identifying and balancing potential or actual risk with benefit as information develops over time.

The occurrence of ADEs and the role of consumers and health-care professionals in reporting these events prompted the Forum on Drug Discovery, Development, and Translation to convene a workshop to explore issues associated with reporting of ADEs and to identify actions to improve the drug safety system. 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?

The workshop took place on November 3 and 4, 2005, in Washington, D.C., and was chaired by Jeffrey Drazen, MD, Editor-in-Chief of the New England Journal of Medicine and Professor of Medicine at Harvard Medical School. The reader is referred to Appendixes A and B for the workshop agenda and speaker biographies. Section 2 reviews current sources of information on adverse drug events, including the FDA’s MedWatch program and the AERS, institutional review boards, and the CMS. Section 3 describes surveillance systems, surveillance technology, and data quality. Section 4 considers the ways that consumers and advocacy groups can be involved in reporting adverse events. Section 5 discusses drug interactions, problems with current databases for capturing and evaluating interactions, and difficulties in communicating information about adverse drug interactions. Section 6 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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