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Governance and pharmacovigilance in Brazil: a scoping review

BACKGROUND: This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigi...

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Autores principales: Moscou, Kathy, Kohler, Jillian C., MaGahan, Anita
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746882/
https://www.ncbi.nlm.nih.gov/pubmed/26862438
http://dx.doi.org/10.1186/s40545-016-0053-y
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author Moscou, Kathy
Kohler, Jillian C.
MaGahan, Anita
author_facet Moscou, Kathy
Kohler, Jillian C.
MaGahan, Anita
author_sort Moscou, Kathy
collection PubMed
description BACKGROUND: This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance. METHODS: Sixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical industry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a pharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing structures, policy instruments, and institutional authority are managed to promote societal interests for patient safety due to medication use. The integration of transnational policy ideas for regulatory governance into pharmacogovernance in Brazil was also investigated. RESULTS: Brazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health products however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in monitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder coordination; effectiveness and efficiency; responsiveness; and intelligence and information. CONCLUSIONS: Pharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of coordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory agenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen pharmacovigilance in Brazil. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40545-016-0053-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-47468822016-02-10 Governance and pharmacovigilance in Brazil: a scoping review Moscou, Kathy Kohler, Jillian C. MaGahan, Anita J Pharm Policy Pract Research BACKGROUND: This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance. METHODS: Sixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical industry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a pharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing structures, policy instruments, and institutional authority are managed to promote societal interests for patient safety due to medication use. The integration of transnational policy ideas for regulatory governance into pharmacogovernance in Brazil was also investigated. RESULTS: Brazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health products however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in monitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder coordination; effectiveness and efficiency; responsiveness; and intelligence and information. CONCLUSIONS: Pharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of coordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory agenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen pharmacovigilance in Brazil. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40545-016-0053-y) contains supplementary material, which is available to authorized users. BioMed Central 2016-02-08 /pmc/articles/PMC4746882/ /pubmed/26862438 http://dx.doi.org/10.1186/s40545-016-0053-y Text en © Moscou et al. 2016 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
Moscou, Kathy
Kohler, Jillian C.
MaGahan, Anita
Governance and pharmacovigilance in Brazil: a scoping review
title Governance and pharmacovigilance in Brazil: a scoping review
title_full Governance and pharmacovigilance in Brazil: a scoping review
title_fullStr Governance and pharmacovigilance in Brazil: a scoping review
title_full_unstemmed Governance and pharmacovigilance in Brazil: a scoping review
title_short Governance and pharmacovigilance in Brazil: a scoping review
title_sort governance and pharmacovigilance in brazil: a scoping review
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746882/
https://www.ncbi.nlm.nih.gov/pubmed/26862438
http://dx.doi.org/10.1186/s40545-016-0053-y
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