Sob a lupa da segurança : uma investigação transversal sobre a farmacovigilância e a atuação do farmacêutico

Abstract

Introduction: Pharmacovigilance is strategic for patient safety and the rational use of medicines, with adverse drug reaction (ADR) reporting as its core component. In Brazil, Law No. 13,021/2014 sets out pharmacists’ ethical–legal duties in this process.Objective: To assess Brazilian pharmacists’ knowledge of pharmacovigilance and identify barriers to ADR reporting.Methods: Analytical, cross- sectional epidemiological study including 390 pharmacists from multiple practice settings (community, hospital, management/academia, industry/compounding, and public services). Data were collected via an online form between July 2024 and May 2025. Analyses were performed in SPSS v26.0 using descriptive statistics, the Kruskal–Wallis test followed by Dunn’s post hoc test, and the likelihood-ratio test (p<0.05).Results: A notable mismatch emerged between declared knowledge and practice. Although 89.5% reported understanding “pharmacovigilance” and 84.4% recognized “ADR,” only 30.5% correctly classified the “rare” ADR frequency, and 59.4% showed insufficient knowledge of causality algorithms. A gap between identification and reporting was evident: 45.2% stated they identify ADRs at least monthly, yet only 14.6% report with that frequency; 85.4% rarely or never report. Only 18.7% submitted any report in the previous 12 months, despite the legal mandate established by Law No. 13,021/2014. Training deficits were evident: 40.5% received no undergraduate training and 61.5% lacked in-service training; only 7.4% felt fully prepared. The most cited barriers were lack of time (52.6%), absence of a safety culture (51.8%), and process-knowledge gaps (29.0%), with significant variation across practice settings.Conclusion: ADR underreporting among pharmacists in Brazil is multifactorial, involving operational, institutional, and educational constraints. Priorities include continuous capacity-building, simplification of reporting workflows and platforms, and strengthening a non-punitive safety culture—consolidating pharmacists as central agents in patient protection.