The Massachusetts Adverse Drug Reacticn Project

Abstract

The Food and Drug Administration (FDA) has maintained a spontaneous voluntary system for the reporting of adverse drug events for over three decades. Based on the experience of the American Medical Association Registry for drug-related aplastic anemia, the current FDA spontaneous reporting system (FDA-SRS) was initiated in response to the public reaction to thalidomide induced phocomelia (1). A serious omission of the system has been a lack of focus on ADR observations by the health care provider. The Massachusetts Division of Food and Drugs was selected to participate in the pilot projects to promote reporting of adverse drug events. The Massachusetts Adverse Drug Reaction Project tried to increase the quantity and quality of adverse drug reaction reports filed by physicians. The basic focus of the project was to utilize various promotional mechanisms to convince providers that ADR reporting is an important public health safeguard. The project also attempted to facilitate access to reporting mechanisms.