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Despite the limitations of spontaneous reports, FDA's program for the surveillance of regulated medical product safety provides vital information of clinical importance. The identification of problems, and the subsequent dissemination of safety-related information to the clinical community at large, begins with reports from astute health professionals.
By viewing adverse event reporting as a professional responsibility, and recognizing that the quality of data generated from spontaneous reports is determined by the quality of the submitted information, health professionals can play a major role in improving the public health.
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