Postmarketing Surveillance of Drugs

Most efforts in postmarketing surveillance are directed at the design of methods to collect information on newly marketed drugs. In the review by Medicine in the Public Interest the majority of fatal adverse reactions seemed to be due to older, standard drugs. Irey reported on a review of 827 fatalities from adverse drug reactions of which he classified 220 as adverse drug reaction "in the usual sense." The leading 10 drugs involved were introduced between 1899 and 1962. These points will be discussed in detail in the following paragraphs: Postmarketing surveillance would be better named "systematic postmarketing drug evaluation." Surveillance suggests a specific study method, whereas multiple complementary methods are required. Perhaps one of the most important and least recognized reasons for systematic evaluation of the customary use of drugs is the current failure to exploit the cumulative experience of the many practitioners of medicine.