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.
Borda IT, Slone D, Jick H. Assessment of Adverse Reactions Within a Drug Surveillance Program. JAMA. 1968;205(9):645–647. doi:10.1001/jama.1968.03140350055016
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