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 UNI-MED, 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 UNI-MED. 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.
Background Chagas disease is endemic throughout most of Bolivia, with prevalence rates of 25% observed in some geographic areas located mainly in the sub-Andean region. Methods Community-based entomological surveillance was carried out in the sub-Andean departments of Cochabamba (municipalities of Cochabamba, Punata and Sacaba), Tarija (municipality of Tarija) and Chuquisaca (municipality of Sucre). The surveillance parameters evaluated were: (i) the proportion of cards with the presence of triatomines; (ii) the distribution of positive cards by area; and (iii) the proportion of cards with the presence of infected triatomines. Results Of the cards returned, in 852 (3.1%) there was a mention of the presence of triatomines. The species Triatoma infestans, Triatoma sordida and Triatoma guasayana were identified in 812 (95.3%), 39 (4.6%) and 1 (0.1%), respectively. The median monthly positivity rate of the cards during 2011-2018 was higher in Punata (9.1%; IQR=3.2–15.4%). The median monthly rate was highest in 2012 (2.7%; IQR=0–5.6%). Fifty positive cards (5.8%) presented insects that were positive for trypanosomatids, mainly in Cochabamba and Punata. Conclusions The report of triatomines foci by inhabitants represents an effective surveillance system coordinated by a network of specialized and multidisciplinary health centers. These strategies, which should be included in the health policies of endemic countries, enable extending and deepening the dialogue among technicians, communities and their local authorities.
2 Introduction: Chagas disease (CD) and Tuberculosis (TB) are important health problems in 3 Bolivia. Current treatments for both infections require a long period of time, and unwanted 4 drug-related adverse events (ADRs) are frequent. 5 Purpose: This study aims to strengthen the Bolivian Pharmacovigilance system, focusing on CD 6 and TB. 7 Methods: A situational diagnosis of Pharmacovigilance in the Department of Cochabamba was 8 performed. The use of a new Local Case Report Form (CRF) was implemented, together with 9 the CRF established by the Unidad de Medicamentos y Tecnología en Salud (UNIMED), in 10 several health care centers. Training and follow-up on drug safety monitoring and ADR 11 reporting was provided to all health professionals involved in CD and TB treatment. A 12 comparative analysis of the reported ADRs using the CRF provided by UNIMED, the new CRF 13 proposal, and medical records, was performed. 14 Results: Out of the total patients starting treatment for CD, 35,35% suffered ADR according to 15 the information collected in the medical records, and 25% of them were classified as 16 moderate/severe (MS) types. Only 51,43% of MS ADRs were reported to UNIMED. Regarding 17 TB treatment, 9,89% of the total patients suffered ADR, 44% of them were classified as MS, 18 and 75% of MS ADRs were reported to UNIMED. 19 Conclusions: The reinforcement of the Bolivian Pharmacovigilance system is an ambitious 20 project that should take a long-term perspective and the engagement of national health 21 workers and other stake holders at all levels. Continuity and perseverance are essential to 2 22 achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to 23 treatment. 24
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.