Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions
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Data de Publicação: | 2019 |
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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/1249 |
Resumo: | Introduction: Thiamine supplementation for alcohol-dependent patients is one of the most important strategies for treating alcohol withdrawal syndrome and preventing and treating more serious neurological related complications. Also, it is used as adjuvant treatment for neurological conditions in geriatric patients. A municipal sanitary surveillance service from São Paulo requested the analysis of batches of thiamine hydrochloride tablets after complaints of therapeutic inefficacy during treatment of distinct neuropsychiatric conditions. Objective: To check if the thiamine therapeutic inefficacy complaints were associated to the medications’ quality. Method: Fiscal analyses were performed including aspect, weight variation, identification and potency of thiamine hydrochloride, uniformity of unitary doses and dissolution. Results: There was no quality deviation in the medications, as all performed assays presented satisfactory results. Conclusions: The administration of quality medications is essential for obtaining expected clinical effects. Other factors not associated to the medication quality such as patients’ adherence to the treatment and poor oral absorption might be associated to the complaints. |
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Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditionsInvestigação de desvios de qualidade em comprimidos de tiamina (vitamina B1) devido à suspeita de ineficácia terapêutica no tratamento de condições neuropsiquiátricasTiaminaAnálise Fiscal de ProdutosControle de QualidadeAlcoolismoDoenças do Sistema NervosoThiamineFiscal Analysis of ProductsQuality ControlAlcoholismNervous System DiseasesIntroduction: Thiamine supplementation for alcohol-dependent patients is one of the most important strategies for treating alcohol withdrawal syndrome and preventing and treating more serious neurological related complications. Also, it is used as adjuvant treatment for neurological conditions in geriatric patients. A municipal sanitary surveillance service from São Paulo requested the analysis of batches of thiamine hydrochloride tablets after complaints of therapeutic inefficacy during treatment of distinct neuropsychiatric conditions. Objective: To check if the thiamine therapeutic inefficacy complaints were associated to the medications’ quality. Method: Fiscal analyses were performed including aspect, weight variation, identification and potency of thiamine hydrochloride, uniformity of unitary doses and dissolution. Results: There was no quality deviation in the medications, as all performed assays presented satisfactory results. Conclusions: The administration of quality medications is essential for obtaining expected clinical effects. Other factors not associated to the medication quality such as patients’ adherence to the treatment and poor oral absorption might be associated to the complaints.Introdução: A suplementação com tiamina em pacientes dependentes de álcool é uma das condutas médicas mais importantes no tratamento da síndrome de abstinência alcoólica e na profilaxia e tratamento de complicações neurológicas mais sérias, sendo também utilizada como adjuvante em quadros neurológicos em pacientes geriátricos. A Vigilância Sanitária de um município de São Paulo solicitou análise de lotes de comprimidos de cloridrato de tiamina devido a queixas técnicas de suspeita de ineficácia terapêutica no tratamento de condições neuropsiquiátricas distintas. Objetivo: Verificar se as suspeitas de ineficácia terapêutica da tiamina estavam relacionadas à qualidade dos medicamentos. Método: Foram realizadas análises fiscais contemplando ensaios de aspecto, variação de peso, identificação e teor de cloridrato de tiamina, uniformidade de doses unitárias e dissolução. Resultados: Não foram encontrados desvios de qualidade nos medicamentos, uma vez que todos os ensaios realizados apresentaram resultados satisfatórios. Conclusões: A administração de medicamentos de qualidade é indispensável para a obtenção dos efeitos clínicos esperados. Outros fatores não relacionados à qualidade dos medicamentos, como a adesão dos pacientes ao tratamento e prejuízo da absorção por via oral, podem estar relacionados às queixas.Instituto Nacional de Controle de Qualidade em Saúde2019-02-28info: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/124910.22239/2317-269X.01249Health Surveillance under Debate: Society, Science & Technology ; Vol. 7 No. 1 (2019): February; 76-80Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 7 Núm. 1 (2019): Febrero; 76-80Vigil Sanit Debate, Rio de Janeiro; v. 7 n. 1 (2019): Fevereiro; 76-802317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1249/991https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1249/1085Copyright (c) 2019 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/openAccessEserian, Jaqueline KalleianLombardo, Márcia2023-06-27T16:49:42Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1249Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T16:49:42Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions Investigação de desvios de qualidade em comprimidos de tiamina (vitamina B1) devido à suspeita de ineficácia terapêutica no tratamento de condições neuropsiquiátricas |
title |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions |
spellingShingle |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions Eserian, Jaqueline Kalleian Tiamina Análise Fiscal de Produtos Controle de Qualidade Alcoolismo Doenças do Sistema Nervoso Thiamine Fiscal Analysis of Products Quality Control Alcoholism Nervous System Diseases |
title_short |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions |
title_full |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions |
title_fullStr |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions |
title_full_unstemmed |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions |
title_sort |
Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions |
author |
Eserian, Jaqueline Kalleian |
author_facet |
Eserian, Jaqueline Kalleian Lombardo, Márcia |
author_role |
author |
author2 |
Lombardo, Márcia |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Eserian, Jaqueline Kalleian Lombardo, Márcia |
dc.subject.por.fl_str_mv |
Tiamina Análise Fiscal de Produtos Controle de Qualidade Alcoolismo Doenças do Sistema Nervoso Thiamine Fiscal Analysis of Products Quality Control Alcoholism Nervous System Diseases |
topic |
Tiamina Análise Fiscal de Produtos Controle de Qualidade Alcoolismo Doenças do Sistema Nervoso Thiamine Fiscal Analysis of Products Quality Control Alcoholism Nervous System Diseases |
description |
Introduction: Thiamine supplementation for alcohol-dependent patients is one of the most important strategies for treating alcohol withdrawal syndrome and preventing and treating more serious neurological related complications. Also, it is used as adjuvant treatment for neurological conditions in geriatric patients. A municipal sanitary surveillance service from São Paulo requested the analysis of batches of thiamine hydrochloride tablets after complaints of therapeutic inefficacy during treatment of distinct neuropsychiatric conditions. Objective: To check if the thiamine therapeutic inefficacy complaints were associated to the medications’ quality. Method: Fiscal analyses were performed including aspect, weight variation, identification and potency of thiamine hydrochloride, uniformity of unitary doses and dissolution. Results: There was no quality deviation in the medications, as all performed assays presented satisfactory results. Conclusions: The administration of quality medications is essential for obtaining expected clinical effects. Other factors not associated to the medication quality such as patients’ adherence to the treatment and poor oral absorption might be associated to the complaints. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-02-28 |
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/1249 10.22239/2317-269X.01249 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1249 |
identifier_str_mv |
10.22239/2317-269X.01249 |
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/1249/991 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1249/1085 |
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 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. 7 No. 1 (2019): February; 76-80 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 7 Núm. 1 (2019): Febrero; 76-80 Vigil Sanit Debate, Rio de Janeiro; v. 7 n. 1 (2019): Fevereiro; 76-80 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_ |
1797042045312827392 |