ABSTRACT
In the early 1960s, widespread use of thalidomide by pregnant women resulted in an epidemic of phocomelia, a previously rare birth defect. Although this problem was mainly centered in Europe, the response to this tragedy was worldwide. In the United States regulatory action was taken in the form of the 1962 Harris-Kefauver amendment to the Federal Pure Food and Drug Act. In order to satisfy the regulations and demonstrate drug safety and efficacy, pharmaceutical companies have come to largely rely on randomized clinical trials. The limitations inherent in previously attempted approaches to postmarketing surveillance of drugs suggest the need for alternative, innovative approaches to this problem. The identification of a potential problem prompts the notification of participating clinical pharmacists, thus increasing the index of suspicion. Case report forms specifically constructed to query outcomes of interest are developed and tested to ensure validity.
