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August 26, 1968

Assessment of Adverse Reactions Within a Drug Surveillance Program

Author Affiliations

From the Division of Clinical Pharmacology, Lemuel Shattuck Hospital, and the Department of Medicine, Tufts University School of Medicine, Boston.

JAMA. 1968;205(9):645-647. doi:10.1001/jama.1968.03140350055016

As part of a comprehensive drug surveillance program, we devised a system for identifying and characterizing adverse reactions to drugs. The overall program includes measurements of drug efficacy and a description of the patient population being studied. The data collected thus far suggest that drug reactions represent a major health hazard. Adverse reaction information on any drug must be evaluated for careful consideration of total drug usage, the reasons for prescribing the drug, and its overall efficacy.