Evaluación de la aplicación de las buenas prácticas de farmacovigilancia en el Hospital Especializado Julio Endara durante el año 2022

Abstract

The objective of the research was to evaluate the compliance of the well-done pharmacovigilance practices at ‘‘Julio Endara’’ Specialized Hospital during 2022. A cross-sectional, non-experimental, and descriptive study was conducted, using the "Verification Guide for Good Pharmacovigilance Practices (GVP)" checklist for establishments in the Integrated Public Health Network and Complementary Private Network at Levels 2 and 3 of hospital care. Additionally, the pharmacovigilance yellow cards reported during the study period were analyzed, and the probability of causality of adverse drug reactions was determined using the Naranjo algorithm. The sample consisted of pharmacovigilance documents, reported adverse reactions, and members of the pharmacovigilance staff of 2022. Statistical analysis was processed using SPSS software, revealing that the hospital's non-compliance rate with good practices was 42.5%, with the most critical areas being record-keeping and documentation. The compliance rate for filling out the yellow card was 86.1%, with antipsychotic medication being the most frequently reported cause of adverse events. In terms of causality and probability, 90.5% of the population fell into the "possible" category. It was concluded that the hospital needs to improve its pharmacovigilance system, as areas of non-compliance were identified, keeping performance at a medium level. The study recommends the formal establishment of a department with qualified and dedicated work staff to adequately carry out the pharmacovigilance activities.