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Workshop Agenda
Forum on Drug Discovery, Development, and Translation The Role of Consumers and Health-Care Professionals in Adverse Drug Event Reporting—Key Challenges and Opportunities
November 3–4, 2005
Phoenix Park Hotel
520 North Capitol Street, NW
Washington, DC 20001
Thursday, November 3, 2005
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8:30 am |
Opening Remarks |
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Jeffrey M. Drazen, MD New England Journal of Medicine |
RARE EVENTS AND NEW DRUGS
Topic 1: Recognition and reporting of adverse drug events by physicians including incentives and disincentives (e.g., rhabdomyolysis with statins; Churg-Strauss syndrome with anti-leukotrienes; liver failure with anti-diabetic drugs; opportunistic infections with immune modulators).
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8:40 am |
Daniel E. Troy, JD Sidley Austin Brown & Wood LLP |
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Anne E. Trontell, MD, MPH U.S. Food and Drug Administration |
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Richard Platt, MD, MS Harvard Medical School |
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Saira A. Jan, PharmD, MS Horizon Blue Cross Blue Shield of New Jersey Rutgers Ernest Mario School of Pharmacy |
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9:30 am |
Discussion |
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10:45 am |
Break |
Topic 2: Once rare event reports have been received, how to identify possible signal and distinguish it from noise.
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11:00 am |
Anne E. Trontell, MD, MPH U.S. Food and Drug Administration |
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David Hunt, MD, FACS CMS Quality Improvement Group |
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11:20 am |
Discussion |
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12:15 pm |
Lunch |
COMMON EVENTS AND THE MODULATION OF THEIR FREQUENCY BY DRUGS
Topic 1: It is possible that drugs can modify the frequency of occurrence of a relatively common event. How can these events be detected?
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1:00 pm |
K. Arnold Chan, MD, ScD Harvard School of Public Health |
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Francesca Cunningham, PharmD U.S. Department of Veterans Affairs |
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Hershel Jick, MD Boston University Medical Center |
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Micky Tripathi, PhD, MPP Massachusetts eHealth Collaborative |
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1:50 pm |
Discussion |
Topic 2: Once a possible association is detected, how are cause and effect confirmed? Are randomized controlled trials needed or is epidemiology adequate? What is the role of regulators? How does one tease out single drug effects from drug-drug interactions?
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2:20 pm |
Ronald Krall, MD GlaxoSmithKline |
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Nancy C. Santanello, MD, MS Merck Research Laboratories |
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Robert Powell, PharmD U.S. Food and Drug Administration |
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Raymond L. Woosley, MD, PhD The Critical Path Institute |
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Alastair J. J. Wood, MD Vanderbilt Medical School |
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3:10 pm |
Discussion |
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3:40 pm |
Break |
THE ROLE OF PATIENTS AND CONSUMERS IN THE ADVERSE EVENT REPORTING SYSTEM
Topic 1: How should consumers be involved in reporting adverse events? What training and organizational support are needed? How should patient advocacy groups be engaged?
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3:55 pm |
Marvin M. Lipman, MD, FACP Consumers Union |
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Michael Katz, MBA International Myeloma Foundation |
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Karen R. Cox, RN, PhD University of Missouri Health Care |
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Alison Rein, MS National Consumers League |
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4:40 pm |
Discussion |
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5:00 pm |
Next Steps for the IOM Drug Forum |
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5:30 pm |
Adjourn |
Friday, November 4, 2005
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8:30 am |
Opening Remarks |
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Jeffrey M. Drazen, MD New England Journal of Medicine |
DRUGS AND ADVERSE HEALTH EVENTS
Topic 1: Is there a comprehensive database of known drug-drug interactions? How is its quality assured? How are the data used? How do we capture events when there are likely multiple sources of drugs?
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8:40 am |
Jacob Abarca, PharmD, MS University of Arizona, College of Pharmacy |
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J. Russell Teagarden, RPh, MA Medco Health Solutions, Inc. |
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Scott Weingarten, MD, MPH Zynx Health |
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Sidney Kahn, MD, PhD Pharmacovigilance and Risk Management, Inc. |
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9:30 am Discussion |
Topic 2: Assuming that a database of adverse drug reactions exists (either rare events or common events that occur alone or as a result of drug-drug interactions), should this information be on a uniform drug label that separates adverse drug events and interactions by severity? How do we encourage physicians to use the information?
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10:00 am |
A. Leander Fontaine, MD Pharmiceutics LLC |
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Rachel E. Behrman, MD, MPH U.S. Food and Drug Administration |
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Ed Staffa, RPh National Association of Chain Drug Stores |
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Cary Sennett, MD, PhD American Board of Internal Medicine |
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10:40 am |
Discussion |
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11:00 am |
Break |
Topic 3: Are there electronic systems that can be used to prompt health care providers to look for adverse drug related events and warn against potential drug-drug interactions? How are these systems deployed?
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11:15 am |
Peter Kilbridge, MD Duke University Health System |
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Stuart Levine, PharmD Institute for Safe Medication Practices |
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11:40 am |
Discussion |
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12:00 pm |
Next Steps for the IOM Drug Forum |
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12:30 pm |
Adjourn |
