Avaliação da implantação de busca ativa de reações adversas a medicamentos com auxílio de ferramentas informatizadas

Abstract

The objective of this study was to assess the implementation of adverse drug reactions (ADR) active surveillance strategies using computerized tools in a pharmacovigilance program of a large private hospital. The study was developed in three phases: I. implementation of the pharmacovigilance service (passive surveillance – intensified voluntary notification); II. active surveillance based on managerial reports of consumption of tracer drugs; III. active surveillance based on the content of forms that were filled out in the electronic system whenever a tracer drug was prescribed. All the ADR detected by the pharmacovigilance service for three and a half years (n = 542) were analyzed. The difference between the ADR/100 patients-day was analyzed by the comparison of two proportions, with a 5% significance level and power of 80%. The rate of ADR/100 patient-day identified in phase II and III (0.26 and 0.15, respectively), that is, after the implementation of computerized tools, was higher than the rate detected in phase I (0.10). The difference between the proportions was statistically significant. The majority of ADR identified presented moderate severity (69%), and an increase in this proportion was observed after the implementation of computerized tools. Regarding the causality assessment, 83.6% of the identified ADR was classified as “possible causality”. The implementation of active surveillance using computerized tools provided a statistically significant increase in the identification of ADR identification, reinforcing the need to intensify such pharmacovigilance strategies.