Strategies for increasing spontaneous Adverse Drug Reaction reporting rates among Portuguese pharmacists

Abstract

Background It is well known worldwide, that Adverse Drug Reactions (ADRs) are an important cause of morbidity and mortality in developed countries. In Portugal, as in many other countries, ADR reporting rate is rather low [1] , [2] , [3] , and as a consequence there is a lack of information being transmitted to the Medicines Regulatory Authority, which does not effectively represent the real number of adverse events. Objective Our aim was to increase the number and relevance of ADR reporting among pharmacists, with workshops and telephone interviews. Method We conducted a cluster-randomized controlled trial, among pharmacists working in the Northern region of Portugal. Results The ADR reporting rate increased 3-fold as a result of this action (RR=3.22; 95% CI 95%: 1.33–7.80) compared with the control group, during the studied period. Besides, the relevance of ADR reported was also increased. In fact, serious ADR reports increased 4-fold (RR=3.87; 95% CI: 1.29–11.61) and unexpected ADR reports increased 5-fold (RR=5.02; 95% CI: 1.33–18.93), compared with the control group. Conclusions Educational interventions are efficient in increasing the ADR spontaneous reporting rate, among Portuguese pharmacists. Among this professional group, workshops are as efficient as telephone interview to improve ADR spontaneous reporting.