Abstract

ABSTRACTOBJECTIVE 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.

Highlights

  • Adverse drug reactions (ADR) are inherent to medicine use[20], and most of them can only be detected after the commercialization of the drug[14]

  • The increase applied to the total number of reports, and to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions

  • We found an increasing trend in the number of ADR reports received by the Northern Pharmacovigilance Centre during the studied period: 2000-2012

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Summary

Introduction

Adverse drug reactions (ADR) are inherent to medicine use[20], and most of them can only be detected after the commercialization of the drug[14]. It is difficult to predict the drug effect among special populations (pregnant women, children, older adults), as they usually do not participate in the clinical research. Because of these limitations, post-marketing surveillance is essential, which is why most countries have pharmacovigilance centers to monitor detected ADR. The fundamental tool used by these centers is the spontaneous reporting of ADR by healthcare professionals and consumers This method consists in describing an adverse episode suspected to be caused by one or more drugs and provides valuable information to the regulatory health authorities, which is important for the decisions about marketed medicines. Many approaches have been completed to fight the major problem of ADR underreporting, such as regular visits to health professionals[10], questionnaire studies[2], educational interventions (including workshops, meetings and presentations)[4,12,16], among others

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