FDA-State Projects to Improve Reporting of Adverse Drug Reactions

Abstract

In an effort to understand physician behavior in reporting adverse drug reactions (ADRs) and to assess ways to improve direct reporting of ADRs, the FDA initiated a contract research program through state health departments in 1985. Maryland and Rhode Island were awarded the first two pilot test contracts to survey physicians' existing attitudes and to design interventions to promote and increase ADR reporting. To investigate the feasibility of increasing ADR reporting within hospitals, a third pilot contract was awarded to Mississippi in 1986. In 1987, Massachusetts and Colorado were awarded contracts to use and build on the interventions developed by the first three states. The program has been successful in stimulating the reporting of ADRs by physicians. However, ongoing interventions are needed to sustain the higher reporting rates. Ideally, five to six ADR reporting centers in different geographic regions should be established nationally.