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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

8:30 am

Opening Remarks

 

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).

8:40 am

Daniel E. Troy, JD

Sidley Austin Brown & Wood LLP

 

Anne E. Trontell, MD, MPH

U.S. Food and Drug Administration

 

Richard Platt, MD, MS

Harvard Medical School



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OCR for page 53
Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary A 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 8:30 am Opening Remarks   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). 8:40 am Daniel E. Troy, JD Sidley Austin Brown & Wood LLP   Anne E. Trontell, MD, MPH U.S. Food and Drug Administration   Richard Platt, MD, MS Harvard Medical School

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary   Saira A. Jan, PharmD, MS Horizon Blue Cross Blue Shield of New Jersey Rutgers Ernest Mario School of Pharmacy 9:30 am Discussion 10:45 am Break Topic 2: Once rare event reports have been received, how to identify possible signal and distinguish it from noise. 11:00 am Anne E. Trontell, MD, MPH U.S. Food and Drug Administration   David Hunt, MD, FACS CMS Quality Improvement Group 11:20 am Discussion 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? 1:00 pm K. Arnold Chan, MD, ScD Harvard School of Public Health   Francesca Cunningham, PharmD U.S. Department of Veterans Affairs   Hershel Jick, MD Boston University Medical Center   Micky Tripathi, PhD, MPP Massachusetts eHealth Collaborative 1:50 pm Discussion

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary 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? 2:20 pm Ronald Krall, MD GlaxoSmithKline   Nancy C. Santanello, MD, MS Merck Research Laboratories   Robert Powell, PharmD U.S. Food and Drug Administration   Raymond L. Woosley, MD, PhD The Critical Path Institute   Alastair J. J. Wood, MD Vanderbilt Medical School 3:10 pm Discussion 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? 3:55 pm Marvin M. Lipman, MD, FACP Consumers Union   Michael Katz, MBA International Myeloma Foundation   Karen R. Cox, RN, PhD University of Missouri Health Care   Alison Rein, MS National Consumers League

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary 4:40 pm Discussion 5:00 pm Next Steps for the IOM Drug Forum 5:30 pm Adjourn Friday, November 4, 2005 8:30 am Opening Remarks   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? 8:40 am Jacob Abarca, PharmD, MS University of Arizona, College of Pharmacy   J. Russell Teagarden, RPh, MA Medco Health Solutions, Inc.   Scott Weingarten, MD, MPH Zynx Health   Sidney Kahn, MD, PhD Pharmacovigilance and Risk Management, Inc.   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? 10:00 am A. Leander Fontaine, MD Pharmiceutics LLC

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary   Rachel E. Behrman, MD, MPH U.S. Food and Drug Administration   Ed Staffa, RPh National Association of Chain Drug Stores   Cary Sennett, MD, PhD American Board of Internal Medicine 10:40 am Discussion 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? 11:15 am Peter Kilbridge, MD Duke University Health System   Stuart Levine, PharmD Institute for Safe Medication Practices 11:40 am Discussion 12:00 pm Next Steps for the IOM Drug Forum 12:30 pm Adjourn