Implementación de un plan de buenas prácticas de farmacovigilancia en la Farmacia Comunitaria Biopharma de la ciudad de Riobamba

Abstract

The Biopharma community pharmacy lacks a good pharmacovigilance practices plan because this issue has been addressed only at the hospital level in Ecuador. Healthcare services in community pharmacies are neglected. The objective of this study was to implement a good pharmacovigilance practices plan at Biopharma community pharmacy in Riobamba city through a non-experimental, mixed-method, and descriptive research. The study population consisted of the staff (2 biochemical pharmacists and 5 pharmacy assistants), and the study proceeded in four phases: diagnosing the pharmacovigilance process in the community pharmacy, developing standard operating procedures for the implementation of the good pharmacovigilance practices plan, communicating the procedures to the staff, and evaluating their implementation. The initial diagnosis of the pharmacovigilance process revealed a 16.67% compliance, due to shortcomings in staff training, documentation control, notification management, archiving, and internal audits. Subsequently, five standard operating procedures were developed: organization and personnel, documentation, notification management, archiving, and internal audits, based on the Health Regulation of the National Pharmacovigilance System - N. ARCSADE-020-2016-YMIH. These procedures were then communicated to the pharmacy staff. Finally, the evaluation of the implementation of the pharmacovigilance standard operating procedures at Biopharma pharmacy showed a final compliance of 82.41%. It was concluded that the implementation of the Good Pharmacovigilance Practices plan in the community pharmacy enabled the correct detection, analysis, and notification of adverse events experienced by patients.