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

Nuria Cortes-Serra,Amílcar Apaza,Ruth Saravia,Jorge Armando González,María-Jesús Pinazo,Faustino Torrico,Brenda Ríos,Rosse Mary Grágeda,Joaquim Gascón

doi:10.1371/journal.pntd.0008370

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.

Highlights

Chagas disease (CD), caused by the parasite Trypanosoma cruzi (T.cruzi), is one of the main health problems in Latin America
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
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 adverse drug reactions (ADRs) reporting system, which will be essential for avoiding patient abandonment and achieving therapeutic success

Summary

Introduction

Chagas disease (CD), caused by the parasite Trypanosoma cruzi (T.cruzi), is one of the main health problems in Latin America. T. cruzi infection has been declared a major public health issue in the region, affecting approximately 6 to 7 million people worldwide. CD is one of the 17 neglected tropical diseases (NTDs), which are characterized by affecting populations with poor socioeconomic status and having limited resources and political priority [1]. Approved drugs for treatment of T. cruzi infection (benznidazole and nifurtimox) are complex, and adverse events reactions (ADRs) are frequent. Onset of ADRs is one of the main causes of patients abandoning treatment, resulting in therapeutic failure or ineffective treatment [4,5,6,7,8,9]

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