Postmarketing surveillance of adverse drug reactions: patient self-monitoring.

BACKGROUND This report summarizes our experience with a new approach to postmarketing drug surveillance using a pharmacy-based patient self-monitoring strategy, developed in collaboration with Eckerd Drug Company, the American Association of Retired Persons Pharmacy Service, and other pharmacies nationwide. METHODS Patients presenting prescriptions to collaborating pharmacies for a targeted drug or a standard drug used as a control received an entry form asking them to register and then call a toll-free telephone number to report possible drug reactions. When contacted by patients, study staff conducted a standardized, computer-driven interview. Two brief mail questionnaires were also employed. RESULTS Original validation data gathered from 1984 through 1986 indicated that the most commonly expected adverse drug reactions caused by antibiotic and tricyclic antidepressants reported by 162 self-monitoring patients closely matched those elicited from a comparable control sample of 1109 patients who were independently interviewed by our staff. Results from subsequent studies are also described. CONCLUSIONS We believe this method has great promise for providing not only a cost-effective, complementary, early alerting mechanism for detecting adverse drug reactions, but also the additional possibility for discovering unsuspected therapeutic benefits of newly marketed drugs.