Comparación de políticas de farmacovigilancia y su impacto en la seguridad del paciente en Ecuador, Chile y España

Abstract

Abstract: The aim of the study was to compare the pharmacovigilance policies of Ecuador, Chile and Spain and analyse their relationship with patient safety. It was a qualitative documentary review, descriptively and comparatively. The search was done in regulations, guidelines, institutional websites, scientific articles published or updated between 2010 and May 2026 and key landmark documents. We selected fifty two sources. We appraised five articles using CASP. The results indicate that Spain has the most coordinated and internationally integrated system, Chile has a consolidated national authority and has made progress in digitalization, and Ecuador is in a process of regulatory strengthening that still requires operational consolidation. The main limitations in all three countries were underreporting which hampers early signal detection and reduces the preventive capacity of regulatory authorities. The conclusion was that regulation alone does not ensure patient safety and its contribution depends on institutional deployment, participation of healthcare professionals and patients, analysis of reports and timely risk communication.