The Role of Consumers and Healthcare 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

Click Here to see a list of workshop attendees.

Thursday, November 3, 2005

8:30 am           Opening Remarks

                       Jeffrey M. Drazen, MD
                       New England Journal of Medicine

8:40 am           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). -- 10 minute presentations

                       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

                       Saira A. Jan, PharmD, MS
                       Horizon Blue Cross and Blue Shield
                       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. -- 10 minute presentations
  
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

1:00 pm          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? -- 10 minute presentations

                       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

Topic 2: Once a possible association is detected, how are cause and effect confirmed?  Are randomized controlled trials (RCTs) needed or is epidemiology adequate?  What is the role of regulators? How does one tease out single drug effects from drug-drug interactions? -- 10 minute presentations
  
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 

3:55 pm           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? -- 10 minute presentations

                       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

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

8:40 am           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? -- 10 minute presentations

                       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 minute presentations
  
10:00 am          A. Leander Fontaine, MD
                       Pharmiceutics LLC

                       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? -- 10 minute presentations
  
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

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