Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:

Detalhes bibliográficos
Autor(a) principal: de Oliveira, Patricia
Data de Publicação: 2020
Outros Autores: Viana, Camila Cátia Vilela, Neto, Orozimbo Henriques Campos, Pereira, Giovana Gonçalves, Santos, André Soares, Zocratto, Keli Bahia Felicíssimo
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/715
Resumo: Objective: to analyze the lawsuits related to chloroquine and hydroxychloroquine, according to indications and records at the National Health Surveillance Agency (Anvisa) as well as in the Clinical Protocols and Therapeutic Guidelines (PCDT) considering the diseases that motivated the claims, under the view of the bioethics for off-label use. Methodology: a documentary, exploratory-descriptive, transversal, quantitative study. The hydroxychloroquine and chloroquine lawsuits in the last 20 years in Minas Gerais were analyzed. Descriptive analysis was performed by considering the following variables: disease; ICD-10; medicines; year of incorporation into the specialized pharmaceutical assistance component (CEAF); and year of the lawsuit. SPSS® software version 19 was used to analyze the data. Results: the corpus of 155 processes analyzed, 148 (95.5%) presented demand for 400mg hydroxychloroquine and 7 (4.5%) for 250mg chloroquine. The analyzed drugs were registered with Anvisa and off-label use was found in 8.1% for hydroxychloroquine and 14.3% for chloroquine. Discussion: the judicial demands for hydroxychloroquine and chloroquine were related to their indications registered in the package leaflet and within the PCDT. However, the presence in the study of its off-label use demonstrated that the Judiciary grants the claims, bringing bioethical implications by impacting the principles of autonomy, non-maleficence, beneficence, and justice. Conclusion: the judicialization of off-label medicine interferes in the planning, execution, and financing of public health policies, in addition to causing citizen exposure to unknown risks, when using medicines with indications not supported by scientific evidence, by Anvisa, and by the production industry itself of the medicine.
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spelling Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil: Cloroquina e hidroxicloroquina: uso fuera de lo indicado en demandas en el estado de Minas Gerais, BrasilCloroquina e hidroxicloroquina: uso off-label em processos judiciais no estado de Minas Gerais: Judicialización de la saludBioéticaHidroxicloroquinaCloroquinaJudicialização da saúde BioéticaHidroxicloroquinaCloroquinaHealth's judicializationBioethicsHydroxychloroquineChloroquineObjective: to analyze the lawsuits related to chloroquine and hydroxychloroquine, according to indications and records at the National Health Surveillance Agency (Anvisa) as well as in the Clinical Protocols and Therapeutic Guidelines (PCDT) considering the diseases that motivated the claims, under the view of the bioethics for off-label use. Methodology: a documentary, exploratory-descriptive, transversal, quantitative study. The hydroxychloroquine and chloroquine lawsuits in the last 20 years in Minas Gerais were analyzed. Descriptive analysis was performed by considering the following variables: disease; ICD-10; medicines; year of incorporation into the specialized pharmaceutical assistance component (CEAF); and year of the lawsuit. SPSS® software version 19 was used to analyze the data. Results: the corpus of 155 processes analyzed, 148 (95.5%) presented demand for 400mg hydroxychloroquine and 7 (4.5%) for 250mg chloroquine. The analyzed drugs were registered with Anvisa and off-label use was found in 8.1% for hydroxychloroquine and 14.3% for chloroquine. Discussion: the judicial demands for hydroxychloroquine and chloroquine were related to their indications registered in the package leaflet and within the PCDT. However, the presence in the study of its off-label use demonstrated that the Judiciary grants the claims, bringing bioethical implications by impacting the principles of autonomy, non-maleficence, beneficence, and justice. Conclusion: the judicialization of off-label medicine interferes in the planning, execution, and financing of public health policies, in addition to causing citizen exposure to unknown risks, when using medicines with indications not supported by scientific evidence, by Anvisa, and by the production industry itself of the medicine.Objetivo: analizar los juicios relacionados con la cloroquina y la hidroxicloroquina, de acuerdo con las indicaciones y registros de la Agencia Nacional de Vigilancia Sanitaria (Anvisa), así como en los Protocolos Clínicos y Guías Terapéuticas (PCDT), considerando las enfermedades que motivaron las reclamaciones, bajo la óptica de la bioética para uso no indicado en la etiqueta. Metodología: estudio documental, exploratorio-descriptivo, transversal, cuantitativo. Se analizaron los juicios de hidroxicloroquina y cloroquina de los últimos 20 años en Minas Gerais. Se realizó un análisis descriptivo, considerando las siguientes variables: enfermedad; ICD-10; medicamentos; año de incorporación al componente de asistencia farmacéutica especializada (CEAF); y año de la demanda. Se utilizó el software SPSS® versión 19 para analizar los datos. Resultados: de los 155 procesos analizados, 148 (95,5%) presentaron demanda de 400 mg de hidroxicloroquina y 7 (4,5%) de 250 mg de cloroquina. Los medicamentos analizados se registraron en Anvisa y el uso fuera de lo indicado se encontró en 8.1% para hidroxicloroquina y 14.3% para cloroquina. Discusión: las demandas judiciales de hidroxicloroquina y cloroquina estaban relacionadas con sus indicaciones registradas en el prospecto y dentro del PCDT. Sin embargo, la presencia en el estudio de su uso fuero de lo indicado demostró que el Poder Judicial otorga los reclamos, trayendo implicaciones bioéticas al incidir en los principios de autonomía, no maleficencia, beneficencia y justicia. Conclusión: la judicialización de los medicamentos fuera de lo indicdo interfiere en la planificación, ejecución y financiamiento de las políticas de salud pública, además de provocar la exposición ciudadana a riesgos desconocidos, al utilizar medicamentos con indicaciones no sustentadas en evidencia científica, por Anvisa y por la propia industria productora. de la medicina.Objetivo: analisar os processos judiciais relacionados à cloroquina e hidroxicloroquina, segundo indicações e registros na Agência Nacional de Vigilância Sanitária (Anvisa), bem como nos Protocolos Clínicos e Diretrizes Terapêuticas (PCDT), considerando as doenças que motivaram os pleitos, sob o olhar da bioética para o uso off-label. Metodologia: estudo documental, exploratório-descritivo, transversal, quantitativo. Foram analisados os processos judiciais por hidroxicloroquina e cloroquina, nos últimos 20 anos em Minas Gerais. Realizou-se a análise descritiva, considerando as seguintes variáveis: doença; CID-10; medicamentos; ano de incorporação no componente especializado da assistência farmacêutica (CEAF); e ano da ação judicial. Foi utilizado o software SPSS® versão 19 na análise dos dados. Resultados: dos 155 processos analisados, 148 (95,5%) apresentaram demanda por hidroxicloroquina 400mg e 7 (4,5%) por cloroquina 250mg. Os medicamentos analisados possuíam registros na Anvisa e o uso off-label foi constatado em 8,1% para hidroxicloroquina e 14,3% para cloroquina. Discussão: as demandas judiciais para a hidroxicloroquina e cloroquina estiveram relacionadas às suas indicações registradas em bula e dentro dos PCDT. No entanto, a presença no estudo de seu uso off-label demonstrou que o Judiciário defere os pleitos, trazendo implicações bioéticas ao impactar nos princípios da autonomia, não maleficência, beneficência e justiça. Conclusão: a judicialização de medicamento off-label interfere no planejamento, execução e financiamento das políticas públicas de saúde, além de causar exposição do cidadão a riscos desconhecidos, ao utilizar medicamentos com indicações não amparadas pelas evidências científicas, pela Anvisa e pela própria indústria produtora do medicamento.Fundação Oswaldo Cruz Brasília2020-12-16info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/71510.17566/ciads.v9i4.715Iberoamerican Journal of Health Law; Vol. 9 No. 4 (2020): (OCT./DEC. 2020); 102-116Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 9 Núm. 4 (2020): (OCT./DEC. 2020); 102-116Cadernos Ibero-Americanos de Direito Sanitário; v. 9 n. 4 (2020): (OUT./DEZ. 2020); 102-1162358-18242317-839610.17566/ciads.v9i4reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/715/780Copyright (c) 2020 Patricia de Oliveira, Camila Cátia Vilela Viana, Orozimbo Henriques Campos Neto, Giovana Gonçalves Pereira, André Soares Santos, Keli Bahia Felicíssimo Zocrattohttps://creativecommons.org/licenses/by-nc/4.0info:eu-repo/semantics/openAccessde Oliveira, PatriciaViana, Camila Cátia Vilela Neto, Orozimbo Henriques CamposPereira, Giovana Gonçalves Santos, André SoaresZocratto, Keli Bahia Felicíssimo de Oliveira, PatriciaViana, Camila Cátia Vilela Neto, Orozimbo Henriques CamposPereira, Giovana Gonçalves Santos, André SoaresZocratto, Keli Bahia Felicíssimo de Oliveira, PatriciaViana, Camila Cátia Vilela Neto, Orozimbo Henriques CamposPereira, Giovana Gonçalves Santos, André SoaresZocratto, Keli Bahia Felicíssimo 2021-01-25T18:14:56Zoai:ojs.cadernos.prodisa.fiocruz.br:article/715Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2021-01-25T18:14:56Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
Cloroquina e hidroxicloroquina: uso fuera de lo indicado en demandas en el estado de Minas Gerais, Brasil
Cloroquina e hidroxicloroquina: uso off-label em processos judiciais no estado de Minas Gerais:
title Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
spellingShingle Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
de Oliveira, Patricia
Judicialización de la salud
Bioética
Hidroxicloroquina
Cloroquina
Judicialização da saúde
Bioética
Hidroxicloroquina
Cloroquina
Health's judicialization
Bioethics
Hydroxychloroquine
Chloroquine
title_short Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
title_full Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
title_fullStr Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
title_full_unstemmed Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
title_sort Chloroquine and hydroxychloroquine: off-label use in lawsuits in the State of Minas Gerais, Brazil:
author de Oliveira, Patricia
author_facet de Oliveira, Patricia
Viana, Camila Cátia Vilela
Neto, Orozimbo Henriques Campos
Pereira, Giovana Gonçalves
Santos, André Soares
Zocratto, Keli Bahia Felicíssimo
author_role author
author2 Viana, Camila Cátia Vilela
Neto, Orozimbo Henriques Campos
Pereira, Giovana Gonçalves
Santos, André Soares
Zocratto, Keli Bahia Felicíssimo
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv de Oliveira, Patricia
Viana, Camila Cátia Vilela
Neto, Orozimbo Henriques Campos
Pereira, Giovana Gonçalves
Santos, André Soares
Zocratto, Keli Bahia Felicíssimo
de Oliveira, Patricia
Viana, Camila Cátia Vilela
Neto, Orozimbo Henriques Campos
Pereira, Giovana Gonçalves
Santos, André Soares
Zocratto, Keli Bahia Felicíssimo
de Oliveira, Patricia
Viana, Camila Cátia Vilela
Neto, Orozimbo Henriques Campos
Pereira, Giovana Gonçalves
Santos, André Soares
Zocratto, Keli Bahia Felicíssimo
dc.subject.por.fl_str_mv Judicialización de la salud
Bioética
Hidroxicloroquina
Cloroquina
Judicialização da saúde
Bioética
Hidroxicloroquina
Cloroquina
Health's judicialization
Bioethics
Hydroxychloroquine
Chloroquine
topic Judicialización de la salud
Bioética
Hidroxicloroquina
Cloroquina
Judicialização da saúde
Bioética
Hidroxicloroquina
Cloroquina
Health's judicialization
Bioethics
Hydroxychloroquine
Chloroquine
description Objective: to analyze the lawsuits related to chloroquine and hydroxychloroquine, according to indications and records at the National Health Surveillance Agency (Anvisa) as well as in the Clinical Protocols and Therapeutic Guidelines (PCDT) considering the diseases that motivated the claims, under the view of the bioethics for off-label use. Methodology: a documentary, exploratory-descriptive, transversal, quantitative study. The hydroxychloroquine and chloroquine lawsuits in the last 20 years in Minas Gerais were analyzed. Descriptive analysis was performed by considering the following variables: disease; ICD-10; medicines; year of incorporation into the specialized pharmaceutical assistance component (CEAF); and year of the lawsuit. SPSS® software version 19 was used to analyze the data. Results: the corpus of 155 processes analyzed, 148 (95.5%) presented demand for 400mg hydroxychloroquine and 7 (4.5%) for 250mg chloroquine. The analyzed drugs were registered with Anvisa and off-label use was found in 8.1% for hydroxychloroquine and 14.3% for chloroquine. Discussion: the judicial demands for hydroxychloroquine and chloroquine were related to their indications registered in the package leaflet and within the PCDT. However, the presence in the study of its off-label use demonstrated that the Judiciary grants the claims, bringing bioethical implications by impacting the principles of autonomy, non-maleficence, beneficence, and justice. Conclusion: the judicialization of off-label medicine interferes in the planning, execution, and financing of public health policies, in addition to causing citizen exposure to unknown risks, when using medicines with indications not supported by scientific evidence, by Anvisa, and by the production industry itself of the medicine.
publishDate 2020
dc.date.none.fl_str_mv 2020-12-16
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/715
10.17566/ciads.v9i4.715
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/715
identifier_str_mv 10.17566/ciads.v9i4.715
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/715/780
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 9 No. 4 (2020): (OCT./DEC. 2020); 102-116
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 9 Núm. 4 (2020): (OCT./DEC. 2020); 102-116
Cadernos Ibero-Americanos de Direito Sanitário; v. 9 n. 4 (2020): (OUT./DEZ. 2020); 102-116
2358-1824
2317-8396
10.17566/ciads.v9i4
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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