Knowledge, attitudes, and practices associated with pharmacovigilance among healthcare professionals in a tertiary hospital in Ecuador

Purpose: Under-reporting of suspected adverse drug reactions (ADRs) limits the performance of pharmacovigilance systems. This study assessed knowledge, attitudes, practices, and perceived barriers related to pharmacovigilance and ADR reporting among healthcare professionals in a tertiary hospital in Ecuador. Methods: An observational, descriptive, cross-sectional survey was conducted in inpatient clinical areas of a tertiary hospital in Cuenca, Ecuador (April–June 2024). A validated questionnaire was translated into Spanish and culturally adapted. The survey was administered in person, anonymized, and analyzed using descriptive statistics. Results: In total, 104 healthcare professionals participated (39 physicians, 15 pharmacists, 50 nurses). Knowledge and attitudes were generally favorable; however, practice was limited, with most respondents reporting no ADRs in the preceding year. Only 43% (45/104) reported knowing the hospital pharmacovigilance contact point, and 46% (48/104) believed that a single ADR report has no impact. The most frequently cited barriers were increased workload related to reporting (57%), lack of time (49%), lack of a professional environment to discuss ADRs (47%), and insufficient knowledge to identify ADRs (46%). A high causality certainty threshold was common (73% agreed that complete certainty is required before reporting). Conclusions: Despite generally adequate knowledge and positive attitudes, suspected ADR reporting was suboptimal. Interventions combining continuous training (emphasizing suspicion-based reporting), workflow facilitation, clear reporting pathways, and feedback and motivational strategies may strengthen hospital pharmacovigilance.