Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil

Detalhes bibliográficos
Autor(a) principal: Passos, Márcia Maria Barros dos
Data de Publicação: 2022
Outros Autores: Pimenta, Thamires Lemos, Oliveira, Danilo Ribeiro de, Freitas, Zaida Maria Faria de, Monteiro, Mariana Sato de Souza Bustamante
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/1996
Resumo: Introduction: Compounded drug is a pharmaceutical preparation obtained by a pharmacotechnical procedure from a prescription of a qualified professional intended for an individualized patient, or whose formula is registered in the National or International Form. Objective: To describe  the profile of notifications related to compounded drugs, reported to the National Health Surveillance Notification  System (Notivisa). Method: Descriptive exploratory study, retrospective to the period 2006-2016, of the notifications of compounded drugs reported to Notivisa. Data were recorded and analyzed using the Excel program, version for Windows 3.5.4. Results: Of a total of 108,400 notifications referring to medicines in the studied period, 335 (0.32%) were related to reports of compounded drugs. Technical complaints (QT) obtained 90.40% of the notifications, while adverse events (AE) obtained 9.60%. The Southeast region was the main notifier (66.00%), and the state of São Paulo was responsible for 54.00% of the total notifications. Hospitals were the institutions with the highest frequency of notification (81.00%). It was possible to evaluate the reasons that generated the notifications, of which the  changes related to the aspect of the pharmaceutical preparation were the predominant among the QT, while for the AEs, the adverse drug reactions stood out. Conclusions: The occurrences observed in the pharmacovigilance of compounded drugs are specific to each product with its particularities, although, what is sought is a pattern. In this way, such observation can prevent the occurrence of damages to the population exposed to similar situations, if it is duly notified and widely disseminated.
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spelling Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in BrazilFarmacovigilância de medicamentos manipulados - Parte 2: notificações de eventos adversos e queixas técnicas no BrasilFarmacovigilânciaMedicamento ManipuladoFarmácia de ManipulaçãoFarmacovigilância de Farmácias MagistraisPharmacovigilanceCompounded DrugPharmaceutical Compounding ServiceIntroduction: Compounded drug is a pharmaceutical preparation obtained by a pharmacotechnical procedure from a prescription of a qualified professional intended for an individualized patient, or whose formula is registered in the National or International Form. Objective: To describe  the profile of notifications related to compounded drugs, reported to the National Health Surveillance Notification  System (Notivisa). Method: Descriptive exploratory study, retrospective to the period 2006-2016, of the notifications of compounded drugs reported to Notivisa. Data were recorded and analyzed using the Excel program, version for Windows 3.5.4. Results: Of a total of 108,400 notifications referring to medicines in the studied period, 335 (0.32%) were related to reports of compounded drugs. Technical complaints (QT) obtained 90.40% of the notifications, while adverse events (AE) obtained 9.60%. The Southeast region was the main notifier (66.00%), and the state of São Paulo was responsible for 54.00% of the total notifications. Hospitals were the institutions with the highest frequency of notification (81.00%). It was possible to evaluate the reasons that generated the notifications, of which the  changes related to the aspect of the pharmaceutical preparation were the predominant among the QT, while for the AEs, the adverse drug reactions stood out. Conclusions: The occurrences observed in the pharmacovigilance of compounded drugs are specific to each product with its particularities, although, what is sought is a pattern. In this way, such observation can prevent the occurrence of damages to the population exposed to similar situations, if it is duly notified and widely disseminated.Introdução: Medicamento manipulado é a preparação farmacêutica obtido por procedimento farmacotécnico a partir de uma prescrição de profissional habilitado destinada a um paciente individualizado ou cuja fórmula esteja inscrita no Formulário Nacional ou Internacional. Objetivo: Descrever o perfil das notificações relacionadas aos medicamentos manipulados, reportadas ao Sistema Nacional de Notificação em Vigilância Sanitária (Notivisa). Método: Estudo exploratório descritivo, retrospectivo ao período de 2006-2016 das notificações de medicamentos manipulados reportadas ao Notivisa. Os dados foram registrados e analisados no programa Excel versão para Windows 3.5.4. Resultados: De um total de 108.400 notificações referentes a medicamentos no período estudado, 335 (0,32%) foram relacionadas a notificações de medicamentos manipulados. As queixas técnicas (QT) obtiveram 90,40% das notificações, enquanto os eventos adversos (EA) obtiveram 9,60%. A Região Sudeste foi a principal notificadora (66,00%) e o estado de São Paulo, responsável por 54,00% do total das notificações. Os hospitais foram as instituições com maior frequência de notificação (81,00%). Foi possível avaliar os motivos que geraram as notificações, das quais as alterações relacionadas ao aspecto da preparação farmacêutica foram as predominantes dentre as QT, enquanto para os EA destacaram-se as reações adversas a medicamentos. Conclusões: As ocorrências observadas na farmacovigilância de medicamentos manipulados são próprias de cada produto com suas particularidades, embora o que se busque seja um padrão. Desta forma,tal observação poderá prevenir a ocorrência de danos à população exposta a situações semelhantes, se for devidamente notificada e amplamente divulgada.Instituto Nacional de Controle de Qualidade em Saúde2022-08-31info: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/199610.22239/2317-269x.01996Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 3 (2022): August; 38-45Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 3 (2022): Agosto; 38-45Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 3 (2022): Agosto; 38-452317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1996/1439https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1996/1517Copyright (c) 2022 Márcia Maria Barros dos Passos, Thamires Lemos Pimenta, Danilo Ribeiro de Oliveira, Zaida Maria Faria de Freitas, Mariana Sato de Souza Bustamante Monteirohttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessPassos, Márcia Maria Barros dosPimenta, Thamires LemosOliveira, Danilo Ribeiro deFreitas, Zaida Maria Faria deMonteiro, Mariana Sato de Souza Bustamante2023-09-01T13:53:34Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1996Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-09-01T13:53:34Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
Farmacovigilância de medicamentos manipulados - Parte 2: notificações de eventos adversos e queixas técnicas no Brasil
title Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
spellingShingle Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
Passos, Márcia Maria Barros dos
Farmacovigilância
Medicamento Manipulado
Farmácia de Manipulação
Farmacovigilância de Farmácias Magistrais
Pharmacovigilance
Compounded Drug
Pharmaceutical Compounding Service
title_short Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
title_full Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
title_fullStr Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
title_full_unstemmed Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
title_sort Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
author Passos, Márcia Maria Barros dos
author_facet Passos, Márcia Maria Barros dos
Pimenta, Thamires Lemos
Oliveira, Danilo Ribeiro de
Freitas, Zaida Maria Faria de
Monteiro, Mariana Sato de Souza Bustamante
author_role author
author2 Pimenta, Thamires Lemos
Oliveira, Danilo Ribeiro de
Freitas, Zaida Maria Faria de
Monteiro, Mariana Sato de Souza Bustamante
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Passos, Márcia Maria Barros dos
Pimenta, Thamires Lemos
Oliveira, Danilo Ribeiro de
Freitas, Zaida Maria Faria de
Monteiro, Mariana Sato de Souza Bustamante
dc.subject.por.fl_str_mv Farmacovigilância
Medicamento Manipulado
Farmácia de Manipulação
Farmacovigilância de Farmácias Magistrais
Pharmacovigilance
Compounded Drug
Pharmaceutical Compounding Service
topic Farmacovigilância
Medicamento Manipulado
Farmácia de Manipulação
Farmacovigilância de Farmácias Magistrais
Pharmacovigilance
Compounded Drug
Pharmaceutical Compounding Service
description Introduction: Compounded drug is a pharmaceutical preparation obtained by a pharmacotechnical procedure from a prescription of a qualified professional intended for an individualized patient, or whose formula is registered in the National or International Form. Objective: To describe  the profile of notifications related to compounded drugs, reported to the National Health Surveillance Notification  System (Notivisa). Method: Descriptive exploratory study, retrospective to the period 2006-2016, of the notifications of compounded drugs reported to Notivisa. Data were recorded and analyzed using the Excel program, version for Windows 3.5.4. Results: Of a total of 108,400 notifications referring to medicines in the studied period, 335 (0.32%) were related to reports of compounded drugs. Technical complaints (QT) obtained 90.40% of the notifications, while adverse events (AE) obtained 9.60%. The Southeast region was the main notifier (66.00%), and the state of São Paulo was responsible for 54.00% of the total notifications. Hospitals were the institutions with the highest frequency of notification (81.00%). It was possible to evaluate the reasons that generated the notifications, of which the  changes related to the aspect of the pharmaceutical preparation were the predominant among the QT, while for the AEs, the adverse drug reactions stood out. Conclusions: The occurrences observed in the pharmacovigilance of compounded drugs are specific to each product with its particularities, although, what is sought is a pattern. In this way, such observation can prevent the occurrence of damages to the population exposed to similar situations, if it is duly notified and widely disseminated.
publishDate 2022
dc.date.none.fl_str_mv 2022-08-31
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/1996
10.22239/2317-269x.01996
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1996
identifier_str_mv 10.22239/2317-269x.01996
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/1996/1439
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1996/1517
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. 3 (2022): August; 38-45
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 3 (2022): Agosto; 38-45
Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 3 (2022): Agosto; 38-45
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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