Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review
Autor(a) principal: | |
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Data de Publicação: | 2022 |
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/1922 |
Resumo: | Introduction: Substandard drugs (SD) present great relevance in the area of pharmacovigilance and should be investigated and monitored as they can lead to several clinical outcomes. Objective: To discuss the characteristics of SD in the area of pharmacovigilance through a narrative review. Method: A comprehensive search was performed on databases using the descriptors “pharmacovigilance”, “technical complaints (TC)”, “SD” and “notification systems” including studies directly concerning the subject conducted in Brazil and published between 2005 and 2020. Results: SD issues might be associated with drug product alterations, content and integrity of the package and labeling. Among the 18 selected studies (14 articles, two book chapters and two dissertations) regarding SD notifications reported as drug TC, two exclusively evaluated drug TC notifications (100.0%), while the rest showed that this type of notification represented 0.6% to 70.0% of the total of notifications made in national health establishments. The main SD issues found were: alterations on the product aspect; absence/reduction in the amount of drug product; and, package problems. Conclusions: Notifications involving SD issues are considered an excellent quality indicator for the drugs available in the market, which contributes to suppliers’ qualification and provision of consistent products for the population. |
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Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative reviewCaracterização e representatividade dos desvios da qualidade de medicamentos no âmbito da farmacovigilância: uma revisão narrativaPharmacovigilanceNotificationQuality ControlPharmaceutical PreparationsFarmacovigilânciaNotificaçãoControle de QualidadePreparações FarmacêuticasVigilância sanitáriaMedicamentosDesvios da qualidadeIntroduction: Substandard drugs (SD) present great relevance in the area of pharmacovigilance and should be investigated and monitored as they can lead to several clinical outcomes. Objective: To discuss the characteristics of SD in the area of pharmacovigilance through a narrative review. Method: A comprehensive search was performed on databases using the descriptors “pharmacovigilance”, “technical complaints (TC)”, “SD” and “notification systems” including studies directly concerning the subject conducted in Brazil and published between 2005 and 2020. Results: SD issues might be associated with drug product alterations, content and integrity of the package and labeling. Among the 18 selected studies (14 articles, two book chapters and two dissertations) regarding SD notifications reported as drug TC, two exclusively evaluated drug TC notifications (100.0%), while the rest showed that this type of notification represented 0.6% to 70.0% of the total of notifications made in national health establishments. The main SD issues found were: alterations on the product aspect; absence/reduction in the amount of drug product; and, package problems. Conclusions: Notifications involving SD issues are considered an excellent quality indicator for the drugs available in the market, which contributes to suppliers’ qualification and provision of consistent products for the population.Introdução: Os desvios da qualidade de medicamentos (DQM) apresentam grande relevância no âmbito da farmacovigilância, devendo ser investigados e monitorados, uma vez que podem levar a uma grande variedade de desfechos clínicos. Objetivo: Discutir sobre a caracterização dos DQM no âmbito da farmacovigilância por meio de uma revisão narrativa da literatura. Método: Foi realizada uma busca abrangente em bases de dados utilizando-se os descritores: “farmacovigilância”, “queixas técnicas (QT)”, “DQM” e “sistemas de notificação”, incluindo estudos relacionados diretamente ao tema proposto, realizados no Brasil e publicados no período de 2005 a 2020. Resultados: Os DQM podem estar relacionados a alterações no próprio medicamento, ao conteúdo e integridade da embalagem e à rotulagem. Dos 18 estudos selecionados (14 artigos, dois capítulos de livro e duas dissertações) contendo notificações de DQM na forma de QT de medicamentos, dois avaliaram exclusivamente notificações de QT de medicamentos (100,0%), enquanto o restante apontou que estas representavam de 0,6% a 70,0% do total de notificações realizadas em estabelecimentos de saúde do país. Os principais DQM evidenciados foram alterações no aspecto do produto, ausência/redução na quantidade do medicamento e problemas nas embalagens. Conclusões: Considera-se que as notificações envolvendo DQM representem um excelente indicador de qualidade dos medicamentos disponíveis no mercado, vindo a contribuir na qualificação de fornecedores e distribuição de produtos conformes à população.Instituto Nacional de Controle de Qualidade em Saúde2022-05-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/192210.22239/2317-269x.01922Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 2 (2022): May; 93-102Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 2 (2022): Puede; 93-102Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 2 (2022): Maio; 93-1022317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1922/1403https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1922/1431Copyright (c) 2022 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologiahttps://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessKalleian Eserian, Jaqueline 2023-06-27T15:14:22Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1922Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:14:22Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review Caracterização e representatividade dos desvios da qualidade de medicamentos no âmbito da farmacovigilância: uma revisão narrativa |
title |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review |
spellingShingle |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review Kalleian Eserian, Jaqueline Pharmacovigilance Notification Quality Control Pharmaceutical Preparations Farmacovigilância Notificação Controle de Qualidade Preparações Farmacêuticas Vigilância sanitária Medicamentos Desvios da qualidade |
title_short |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review |
title_full |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review |
title_fullStr |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review |
title_full_unstemmed |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review |
title_sort |
Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review |
author |
Kalleian Eserian, Jaqueline |
author_facet |
Kalleian Eserian, Jaqueline |
author_role |
author |
dc.contributor.author.fl_str_mv |
Kalleian Eserian, Jaqueline |
dc.subject.por.fl_str_mv |
Pharmacovigilance Notification Quality Control Pharmaceutical Preparations Farmacovigilância Notificação Controle de Qualidade Preparações Farmacêuticas Vigilância sanitária Medicamentos Desvios da qualidade |
topic |
Pharmacovigilance Notification Quality Control Pharmaceutical Preparations Farmacovigilância Notificação Controle de Qualidade Preparações Farmacêuticas Vigilância sanitária Medicamentos Desvios da qualidade |
description |
Introduction: Substandard drugs (SD) present great relevance in the area of pharmacovigilance and should be investigated and monitored as they can lead to several clinical outcomes. Objective: To discuss the characteristics of SD in the area of pharmacovigilance through a narrative review. Method: A comprehensive search was performed on databases using the descriptors “pharmacovigilance”, “technical complaints (TC)”, “SD” and “notification systems” including studies directly concerning the subject conducted in Brazil and published between 2005 and 2020. Results: SD issues might be associated with drug product alterations, content and integrity of the package and labeling. Among the 18 selected studies (14 articles, two book chapters and two dissertations) regarding SD notifications reported as drug TC, two exclusively evaluated drug TC notifications (100.0%), while the rest showed that this type of notification represented 0.6% to 70.0% of the total of notifications made in national health establishments. The main SD issues found were: alterations on the product aspect; absence/reduction in the amount of drug product; and, package problems. Conclusions: Notifications involving SD issues are considered an excellent quality indicator for the drugs available in the market, which contributes to suppliers’ qualification and provision of consistent products for the population. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-05-31 |
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/1922 10.22239/2317-269x.01922 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1922 |
identifier_str_mv |
10.22239/2317-269x.01922 |
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/1922/1403 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1922/1431 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2022 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia https://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2022 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia https://creativecommons.org/licenses/by-nc/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. 2 (2022): May; 93-102 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 2 (2022): Puede; 93-102 Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 2 (2022): Maio; 93-102 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 |
_version_ |
1797042046556438528 |