Monitoring adverse reactions to drugs: toward a therapeutic audit.

Abstract

Concern about adverse reactions to drugs was first apparent in the 19th century, but organizations for routine monitoring and the premarketing testing of drugs were first set up in the early 1960s following the thalidomide tragedy. Information about adverse drug reactions comes from many sources, including reports in the medical literature and reports to national monitoring organizations. The World Health Organization has played an important role both in developing computer systems for monitoring and in aiding international cooperation. Intensive hospital monitoring systems have been developed, but epidemiologic studies of adverse reactions in the community are in their infancy. It is important to consider the problem of adverse reactions in relation to the use of drugs in the community. Studies of patterns of drug use in Northern Ireland have been conducted and a working party of the World Health Organization has been set up to compare drug use in different countries. The epidemiologic study of adverse reactions to drugs, an important new field for clinical pharmacology, should be viewed as only a part of a much larger, more embracing discipline: the therapeutic audit.