Workshop- and Telephone-Based Interventions to Improve Adverse Drug Reaction Reporting
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ORIGINAL RESEARCH ARTICLE
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Workshop- and Telephone-Based Interventions to Improve Adverse Drug Reaction Reporting A Cluster-Randomized Trial in Portugal Maria Teresa Herdeiro,1,2,3,4 Ineˆs Ribeiro-Vaz,1,2 Mo´nica Ferreira,4 Jorge Polo´nia,1 Amı´lcar Falca˜o5,6 and Adolfo Figueiras7,8 1 Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto, Porto, Portugal 2 Centre for Health Technology and Information Systems Research (Centro de Investigac¸a˜o em Tecnologias e Sistemas de Informac¸a˜o em Sau´de – CINTESIS), Porto, Portugal 3 Health Technology Research Centre (Centro de Investigac¸a˜o em Tecnologias da Sau´de – CITS), IPSN-CESPU, Gandra, Portugal 4 Centre for Cell Biology, University of Aveiro, Aveiro, Portugal 5 Centre for Neuroscience and Cell Biology – CNC, University of Coimbra, Coimbra, Portugal 6 Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal 7 Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain 8 Consortium for Biomedical Research in Epidemiology and Public Health (CIBER en Epidemiologı´a y Salud Pu´blica – CIBERESP), Barcelona, Spain
Abstract
Background: Spontaneous reporting of adverse drug reactions (ADRs) is the method most widely used by pharmacovigilance systems, with the principal limitation being the physician’s underreporting. Objective: This study sought to evaluate the results of workshop and telephone-interview interventions designed to improve the quantity and relevance of ADR reporting by physicians. Methods: A cluster-randomized controlled trial was conducted on 6579 physicians in northern Portugal in 2008. Following randomization, we allocated 1034 physicians to a telephone-interview intervention, 438 to a workshop intervention and the remaining 5107 to the control group. At the workshop, a real clinical case was presented and participants were then asked to report on it by completing the relevant form. In the telephone intervention, participants were asked (i) whether they had ever had any suspicion of ADRs; (ii) whether they had experienced any difficulties in reporting; (iii) whether they remembered the different methods that could be used for reporting purposes; and (iv) whether they attached importance to the individual physician’s role in reporting. We followed up physicians to assess ADR reporting rates to the Northern Pharmacovigilance Centre. In terms of relevance,
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adverse reactions were classified as serious or unexpected. Statistical analysis was performed on an intention-to-treat basis, and generalized linear mixed models were applied using the penalized quasi-likelihood method. The physicians studied were followed up over a period of 20 months. Results: Two hundred physicians underwent the educational intervention. Comparison with the control group showed that the workshop intervention increased the spontaneous ADR reporting rate by an average of 4-fold (relative risk [RR] 3.97; 9
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