October GPhA Journal 2012 by Georgia Pharmacy Association

October 2012

October

American Pharmacist Month article on page 6

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contents October is American Pharmacist Month

GPhA News Briefs • October is American Pharmacists Month. Check out tools and resources you can use to promote your profession here: http://www.pharmacist.com/americanpharmacists-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 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 14 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

Robert Hatton President Georgia Pharmacy Association

Answering October’s Opportunities

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 regarding 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.

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

Have you ever arrived home and wondered, “Did I forget something?”

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 profession, 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 profession through their membership in the Georgia Pharmacy 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 pharmaceutical 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. Following 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 professional 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 member 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?

American Pharmacists Month October 2012

Pharmacists are experts in helping patients get the most out of todayâ&#x20AC;&#x2122;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 selection, 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 â&#x20AC;&#x153;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.â&#x20AC;? 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, Honeywell International and the American Bankers Association, for example. There are also plenty of myths and misconceptions 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 members 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 contributions to support candidates that share our philosophy—to protect the profession of pharmacy and its patients. PharmPAC is a tool to maximize on that philosophy.

VOCA

C Y

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 important 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. 7

Getting Around the

Georgia State Capitol Without Leaving Your Seat

by Amy DeFaveri

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

Health Mart Healthy Living Tour Provides More Than 150 Free Health Screenings at Georgia Health Mart Pharmacies Five GPhA member Health Mart Pharmacists 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 Pharmacy, Jasper Drug Store, Huff’s Drug Store, Brasstown Pharmacy and Riverside Pharmacy & 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 pharmacies, 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 customers,” he said. “We’re always available to answer questions.” For the past five years, Dunn has served as president of the Georgia Pharmacy Association, 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 Center), 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 pharmacists 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 existing 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 cholesterol and hemoglobin A1C levels. Co-sponsored by Bayer Diabetes Care and Novo Nordisk, the Health Mart Healthy Living 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.

recylcing inhalers

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 Details Pharmacies 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 program as they pick up their GSK respiratory inhaler prescriptions, 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 remove 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 10

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 Impact The Complete the Cycle™ Recycle Program for GSK Respiratory 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 designed in response to the growing U.S. interest in environmental 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 selection.[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 difference 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 Individua Behavior – a Twenty Year Evolution. 2011

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:

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138th GPhA Convention Amelia Island Omni Resort Amelia, Island FL

June 22-25, 2013

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

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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.

Team Up. Pressure Down. Coaching Patients to Take Control. A Free One Hour On Demand CPE Activity REGISTER AT www.GoToCEI.org Citing strong evidence of effectiveness, the U.S. Preventive Services Task Force in May 2012 recommended team-based care -- uniting the efforts 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 Heartsâ&#x201E;˘ initiative that offers support and resources for health care professionals working to help Americans improve medication adherence and more effectively manage their blood pressure. Learning Objectives: Upon completion of this knowledge-based CPE activity, pharmacists will be able to: 1. Discuss the Million Heartsâ&#x201E;˘ Team Up. Pressure Down. initiative 2. Describe the incidence and effect 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. Effectively counsel, engage and coach patients on ways to manage their hypertension Faculty: CoraLynn B. Trewet, MS, PharmD, BCPS, CDE Associate Professor (Clinical) University of Iowa Broadlawns Family Health Center

Dr. Trewet does not report any actual or potential conflicts 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 Education as a provider of continuing pharmacy education. UAN: 107-999-12-078-H04-P 0.1 CEU/1.0 Hr Initial 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 offerings in September 2012. 12

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 Register 3. Enter username and password or create a profile 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 Activities 6. After completing CPE activity, you will be directed to complete Exam and Evaluation 7. After successful completion, you will have access to CPE Statement *Please record your CPE Monitor e-profile ID in your CEI profile. 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, csmith@gotocei.org 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 offers support for health care professionals helping Americans improve medication adherence and more effectively 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 offers 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.

First Pharmacist Appointed to HHS National Vaccine Advisory Committee

n 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 recognition 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 14

Get Out Your Driver’s License When You Renew Your Georgia Pharmacist License It’s time to renew your Georgia Pharmacist license. Your license expires December, 31, 2012, so visit the Georgia 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 addresses 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 Attorney 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.

every pharmacist renewing their license for this cycle must provide a copy of their driver’s license in order to prove U.S. CitizenThe Board of Pharmacy and the Georgia Drugs and Narcotics Agency have been informed that

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 driver’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.

PHARMPAC LOGO PLACEHOLDER

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, Cfts Jim R. Bracewell Thomas 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., FIACP John Ashley Dukes, R.Ph. Jack Dunn, Jr. R.Ph. Neal Florence, R.Ph. Andy Freeman Martin 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. 16

Brandall S. Lovvorn, Pharm.D. Eddie M. Madden, R.Ph. Jonathan Marquess, Pharm.D., CDE, CPT Pam Marquess, Pharm.D. Kenneth A. McCarthy, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Jay Mosley, R.Ph. Allen Partridge, R.Ph. Houston Lee Rogers, Pharm.D., CDM Tim 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, CACII William 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., CDM Kevin 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. Tarrant Henry Dallas Wilson, III, Pharm.D. Silver Level $300 minimum pledge Renee D. Adamson, Pharm.D. Ed Stevens Dozier, R.Ph. Terry Dunn, R.Ph. Charles Alan Earnest, R.Ph. Marshall L. Frost, Pharm.D. Johnathan Wyndell Hamrick, Pharm.D. James A. Harris, Jr., R.Ph. Michael O. Iteogu, Pharm.D. Joshua D. Kinsey, Pharm.D. Willie O. Latch, R.Ph. Kalen Porter Manasco, Pharm.D. Michael L. McGee, R.Ph. William J. McLeer, R.Ph. Sheri D. Mills, C.Ph.T. Albert B. Nichols, R.Ph. Richard Noell, R.Ph. Leslie Ernest Ponder, R.Ph. William Lee Prather, R.Ph. Kristy Lanford Pucylowski, Pharm.D. Ola Reffell, R.Ph. Edward Franklin Reynolds, R.Ph. Sukhmani Kaur Sarao, Pharm.D. David J. Simpson, R.Ph. James N. Thomas, R.Ph. Archie R. Thompson, Jr., R.Ph. Alex S. Tucker, Pharm.D. William H. Turner, R.Ph.

Flynn W. Warren, M.S., R.Ph. Walter Alan White, R.Ph. Charles W. Wilson, Jr., R.Ph. Steve Wilson, Pharm.D. William T. Wolfe, R.Ph. Sharon Zerillo, R.Ph. Bronze Level $150 minimum pledge Sylvia Ann Davis Adams,R. Ph. Monica M. Ali-Warren, R.Ph. Julie Wickman Bierster, Pharm.D. Nicholas O. Bland, Pharm.D. Lance P. Boles, R.Ph. Michael A. Crooks, Pharm.D. William Crowley, R.Ph. Rabun E. Deckle, Pharm.D. Helen DuBiner, Pharm.D. Charles Alan Earnest, R.Ph. Vaspar Eddings, R.Ph. Randall W. Ellison, R.Ph. Mary Ashley Faulk, Pharm.D. James W. Fetterman, Jr., Pharm.D. Amanda R. Gaddy, R.Ph. Charles C. Gass, R.Ph. Winton C. Harris, Jr., R.Ph. Lura Elizabeth Jarrett, Pharm.D. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Anabelle D. Keohane, Pharm.D. Brenton Lake, R.Ph. Allison L. Layne, C.Ph.T. William E. Lee, R.Ph. Tracie D. Lunde, Pharm.D.

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Welcome New GPhA Members 1st Year Post-Graduate Lia Churchill, Pharm.D. Pooler, GA Phuong V. Nguyen Atlanta, GA

Pharmacy Student

Antwon Ervin University of Southern California School of Pharmacy Gardena, CA Dure Kim Mercer University Atlanta, GA 17

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 ______________________________________________________________________________ Delivery live training seminar, the final examinaPharmacy-Based Immunization Delivery is an tion, and the injection technique assessment. innovative and interactive practice-based Statements of Credit and Certificates will be issued educational program that provides pharmacists with within 4-6 weeks of APhA’s receipt of program the skills necessary to become primary sources for materials. vaccine advocacy, education, and administration. After completing the live training seminar, The program reviews the basics of immunology, participants will be able to: identifies legal and regulatory issues pharmacists  Identify opportunities for pharmacists to must consider before starting an immunization become involved in immunization delivery. program, and focuses on practice implementation.  Describe how vaccines evoke an immune This program is priced as follows: response and provide immunity. GPhA Members: $400  Identify the vaccines available on the U.S. market for each vaccine-preventable disease GPhA Student Members: $175 and classify each vaccine as live attenuated or All GPhA Potential Members: $495 inactivated. Faculty:



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 patientspecific vaccine recommendations based on the appropriate immunization schedule.



Discuss the legal, regulatory, and liability issues involved with pharmacy-based immunization 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.

TBD

The purpose of this educational program is to: 

Provide comprehensive education and training.



Provide pharmacists with the knowledge, skills, and resources necessary to establish and promote a successful immunization service.

 

immunization

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 18

AIP Fall Meeting Sunday, October 21, 2012 Macon Marriott & Centreplex Macon, GA

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continuing education for pharmacists Volume XXX, No. 8

Clostridium difficile Infection Overview and Treatment with New Drug Fidaxomicin Mona T. Thompson, R.Ph., PharmD Dr. Mona T. Thompson has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide a review of Clostridium difficile infection (CDI) to include epidemiology and pathophysiology of the disease, risk factors, transmission, clinical diagnosis, and adult treatment. In addition, a new entity and treatment option for CDI, fidaxomicin (Dificid速), will be reviewed. Surgical and nonpharmacological treatment will not be discussed in this lesson. Objectives. At the completion of this activity, the participant will be able to: 1. demonstrate an understanding of the epidemiology, pathophysiology, risk factors, transmission, and clinical diagnosis for CDI; 2. recognize the general treatment options and management of CDI; and 3. identify key prescribing and counseling points for each entity discussed including fidaxomicin (Dificid速).

Introduction

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

in 20 to 30 percent of patients with antibiotic-associated diarrhea, 50 to 75 percent of those with antibiotic-associated colitis, and more than 90 percent of those with antibioticassociated pseudomembranous colitis. Additional complications may include bowel perforation and septicemia resulting in death. CDI or CDAD was traditionally considered a hospital-acquired infection affecting elderly and frail patients, but is now presenting in the community setting. The rates of CDI are increasing dramatically, and some experts feel it is an underrecognized cause of severe illness and death. CDI is an important public health concern which demands additional media and public health awareness and prevention education.

Epidemiology

According 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 million 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 insurance status and access to care. Whites are more likely to receive antimicrobial treatment putting them at risk for CDI. It is also hypothesized 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 considered 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; however since then almost all antimicrobials have been linked with CDAD. There also appears to be a relationship between the widespread use of fluoroquinolones and CDAD. Table 1 lists the frequency for which antimicrobials are associated with CDAD and colitis. Cancer chemotherapy agents that possess antimicrobial properties and bowel preparation regimens rarely result 23

Figure 1 Pathogenesis of Clostridium difficile-associated diarrhea and colitis Antibiotic Therapy ↓ ↓ Altered colonic microflora ↓ ↓ C. difficile exposure and colonization ↓ ↓ Toxin production Protective immune response

Table 1 Antimicrobial 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

No protective immune response ↓

↓ Asymptomatic carriage

Diarrhea and colitis

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

in sufficient disturbance of the intestinal microflora. The second step is the acquisition 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 patients. 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 development of clinical disease, though some patients may remain asymptomatic after colonization. The exact incubation time is not known, but is thought to be no longer than seven days. Development of symptomatic disease is determined by the patient’s ability to develop an immune response to the toxin.

Risk Factors

Risk factors for the development 24

of CDI in addition to antimicrobial therapy include increasing age, severity of underlying disease, use of nasogastric tubes, gastrointestinal procedures, and length of hospital stay. Additionally, patients undergoing cytotoxic chemotherapy and those with human immunodeficiency 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) issued 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 communication, 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 increased risk of CDAD with PPI use. Because gastric acidity is a mechanism that protects the host against ingested pathogens, it is proposed that the reduction of gastric acid could allow a greater number of viable C. difficile spores to reach the colon. However, spores are considered 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 control 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-

pital rooms, where possible, with contact precautions for the duration of diarrhea. It is important to note that alcohol-based hand sanitizers which are commonly available 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 diarrhea should be considered in any patient with acute diarrhea who has received antibiotics within the previous three months, and especially in anyone whose diarrhea began 72 hours or more after hospitalization. Clostridium difficile infection is defined by the presence 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 pseudomembranous colitis. Testing for C. difficile 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, specificity, and sensitivity. The same criteria are used to diagnose recurrent CDI. Recent use of antibiotics is not required for diagnosis due to occasional reports of communityacquired cases.

Treatment

The first step in treating CDI is to discontinue therapy with the causative 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 problems. If severe or complicated CDI is suspected, empirical treatment should begin as soon as the diagnosis is suspected, followed by stool toxin assay for confirmation. If the result is negative, the decision to alter therapy must be individualized. Antiperistalic agents, such as loperamide, should be avoided when possible as they may hide symptoms and precipitate toxic megacolon.

Initial Episode of CDI

According to the 2010 clinical practice guidelines published by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA), the following recommendations 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. Vancomycin 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 references suggest doses of 125-500mg for moderate to severe CDI while higher doses are generally reserved for more critical patients). Vancomycin orally (and per rectum, if ileus is present, since ileus may prevent the delivery of oral vancomyin 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 approximately 100mL normal saline per rectum every six hours as a retention 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/ÂľL (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 vancomycin, using a tapered or pulse regimen. Metronidazole is not recommended beyond the first recurrence or for long term therapy because it may be associated with cumulative neurotoxicity. The following is an example of an acceptable taper schedule; however, there are various regimens. Begin with vancomycin 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 allows 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 vegetative forms to be kept in balance while allowing the normal flora to be reestablished. While the taperpulse 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 attempted if further failure occurs. In addition to the select newer alternative antimicrobials that will be discussed below, evidence suggests that intravenous immunoglobulin infusion and fecal microbiota 25

Table 2 Recommendations for the treatment of Clostridium difficile infection (CDI) Clinical definition Initial episode, mild to moderate

Supportive clinical data Leukocytosis with WBC <15 and SCr <1.5 times premorbid level

Recommended treatment Metronidazole: 500mg three times a day by mouth for 10 to 14 days

Initial episode, severe

Leukocytosis with WBC >15 or SCr >1.5 times premorbid level

Vancomyin: 125mg four times a day by mouth for 10 to 14 days

Initial episode, severe, complicated

Hypotension or shock, ileus, megacolon

Vancomycin: 500mg four times a day by mouth or nasogastric tube, plus metronidazole 500mg every 8 hours intravenously. If complete 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.

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 CDI

Table 2 includes recommendations for the treatment of C. difficile infection. Metronidazole (FlagylÂŽ). 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 similar. 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 26

the recommendation that metronidazole 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 mucosa. The tablet may also be crushed and administered through a nasogastric tube if needed. Intravenous metronidazole is an alternative for patients who canâ&#x20AC;&#x2122;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 impairment, CNS disease, or long term therapy in patients with severe renal impairment (CrCl <10mL/min). Disulfiram-like reactions to ethanol (flushing, headache, nausea, vomiting, sweating, or tachycardia) have been reported with oral metronidazole; therefore, alcoholic beverages should be avoided during therapy and for three days following regimen completion. Metronidazole should be taken on an empty stomach. If gastrointestinal upset occurs, it may be taken with food. Vancomycin (VancocinÂŽ). 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 expensive than metronidazole ($600 to $1300, versus $15, for a 10-day course), and concerns of spreading 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 administered through a nasogastric tube if oral administration is not possible. In addition, oral, nasogastric, 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 important to note that for the treatment of CDI, intravenous vancomycin is not appropriate because effective colonic concentrations are not obtained. Common side effects associated with oral administration include bitter taste, nausea, vomiting, and stomatitis. Vancomycin can be

taken with food. Oral administration 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®). Nitozoxanide is a synthetic antiprotozoal 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 Cryptosporidium parvum. It exerts its activity by interfering with anaerobic metabolism 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 gastrointestinal 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 metronidazole and is effective for patients who experience treatment failure with metronidazole. Musher et. al. conducted the first prospective, double-blind, randomized controlled trial comparing nitozoxanide to vancomycin. Fifty patients were included in the trial and received either Alinia 500mg by mouth twice daily or vancomycin 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 nitozoxanide 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 treatment of outpatients with mild to moderate disease. A much larger

study is required before it may be considered as a substitute for vancomycin 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 formulation. It has not been studied in patients with renal or hepatic impairment and should, therefore, be used with caution in these populations. The most common adverse events reported with therapy include headache, abdominal pain, diarrhea, nausea, and vomiting. Rifaximin (Xifaxin®). Rifaximin is an antibiotic that is currently indicated for the treatment of traveler’s diarrhea caused by noninvasive strains of E. coli and reduction in the risk of overt hepatic encephalopathy recurrence. It has been studied off-label and prescribed as an alternative for Clostridium difficile-associated diarrhea. Rifaximin inhibits bacterial 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 resistance. 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 rifaximin. The patients were treated with vancomycin until symptoms resolved followed by rifaximin for 14 days. The results were promising; 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 formulation, 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 include peripheral edema, dizziness, fatigue, ascites, nausea, headache, pruritis, and abdominal pain.

New Drug: Fidaxomicin (Dificid ® )

Fidaxomicin is an oral macrolide antibacterial agent that was FDAapproved in 2011 for the treatment of Clostridium difficile-associated diarrhea in adults, making it the second antibiotic with FDA approval for this diagnosis. Dificid should only be prescribed when there is either strong suspicion or a confirmed diagnosis of CDI. Fidaxomicin exerts its bactericidal activity by inhibiting RNA synthesis by RNA polymerases in susceptible organisms (C. difficile). Dificid was granted FDA approval 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 (resolution of symptoms and no need for further therapy for CDI on the second day after the end of therapy). The secondary end points were defined as recurrence of CDI (diarrhea 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 pa27

Table 3 Counseling 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 complete 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 likelihood that the bacteria will develop resistance. •Pregnancy category risk B •The most common adverse reactions are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia.

tients who completed the clinical study, 92.1 percent of the patients (245 of 265 patients) in the fidaxomicin group and 89.8 percent of the patients (254 of 283) in the vancomycin group met the criteria 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 significant differences in safety between the two groups. In discussion, the authors of this study highlight the benefit of reduced recurrence with fidaxomicin for the approximate 64.1 percent 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 28

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 contraindications 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, fidaxomicin 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 mothers warrants caution. There are currently no significant drug-drug interactions to report. It is metabolized 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 vomiting. Other gastrointestinal adverse events include nausea, gastrointestinal hemorrhage, and abdominal pain. Dificid is also associated with hematologic events such as anemia and neutropenia. Fidaxomicin costs approximately $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 current 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 probiotics may be effective in the treatment 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 immune 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 formulation 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 addition, since probiotics are categorized 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 recommended for primary treatment of CDI in most patients. They may be considered in patients with recurrent disease that is not severe, as long as there are no significant comorbidities. Probiotics may be used in combination with vancomycin. They are also not suggested for prevention in most patients, except for the elderly without significant comorbidities and who are also receiving antibiotic therapy. The two most commonly studied probiotics are the Lactobacillus species and Saccharomyces boulardii. Published clinical studies should be reviewed prior to recommending a probiotic product. Cases of probiotic-associated bacteremia or fungemia have been reported. In most incidents, the susceptible patients had severe comorbidities, were on immunosuppressive therapy, had a recent surgical procedure, or had a recent

prolonged hospitalization. The probiotics linked to these negative outcomes were most often Saccharomyces boulardii and Lactobacillus rhamnosus GG.

Summary

Clostridium difficile infection is a significant public health concern and the cause of increasing antibiotic-related diarrhea and mortality. Proper hand hygiene is the primary method for decreasing transmission 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速) which was approved in 2011.

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 additional reading and inquiry is available upon request. This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.

Program 0129-0000-12-008-H01-P Release date: 8-15-12 Expiration date: 8-15-15

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

continuing education quiz

Please print.

Clostridium difficile Infection Overview and Treatment with New Drug Fidaxomicin

Address_____________________________________________

1. Clostridium difficile infection was traditionally considered 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.

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

Completely fill in the lettered box corresponding to your answer. [b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] [d] [d] [d] [d]

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

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

[c] [c] [c] [c] [c]

Email_______________________________________________ NABP e-Profile ID*__________________________________ (MMDD)

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

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

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

City, State, Zip______________________________________

Birthdate____________

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

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

Name________________________________________________

*Obtain NABP e-Profile number at www.MyCPEmonitor.net.

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.

1. 2. 3. 4. 5.

Program 0129-0000-12-008-H01-P 0.15 CEU

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

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 antiprotozoal 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 received after July 1, 2012 will be uploaded to the CPE Monitor Program and a statement of credit will not be mailed. Send inquiries to opa@ohiopharmacists.org.

august 2012 30

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Lee Jack Dunn Chairman of the Board President Robert M. Hatton Pamala S. Marquess President-Elect First Vice President Robert B. Moody Second Vice President Thomas H. Whitworth Hugh M. Chancy State At Large State At Large Liza G. Chapman Keith N. Herist State At Large State At Large Joshua D. Kinsey State At Large Tracie D. Lunde Eddie M. Madden State At Large State At Large Jonathan G. Marquess Christine Somers 1st Region President Ed S. Dozier 2nd Region President Renee D. Adamson 3rd Region President Nicholas O. Bland 4th Region President Julie W. Bierster 5th Region President Sherri S. Moody 6th Region President Amanda McCall 7th Region President Michael Lewis 8th Region President Kristy L. Pucylowski 9th Region President Lance P. Boles 10th Region President 11th Region President Ashley London Ken Von Eiland 12th Region President Thomas R. Jeter ACP Chairman Sharon B. Zerillo AEP Chairman Archie R. Thompson AHP Chairman AIP Chairman Drew Miller Linda Gail Lowney APT Chairman Robert Bentley ASA Chairman John T. Sherrer Foundation Chairman Michael E. Farmer Insurance Trust Chairman Bill Prather Georgia State Board of Pharmacy Representative Kenneth G Jozefcyk Georgia Society of Health Systems Pharmacists Amy C. Grimsley Mercer Faculty Representative Rusty Fetterman South Faculty Representative Sukhmani K. Sarao UGA Faculty Representative Negin Sovaidi Moon ASP, Mercer University TBD ASP President, South University James William Spence ASP President, UGA Jim Bracewell Executive Vice President & CEO 31

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