Alerta de reação adversa a medicamento: elaboração e avaliação de uso de instrumento

Abstract

Introduction: The emergence of new diseases and new drugs makes pharmacovigilance increasingly visible. Spontaneous reporting by health professionals and users is the method traditionally used in pharmacovigilance. However, other more effective tools for detecting Adverse Drug Reactions (ADRs) have been developed and used by several institutions worldwide. One of these methods is the trigger tool that can identify up to ten times more ADRs than the traditional voluntary reporting method. Objectives: To develop and test an active search tool for ADRs based on triggers, and to describe the spontaneous Pharmacovigilance notifications performed in the institution. Methods: A study using different methodologies conducted in two stages at university hospital Cassiano Antônio Moraes in Vitória, Espírito Santo, whose analysis period was from January 2020 to December 2021. First, an observational, cross-sectional, retrospective study was developed that involved the analysis of spontaneous Pharmacovigilance notifications. Then, a methodological research was conducted with the creation and testing of the active search instrument from the retrospective review of 40 medical records. Results: After the analysis of the 426 notifications, it was noted the registration of 14 related to ADR, which motivated the development and testing of the active search instrument. For this, 40 randomly selected medical records from July and September 2021 were considered. The positive predictive value (PPV) found corresponded to 15 ADRs per 100 medical records. An average of 2.25 triggers per medical record was found and 4 triggers were positive to identify 6 suspected ADRs. Final considerations: The developed tool proved feasible to be regularly used by health professionals to measure adverse reactions, and may be extended to the active search for other Adverse Drug Events (ADRs).