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ADVERSE DRUG REACTION REPORTS INCREASED 17-FOLD

Executive Summary

ADVERSE DRUG REACTION REPORTS INCREASED 17-FOLD in Rhode Island over a three-year period as a result of physician education programs, according to a study in the April 4 issue of the Journal of the American Medical Association. "By 1988, direct ADR [adverse drug reaction] reports" from the Rhode Island Adverse Drug Reaction Reporting Project to FDA had increased more than 17-fold from the pre-intervention average (1981 through 1985)," the study says. The study was conducted by FDA's Office of Epidemiology and Biostatistics and the Rhode Island Department of Health in Providence. Rhode Island was one of two states, along with Maryland, picked in September 1985 for a pilot program on direct physician original ADR reporting. Mississippi, Colorado and Massachusetts were later added to the program. To evaluate changes in reporting behavior, the project monitored the number and type of ADR reports and compared Rhode Island and U.S. rates per million population. An early 1986 preintervention survey of physicians had a 75.3% response rate; a 1988 follow-up survey that had a response rate of 69.2% evaluated changes in physicians' knowledge and attitudes about the ADR reporting system. Results of the study show that "from 1981 to 1985, direct reports averaged 11.6 per year (range, 3 to 22). By 1988, there were 201 direct reports, a 17-fold increase." These figures represent the total number of reports from Rhode Island received by the FDA from all sources including manufacturers. "By 1987, the number of reports from Rhode Island increased significantly over 1985 compared with the number from the U.S. as a whole," the study reports. From 1981 to 1985, Rhode Island submitted 0.4% of the 13,789 total direct adverse reaction reports received by the FDA, according to the study. By comparison, the study found that in 1988, the state reports "represented 3.5% of 5,814 total direct reports received by FDA, a percentage nine times higher than its proportion of the U.S. population," which is 0.4% based on 1985 census estimates. Reporting rates for "serious" ADRs were similar to those of direct reports. From 1981 through 1985, Rhode Island reports represented 0.4% of 3,444 serious reports received by the FDA. In 1988, the study found, the serious ADR reports received directly from Rhode Island "represented 3.6% of the 1988 total direct serious reports received by the FDA." Of those serious reports, the study notes, "31 received by the project through 1988 were of serious reactions not listed in the product labeling." The reporting forms, modeled on FDA's "Adverse Reaction Report" form 1639A, postage-paid and pre-addressed to the Department of Health, were distributed to physicians starting in June 1986. In August 1987, a telephone information and reporting line was set up for Rhode Island doctors. The project promoted the reporting system through various means of professional education, including direct mailings, presentations to physician groups, advertisements and articles in local medical periodicals. From June 1986 through September 1988, physicians received 12 separate mailings including report forms and information on reporting procedures. In the preintervention survey, 55% of respondents indicated they were familiar with FDA's ADR reporting system, and 39% said they were familiar with the specific reporting procedures. In the follow-up survey, 85% reported familiarity with the FDA/Department of Health ADR reporting system, and 69% were familiar with the reporting procedures.
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