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Development of a pharmacovigilance system in a resource-limited country : the experience of the Democratic Republic of Congo

Nzolo, Didier and Kuemmerle, Andrea and Lula, Yves and Ntamabyaliro, Nsengi and Engo, Aline and Mvete, Bibiche and Liwono, Jerry and Lusakibanza, Mariano and Mesia, Gauthier and Burri, Christian and Mampunza, Samuel and Tona, Gaston. (2019) Development of a pharmacovigilance system in a resource-limited country : the experience of the Democratic Republic of Congo. Therapeutic advances in drug safety, 10. p. 2042098619864853.

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Abstract

Implementation of pharmacovigilance (PV) systems in resource-limited countries is a real endeavor. Despite country- and continent-specific challenges, the Democratic Republic of the Congo (DRC) has been able to develop one of the most active PV systems in the sub-Saharan Africa. The World Health Organization (WHO) regional Office identified the DRC experience to set up a PV system for antimalarial drugs safety monitoring as a 'best practice' that needed to be documented in order to help DRC improve its PV system and to be scaled up in other African countries. In response to the WHO request, a best practices and bottlenecks analysis was conducted in 2015. This analysis was updated in 2018 in the light of the minimum requirements of the WHO to set up a PV system taking into account other guidance for PV systems. The following themes were retained for analysis: (1) creation of the national PV center; (2) implementation of PV in the health system; (3) data collection and analysis; (4) collaboration with public health programs; (5) collaboration with the National Regulatory Authority. Lessons learnt from the DRC experience show that it is possible to implement PV systems in order to promote patients' safety in resource limited sub-Saharan African countries with no guaranteed funding. The ability of national PV centers to collaborate with Public health stakeholders, including public health authorities at all levels as well as public health programs, and to use existing health information systems are considered the main key to success and may substantially reduce the cost of PV activities.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Medicine > Medicines Implementation Research (Burri)
UniBasel Contributors:K├╝mmerle, Andrea and Burri, Christian
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Sage Publ.
ISSN:2042-0994
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:12 Aug 2019 09:36
Deposited On:12 Aug 2019 09:36

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