EVALUATION OF THE IMPLEMENTATION OF COMPUTERIZED TOOLS FOR ADVERSE DRUG REACTIONS ACTIVE SURVEILLANCE

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.