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Opinion 9.032 - Reporting Adverse Drug or Device Events

A physician who suspects the occurrence of an adverse reaction to a drug or medical device has an obligation to communicate that information to the broader medical community, (eg, through submitting a report or letter to a medical journal or informing the manufacturer of the suspect drug or device). In the case of a serious adverse event, the event should be reported to the Food and Drug Administration (FDA). Spontaneous reports of adverse events are irreplaceable as a source of valuable information about drugs and medical devices, particularly their rare or delayed effects, as well as their safety in vulnerable patient populations. Although premarketing and mandated postmarketing studies provide basic safeguards for the public health, they suffer from inherent deficiencies that limit their ability to detect rare or unexpected consequences of drug or medical device use. Physicians who prescribe and monitor the use of drugs and medical devices constitute the group best able to observe and communicate information about resulting adverse events.

Serious adverse events, such as those resulting in death, hospitalization, or medical or surgical intervention, are the most important to report and are the only adverse events for which the FDA desires a report. Certainty, or even reasonable likelihood, of a causal relationship between the drug or medical device and the serious adverse event will rarely exist and is not required before reporting the event to the FDA. Suspicion of such a relationship is sufficient to give rise to an obligation to participate in the reporting system. (I, V, VII)

Issued June 1993 based on the report "Reporting Adverse Drug and Medical Device Events," adopted June 1993; Updated June 1994 (Food & Drug Law J. 1994;49:359-66).