Drug Surveillance Utilizing Epidemiologic Methods a Report from the Boston Collaborative Drug Surveillance Program

Abstract

General findings from an ongoing epidemiologic study of clinical drug effects are reported. Specially-trained monitors stationed on medical wards in nine hospitals record informatibn on cpnsecutively admitted patients. Data are collected on patient characteristics, diagnoses, therapeutic effects of all dnigs, dosage, duration of therapy and adverse reactions. About one-third of all drugs were prescribed as symptomatic therapy in most wards. About 12% of the rated drug exposures resulted in an unsatisfactory therapeutic response according to the prescribing physician. In about 6% of all drug exposures and 28% of all patients, adverse reactions occurred. About 10% of the adverse reactions were classified as being of major severity. In about 4% of the patients, an adverse drug reaction either caused or strongly influenced hospital admission. Drug surveillance by the epidemiologic methods described in this report has proven to be a useful tool for determining the frequency of adverse drug reactions, detecting and evaluating drug interactions, discovering unsuspected adverse drug reactions and investigating factors which influence drug efficacy and toxicity.