Dataset Information

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.

SUBMITTER: Cortes-Serra N

PROVIDER: S-EPMC7529217 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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

Cortes-Serra Nuria N Saravia Ruth R Grágeda Rosse Mary RM Apaza Amílcar A González Jorge Armando JA Ríos Brenda B Gascón Joaquim J Torrico Faustino F Pinazo María-Jesús MJ

PLoS neglected tropical diseases 20200921 9

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 Med ...[more]

PMID: 32956348

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Project description:BackgroundSurveillance is a core component of an effective system to support malaria elimination. Poor surveillance data will prevent countries from monitoring progress towards elimination and targeting interventions to the last remaining at-risk places. An evaluation of the performance of surveillance systems in 16 countries was conducted to identify key gaps which could be addressed to build effective systems for malaria elimination.MethodsA standardized surveillance system landscaping was conducted between 2015 and 2017 in collaboration with governmental malaria programmes. Malaria surveillance guidelines from the World Health Organization and other technical bodies were used to identify the characteristics of an optimal surveillance system, against which systems of study countries were compared. Data collection was conducted through review of existing material and datasets, and interviews with key stakeholders, and the outcomes were summarized descriptively. Additionally, the cumulative fraction of incident infections reported through surveillance systems was estimated using surveillance data, government records, survey data, and other scientific sources.ResultsThe landscaping identified common gaps across countries related to the lack of surveillance coverage in remote communities or in the private sector, the lack of adequate health information architecture to capture high quality case-based data, poor integration of data from other sources such as intervention information, poor visualization of generated information, and its lack of availability for making programmatic decisions. The median percentage of symptomatic cases captured by the surveillance systems in the 16 countries was estimated to be 37%, mostly driven by the lack of treatment-seeking in the public health sector (64%) or, in countries with large private sectors, the lack of integration of this sector within the surveillance system.ConclusionsThe landscaping analysis undertaken provides a clear framework through which to identify multiple gaps in current malaria surveillance systems. While perfect systems are not required to eliminate malaria, closing the gaps identified will allow countries to deploy resources more efficiently, track progress, and accelerate towards malaria elimination. Since the landscaping undertaken here, several countries have addressed some of the identified gaps by improving coverage of surveillance, integrating case data with other information, and strengthening visualization and use of data.

Project description:BackgroundGlobal pandemic influenza preparedness relies heavily on public health surveillance, but it is unclear that current surveillance fully meets pandemic preparedness needs.MethodsWe first developed a conceptual framework to help systematically identify strategies to improve the detection of an early case or cluster of novel human influenza disease during the pre-pandemic period. We then developed a process model (flow diagram) depicting nine major pathways through which a case in the community could be detected and confirmed, and mapped the improvement strategies onto this model. Finally, we developed an interactive decision tool by building quantitative measures of probability and time into each step of the process model and programming it to calculate the net probability and time required for case detection through each detection pathway. Input values for each step can be varied by users to assess the effects of different improvement strategies, alone or in combination. We illustrate application of the tool using hypothetical input data reflecting baseline and 12-month follow-up scenarios, following concurrent implementation of multiple improvement strategies.ResultsWe compared outputs from the tool across detection pathways and across time, at baseline and 12-month follow up. The process model and outputs from the tool suggest that traditional efforts to build epidemiology and laboratory capacity are efficient strategies, as are more focused strategies within these, such as targeted laboratory testing; expedited specimen transport; use of technologies to streamline data flow; and improved reporting compliance. Other promising strategies stem from community detection - better harnessing of electronic data mining and establishment of community-based monitoring.ConclusionOur practical tool allows policymakers to use their own realistic baseline values and program projections to assess the relative impact of different interventions to improve the probability and timeliness of detecting early human cases or clusters caused by a novel influenza virus, a possible harbinger of a new pandemic. Policymakers can use results to target investments to improve their surveillance infrastructure. Multi-national planners can also use the tool to help guide directions in surveillance system improvements more globally. Finally, our systematic approach can also be tailored to help improve surveillance for other diseases.

Dataset Information

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

Publications

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

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