Code of Medical Ethics Opinion 8.8

Physicians’ professional commitment to advance scientific knowledge and make relevant information available to patients, colleagues, and the public carries with it the responsibility to report suspected adverse events resulting from the use of a drug or medical device.

Mandated pre- and post-marketing studies provide basic safeguards for public health, but are inherently limited in their ability to detect rare or unexpected consequences of use of a drug or medical device. Thus spontaneous reports of adverse events, especially rare or delayed effects or effects in vulnerable populations are irreplaceable as a source of information about the safety of drugs and devices. As the professionals who prescribe and monitor the use of drugs and medical devices, physicians are best positioned to observe and communicate about adverse events.

Cases in which there is clearly a causal relationship between use of a drug/device and an adverse event, especially a serious event, will be rare. Physicians need not be certain that there is such an event, or even that there is a reasonable likelihood of a causal relationship, to suspect that an adverse event has occurred. A physician who suspects that an adverse reaction to a drug or medical device has occurred has an ethical responsibility to:

  1. Communicate that information to the professional community through established reporting mechanisms.
  2. Promptly report serious adverse events requiring hospitalization, death, or medical or surgical intervention to the appropriate regulatory agency.
AMA Principles of Medical Ethics: I, V, VII

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