Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089 |
Resumo: | Introduction: Hospitals are essential for the universal coverage of any health system, as well as sources of valuable information on adverse events and technical complaints of products subjects to health surveillance. Objective: To identify the potentialities and limitations of the Sentinel Network to improve post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa. Method: A descriptive quantitative study that used data from a national administrative survey applied to the Sentinel Network, which was conducted between August 4 and September 2, 2021, by the Anvisa. Data were collected using an electronic structured questionnaire. Statistical analyzes were performed in the Gretl-2022a software, including the calculation of absolute and relative frequencies, medians, and interquartile ranges. Results: A response rate of 69.1% (181/262) was obtained. Among the potentialities, the following stand out: acting as a center for study, teaching, and research of health establishments (n = 145; 80.1%), presence of implanted electronic medical records (n = 142; 78.4%) and the development of initiatives focused on innovation involving risk management of health products (n = 94; 52.0%). As one of the limitations, health establishments that do not have any current excellence/quality certifications predominate (n = 104; 57.5%). Conclusions: The Sentinel Network has several potentialities and limitations that affect the post-marketing/post-use monitoring of products subject to health surveillance. Identifying them, as was the objective of this study, demonstrates the need to promote actions that offer the possibility of expanding the potentialities and mitigate the limiting factors to the improvement of post-marketing/post-use monitoring adopted by Anvisa. |
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Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by AnvisaPotencialidades e limitações da Rede Sentinela para o aperfeiçoamento do monitoramento pós-comercialização/pós-uso de produtos sob vigilância sanitária adotado pela AnvisaAgência Nacional de Vigilância SanitáriaEfeitos Colaterais e Reações Adversas Relacionados a MedicamentosMonitoramento SanitárioSegurança do PacienteVigilância de Produtos ComercializadosBrazilian Health Surveillance AgencyDrug-Related Side Effects and Adverse ReactionsHealth MonitoringPatient SafetyMarketed Products SurveillanceIntroduction: Hospitals are essential for the universal coverage of any health system, as well as sources of valuable information on adverse events and technical complaints of products subjects to health surveillance. Objective: To identify the potentialities and limitations of the Sentinel Network to improve post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa. Method: A descriptive quantitative study that used data from a national administrative survey applied to the Sentinel Network, which was conducted between August 4 and September 2, 2021, by the Anvisa. Data were collected using an electronic structured questionnaire. Statistical analyzes were performed in the Gretl-2022a software, including the calculation of absolute and relative frequencies, medians, and interquartile ranges. Results: A response rate of 69.1% (181/262) was obtained. Among the potentialities, the following stand out: acting as a center for study, teaching, and research of health establishments (n = 145; 80.1%), presence of implanted electronic medical records (n = 142; 78.4%) and the development of initiatives focused on innovation involving risk management of health products (n = 94; 52.0%). As one of the limitations, health establishments that do not have any current excellence/quality certifications predominate (n = 104; 57.5%). Conclusions: The Sentinel Network has several potentialities and limitations that affect the post-marketing/post-use monitoring of products subject to health surveillance. Identifying them, as was the objective of this study, demonstrates the need to promote actions that offer the possibility of expanding the potentialities and mitigate the limiting factors to the improvement of post-marketing/post-use monitoring adopted by Anvisa.Introdução: Os hospitais são essenciais para a cobertura universal de qualquer sistema de saúde, bem como são fontes de informações valiosas sobre eventos adversos e queixas técnicas de produtos sob vigilância sanitária. Objetivo: Identificar as potencialidades e limitações da Rede Sentinela para o aperfeiçoamento do monitoramento pós-comercialização/pós-uso de produtos sob vigilância sanitária adotado pela Anvisa. Método: Estudo descritivo quantitativo que utilizou dados de levantamento administrativo nacional aplicado à Rede Sentinela realizado entre 4 de agosto e 2 de setembro de 2021 pela Anvisa. Os dados foram coletados por meio de questionário estruturado eletrônico. As análises estatísticas foram executadas no software Gretl-2022a, compreendendo o cálculo das frequências absoluta e relativa, medianas e intervalos interquartis. Resultados: Obteve-se uma taxa de resposta de 69,1% (181/262). Dentre as potencialidades, destacam-se: a atuação como centro de estudo, ensino e pesquisa dos estabelecimentos de saúde (n = 145; 80,1%), a presença de prontuário eletrônico implantado (n = 142; 78,4%) e o desenvolvimento de iniciativas voltadas para a inovação envolvendo a gestão de risco de produtos de saúde (n = 94; 52,0%). Como uma das limitações, predominam os estabelecimentos de saúde que não possuem quaisquer certificações de excelência/qualidade vigentes (n = 104; 57,5%). Conclusões: A Rede Sentinela apresenta várias potencialidades e limitações que afetam o monitoramento pós-comercialização/pós-uso de produtos sob vigilância sanitária. Identificá-las, como foi o objetivo deste estudo, demonstra a necessidade de fomentar ações que ofereçam a possibilidade de ampliar as potencialidades e mitigar os fatores limitantes ao aperfeiçoamento do monitoramento pós-comercialização/pós-uso adotado pela Anvisa.Instituto Nacional de Controle de Qualidade em Saúde2022-11-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Guest Article""Artigo de convidado""Artigo de convidado"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/208910.22239/2317-269x.02089Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 4 (2022): November - Commemorative Edition: 10 Years of Visa in Debate; 20-31Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 4 (2022): Noviembre - Edición Conmemorativa: 10 Años de Visa en Debate; 20-31Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 4 (2022): Novembro - Edição comemorativa: 10 anos da Visa em Debate; 20-312317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089/1461https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089/1506Copyright (c) 2022 Daniel Marques Mota, Dolly Milena Ovando Talavera Cammarota, Leonardo Oliveira Leitão, Ana Paula Coelho Penna Teixeira, Viviane Vilela Marques Barreiros, Fabiana Rodrigues Gomes, Lucia Eichenberg Surita, Suzie Marie Teixeira Gomes (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessMota, Daniel Marques Cammarota, Dolly Milena Ovando TalaveraLeitão, Leonardo OliveiraTeixeira, Ana Paula Coelho PennaBarreiros, Viviane Vilela MarquesRodrigues Gomes, FabianaSurita, Lucia EichenbergGomes, Suzie Marie Teixeira2023-12-14T14:27:52Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2089Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-12-14T14:27:52Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa Potencialidades e limitações da Rede Sentinela para o aperfeiçoamento do monitoramento pós-comercialização/pós-uso de produtos sob vigilância sanitária adotado pela Anvisa |
title |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa |
spellingShingle |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa Mota, Daniel Marques Agência Nacional de Vigilância Sanitária Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Monitoramento Sanitário Segurança do Paciente Vigilância de Produtos Comercializados Brazilian Health Surveillance Agency Drug-Related Side Effects and Adverse Reactions Health Monitoring Patient Safety Marketed Products Surveillance |
title_short |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa |
title_full |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa |
title_fullStr |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa |
title_full_unstemmed |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa |
title_sort |
Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa |
author |
Mota, Daniel Marques |
author_facet |
Mota, Daniel Marques Cammarota, Dolly Milena Ovando Talavera Leitão, Leonardo Oliveira Teixeira, Ana Paula Coelho Penna Barreiros, Viviane Vilela Marques Rodrigues Gomes, Fabiana Surita, Lucia Eichenberg Gomes, Suzie Marie Teixeira |
author_role |
author |
author2 |
Cammarota, Dolly Milena Ovando Talavera Leitão, Leonardo Oliveira Teixeira, Ana Paula Coelho Penna Barreiros, Viviane Vilela Marques Rodrigues Gomes, Fabiana Surita, Lucia Eichenberg Gomes, Suzie Marie Teixeira |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Mota, Daniel Marques Cammarota, Dolly Milena Ovando Talavera Leitão, Leonardo Oliveira Teixeira, Ana Paula Coelho Penna Barreiros, Viviane Vilela Marques Rodrigues Gomes, Fabiana Surita, Lucia Eichenberg Gomes, Suzie Marie Teixeira |
dc.subject.por.fl_str_mv |
Agência Nacional de Vigilância Sanitária Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Monitoramento Sanitário Segurança do Paciente Vigilância de Produtos Comercializados Brazilian Health Surveillance Agency Drug-Related Side Effects and Adverse Reactions Health Monitoring Patient Safety Marketed Products Surveillance |
topic |
Agência Nacional de Vigilância Sanitária Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Monitoramento Sanitário Segurança do Paciente Vigilância de Produtos Comercializados Brazilian Health Surveillance Agency Drug-Related Side Effects and Adverse Reactions Health Monitoring Patient Safety Marketed Products Surveillance |
description |
Introduction: Hospitals are essential for the universal coverage of any health system, as well as sources of valuable information on adverse events and technical complaints of products subjects to health surveillance. Objective: To identify the potentialities and limitations of the Sentinel Network to improve post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa. Method: A descriptive quantitative study that used data from a national administrative survey applied to the Sentinel Network, which was conducted between August 4 and September 2, 2021, by the Anvisa. Data were collected using an electronic structured questionnaire. Statistical analyzes were performed in the Gretl-2022a software, including the calculation of absolute and relative frequencies, medians, and interquartile ranges. Results: A response rate of 69.1% (181/262) was obtained. Among the potentialities, the following stand out: acting as a center for study, teaching, and research of health establishments (n = 145; 80.1%), presence of implanted electronic medical records (n = 142; 78.4%) and the development of initiatives focused on innovation involving risk management of health products (n = 94; 52.0%). As one of the limitations, health establishments that do not have any current excellence/quality certifications predominate (n = 104; 57.5%). Conclusions: The Sentinel Network has several potentialities and limitations that affect the post-marketing/post-use monitoring of products subject to health surveillance. Identifying them, as was the objective of this study, demonstrates the need to promote actions that offer the possibility of expanding the potentialities and mitigate the limiting factors to the improvement of post-marketing/post-use monitoring adopted by Anvisa. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-11-30 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Guest Article" "Artigo de convidado" "Artigo de convidado" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089 10.22239/2317-269x.02089 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089 |
identifier_str_mv |
10.22239/2317-269x.02089 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089/1461 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2089/1506 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 4 (2022): November - Commemorative Edition: 10 Years of Visa in Debate; 20-31 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 4 (2022): Noviembre - Edición Conmemorativa: 10 Años de Visa en Debate; 20-31 Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 4 (2022): Novembro - Edição comemorativa: 10 anos da Visa em Debate; 20-31 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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1797042046713724928 |