Como colaborar na implantação da farmacovigilância em nosso país?

Dainesi, Sonia Mansoldo

doi:10.1590/s0104-42302005000400008

Cited by 2 publications

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“…Dainesi (2005) found that health care professionals’ reluctance to report errors, adverse events and treatment failures was an impediment to pharmacovigilance. ANVISA, industry and academia must each promote ‘values that should guide corporate governance’ : a culture of transparency, justice, overall compliance with regulations, and accountability ([53], p186).…”

Section: Resultsmentioning

confidence: 99%

Governance and pharmacovigilance in Brazil: a scoping review

Moscou

Köhler

MaGahan

2016

J of Pharm Policy and Pract

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BackgroundThis 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.MethodsSixty-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.ResultsBrazil'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.ConclusionsPharmacogovernance 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 materialThe 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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Section: Resultsmentioning

confidence: 99%

Governance and pharmacovigilance in Brazil: a scoping review

Moscou

Köhler

MaGahan

2016

J of Pharm Policy and Pract

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“…Por sua vez, em relação à falta de registros, infelizmente é sabido que a subnotificação é uma característica comum da farmacovigilância em todo o mundo [32][33][34] . Referindo-se ao Brasil, muito ainda tem que ser feito, mas diferentes estratégias têm sido viabilizadas para promover a notificação 35 .…”

Section: Resultsunclassified

Reações adversas causadas por fármacos que atuam no sistema nervoso: análise de registros de um centro de farmacovigilância do Brasil

Fonteles¹,

Francelino

Santos³

et al. 2009

Rev. psiquiatr. clín.

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Como colaborar na implantação da farmacovigilância em nosso país?

Cited by 2 publications

References 0 publications

Governance and pharmacovigilance in Brazil: a scoping review

Governance and pharmacovigilance in Brazil: a scoping review

Reações adversas causadas por fármacos que atuam no sistema nervoso: análise de registros de um centro de farmacovigilância do Brasil

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