Post-marketing surveillance: drug epidemiology.

A description of the need for and appropriateness of a multi-component application of epidemiological methods to the post-marketing evaluation of drugs is presented. There is a need for the development of the art and science of Drug Epidemiology. The large number of drugs introduced over the last 40 years and the number of interventions constitute an issue of public health interest. It is appropriate that scientifically sound information be collected about medications. There has been considerable discussion about the methods to be used in any such systematic approach. The choice of method is obviously dependent upon the questions to be addressed and the functions to be satisfied. The proposal is presented for the appropriate content functions of post-marketing drug evaluation, and a description of some and currently employed approaches show how they differentially satisfy the functions. It is concluded that there is a need for the development and application of multiple complementary methods to satisfy the requirements of a meaningful system for post-marketing drug evaluation.