Improving the reporting of adverse drug reactions - A cluster-randomized trial among pharmacists in Portugal

• Type: Article in International Scientific Journal
• Date: 2008

Authors

Maria T Herdeiro (Author) Other; Jorge Polonia (Author) FMUP; Juan J Gestal Otero (Author) Other; Adolfo Figueiras (Author) Other

Journal

Title: Drug Safety

Vol. 31

Pages: 335-344

ISSN: 0114-5916

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 39 Citations

Scopus - 38 Citations

Scientific classification

FOS: Medical and Health sciences > Basic medicine

Other information

Authenticus ID: P-004-32B

Abstract (EN): Background: Adverse drug reaction (ADR) reporting systems are the basic component for comprehensive postmarketing surveillance of the risk of drug-induced adverse effects. The aim of this study was to evaluate the effectiveness of educational outreach visits aimed at improving ADR reporting by pharmacists. Methods: The study population comprised all pharmacists working in a catchment area covered by Portugal's Northern Regional Health Authority. Using unequal randomization, four spatial-clusters were assigned to the intervention group (n = 342) and eleven to the control group (n = 1091). The intervention took the form of I-hour long educational outreach visits tailored to training needs detected in a previous study, with a 13- to 16-month follow-up period (March-June 2004 through June 2005). This study is registered as an international standard randomized controlled trial, number ISRCTN45894687. Results: At baseline, ADR reporting rates (per 1000 pharmacist-years) did not differ significantly between the intervention and control groups (32.28 vs 29.16). The adjusted increase in ADR reporting attributable to the intervention was 275.63 per 1000 pharmacist-years (95% CI 162.15, 389.12; relative risk [RR] = 5.87, 95% CI 1.98, 17.39). The intervention succeeded in multiplying the reporting rate of: serious ADRs, 10-fold (RR = 9.79; 95% CI 2.24, 42.66); unexpected ADRs, 4-fold (RR =4.41; 95% CI 1.11, 17.53); high-causality ADRs, 9-fold (RR = 8.67; 95% CI 2.12,35.42); and new drug-related ADRs, 9-fold (RR = 9.33; 95% CI 2.53, 34.40). While the greatest effect was registered during the first 4 months post-intervention, differences remained statistically significant for 8 months. Conclusions: Educational outreach visits improve ADR reporting by pharmacists in terms of quantity and relevance.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 10