| アブストラクト | 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. |
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| ジャーナル名 | Journal of pharmaceutical policy and practice |
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| 投稿日 | 2016/2/11 |
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| 投稿者 | Moscou, Kathy; Kohler, Jillian C; MaGahan, Anita |
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| 組織名 | Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street,;Toronto, Ontario M5S 3M2 Canada.;Toronto, Ontario M5S 3M2 Canada ; Munk School of Global Affairs, 1 Devonshire;Place (At Trinity College), Toronto, Ontario M5S 3K7 Canada.;Munk School of Global Affairs, 1 Devonshire Place (At Trinity College), Toronto,;Ontario M5S 3K7 Canada ; Rotman School of Management, Joseph L. Rotman School of;Management, 105 St George Street, Toronto, Ontario M5S 3E6 Canada. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/26862438/ |
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