Assessment of the Pharmacovigilance System in One of the Largest Hospitals in Indonesia.

Abstract

Background: As a developing country, Indonesia must strengthen pharmacovigilance to enhance drug safety. This study assessed the pharmacovigilance system profile, which is defined as the organization's structures and processes for monitoring drug safety in one of the largest government hospitals in South Borneo, Indonesia. The evaluation specifically utilized the World Health Organization (WHO) framework and focused on structural, process, and outcome indicators to identify problems, influencing factors, and efforts that have been made regarding pharmacovigilance.

Methods: This cross-sectional descriptive study was conducted from December 2021 to January 2022. Information was collected from respondents who were responsible for pharmacovigilance activities in each department using a modified version of the WHO pharmacovigilance indicators.

Results: The results on structural, process, and outcome or impact indicators show that pharmacovigilance has been carried out in the hospital, although it has not yet covered all existing aspects. Several problems were identified for each assessment indicator. The influencing factors included regulation and standardization, facilities and accessibility, as well as health workers and patients. This indicates that the pharmacovigilance system was not optimal.

Conclusion: Appropriate interventions are needed to optimize the pharmacovigilance system, which is carried out continuously in stages. Pharmacovigilance system assessments should also be conducted periodically to oversee the optimization of the pharmacovigilance system in the hospital.