October GPhA Journal 2012

October 2012

October is American Pharmacist

Montharticle on page 6

*This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800.247.5930.**Compensated endorsement.Not all products available in every state. The Pharmacists Life is licensed in the District of Columbia and all states except AK, FL, HI, MA, ME, NH, NJ, NY and VT. Check with your representative or the company for details on coverages and carriers.

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*This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800.247.5930.**Compensated endorsement.Not all products available in every state. The Pharmacists Life is licensed in the District of Columbia and all states except AK, FL, HI, MA, ME, NH, NJ, NY and VT. Check with your representative or the company for details on coverages and carriers.

For more information, contact your local representative:

www.phmic.com*

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

PO Box 370 • Algona Iowa 50511

Life insurance solutions from The Pharmacists Life Insurance Company.

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Hutton Madden800.247.5930 ext. 7149

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c o n t e n t s

Robert Hatton’s Column

Jim Bracewell’s Column

American Pharmacist Month

Georgia Governor Declares October Pharmacist Month

Be Part of the Voice & the Process

Getting Around the Capitol Without Leaving Your Seat

Health Mart Healthy Living Tour & Jack Dunn

Recylcing Inhalers

Reinforcing the GPhA Brand

Team Up. Pressure Down. Coaching Patients to Take Control

First Pharmacist Appointed to HHS National Vaccine Advisory Committee

Get Out Your Driver’s License When You Renew Your Georgia Pharmacist License

PharmPAC Supporters

Welcome New Members

Pharmacy Based Immunization Delivery Program

Continuing Education for Pharmacists

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October is American Pharmacist Month

GPhA News Briefs• October is American Pharmacists Month. Check out tools and resources you can use to promote your pro-fession here: http://www.pharmacist.com/american-pharmacists-month-2012.

• Pharmacy-Based Immunization Delivery Program, October 27, 2012, 8:00am - 6:00pm at PCOM School of Pharmacy, hosted by GPhA.

• GPhA’s signature event is VIP Day, February 14, 2013. VIP Day stands for Voice in Pharmacy.

• The 138th GPhA Convention will be held at the Omni Amelia Island Resort, June 22-25, Amelia Island, Florida.

Robert HattonPresidentGeorgia Pharmacy Association

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s your President, I am focused on ‘Answering Opportunity’, my 2012-2013 theme, in a number of ways. Our key opportunity is to be a strong presence in advocacy with the Georgia General Assembly and the Board of Pharmacy, especially at a time when patient care is on the forefront of health care reform. All of us need to remain aware of how and when we can best influence, and send a strong message to our state government and policy regulators to envision pharmacists as health care providers to all Georgians.

The month of October brings another important occasion for your Executive Committee. The National Community Pharmacist Association is having their 114th Annual Convention and Trade Exposition in San Diego, October 13-17, 2012 and we’ll be there to hear educational programming around practice niches regard-ing short cycle changes in long-term-care and whether a 340B pharmacy is a good or bad move for your business.

Region Meetings around the State are already underway where in-person outreach opportunities abound for our work in the field. We hope you’ll take time to attend your local event to meet with your EC, your state legislator and other GPhA members to learn more about our latest advocacy agenda. Visit the GPhA website at www.gpha.org for the Region Meeting schedule.

It’s an exciting time for Pharmacy. GPhA is committed to being the premier organization for community, independent and all other pharmacists in the State of Georgia. This is a great time and opportunity for you to make your voice heard and be part of our advocacy process. You can read more on page 6 in this issue of the journal.

The coming year will be a busy and thriving time for GPhA and I am honored to be its President.

Answering October’s Opportunities

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James ‘Jim’ R. Bracewell Executive Vice President & CEO Georgia Pharmacy Association

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Was there something else as a professional pharmacist you were supposed to do today, other than dispense prescriptions?

Were you suppose to thank your fellow pharmacists who worked in the past to set the education standards that have made pharmacy such a financially rewarding profes-sion, or who lobbied for a professional practice act that has protected and even expanded your scope of practice?

Today, pharmacy is still one of the most rewarding and sought after professions in health care. Talk to pharmacy students at any of the four colleges of pharmacy in our state. Feel their enthusiasm for the future and for their profession.

How did all of this success come about? Was it serendipity?

No! A large number of pharmacists came together in a concerted effort for many years to advocate for our pro-fession through their membership in the Georgia Phar-macy Association.

In the summer of 1875, a concerned group of Georgia pharmacists sent a notice to all the pharmacists of the state, requesting them to assemble in Macon on October 20, 1875, “to consider the organization of a pharmaceu-tical association, binding each other with closer ties of friendship and to promote interest in the junior members of the fraternity and exciting the spirit of emulation and ambition; the interchange and dissemination of scientific researches; the framing of laws to be enacted that will result not only in the protection of the profession but the public in general.”

Georgia’s newspapers published the notice at no charge and the railroads agreed to provide reduced rates from any point in the state to Macon for anyone who wished to attend the meeting.

At least twenty pharmacists were present in Macon at Freeman’s Hall at eight o’clock on the evening of October 20, 1875. The meeting included brief presentations by a member of the State Board of Health and three physicians from the Macon Medical Society, all of whom assured cooperation and support from their organizations. Fol-lowing these presentations, the delegation of pharmacists adopted a constitution with an objective to bring together all the “reputable druggists” of the state in an association in the interests of the profession at large, specifying that every druggist and apothecary of good moral and profes-sional standing whether in business, or in retirement from business, or employed by another, and the teachers of pharmacy, chemistry, materia medica, and botany, who may be professors in any college of pharmacy, should constitute the membership of the association. Thus, the Georgia Pharmaceutical Association was established.

There is a familiar old parable about owning a goose that lays a golden egg and it is truly wonderful, but if the goose is not cared for, then it does not stay healthy and grow, and the golden eggs will soon stop coming.

You are receiving this journal because you are a mem-ber of GPhA, but isn’t it time you invited your pharmacy partner and other pharmacy colleagues to become a part of the winning team that has long worked for pharmacy profession in Georgia?

Have you ever arrived home and wondered,

“Did I forget something?”

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American Pharmacists Month October 2012

Pharmacists are experts in helping patients get the most out of today’s complicated medications. They are an integrated member of the health care team and are directly involved in patient care. Pharmacists advise patients and health care providers on the selec-tion, dosages, interactions, and side effects of medications. Pharmacists have a significant role in assessing medication management in patients, and in referring patients to physicians, as they are often the first point-of-contact for patients with health inquiries. They have a passion for the profession and a strong commitment to patient safety.

Georgia Governor Delcares October 2012 Pharmacist Month

“Pharmacists play a vital role in providing quality health care to the citizens of our great state. I am pleased to join the Georgia Pharmacy Association and the American Pharmacists

Association in recognizing October as Pharmacists Month in the State of Georgia.”Quote from Governor Nathan Deal

Be Part of the VOICE and the PROCESS by Amy DeFaveri

There are hundreds of PACs, large and small, representing diverse interests—the National Association of Realtors, Hon-eywell International and the American Bankers Association, for example. There are also plenty of myths and misconcep-tions about PACs. Chief among them is that money is used to ‘buy’ votes or that a PAC is simply the price to pay to play the political game. A PAC is neither of these, but a PAC has been an important part of our political process since 1944, when the Congress of Industrial Organizations (CIO) raised money to help re-elect President Franklin Roosevelt.

A PAC is a legal mechanism for individuals to combine financial resources to support political candidates who share their interests. GPhA established PharmPAC with the same goal, combining resources to support political candidates who are our interests. PharmPAC does not contribute to any candidate to ‘buy’ access. We believe that PharmPAC and our mem-bers have the right of access as citizens in a representative democracy.

Just a few years ago, PharmPAC was raising $40,000 - $50,000 per year. We had one of the smallest PACs in Georgia of healthcare professionals. Last year we raised over $100,000 and are on track to do that again this year. We now have the largest Pharmacy Association PAC in the Southeast and one of the largest in the Country. PharmPAC has made contribu-tions to support candidates that share our philosophy—to protect the profession of pharmacy and its patients. Pharm-PAC is a tool to maximize on that philosophy.

An important part of our advocacy mission is to gain credibility and visibility with those in the State Legislature who oversee the laws that govern the day to day practice of our profession. Whether it is by a strong showing at VIP day of our members or by electing the fifth Pharmacist to the State Legislature (more than any other state in the country) or by providing reliable information to elected officials and other policy makers, GPhA is becoming a leading voice on health care policy in the state of Georgia. With your support of our advocacy program and PharmPAC, we can become THE VOICE on health care.

Advocacy is one of those rather nebulous words—What is it really?—you may ask yourself: What can I do? What do I know about advocacy? The most important thing you can do is to participate actively with others who share the goal of defending, protecting, and preserving our profession and our ability to provide quality healthcare to our patients. It requires an investment of your time, energy and money. A contribution to PharmPAC is all of those things. It signals your intent to invest yourself in our cause. It means you’ve recognized one of the tools we have at our disposal: combining our resources to support political candidates who share our interests.

The key to success is simple: strength in numbers. If each GPhA member contributed to PharmPAC, pharmacists and pharmacies in Georgia would have a significant voice in the election of members of the Georgia State Legislature. Even if you make only a contribution of $100, you will be part of the voice and the process. We need each other at this very im-portant time. Please help GPhA defend our profession with a contribution to PharmPAC today. I believe you’ll feel proud to see your name among the PharmPAC roll call contributors in the monthly GPhA Journal.

A D V O C A C Y

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Looking for your elected state representative or senator? Want to know which proposed legislation was being considered at the Georgia General Assembly? We’ve tried to pull much of this information together in one place for you—visit and bookmark the websites below for information you just might find of interest. Tracking a bill through the Georgia General Assembly Find your legislator, search legislation or watch live broadcasts of the Georgia Senate Chamber or House Chamber when they’re in session, January--March. http://www.legis.ga.gov/en-US/default.aspx Georgia Government & Politics Everything you ever wanted to know about the operations of the Georgia General Assembly and the legislative process. http://www.georgiaencyclopedia.org/nge/Article.jsp?id=h-3164

Passing a law in the Georgia General Assembly Learn the path of how legislation is passed in the Georgia General Assembly, Georgia’s history, maps of the State and voter information. http://georgiainfo.galileo.usg.edu/legchart/legchart.htm Welcome to the Digital Library of Georgia The Digital Library of Georgia is a gateway to Georgia’s history and culture found in digitized books, manuscripts, photographs, government documents, newspapers, maps, audio, video and other resources. http://dlg.galileo.usg.edu/?Welcome Elections and Voter Registration Calendar http://www.sos.ga.gov/Elections/election_dates.htm

Georgia General Assembly Legislation Easy look up of any bill by legislative session, member, committee, key words, Georgia Code Title, bill type or bill number. http://www.legis.ga.gov/Legislation/en-US/Search.aspx Georgia Debt—to the penny It won’t tell you where the money goes, but you can see exactly what the amount is in real time. http://www.usdebtclock.org/state-debt-clocks/state-of-georgia-debt-clock.html

Getting Around the

Georgia State Capitol

Without Leaving Your Seat

by Amy DeFaveri

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Five GPhA member Health Mart Pharma-cists recently offered free health screenings to more than 150 patrons at recent events as a part of the Health Mart Healthy Living Tour. This unique mobile health campaign is designed to help identify people who are at risk for diabetes and encourage those already affected by the disease to better manage their condition with the support from their community pharmacist. In July, the Tour visited Scott’s Health Mart Phar-macy, Jasper Drug Store, Huff’s Drug Store, Brasstown Pharmacy and Riverside Phar-macy & The Gift Nook.

At the Jasper Drug event, former GPhA president Jack Dunn was honored with a Health Mart® Diabetes Care Excellence Award for going above and beyond the call of duty to provide exemplary education, guidance and service to people managing diabetes. Health Mart®, a national network of nearly 3,000 independently owned phar-macies, presented this prestigious award as one of just five to be given to pharmacists across the country.

For Dunn, pharmacy is a bit of a family affair. His father started Jasper Drug Store in 1952, and Jack Dunn worked there as a teenager. Born and raised in Jasper, Dunn is deeply ingrained within the community. “My friend calls us the hugging store, because we’re always hugging our custom-ers,” he said. “We’re always available to answer questions.”

For the past five years, Dunn has served as president of the Georgia Pharmacy Asso-ciation, helping to grow membership and influence. Dunn recently became chairman of the board, where he will continue to advocate on behalf of pharmacists across Georgia.

Jasper Drug Store offers three diabetes education seminars each month, with one at the pharmacy (and a Diabetes Life Cen-ter), one at a local senior center and a third in a retirement community. Dunn has been generous with his time, working to support Georgia pharmacy and most importantly, to make a difference in the lives of those who are affected by diabetes.

The Health Mart Healthy Living Tour is on the road this summer raising diabetes awareness at Health Mart pharmacies across the country. Both new and existing pharmacy patients received complimentary health screenings, mirroring the ongoing contributions that these independent phar-macists make to the people of Alabama every day. For Health Mart pharmacists, the events are indicative of Health Mart’s effort to help independent pharmacies attract new customers and maximize the value of exist-ing customers through marketing support. Aboard the 40-foot mobile screening unit, tour staff are capable of conducting more than 35 screenings per visit, measuring blood pressure, blood glucose, total choles-terol and hemoglobin A1C levels. Co-sponsored by Bayer Diabetes Care and Novo Nordisk, the Health Mart Healthy Liv-ing Tour will visit more than 70 pharmacies and screen thousands of Americans along the way. The tour aims to raise awareness of the growing diabetes epidemic—the disease affects approximately 25.8 million Americans. To learn more about Health Mart or the Health Mart Healthy Living Tour, visit www.healthmarthealthyliving.com.

Health Mart Healthy Living Tour Provides More Than 150 Free Health Screenings at Georgia Health Mart Pharmacies

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GlaxoSmithKline is initiating a new program in 31 U.S. markets to collect and recycle empty GSK inhalers used in the delivery of its prescription respiratory medicines. The “Complete the Cycle™ Recycle Program for GSK Respiratory Inhalers” beginning in October will provide participating retail pharmacies with an in-store location for customers to drop off their empty GSK respiratory inhalers for shipment to a specialized recycler.

Retail pharmacies can learn more about or enroll in the Complete the Cycle™ program by visiting the program’s website, www.GSKCompleteTheCycle.com. Once enrolled, pharmacies will receive in-store materials which include a small collection container and informational materials for customers, as well as pre-paid shipping envelopes for the empty GSK inhalers.

Program DetailsPharmacies that enroll in the program will receive a Complete the Cycle™ recycle kit that contains a collection container that holds 20-25 empty GSK respiratory inhalers and prepaid shipping envelopes. They will also receive a pharmacist information sheet and a supply of consumer brochures with recycle stickers. Participating pharmacies can inform customers of the pro-gram as they pick up their GSK respiratory inhaler prescrip-tions, and by placing brochures in the bags and stickers on the cartons of GSK respiratory inhalers. Empty GSK respiratory inhalers returned to a pharmacy are placed in the recycle container that is lined with a prepaid shipping envelope. Once the boxes are full, pharmacies re-move the shipping envelope and send the inhalers directly to a specialized recycler where the inhalers will be sorted into material type and recycled. The plastics will be used to make new household products, such as plastic hangers

and plastic flower pots. The recovered aerosol canister will be sent to a specialist company that will capture remaining gas and recycle the metal components. The inhalers will not be recycled to produce new inhalers. Environmental ImpactThe Complete the Cycle™ Recycle Program for GSK Respi-ratory Inhalers is designed to reduce the environmental impact of the GSK inhalers sent to landfills.The GSK program aligns with other efforts offered by many pharmacies to collect and recycle items, such as empty drink containers, plastic bags or pill bottles, and was de-signed in response to the growing U.S. interest in environ-mental sustainability. In a survey of over 6,400 customers, conducted by the Grocery Manufacturers Association and Deloitte Consulting, 54 percent considered sustainability to be a key decision-making factor in product and store selec-tion.[i] In 2011, a study from SC Johnson and GfK Roper showed increasing interest in recycling, with 58 percent of American respondents reporting that they recycle on a regular basis.[ii] GSK is committed to providing medicines that make a dif-ference while protecting natural resources. The company aims to minimize environmental impact across the value chain and lifecycle of its products by setting ambitious goals to reduce its carbon footprint, water footprint and waste. Among the long-term goals, GSK aims to be carbon neutral by 2050, with this ambition extending across the company’s operations, suppliers and customers.

[i] Bearse S, Capozucca P,Favret L, et al. GMA and Deloitte Consulting LLP. Finding the green in today’s shoppers: sustainability trends and new shopper insights. Available at: https://www.deloitte.com/assets/Dcom-Lebanon/Local%20Assets/Documents/Consumer%20Business/DeloitteGreenShopperStudy_2009.pdf . September 2009 [ii] SC Johnson and GfK Roper: The Environment: Public Attitudes and IndividuaBehavior – a Twenty Year Evolution. 2011

recylcing inhalers

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REINFORCING THE GPhA BRAND We’re a group of people just like you—committed to the important role that pharmacists and pharmacies play in the lives of individuals and families. Passionate about preserving your way of serving your patients. And strong because we’re a community that focuses on advocacy—with one voice at the Georgia State Capital.

As a GPhA member, you benefit from: understanding how the latest laws and refulations affect the way you practice….accessing exclusive members-only analysis of regulatory and legislative proposals…participating in our Annual VIP at the Capitol on February 14, 2013….and being a collective voice at the state klevel. Join us know and help us become even stronger in advocacy, dialogue, learning, research and visibility. When you join GPhA, you take a stand for the value of pharmacists and for improving the healthcare of your patients. One person can’t always be heard, but standing together we can speak loudly and clearly.

by Amy DeFaveri

Pharmacists Need Time for Financial Planning

This ad entitles you to:

A cup of coffee, and asecond opinion.

You’re welcome to schedule a time to come in or talk via conference call about your financial concerns and what your portfolio is intended to do for you and your family. I’ll review it with you and give you my opinion – without

obligation.

Either way, the coffee is on me.

Michael T. Tarrant

• Independent Financial Planner since 1992

• Focusing on Pharmacy since 2002

• PharmPAC Supporter • Speaker & Author

Financial Network Associates 1117 Perimeter Center West, Suite N-307

Atlanta, GA 30338 ● 770-350-2455 [email protected] www.fnaplanners.com

♦Securities, certain advisory services and insurance products are offered through

INVEST Financial Corporation (INVEST), member FINRA/SIPC, a federally registered Investment Adviser, and affiliated insurance agencies. INVEST is not affiliated with Financial Network Associates, Inc. Other

advisory services may be offered through Financial Network Associates, Inc., a registered investment adviser.

138th GPhA Convention Amelia Island Omni Resort

Amelia, Island FL

June 22-25, 2013

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Team Up. Pressure Down.Coaching Patients to Take Control.

A Free One Hour On Demand CPE Activity

REGISTER ATwww.GoToCEI.org

Citing strong evidence of eff ectiveness, the U.S. Preventive Services Task Force in May 2012 recommended team-based care -- uniting the eff orts of physicians, pharmacists, nurses and other health care professionals -- to improve blood pressure control. Participate in the free one hour On Demand CPE activity to learn more about Team Up. Pressure Down. Coaching Patients to Take Control.*, a new Million Hearts™ initiative that off ers support and resources for health care professionals working to help Americans improve medication adherence and more eff ectively manage their blood pressure.

Learning Objectives: Upon completion of this knowledge-based CPE activity, pharmacists will be able to:1. Discuss the Million Hearts™ Team Up. Pressure Down. initiative 2. Describe the incidence and eff ect of hypertension on the health of Americans 3. Discuss the obstacles and impact of adherence in patients with hypertension 4. Utilize tools to identify and assist non-adherent patients to achieve better health outcomes 5. Examine the use of motivational interviewing techniques to help patients improve blood pressure control 6. Eff ectively counsel, engage and coach patients on ways to manage their hypertension

Faculty:CoraLynn B. Trewet, MS, PharmD, BCPS, CDEAssociate Professor (Clinical)University of IowaBroadlawns Family Health CenterDr. Trewet does not report any actual or potential confl icts of interest in relation to this continuing pharmacy education activity. Off -label use of medication will not be discussed.

CPE Credit Information: The Collaborative Education Institute is accredited by the Accreditation Council for Pharmacy Edu-cation as a provider of continuing pharmacy education.UAN: 107-999-12-078-H04-P 0.1 CEU/1.0 HrInitial Release Date: 9/5/2012 Planned Expiration Date: 9/5/2015

Target Audience: Pharmacists interested in helping their patients better manage their blood pressure and reduce their risk of heart attack and stroke.

*This CPE activity was recorded and repurposed for On Demand use from live webinar off erings in September 2012.

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To Obtain 1 Hour of Free CPE Credit:

1. Go to www.GoToCEI.org click on Team Up. Pressure Down. Coaching Patients to Take Control. under Featured Activities

2. Select Register3. Enter username and password or create a profi le if you are new to CEI (may need to re-enter

Portfolio once complete) *4. After completing registration, click on “Click Here to Go to Activity”5. Scroll down and click on Team Up. Pressure Down. Coaching Patients to

Take Control. under My Activities6. After completing CPE activity, you will be directed to complete Exam and

Evaluation7. After successful completion, you will have access to CPE Statement

*Please record your CPE Monitor e-profi le ID in your CEI profi le. Record of successful participation will be sent to CPE Monitor within 45 days. Obtain your number at www.MyCPEmonitor.net.

Questions regarding registration, please contact Cindy Smith, [email protected] or 515-270-8118.

Financial Support:This CPE activity is made available through a subcontract with the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention (CDC).

Million Hearts™ Team Up. Pressure Down. Initiative and Materials: (http://millionhearts.hhs.gov)• Million Hearts™ is a national public-private initiative led by the U.S. Department of Health and Human

Services (HHS) with the goal of preventing 1 million heart attacks and strokes by 2017. • Launched September 5, Team Up. Pressure Down. is a Million Hearts™ educational program that promotes

team-based care and off ers support for health care professionals helping Americans improve medication adherence and more eff ectively manage their blood pressure.

• Team Up. Pressure Down. was developed by the Centers for Disease Control and Prevention (CDC) in collaboration with practicing pharmacists, national pharmacist groups, and other stakeholders supporting the Million Hearts™ initiative.

• A suite of materials off ers time-saving resources that encourage and support pharmacists in providing advice and counseling to patients with high blood pressure, and can be tailored for any pharmacy setting.

REGISTER ATwww.GoToCEI.org

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First Pharmacist Appointed to HHS National Vaccine Advisory Committee

On September 11, Mitchel Rothholz, RPh, MBA was sworn into a four year term as an individual member of HHS’ National Vaccine Advisory Committee (NVAC). The purpose of NVAC is to advise and make recommendations to the Assistant Secretary of Health, Director of the National Vaccine Program, on matters related to program responsibilities, including the development and implementation oversight of the National Vaccine Plan. Rothholz was appointed in recog-nition of his more than 18 years of leadership work within the immunization and pharmacy community to increase our nation’s vaccination rates and for his work in facilitating the role of pharmacists in immunizations.

Rothholz currently serves as the Chief Strategy Officer of the American Pharmacists Association. He is a member of the Executive Committees of the AMA/CDC National Influenza Vaccination Summit (NIVS) and the AMA/CDC/HHS National Adult Immunization Summit the Advisory Board of the Immunization Action Coalition, and served on HHS - NVAC’s Adult Vaccination Working Group. He has assisted numerous pharmacists in implementing immunization services, facilitated collaboration among immunization stakeholders, and has made numerous presentations to public policy makers and the media on pharmacy-based immunizations and immunizations across the lifespan.

More than 185,000 pharmacists have been trained to give immunizations. In 2011-12, pharmacists administered roughly 18% of the influenza vaccinations, as well as many other vaccines, like pneumococcal, Zoster and Td/Tdap to meet the needs of their communities. Visit APhA’s Immunization Center for more immunization news, tools, and resources and see pharmacist.com for additional information on Rothholz’s appointment to the NVAC.

More than 185,000 pharmacists have been trained to give immunizations

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It’s time to renew your Georgia Pharmacist license. Your license expires December, 31, 2012, so visit the Geor-gia Secretary of State’s office online at www.sos.ga.gov any time before then to renew. Click on the License Renewal link to begin the process and you’ll find step-by-step instructions to complete your renewal.

The online renewal process takes only a few minutes. After updating both your physical and your mailing ad-dresses and answering the renewal questions, you may pay using your American Express, MasterCard or Visa using their secure server. You’ll be able to verify your renewal online by the end of the next business day and you’ll receive your renewed license in the mail. NEW: Under Georgia law, all licensees who renew a license must submit secure and verifiable documentation with their renewal. A list of the approved Secure and Verifiable Documents may be found on the Georgia Attor-ney General’s website, www.law.ga.gov. Click on that link to see which document you should submit. You will have the option to upload your document later in the renewal process or you may fax or mail the document. Continuing Education documents will not satisfy the requirement to submit a Secure & Verifiable Document; send CE documents only if you are audited.

The Board of Pharmacy and the Georgia Drugs and Narcotics Agency have been informed that every pharmacist renewing their license for this cycle must provide a copy of their driver’s license in order to prove U.S. Citizen-ship. This new law is Georgia’s Immigration Law, HB87, and just like with driver’s licenses, you now have to prove your U.S. Citizenship in order to renew an existing license. This is true for any personal license issued by the State of Georgia. . BOTTOM LINE: In order to renew, everyone has to upload, fax or mail a copy of some document such as a driv-er’s license (issued in any of the United States or territories), a passport, etc., when transmitting their renewal. These instructions are pretty straight-forward and spell out how to send in these documents with your renewal or fax/mail them to the board office. Don’t delay or wait until the last few days of the renewal cycle to renew! And please realize - this process is not because of the Board or the Secretary of State’s office trying to make renewal more difficult, it is solely because of the new Georgia Immigration Law. In fact, the Sec of State’s office has made this process about as simple and streamlined as possible for any board issued license, which would include pharmacists.

Get Out Your Driver’s License When You Renew Your Georgia Pharmacist License

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Thank You to All PharmPAC Supporters

Recent contributors are highlighted in bold blue. The information provided below is effective as of September 21, 2012

Diamond Level$4,800 minimum pledge

Cynthia K. Moon

Titanium Level$2,400 minimum pledge

T.M. Bridges, R.Ph.Ben Cravey, R.Ph.Michael E. Farmer, R.Ph.David B. Graves, R.Ph.Raymond G Hickman, R.Ph.Ted M. Hunt, R.Ph.Robert A. Ledbetter, R.Ph.Jeffrey L. Lurey, R.Ph.Marvin O. McCord, R.Ph.Scott Meeks, R.Ph.Judson Mullican, R.Ph.Mark Parris, Pharm.D.Loren B. Pierce, R.Ph.Fred F. Sharpe, R.Ph.Jeff Sikes, R.Ph.Dean Stone, R.Ph., CDM

Platinum Level$1,200 minimum pledge

Ralph W. Balchin, R.Ph.Robert Bowles, Jr., R.Ph., CDM, CftsJim R. BracewellThomas E. Bryan Jr., R.Ph.William G. Cagle, R.Ph.Hugh M. Chancy, R.Ph.Keith E. Chapman, R.Ph.Dale M. Coker, R.Ph., FIACPJohn Ashley Dukes, R.Ph.Jack Dunn, Jr. R.Ph.Neal Florence, R.Ph.Andy FreemanMartin T. Grizzard, R.Ph.Robert M. Hatton, Pharm.D.Ted Hunt, R.Ph.Alan M. Jones, R.Ph.Ira Katz, R.Ph.Hal M. Kemp, Pharm.D.George B. Launius, R.Ph.

Brandall S. Lovvorn, Pharm.D.Eddie M. Madden, R.Ph.Jonathan Marquess, Pharm.D., CDE, CPTPam Marquess, Pharm.D.Kenneth A. McCarthy, R.Ph.Drew Miller, R.Ph., CDMLaird Miller, R.Ph.Jay Mosley, R.Ph.Allen Partridge, R.Ph.Houston Lee Rogers, Pharm.D., CDMTim Short, R.Ph.Benjamin Lake Stanley, Pharm.D.Danny Toth, R.Ph.Christopher Thurmond, Pharm.D.Tommy Whitworth, R.Ph., CDM

Gold Level$600 minimum pledge

James Bartling, Pharm.D., ADC, CACIIWilliam F. Brewster, R.Ph.Bruce L. Broadrick, Sr., R.Ph.Liza G. Chapman, Pharm.D.Craig W. Cocke, R.Ph.J. Ernie Culpepper, R.Ph.Mahlon Davidson, R.Ph., CDMKevin M. Florence, Pharm.D.Kerry A. Griffin, R.Ph.James Jordan, Pharm.D.Marsha C. Kapiloff, R.Ph.Earl W. Marbut, R.Ph.John W. McKinnon, Jr., R.Ph.Robert B. Moody, R.Ph.Sherri S. Moody, Pharm.D.William A. Moye, R.Ph.Anthony Boyd Ray, R.Ph.Jeffrey Grady Richardson,

R.Ph.Andy Rogers, R.Ph.Daniel C. Royal, Jr., R.Ph.John Thomas Sherrer, R.Ph.Sharon Mills Sherrer, Pharm.D.Michael T. TarrantHenry Dallas Wilson, III, Pharm.D.

Silver Level$300 minimum pledge

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16

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Michael Lewis, Pharm.D.Ashley Sherwood LondonMax A. Mason, R.Ph.Amanda McCall, Pharm.D.Susan W. McLeer, R.Ph.Sheila D. Miller, R.Ph.Natalie NielsenAmanda Rose Paisley, Pharm.D.Rose Pinkstaff, R.Ph.Sara W. Reece Pharm.D., BC-ADM, CDE Leonard Franklin Reynolds, R.Ph.Don K. Richie, R.Ph.Laurence Neil Ryan, Pharm.D.Richard Brian Smith, R.Ph.Benjamin Lake Stanley, Pharm.D.Dana E. Strickland, R.Ph.Charles Storey, III, R.Ph.Archie Thompson, Jr., R.Ph.William C. Thompson, R.Ph.Carrie-Anne WilsonMax Wilson

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To join PharmPAC, please visit our website at gpha.org.

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17

Welcome New GPhA Members

1st Year Post-GraduateLia Churchill, Pharm.D.

Pooler, GA

Phuong V. NguyenAtlanta, GA

Pharmacy Student

Antwon ErvinUniversity of Southern California School of Pharmacy

Gardena, CA

Dure KimMercer University

Atlanta, GA

PHARMACY BASED IMMUNIZATION DELIVERY PROGRAM

Become a Pharmacy Based Immunizer in Suwanee!

Saturday, October 27, 2012 from 8am - 6pm

A CERTIFICATE PROGRAM FOR PHARMACISTS

HOSTED BY GPHA AT PCOM SCHOOL OF PHARMACY______________________________________________________________________________

Pharmacy-Based Immunization Delivery is an innovative and interactive practice-based educational program that provides pharmacists with the skills necessary to become primary sources for vaccine advocacy, education, and administration. The program reviews the basics of immunology, identifies legal and regulatory issues pharmacists must consider before starting an immunization program, and focuses on practice implementation.

This program is priced as follows:

GPhA Members: $400

GPhA Student Members: $175

All GPhA Potential Members: $495

Faculty:

TBD

The purpose of this educational program is to: Provide comprehensive immunization

education and training. Provide pharmacists with the knowledge, skills,

and resources necessary to establish and promote a successful immunization service.

Teach pharmacists to identify at-risk patient populations needing immunizations.

Teach pharmacists to administer immunizations in compliance with legal and regulatory standards.

Pharmacy-Based Immunization Delivery is conducted in two parts: the self-study and the live training. To earn a Certificate of Achievement, participants must complete all components of the program including the self-study, the self-study assessment, the Pharmacy-Based Immunization

Delivery live training seminar, the final examina-tion, and the injection technique assessment. Statements of Credit and Certificates will be issued within 4-6 weeks of APhA’s receipt of program materials.

After completing the live training seminar, participants will be able to: Identify opportunities for pharmacists to

become involved in immunization delivery. Describe how vaccines evoke an immune

response and provide immunity. Identify the vaccines available on the U.S.

market for each vaccine-preventable disease and classify each vaccine as live attenuated or inactivated.

Evaluate a patient’s medical and immunization history and determine in the patient falls into the target groups for each vaccine based on the Advisory Committee for Immunization Practices (ACIP) recommendations.

Review a patient case and determine patient-specific vaccine recommendations based on the appropriate immunization schedule.

Discuss the legal, regulatory, and liability issues involved with pharmacy-based immun-ization programs.

Describe the signs and symptoms of adverse reactions that can occur after vaccination

Describe the emergency procedures for management of patients with adverse reactions to vaccination.

List the steps for appropriate intranasal administration technique for the live attenuated influenza vaccine.

Demonstrate appropriate intramuscular and subcutaneous injection technique for adult Immunization.

18

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

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.

©2012 RxAlly, Inc. All rights reserved. RxAlly, the RxAlly logo, and other trademarks, service marks, and designs are registered or unregistered trademarks of RxAlly. 3/12

Visit RxAlly.com Email [email protected] Call 1-855-RxAlly-1

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22

continuing educat ion for pharmacists

Clostr idium dif f ic i le Infect ion Overview and Treatment with New Drug Fidaxomicin

Volume XXX, No. 8

Mona T. Thompson, R.Ph., PharmD

Goal. The goal of this lesson is to provide a review of Clostridium difficile infection (CDI) to include epidemiology and pathophysiol-ogy of the disease, risk factors, transmission, clinical diagnosis, and adult treatment. In addition, a new entity and treatment option for CDI, fidaxomicin (Dificid®), will be reviewed. Surgical and non-pharmacological treatment will not be discussed in this lesson.

Objectives. At the completion of this activity, the participant will be able to:

1. demonstrate an understand-ing of the epidemiology, pathophys-iology, risk factors, transmission, and clinical diagnosis for CDI;

2. recognize the general treat-ment options and management of CDI; and

3. identify key prescribing and counseling points for each entity discussed including fidaxomicin (Dificid®).

IntroductionClostridium difficile (C. difficile) is an obligate anaerobic, spore-pro-ducing, gram positive rod that was first described in 1935. It has since been linked with Clostridium dif-ficile-associated diarrhea (CDAD) and pseudomembranous colitis, an infection of the large intestine characterized by an inflamed and bleeding lining of the colon. C. dif-ficile is the responsible pathogen

in 20 to 30 percent of patients with antibiotic-associated diarrhea, 50 to 75 percent of those with antibiot-ic-associated colitis, and more than 90 percent of those with antibiotic-associated pseudomembranous colitis. Additional complications may include bowel perforation and septicemia resulting in death. CDI or CDAD was traditionally consid-ered a hospital-acquired infection affecting elderly and frail patients, but is now presenting in the com-munity setting. The rates of CDI are increasing dramatically, and some experts feel it is an under-recognized cause of severe illness and death. CDI is an important public health concern which de-mands additional media and public health awareness and prevention education. EpidemiologyAccording to a study published by the Centers for Disease Control and Prevention (CDC) in 2007, reported mortality rates from C. difficile disease in the United States increased from 5.7 per mil-lion population in 1999, to 23.7 per million in 2004. The study also found that mortality rates were higher for whites than for other racial or ethnic groups. One reasonable justification for this observation may be attributed to racial/ethnic differences in insur-ance status and access to care. Whites are more likely to receive antimicrobial treatment putting them at risk for CDI. It is also hy-pothesized that the increased rate of overall mortality may be due to

the emergence of highly virulent strains of C. difficile such as the North American pulsed-field type 1 (NAP1), restriction-endonuclease analysis type BI, and polymerase chain reaction (PCR) ribotype 027, collectively referred to as the NAP1/BI/027 strain. This virulent strain is also associated with the production of 10 times more toxin A, up to 23 times more toxin B, and a third toxin referred to as binary toxin. In addition, it is resistant to fluoroquinolones which may have contributed to its prevalence. Since the emergence of the NAP1/BI/027 strain, CDI is now being diagnosed in the community and is affecting patients previously con-sidered low risk for contracting the disease, including young, healthy individuals without prior exposure to hospitals or antibiotics.

Pathogenesis The pathogenesis of CDI requires a three-step process (Figure 1). First, an alteration of the normal colonic microflora by antibiotics occurs or, rarely, from chemotherapeutic agents. Clindamycin was the first antibiotic to be associated with pseudomembranous colitis; howev-er since then almost all antimicro-bials have been linked with CDAD. There also appears to be a relation-ship between the widespread use of fluoroquinolones and CDAD. Table 1 lists the frequency for which antimicrobials are associated with CDAD and colitis. Cancer chemo-therapy agents that possess an-timicrobial properties and bowel preparation regimens rarely result

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

23

Table 1Antimicrobial agents that predispose to

Clostridium difficile-associated diarrhea and colitis

Most Frequently Ampicillin and amoxicillin Cephalosporins Clindamycin Fluoroquinolones Less Frequently Macrolides (including erythromycin) Other penicillins Sulfonamides Trimethoprim/sulfamethoxazole

Rarely or Never Bacitracin Carbapenems Chloramphenicol Daptomycin Metronidazole Parenteral aminoglycosides Rifampin Rifaximin Tetracycline Tigecycline Vancomycin

Figure 1Pathogenesis of Clostridium

difficile-associated diarrhea and colitis

Kyne L, Farrell R, Kelly CP. Clostridium difficile. Gastroen-terol Clin North Am 2001; 30:753.

Antibiotic Therapy↓↓

Altered colonic microflora↓↓

C. difficile exposure and colonization↓↓

Toxin production

No protectiveimmune response

Protectiveimmuneresponse

Asymptomaticcarriage

Diarrheaand colitis

in sufficient disturbance of the intestinal microflora.

The second step is the acqui-sition of a toxigenic strain of C. difficile. C. difficile spores are generally found in the hospital environment, with the risk of contamination being greatest in areas close to symptomatic pa-tients. Most disease transmission is caused by the transient carriage on healthcare workers’ hands. The impaired protective barrier of the intestines then becomes colonized with C. difficile.

The third step is the develop-ment of clinical disease, though some patients may remain asymp-tomatic after colonization. The exact incubation time is not known, but is thought to be no longer than seven days. Development of symp-tomatic disease is determined by the patient’s ability to develop an immune response to the toxin.

Risk Factors Risk factors for the development

of CDI in addition to antimicrobial therapy include increasing age, se-verity of underlying disease, use of nasogastric tubes, gastrointestinal procedures, and length of hospital stay. Additionally, patients under-going cytotoxic chemotherapy and those with human immunodefi-ciency virus (HIV) are also at risk due to frequent antibiotic usage, nosocomial exposure, and severe comorbidity.

In February 2012, the Food and Drug Administration (FDA) is-sued a drug safety communication regarding the possible association of CDAD and stomach acid drugs. While proton pump inhibitors (PPIs) are specifically highlighted in this drug safety communica-tion, H2 antagonists are also being investigated. FDA states that patients taking PPIs who develop diarrhea that does not improve should be considered for a CDAD diagnosis. They are also working with manufacturers to update the PPI labels with the added caution-

ary statement regarding the in-creased risk of CDAD with PPI use. Because gastric acidity is a mecha-nism that protects the host against ingested pathogens, it is proposed that the reduction of gastric acid could allow a greater number of vi-able C. difficile spores to reach the colon. However, spores are consid-ered to be relatively acid-resistant. Other experts suggest that there is an antibiotic effect with PPIs that changes the flora of the lower intestine. Past studies have been observational, and randomized trials are needed to determine the strength of the association.

Transmission The primary mode of C. difficile transmission resulting in disease is person-to-person spread through the fecal-oral route, primarily within healthcare facilities (e.g., long term care, rehabilitation). The most important infection con-trol measures include (1) the use of gloves and gowns by healthcare workers and visitors upon entry into the hospital room of a patient with CDI; (2) compliance with good hand hygiene; and (3) private hos-

↓ ↓

24

pital rooms, where possible, with contact precautions for the dura-tion of diarrhea. It is important to note that alcohol-based hand sani-tizers which are commonly avail-able in healthcare facilities are not effective in killing C. difficile in its spore form, and may just displace the spores. Spores should be removed by washing hands with soap or chlorhexidine and running water.

Diagnosis The diagnosis of C. difficile diar-rhea should be considered in any patient with acute diarrhea who has received antibiotics within the previous three months, and espe-cially in anyone whose diarrhea began 72 hours or more after hos-pitalization. Clostridium difficile infection is defined by the pres-ence of symptoms which is usually diarrhea (passage of three or more unformed stools in 24 or fewer consecutive hours), and either a positive stool test for C. difficile toxins or toxigenic C. difficile, or colonoscopic or histopathologic findings revealing pseudomembra-nous colitis. Testing for C. dif-ficile or its toxins should only be performed on diarrheal (unformed) stool, unless ileus due to C. difficile is suspected. Ileus is a condition where the bowel is not working correctly, leading to an immobility issue where no structural problem exists. In patients with ileus or colonic distension with minimal or no diarrhea, testing can be done on available stool. Various methods are used to test stool for CDI. They differ in cost, speed of results, spec-ificity, and sensitivity. The same criteria are used to diagnose recur-rent CDI. Recent use of antibiotics is not required for diagnosis due to occasional reports of community-acquired cases.

Treatment The first step in treating CDI is to discontinue therapy with the caus-ative antimicrobial agent(s) as soon as possible in order to reduce the risk of recurrent infection. In 15 to 25 percent of patients, diarrhea

may resolve without specific C. difficile treatment. However, this therapy alone is not recommended for patients who are severely ill or who have other medical prob-lems. If severe or complicated CDI is suspected, empirical treatment should begin as soon as the diagno-sis is suspected, followed by stool toxin assay for confirmation. If the result is negative, the decision to alter therapy must be individual-ized. Antiperistalic agents, such as loperamide, should be avoided when possible as they may hide symptoms and precipitate toxic megacolon.

Initial Episode of CDIAccording to the 2010 clinical prac-tice guidelines published by the So-ciety for Healthcare Epidemiology of America (SHEA) and the Infec-tious Diseases Society of America (IDSA), the following recommenda-tions have been provided for CDI treatment in adults. Metronidazole is the drug of choice for an initial episode of mild to moderate CDI at a dosage of 500mg orally three times a day for 10 to 14 days. Van-comycin is the drug of choice for an initial episode of severe CDI at a dosage of 125mg orally four times a day for 10 to 14 days (some refer-ences suggest doses of 125-500mg for moderate to severe CDI while higher doses are generally reserved for more critical patients). Van-comycin orally (and per rectum, if ileus is present, since ileus may prevent the delivery of oral vanco-myin to the colon) with or without intravenous metronidazole is the regimen of choice for the treatment of severe, complicated CDI. In this instance, the guidelines suggest vancomycin 500mg orally four times a day and 500mg in approxi-mately 100mL normal saline per rectum every six hours as a reten-tion enema. Metronidazole should be dosed at 500mg intravenously every eight hours. These agents will be discussed in further detail in this lesson. Recurrent CDI Recurrent CDI is either a result

of a relapse of the infection due to the original strain, or re-infection of patients who remain susceptible and are exposed to a new strain. For the first recurrence, the same antibiotic that was used for the initial episode is recommended. However, vancomycin should be chosen over metronidazole if the white blood cell (WBC) count is 15,000 cells/µL (15) or higher, or if the patient has a rising serum creatinine (SCr) level indicating that the patient is at a higher risk of developing complications.

The recommended treatment for a second recurrence is vancomy-cin, using a tapered or pulse regi-men. Metronidazole is not recom-mended beyond the first recurrence or for long term therapy because it may be associated with cumula-tive neurotoxicity. The following is an example of an acceptable taper schedule; however, there are vari-ous regimens. Begin with vanco-mycin 125mg orally four times a day for 10 to 14 days, followed by 125mg two times a day for one week, followed by 125mg once per day for a week, followed by 125mg every two or three days for two to eight weeks. The rationale behind this tapered regimen is that it al-lows time for the spores to convert to the C. difficile vegetative forms and then be killed on the days that vancomycin is administered. It also allows the C. difficile vegeta-tive forms to be kept in balance while allowing the normal flora to be reestablished. While the taper-pulse course has shown efficacy, concern does exist that vancomycin will increase susceptibility to CDI by killing off too much of the gram positive organisms in the gut. It may also predispose the patient to vancomycin-resistant enterococci (VRE). C. difficile resistance to vancomycin is rare.

There are a number of other treatment options that may be at-tempted if further failure occurs. In addition to the select newer alter-native antimicrobials that will be discussed below, evidence suggests that intravenous immunoglobu-lin infusion and fecal microbiota

25

transplantation are encouraging options. Toxin binders, such as cholestyramine and colestipol, may be used as adjunct therapy to control diarrhea, but should not be prescribed as primary therapy.

Select Antibiotics for the Treatment of CDITable 2 includes recommendations for the treatment of C. difficile infection.

Metronidazole (Flagyl®). Metronidazole is preferred as first line for mild to moderate disease because it is inexpensive and effective. Data prior to 2000 indicated that the failure rates for treatment with metronidazole and vancomycin were very simi-lar. However, since 2000, higher failure rates have been reported with metronidazole (average 19 percent, ranging from 7 to 38 percent). In a retrospective study, the time to resolution of diarrhea in metronidazole-treated patients was significantly longer than in those treated with vancomycin. In mild disease, both treatments yield similar response rates, leading to

the recommendation that metro-nidazole only be used first line for mild to moderate disease.

Oral metronidazole therapy is well absorbed in the upper intestine and reaches high fecal concentrations in patients with C. difficile colitis because it is secreted through inflamed intestinal muco-sa. The tablet may also be crushed and administered through a naso-gastric tube if needed. Intravenous metronidazole is an alternative for patients who can’t tolerate oral medication. Metronidazole is a pregnancy category risk factor B, yet contraindicated in the first trimester. It has been carcinogenic in some animal species raising concern that it should not be used during pregnancy. The American Academy of Pediatrics (AAP) rates metronidazole as not compatible with nursing, as it enters breast milk and is not recommended.

Metronidazole is generally well tolerated. Common side effects include nausea, metallic taste, and peripheral sensory neuropathy with prolonged therapy. It should be used with caution in patients

with severe liver impairment, history of seizures, CHF, or other sodium-retaining states. Dose reductions should be considered in patients with severe liver impair-ment, CNS disease, or long term therapy in patients with severe re-nal impairment (CrCl <10mL/min). Disulfiram-like reactions to ethanol (flushing, headache, nausea, vomit-ing, sweating, or tachycardia) have been reported with oral metronida-zole; therefore, alcoholic beverages should be avoided during therapy and for three days following regi-men completion. Metronidazole should be taken on an empty stomach. If gastrointestinal upset occurs, it may be taken with food.

Vancomycin (Vancocin®). Vancomycin is the second-line agent for mild to moderate CDI, but preferred for severe and/or complicated CDI based on clinical study response rates. It was the first antibiotic with FDA approval for CDI. Vancomycin is more ex-pensive than metronidazole ($600 to $1300, versus $15, for a 10-day course), and concerns of spread-ing VRE exist. It is also preferred for long term therapy and during pregnancy. When given orally, it is a pregnancy risk factor B (injection is category C). It does enter breast milk and is not recommended for nursing mothers. It may be ad-ministered through a nasogastric tube if oral administration is not possible. In addition, oral, naso-gastric, and rectally administered vancomyin are not systemically absorbed from the gut; therefore, systemic laboratory monitoring does not generally apply. However, in some cases of long term courses of 2 grams per day in patients with renal failure, a serum trough level may be warranted to avoid nephro-, neuro-, or ototoxicity. It is impor-tant to note that for the treatment of CDI, intravenous vancomycin is not appropriate because effec-tive colonic concentrations are not obtained.

Common side effects associated with oral administration include bitter taste, nausea, vomiting, and stomatitis. Vancomycin can be

Table 2Recommendations for the treatment of

Clostridium difficile infection (CDI)

Clinical definition Supportive clinical data Recommended treatment Initial episode, mild Leukocytosis with WBC Metronidazole: 500mg three to moderate <15 and SCr <1.5 times times a day by mouth for 10 premorbid level to 14 days Initial episode, Leukocytosis with WBC Vancomyin: 125mg four severe >15 or SCr >1.5 times times a day by mouth for 10 premorbid level to 14 days Initial episode, Hypotension or shock, Vancomycin: 500mg four severe, complicated ileus, megacolon times a day by mouth or nasogastric tube, plus met- ronidazole 500mg every 8 hours intravenously. If com- plete ileus, consider adding rectal vancomycin First recurrence Same as initial episode Second recurrence Vancomyin in a tapered and/ or pulsed regimen Adapted from 2010 practice guidelines for C. difficile infections in adults published by SHEA/IDSA.

26

taken with food. Oral administra-tion includes use of commercially available oral capsules or an oral solution that is compounded using reconstituted powder for injection. The latter is commonly used in healthcare facilities as it is more cost effective and appropriate for nasogastric use.

Cholestyramine, colestipol, and other anion-exchange resins bind to vancomycin; concomitant use for this indication is contraindicated.

Nitozoxanide (Alinia®). Ni-tozoxanide is a synthetic antiproto-zoal agent that has been proposed as a treatment alternative for CDI. It is currently indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidi-um parvum. It exerts its activity by interfering with anaerobic metabo-lism of protozoa and bacteria. In vitro testing indicated that it was effective in killing C. difficile. In addition, favorable kinetics for CDI include that nitozoxanide is largely nonabsorbed by the gastrointesti-nal tract and two-thirds is excreted in feces. Clinical data has reported that when used to treat CDI, it is at least as effective as metronida-zole and is effective for patients who experience treatment failure with metronidazole.

Musher et. al. conducted the first prospective, double-blind, ran-domized controlled trial comparing nitozoxanide to vancomycin. Fifty patients were included in the trial and received either Alinia 500mg by mouth twice daily or vancomy-cin 125mg by mouth four times a day. In those who completed the therapy, response rates were 87 percent (20 of 23 patients) in the vancomycin group and 94 percent (17 of 18 patients) in the nitozo-xanide group. The authors state that this small sample does not confirm noninferiority of Alinia to vancomycin.

The cost of Alinia for 10 days of therapy is approximately $400 to $500. Based on cost, the authors suggest that nitozoxanide should not replace metronidazole for treat-ment of outpatients with mild to moderate disease. A much larger

study is required before it may be considered as a substitute for van-comycin for severe CDI.

Nitozoxanide is categorized as pregnancy risk factor B, and its excretion in breast milk has not been studied and is unknown. It is contraindicated in patients with a history of hypersensitivity to the agent or any component of the for-mulation. It has not been studied in patients with renal or hepatic impairment and should, therefore, be used with caution in these popu-lations. The most common adverse events reported with therapy include headache, abdominal pain, diarrhea, nausea, and vomiting.

Rifaximin (Xifaxin®). Ri-faximin is an antibiotic that is currently indicated for the treat-ment of traveler’s diarrhea caused by noninvasive strains of E. coli and reduction in the risk of overt hepatic encephalopathy recur-rence. It has been studied off-label and prescribed as an alternative for Clostridium difficile-associated diarrhea. Rifaximin inhibits bacte-rial RNA synthesis by binding to bacterial DNA-dependent RNA polymerase.

Rifaximin has been shown to be effective against C. difficile in some small case studies, but has also revealed the development of resis-tance. For example, eight patients in one report who had four to eight previous episodes of CDI and failed combinations of standard therapy (vancomycin, metronidazole) were treated with an unconventional regimen of vancomycin and ri-faximin. The patients were treated with vancomycin until symptoms resolved followed by rifaximin for 14 days. The results were promis-ing; however, large-scale trials are needed.

Xifaxin is a poorly-absorbed rifampin derivative. When used off-label for CDI, the dose ranges from 200 to 400mg two or three times a day for 14 days. The cost of therapy, dosed at 400mg three times a day, is approximately $700. It may be taken with or without food. It is a pregnancy category risk C; since excretion in breast milk is

unknown, it is not recommended for nursing mothers. Rifaximin is contraindicated in patients with previous hypersensitivity to the entity, a component of the formula-tion, or other rifamycin antibiotics. It should not be given with BCG, the vaccine against tuberculosis. Xifaxin has not been studied in patients with renal impairment, and should be used with caution in patients with severe hepatic impairment. The most common adverse events experienced in-clude peripheral edema, dizziness, fatigue, ascites, nausea, headache, pruritis, and abdominal pain.

New Drug: Fidaxomicin (Dificid®) Fidaxomicin is an oral macrolide antibacterial agent that was FDA-approved in 2011 for the treatment of Clostridium difficile-associated diarrhea in adults, making it the second antibiotic with FDA approv-al for this diagnosis. Dificid should only be prescribed when there is either strong suspicion or a con-firmed diagnosis of CDI. Fidaxomi-cin exerts its bactericidal activity by inhibiting RNA synthesis by RNA polymerases in susceptible organisms (C. difficile).

Dificid was granted FDA ap-proval based on the results of the fidaxomicin versus vancomycin for Clostridium difficile infection clinical trial which was designed to look for non-inferiority. Adults with acute symptoms of C. difficile infection and a positive result on a stool toxin test were eligible for the study. Patients were randomly assigned to receive fidaxomicin 200mg twice daily or vancomycin 125mg four times a day orally for 10 days. The primary end point was defined as clinical cure (reso-lution of symptoms and no need for further therapy for CDI on the second day after the end of thera-py). The secondary end points were defined as recurrence of CDI (diar-rhea and a positive result on a stool toxin test within four weeks after treatment) and global cure (cure with no recurrence).

In the analysis of those pa-

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tients who completed the clinical study, 92.1 percent of the patients (245 of 265 patients) in the fidaxo-micin group and 89.8 percent of the patients (254 of 283) in the vancomycin group met the crite-ria for clinical cure. The rates of recurrence in both groups were similar among patients with the NAP1/BI/027 strain. However, among patients with other strains, the rate of recurrence was lower and statistically significant in the fidaxomicin group. These rates were reported as 7.8 percent (eight of 103 patients) for fidaxomicin versus 25.5 percent (27 of 106) with vancomycin. There were no signifi-cant differences in safety between the two groups.

In discussion, the authors of this study highlight the benefit of reduced recurrence with fidaxomi-cin for the approximate 64.1 per-cent of patients who were infected with the non-NAP1/BI/027 strain of C. difficile. It is important to note that patients with life-threatening or fulminant CDI, toxic megacolon, previous exposure to fidaxomicin, and history of ulcerative colitis or Crohn’s disease were excluded from

the study. The recommended dosage for

fidaxomicin is 200mg twice daily with or without food for 10 days. It is not systemically absorbed, and, currently, there are no contrain-dications for its use. Fidaxomicin is not appropriate for systemic infections. It is listed as pregnancy risk category B. Reproductive studies in rats and animals did not reveal evidence of harm to the fetus. However, there are no adequate, well controlled studies in pregnant women; therefore, fidaxo-micin should only be used during pregnancy when clearly needed. It is presently unknown whether Dificid is excreted in breast milk; therefore, its use in nursing moth-ers warrants caution. There are currently no significant drug-drug interactions to report. It is me-tabolized by intestinal hydrolysis to a less active metabolite and largely excreted in the feces. No dosage adjustments are required for either renal or hepatic impairment.

The most common reason for discontinuation of fidaxomicin during clinical trials was vomit-ing. Other gastrointestinal adverse events include nausea, gastrointes-tinal hemorrhage, and abdominal pain. Dificid is also associated with hematologic events such as anemia and neutropenia.

Fidaxomicin costs approxi-mately $2700 for a 10-day course of therapy. Its benign safety profile and initial clinical studies indicate that it has a promising future in treating CDI; however, its cur-rent place in therapy has not been established at the time of writing this lesson. Counseling points are included in Table 3.

Role of Probiotics Probiotics are live, nonpathogenic bacteria that can colonize in the colonic mucosa. They are available over-the-counter, in health food stores or, more often, in fermented foods and dairy products such as yogurt. Various mechanisms have been proposed by which probiot-ics may be effective in the treat-ment and prevention of CDI. These

include altering the intestinal flora, exerting antimicrobial activity, interfering with the binding of C. difficile toxins to the intestinal wall, and stimulating the im-mune system. When probiotics are ingested, it is thought that they temporarily colonize the gut creating competition for nutrients and epithelial adhesion leading to an unfavorable environment for C. difficile to flourish. Despite the number of clinical trials that have been conducted, the role of probiotics remains uncertain. Not only have results been conflicting, but it is difficult to extrapolate the results from one probiotic formu-lation to another. The trials have been conducted with products containing distinctive probiotic species with various characteristics (i.e., acid resistance, colonization of lower intestinal tract, and cytokine secretion) and quantities. In ad-dition, since probiotics are catego-rized as dietary supplements, the manufacturers are not required to prove safety or evidence of good manufacturing practices. Hence, probiotics’ product labeling may not accurately reflect the number of live cultures listed.

Probiotics are currently not rec-ommended for primary treatment of CDI in most patients. They may be considered in patients with re-current disease that is not severe, as long as there are no significant comorbidities. Probiotics may be used in combination with vancomy-cin. They are also not suggested for prevention in most patients, except for the elderly without sig-nificant comorbidities and who are also receiving antibiotic therapy. The two most commonly studied probiotics are the Lactobacillus species and Saccharomyces bou-lardii. Published clinical studies should be reviewed prior to recom-mending a probiotic product.

Cases of probiotic-associated bacteremia or fungemia have been reported. In most incidents, the susceptible patients had severe comorbidities, were on immuno-suppressive therapy, had a recent surgical procedure, or had a recent

Table 3Counseling points for fidaxomicin (Dificid®)

•The recommended dose is 200mg orally twice daily for 10 days with or without food. •It is indicated for adults 18 years of age and older. •Dificid should not be used to treat systemic infections. It only treats CDAD and should not be used to treat any other infection. •Patients should be advised to com-plete the entire course of therapy. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the treatment and increase the likeli-hood that the bacteria will develop resistance.•Pregnancy category risk B •The most common adverse reac-tions are nausea, vomiting, abdomi-nal pain, gastrointestinal hemor-rhage, anemia, and neutropenia.

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Program 0129-0000-12-008-H01-PRelease date: 8-15-12

Expiration date: 8-15-15CE Hours: 1.5 (0.15 CEU)

The author, 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 ad-ditional reading and inquiry is avail-able upon request.

This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.

The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

prolonged hospitalization. The probiotics linked to these negative outcomes were most often Saccha-romyces boulardii and Lactobacil-lus rhamnosus GG.

Summary Clostridium difficile infection is a significant public health concern and the cause of increasing antibi-otic-related diarrhea and mortality. Proper hand hygiene is the primary method for decreasing transmis-sion among healthcare workers. Vancomycin and metronidazole are the two agents primarily outlined in SHEA/IDSA guidelines for treatment of CDI. They are the most widely studied agents, and those most commonly used for CDI. However, several newer agents have recently been investigated, including fidaxomixin (Dificid®) which was approved in 2011.

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continuing educat ion quiz Clostr idium dif f ic i le Infect ion Overview andTreatment with New Drug Fidaxomicin

Program 0129-0000-12-008-H01-P0.15 CEU

Please print.

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Completely fill in the lettered box corresponding to your answer.1. [a] [b] 6. [a] [b] [c] [d] 11. [a] [b] [c] [d] 2. [a] [b] [c] 7. [a] [b] [c] [d] 12. [a] [b] [c] [d] 3. [a] [b] [c] [d] 8. [a] [b] [c] [d] 13. [a] [b] [c] [d] 4. [a] [b] [c] [d] 9. [a] [b] [c] [d] 14. [a] [b] [c] [d] 5. [a] [b] 10. [a] [b] [c] [d] 15. [a] [b] [c] [d]

I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.

1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor)2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________3. Was the content balanced and without commercial bias? yes no4. Did the program meet your educational/practice needs? yes no5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

1. Clostridium difficile infection was traditionally consid-ered an infection acquired: a. in the community. b. in the hospital. 2. All of the following are characteristics associated with the newly recognized virulent C. difficile strain NAP1/BI/027 EXCEPT: a. produces up to 23 times more toxin A. b. produces binary toxin. c. is resistant to fluoroquinolones.

3. In addition to antimicrobial therapy, all of the following are potential risk factors for development of CDI EXCEPT: a. use of proton pump inhibitors. b. gastrointestinal procedures. c. ventilator use. d. length of hospital stay.

4. C. difficile transmission primarily occurs through which of the following routes? a. Oral-oral c. Vertical transmission b. Droplet d. Fecal-oral

5. Alcohol-based hand sanitizers are effective in killing C. difficile in its spore form. a. True b. False

6. The first step in treating CDI is to: a. conduct a stool culture on formed stool. b. conduct a stool culture on unformed stool. c. initiate treatment with metronidazole. d. discontinue therapy with the causative antimicrobial as soon as possible. 7. What is the drug of choice for an initial episode of mild to moderate CDI? a. Metronidazole c. Rifaximin b. Nitozoxanide d. Vancomycin

8. Which of following agents for CDI is preferred for long term therapy and during pregnancy? a. Metronidazole c. Rifaximin b. Nitozoxanide d. Vancomycin

9. For treatment of CDI, vancomycin can be administered by all of the following routes EXCEPT: a. intravenously. c. rectally. b. orally. d. via nasogastric tube.

10. Which of the following antibiotics is a synthetic anti-protozoal agent that has been shown to kill C. difficile in in vitro testing? a. Metronidazole c. Rifaximin b. Nitozoxanide d. Vancomycin

11. Which of the following agents is a rifampin derivative and should not be given with BCG vaccine? a. Metronidazole c. Rifaximin b. Nitozoxanide d. Vancomycin

12. Patient counseling for fidaxomicin includes: a. it is pregnancy risk category D. b. it is indicated for individuals age 12 years and older. c. therapy should be discontinued as soon as diarrhea is resolved. d. it should not be used to treat systemic infections.

13. The recommended dosage for fidaxomicin is: a. 400mg three times a day for 10 days. b. 400mg three times a day for 14 days. c. 200mg twice daily for 10 days. d. 200mg twice daily for 14 days.

14. The most common reason for discontinuing fidaxomicin during clinical trials was: a. vomiting. c. abdominal pain. b. nausea. d. gastrointestinal hemorrhage.

15. The proposed mechanism of action for probiotics in treating and preventing CDI includes all of the following EXCEPT: a. altering intestinal flora. b. interfering with anaerobic metabolism of bacteria. c. stimulating the immune system. d. interfering with the binding of C. difficile toxins to the intestinal wall.

To receive CE credit, your quiz must be received no later than August 15, 2015. A passing grade of 80% must be attained. All quizzes re-ceived after July 1, 2012 will be uploaded to the CPE Monitor Program and a statement of credit will not be mailed. Send inquiries to [email protected].

august 2012

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The Georgia Pharmacy JournalEditor Jim Bracewell [email protected]

Managing Editor Amy W. DeFaveri [email protected]

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.

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2012-2013 GPhA BOARD OF DIRECTORSName PositionLee Jack Dunn Chairman of the BoardRobert M. Hatton PresidentPamala S. Marquess President-ElectRobert B. Moody First Vice PresidentThomas H. Whitworth Second Vice PresidentHugh M. Chancy State At LargeLiza G. Chapman State At LargeKeith N. Herist State At LargeJoshua D. Kinsey State At LargeTracie D. Lunde State At LargeEddie M. Madden State At LargeJonathan G. Marquess State At LargeChristine Somers 1st Region PresidentEd S. Dozier 2nd Region PresidentRenee D. Adamson 3rd Region PresidentNicholas O. Bland 4th Region PresidentJulie W. Bierster 5th Region PresidentSherri S. Moody 6th Region PresidentAmanda McCall 7th Region PresidentMichael Lewis 8th Region PresidentKristy L. Pucylowski 9th Region President Lance P. Boles 10th Region PresidentAshley London 11th Region President Ken Von Eiland 12th Region PresidentThomas R. Jeter ACP ChairmanSharon B. Zerillo AEP ChairmanArchie R. Thompson AHP ChairmanDrew Miller AIP ChairmanLinda Gail Lowney APT ChairmanRobert Bentley ASA ChairmanJohn T. Sherrer Foundation ChairmanMichael E. Farmer Insurance Trust ChairmanBill Prather Georgia State Board of Pharmacy RepresentativeKenneth G Jozefcyk Georgia Society of Health Systems PharmacistsAmy C. Grimsley Mercer Faculty RepresentativeRusty Fetterman South Faculty RepresentativeSukhmani K. Sarao UGA Faculty RepresentativeNegin Sovaidi Moon ASP, Mercer University TBD ASP President, South University James William Spence ASP President, UGA Jim Bracewell Executive Vice President & CEO

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