Guidelines for decision making in postmarketing surveillance of drugs

At the time a drug is marketed, its full safety profile has not yet been elucidated. Currently, the FDA's informal spontaneous reporting system (SRS) monitors adverse experiences in the general population. The passive SRS, however, detects but does not evaluate adverse drug effects. Conversely, complete formal postmarketing surveillance examining thousands of persons using a prospective cohort design is restricted by cost and logistics. Therefore, the need exists for guidelines that focus on the process of deciding whether or not to conduct a formal postmarketing project. Thirty-eight experts in the field were surveyed in three separate mailings to generate a set of guidelines that could be used as a framework for decision making related to the type and extent of postmarketing surveillance that may be of benefit with a newly-marketed drug. Use of these guidelines shouls allow rational, well-balanced decisions to be made.