Promoting adverse drug reaction reporting: comparison of different approaches

• Main Authors: Inês Ribeiro-Vaz, Cristina Costa Santos, Ricardo Cruz-Correia
• Format: Article
• Language: English
• Published: Universidade de São Paulo 2016-01-01
• Series: Revista de Saúde Pública
• Subjects: Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos; Controle de Formulários e Registros; Monitoramento de Medicamentos; Sistemas de Notificação de Reações Adversas a Medicamentos; Farmacovigilância
• Online Access: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0034-89102016000200212&lng=en&tlng=en

ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.