Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species

Detalhes bibliográficos
Autor(a) principal: de Lima, Luciane Otaviano
Data de Publicação: 2015
Outros Autores: Vosgerau, Milene Zanoni da silva, Gomes, Eliane Carneiro
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/248
Resumo: Medicinal plants, used by humans for millennia, constitute a weak link in the therapeutic context, because of the regulation under construction and the indiscriminate use by your taxing of safety. Monitoring and attention to pharmacovigilance is essential for identifying, evaluating, understanding, and preventing undesirable events associated with these products. This study aimed to identify the general profile of notifications for products based on plants species reported as medicinal in the National System of Health Surveillance Notifications (NOTIVISA) from 2008 to 2012 in Brazil. Data were obtained from NOTIVISA and analyzed using EpiInfo software, version 3.5.4 for Windows. A total of 50,824 notifications for medications were analyzed, of which 399 were associated with products based on plant species, with 10 representing complaints of adverse events and 389 representing complaints about techniques. Among the latter, 48.6% corresponded to notifications of “companies without operating permit/product suspected of being unregistered.” Among all fields of the reports analyzed, approximately 50% were not filled out, weakening the process of pharmacosurveillance and constituting an indicator of poor report quality.
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spelling Pharmacosurveillance in Brazil: Profile of notifications of products based on plant speciesFarmacovigilância no Brasil: perfil das notificações de produtos a base de espécies vegetais base de espécies vegetaisFarmacovigilânciaFitoterapiaPlantas medicinaisNOTIVISAPharmacosurveillancePhytotherapyMedicinal plantsNOTIVISAMedicinal plants, used by humans for millennia, constitute a weak link in the therapeutic context, because of the regulation under construction and the indiscriminate use by your taxing of safety. Monitoring and attention to pharmacovigilance is essential for identifying, evaluating, understanding, and preventing undesirable events associated with these products. This study aimed to identify the general profile of notifications for products based on plants species reported as medicinal in the National System of Health Surveillance Notifications (NOTIVISA) from 2008 to 2012 in Brazil. Data were obtained from NOTIVISA and analyzed using EpiInfo software, version 3.5.4 for Windows. A total of 50,824 notifications for medications were analyzed, of which 399 were associated with products based on plant species, with 10 representing complaints of adverse events and 389 representing complaints about techniques. Among the latter, 48.6% corresponded to notifications of “companies without operating permit/product suspected of being unregistered.” Among all fields of the reports analyzed, approximately 50% were not filled out, weakening the process of pharmacosurveillance and constituting an indicator of poor report quality.As plantas medicinais, utilizadas milenarmente pela humanidade, constituem um elo frágil dentro do contexto terapêutico, tanto pela regulamentação, ainda em construção, como pelo uso indiscriminado por sua taxação de inocuidade. Desse modo, seu monitoramento e acompanhamento pela farmacovigilância são essenciais para identificar, avaliar, compreender e prevenir eventos não desejáveis relacionados com estes produtos. Com isso, o presente estudo objetivou identificar o perfil geral das notificações de produtos à base de espécies vegetais notificados como medicamento no Sistema Nacional de Notificações para a Vigilância Sanitária (NOTIVISA) de 2008 a 2012. Os dados foram obtidos do Sistema NOTIVISA e analisados no programa Epiinfo, versão para Windows 3.5.4. Foram analisadas 50.824 notificações referentes a medicamentos no período proposto, das quais 399 corresponderam a notificações de produtos a base de espécies vegetais, em que dez tratavam de eventos adversos e 389 de queixas técnicas. Dentre essas últimas, 48,6% corresponderam a notificações de “empresas sem Autorização de Funcionamento de Empresa (AFE)/produto com suspeita de estar sem registro”. Dentre todos os campos das notificações analisados foi verificado que aproximadamente 50% dos mesmos não estavam preenchidos, o que se torna um indicador da qualidade das notificações e fragiliza o processo da farmacovigilância.Instituto Nacional de Controle de Qualidade em Saúde2015-02-24info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/24810.3395/2317-269x.00248Health Surveillance under Debate: Society, Science & Technology ; Vol. 3 No. 1 (2015): February; 105-115Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 1 (2015): Febrero; 105-115Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 1 (2015): Fevereiro; 105-1152317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/248/209Copyright (c) 2015 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessde Lima, Luciane OtavianoVosgerau, Milene Zanoni da silvaGomes, Eliane Carneiro2023-06-27T14:59:29Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/248Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T14:59:29Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
Farmacovigilância no Brasil: perfil das notificações de produtos a base de espécies vegetais base de espécies vegetais
title Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
spellingShingle Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
de Lima, Luciane Otaviano
Farmacovigilância
Fitoterapia
Plantas medicinais
NOTIVISA
Pharmacosurveillance
Phytotherapy
Medicinal plants
NOTIVISA
title_short Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
title_full Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
title_fullStr Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
title_full_unstemmed Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
title_sort Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
author de Lima, Luciane Otaviano
author_facet de Lima, Luciane Otaviano
Vosgerau, Milene Zanoni da silva
Gomes, Eliane Carneiro
author_role author
author2 Vosgerau, Milene Zanoni da silva
Gomes, Eliane Carneiro
author2_role author
author
dc.contributor.author.fl_str_mv de Lima, Luciane Otaviano
Vosgerau, Milene Zanoni da silva
Gomes, Eliane Carneiro
dc.subject.por.fl_str_mv Farmacovigilância
Fitoterapia
Plantas medicinais
NOTIVISA
Pharmacosurveillance
Phytotherapy
Medicinal plants
NOTIVISA
topic Farmacovigilância
Fitoterapia
Plantas medicinais
NOTIVISA
Pharmacosurveillance
Phytotherapy
Medicinal plants
NOTIVISA
description Medicinal plants, used by humans for millennia, constitute a weak link in the therapeutic context, because of the regulation under construction and the indiscriminate use by your taxing of safety. Monitoring and attention to pharmacovigilance is essential for identifying, evaluating, understanding, and preventing undesirable events associated with these products. This study aimed to identify the general profile of notifications for products based on plants species reported as medicinal in the National System of Health Surveillance Notifications (NOTIVISA) from 2008 to 2012 in Brazil. Data were obtained from NOTIVISA and analyzed using EpiInfo software, version 3.5.4 for Windows. A total of 50,824 notifications for medications were analyzed, of which 399 were associated with products based on plant species, with 10 representing complaints of adverse events and 389 representing complaints about techniques. Among the latter, 48.6% corresponded to notifications of “companies without operating permit/product suspected of being unregistered.” Among all fields of the reports analyzed, approximately 50% were not filled out, weakening the process of pharmacosurveillance and constituting an indicator of poor report quality.
publishDate 2015
dc.date.none.fl_str_mv 2015-02-24
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/248
10.3395/2317-269x.00248
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/248
identifier_str_mv 10.3395/2317-269x.00248
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/248/209
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 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. 3 No. 1 (2015): February; 105-115
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 1 (2015): Febrero; 105-115
Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 1 (2015): Fevereiro; 105-115
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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