pharmacist, Robert Bowles, identified a potential cost savings opportunity. The pharmacist discussed similarly effective yet less expensive depression therapy options with the patient and with the patient’s permission, consulted with her physician. The physician agreed with the pharmacist’s recommendation and approved the medication change. The pharmacist’s intervention reduced the patient’s monthly drug costs while maintaining disease control. Keep up the good work, Robert!

Pharmacy Contracting: To participate, each pharmacy must complete an Outcomes MTM Network Participation Agreement. Go to www.getoutcomes.com Click on the tab labeled “Pharmacists” at the bottom of the screen Select “Pharmacy Contracting” Pharmacist Training: To be eligible to provide these MTM services and receive professional fees, pharmacists must complete the Outcomes Personal Pharmacist™ training program. Go to www.getoutcomes.com Click on the tab labeled “Pharmacists” at the bottom of the screen Select “Pharmacist Training”

Patients in Outcomes MTM programs are eligible for a full menu of services, including a once-annual Comprehensive Medication Review; Prescriber Consultations for cost (such as the intervention featured above), quality and safety issues; Patient Compliance Consultations and Patient Education & Monitoring. MTM fees available for each covered service appear below: Comprehensive Medication Reviews (CMR) Prescriber Consultations Patient Compliance Consultations Patient Education & Monitoring

For more information, please contact Outcomes at 877.237.0050 or info@getoutcomes.com.

$50.00 $20.00 $20.00 $10.00

Pharmacy-specific lists of eligible patients are available upon log-in to the Outcomes MTM documentation and billing platform (www.getoutcomes.com). In addition to pharmacist-identified services, Outcomes also works to assist pharmacists with the identification of MTM services. Known as TIPs®, these interventions may target cost savings opportunities for the patient, inappropriate compliance, potentially contraindicated drugs, and other drug therapy problems. Outcomes uploads

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GEORGIA DRUGS AND NARCOTICS NEWS

Generic Substitution in the State of Georgia Michael Karnbach, Pharm.D. Special Agent Georgia Drugs and Narcotics

harmacists in the State of Georgia, utilize education, training and experience to form professional opinions within the practice of pharmacy. Generic substitution is one of the best examples of utilizing professional opinion to serve the patient. The Georgia State Board of Pharmacy, through Georgia law, provides guidance regarding generic substitution. The Georgia Pharmacy Practice Act O.C.G.A. 26-4-81(a) reads as follows:

the prescriber. A prescriber may also request the prescription to be filled with the brand name product. According to O.C.G.A 26-4-81(g):

“In accordance with this Code section, a pharmacist may substitute a drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist´s reasonable professional opinion, pharmaceutically equivalent.”

Please remember, state law will vary regarding generic substitution. Pharmacists licensed in other states are encouraged to educate themselves regarding their applicable state’s laws and regulations. To read more on The Georgia Pharmacy Practice Act, please visit http://www.lexisnexis.com/hottopics/ gacode/default.asp Title 26, Chapter 4, Article 5.

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While pharmacists are allowed to make generic substitutions, there are two situations in which the pharmacist must fill the prescription with the brand name medication. The first situation is at the patient’s request. If the patient would rather have the brand name product, the patient may instruct the pharmacist not to substitute the generic product.

“A practitioner of the healing arts may instruct the pharmacist not to substitute a generic name drug in lieu of a brand name drug by including the words ‘brand necessary’ in the body of the prescription. Such indication of brand necessary must be in the practitioner´s own handwriting and shall not be printed, applied by rubber stamp, or any such similar means.”

The second situation in which a pharmacist is prohibited from making a generic substitution, is initiated by The Georgia Pharmacy Journal

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PHARMACY NEWS

Innovative Pharmacy Practice - The Patient Centric Model

Jessica Baugh, Pharm. D. Executive Resident 2009­2010 National Alliance of State Pharmacy Associations (NASPA) Molly Skinner, Pharm. D. NASPA Executive Resident 2008­2009

This model, developed in 1996 by pharmacist John Sykora of Long Beach Island, California, was initiated to manage patients’ prescriptions, with the added benefit of managing work flow, inventory, billing, and hours of operation. He discovered it also reduced stress for the patient and business and allowed the pharmacist to provide more direct patient care services such as MTM and disease state management. In 2008, the National Alliance of State Pharmacy Associations (NASPA) began working with state pharmacy associations on a pilot program to implement PCM in pharmacies nationwide. The goal for the PCM pilot was to have approximately 150 pharmacies enrolled with a total of 3,000 patients by the end of 2009.

“Drugs don’t work if people don’t take them.” - C. Everett Koop, 1985

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he typical pharmacy model has not changed for many years. The pharmacy is dependent on the patient bringing in their new prescription or calling when and if they remember to get their prescriptions refilled. The pharmacy staff answers inbound phone calls, contacts physicians, waits for callbacks and then fills prescription orders. The expectation is that the patient arrives at the pharmacy to pick up their medicines. This system is both endemic and inefficient. Patients with multiple prescriptions often call multiple times during the month, which results in inefficiencies for both patients and store operations. This method of operation is full of “unknowns,” and diminishes the ability of the pharmacy staff to implement efficiencies that would free up valuable time for other pharmacy services. The Patient Centric Model (PCM) is a synchronized prescription refill program that allows the pharmacist to take control of his or her practice, ending the “tail wagging the dog” scenario common to community pharmacy practice. The purpose of the program is to improve patient’s medication persistency which could lead to improved health outcomes. The goal is to migrate the patients that are taking multiple, ongoing prescriptions for chronic conditions to an appointment-based model. With the implementation of the program, patients are able to work together with their pharmacy and play a more active role in their own health care. They no longer have to remember to call in chronic prescription refills; they build a relationship with their pharmacy, and save valuable time each month. The pharmacy also benefits as the program improves the operational efficiencies such as inventory turnover, inventory on hand, and staff satisfaction.

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When patients are informed about the program, they are excited about the potential to only have to make one trip to the pharmacy a month, and to form better relationships with their pharmacy staff. After JS, a community pharmacy patient was told about the program, her response was, “Oh, I would love to sign up my husband for this program. He takes so many pills that I go to the pharmacy at least once a week to pick up his prescriptions. By going once a month, it will save me time and money, and I will be assured that he is taking all his medications as he should.” Not only can one patient’s medications be dispensed on the same day each month, but families that have more than one member with multiple chronic medications can also work with their pharmacy to have all family members’ prescriptions dispensed on the same day.

Those that have implemented the program are already benefiting and have found that their patients are as well. Pharmacist Robert Frankil from Skippack and Sellersville Pharmacy says, “I am finding that the best benefit of this program is customer satisfaction. Saving my customers time in calling in refills and calling their doctors is greatly appreciated. Also, we don’t have short fills for these customers anymore.” So in the long run, with implementation of this program, overall pharmacy life is expected to improve for both the pharmacy and its staff and the patients. In addition to enhancing pharmacy work flow and inventory efficiencies, the benefits to the pharmacy include the ability to recognize and react to changes in patient therapies and identify medication noncompliance. By synchronizing patients’ prescription refills, the pharmacy will spend less time reacting to phone calls and last-minute refill requests, and can devote more time to proactively engaging in activities focused on patient care.

So how exactly does PCM work? The program is “opt-in,” so patients are identified by the pharmacy staff. Ideal patients include those that are on multiple, on-going prescriptions for chronic disease conditions such as diabetes or hypertension. Those patients that agree to participate in the program are assigned an appointment day that is convenient for them, and a list of their chronic medications is compiled. They will then have refills for their chronic medications “synchronized” to come due on the same day of the month. Each month, the patient is interviewed by phone about any recent doctor’s appointments, hospitalizations, or changes in medications, and their file is updated. They are also asked about each medication, and it is determined whether or not they need that medication refilled, and if not, why. Their medications are then dispensed and ready to pick up on their appointment day. Contact with the doctor is done by the pharmacy staff in advance, and patients are notified if for any reason refills are not available.

For patients, the benefits include greater convenience and less stress from numerous phone calls and trips to the pharmacy, better understanding of their medication therapy, and most importantly, improved relationships with their pharmacy and other members of their health care team. For more information, contact the PCM Project Manager at pcm@naspa.us.

Patient Centric Model Benefits For Patients Convenience • No need to call in prescription refills • Fewer trips to the pharmacy • No worries about running out of medications • Monthly consultations with the pharmacist about medications Improved health outcomes through improved medication persistence The Georgia Pharmacy Journal

For Pharmacies Operational Efficiencies • More control over time and work flow • Increased inventory turnover • Decreased inventory on hand Proactive Patient Care • Ability to recognize and respond to changes in patients’ therapies • More time to consult with patients 15

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GPHA MEMBER NEWS

Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Zheer Alan, Norcross Emily Allen, Atlanta Sarah Baggett, Atlanta Susan Bailey, Atlanta Nicholas Blackwell, Atlanta Dustin Blalock, Fort Valley Melissa Blount, Savannah Ashleigh Bridges, Savannah Lauren Brown, Pooler Dennis Cai, Atlanta Charity Calhoun, Atlanta Lindsey Cantrell, Canton Jenelle Capehart, Atlanta Joanna Catravas, Atlanta Vanessa Chan, Cumming Sapna Charania, Atlanta Victoria Chen, Atlanta Katie Childers, Pooler Sean Chitwood, Tucker Brian Cho, Shellville Ji Choi, Atlanta Shu-Hui Chuang, Duluth Lia Churchill, Savannah Adam Clark, Statesboro Monika Clark, Newnan Phillip Coleman, Savannah Catherine Cook, Chamblee The Georgia Pharmacy Journal

Meredith Cook, Atlanta Laurie Copeland, Atlanta Melissa Crooks, Atlanta Lindsey Cross, Pineview Matthew Crowe, Savannah Marcus Cuffie, Lithia Springs Michelle Cummings Rachel Cummings, Valdosta Janna Curvey, Alpharetta Jenna Dailey, Millen Steven Daly, Omaha, NE Minh Thu Dang, Morrow Melvin Daniel Jozetta DeJean, Atlanta Khanh Dinh, Savannah Allison Doerr, Atlanta Jessica Domm, Lawrenceville Crystal Dong, Atlanta Donna Dove, Tignall Ashley Dyett, Savannah Christopher Elder, Savannah Michael Elkhatib, Berkeley, IL Amy Ely, Atlanta Rachel Evans, Smyrna Tyler Ferguson, Savannah Itzelis Fernandez, Savannah Julya Friedman, Alpharetta 16

James Gay, Dunwoody Justin George, Lawrenceville Fariborz Ghafoori, Irvine Jenna Gilbert, Atlanta Christina Gonzalez, Norcross Sweta Goswami, Lawrenceville Demetria Griffin, Atlanta Sima L. Gupta O.D., MPH, Atlanta Stephen Hammond, Tucker Kelly Hancock, Savannah Richard Hardeman, Savannah Conrad Harris, Savannah Kristopher Harrop, Atlanta Joshua Hartsell, Atlanta Ashley Hauser, Bloomingdale Heather Hendrix, Rossville Whitney Hill, Savannah Sarah Himic, Atlanta Phuong Hoang, Alto Leslie E. Howland, Pharm.D., Douglasville

Darshini Jani, Duluth Mina Jun, Atlanta Yu-Jin Jung, Suwanee Robert Kalch, Atlanta Wendy Kang, Atlanta Amir Khan, Atlanta Britta Kiskadden, East Point January 2010


Whitney Komorner, Marietta Alvin Lam, Omaha, NE Ashlee Lane, Savannah Kauren Lasner Spencer LeCorchick, Atlanta Hallie Lee, Atlanta David Lequan, Dayton, TN Andrew Levitz, Marietta Elizabeth Lim, Roswell Jennifer N. Lind, Pharm.D., Ellenwood

Madaleine Lockwood, Savannah Christy Luckey, Savannah Kelly Lytjenm, Savannah Regina B. Maniquis, Pharm.D., Columbus

Kelly Mason, Savannah Brian McNeill, Atlanta Shruti Mehta, Suwanee Bridget Melton, Stone Mountain Jennifer Millisor, Greensboro, NC Kristina Mindel, Atlanta Angela Minimah, Chamblee Hena Modi, Darien Natalie Moore, Savannah Delaram Moshkelani, Duluth Susiana Mulyadi, Lawrenceville Elisha Neumann, Atlanta Robert Newsome, Madison Gia Nguyen, Tucker Matthew Nguyen, Duluth Phuong Nguyen, Alto Phuong Uyen Nguyen, Atlanta

Dora Niculas, Buford Lauren Odgen, Sandy Springs Sharon Oh, Alpharetta Sohee Oh, Savannah Kelley O'Neal Amit Patel, Waycross Payal Patel, Atlanta Roshni Patel, Atlanta Mitchell Patterson, Atlanta Hang Pham, Oakland MinhChau Pham, Norcross Emmanuelle Pierre-Jean Heather Porcel, Twin City Misty Jones Potts, R.Ph., Jesup Amanda Pradarits, Bonaire Nattima Pranayanantn, Atlanta Dawud Rasheed, Chamblee Corinne Rayman, Lawrenceville Eric Reddington, Atlanta Brandy Ridley, Savannah Denise Ross, Atlanta Chitchawal Sahatenvasukont Jose Alvarez Sanchez, Savannah Jennifer Schriber, Savannah Katie Schulz, Peachtree City Amy Sellers, Tucker Nara Shin, Atlanta Andrea Nicole Sikora, Athens Ivy Simmons, Atlanta Saundra Simonds, Knoxville, TN Jared Skelton, Carrollton

Jessica Smith, Atlanta Haley Snyder, Hahira Kimberly Taylor, Sandersville Evelyne Temah, Atlanta Thomas Temesgen, Savannah Deidre Thompson, Oxford Kayla Thornton, McDonough Teddi Timmons, Jasper Tara Tolbert, Lilburn David Tran, Atlanta Erin Trowbridge, Atlanta Alan Tucker, Atlanta Geoffrey Turner, Union Point Mukund Udvadia, Lawrenceville Carolyn Valle, Atlanta Anna Vargo, Atlanta Nguyen Vo, Lawrenceville Tuquy Vo, Norcross Anh Vu, Atlanta Erin Wagner, Savannah Shuonan Wang Jodi Watts, McDonough Christiana Weaver, Lawrenceville Joshua Welch, Savannah Benjamin Wilson Adam Woodsmall, Flowery Branch Peterson Worrell, Macon Christopher Wu, Fort Lauderdale, FL Jessica Yoon, Alpharetta Amanda Zell, Dunwoody Vladislav Zima, Alpharetta

If you or someone you know wishes to join the Georgia Pharmacy Association you need only visit www.gpha.org and click “Join� at the top of the page. You can pay by credit card and your membership begins immediately. If you have any questions please call Kelly McLendon at 404-419-8116. The Georgia Pharmacy Journal

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Pharm PAC would like to encourage you to make a contribution today and help pharmacy look forward to a bright future in the state of Georgia.

Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D. • Professional Licensure Disciplinary Proceedings • Medicaid Recoupment Defense • Challenges in Medicaid Audits • OIG List Problems • SCX or Other Audits

Name: ________________________________ Address: _______________________________ _____________________________________ Phone Number: __________________________

Leroy Toliver has been a Georgia Registered Pharmacist for 34 years. He has been a practicing attorney for 25 years and has represented numerous pharmacists and pharmacies in all types of cases. Collectively, he has saved his clients millions of dollars.

Email Address: __________________________ Contribution: $__________________________ (Circle the Pledge Level to which you wish to belong.) $1 - $250 - Patriot $251 - $500 - Representative $501 - $1000 - Senator $1001+ - Governor’s Circle

Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 altoliver@aol.com 770.929.3100

Sustainers Circle: When you check this box and provide valid credit card information you are making a 5 year commitment to make the same contribution for the next 5 years. Your credit card will automatically be charged annually on the date of your initial contribution. Contributions or gifts to Pharm PAC are not deductible as charitable contributions for Federal income tax purposes. Name on the Credit Card: _____________________________________ Credit Card Number: _____________________________________ CSV#: ________ Expiration Date: ____________ Signature: ______________________________ Contributions made to Pharm PAC are not tax deductible.

Detach this form and complete it and return it to:

Pharm PAC, 50 Lenox Pointe, NE Atlanta, GA 30324 You may also donate online. The Georgia Pharmacy Journal

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Call for awards nominations... The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 135th Annual Convention in 2010. A brief description and criteria of each award is noted 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 completes nomination form is March 12, 2010. Nominations will be received by the Awards Committee and an individual will be selected for presentation of the Award at GPhA’s 135th Annual Convention at the Embassy Suites Conference Center, Myrtle Beach, SC.

Bowl of Hygeia Award (sponsored by Pfizer) 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 well on the profession.

Distinguished Young Pharmacist Award (sponsored by Pharmacist Mutual) 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) To encourage new pharmacists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) The nominee must have received entry degree in pharmacy less than ten years ago; 2) Nominees must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.

Innovative Pharmacy Practice Award (sponsored by NASPA/GPhA) 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 GPhA in the year of selection.

2010 Awards Nominations 2010 Bowl of Hygeia

Distinguished Young Pharmacist

Innovative Pharmacy Practice Award

Nominee’s Full Name _________________________________________________________________ Home Address ______________________________ City ______________ ST _______ Zip _________ Practice Site________________________________________________________________________ Work Address _______________________________ City ______________ ST _______ Zip _________ College/School of Pharmacy _____________________________________________________________ List of Professional activites, state /national pharmacy organization affiliations, and/or local civic and church activities _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Supporting information (required) ________________________________________________________ _________________________________________________________________________________ Submitted by (optional): _______________________________________________________________ Submite this completed form by March 12, 2010 to GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324. Complete this form online at www.gpha.org. The Georgia Pharmacy Journal

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Continuing Education for Pharmacists Access to Good Quality Dietary Supplements This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papers prepared by the Council of the Convention (CoC) titled "Focus On: Future Directions for USP." The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association's (NASPA) Continuing Education Advisory Panel. No financial support was received for this activity. This activity may appear in other state pharmacy association journals. Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements Mary H. Hager, Ph.D., R.D., F.A.D.A., Section Chair (American Dietetic Association) E. James Bradford, Ph.D. (AOAC-International) Marvin M. Lipman, M.D. (Member-at-Large) Lyn O. Nabors (International Food Additives Council)

Goals: The goals of this lesson are to provide background information on Dietary supplements and to review proposals for consideration to further improve the quality of dietary supplements. Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Describe the regulatory framework of dietary supplements 2. Give examples of the proposals that will be considered for further improvement of the quality of dietary supplements Introduction: The 1994 Dietary Supplement Health and Education Act (DSHEA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) provided a regulatory framework to allow marketing of vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Now, more than 15 years later, a vast array of dietary supplements in different combinations and amounts are available to United States

patients/consumers. Sales of dietary supplements are approaching $25 billion/year, with about $4 billion of this amount representing sales of botanicals. While DSHEA was instrumental in providing consumers with easy access to dietary supplements, a recent U.S. Government Accountability Office (GAO) report stated that consumers of dietary supplements are not adequately protected under current U.S. law and regulations.1 Pre-market oversight and registration of products are recommended in the GAO report.2 Outside the United States, dietary supplements are frequently considered as traditional medicines with few standards and conformity assessments to these standards. In this white paper, USP’s Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements provides background information on the topic and advances proposals for consideration by the Convention membership to further improve the quality of dietary supplements. National Approaches:

1. Congress: Provisions of DSHEA: Through DSHEA, Congress defined dietary supplements as “foods.” As with all foods, DSHEA provisions in the FDCA do not require premarket review of a dietary supplement by the Food and Drug Administration (FDA) if the ingredients have a safe history of use in food or supplements prior to 1994. Instead, Congress put in place a notification process for a new dietary ingredient to ensure that ingredients that do not have a safe history of use are reviewed by the FDA prior to entry into the U.S. market. In addition, DSHEA essentially places the burden of proof on the FDA to demonstrate that a dietary supplement presents “significant or unreasonable risk of illness or injury” before it can be removed from the market. With regard to the United States Pharmacopeia (USP), Section 403(s)(2)(D) of the FDCA states that if a dietary supplement is 1) covered by the specifications (tests, procedures, and acceptance criteria of a monograph) of an official compendium of the United States (USP, National Formulary [NF], or the Homeopathic Pharmacopoeia), 2) is represented as conforming to the specifications of an official compendium, and 3) fails to so

1. Government Accountability Office report. 2009 Dietary supplements. FDA Should Take Further Actions to Improve Oversight and Consumer Understanding http://www.gao.gov/new.items/d09250.pdf. 2. Ibid.

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conform, then the supplement is considered to be misbranded. Accordingly, unlike the provisions relating to prescription drugs (where conformance with USP standards is mandatory, whether labeled as such or not), Section 403(s)(2)(D) of the FDCA makes compliance with the specifications of an official compendium strictly voluntary for dietary supplement manufacturers (unless the manufacturer chooses to represent the product as conforming to USP). As a consequence, this statutory reference to official compendia provides legal recognition to USP, but effectively creates a disincentive for its use, because it exposes only those manufacturers who so label (and not others who make no reference to USP standards at all) to a potential misbranding violation if found not to conform to USP.3 2. The Food and Drug Administration: In 2007, the FDA finalized Current Good Manufacturing Practices (cGMPs) for dietary supplements. These regulations allow manufacturers to establish product specifications and to use “appropriate and scientifically valid” methods to determine whether those specifications are met. The cGMPs do not define the words “scientifically valid” nor is validation of analytical procedures required. The FDA has indicated that “a scientifically valid method is one that is accurate, precise, and specific for its intended purpose—in other words, a scientifically valid test is one that consistently does what it is intended to do. As a result, dietary supplement manufacturers develop private procedures, tests, and assays, which may or may not receive regulatory scrutiny. Standards for a

dietary supplement under a specified name may not have comparable requirements and thus may be dissimilar in quality, benefit, and safety to consumers. The cGMPs do not require dissolution and disintegration testing, and manufacturers set their own limits for contaminants such as heavy metals, microbial limits, fungal toxins, or pesticides. USP has published an article describing the current regulatory scheme as one that creates “standards without standardization.”4 3. United States Pharmacopeial Convention: Following enactment of DSHEA in 1994, the 1995 USP Convention adopted Resolution 12 that encouraged the USP to explore the feasibility and advisability of establishing standards and developing information concerning dietary supplements. This resolution was taken up and implemented by USP’s Board of Trustees and Council of Experts, resulting in a well-evolved section of USP for dietary supplement monographs, with allied USP Reference Standards offered in USP’s catalogue.5 USP32NF27 now contains approximately 430 dietary supplement and ingredient monographs and general chapters, which cover a large percentage (+90%) of the dietary supplements commonly marketed in the United States. USP’s Council of Experts Dietary Supplement Information Expert Committee applies admission criteria together with a safety review guideline to allow exclusion of some dietary supplements from USP, even though they may be legally marketed in the United States. This approach mirrors the work of the Scope Committee of the Committee of

Revision (the predecessor of the Council of Experts) that ended in the 1990s. USP also includes a General Chapter on Manufacturing Practices for Dietary Supplements <2750>, which was developed prior to finalization of FDA’s cGMPs and is generally more stringent and specific than those regulations. In June 2009, USP introduced a separate USP Dietary Supplements Compendium that includes official text from USP (monographs and general chapters relating to dietary supplements) as well as authorized explanatory text and graphics intended to provide useful information to dietary supplement manufacturers. International Approaches While vitamins, minerals, amino acids, botanicals, and other plant and animal substances are available in the U.S. as dietary supplements, they are variably regulated as health products, traditional medicines, or drugs in other countries. This varied international approach on the regulation of dietary supplements provides different paradigms for consideration and exploring options for domestic regulatory oversight. Quality standards also are quite variable around the globe. Issues of quality are present in the international commerce of dietary supplements, which is evident in cases such as protein adulteration with melamine or dietary supplements containing toxic metals, high levels of pesticides or unapproved drugs. Information from the World Health Organization (WHO) details the widespread consumer misconception that “natural” always means “safe,” and a common belief that remedies from natural origin

3. It should be noted that the FDA has indicated that DSHEA will not apply to dietary supplement products intended for use in animals. As such, animal dietary supplements currently are regulated generally as "food" without the additional protection afforded human dietary supplement products under DSHEA. It is generally felt in the veterinary community that the need for evidence of quality, safety, and efficacy are similar for veterinary and human patients alike. For more information, see Safety of Dietary Supplements for Horses, Dogs and Cats, Committee on Examining the Safety of Dietary Supplements for Horses, Dogs and Cats, National Research Council, National Academic Press, 2008. 4. Miller RK, Celestino C, Giancaspro GI, Williams RL. 2008. FDA's dietary supplement CGMPs: Standards without standardization. Food and Drug Law Journal 63 (4), 929-942+iv. 5. More information on USP dietary supplements Expert Committees is available through http://www.usp.org/support/products/uspNewslettersRequest.html

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are harmless and carry no risk.6 Also of concern is that healthcare providers are frequently unaware of the dietary supplements their patients are taking; either because they do not ask, or patients do not offer the information.7 Under the current law and regulations, there is no way of knowing the quality standards to which each product is held, and thus, there is no way to determine whether two products with the same dietary supplement ingredients are the same or different. Proposals: The Council of the Convention Section on Food Ingredients and Dietary Supplements suggests for consideration the following opportunities for possible USP Convention action and improvement in the regulation of dietary supplements. 1. Public Monographs and Reference Materials: The universe of products in the market is constantly expanding, creating gaps where monographs and reference materials are missing. To the extent feasible, documentary standards and reference materials offered by USP should expand to cover all the products in the dietary supplements market. 2. Adherence to Public Standard: Public quality standards arising from the open and participatory process conducted by USP conserve both regulatory and manufacturer resources. They work to achieve consistency in the quality of a dietary supplement both within and between manufacturers, and allow updating. This consistency is more

likely to be achieved if manufacturers are required to comply with public standards. Thus, USP might consider informing and engaging in discussions with Congress about the desirability of strengthening section 403(s)(2)(D) of the FDCA to require dietary supplements and dietary supplement ingredients to conform to the standards established in USP-NF, where such standards exist. USP also might consider making Congress aware of the benefits of strengthening the adulteration provisions of the FDCA to ensure that all dietary supplements conform to the relevant standards promulgated in USP-NF. However, it is not clear, at this time, that industry supports such mandatory standards. 3. International Harmonization: Amidst the increasingly complex global supply of dietary supplement ingredients and products, ensuring quality and harmonization of standards is important, irrespective of how dietary supplement products are labeled and regulated—whether as traditional medicines, drugs, or supplements. Global harmonization of public standards would ensure quality, identity, and label uniformity in international commerce, and could facilitate international commerce of good quality dietary supplements. To start its work in this area, USP standards and analytical methods could complement the descriptions of quality, dosage, safety, and pharmacological activity of

botanical monographs offered by other standards setting bodies of the world.8 For these reasons, USP should cooperate with international health organizations to promote standards for traditional medicines that are also dietary supplements in the United States. Examples of such organizations include the WHO, the Canadian Natural Health Products Directorate in Health Canada, the European Directorate for the Quality of Medicines and HealthCare (EDQM), and the Indian and Chinese Pharmacopoeia Commissions. 4. Education: There is a dearth of unbiased dietary supplement information for consumers and practitioners. Gaps in practitioner training and consumer education are clear impediments to the safe use of dietary supplements. Practitioners should receive training on proper counseling of consumers on the use of dietary supplements and consumers should be educated about the importance of disclosing such usage to healthcare providers. In this way, practitioners and consumers can monitor and prevent possible adverse effects that may occur from the combined use of certain dietary supplements and drugs. USP could expand its educational programs to meet the needs of practitioners and patients/consumers with respect to dietary supplements. The USP Dietary Supplements Information Expert Committee earlier

6. WHO. 2004. Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance systems. WHO Department of Essential Drugs and Medicines Policy: Geneva. http://apps.who.int/medicinedocs/index/assoc/s7148e/s7148e.pdf 7. Gardiner P, Sarma DN, Low Dog T, Barrett ML, Chavez ML, Ko R, Mahady GB, Marles RJ, Pellicore LS, and Giancaspro GI. 2008. The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiology and Drug Safety. 17: 962–970. 8. Ko RJ. 2004. A U.S. perspective on the adverse reactions from traditional Chinese medicines. J Chin Med Assoc. 67(3):109-116. 9. Gardiner et al, 2008 (see reference 5 above).

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recommended education of practitioners regarding suitable practices for safe use and prevention of interactions with other therapeutic agents.9 USP should consider developing Pharmacopeial Education courses for practitioners and consumers in this regard, and additional courses on compendial approaches to quality standards for dietary supplements to help manufacturers, testing labs, and regulators understand the value of USP public standards and reference materials. 5. Verification: USP Verification Programs could also be used to increase confidence that ingredients and products moving in the international market comply with the quality specifications to help ensure public safety, including absence of known/identified adulterants and contaminants. Although FDA has not endorsed the use of third party certifications of dietary supplements, it has recognized the value of third-party certifications in its recent guidance on foods.10 Broad implementation of USP’s Verification Programs for dietary supplements and dietary supplement ingredients could assist in raising supplement quality, help patients make informed decisions, restore consumer confidence, and allow healthcare practitioners to recommend verified dietary supplements with some level of confidence. The various elements of USP’s Verification Programs (audits, testing, document review, and market surveillance) would act synergistically with the cGMPs already in place, thus helping conserve FDA resources. Because

cGMPs provide minimum requirements, implementation of USP Verification Programs would add value for greater assurance of the quality of supplements. The concern about the quality and purity of ingredients moving in the international market also could be addressed through a system of USP Verification Programs’ inspecting companies and testing products overseas. With sites in China, India, and Brazil, USP is very well positioned to contribute worldwide to raising the quality of dietary supplements. It is also possible that the challenges faced by regulatory differences with other countries could be addressed through credible USP Verification Programs. 6. Regulatory Oversight: Dietary supplement product registration or pre-market notification might be considered as a means of monitoring the number and type of dietary supplements moving in commerce in the U.S. and helping to assure the safety of dietary supplements prior to sale to the consumer. To accomplish this, the FDA would need sufficient resources to adequately assess and address the safety of dietary supplement products, and the FDCA would need to be amended to provide the FDA with authority in this area. The Council of the Convention Section on Food Ingredients and Dietary Supplements welcomes input on these proposals from the Convention, as well as additional comments on how USP might build upon its past efforts and expand its

work to help assure the quality and appropriate use of dietary supplements worldwide.

A BOUT USP and NA SPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP’s standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us Reprinted with permission. Copyright 2010, The United States Pharmacopeial Convention. All rights reserved.

10. Third-party verification – The FDA is endorsing third party verification of foods through its Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds. 2009. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125431.htm

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Continuing Education for Pharmacists Quiz and Evaluation Access to Good Quality Dietary Supplements 1. The Dietary Supplement Health and Education Act was introduced in what year? a. 1993 c. 1995 b. 1994 d. 1996

7. In 1995 the USP Convention adopted the following resolution that encouraged the USP to explore the feasibility and advisability of establishing standards and developing information concerning dietary supplements a. Resolution 11 c. Resolution 13 b. Resolution 12 d. Resolution 14

2. Sales of botanicals are approximately ___ of an approaching 25 billion/year a. 1 billion c. 3 billion b. 2 billion d. 4 billion

8. Which of the following includes official text from USP as well as authorized explanatory text and graphics intended to provide useful information to dietary supplement manufacturers? a. USP Dietary Supplements Compendium b. Manufacturing Practices for Dietary Supplements c. Homeopathic Pharmacopeia d. None of the above

3. Through the Dietary Supplement Health and Education Act (DSHEA) Congress defined dietary supplements as which of the following? a. Drugs c. Foods b. Vitamins d. Botanicals 4. Which of the following is considered an official compendium of the United States a. USP b. National Formulary c. Homeopathic Pharmacopeia d. All of the above

9. Which of the following is available in the U.S. as a dietary supplement? a. Vitamins c. Amino acids b. Minerals d. All of the above

5. In which year was the Current Good Manufacturing Practices (cGMPs) for dietary supplements finalized by the FDA? a. 2000 c. 2007 b. 2003 d. 2009 6.

10. Which of the following is true regarding public quality standards? a. They conserve only regulatory resources b. They work with only certain manufacturers c. They do not allow updating d. They arise from the open and participatory process conducted by USP

Which of the following is false regarding cGMPs? a. They were finalized by the FDA b. They do not define the words “scientifically valid� c. They allow manufacturers to establish product specifications d. They require dissolution and disintegration testing

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Journal CPE Answer Sheet The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Access to Good Quality Dietary Supplements This lesson is a knowledge-based CPE activity is targeted to pharmacists. GPhA code: J10-01 ACPE#: 142-000-10-001-H04-P Contact Hours: 1.5 (0.15 CEU) Release Date: 01/02/2010 Expiration Date: 01/02/2013 1. Select one correct answer per question and circle the appropriate letter below using blue or black ink (no red ink or pencil.) 2. Members submit $4.00, Non-members must include $10.00 to cover the cost of grading and issuing statements of credit/ Please send check or money order only. Note: GPhA members will receive priority in processing CE. Statements of credit for GPhA members will be mailed within four weeks of receipt of the course quiz. 1. 2. 3. 4. 5.

A A A A A

B B B B B

C C C C C

D D D D D

6. A B C D 7. A B C D 8. A B C D 9. A B C D 10. A B C D

Activity Evaluation: must be completed for credit Please rate the following items on a scale from 1 (poor) to 5 (excellent). 1. 2. 3. 4. 5.

The activity met my educational needs: Relevance to pharmacy practice: The learning objectives were achieved: Activity was presented in a fair and unbiased manner: How long did it take to complete this activity? ______

1 1 1 1

2 2 2 2

3 3 3 3

4 4 4 4

5 5 5 5

A passing grade of 70% is required for each examination. A person who fails the exam may resubmit the quiz only once at no additional charge. Please check here if you are indicating a change of address ďż˝

Phone #: _______________________________

Name: ____________________________________________________________________________ License Number(s) and State(s): ___________________ Email Address: ___________________________ Address: __________________________________________________________________________ City: _________________ State: __________ Zip: __________ Remove this page from the Journal and mail this completed quiz and evaluation to: GPhA, 50 Lenox Pointe NE, Atlanta, GA 30324.

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2009 - 2010 GPhA BOARD OF DIRECTORS

The Georgia Pharmacy Journal Editor:

Jim Bracewell jbracewell@gpha.org

Managing Editor & Designer:

Kelly McLendon kmclendon@gpha.org

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2010, 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 who are 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 e-mail the editorial offices as listed above.

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 at www.gpha.org upon request. All advertising and production orders should be sent to the GPhA headquarters as listed above.

GPhA HEADQUARTERS 50 Lenox Pointe, NE Atlanta, Georgia 30324 Office: 404.231.5074 Fax: 404.237.8435

Position

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Chairman of the Board President President-Elect First Vice President Second Vice President Executive Vice President/CEO State-at-Large State-at-Large State-at-Large State-at-Large State-at-Large State-at-Large State-at-Large Region One President Region Two President Region Three President Region Four President Region Five President Region Six President Region Seven President Region Eight President Region Nine President Region Ten President Region Eleven President Region Twelve President ACP Chairman AEP Chairman AHP Chairman AIP Chairman APT Chairman ASA Chairman Foundation Chairman Insurance Trust Chairman Ex Officio - President, GA Board of Pharmacy Ex Officio - Chairman, GSHP Ex Officio Mercer Ex Officio Mercer ASP Ex Officio South Ex Officio South ASP Ex Officio UGA Ex Officio UGA ASP

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Print: Star Printing - 770.974.6195

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