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Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
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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

Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×

 

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

Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×

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

Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×

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

Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×

 

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

Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×
Page 53
Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×
Page 54
Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×
Page 55
Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×
Page 56
Suggested Citation:"A Workshop Agenda." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.
×
Page 57
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Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during premarket studies, but also about the responsibility for ongoing surveillance of drugs once they are on the market. Sometimes serious adverse drug reactions are fully appreciated only after a drug has been on the market for years. Therefore, when a drug is approved and released to the market, large numbers of patients will be exposed before all the potential adverse effects have been identified and thoroughly studied. Currently, there is no clearly defined process for addressing safety questions about drugs after premarketing research has occurred.

In November 2005, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation convened a workshop to explore issues associated with the reporting of ADEs. The workshop addressed the following questions: How can ADEs be effectively identified, particularly when the adverse effects are rare? How can the direct, causal effects of drugs be distinguished from simple associations? How can health-care professionals and their patients' aid in the identification of drug-related adverse events? How can knowledge of ADEs be more effectively used in clinical practice?

Adverse Drug Event Reporting reviews current sources of information on adverse drug events, including the FDA's MedWatch program and the AERS, institutional review boards, and the CMS. This report considers the ways that consumers and advocacy groups can be involved in reporting adverse events, and discusses drug interactions, problems with current databases for capturing and evaluating interactions, and difficulties in communicating information about adverse drug interactions. This report also describes new requirements for information contained on drug labels and how labels can be used to communicate information about risks and drug interactions to consumers and practitioners.

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