Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency

Detalhes bibliográficos
Autor(a) principal: Daniel Marques Mota
Data de Publicação: 2018
Outros Autores: Álvaro Vigo, Ricardo de Souza Kuchenbecker
Tipo de documento: Artigo
Idioma: eng
por
Título da fonte: Cadernos de Saúde Pública
Texto Completo: https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799
Resumo: This scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.
id FIOCRUZ-5_af7b9902f2d5f357de1452464c517a92
oai_identifier_str oai:ojs.teste-cadernos.ensp.fiocruz.br:article/6799
network_acronym_str FIOCRUZ-5
network_name_str Cadernos de Saúde Pública
repository_id_str
spelling Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory AgencyEvolução e elementos-chave do sistema de farmacovigilância do Brasil: uma revisão de escopo a partir da criação da Agência Nacional de Vigilância SanitáriaHealth EvaluationHealth Information SystemsPharmacovigilanceDrug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsAvaliação em SaúdeSistemas de Informação em SaúdeFarmacovigilânciaEfeitos Colaterais e Reações Adversas Relacionados a MedicamentosSistemas de Notificação de Reações Adversas a MedicamentosThis scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.Esta revisión de alcance tiene como objetivo describir y caracterizar el sistema de farmacovigilancia de Brasil (SINAF) y constatar su adscripción a los requisitos mínimos propuestos por la Organización Mundial de la Salud, respecto al desempeño funcional de los sistemas nacionales de esta naturaleza. La estrategia de investigación bibliográfica utilizó recomendaciones del STARLITE y términos de búsqueda en las bases de datos MEDLINE/PubMed, Google, Imprenta Nacional de Brasil y de la página web de la Agencia Nacional de Vigilancia Sanitaria (Anvisa), comprendiendo el período entre 1999, año de creación de la Anvisa, y marzo de 2016. Se incluyeron 47 (4,4%) publicaciones, de un total de 1.068 identificadas, predominando por este orden: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos y 10 (21,3%) artículos científicos. Los estudios y documentos técnicos analizados incluyeron la creación, en el ámbito federal, de la primera unidad técnica de farmacovigilancia, el sistema de notificación de eventos adversos, el Centro Nacional de Monitoreo y la Cámara Técnica de Medicamentos. La tasa de notificación de eventos adversos en medicamentos dentro de Brasil correspondió, en 2013, a 36 notificaciones/1 millón de habitantes, bastante inferior a la meta propuesta en la literatura internacional, que sugiere 300 notificaciones/1 millón de habitantes. Este estudio identificó aspectos estructurales y funcionales que pueden comprometer el desempeño del SINAF, como la falta de legislación que instituya oficialmente al propio sistema y sus finalidades.Esta revisão de escopo objetiva descrever e caracterizar o sistema de farmacovigilância do Brasil (SINAF) e averiguar o atendimento aos requisitos mínimos propostos pela Organização Mundial da Saúde para um desempenho funcional de sistemas nacionais dessa natureza. A estratégia de pesquisa bibliográfica utilizou recomendações do STARLITE e termos de busca nas bases de dados MEDLINE/PubMed, Google, Imprensa Nacional e website da Agência Nacional de Vigilância Sanitária (Anvisa), compreendendo o período entre 1999, ano de criação da Anvisa, e março de 2016. Foram incluídas 47 (4,4%) publicações, de um total de 1.068 identificadas, prevalecendo, nesta ordem: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos e 10 (21,3%) artigos científicos. Os estudos e documentos técnicos analisados compreenderam a criação, em âmbito federal, da primeira unidade técnica de farmacovigilância, o sistema de notificação de eventos adversos, o Centro Nacional de Monitorização e a Câmara Técnica de Medicamentos. A taxa de notificação de eventos adversos a medicamentos no Brasil correspondeu, em 2013, a 36 notificações/1 milhão de habitantes, bastante inferior à meta proposta na literatura internacional, que sugere 300 notificações/1 milhão de habitantes. Este estudo identificou aspectos estruturais e funcionais que podem comprometer o desempenho do SINAF, como a falta de legislação que institua oficialmente o próprio sistema e suas finalidades.Reports in Public HealthCadernos de Saúde Pública2018-10-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmltext/htmlapplication/pdfapplication/pdfhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799Reports in Public Health; Vol. 34 No. 10 (2018): OctoberCadernos de Saúde Pública; v. 34 n. 10 (2018): Outubro1678-44640102-311Xreponame:Cadernos de Saúde Públicainstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZengporhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14688https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14689https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14690https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14691Daniel Marques MotaÁlvaro VigoRicardo de Souza Kuchenbeckerinfo:eu-repo/semantics/openAccess2024-03-06T15:29:31Zoai:ojs.teste-cadernos.ensp.fiocruz.br:article/6799Revistahttps://cadernos.ensp.fiocruz.br/ojs/index.php/csphttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/oaicadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br1678-44640102-311Xopendoar:2024-03-06T13:07:46.764791Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)true
dc.title.none.fl_str_mv Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
Evolução e elementos-chave do sistema de farmacovigilância do Brasil: uma revisão de escopo a partir da criação da Agência Nacional de Vigilância Sanitária
title Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
spellingShingle Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
Daniel Marques Mota
Health Evaluation
Health Information Systems
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Adverse Drug Reaction Reporting Systems
Avaliação em Saúde
Sistemas de Informação em Saúde
Farmacovigilância
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Sistemas de Notificação de Reações Adversas a Medicamentos
title_short Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
title_full Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
title_fullStr Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
title_full_unstemmed Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
title_sort Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency
author Daniel Marques Mota
author_facet Daniel Marques Mota
Álvaro Vigo
Ricardo de Souza Kuchenbecker
author_role author
author2 Álvaro Vigo
Ricardo de Souza Kuchenbecker
author2_role author
author
dc.contributor.author.fl_str_mv Daniel Marques Mota
Álvaro Vigo
Ricardo de Souza Kuchenbecker
dc.subject.por.fl_str_mv Health Evaluation
Health Information Systems
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Adverse Drug Reaction Reporting Systems
Avaliação em Saúde
Sistemas de Informação em Saúde
Farmacovigilância
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Sistemas de Notificação de Reações Adversas a Medicamentos
topic Health Evaluation
Health Information Systems
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Adverse Drug Reaction Reporting Systems
Avaliação em Saúde
Sistemas de Informação em Saúde
Farmacovigilância
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Sistemas de Notificação de Reações Adversas a Medicamentos
description This scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.
publishDate 2018
dc.date.none.fl_str_mv 2018-10-11
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799
url https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799
dc.language.iso.fl_str_mv eng
por
language eng
por
dc.relation.none.fl_str_mv https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14688
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14689
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14690
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6799/14691
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
text/html
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Reports in Public Health
Cadernos de Saúde Pública
publisher.none.fl_str_mv Reports in Public Health
Cadernos de Saúde Pública
dc.source.none.fl_str_mv Reports in Public Health; Vol. 34 No. 10 (2018): October
Cadernos de Saúde Pública; v. 34 n. 10 (2018): Outubro
1678-4464
0102-311X
reponame:Cadernos de Saúde Pública
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos de Saúde Pública
collection Cadernos de Saúde Pública
repository.name.fl_str_mv Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br
_version_ 1798943386811498496

Registros relacionados