Strengthening Bolivian Pharmacovigilance system: new therapeutic strategies to improve health of Chagas Disease and Tuberculosis patients

ABSTRACT Introduction Chagas disease (CD) and Tuberculosis (TB) are important health problems in Bolivia. Current treatments for both infections require a long period of time, and unwanted drug-related adverse events (ADRs) are frequent. Purpose This study aims to strengthen the Bolivian Pharmacovigilance system, focusing on CD and TB. Methods A situational diagnosis 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 health care 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 performed. Results Out of the total patients starting treatment for CD, 35,35% suffered ADR according to the information collected in the medical records, and 25% of them were classified as moderate/severe (MS) types. Only 51,43% of MS ADRs were reported to UNIMED. Regarding TB treatment, 9,89% of the total patients suffered ADR, 44% of them were classified as MS, and 75% of MS ADRs were reported to UNIMED. Conclusions The reinforcement of the Bolivian Pharmacovigilance system is an ambitious project that should take a long-term perspective and the engagement of national health workers and other stake holders at all levels. Continuity and perseverance are essential to achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to treatment.