RT Journal Article
SR Electronic
T1 Postmarketing Surveillance Of Adverse Drug Reactions: Patient Self-Monitoring
JF The Journal of the American Board of Family
                Practice
JO J Am Board Fam Med
FD American Board of Family Medicine
SP 17
OP 25
DO 10.3122/jabfm.5.1.17
VO 5
IS 1
A1 Fisher, Seymour
A1 Bryant, Stephen G.
YR 1992
UL http://www.jabfm.org/content/5/1/17.abstract
AB 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.