An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial

JAMA : the Journal of the American Medical Association
Adolfo FigueirasJuan Jesus Gestal-Otero


Data on the adverse effects of newly marketed drugs are limited. Voluntary reporting is an important part of postmarketing surveillance but is underused by physicians. To evaluate the effectiveness of educational outreach visits for improving adverse drug reaction (ADR) reporting by physicians. A cluster-randomized controlled trial covering all National Health System physicians in the north of Portugal, with intervention in March 2004 through July 2004, and 13 to 16 months of follow-up. A total of 1388 physicians were assigned in 4 spatial clusters to the intervention group, and 5063 were assigned in 11 clusters to the control group. One-hour educational outreach visits tailored to training needs identified in a previous study. Change in total number of reported ADRs and number of serious, high-causality, unexpected, and new-drug-related ADRs, using generalized linear mixed models adjusted for baseline ADR reporting, age, specialty, and work setting. At baseline, ADR reporting rates (per 1000 physician-years) did not differ significantly between the intervention groups and the control groups in reporting ADRs overall (7.6 vs 11.3), nor did they differ significantly by category: serious, 4.3 vs 6.0; high-causality, 5.4 vs 7.6; u...Continue Reading

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