Strengthening the Bolivian pharmacovigilance system: New surveillance strategies to improve care for Chagas disease and tuberculosis

Abstract

Chagas disease (CD) and tuberculosis (TB) are important health problems in Bolivia. Current treatments for both infections require a long period of time, and adverse drug reactions (ADRs) are frequent. This study aims to strengthen the Bolivian pharmacovigilance system, focusing on CD and TB. A situation analysis of pharmacovigilance in the Department of Cochabamba was performed. The use of a new local case report form (CRF) was implemented, together with the CRF established by the Unidad de Medicamentos y Tecnología en Salud (UNIMED), in several healthcare centers. Training and follow-up on drug safety monitoring and ADR reporting was provided to all health professionals involved in CD and TB treatment. A comparative analysis of the reported ADRs using the CRF provided by UNIMED, the new CRF proposal, and medical records, was also performed. Our results showed that out of all patients starting treatment for CD, 37.9% suffered ADRs according to the medical records, and 25.3% of them were classified as moderate/severe (MS). Only 47.4% of MS ADRs were reported to UNIMED. Regarding TB treatment, 9.9% of all patients suffered ADRs, 44% of them were classified as MS, and 75% of MS ADRs were reported to UNIMED. These findings show that the reinforcement of the Bolivian pharmacovigilance system is an ambitious project that should involve a long-term perspective and the engagement of national health workers and other stakeholders at all levels. Continuity and perseverance are essential to achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to treatment. Chagas disease and tuberculosis are important public health problems in Bolivia, where the prevalence and incidence of these diseases are high compared to other Latin American countries. Treatment for both infections requires a long period of time, and adverse drug reactions (ADRs) are frequent. One of the main challenges in the management of Chagas disease and tuberculosis is poor adherence to treatment. In this context, strengthening the Bolivian pharmacovigilance system is proposed as a key issue to reinforce therapeutic strategies. Several interventions were carried out in fifteen health centers of the Department of Cochabamba and included a situation analysis of pharmacovigilance, the implementation of a new local case report form, specific training on drug safety monitoring and reporting, and follow-up visits. ADRs were also analyzed. Overall, our findings suggest that the Bolivian pharmacovigilance system still presents some challenges that should be addressed in the coming years in order to achieve a strong, integrated and consolidated ADR reporting system, which will be essential for avoiding patient abandonment and achieving therapeutic success.