Quality of the package inserts of phytomedicines in Brazil

Detalhes bibliográficos
Autor(a) principal: da Silva, Jéssica Domingos
Data de Publicação: 2016
Outros Autores: Passos, Márcia Maria Barros dos, Simas, Naomi Kato, dos Santos, Maria Isabel Sampaio
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/677
Resumo: The objective of this study was to assess whether the package inserts of industrialized phytomedicines are in line with current Brazilian legislation or not. Forty-one package inserts of phytomedicines containing artichoke, horse chestnut, ginkgo and senna were accessed in the respective proprietary websites and then analyzed. The analysis aimed to verify the presence of items required by the normative RDC 47/2009 and the usage indication, dosage and side effects compared to standard package inserts and to the scientific literature. Quantitative analysis proved that the package inserts are in accordance with the current legislation. However, in qualitative analysis, all phytomedicines analyzed in this study had at least one error related to dosage, posology or adverse reactions. A gradual improvement of the package inserts of phytomedicines has been noticed but, even with the availability of standard package inserts, some mistakes persist, which can induce the patient to incorrect use.
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spelling Quality of the package inserts of phytomedicines in BrazilQualidade das bulas de fitoterápicos no BrasilBulas de MedicamentosFitoterápicosLegislação SanitáriaVigilância SanitáriaMedicine Package InsertsPhytomedicinesHealth LegislationHealth SurveillanceThe objective of this study was to assess whether the package inserts of industrialized phytomedicines are in line with current Brazilian legislation or not. Forty-one package inserts of phytomedicines containing artichoke, horse chestnut, ginkgo and senna were accessed in the respective proprietary websites and then analyzed. The analysis aimed to verify the presence of items required by the normative RDC 47/2009 and the usage indication, dosage and side effects compared to standard package inserts and to the scientific literature. Quantitative analysis proved that the package inserts are in accordance with the current legislation. However, in qualitative analysis, all phytomedicines analyzed in this study had at least one error related to dosage, posology or adverse reactions. A gradual improvement of the package inserts of phytomedicines has been noticed but, even with the availability of standard package inserts, some mistakes persist, which can induce the patient to incorrect use.O objetivo deste trabalho foi avaliar se as bulas de medicamentos fitoterápicos industrializados estão de acordo com a legislação nacional vigente. Foram analisadas 41 bulas dos medicamentos fitoterápicos compostos por alcachofra, castanha da Índia, ginkgo e sene, adquiridas nos sites das empresas titulares dos registros. A análise foi feita quanto à presença de itens segundo a RDC nº 47 de 2009 e ao conteúdo de indicação de uso, posologia e reações adversas comparada às bulas padrão e à literatura científica. A análise quantitativa provou que as bulas têm cumprido o que é exigido pela legislação vigente. No entanto, quanto à análise qualitativa, todos os fitoterápicos analisados neste trabalho possuíam pelo menos uma bula com erro relacionado à posologia, indicações de uso e reações adversas. Houve uma melhora gradativa das bulas dos medicamentos fitoterápicos, porém mesmo com as bulas padrão ainda existem erros, que podem induzir o paciente ao uso incorreto do medicamento.Instituto Nacional de Controle de Qualidade em Saúde2016-05-31info: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/67710.3395/2317-269x.00677Health Surveillance under Debate: Society, Science & Technology ; Vol. 4 No. 2 (2016): May; 56-64Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 4 Núm. 2 (2016): Puede; 56-64Vigil Sanit Debate, Rio de Janeiro; v. 4 n. 2 (2016): Maio; 56-642317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/677/302Copyright (c) 2016 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/openAccessda Silva, Jéssica DomingosPassos, Márcia Maria Barros dosSimas, Naomi Katodos Santos, Maria Isabel Sampaio2023-06-27T15:16:52Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/677Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:16:52Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Quality of the package inserts of phytomedicines in Brazil
Qualidade das bulas de fitoterápicos no Brasil
title Quality of the package inserts of phytomedicines in Brazil
spellingShingle Quality of the package inserts of phytomedicines in Brazil
da Silva, Jéssica Domingos
Bulas de Medicamentos
Fitoterápicos
Legislação Sanitária
Vigilância Sanitária
Medicine Package Inserts
Phytomedicines
Health Legislation
Health Surveillance
title_short Quality of the package inserts of phytomedicines in Brazil
title_full Quality of the package inserts of phytomedicines in Brazil
title_fullStr Quality of the package inserts of phytomedicines in Brazil
title_full_unstemmed Quality of the package inserts of phytomedicines in Brazil
title_sort Quality of the package inserts of phytomedicines in Brazil
author da Silva, Jéssica Domingos
author_facet da Silva, Jéssica Domingos
Passos, Márcia Maria Barros dos
Simas, Naomi Kato
dos Santos, Maria Isabel Sampaio
author_role author
author2 Passos, Márcia Maria Barros dos
Simas, Naomi Kato
dos Santos, Maria Isabel Sampaio
author2_role author
author
author
dc.contributor.author.fl_str_mv da Silva, Jéssica Domingos
Passos, Márcia Maria Barros dos
Simas, Naomi Kato
dos Santos, Maria Isabel Sampaio
dc.subject.por.fl_str_mv Bulas de Medicamentos
Fitoterápicos
Legislação Sanitária
Vigilância Sanitária
Medicine Package Inserts
Phytomedicines
Health Legislation
Health Surveillance
topic Bulas de Medicamentos
Fitoterápicos
Legislação Sanitária
Vigilância Sanitária
Medicine Package Inserts
Phytomedicines
Health Legislation
Health Surveillance
description The objective of this study was to assess whether the package inserts of industrialized phytomedicines are in line with current Brazilian legislation or not. Forty-one package inserts of phytomedicines containing artichoke, horse chestnut, ginkgo and senna were accessed in the respective proprietary websites and then analyzed. The analysis aimed to verify the presence of items required by the normative RDC 47/2009 and the usage indication, dosage and side effects compared to standard package inserts and to the scientific literature. Quantitative analysis proved that the package inserts are in accordance with the current legislation. However, in qualitative analysis, all phytomedicines analyzed in this study had at least one error related to dosage, posology or adverse reactions. A gradual improvement of the package inserts of phytomedicines has been noticed but, even with the availability of standard package inserts, some mistakes persist, which can induce the patient to incorrect use.
publishDate 2016
dc.date.none.fl_str_mv 2016-05-31
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/677
10.3395/2317-269x.00677
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/677
identifier_str_mv 10.3395/2317-269x.00677
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/677/302
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. 4 No. 2 (2016): May; 56-64
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 4 Núm. 2 (2016): Puede; 56-64
Vigil Sanit Debate, Rio de Janeiro; v. 4 n. 2 (2016): Maio; 56-64
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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