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Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries

BACKGROUND: Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President’s Malaria Initiative (PMI) account for the majority of donor support for malaria control and pr...

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Autores principales: Kovacs, Stephanie D., Mills, Brianna M., Stergachis, Andy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5504670/
https://www.ncbi.nlm.nih.gov/pubmed/28693488
http://dx.doi.org/10.1186/s12936-017-1921-x
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author Kovacs, Stephanie D.
Mills, Brianna M.
Stergachis, Andy
author_facet Kovacs, Stephanie D.
Mills, Brianna M.
Stergachis, Andy
author_sort Kovacs, Stephanie D.
collection PubMed
description BACKGROUND: Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President’s Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank’s grants for malaria prevention and control. METHODS: All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0. RESULTS: The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance–related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug quality monitoring, especially among the PMI grants. CONCLUSIONS: The results of the analysis demonstrate that funding for PV has not been sufficiently prioritized by either the key malaria donor organizations or by the recipient countries, as reflected in their grant proposal submissions and MOPs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12936-017-1921-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-55046702017-07-12 Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries Kovacs, Stephanie D. Mills, Brianna M. Stergachis, Andy Malar J Research BACKGROUND: Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President’s Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank’s grants for malaria prevention and control. METHODS: All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0. RESULTS: The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance–related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug quality monitoring, especially among the PMI grants. CONCLUSIONS: The results of the analysis demonstrate that funding for PV has not been sufficiently prioritized by either the key malaria donor organizations or by the recipient countries, as reflected in their grant proposal submissions and MOPs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12936-017-1921-x) contains supplementary material, which is available to authorized users. BioMed Central 2017-07-11 /pmc/articles/PMC5504670/ /pubmed/28693488 http://dx.doi.org/10.1186/s12936-017-1921-x Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Kovacs, Stephanie D.
Mills, Brianna M.
Stergachis, Andy
Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
title Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
title_full Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
title_fullStr Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
title_full_unstemmed Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
title_short Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
title_sort donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5504670/
https://www.ncbi.nlm.nih.gov/pubmed/28693488
http://dx.doi.org/10.1186/s12936-017-1921-x
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