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?


Since the FDA has limited options for addressing safety questions about drugs after premarketing research has occurred, identifying ADEs requires the participation of health-care providers, consumers, and others. MedWatch, the FDA’s program for postmarket surveillance, collects clinical information involving drugs from health-care professionals and consumers through a variety of channels, including mail, Internet, and telephone. The largest source of postmarket information on ADEs is drug companies themselves. Companies typically submit large numbers of reports at a time in batch form to the FDA. Data on adverse events are placed in the AERS, and are evaluated by FDA staff to detect safety signals and monitor drug safety.

Potential adverse events are also identified through case reports in the medical literature and through epidemiologic surveillance of electronic claims and other data. Surveillance systems screen claims data for adverse events and notify health-care providers who then determine if follow-up reporting is required. The Centers for Medicare and Medicaid Services captures data on drug use and clinical services for individual subscribers. And institutional review boards of individual health systems capture many adverse events in clinical trials.

Challenges associated with current systems for reporting ADEs were discussed by workshop participants. Underreporting and incomplete reporting and poor quality of data are concerns about all reporting systems. There have been suggestions that streamlining these systems and ensuring anonymity may motivate health-care providers to file adverse event reports with greater frequency and accuracy. Participants discussed the need for incentives to encourage the development of long-term safety studies. Furthermore, it was suggested that informing consumers about known drug risks and benefits may encourage consumer reporting of ADEs and participation in follow-up studies.

The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001

Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement