The Georgia Pharmacy Journal: February 2010

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For more information visit www.gphainsurance.com. * Association Program subject to state approval.

Policy forms HH 750, HH 702, HH 703. This is a general summary only. Additional guidelines apply. Disability insurance has limitations and exclusions. For costs and details of coverage, contact your Principal Life financial representative.

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February 2010

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VIP (Very Involved Pharmacist) Day at the Capitol February 17, 2010 FEATURE ARTICLES

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Departments 10 15 16 19 20 22 31

Alaska CE at Sea Membership Directory Information GPhA New Members GPhA Members in the News Pharm PAC Contribution Card Call for Awards Nominations GPhA Board of Directors

Convention Save the Date Advertisers

Pharmacy Schools News: Mercer, South and University of Georgia

The Fourteenth Annual Southeastern PRN Conference Held November 13-15, 2009

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Pharmacy Time Capsule

The Insurance Trust Principal Financial Group Pharmacists Mutual Companies Logix, Inc. Michael T. Tarrant PharmStaff AIP Georgia campus - Philadelphia College of Osteopathic Medicine Melvin M. Goldstein, P.C. Toliver & Gainer Georgia’s Own Credit Union The Insurance Trust

CPE Opportunity: Opportunities for Drug Information and Use Standards

COLUMNS

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President’s Message Editorial

For an up-to-date calendar of events, log onto

www.gpha.org.

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February 2010

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

Very Involved Pharmacist (VIP)

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harmacy is a highly regulated profession. Every action that you are licensed to do comes from laws and rules that govern our professional activities. As a licensed pharmacist, you have been educated and trained to practice your profession within these guidelines. The State has given you this authority, and by so doing the State has established a regulatory Board of Pharmacy to oversee the actions of pharmacists and pharmacies throughout Georgia.

As a practicing pharmacist of nearly 40 years, I am amazed at the caliber of our young pharmacists and of the educational talent they possess. I have had the opportunity to test many of these beginning pharmacists through my experience from serving on the State Board of Pharmacy. They are highly trained to move to a new level of patient care where the pharmacist can play a more active role in the management of drug therapy. Yet, they are hampered by “scope of practice” laws that prohibit the type of actions required in effectively managing drug therapy at the pharmacist’s level. This is a national vision for the future of pharmacy. Unfortunately, each state regulates the scope of practice of the professions within the state. This creates a wide disparity of scope of practices from state to state. This has been evidenced by the slow movement of pharmacists being able to immunize across the nation.

Additionally, pharmacists and pharmacies are also regulated by the Federal Government with the declaration that prescription drugs are restricted to be dispensed only by a prescription and the possession of these drugs are under the control of pharmacists and physicians. The Drug Enforcement Administration also weighs in on the proper handling of controlled substances. In the last decade, pharmacy has encountered a new form of control in the dispensing of medications.

I say all of the above to make an important point.

There are many issues that face the practice of pharmacy. They all require action either on a state or national basis. To achieve effective action requires that every pharmacy practitioner understand the importance of becoming a very involved pharmacist (VIP). This involvement is important to the state and national efforts to make changes for the betterment of pharmacy practice.

The pharmacy benefit manager (PBM) has been thrust upon the profession under the auspices of managing the increased cost of prescription drug usage. This has created chaos in the pharmacist’s daily activities of dispensing and counseling patients. Countless hours are spent daily on the phone to various benefit managers, who now seem to be using off shore personnel with no clue of what the issues are.

Frustration with this process adds another layer of unneeded stress to the role of the pharmacist!

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How can you make a difference? First and foremost everyone can become an active grassroots supporter of pharmacy. I can attest to the fact that nothing was 4

February 2010

more important to me as a state Senator than having a constituent and supporter that I knew personally.

Every legislator, both state and federal, works hard to represent their constituency, and they recognize that their tenure in their elected office will only continue if they meet the expectations of their constituency. I could site many instances where a constituent relationship has generated an important outcome on both the state and federal level.

elected every two years, they are in a greater need for support during campaigns. They appreciate those that volunteer to help with district fundraising functions to meet with constituents and seek contributions to their campaigns.

Unlike state elected officials, federal elections laws mandate that they cannot receive corporate contributions, which makes your contribution more meaningful to them. During the campaigns they have district campaign offices set up. Make a call to this office and express an interest in meeting with the congressman and making a contribution to his campaign or find out when he is having a fundraiser and attend this event with a contribution. Always try to personally give your contribution to the congressman so that a “name to a face” will be applied when you call later asking for his support on an issue.

We all live in a Georgia House and Senate member’s district. While the member may live miles away in another county, it takes little effort to make contact and get to know them on a personal basis. It is a false inhibition that makes you believe that they are too busy and would not view your contact in a positive way. Particularly, with the Georgia Legislators, they do not have district staff and are easily accessible at home. To be an effective grassroots supporter, you must have a relationship with the elected official.

They must be able to put a face to a name when you make a call seeking their support on issues. Make a call and ask them if you can make an appointment to meet with them or if they can stop by your practice.

You will be surprised at how effective this request will be. Two-thousan-ten is an election year for all of them and they will be aggressively seeking support and contributions for their re-elections.

Beyond developing your grassroots effectiveness, you can also contribute and support Pharm PAC to strengthen our state association’s effectiveness with the Georgia Legislature. GPhA is working with the legislature year round to make our Association a recognized political force. Likewise, contributions to our National Associations’ PACs are another important way to have pharmacy at the table on national issues. APhA and NCPA are striving to strengthen their political effectives by developing a stronger PAC.

I have come to realize that we have to become more involved with federal legislation since so much has happened to our profession with the enactment of Medicare D. With health care reform on the horizon, pharmacists are seeking a greater opportunity to expand their role in patient care. With the federal government paying more than half of all health care costs, reimbursement for pharmacy services is an important issue that has to be of concern to pharmacists.

A good way to begin becoming a Very Involved Pharmacist would be to participate in the VIP Day at the Georgia Capitol on February 17. It is an impressive sight to see the Capitol flooded with so many pharmacists wearing their white coats. It is an excellent opportunity to get face to face time with your House or Senate member. Your association needs your support and participation. Go to our website at www.gpha.org and register to participate in this event.

I look forward to seeing you there.

Becoming an effective grassroots pharmacist is a little more difficult on the congressional level.

Congressmen represent a much larger constituency and have several regional offices within their district.

They are supported with a paid staff that fields constituent requests and direct the congressman’s time in an efficient manner. They too, are most interested in what their constituency desires and will try to respond to your request. With congressmen being The Georgia Pharmacy Journal

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February 2010

GPhA’s VIP (Very Involved Pharmacist) Day at the Capitol February 17, 2010

Sign up online at www.gpha.org or call 404-231-5074.

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February 2010

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

If I Had a Hammer...

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419-8116. She needs your email address and you are connected to the most current information you can find on pharmacy political issues in Georgia.

If I had a hammer I’d hammer in the morning I’d hammer in the evening All over this land I’d hammer out danger I’d hammer out a warning I’d hammer out love between my brothers and my sisters All over this land

But wait, there is more...

hose who can remember the popular trio Peter, Paul and Mary of the 1970’s will recall the lyrics

You can participate in our VIP Day at the Capitol – see the cover of this Journal. VIP stands for Very Involved Pharmacist and it stands for you. Once each year, pharmacists and student pharmacists come to the capitol to physically demonstrate the united voice of the profession of pharmacy. The cost is free, the breakfast is free, the networking is free and the impact on the Legislature is priceless.

Having the right tool for the job is critical to your success as all professionals and most weekend repairmen will tell you.

There is still more...

GPhA’s Grassroots Political Network is your opportunity to stay connected with your state representative and state senator. You can be as active as your time permits, but building ongoing relationships are key to great legislative outcomes. It is key to build this relationship with your legislator before you need their vote and support.

My message to you today is that the Georgia Pharmacy Association has the right tools for the pharmacist professional to have tremendous impact on the laws and regulations that govern the practice of pharmacy in our state.

How do I get my GPhA Political Hammer?

With the Georgia Pharmacy Association you have all the tools to do a great job building the future for the practice of pharmacy. You also have the opportunity to repair some of the damage done by past storms that have hit the profession.

The Pharm O Gram is GPhA’s Political Hammer for the members of the Georgia Pharmacy Association. It is a weekly emailed publication compiled by our Director of Government Affairs, Stuart Griffin. It addresses exclusively the current issues that affect pharmacy that are actively being considered by the Georgia General Assembly.

If you had a Political Hammer, what would you do? Don’t let these tools rust from lack of use. They are yours and the future direction of pharmacy is yours.

Your Political Hammer is waiting for you as a member of GPhA. All you need to do is email Kelly McLendon kmclendon@gpha.org or call her at her direct line at 404The Georgia Pharmacy Journal

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February 2010

GPhA Convention June 26-30, 2010 Embassy Suites & Conference Center at Kingston Plantation, Myrtle Beach, South Carolina Save the Date GPhA’s 2010 Convention will be held at the Kingston Plantation in June. This is a favorite venue of GPhA members.

With direct access to the to the beach and beautiful accommodations, we are assured a relaxing and educational convention.

GPhA early bird registration will be $295 for a GPhA member. Hotel rooms fill quickly so make your reservations now and plan to attend the 2010 Convention. Look for Registration online soon at www.gpha.org.

2010 Convention Room Block Embassy Suites Hotel Oceanfront Suite – King Oceanview Suite

$234.00 $174.00

Embassy suites are two-rooms with in room microwave and refrigerator and rate includes a complimentary buffet breakfast and complimentary manager’s reception (5:30 – 7:30pm daily- based on single/double occupancy).

Brighton Tower Condo Two Bedroom Oceanview Three Bedroom Oceanview

$220.00 $262.00

Does not include complimentary buffet breakfast or reception The units are a typical condo set up with living room, dining, full kitchen and a patio area. Units are individually owned and will vary in decoration. Daily maid service includes only removing trash, vacuuming, making beds with existing linens and replacing bath linens.

Plantation Villa One Bedroom Resortview Two Bedroom Resortview

$164 $174

Villas have full living area and full kitchens.

Does not include complimentary buffet breakfast or reception Daily maid service includes only removing trash, vacuuming, making beds with existing linens and replacing bath linens.

Call for Reservations: 1-800-876-0010 - Tell reservations the Group Code: GPA

Change in Convention Format: Due to comments on the 2009 Convention Survey and input from the Convention Planning Committee and GPhA Executive Committee, it was decided from this input that attendees would welcome a change to the convention format to include an evening of free time. Taking these suggestions into consideration, there will be a change in the Sunday evening format. To allow this change, plans now are to have a heavy hors d’oeuvres reception in the Exhibit Hall on both Saturday and Sunday and not a dinner on Sunday evening.

Then we have planned a coffee and dessert reception at approximately 9:30 p.m. on Sunday with plans for the return of Kevin Lepine the Hypnotist that has been such a hit at our convention on several occasions. That show is scheduled for 10:00 p.m. to 11:00 p.m.. So registrants will have an evening free to spend with family and friends plus get time to socialize.

The Georgia Pharmacy Association is accredited by the Accreditation Council of Pharmacy Education as a provider of continuing pharmacy education. These activities are eligible for ACPE credit; see final CPE activity announcement for specific details as they become available on the GPhA website.

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PHARMACY SCHOOLS’ NEWS

Mercer University APhA ASP Chapter Update Megan Spencer Barbee, Mercer ASP Chapter President he Mercer University College of Pharmacy and Health Sciences Chapter of the Academy of Student Pharmacists, American Pharmacists Association is proud to announce the results of our year end review. From 2008 to 2009, the number of patients screened for diabetes increased by 48 percent, and the number of patients screened for heartburn and GERD increased by 1260 percent. Also, over the course of the year, student pharmacists immunized over 900 patients, an increase in 1180 percent from 2008. Our chapter participated in three large health fairs, and provided a number of different educational services as well as screenings. Most recently, forty of our chapter members volunteered at the annual King Center Health and Wellness Forum on January 9, 2010. We are looking forward to an exciting year in 2010, highlights of which include VIP Day at the Capitol on February 17, our chapter trip to Washington, D.C. in March for the APhA Annual Meeting and Exposition and the GPhA-ASA Third Annual Multicultural Community Health Fair on April 17.

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South University APhA ASP Chapter Update Rick Wilhoit, South ASP Chapter President he South University School of Pharmacy will be increasing its enrollment this year by expanding the program to its Columbia, South Carolina campus. This is made possible by its continued use of industry-relevant technology that will allow simultaneous student and professor interactions through two-way video conferencing.

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“The technology we are investing in today is not new; it has been tested and has been proven effective at creating collaborative learning environments,” says James Freyburger, Vice President of Technology for South University. “The crucial element of our efforts is that we will be able to provide our pharmacy students with access to the best instruction that the University has to offer, regardless of geography.”

The exciting part of this isn’t just that the large lecture halls are being fitted with the teleconferencing equipment, but it is that the small group rooms will also have the equipment installed. This will make it possible for professors to interact with small discussion groups on both campuses while being stationed at one location. This will facilitate learning in classes that contain these small groups, such as the pharmacokinetics classes.

The professional organizations on each campus will have use of the equipment as well. This means that when organizations like the American Pharmacists Association- Academy of Student Pharmacists have officer’s meetings, as well as their general meetings, they will be able to include their counterparts at the other campus. Having this ability will make it easier to plan meetings and to open up the meetings on each campus to speakers who may otherwise have travel limitations that would prevent their attendance at a specific campus.

The equipment will be installed and go online at the Savannah campus this coming March. This gives professors and students an entire academic quarter to adjust and work out potential problems before the first class in Columbia begins this coming June. Allowing this adjustment period is what will ensure a quick and successful expansion of the curriculum. This teleconferencing equipment is the next step in the use of technology at SUSOP, as the program already uses tools such as “audience response clickers” and the distribution of course materials in a computer-based format.

The Columbia campus will still have some components of the curriculum that will use traditional methods. This includes the pharmacy skills and physical assessment laboratories, as well as small group recitations and problem-based learning activities.

This expansion is an exciting time in the history of SUSOP, and the linking of both campuses via technology is an innovative way to strengthen the education provided by SUSOP to its student pharmacists.

University of Georgia APhA ASP Chapter Update Kyle Burcher, UGA ASP Chapter President he American Pharmacists Association Academy of Student Pharmacists, APhA-ASP, is the largest organization at the University of Georgia College of Pharmacy. With 250 members, our chapter is part of a national organization that represents over 28,000 student pharmacists from each school and college of pharmacy around the country. Our Mission is “to be the collective voice of student pharmacists, to provide opportunities for professional growth and to envision and actively promote the future of pharmacy.” Membership in

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Continued on page 12

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ASP is available to all students enrolled at the College of Pharmacy; enrollment includes membership in the national pharmacy organization, the American Pharmacists Association (APhA), as well as the state pharmacy organization, the Georgia Pharmacy Association (GPhA).

APhA-ASP provides students with opportunities to become involved in a variety of arenas. In the summer of 2009, over 30 students from our chapter attended the GPhA annual convention, held in Ponte Vedra, Florida. We participated in student-focused activities such as a career showcase and attended continuing education seminars; we also explored the exposition hall where students were able to speak with potential employers and representatives from the pharmacy industry. There were also many opportunities to meet with future preceptors and employers and spend time with students from Mercer University and South University. Even though we had a busy week, there was still plenty of time for the beach, golf, tennis, and sightseeing.

This fall proved exciting and busy for our APhA-ASP chapter. We hosted several speakers from various areas of pharmacy, to share their stories with chapter members. From national APhA representatives to independent pharmacy owners, we believe in supplying a variety of perspectives to our members. Showcasing the depth that a pharmacy career can offer empowers our members to seek their own path in the profession and find what best suits their skills and needs.

The Seventh Annual Dawgtoberfest: RX for Good Health was this fall’s largest event. Dawgtoberfest is a health fair that allows the College of Pharmacy to educate the student, faculty, and staff at UGA and members of the greater Athens community about the multitude of services that a neighborhood pharmacy can provide. Each student organization hosted a booth, and with over thirty different stations, the collaboration between the student groups made this year’s Dawgtoberfest the best yet. The College of Public Health and the College of Veterinary Medicine also hosted booths on H1N1 and pet obesity respectively. In addition to informational stations and booths on fad dieting, heartburn awareness, sleep, and women’s health, our students also provided immunizations, diabetes screening, and body fat analyses. The weather prevented any outdoor promotions that day but we managed to hold the event inside the new Pharmacy South building and it was a great success.

Dawgtoberfest would not have been possible without the tremendous help of Dr's. Paul Brooks, Trina Van Waldner, Henry Cobb, George Francisco, Dean Svien Øie, Daniel Forrister, Merrill Norton, and many others. They all deserve special thanks for their continuous support and dedication to the students. We greatly appreciate our wonderful and generous sponsor, Walgreens who provided their assistance and allowed this event to be free for all our participants. Thanks to Smoothie King as well for providing healthy snacks. We appreciate all that they do!

Our APhA-ASP chapter also provides opportunities for our members to develop their leadership skills in many programs set forth by our national association, APhA. Our Patient Care Project committees: Heartburn Awareness Challenge, Operation Diabetes, and Operation Immunization offer health screenings and information to various community groups and organizations; they continue to offer invaluable services to patient populations and highlight disease states often overlooked by other areas of medicine. In addition to our patient care initiatives, we also participate in the APhA National Patient Counseling Competition. The winner of our chapter counseling competition, which was held in November 2009, receives a free trip to compete in the National Competition, which will be held at the 2010 APhA National Convention in Washington, D.C. APhA-ASP is dedicated to making a difference in our community. In addition to our Patient Care Project committees, our Community Service committee has continued a strong relationship with the Mercy Clinic allowing students the opportunity to work with under served patients in the community. Recently formed, our Women’s Health committee is focused on providing valuable health information to women at the University and in the general community. They also have plans to visit local high schools and educate young women on the importance of making smart and health-conscious decisions. This spring, our Fifth Annual Multicultural Health Fair is being organized as a statewide effort through the GPhA Academy of Pharmacy Students and Academicians (ASA), along with Mercer University and South University. We anticipate that by reaching out to the multicultural communities in Athens, Atlanta, and Savannah, the three schools will be able to offer even more health services and screenings to a greater variety of patient populations.

This past year, our APhA-ASP chapter has been able to reach many goals that would have previously been unthinkable! Special thanks to the 20082009 Chapter President, Walter Williams. With his dedication and creative ideas, we were able to have one of the most successful years in the history of our chapter. We look forward to the future, and as always, we strive to retain the ultimate voice for the practice of pharmacy and its student practitioners here at the University of Georgia College of Pharmacy.

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February 2010

Foundation News

The 14th Annual Southeastern PRN Conference Held November 13-15, 2009 he Georgia Pharmacy Foundation and Georgia PharmAssist Committee hosted the Fourteenth Annual Southeastern PRN Conference, November 13-15, 2010, at the beautiful Simpsonwood Conference Center in Norcross, Georgia, just north of Atlanta. This conference is a huge success due to the commitment and dedication of two of our members, Jim Bartling, Pharm.D., CAC II, Intervention Coordinator, Georgia PharmAssist Program, and Richard B. Smith, R.Ph., Chairman of the Georgia PharmAssist Program. They are the leading forces of this conference and are to be commended for their dedication to its success.

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Although the conference is advertised as being a “southeastern” meeting, it is recognized around the U.S. and has attendees from across the country. We are proud to say that one of the most well-known PRN websites www.usaprn.org promotes this conference and includes photos from some of the meetings.

Student Pharmacists are also encouraged to attend this conference to advance their knowledge about the disease of addiction. Samford University’s McWhorter School of Pharmacy, Mercer University College of Pharmacy & Health Sciences, South University School of Pharmacy and UGA College of Pharmacy all had participants at this year’s meeting. Without fail someone will comment they had no clue about the extensive information available and how little they really knew about the disease.

Since the students do not need the CPE available (10 contact hours), each student receives a certificate

The Georgia Pharmacy Journal

acknowledging their participation in this Conference.

Likewise, Pharmacy Technicians are encouraged to attend. They receive CPE credits for their participation. This conference is open for anyone who wants to learn more about the disease of addiction. A number of participants attend this meeting every year. Everyone is invited to attend since most do not fully understand the depths of the disease.

Tales: A Story of the Fowled-Up Family, A Study in Alcoholism and Its Effect on the Family System.” The slides were in a fun cartoon format, but the message was very real.

On Sunday Brian Fingerson delivered a spirituality presentation on “Left Brain Continued on page 14.

This year’s program included the opening presentation on Saturday by Dr. Susan K. Blank, the Director of Medical & Clinical Services at Foundations Atlanta – Foundations Recovery Network. Her topic covered “Treating Chronic Pain in the Addicted Patient While Treating Their Addiction.”

Charlie Broussard, R.Ph., M.Ed., editor of the USAPRN Website, discussed “A Prospective on Pharmacist Recovery Networks – Learning from Our Past.” Brian Fingerson, R.Ph., president of Brian Fingerson, Inc. dba KY Professionals Recovery Network KYPRN, spoke about “Chemical Dependency Among Healthcare Professionals.” Always a popular portion of the program is when someone gives their “personal story” about their recovery. This almost always moves everyone in the room. This year was no exception and the individual received a standing ovation. (Name is not provided in consideration for their privacy.) The last speaker of the day was Russ Hopper, EDAC, CADC and Executive Director of QuestHouse, Inc. QuestHouse was also one of our exhibitors and has been for several years. Russ gave a very entertaining presentation titled “Chicken

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Right Brain Connections in the 12-Steps of AA.” Another of the Pharmacy Recovery Network’s favorite speakers, Merrill Norton, D.Ph., NCAC II, CCS, Clinical Assistant Professor at UGA, made a presentation on “Pharmacists Addiction Predictability – 2009.” As part of his presentation, Melissa Weaver, one of Merrill’s students, helped him provide information from a study that is being conducted at UGA regarding the Student Pharmacist Risk Factors for Addiction.

Russ Hopper from QuestHouse ended the conference covering “The Disease of Addiction…It’s A Brain Thing!” We cannot thank our speakers enough for all their hard word and commitment to this program.

The Georgia Pharmacy Foundation and Georgia PharmAssist Committee want to thank the following Exhibitors and Sponsors for their support of this Conference: Cornerstone of Recovery, Inc. FirstLab Florida Recovery Center Foundations Atlanta MARR, Inc. Palmetto Addiction Recovery Center Publix Super Market Charities QuestHouse, Inc. Talbott Recovery Campus Their assistance helped make this Conference possible and is very much appreciated. We also thank each representative who attended and for their contributions to its success! We look forward to seeing you at next year’s Conference.

Mark Your 2010 Calendar!

The 2010 SE PRN Conference will be held at Simpsonwood on November 12-14, 2010 Should you or someone you know need assistance with an addiction issue, please do not hesitate to call the: PharmAssist Hotline Number (24 hours/7 days a week) 404-362-8185 Your call will be returned as quickly as possible.

Students from Mercer and the University of Georgia enjoying a free moment before the program began after lunch.

Scott Lancaster, Assistant Professor of Pharmacy Practice, Ambulatory Care at South University and some of the South University Students who attended the 2009 SE PRN Conference.

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February 2010

Membership Directory Now Available n order to better serve GPhA Members we have recently created an online Membership Directory. To find the Directory go to www.gpha.org, click “Member Login” at the top of the page. Enter your username and password.

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If you do not know your username and password follow the directions on the website. If you have any questions call Kelly McLendon at 404-419-8116.

Once you have logged in scroll down the page until you see “Group/Committee Participation” Under this heading click “GPhA Membership Directory.” This will take you to a page where you can search for members by their last name or by the city where they live.

We encourage you to use this whenever possible to network and contact your friends.

If there are other online functions you would like GPhA to offer please email Kelly Mclendon at kmclendon@gpha.org or call her at 404-419-8116.

Pharmacy Time Capsule 1985—Twenty-five years ago: • AIDS test for blood approved by FDA in its first major action to protect patients from infected donors.

• The Kroger Company of Cincinnati outbid Rite Aid for the Hook’s Drug Stores chain of Indianapolis and combined it with their Super-Rx units.

• First oral drug approved to prevent/reduce recurrent outbreaks of genital herpes Zovirax (Burroughs Wellcome) 1960—Fifty Years Ago: • 5-year BS implemented as the minimum standard for U.S. colleges of pharmacy.

• Eugene White of Berryville, VA opened an office based pharmacy that stressed relationships with patients and utilized formal patient prescription monitoring.

1935—Seventy-five Years Ago: • First reports of the clinical effectiveness of Gerhard Domagk’s new medicine [Prontosil] for infections appear • Formulary of the University Hospital, University of Michigan developed by Harvey A.K. Whitney, Sr. 1910—One hundred Years Ago: • First Pharmaceutical Syllabus issued providing the basic course of study for the 2-year PhG and providing a more objective basis for licensure examinations and reciprocity.

• Founding of Arizona Pharmaceutical Association • Phi Delta Chi ratifies the change of its name from Phi Chi to avoid confusion with Phi Chi Medical Fraternity By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH

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February 2010

GPHA MEMBER NEWS

Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association!

Ashley Acosta, Savannah Hyun Acres, Augusta Nikki Adeniyi, Stockbridge Sveta Amin Ora Jess Bailey, Conyers Crystal Beal, Jonesboro Jennifer Berg, Savannah Daye M. Bexley, Peachtree City Richard Brook, Savannah Candice Broome, Cochran Brianna Brown, Athens Hannah Carsillo, Kennesaw Meghan Caylor, Athens Ameen Chaudhry, Doraville Chris Chin, Athens Lyndsey Coursey, Evans Karne Curzio, Pharm.D., Atlanta Samantha Dempsey, Atlanta Jamie Diagostino, Marietta Nguyen Do, Savannah Katherine Dollar, Athens Rachel Doyle, Athens Ray Dwan, Athens Mary Dyer, Athens The Georgia Pharmacy Journal

Stephanie Ellis, Athens Sarah Evans, Athens Jeffrey Felton, Athens Rola Franks, Duluth Jennifer Gaddie, Athens Elizabeth Gardner, Augusta Kimberly Dawn Grubbs, B.S., Watkinsville Andrea Hamby, Savannah Andrew Morrison Hassell, III, B.S., Athens Elizabeth Black Heard, B.S., R.Ph., Grayson Chris Hearon, Augusta Catherine Henry, Athens Heidi Hesprich, Athens Hannah Higgins, Alpharetta Alexander Holmes, Athens Roxanne Hotz, Martinez Jennifer Huggins Lydia Im, Athens Lindsay Joiner, Athens Veronica Kilpatrick, Savannah Bob Kim, Athens Eunice Kim, Duluth Ji Won Kim, Lawrenceville Kristen Kinamon, Flowery Branch 16

February 2010

Jaime Kroll, Athens Emilie Landreth, Stockdale, NC Ashley Lanier, Athens Lauren Lantz, Savannah Beth Layer, Savannah Thaovy Le, Savannah Trucvy Le, Houston, TX Richard Lee, Augusta Bryan Lewis, Ricmond Hill Peter Lunt, Athens Holly Matthews, Athens Tawnya McAhren, Savannah Martina McCauley, Athens Mindi S. Miller, Pharm.D., Atlanta Phillip Mohorn, Statesboro Rachel Morgan, Athens Kacy Mulligan, Athens Kevin A. Murphy, OD, Douglas Melissa Murray, Athens Chadwick Nicholson, Lilburn Robby Nunns, Savannah Desalegn Ogbamichael, Tucker Uchechi Okereke, Lawrenceville Lora Oliver, Watkinsville Elizabeth Owen, Savannah Sheree Pack, Savannah Nilesh Patel, Savannah Nisha Patel, McDonough Sonia Patel, Alpharetta

Lauren Paul, Athens Stephanie Peccia, Athens Cameron Perkins, Athens Sara Pittman, Hull Diane Powell, Athens Zen B. Rondowsky, OD, Atlanta Shayla Rose Manav Saini, Ocean, NJ Heather Slayton, Trion Manali Soni-Talsania, Springfield, IL Erin Sosbee, McDonough Bryan Summerford, Moultrie Kaitlin Talisse, Athens Margie Temple, Danielsville Courtney Terry, Rochelle Sarah Thompson, Athens Patrick Tu, Norcross Jessica Wallace, Athens Jeffrey Wang, Athens Grady Eugene West, Jr., B.S., R.Ph., Warwick Tyler Whitaker, Douglasville Angie Williams, Athens Crystal Willis, Athens Stephanie Worrall, Athens Anqi Zhou, Norcross

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

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GPHA MEMBERS IN THE NEWS On October 28-29, 2009, the Task Force on Prescription Monitoring Program Standards convened in Northbrook, IL. The group included William Prather, R.Ph., of the Georgia State Board of Pharmacy and Frederick Karsten, R.Ph., director of the Georgia Drugs and Narcotics Agency.

If you have an item that you would like included in the GPhA Members in the News section of The Georgia Pharmacy Journal please email the item of news to Kelly Mclendon at kmclendon@gpha.org or fax it to her attention to 404-237-8435.

• 55% of independent community pharmacies are located in an area with a population of less than 20,000.

• The average independent is open six days and 55 hours per week.

• Staff pharmacist wages rose 1.7% to $50.45 per hour in 2008.

Thanks to all of you who participated in the GPhA membership survey. We had 233 responses. We will be implementing many of the changes you requested in the near future. As part of this survey we promised a $100 American Express Gift Card to one of the survey participants. The winner of the gift card was Brett Wrenn of Suwannee, GA.

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Independent Pharmacy Today

• Pharmacy technician wages rose 2.8% to $13.24 per hour.

• In 2009, the average cost for dispensing a prescription for all retail pharmacies was $11.01, up from $10.89 in 2008.

Source: 2009 NCPA Digest, sponsored by Cardinal Health

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

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

Name: ________________________________ Address: _______________________________ _____________________________________ Phone Number: __________________________

Leroy Toliver has been a Georgia Registered Pharmacist for 34 years. He has been a practicing attorney for 25 years and has represented numerous pharmacists and pharmacies in all types of cases.

Collectively, he has saved his clients millions of dollars.

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

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

�

Sustainers Circle: When you check this box and provide valid credit card information you are making a 5 year commitment to make the same contribution for the next 5 years. Your credit card will automatically be charged annually on the date of your initial contribution.

Contributions or gifts to Pharm PAC are not deductible as charitable contributions for Federal income tax purposes.

Name on the Credit Card: _____________________________________ Credit Card Number: _____________________________________ CSV#: ________ Expiration Date: ____________ Signature: ______________________________ Contributions made to Pharm PAC are not tax deductible.

Detach this form and complete it and return it to:

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

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February 2010

Call for awards nominations...

The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 135th Annual Convention in 2010. A brief description and criteria of each award is noted below. Please select the award for which you would like to nominate someone and indicate their name on the form below. Deadline for submitting the completes nomination form is March 12, 2010. Nominations will be received by the Awards Committee and an individual will be selected for presentation of the Award at GPhA’s 135th Annual Convention at the Embassy Suites Conference Center, Myrtle Beach, SC.

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

Distinguished Young Pharmacist Award (sponsored by Pharmacist Mutual) Created in 1987 to recognize the achievements of young pharmacists in the profession, the Award has quickly become one of GPhA’s most prestigious awards. The purpose of the Award is two-fold: 1) To encourage new pharmacists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) The nominee must have received entry degree in pharmacy less than ten years ago; 2) Nominees must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.

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

2010 Awards Nominations 2010 Bowl of Hygeia

Distinguished Young Pharmacist

Innovative Pharmacy Practice Award

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

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Continuing Education for Pharmacists Opportunities for Drug Information and Use Standards This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papers prepared by the Council of the Convention (CoC) titled "Focus On: Future Directions for USP." The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association's (NASPA) Continuing Education Advisory Panel. No financial support was received for this activity. This activity may appear in other state pharmacy association journals.

Council of the Convention Section on the Quality of Patient Care Rita Munley Gallagher, Ph.D., R.N., Section Chair (American Nurses Association) Thomas R. Clarkm R.Ph., M.H.S. (American Society of Consultant Pharmacists) Charles W. Maas, M.D., M.P.H. (California Medical Association) Stephen P. Speilberg, M.D. (Association of American Medical Colleges)

Goals: The goals of this lesson are to review USP’s contributions to the provision of information supporting rational therapeutic decision-making and safe medication use, focusing on the general topic of drug information and use standards.

Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Recognize the role USP has played in providing drug information 2. Describe new opportunities that USP is exploring for drug information and use standards Introduction: As a standards-setting organization for medicines and other healthcare articles, the United States Pharmacopeial Convention (USP) has contributed broadly and deeply to the provision of information supporting rational therapeutic decision-making and safe medicine use. In this white paper, USP’s Council of the Convention Section on the Quality of Patient Care provides a situation analysis of these and allied contributions, focusing on the general topic of drug information and use standards. A separate white paper will consider safe medication use.

Standards generally apply to people, processes/practices, and/or products.

USP now provides an extensive array of product standards for drug and food articles in the United States Pharmacopeia

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(USP), National Formulary (NF), Food Chemicals Codex (FCC), and allied compendia. These product standards support testing to assure identity, strength, quality, and purity of foods and drugs. Beyond these product standards lie others that support rational therapeutic use—process and practice standards—and perhaps clinical practice standards as well that can be associated with education and training.

Process/practice standards also might promote improved operations of healthcare teams and systems. This paper uses the term drug information and use standards to define collectively the concept of standards to promote rational and cost-effective therapeutic decisionmaking for medicines. Such standards could be applied in the paradigm that moves from diagnosis to treatment. Once a diagnosis is made, many therapeutic guidelines exist; many are maintained on an Agency for Healthcare Research and Quality (AHRQ) web page at http://www.ahrq.gov/clinic/, that speak to multiple treatment interventions ranging from the extremely simple to the highly complex. Use of medicines also ranges from the simple to the complex, and the complexity in an era of biomolecules and molecular medicine is increasing by the year. Typically, information and use standards for medicines begin with Food and Drug Administration (FDA)-approved efficacy and safety information in drug labeling.

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This information is amplified over time with further studies and clinical usage.

How this further information is generated and applied is a subject of considerable societal interest. It relates not only to rational therapeutic decisionmaking but also to payor and quality of care needs and decision-making. Such information is needed more critically now than ever before. The cost to provide continuing information and standards about a medicine is borne primarily by the private sector—and increasingly the information itself is a web-based commodity. Multiple compendia provide a basis for reimbursement, and many hundreds, if not thousands, of pharmacy and therapeutic committees provide administrative decisions to support costeffective treatment for defined populations. USP’s foray into drug information and use standards might build on the organization’s ongoing responsibility for maintenance of the Medicare Model Guidelines. Many other organizations also are involved in such standards, and USP would necessarily ally with them in its “neutral convenor” role in any further standards-setting attempts. Increasingly, as a dominant payor, the United States Federal government is involved, and a publicprivate model of some sort might be optimal. If such a model is considered, financing, scope, governance, and many

February 2010

other questions and challenges will arise.

With the exception of the every-threeyear Medicare Model Guidelines updates, or the most part, USP has exited activities associated with the provision of drug information and use standards. The larger question for the organization now relates to its specific role as a practitioner-based, volunteer-driven, standards-setting organization. USP can do anything it wishes in the way of drug information and use standards, being bound only by resource constraints. The issues for consideration in this white paper might thus be: ∙ In an era of health care crisis and reform, what are the societal needs for drug information and use standards to support rational therapeutic decisionmaking? ∙ If these needs can be defined and USP, by virtue of its structure and history, can uniquely fulfill them—with availability of adequate resources—does it have a responsibility to do so?

USP’s History in Drug Information: 1. United States Dispensatory: When the first United States Pharmacopeia (USP) appeared in 1820, it deliberately excluded most explanatory material regarding preparation techniques, which the authors considered to be too rudimentary. However, a need did exist for a Dispensatory—a volume that would not only select official drugs and provide recipes for preparations, but would also give full descriptions and indications of the drugs and explain applicable practitioner techniques. George B. Wood and Franklin Bache, two of USP’s founding physicians, produced the first Dispensatory of the United States of America (USD) in 1832. They viewed its purpose as both instructional (for poorly trained physicians and pharmacists) and as a means to solidify the national authority of the USP, to which the USD deferred. The USD went on to become one of the most popular American

medical reference books of the 19th century, overshadowing the USP itself in terms of everyday usage. The USD continued to be popular well into the 20th century, but started to lose its authority with the rise of the Food and Drug Administration and other sources of drug information as they emerged. Its link to the USP was formally severed in 1880. The last (27th) edition of the USD was published in 1973.

2.

USP DI Series: The USP Drug Information resource (USP DI) was created in 1980 as a complete, unbiased compilation of clinically relevant information about therapeutic products, for the use of practitioners (physicians, nurses, pharmacists) and patients. USP DI was recognized in the Social Security Act as an authority for reimbursable offlabel use under Medicare and Medicaid.

It comprised three volumes—USP DI Volume I: Drug Information for the Health Care Professional; USP DI Volume II: Advice for the Patient, and USP DI Volume III: Approved Drug Products and Legal Requirements. Originally produced in print format only, a USP DI product line extension in the form of an interactive laser disk focusing on a single disease (About Your Diabetes) was attempted in the late 1980s. Maintenance proved a costly and time-consuming hurdle, and the disk was discontinued in the mid1990s.

Another attempt to move the USP DI into the increasingly important online delivery mode was attempted in 1994, when USP acquired the Drug Evaluations database from the American Medical Association (AMA-DE). The goal was to integrate the AMA-DE data into the USP DI database. Again, technical complexity and the difficulty and expense of maintenance led to the project’s termination. A third attempt to develop a USP DI relational database was launched in the mid-1990s, this time contracting with Carepoint, a provider of

pharmacy management software. Yet again, the program was abandoned due to technical complexity and costs. In 1998, USP sold the USP DI database and licensed the USP DI trademark to Thomson Healthcare, but retained editorial oversight of the off-label use material in the publication. In 2000, Thomson launched the USP DI Desktop Series CD ROM, capturing a “large share” of healthcare web portal and hospital web site segments with USP DI branded content. However, changes in some state pharmacy regulatory requirements in 2001 resulted in a sharp decline in the number of pharmacies ordering the product. In addition, the chain pharmacy market was demanding a single vendor for all electronic solutions, which the Thomson USP DI could not provide. USP and Thomson explored a variety of strategic options over the next few years, but ultimately it made the most financial and operational sense for USP to exit the business completely. In 2004, the USP DI Volume I and Volume II became the responsibility of Thomson Healthcare. Under the agreement, Thomson could edit, create content, and publish these texts under the USP DI name until the 2007 edition, after which Thomson’s right to use the name ceased.

USP DI Volume III continued to be owned in its entirety by USP. Thomson continues the USP-DI product under the name DrugPoints.

Many other entities have provided drug information in various compendia to support sound therapeutic decisionmaking. An analysis of these types of compendia appeared in a series of three articles earlier this year in the Annals of Internal Medicine; a summary editorial references the three articles.1 Overall these articles and summary editorial are generally critical of the various compendia in terms of their currency, consistency, and other factors.

3. Model Guidelines: The Medicare Modernization Act (MMA) of 2003

1 Sox, HC. 2009. Editorial: evaluating off-label use of anticancer drugs. Annals of Internal Medicine, Volume 150, Number 5

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defines the role of USP (Section 1860D4(b)(3)(C): (ii) MODEL GUIDELINES – The secretary shall request the United States Pharmacopeia to develop, in consultation with pharmaceutical benefit managers and other interested parties, a list of categories and classes that may be used by prescription drug plans under this paragraph and to revise such classification from time to time to reflect changes in therapeutic uses of covered part D drugs and the additions of new covered part D drugs.

In addition, Section 1860D11(e)(2)(D) creates a “safe harbor:” (ii) USE OF CATEGORIES AND CLASSES IN FORMULARIES – The Secretary may not find that the design of categories and classes within a formulary violates clause (i) if such categories and classes are consistent with guidelines (if any) for such categories and classes established by the United States Pharmacopeia.

With this legislative mandate and on behalf of the Secretary of the Department of Health and Human Services, the Centers for Medicare and Medicaid (CMS) awarded USP a cooperative agreement to develop and revise the Part D Prescription Drug Benefit Model Guidelines. A new Model Guidelines Expert Committee was formed to accomplish the task. While the MMA did not specify the frequency of updates to the Guidelines (“…from time to time…”), the Expert Committee and CMS agreed that an annual update was appropriate given the rapidly evolving nature of pharmaceuticals. Version 1.0 was a large effort, involving a review of

how other formularies are categorized and presented.

At its highest usage (2006), 74% of health plans were using the USP Model Guidelines (Version 1.0). The Model Guidelines Categories and Classes provided a formulary structure that helped ensure beneficiary access while preserving needed flexibility for pharmacy benefit managers (PBMs) and health plans. USP developed an additional component to the Model Guidelines: Formulary Key Drug Types (FKDT), which offered additional protection for beneficiaries and a useful tool for CMS in reviewing formularies.

Although not mandatory, the FKDT have been utilized by CMS as part of its Formulary Review Guidance, and serve as standards that promote consistency, fairness, and ease of administration.

Usage of the Model Guidelines lessened in subsequent years, primarily due to plan consolidation and a broader use of internal classification systems due to plans’ comfort with the CMS process.

Nevertheless, the guidelines contributed substantially to the availability of a comprehensive, yet affordable, benefit.

As with all its standards, USP actively solicited and welcomed participation and input on Guidelines development from interested stakeholders, including manufacturers, drug plans, practitioners, and patients. USP’s experience with the Model Guidelines was summarized in a report published in Annals of Internal Medicine in 2006.2 Its work on behalf of the Federal government followed a primary activity where USP participated in a consortium of interested organizations to produce a document entitled “Principles of a Sound Drug Formulary System” (2000).3 By 2008, CMS decided that the Guidelines had achieved a significant level of success and stability. Based on this, USP and CMS agreed to move from an annual revision timeline to a three-

year cycle. CMS continues to use the current Model Guidelines and FKDT through plan year 2011, and USP is maintaining the current versions on its web site. The goal is for USP to start work on Version 5.0 in 2010.

Exploration of New Opportunities: 1. Drug Information Consultations: In 2005 and again in 2006, USP convened special meetings, called Drug Information Consultations, where individuals and organizations gathered to discuss the feasibility and advisability of developing practice standards associated with drug information. In these meetings, USP sought a clear understanding of the current gaps in drug information and where its standards-setting expertise might be used to augment information used by practitioners, plans, and patients in decision-making about rational drug use. At the time of these meetings, USP was engaged in the development of Model Guidelines for the Medicare Prescription Drug Benefit and was considering how that activity might also be supported with additional drug information for the healthcare community. Despite a number of useful suggestions from a broad range of participants, these consultations did not generate any specific activity (notes of meetings are available). A Board Task Force (2005-2010) was formed to monitor USP’s interests in the topic.

2. Applied Drug Information Resource: Working with the American Medical Association, the American Nurses Association, and the American Pharmacists Association, USP led a series of meetings that explored the concept of an Applied Drug Information Resource (ADIR). The general idea for the ADIR was to advance “personalized medicine” concepts, in which general information about a medicine would be adjusted by patient-specific characteristics. The product would yield information directed to diverse practitioner and patient

2 Narrative review: the US Pharmacopeia and Model Guidelines for Medicare Part D Formularies. USP Model Guidelines Expert Committee, USP Staff [William, RL] Ann Intern Med 145, 448-453 (2006) 3 http://www.usp.org/hgi/patientSafety/resources/soundFormularyPrinciples.html 2009

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constituencies. The opportunity did not progress.

3. Comparative Effectiveness: Comparative effectiveness (CE) studies of specific treatment approaches— including various pharmacotherapies, lifestyle changes, imaging procedures, and surgical interventions—have great current and potential value. They add to the body of knowledge that helps health care practitioners, as well as patients and their families, make treatment decisions.

The infusion of funds (through the American Recovery Reinvestment Act of 2009, also known as the “Economic Stimulus” Legislation) that will support additional research is a welcome development. The bill provides $1.1 billion for CE research: ∙ $300 million to the Agency for Healthcare Research and Quality (AHRQ); ∙ $400 million to National Institutes of Health (NIH); and ∙ $400 million to the Department of Health and Human Services (DHHS).

Observations about this funding that are relevant to USP include: ∙ Organizations can make proposals for CE project funding (the process is still being determined by agencies). ∙ According to the conference report, funding is not to be used to mandate coverage decisions, but instead is for generating useful research comparing clinical outcomes. ∙ The law also establishes the Federal Coordinating Council for Comparative Effectiveness Research, made up of highlevel government officials, for the purpose of coordinating healthcare research across the Federal government. ∙ IOM has engaged the community in a

better understanding of the types of CE studies needed.

include:

4

∙ AHRQ-funded evidence-based studies,

∙ AHRQ has conducted workshops and engaged in other tasks to generate evidence-based information and engage the community in understanding how database analyses can generate useful CE information.

5

CE studies per se will be valuable and must, more frequently, become one of the inputs used by practitioners and patients to guide therapy following diagnosis, despite the fact that CE is sometimes linked in public discourse to rationing of healthcare. Diagnosis and treatment can be aided by development of a treatment model—captured and presented as a generally applicable set of process standards—that addresses key aspects of the decision-making process that are often considered in an ad hoc fashion, if at all. In turn, these process standards support treatment programs (protocols) to guide the practitioner and patient/consumer alike. These treatment programs themselves are also process standards that are frequently lacking for the individual patient when he or she leaves the immediate healthcare provider’s setting.

4. Pharmacotherapy Guidelines: Comparative Effectiveness results could be put into action through extended pharmacotherapy treatment standards.

USP could serve as a convener of organizations to 1) develop an innovative, multidisciplinary, patient inclusive approach for integrating CE research study outcomes into pharmacotherapy standards/guidelines—treatment program standards— and 2) apply this approach to two separate, established, model standards or guidelines for particular disease treatments.

Aspects/features of the approach

including CE studies;

∙ Conferences and Webinar(s); and ∙ Disease/condition candidates for which a wide range of treatment therapies exist, the cost of therapies varies widely, and which are part of a discrete patient population that would be affected.

In all cases, transparency of work would be emphasized, partners would represent the interdisciplinary health care team (including patients and payors), and USP committees and members would be part of the process.

5. Specialty Medicines: Specialty medicines are the product of innovative technologies (often, but not solely, biotechnology engineered molecules) that target unmet medical needs and are expensive because of limited patient populations, high cost of manufacture, and the increased risk and cost of development programs. In addition, the forced evolution of the pharmaceutical industry business model from reliance on historically successful but fading “blockbusters” to larger numbers of innovative specialty medicines requires higher prices to fuel growth.

Exacerbating the cost problem is that, as a consequence of structural and financial realities in the approval process and the costs and risks of development, these medicines are often used for unapproved indications for which evolving data sets are suboptimal when compared with data supporting their use in approved indications. Such use is generally for chronic, inadequately treated diseases with high morbidity and mortality, creating compelling demand for utilization and making it difficult to deny access. Access may seem arbitrary, depending upon the sophistication of the

4 www.iom.edu/cepriorities (July 2009) 5 http://www.ahrq.gov/clinic/outcomes.htm (July 2009)

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practitioner and patient in confronting the payor, which contributes to a growing sense of unfairness.

The payment for these medicines varies considerably among plans. Medicare covers specialty pharmaceuticals under Parts B and D, depending upon seemingly unrelated factors, including the route and place of administration.

Therefore, care may be driven by reimbursement rather than clinical considerations. Both private and public (Medicare) payors use tier structures (essentially a cost shift to patients) to reimburse for these medicines. Since Medicare Part B (and most private plans) lacks out-of-pocket maximums and these medicines can cost tens of thousands of dollars per year, they are simply unaffordable for many under the current system.

To effectively allocate scarce health care resources, standards are needed to support rational therapeutic use of specialty medicines. These standards are now left to individual pharmacy and therapeutics committees, their health plans, and/or individual practitioner and patient decision-making. The question arises whether a national process could lead to standards to better inform these decisions.

The sensitive and inevitably controversial nature of these standards requires that this process be inclusive, transparent, and objective. USP possesses a structure and history that uniquely position it to achieve these objectives.

6. Information Standards: USP’s Information Expert Committee chairs have advocated that USP provide information standards rather than the information itself. Such standards would serve as a framework within which others could create information. This concept

relates directly to USP’s standards-setting and practitioner-based character and links the quality of patient care to the quality of the information used by healthcare professionals and patients.

Examples of information standards (as distinct from information) could include the adequacy of research study design, methodology, analysis, and communication of results. Other standards could include:

∙ Linguistic competency for verbal or aural messaging and comprehension targeted at specific audiences, e.g., level of language used, languages available, visual depictions, words presented per minute; ∙ Cultural sensitivity in messaging: ethnicity, gender, age, etc.; ∙ Ethics in targeting vulnerable populations: elderly, children, terminally ill;

contract the WHO list to meet local needs. In principle, USP’s Model Guidelines provides a “table of contents” for a U.S. national formulary. Combining the approach with the AMA-DE in evaluating individual medicines within each category and class of the Model Guidelines further supports a U.S. national formulary, which does not now exist. The opportunities and challenges of such an approach are generally well known. An essential medicines list speaks to the best medicines within a country, region, or even the globe. In this context, it speaks to official medicines in the United States Pharmacopeia, which were always intended to be the best medicines.

The National Formulary in the United States provided quality standards for non-official medicines. It was adopted by USP in the 1970s and has evolved into a book of excipient monographs. A seminal paper by T. Donald Rucker, Ph.D., argued that USP should advance a “true” national formulary in the U.S.7

∙ Competency in decision-making: use of duress, undue influence, physical and mental capacity, etc.;

∙ Patient–provider relationships and conflicts of interest; ∙ Direct to patient advertising: “free” samples; and ∙ Requirements for post-regulation marketing surveillance.

7. National and International Approaches: Through its Essential Medicines List, the World Health Organization (WHO) has sought to provide a limited list of medicines to decrease inappropriate prescribing and promote rational use.6 The WHO Essential Medicines List is used by many nations throughout the world to create national formularies that expand and/or

Summary: At the outset, this white paper asked the following questions: ∙ In an era of health care crisis and reform, what are societal needs for drug information and use standards to support rational therapeutic decision-making? ∙ If these needs can be defined and USP, by virtue of its structure and history, can uniquely fulfill them—with availability of adequate resources—does it have a responsibility to do so?

The U.S. Federal government has turned to USP’s standards-setting activities and expertise on many occasions over more than 100 years, not only when it recognized USP and NF as official compendia of the United States, but also for purposes of reimbursement on two occasions8 and, more recently, to assure beneficiary access in the Medicare Part D legislation. In these cases, USP was

6 Reidenberg, NM. Can the selection and use of essential medicines decrease inappropriate drug use?. 2009. Clinical Pharmacology and Therapeutics, Volume 85, Number 6.

7 Rucker, TD. November 15, 1999. A public-policy strategy for drug formularies: preparation or procrastination?. American Journal of Health-Systems Pharmacists, Volume 56.

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recognized as a trusted, neutral organization that could bring together diverse stakeholders and make objective, science-based decisions through an open and transparent process. In the current state of healthcare reform and crisis, it may be time to call upon USP again.

There is a deep logic, expressed in many countries over many years, for governments to seek non-governmental practitioner experts to achieve a public health good, such as drug information and use standards. But even if the U.S. Federal government does not turn to USP at this juncture, this does not mean that USP should not act. While USP has a need for sufficient financial resources to set drug use and information standards, it has access to the greatest resource of all: a cadre of healthcare experts from around the world who have, can, and could set, through activities of the Council of Experts, drug information and use standards in ways that would speak profoundly to patients and practitioners in a time of great need. The Council of the Convention Section on the Quality of Patient Care seeks creative thinking about a strengthened role for USP in setting drug use and information standards.

Comments on this white paper may be submitted to CoC@usp.org.

www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.

ABOUT USP and NASPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP’s standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.

More information can be found at 8 Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508) signed into law November 5, 1990 and The Omnibus Reconciliation Act of 1993 (Public Law 103-66) 107 Stat. 312, enacted August 10, 1993. http://assembler.lew.cornell.edu/usc-cgi/get_external.cgi?type=pubL&target=103-66), (http://www.answers.com/topic/united-statesstatutes-at-large)

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Continuing Education for Pharmacists Quiz and Evaluation Opportunities for Drug Information and Use Standards 1.

USP provides an extensive array of product standards for all of the following except: a. National Formulary b. Food Chemicals Codex c. Allied compendia d. They provide for all of the above

7.

The highest usage of the USP Model Guidelines was in 2006, representing what percentage of health plans? a. 70% c. 74% b. 72% d. 76% 8.

Which of the following is true regarding the Formulary Key Drug Types (FKDT)? a. It offers no additional protection b. It was established prior to the Model Guidelines c. It is mandatory d. It has been utilized by CMS

2.

Who produced the first Dispensatory of the United States of America (USD) in 1832? a. George B. Wood b. Franklin Bache c. A+B d. None of the above 3.

9.

Which association(s) did USP work with to lead a series of meetings to explore the concept of Applied Drug Information Resource (ADIR)? a. American Nurses Association b. American Pharmacists Association c. American Medical Association d. All of the above

When was the last edition of the USD published? a. 1973 c. 1993 b. 1983 d. 2003

4.

Which volume of the USP Drug Information resource (USP DI) is Drug Information for the Health Care Professional? a. 1 c. 3 b. 2 d. 4

10.

The American Recovery Reinvestment Act of 2009 provided which of the following? a. $300 million to National Institutes of Health b. $300 million to the American Medical Association c. $400 million to Department of Health and Human Services d. $400 million to Agency for Healthcare Research and Quality

5.

Which volume of the USP Drug Information resource (USP DI) is Advice for the Patient a. 1 c. 3 b. 2 d. 4 6.

Who launched the USP DI Desktop Series CD ROM? a. Thomson Healthcare b. Carepoint c. American Medical Association d. Medicare

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

Opportunities for Drug Information and Use Standards This lesson is a knowledge-based CPE activity is targeted to pharmacists.

GPhA code: J10-02 ACPE#: 142-000-10-002-H04-P Contact Hours: 1.5 (0.15 CEU) Release Date: 02/01/2010 Expiration Date: 02/01/2013 1. Select one correct answer per question and circle the appropriate letter below using blue or black ink (no red ink or pencil.)

2. Members submit $4.00, Non-members must include $10.00 to cover the cost of grading and issuing statements of credit/ Please send check or money order only. Note: GPhA members will receive priority in processing CE. Statements of credit for GPhA members will be mailed within four weeks of receipt of the course quiz.

1.

2.

3.

4.

5.

A A A A A

B B B B B

C C C C C

D D D D D

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

Activity Evaluation: must be completed for credit Please rate the following items on a scale from 1 (poor) to 5 (excellent)as to how well the activity: 1.

2.

3.

4.

5.

6.

7.

8.

Met my educational needs: Relates to pharmacy practice: Achieves the stated learning objectives: Faculty presented the information: Teaching methods conveyed information: Post-test aided in assessing my grasp of the information: Avoided any bias or commercial bias: How long did it take to complete this activity?

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 _______________________

A passing grade of 70% is required for each examination. A person who fails the exam may resubmit the quiz only once at no additional charge.

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Phone #: _______________________________

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

The Georgia Pharmacy Journal

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February 2010

2009 - 2010 GPhA BOARD OF DIRECTORS

The Georgia Pharmacy Journal Editor:

Jim Bracewell jbracewell@gpha.org

Managing Editor & Designer:

Kelly McLendon kmclendon@gpha.org

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2010, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor.

All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.

ARTICLES AND ARTWORK Those who are interested in writing for this publication are encouraged to request the official GPJ Guidelines for Writers. Artists or photographers wishing to submit artwork for use on the cover should call, write or e-mail the editorial offices as listed above.

SUBSCRIPTIONS AND CHANGE OF ADDRESS The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia.

The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe NE, Atlanta, GA 30324.

Periodicals postage paid at Atlanta, GA and additional offices.

POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324.

ADVERTISING Advertising copy deadline and rates are available at www.gpha.org upon request. All advertising and production orders should be sent to the GPhA headquarters as listed above.

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

Position

Robert Bowles Eddie Madden Dale Coker Jack Dunn Robert Hatton Jim Bracewell Hugh Chancy Ashley Dukes Keith Herist Jonathan Marquess Sharon Sherrer Andy Rogers Alex Tucker Heather DeBellis Tony Singletary John Drew Bill McLeer Shobhna Butler Bobby Moody Mike Crooks Larry Batten David Gamadanis Chris Thurmond Marshall Frost Ken Eiland Renee Adamson Liza Chapman Burnis Breland Tim Short DeAnna Flores Rick Wilhoit John T. Sherrer Michael Farmer Mickey Tatum

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

Don Davis Gina Ryan Johnson Meagan Spencer Barbee Rusty Fetterman Garrick Schenck Daniel Forrister Lance Faglie

www.gpha.org

Print: Star Printing - 770.974.6195

The Georgia Pharmacy Journal

Name

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February 2010