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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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Departments
UGA Pharmacy South Building Dedication FEATURE ARTICLES
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GPhA Member Galdo Wins RESPy Award Pharmacy Time Capsules 2009 (4th Quater) UGA Alum Named Rite Aid EVP of Pharmacy Foundation Annual Fund Members: Thank you! CPE Opportunity: USP’sRole in Setting Enforceable Quality Standards for Medicines
5 8 12 13 14 18 30
New Members New Practitioner Leadership Conference Nomination Form Mercer University News South University News GPhA Member News Pharm PAC Contribution Card GPhA Board of Directors
Advertisers 2 2 6 11 12 16 17 18 18 21
The Insurance Trust Principal Financial Group Pharmacists Mutual Companies Design Concepts PharmStaff AIP Michael T. Tarrant Melvin M. Goldstein, P.C. Toliver & Gainer Southeastern “Girls of Pharmacy” Leadership Weekend 32 The Insurance Trust
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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PRESIDENT’S MESSAGE Eddie M. Madden, R.Ph. GPhA President
Georgia Pharmacy Association’s Strategic Planning t the first of May, I was invited to attend the annual Pharmacist Mutual’s Leadership conference held at Merck’s headquarters near Philadelphia, Pennsylvania. The conference had more than forty state leaders present with their Executive Directors.
This is my fourth year on the Executive Board. All of our members have been dedicated and work hard to achieve success for our association. A strategic plan would have made our work easier. The purpose of a strategic plan has many values for the board of directors and the staff of the association. This plan creates a framework and identifies priorities. It facilitates consistent transition from board chair to board chair. It identifies goals to set the course for several years and allocates the best use of the association’s limited resources. It becomes an action plan, which facilitates integration and alignment with the committees and the annual budget.
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A major portion of the program was a presentation by association’s guru, Robert Harris. Bob has studied thousands of associations, chambers, and charities to develop best practices. His career started in Washington, D.C., with PRESIDENTIAL CLASSROOM. Later, he built an association management company in Tallahassee, Florida. He has been called the Martha Stewart of association management for his willingness to share tips and templates. Bob’s presentation ranged from roles and responsibilities of a board, scrutiny on operations of a non-profit organization, effective committees, and strategic direction.
On Saturday, October 11, and Sunday, October 12, selected volunteer leaders of the Georgia Pharmacy Association met in Atlanta to participate in a strategic planning meeting. These participants were chosen for their leadership skills, diversity, and commitment to our association’s success. I would like to thank the members and staff participants: Drew Miller, R.Ph.; Whitney Unterwagner, Pharm.D.; Andy Rogers, R.Ph.; Amanda Gaddy, R.Ph.; John McKinnon, R.Ph.; Tommy Whitworth, R.Ph., CDM; Chris Thurmond, Pharm.D.; John Drew, Pharm.D.; Marshall Frost, Pharm.D.; Jack Dunn, R.Ph.; Ruth Ann McGehee; and Jim Bracewell for making our goal of a strategic plan a success! They graciously gave up their weekend and worked hard on developing Georgia Pharmacy Association’s strategic five-year plan.
It did not take long in Bob’s discussions to realize the significant responsibility that the Board of a non-profit organization has agreed to shoulder. As president of an organization, you are not only expected to operate effectively for the membership, but steer the corporation through a maze of legal requirements. While this portion of his presentation was quite educational, I was more interested in what he presented as another important topic for an association strategic planning. Bob had two strategic plans that he had acquired from the Texas Pharmacy Association and the Florida Pharmacy Association. The Texas plan was for 2009-2011. The Florida plan was for 2003-2006 (which needed updating). When he asked about other state association’s strategic plans, Georgia, like several other states, were among those that had none.
The Georgia Pharmacy Journal
David Miller, R.Ph., of Merck Pharmacy Affairs, facilitated this event. Dave is a former state executive director and has a deep understanding of the problems facing state associations. He and Merck have been outstanding supporters of state associations, and we owe a big debt of gratitude for their support of the Georgia Pharmacy
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Association. I have participated in developing strategic plans before, but have never experienced the skill and technique that Dave Miller utilized to make this plan come together so quickly. Not only was a strategic plan developed but key ideas to enact the plan were provided.
Pharmacy Association will strengthen its membership and become more vital to the profession. A strong association is important for advancing our profession. It is something that every pharmacist should not take for granted. There are several states that have lost their associations. Oregon only four or five years ago was an outstanding state association and is now struggling for its survival.
The strategic plan that the planning committee developed must now go to the Executive Committee for review and then be presented to the Board of Directors in January for adoption by the association. It will then be available for our membership to view.
Our association has survived for over 135 years. There have been tough times in the past but the work and leadership of its members this past weekend will provide a framework of success for the next five years.
I am excited about the outcome of this plan. I believe that when this plan’s execution gets underway, Georgia
Participants in the Strategic Planning Meeting were, from left to right, Dave Miller, Jack Dunn, John McKinnon, Whitney Unterwagner, John Drew, Ruth Ann McGehee, Drew Miller, Andy Rogers, Amanda Gaddy, Chris Thurmond, Eddie Madden and Marshall Frost. (Not pictured: Tommy Whitworth and Jim Bracewell.)
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Christopher J. Bass, Cochran Donald E. Black, R.Ph., Rome Samuel Alton Brewton, III, Pharm.D., Molena Rodney H. Brown, Waycross Daniel Chastain, Cairo Stacie M. Cooper, Pharm.D., Atlanta Clayton A. Eubanks, Jr., R.Ph., Atlanta Kerrie Glass, R.Ph., Woodstock Jennifer Williams Graham, C.Ph.T., East Dublin Lauren H. Grahl, Fort Valley Andrew Miller Harley, Metter Anabelle D. Keohane, Pharm.D., Peachtree City Rosa Jangmi Lee, Cumming Clay Lewis, Centerville The Georgia Pharmacy Journal
Jonathan Courtney McKoy, Colbert Lacey Jay Miller, Savannah Joyce M. Nations, Canton Machelle Thigpen Pierce, Pharm.D., McDonough Crystal Victoria Rennis, Stockbridge Becky Darlene Rich, Tifton Joseph L. Rouw, OD, Buford Erika Danielle Rylee, Gainesville Lori A. White, Pharm.D., Suwanee Richard Lee White, Pharm.D., Suwanee Courtney Elizabeth Williams, Evans Nancy Street Williams, R.Ph., Atlanta Alicia Wilson, R.Ph., Conyers Sherilyn Audrey Woodcome, Pharm.D., Atlanta
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EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
Strategic Planning is Hard Work Dynamic” and “dynamite” are not words I generally associate with a fall weekend spent in a closed hotel meeting room while the leaves fall and football is played, but those are the two words that quickly came to my mind as I reviewed the events of October 11 and 12 at the Double Tree Hotel in Atlanta.
GPhA. I personally have never participated in such a productive exercise as we went through using techniques normally reserved for corporate board rooms in America. We fostered a team effort to lay out challenges for GPhA in simple terms and measurable quantifiable goals.
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This is not the end of the project, rather this is the beginning of a new way of looking at the future of our association and which needs we address for the profession.
When someone today suggests a Strategic Planning Retreat, most minds picture a rustic or resort setting with time to play team building games and some free time to hike, play golf or other personal time to enjoy yourself. The end product is often lofty ideals placed in a large three ring binder that looks good on the office bookshelf.
GPhA cannot be all things to all pharmacists, but we can be the forum for deciding what issues we can and should address for the profession.
None of this was the case for the members of GPhA who accepted the challenge to come to Atlanta for a virtual lockdown, hardnosed, work to the bones session with some of the brightest minds in GPhA.
The profession and the membership of GPhA owe a sincere measure of gratitude to these members and especially to David Miller, R.Ph., a former state association executive who coached this team through the weekend. At times he beat and drove the team through the weekend. Have you ever had people routinely say, “My brain hurts I have been thinking so intently?” You would last weekend. When you see these members remember to say “thank you.” If or when the Board of Directors adopts this plan it will be posted to our website and a feature article will cover it in the JOURNAL. You will have a resource to say this is where GPhA is going and this is what it is doing for me and the profession of pharmacy.
Their challenge, in twelve hours of intense focused team effort, was to address the needs of GPhA in the next 36 months and the next 60 months in a fashion that could be taken to the GPhA Board in January for their consideration for adoption. The Georgia Pharmacy Association has for years had phenomenal leadership at the helm as the Executive Committee and the Board of Directors, but we have never engaged a focus group of the membership to address the strategic direction for the
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UNIVERSITy OF GEORGIA NEWS
Pharmacy South Dedication Takes Place standing-room-only crowd of some 250 people gathered into the 194-seat auditorium on September 10 to witness the dedication of the long-awaited Pharmacy South addition to the University of Georgia College of Pharmacy. Officiating were UGA President Michael Adams, Dean Svein Øie, VisionPlus board member Robert Thompson (‘76), and Mike Dorchak, chair of the Dean’s Student Advisory Council. Also attending were current and former Georgia state legislators, Eddie Madden, R.Ph. (‘71), Rep. Earl “Buddy” Carter, R.Ph. (‘80), and Rep. Oren “Buddy” Harden, R.Ph. (‘62), along with the VisionPlus Capital Campaign, UGA vice presidents, alumni, faculty, staff and friends of the College.
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“Everyone in the state has a vested interest in the progress of the pharmacy school addition, and our citizens deserve the first-rate care that will come from the students educated here,” said Adams as he greeted the audience. High Tech Facility The $44 million, 93,288 square foot addition, built adjacent to the Robert C. Wilson pharmacy building, has biodiesel generators and is the first building on campus to be registered for the Leadership in Energy and Environmental Design (LEED) Certification, the national benchmark for design, construction and operation of high-performance green buildings. In addition its high tech research labs utilize a chemical fume hood control system that is integrated with the building’s heating and air conditioning system to minimize energy consumption.
Øie thanked former deans Howard Ansel and Stuart Feldman for their vision in conceiving and implementing the plan to build the new facility. “The idea for the new building originated in 1979, some 30 years ago, during Howard Ansel’s tenure as dean; Stuart Feldman and I carried this vision forward with us,” said Øie, noting that the groundbreaking ceremony for Pharmacy South occurred in November 2007. “It has been a fantastic, joyous voyage to achieve what we call Pharmacy South, but it has also been long and torturous. Our voyage was not just about a building, though, it was about transforming the College of Pharmacy. It was not just about the physical, it was about the people in the building who are leading the way for the profession.”
Pharmacy South features state-of-the art classrooms and teaching labs, complete with video recording and distance learning capabilities and sensor-driven lighting for efficiency and programmed control. Points of pride include the Student Learning Center with its wireless Internet computer stations, small-group seating areas and continued on page 10
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November 2009
technology support area, plus a complete Community Pharmacy Care Center and Skills Lab, and a Hospital Pharmacy Care Center. In addition to the two 194-seat auditoria are three 30-seat classrooms, one 15-seat seminar room and seven small discussion rooms, all designed to provide critical classroom and laboratory space to support the Doctor of Pharmacy and graduate programs. Other highlights include a student affairs office suite, a lounge, an executive conference room and two large open research labs, allowing for the expansion of research programs in drug discovery and delivery.
(‘81), Robert Tamplin (‘70), Robert Thompson, R.Ph. (‘76) and Kevin Woody, R.Ph. (95). “If it weren’t for the dedicated members of our VisionPlus board, I don’t think we would’ve done nearly as well. Their attendance at our quarterly meetings has been exemplary, as well as their outreach efforts with our alumni. Their own personal contributions exceeded $1 million,” said Dana Strickland, the College’s director of development who was credited by Lurey as being “the glue, the inspiration and the driving force for all our efforts.”
Vision 2003 and VisionPlus Campaigns In 1995 the College created the Vision 2003 board to raise private funds for the new building and help secure appropriations from the state of Georgia. After the College’s centennial celebration in 2003, the board’s name was changed to VisionPlus.
Naming Opportunities Part of the funds raised by Pharmacy alumni included specific donations in the form of Naming Opportunities for the new building project. They were: Kroger Pharmacy – Student Learning Center, $250,000 Billy (‘65) and Dennis (‘88) Strickland – Community Pharmacy Care Center, $125,000, Richard F. Bryan estate – Hospital Pharmacy Care Center, $125,000 Hubert F. Chancy Family – Lounge, $125,000 Dennis and Beverly Bloodworth – Executive Conference Room, $100,000 Publix Super Market Charities – Three Discussion Rooms, $100,000 Michael Gigandet (‘72) – Alumni Suite, $75,000 Henry Holland Memorial Fund – Dean’s Office, $50,000 Walgreens – Classroom, $50,000 Al (‘51) and Shirley Greenway – Faculty Office, $25,000 Class of 2009 – Book Shelf, $525 Numerous donors, Auditorium Chairs, $250 each.
The 14-year campaign raised $11.2 million in donations from alumni, corporations and friends of the College toward the construction of the addition to the 31-year-old pharmacy building. As part of UGA’s Archway to Excellence campaign, which began in 2001, the board originally set its goal at $7.6 million and reached that goal in 2006. “Moving up and down the Board of Regents’ list of priorities, after having started at Number 25, seemed like following the Dawgs up and down the football polls,” said Jeff Lurey, R.Ph., chair of the VisionPlus board. “However it felt like 1980 all over again, winning the national championship, when our College’s vision for a new facility became the Regents’ Number One priority. Seeing Pharmacy South come to fruition has been a wonderfully rewarding experience.” The original members of Vision 2003 and VisionPlus boards are Lurey, Ashley Dukes, R.Ph. (‘71) and Harris Morgan, Jr., R.Ph. (‘75). Other current and past members are Dennis Bloodworth, Bryan Brown (‘70), Nabil Elkareh, Samee Ellerbee, R.Ph., CDE, MPH(c) (‘74), Stuart Feldman, Stewart Flanagin, Jr., R.Ph. (‘72), co-chair Michael Gigandet (‘72), Jim Gore, Valerie Green, Alton Greenway, R.Ph. (‘51), Renee Hay (‘84), Susan Kane, R.Ph.. (‘93), Jan Mackey (‘78), Scott Miller, Sheila Miller (‘87), Steve Moore, Elizabeth Mottern, Dean Svein Øie, Rep. Larry “Butch” Parrish, R.Ph. (‘64), Steven Purvis, R.Ph. (‘98), Dana Strickland, R.Ph. The Georgia Pharmacy Journal
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MERCER UNIVERSITy NEWS Meagan Spencer Barbee Pharm.D. Candidate Mercer Univeristy
Mercer University ASP Chapter Update he Mercer APhA-ASP Chapter has had an exciting year thus far. At our October chapter meeting, we hosted Adriane Irwin, National APhA-ASP President who talked about involvement in APhA-ASP. At our September chapter meeting, we hosted Dr. Sharon Sherrer to speak on health care reform and disaster preparedness. The chapter has been actively involved in policy through drafting resolutions for our Mid-Year Regional Meeting and through our video and letter writing campaigns to legislators and congressmen.
The chapter is actively seeking licensed pharmacists in the community to increase participation and outreach. If you are interested in volunteering at an event or hosting a screening event at your pharmacy, please contact Meagan Barbee, Chapter President at Meagan.e.spencer@student.mercer.edu.
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For October, American Pharmacists Month, Mercer APhA-ASP participated in a variety of patient caring, educational, professional events. We put together teams for the Memory walk and AIDS walk, and raised over $600 for AID Atlanta. Several of our students presented to Hawthorne Elementary school students at their general assembly on the difference between medicine and candy. We also participated in Red Ribbon week and had four students who attended the Mid Year Regional Meeting in Charleston, SC. One of our members ran for Regional Member at Large at this meeting.
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Future programming consists of holding the National Patient Counseling Competition and the GPhA Foundation sponsored Brown Bag Competition to enhance student pharmacist education. The chapter also has planned numerous patient caring and outreach activities such as diabetes and hypertension screenings, clinical education to the underserved populations, and several health fairs including the Third Annual Multicultural Community Health Fair, sponsored by GPhA, scheduled for April 17, 2010. The chapter is looking forward to collaborating with GPhA and the other pharmacy schools at the Very Involved Pharmacist Day at the Georgia Capitol on February 17, 2010.
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SOUTH UNIVERISTy NEWS Richard Wilhoit Pharm.D. Candidate South Univeristy
South University ASP Chapter Update he South University chapter of APhA-ASP has been busy celebrating Pharmacy month and promoting wellness in the community! We kicked off October with a meeting on campus on the 1st to introduce the 2012 class to our organization and discuss upcoming events for the month. We closed the meeting with our chapter president giving a motivational talk on the importance of being involved in professional organizations and advocating for our profession.
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Next up was our school’s Day of Dignity event. On Oct. 11, we had 24 students and two faculty members and their children serve food to a few hundred homeless Savanians at Forsythe Park. In addition, we were able to raise money on campus to provide “goodie bags” containing toiletries and other useful items. The 15th was our GPhA Regional Fall meeting at Love’s Seafood. With our chapter advisor, Dr. Heather DeBellis, currently holding office as region president, we had a great faculty and student turnout. We do like to mix in some downtime to help everyone relax, so on the 16th we had a chapter outing to the movies to see “Where the Wild Things Are.” Then on the 17th, the chapter will be providing health screenings at the American Diabetes Associations Sunsplash event at the UGA Extension Service Aquarium on Skidaway Island. We will be doing glucose, blood pressure, and heartburn screenings, as well as providing information on immunizations. To celebrate the end of pharmacy month in style, we will be heading to Charleston, SC to attend APhA-ASP’s Midyear Regional Meeting. It should be a fun and educational end to a very rewarding month.
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GPHA MEMBER NEWS
Daniel Forrister, Pharm.D., University of Georgia Clinical Assistant Professor, and Sukhmani Sarao, Pharm.D., Clinical Assistant Professor, presented a poster, “A ServiceLearning Course Engages Pharamcy Students in Providing Community Health Care,” at the National Outreach Scholarship Conference in Athens. Brad Phillips, BCPS, Pharm.D. University of Georgia Professor and Head of Clinical and Administrative Pharmacy was appointed as Vice Chair of the 2010 American College of Clinical Pharmacy Publications Committee.
teaches pharmacists the skills necessary to become a primary source for vaccine information and administration. The program teaches the basics of immunology and focuses on practice implementation and legal/regulatory issues. As part of the training, the participants gave (and received) subcutaneous and intramuscular injections. Twentynine participants attended this program. Each participant was awarded a certificate of achievement, and a total of 20 contact hours of CPE credit for successful completion of all components of the program. Participants who attended this program:
The Georgia Pharmacy Foundation distributed the following scholarships to students at Mercer University:
Renee Adamson, Pharm.D. Melissa Basden, Pharm.D. Michael Briscoe, R.Ph. Bruce Broadrick, R.Ph. ∙ The Regina Baird Scholarship to Winston Brock, Pharm.D. Meagan Spencer Barbee and Lisa Cleveland Brown, R.Ph. Saucier ($1,000 each) Krystal Bugden, Pharm.D. Tina Chancy, R.Ph. ∙ The Neal L. Pruitt, Sr. Jeffrey Cox, Pharm.D. Entrepreneurship Scholarship to Douglas Donedoo, R.Ph. Destin Sampson ($1,000) Jack Dunn, Jr., R.Ph. Amy Galloway, R.Ph. ∙ The Carlton Henderson Justin Gardner Scholarship to Tina Roberts Katie Glover, Pharm.D. ($1,000) Cara Hawkins Michael Iteogu, Pharm.D. A Pharmacy-Based Immunization Wendell Lovett, R.Ph. Program was recently held at Eddie Madden, R.Ph. Mercer University in Atlanta, GA. Catherine Maraman, Pharm.D. This is an interactive and Henry McGill innovative training program that Ginger Mendoza, R.Ph. The Georgia Pharmacy Journal
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Darby Norman, R.Ph. Irvin Pinnell, R.Ph. Shemane Ramay, Pharm.D. Carole Ray Michael Rogers, R.Ph. Max Standefer Robert Stitt, R.Ph. Kristen Whechel, Pharm.D. Stephanie Williams, Pharm.D. Brett Winslette Brooke Winslette On September 24, 2009, Liza G. Chapman, Pharm.D., testified at the Georgia State Senate Health and Human Services Committee hearing. She shared what pharmacists have done to prepare for the H1N1 and Seasonal Flu; the role of pharmacists in vaccine administration; and what can be done to breakdown barriers to access to vaccines.
If you have an item that you would like included in the GPhA Member News section of THE GEORGIA PHARMACY JOURNAL please email the news to Kelly McLendon at kmclendon@gpha.org or fax it to her attention at 404.237.8435.
November 2009
GPHA MEMBER NEWS
GPhA Member Galdo Wins RESPy Award ohn “Jake” Galdo of Marietta, a third year student at the University of Georgia College of Pharmacy, is recipient of the 2009 Pharmacy Times/Wal-Mart RESPy (respect, excellence, and service in pharmacy) Award. The national, competitive award recognizes outstanding student pharmacists who have been nominated by their college deans for their community service efforts.
“If all pharmacists had Jake’s dedication to helping patients and advancing pharmacy practice, our profession would find itself playing an even greater role in maintaining and improving public health,” said Dr. Alan Wolfgang, assistant dean for Student Affairs at the College of Pharmacy, in his letter of nomination.
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As the RESPy award recipient Galdo will receive a $1,000 tuition scholarship, an original, handcrafted piece of commemorative art and recognition in PHARMACY TIMES magazine.
Galdo is praised for being an outstanding volunteer and advocate for patient care in the Athens community. He is in charge of the prescription assistance program at Mercy Clinic, which identifies the needs of individual patients and secures free medications from manufactures. He also teaches a diabetes education classes to patients in the clinic, which is a local nonprofit organization that provides health care services to uninsured people in the area. Galdo was also a primary organizer of 2009 PharmFest, a health fair where pharmacy students educated community members on such topics as osteporosis, diabetes, and smoking cessation. The event placed special emphasis on educating hispanic citizens; Galdo’s fluency in Spanish allowed him to educate patients and help train pharmacy students in their health care. A third example of his professionalism and public service is his volunteer efforts on a pharmacy team providing service to migrant farm workers in South Georgia. This year, for the first time, the clinic that had already been offering free medical services could also provide pharmaceutical care. In addition the pharmacy students gained experience being part of an interdisciplinary health care team.
Jake Galdo, right, receives congratulations from Dan Bucciarelli, regional talent specialist for Wal-Mart. The Georgia Pharmacy Journal
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November 2009
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PHARAMCy TIME CAPSULE
Pharmacy Time Capsules 2009 (Fourth Quarter) 1984—Twenty-five years ago: ∙ The 50th anniversary of the APhA headquarters building on Constitution Avenue was celebrated. ∙ Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch) simplifying the Abbreviated New Drug Application process and extending patent life for exclusivity lost as a consequence of FDA delays was signed into law. ∙ FDA approved Nicorette 2mg on January 13, 1984, for prescription use only. One of only three NDAs classified as 1-A in 1984.
1959—Fifty years ago ∙ Bill Apple became secretary of APhA replacing Robert Fischelis. ∙ Alaska and Hawaii become the 49th and 50th states.
1934—Seventy-five year ago ∙ North Carolina pharmacist and University of Maryland graduate, Caleb Bradham died. Bradham developed a soda drink that incorporated vanilla, essential oils, and kola nut that he named Pepsi-Cola. ∙ There was an open protest against the sale of grocery items in drugstores at the annual meeting of the South Dakota Pharmaceutical Association. ∙ A number of states still licensed pharmacy assistants allowing pharmacy assistants to operate a drugstore in the temporary absence of a registered pharmacist. Temporary defined as short as 2 consecutive hours (Indiana) to no more than one-third of the time per week that the store is open (Tennessee).
1909—One hundred years ago ∙ Founded by pharmacist Al Falkenhainer, Druggists Mutual Insurance Company (now Pharmacists Mutual) was chartered by Iowa on October 16. ∙ University of Tennessee moved its pharmacy program from Knoxville to Memphis.
1859—One hundred fifty years ago ∙ Chicago College of Pharmacy formed; later merged (1896) with the pharmacy program at the University of Illinois. By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org
The Georgia Pharmacy Journal
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Pharm PAC would like to encourage you to make a contribution today and help pharmacy look forward to a bright future in the state of Georgia.
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November 2009
PHARMACy NEWS
University of Georgia Alum Named Rite Aid EVP of Pharmacy ite Aid announced last month that Robert I. Thompson, formerly Senior Vice President, Pharmacy Operations, has been promoted to Executive Vice President, Pharmacy.
health-care related businesses, including the fourth largest dental practice management company in the U.S. and an international medical equipment manufacturer. He holds a Bachelor of Science degree in Pharmacy from the University of Georgia College of Pharmacy.
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The company also announced that Bill Wolfe, formerly Group Vice President, Managed Care and Government Affairs, has been promoted to Senior Vice President, Managed Care and Government Affairs.
Wolfe, 46, with 23 years experience in managed care and pharmacy benefit management, will continue to oversee managed care, the company’s PBM services and government affairs. He reports to Thompson.
Thompson, 56, a pharmacist and seasoned retail drugstore veteran, will oversee pharmacy operations, pharmacy purchasing, managed care, clinical services, the company’s pharmacy benefit management services and pharmacy business development, as well as government affairs. He reports to John Standley, Rite Aid President and Chief Operating Officer.
“Bill’s broad-based expertise in the area of managed care has been critical to our success in managing through the challenging and ever changing healthcare environment,” Standley said. “He also has been instrumental in helping us work through recent complex legislative changes.”
“Robert has a unique background that combines extensive experience in retail pharmacy and store operations with health care business development,” Standley said. “He’s been a terrific asset to Rite Aid over the past five years, making many valuable contributions to our company. With this promotion, he is now positioned to bring even greater value in this larger role overseeing all aspects of pharmacy.”
Wolfe joined Rite Aid in 1998 as Chief Operating Officer of Eagle Managed Care, Rite Aid’s pharmacy benefit management subsidiary at that time. During his tenure, he continued to take on roles of increasing leadership, including adding Rite Aid Director, Pharmacy Services to his Eagle Managed Care title. In 2000, he was named Vice President of Managed Care and in 2008 was promoted to Group Vice President, Managed Care and Government Affairs.
Joining Rite Aid in July, 2004 as Vice President, Pharmacy Business Development, Thompson has served in a variety of management positions including Senior Vice President, Pharmacy Operations; Senior Vice President, Operations for the Northeastern Division and Manager of the company’s integration of the Brooks Eckerd drugstore chain.
He started his career in managed care in 1986 as a management intern in the legal department at Pennsylvania Blue Shield where he was later named an Associate General Counsel and then moved to Keystone Health Plan Central, where he moved up the ranks from Director, Legal and Regulatory Affairs to General Counsel and in 1995 to Vice President, Planning, Legal and Corporate Secretary. He is a graduate of the Dickinson School of Law in Pennsylvania and holds a Bachelor’s Degree from Penn State University.
Starting his chain drug career in 1978 as a practicing pharmacist, Thompson rose through the ranks at the former Revco drugstore chain from 1978 until the company was sold in 1997. He moved up to store manager, district manager, director of store operations and regional director of pharmacy operations before being named Vice President, Pharmacy Operations for Revco in 1995.
Rite Aid is one of the nation’s leading drugstore chains with more than 4,800 stores in 31 states and the District of Columbia with fiscal 2009 annual sales of more than $26.3 billion. Information about Rite Aid, including corporate background and press releases, is available through Rite Aid’s website at www.riteaid.com.
Before joining Rite Aid, Thompson was involved in operations and new business development for several
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November 2009
Southeasttern “Girls off Pha Southeastern Pharmacyâ€? armacyâ€? rmacyâ€?yâ€? January ary 15-17, 2010 Leadershipip Weekendd Grove ParkJanua Leadershi Inn Inn;n; Asheville, NC Gather your girlfrie girlfriends ends for a weekend of fun fun, n, facts, and facials! With the growing demand of this is popular event, space is limited. Register R today to ensure your y spot at the 2010 Southeastern theastern “Girls of Pharmacyâ€? macyâ€? Leadership Weekend. W eekend Full re eekend. registration egistration includes: CE programming, programming p event mater materials, rials two breakfasts, rials, breakfasts and one dinner re reincluded includes: ception with includ ded drink ticket. Saturday y only registration includes s: CE programming, event nt materials, and Extra separately.. (Men - Don’t be shy! Y You one breakfast. Ex xtra reception tickets can be b purchased separately ou u can attend too!) Rooms are availab available ble at the Grove Park Inn for $136 per night. Call (800) 800) 438-5800 to book your our room today today.. for You Spa appointments s will be made available fo or reservation through the Grove Park Inn. Y ou must musst be registered make SCPhA’s appointment Visit www.spaweekend.org for the event to ma ake reservations through SCPhA ’s reserved appoin ntment times. V isit www .spaweekend.org for more details. (Those ( already registered - watch your email!) attend www.scrx.org If you wish to atten nd the Southeastern “Girls s of Pharmacyâ€? Leadership ip W Weekend eekend 2010, visit www ww ww.scrx.org to UHJLVWHU RQOLQH RU ÂżOO RXW WKH IRUP EHORZ DQG UHWXUQ WR 6&3K$ %URZQLQJ 5RDG &ROXPELD 6& RU UHJLVWHU RQOLQH RU Âż ÂżOO RXW WKH IRUP EHORZ DQG UHWXUQ WR 6&3K$ % %URZQLQJ 5RDG &ROXPELD 6& RU ID[ WR )RU TXHVWLRQV SOHDVH FDOO ID[ WR )RU TXHVWLRQV SOHDVH H FDOO Pharmacy accredited Accreditation South Carolina Ph harmacy y Association is ac credited byy the Accreditat tion Council for Pharmacyy Education DV D SURYLGHU RI FRQWLQXLQJ SKDUPDF\ HGXFDWLRQ 7KLV DFWLYLW\ LV HOLJLEOH IRU $&3( FUHGLW VHH ÂżQDO &3( WL L K G DWLRQ WL 7KLV DFWLYLW\ LV HOLJLE 7KL WL LW L OL LE EO I GLW Âż O &3( DV D SURYLGHU RI FR LG I RQWLQXLQJ SKDUPDF\ HGXFD EOH IRU $&3( $&3( FUHGLW VHH Âż ÂżQDO &3( DFWLYLW\ DQQRXQFHPHQW IRU VSHFLÂżF GHWDLOV DFWLYLW\ DQQRXQFHP PHQW IRU VSHFLÂżF GHWDLOV Yes! Y es! I wou would ld like to register for the 201 2010 0 Southeastern “Girls of Pharmacyâ€? armacyâ€? Leadership W Weekend. eeken e nd. REGISTRATION REGISTRA ATION DEADLINE: Januaryy 5, 2010 1DPHBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB Ć‘ 53K Ć‘ 7HFKQLFLDQ /LF 5HJ BBBBBB 1DPHBBBB BBBBBBBBBBBBBBBBBBBBBBB BBBBBBBBBBBBBBBBBBBB Ć‘ 53K Ć‘ 7H HFKQLFLDQ /LF 5HJ BBBBBB Address_____________________________________________________________________________ Address__ _______________________ _______________________ ________________________________ __________ City, City, State, State, Zip________________________________________________________________________ ______________________________________________________ ________________________________ __________ Phone__________________ Phone____ _______________ Email______________________________________________________ Email__ _______________________ _______________________________ _________ Registration Registratio on Fees (Guest registrations DO NOT include CE but do cover meal function costs): Ć‘ )XOO 3DUWLFLSDWLQJ 6WDWH $VVRFLDWLRQ 0HPEHU Z &( Ć‘ )XOO 3DUW ) OO 3 WLW L WL 6W WLFLSDWLQJ 6WDWH W $VVRFLDWLRQ 0 $ L WL 0HPEHU Z &(
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Continuing Education for Pharmacists USP’s Role in Setting Enforceable Quality Standards for Medicines 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. Goals: The goals of this lesson are to provide an overview and update on the current status of USP and address some of the challenges they are facing in acquiring and maintaining sound public standards. Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Discuss the current status of USP standards and the deficiencies that exist in the USP and NF 2. Explain the challenges USP is facing in acquiring and maintaining sound public standards and some approaches taken to address these challenges 3. Describe how USP is moving towards more harmonized standards Introduction: For nearly two hundred years, the United States Pharmacopeial Convention (Convention or USP) has worked to set quality standards for drugs (medicines and their ingredients). Much has changed during that period, including the globalization of the pharmaceutical industry, ongoing availability of better drugs to promote health and treat disease, demands for access to good quality medicines, systems that deliver interchangeable multi-source products after periods of patent and market protection, advances in measurement and manufacturing science, and calls for regulatory and compendial harmonization. In these contexts, USP’s public standards continue to play an important role in assuring both practitioners and patients that the medicines they use are of good quality relative to their safety and efficacy. If
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anything, recent events such as the rise in counterfeit and substandard medicines and adulteration crises (diethylene glycol, melamine, heparin) have heightened concerns about the quality of drugs, and reinforced the importance of USP’s public standards as part of the safety net that protects practitioners and patients in the U.S. and elsewhere. USP’s standard-setting activities have a long and distinguished history. At the first meeting of the Convention in 1820, the convening practitioners established recipes for the first Pharmacopeia of the United States of America (United States Pharmacopeia or USP). These recipes were used in the preparation of medicines to assure their consistency— process standards for articles of medicinal commerce. In the latter part of the 19th century, Charles Rice, Chair of the Committee of Revision (predecessor of the Council of Experts), transformed the United States Pharmacopeia from a book of recipes to a book of tests with procedures and acceptance criteria for medicines and their ingredients—product standards for articles of medicinal commerce. The National Formulary (NF), originally a repository for preparations deleted from the USP when such preparations were deemed less effective, later became a compendium of excipient product standards. NF was acquired by the Convention in the 1970s, and USP-NF is published now as a combined text of documentary standards. In the early part of the 20th century, the Convention began offering reference materials to assist analysts in the conduct of monograph procedures. Today the
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procedures for all monographs in USPNF are likely to (or should) have an allied reference material. USP’s drug standards are given special force by their long-standing recognition in U.S. law. In the 1906 Pure Food and Drug Act, Congress created a role for the Federal government to enforce (assess conformity to) Convention standards by naming USP as an official compendium of the United States. Congress strengthened this role in the 1938 Federal Food, Drug, and Cosmetic Act (FDCA) and made USP’s standards enforceable by the newlycreated Food and Drug Administration (FDA) under the adulteration and misbranding provisions of the FDCA. NF was subsequently added as well as an official compendium of the United States. Today, the FDCA continues to mandate compliance with USP-NF standards, giving them broad impact across both the innovator and generic pharmaceutical industry. This legal status and the public-private partnership between the United States Federal government and USP created through these laws reflects a societal agreement recognizing the importance of public standards for both manufactured and compounded medicines. Many state laws also recognize USP’s standards, reaffirming this societal agreement. With this history in mind and looking towards the future, the Council of the Convention Section on Quality of Manufactured Medicines describes in this white paper ways that USP might be further transformed to better fulfill its historic and legal role of establishing quality standards for drugs and helping to
November 2009
address current challenges in assuring a safe global drug supply. A general thesis of this white paper is that the original societal agreement reflected in Federal and state laws tying the Convention and FDA together in the early part of the 20th century must evolve in today’s environment to allow continued availability of public standards to help assure the quality of drugs. At the same time, modern measurement science allows opportunity for change that can transform USP and pave the way both for global harmonization and rapid detection of adulterated medicines. The Overview section below discusses the current status of USP standards, and the deficiencies that exist today in the USP and NF. The next section explains the challenges USP faces in acquiring and maintaining sound public standards. It also describes the innovative approaches USP has taken to address these challenges, and how USP is working to facilitate movement towards more harmonized standards while advancing the measurement science behind its standards. The last two sections explore the current societal problems of adulteration and contamination and ways that USP identity standards can play a role.
practices. Based on consistency in quality attributes over time (sometimes termed “equivalence”) relative to clinical study materials, practitioners and patients can expect predictable safety and efficacy outcomes when a medicine is administered. For new drugs, quality attributes are developed and maintained privately as part of the new drug application process and eventually, if a manufacturer is willing to provide this information to USP, can become public standards in USP. The private and public standards contain tests, procedures, and acceptance criteria that form the specification for the article, for both the medicine itself and its ingredients. Those in Congress and at USP framing the societal agreement embodied in the legislation of 1906 and 1938 may have expected a public standard for all medicines legally marketed in the U.S. While that expectation is currently expressed in USP’s Board of Trustees strategic plan for the 2005-2010 cycle, it has not been realized. The table below indicates the current status of USP in terms of monographs in four stages: 1) approved drug articles where no monograph exists, 2) articles with newly
acquired monographs that are not official, 3) articles with official monographs that need updating, and 4) articles with official monographs reflecting the state of the industry. Monograph Acquistion and Modernization: 1. Challenges to Developing and Maintaining Public Standards: A key reason for the lack of up-to-date monographs in USP lies in the fact that USP has no way to compel information and receipt of candidate materials to support a public monograph. Via the FDA Freedom of Information Act exemptions at 21 CFR Part 20, FDA is prohibited from giving USP the private regulatory specification—a prohibition generally termed trade secret or data protection. Manufacturers may resist voluntary donation of needed information and materials because of: 1) the need for some time after market access for controls in the private specifications to finalize, 2) the involved resource burden, and 3) a desire to protect trade secret information. Moreover, despite the fact that the societal agreement reflected in federal
Overview and Current Status of USP Standards: Although the complexity of the discovery, development, registration, and utilization processes for a medicine can be staggering, the concepts behind these processes are straightforward. A medicine and its ingredients must have specified quality and be produced under good manufacturing
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November 2009
law does not distinguish between singlesource and multi-source drugs, the innovator industry sometimes questions the need and rationale for a public monograph prior to generic entry. USP has been slow to develop a monograph in the absence of donated information and material because of the difficulty in developing suitable analytical procedures and certain science and technical constraints. For example, without knowledge of synthetic and degradation routes for a drug substance (active pharmaceutical ingredient or API), USP has little understanding of which impurities exist within a drug product or its ingredients. Similarly, understanding of degradant impurities requires special studies that are, for the most part, beyond USP’s capability to conduct. Patent barriers may limit access to and availability of certain reference materials. 2. USP Efforts to addresses Challenges a. Alternative Monograph Development Paths: One way in which USP has attempted to respond to its monograph acquisition challenges is to develop alternative pathways for monograph development. These allow greater flexibility for manufacturers and may enhance the usefulness of monographs to manufacturers, regulators, and— ultimately—practitioners and patients/consumers. ● The flexible monograph moves away from a “one size fits all” approach for the monograph’s specification to an approach that allows differences in the tests, procedures and acceptance criteria of the monograph depending on routes of synthesis, differences in formulation, or other factors. This approach facilitates voluntary donation of information from multi-source manufacturers of pharmaceutical ingredients and products and reduces the likelihood of “lock-out” specifications from any single manufacturer. ● The pending monograph encourages
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voluntary submission of information and material to support a Web-based public monograph in advance of a regulatory decision, coupled with rapid advance to official status in USP at the time of regulatory approval. This approach is particularly applicable to multi-source manufacturers. ● A non-U.S. monograph allows USP to develop Web-based monographs for medicines and their ingredients that are marketed outside the United States. This approach is an effort to provide standards for manufacturers and the public interested in having a sound public monograph irrespective of (and at times in the absence of) strong regulatory systems. Thus, these monographs may be of special value to manufacturers, purchasers and regulatory authorities in developing countries who are seeking assurance of quality. The program is limited now to medicines and their ingredients intended to treat neglected infectious disease, and thus has a very targeted public health focus. ● The performance based monograph (PBM) is a new idea to USP, although the approach has been widely used by other industries. Conceptually, the model is straightforward. A PBM might consist of tests and acceptance criteria, as presented now, but the procedures of the monograph would not be specified. Instead criteria for an acceptable procedure would be provided, and over time a list of acceptable procedures would be made available. The approach is based on the availability of a qualified reference material, and this reference material preferably would be certified. The reference material would be the drug substance itself or an “equivalent” material, or one or more impurities. Taken together, the general approach has many positive advantages,as well as features that merit special consideration. From a global standpoint, the approach might allow rapid advance towards compendial harmonization. Only the tests and acceptance criteria would need
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to be harmonized— the procedures themselves would be the responsibility of manufacturers and their corresponding regulatory agencies. Any acceptable procedure would be allowed for determining if a medicine or its ingredients were suitable for use. And these procedures could be public or private, depending on the interests of involved parties. The relationship between these repositories can be clearly understood based on modern metrological principles and careful collaborative studies. The PBM approach is still in the exploratory stage and there are many important questions to be answered, including those related to FDA’s need for a default or referee procedure in a monograph to readily determine non-compliance with USP standards. While all of these opportunities are of interest and have some value, those implemented to date have not had a substantial impact on the acquisition of new monographs or the updating of existing monographs. Comparisons of monograph backlogs at the beginning and close of the 2005-2010 cycle indicate a rise in the backlog (i.e. the number of articles for which there is no up-to-date monograph). b.Sponsor Outreach and Prioritization Efforts: USP has increased its efforts in recent years to educate manufacturers as to USP’s role and the value of public standards. In order to lessen the resources required from manufacturers to provide needed information, USP has assisted with monograph development— including providing easy-to-use templates for monograph submission and furnishing USP staff on-site at a manufacturer’s facilities to work on monographs. Although these efforts seem to have been well-received, as the table above indicates they have not had an appreciable effect in increasing the development of USP standards. Understanding that the effort needed to correct all of the deficiencies in USP is an immense challenge, USP has made efforts to prioritize its monograph
November 2009
acquisition and modernization activities so that it can conduct more targeted outreach to manufacturers. This includes working with industry to identify those monographs that are of greatest importance in terms of public health impact. Such prioritization activities help USP to more effectively utilize its acquisition resources, and make it easier for manufacturers to understand and allocate the resources requested of them for development of high-priority monographs. USP has also worked to expand the recognition it gives to sponsors of monographs and reference standards, so that it can more publicly acknowledge the contribution that monograph sponsors make to the public health. It is too early to tell whether these efforts will prove fruitful in increasing the quantity of monograph submissions. 3. International Conpendia and Compendial Harmonization: In todayâ&#x20AC;&#x2122;s global pharmaceutical market, the desire
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and need of industry for harmonized standards and requirements have become more pressing, and USP has recognized this. Harmonization of regulatory requirements has occurred in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for countries and regions with advanced drug regulatory systems, and at the World Health Organization (WHO) for all countries. The primary mechanism for compendial harmonization has been the Pharmacopoeial Discussion Group (PDG), begun through Convention impetus in 1989, which continues to this date and operates in connection with ICH. PDG includes representation from organizations that elaborate the major compendia of the worldâ&#x20AC;&#x201D;the European Pharmacopoeia (European Department for the Quality of Medicine and Health Care or EDQM), the Japanese Pharmacopoeia (Ministry of Health,
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Labor, and Welfare or MHLW), and USP, with WHO as an observer. WHO itself continues to elaborate The International Pharmacopoeia, which focuses on essential medicines. PDG does not work to harmonize monographs for medicines or their active ingredients; rather, PDG has concentrated on excipient monographs and allied general chapters (with 40 monographs and 26 general chapters concluded to date) and other non-excipient general chapters. PDG-harmonized documents may undergo a further evaluation in ICH to become guidances to assist in developing the private regulatory specification for the ICH regulatory agencies (FDA, Japanâ&#x20AC;&#x2122;s MHLW, and the authorities of the European Union, including the European Medicines Agency). Recently, PDG participants agreed to continue and expand their work. However, the PDG process, which requires the pharmacopoeias to retroactively revise varying and conflicting standards to achieve harmonization, remains slow and laborious. Moreover, although a 2005 Convention resolution encouraged USP to broaden harmonization efforts outside of PDG, for the most part this has not occurred as a PDG activity, although all major pharmacopoeias hope for and at times realize opportunities to work together. USP has been particularly vigorous in these activities in this cycle, reflecting the intent of prior Convention
November 2009
resolutions. Another harmonization opportunity has arisen through a pilot currently being conducted by USP and EDQM, known as “prospective harmonization,” in which a manufacturer works with USP and EDQM simultaneously on the development of a monograph and accompanying reference standard. The advantage of this approach is that a monograph would at least be harmonized between the European Pharmacopoeia and USP from the outset, avoiding the difficult process of attempting to harmonize such standards after the fact. In addition, because manufacturers benefit from obtaining a harmonized monograph through a single process, they may be willing to provide the necessary information and materials for such monograph and reference standards at an earlier stage in the life of the product. Although, again, it is far too soon to tell whether this new approach will be successful in significantly accelerating the development of harmonized monographs. Early phases of the pilot have proceeded well. Harmonization with lessdeveloped pharmacopoeias may also be advanced through USP’s “adopt/adapt” approach. Under this activity (started in the 1990s with plans to reinvigorate the general approach), USP permits pharmacopoeias in regions with limited resources to incorporate USP monographs and general chapters in their own pharmacopoeias as they see fit. While the primary purpose of this initiative is to help these countries develop better standards for use with their domestic manufacturers and raise the standard of quality in these regions, it may also result in de facto harmonization between USP and other pharmacopoeias. 4. Modern Measurment Science: In recent years, USP’s standard development activities have been aided by its growing understanding and application of measurement science— termed “metrology.” Metrology is the science of measurement and embraces both legal and fundamental aspects. The
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societal agreement created by Congress between FDA and USP relies on metrology, which in this context helps assure that a material is fit for its intended use; i.e., that a medicine may be used suitably by practitioners and patients to maintain health and treat disease. Today, modern measurement science undergirds the tests, procedures, and acceptance criteria in USP’s standards. Metrology originally was driven by needs of commerce, and commerce still is the major motivation for legal aspects of metrology. Fundamental metrology is of more academic interest and involves the establishment and realization of measurement units (such as the International System of Units or SI), research into new measurement methods, the development of measurement standards, and the transfer of metrological traceability throughout a measurement system. A country’s national metrology institute—in the United States, the National Institute of Standards and Technology—typically has statutory responsibility for a nation’s measurement system, including the advancement and maintenance of the nation’s primary standards. The interface of legal metrology and fundamental metrology is often called “applied metrology,” which concerns the application of measurement science to manufacturing, ensuring the suitability of measurement instruments, their calibration, and quality control of measurements. The Convention’s official compendia, USP and NF, represent the application of applied metrology, which includes both legal and fundamental metrology. Through staff and Council of Experts’ activities, the Convention has worked to enhance metrological science in USP. In part, the way has been made easier by a general movement of national drug control laboratories (official medicines control laboratories) towards International Organization for Standardization (ISO) 17025 and other standards. These standards encourage traceability of results to enhance
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consistency and reliability of measurements. A specific example of the Convention’s use of applied metrology is release of a certified reference material as an official USP Reference Standard by the Council of Experts Reference Standard Committee. Such certified reference materials may result in a better understanding of repositories of reference materials at the global (global primary), regional (regional primary), national (national primary), and manufacturer (secondary, house, or working standards) levels and their respective uses to assess the quality of drugs in global commerce. They also allow manufacturers, regulators, and others to compare results across different procedures—a critical task now with supplier-purchaser relationships in question—and also assess contributions of manufacturing and analytical variability to avoid “out of specification” results. Determining “Quality” Medicines: Concepts of Adulteration and Identity: In some respects, issues of adulterated or substandard medicine — and the challenges USP faces in trying to address these through compendial standards—are far from new. Even in the earliest edition of the USP, the presence of a recipe to assure consistency in the quality of what we would now term a “compounded medicine” could not protect against the possibility of a medicine that might be deemed unacceptable or adulterated. Efforts to protect patients gained great force in Congressional decisions of the early 20th century as the Federal government sought ways to remove medicines from the market that were unsafe, ineffective, and/or of substandard quality. Congress relied on the terms “adulteration” and “misbranding” in the FDCA, and it is in these provisions that USP and NF are specifically recognized as official compendia of the United States as a means of assessing adulterated or misbranded products. In modern terms, USP’s standards speak to the identity of a medicine, as well as its strength, quality,
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and purity—terms now comprised, through harmonization, under the overarching term “quality.” Our understanding of identity insofar as it relates to a medicine, its ingredients, and its packaging is rapidly evolving based on the science of spectroscopy. The use of both identity testing and spectroscopy to help combat today’s problems of substandard and intentionally adulterated drugs is addressed below. 1. Adulteration: Over the years, many countries around the world, including the United States have been challenged by economically motivated adulteration. Examples include melamine in pet food and infant formula, oversulfated chondroitin sulfate in heparin, and diethylene glycol in glycerin. Such instances involve the deliberate substitution of a less costly substance for a more expensive one, resulting in patient harm and even death. USP’s role in helping to address these challenges stems from its legal recognition and the requirement under the FDCA that medicines meet the identity, strength, quality, and purity standards in USP relative to an established name, as discussed more fully below. Even a well manufactured medicine may at times fail these standards and must be removed from the marketplace or risk a claim of adulteration. The approach is used daily by manufacturers (first parties), and information about it is often publicly available at www.fda.gov/Safety/Recalls/ default.htm. The public-private partnership established by Congressional and Convention forebears a century ago thus works still today—quietly and without notice—when a manufacturer tests a batch to assure it meets requirements in USP or withdraws a drug from the marketplace when it does not. The matter becomes more challenging when manufacturers themselves may unknowingly or, worse, intentionally adulterate a medicine or its ingredients. Work at FDA and in the Convention is advancing approaches that rely on identity standards to reduce the
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likelihood of economically motivated adulteration. Placement of limits on known adulterants in the Identification test of a USP monograph requires manufacturers of a medicine to test to assure absence of the adulterant prior to use of a material in manufacturing. The approach relies on knowledge of the adulterant and thus is limited to known examples. Unfortunately, there are many other materials that might be used to adulterate a medicine, either for economic or other motivations, which at this time remain unknown. 2. Identity Provisions in the FDCA: Identity standards (and related tests and reference standards) play an important role in defining or characterizing what is meant by a “drug” as defined in USP. The identity component of a compendial standard is distinct from the array of specifications related to strength, quality, and purity. Identity may not legally vary from the USP specifications, although strength, quality, and purity can, if a medicine is appropriately labeled. The 1906 Pure Food and Drug Act first officially recognized the role of USP standards for strength, quality, or purity in terms of defining when a drug would be deemed to be adulterated. The 1938 FDCA built on the 1906 Act with Section 501(b), which contains the more extensive, two-part, modern, USP-related provisions related to adulteration: 501(b) - “If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, . . . .” FDCA 501(b). The first section (underlined) creates an implicit compendial role in establishing standards for identity (i.e., is
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it, or is it not, the drug addressed in the compendium?). The second section (italicized) includes the explicit compendial role for standards related to strength, quality and purity (i.e., whether the drug measures up in terms of various quality parameters). FDA regulations subsequently established an important and unambiguous role for compendial standards of identity, and reflect the interconnection between the naming and identity authority in FDCA [at 502(e)] and the compendial adulteration standards [at 501(b)]. Part 299 of the Code of Federal FDA regulations concerns official and established names. One subsection in particular addresses the role of compendial naming and identity requirements, as well as other compendial standards; it has remained unchanged in FDA regulations since Part 299 was first promulgated in 1975 (40 Fed. Reg. 14041, March 27, 1975). Under FDCA and in Part 299, a drug with a name recognized in USP must comply with compendial identity standards or be deemed adulterated, misbranded, or both. Such drugs may vary in terms of strength, quality, or purity, if truthfully labeled [per FDCA 501(b)], but they may not vary from the compendial identity specified for such a drug. As noted above, USP has worked with FDA to leverage this distinctive role of identity standards to address recent cases of intentional adulteration. These recent efforts reaffirm the value of the public-private partnership created in law and reinforce the ongoing importance of public standards in today’s environment. 3. The Role of Spectoscopy: Identity frequently relies on use of portions of the electromagnetic spectrum to “see” an article —just as humans recognize each other (relative to their established names) by sight —which relies on the visible portion of the electromagnetic spectrum. For well-manufactured medicines, USP has long allowed the use of infrared (IR) spectra as a means of
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establishing identity in the USP Identification test (General Chapter <197> Spectrophotometric Identification Tests). And spectral images (photographs) have long been used by practitioners to identify medicines, e.g., Physician Desk Reference (PDR) photographs. Modern analytical instrumentation offers the opportunity to use far larger portions of the electromagnetic spectrum and with modern informatics and hand-held devices can now bring identity tests to any site on the globe for screening purposes. Using near-IR instrumentation, China’s government has led the way in the use of mobile vans and personnel to utilize this technology to check for counterfeit and substandard medicines. USP has considered using Raman spectroscopy to assess identity in the field, and pharmaceutical manufacturers have built non-public spectral libraries to allow rapid identification of incoming materials. Results typically require confirmation via more in-depth laboratory studies—as with the eye, instrumentation recognizes what it has seen before. Consequently, identification of materials used to adulterate for economic or other purposes require additional study. But even here, understanding of likely adulterants would pave the way for spectral libraries using repositories of likely and potentially dangerous adulterants. For episodes of intentional adulteration, such as the production of fake medicines (counterfeits), rapid reporting systems might allow the detection of outbreaks of poor quality manufacturing, just as we now identify outbreaks of infectious disease. Thus, scientific advances in instrumentation and informatics, linked with repositories of spectral images of legally marketed medicines (and their ingredients and packaging), coupled with spectral images of undesirable materials and medicines, allow understanding of identity in ways that would have amazed Convention forbears 100 years ago. At the same time, the use of “sight” to establish the identity of a medicine and its ingredients would have been entirely
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comprehensible to them. USP intends to continue the exploration of spectral libraries as a potentially important weapon in the ongoing global battle against adulterated and substandard medications. Conclusion: This white paper suggests several avenues that might be pursued to help resolve current deficiencies in the availability of public monographs and reference materials, promote compendial harmonization, advance the availability of good quality medicines, and detect and deter adulterated (counterfeit/substandard) medicines. The basic approach remains the concept of a public monograph containing product standards for all legally marketed medicines and their ingredients, allied with publicly available reference materials. The procedures of the monograph would be clearly linked to and supported by global, regional, national, and manufacturer reference materials for both the medicine (drug product) and its ingredients and their packaging. Availability of this material would allow comparisons across procedures and yield results, where feasible, traceable to SI units. Public reference materials would be a public repository of chemicals and mixtures of chemicals reflective of legally marketed medicines and their ingredients. The repository would also include likely adulterants. The materials of the repository would be associated with spectral images drawn from the electromagnetic spectrum to allow screening to assure identity and to detect and deter adulterants. Many aspects of the approach are transformational. Yet none are beyond current scientific capability, nor would the general approach require major changes in policy, with possibly the exception of adjustment in barriers to the availability of reference materials. While full expression of the concept might await stronger global institutions, the approach could be implemented now nationally or regionally. The USP Convention might be a major advocate
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for advancing the general approach, working on the assumption that the Convention itself supports public standards for medicines and their ingredients—in the 21st century as it did in the 19th and 20th centuries—and recognizes the value of such standards in assuring patients and practitioners of good quality medicines. About USP and NASPA At its core, the United States Pharmacopeial Convention (USP) is a standards-setting organization with an important national history and gathering recognition around the world. The USP leadership has transformed the organization in remarkable ways in the last decade and will depend on the wisdom and the will of its member organizations to help guide it into the future - a future that promises to be equally amazing and challenging. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us
Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.
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Continuing Education for Pharmacists Quiz and Evaluation USP’s Role in Setting Enforceable Quality Standards for Medicines 1. What percentage correctly represents the USP Monograph status for articles with newly acquired monographs that are not official? a. 4% c. 34% b. 10% d. 52%
6. Which year did the Pharmacopoeial Discussion group begin? a. 1980 c. 2000 b. 1989 d. 2009 7. In “prospective harmonization” USP works simultaneously with which of the following? a. European Department for the Quality of Medicine and Health Care (EDQM) b. World Health Organization (WHO) c. Pharmacopoeial Discussion Group (PDG) d. Food and Drug Administration (FDA) 8. Which of the following is true regarding “metrology?” a. It is not considered a science, but a measurement b. It was originally driven by the needs of commerce c. It embraces only legal aspects d. It embraces only fundamental aspects 9. An example of adulteration is: a. Melamine in pet food b. Oversulfated chondroitin sulfate in heparin c. Diethylene glycol in glycerin d. All of the above 10. Which of the following can NOT legally vary from the USP specifications? a. Strength c. Quality b. Identity d. Purity
2. Which type of alternative monograph development pathway moves away from the “one size fits all” approach? a. Performance based monograph b. Pending monograph c. Flexible monograph d. Non-U.S. monograph 3. The pending monograph approach is particularly applicable to which of the following? a. Single source manufacturers b. Multi source manufacturers c. Regulatory authorities d. Purchasers 4. Which of the following would need to be harmonized under compendial harmonization? a. Tests b. Acceptance criteria c. Procedures d. A and B 5. Who has been the primary mechanism for compendial harmonization? a. European Department for the Quality of Medicine and Health Care (EDQM) b. World Health Organization (WHO) c. Pharmacopoeial Discussion Group (PDG) d. Food and Drug Administration (FDA)
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2009 - 2010 GPhA BOARD OF DIRECTORS
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The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2009, 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.
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