Judicialization effects of antineoplastic drugs in a public cancer care facility
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2022 |
| Outros Autores: | , , , |
| 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/802 |
Resumo: | Objective: to analyze the effects of lawsuits regarding the regulatory, technical, logistical and clinical aspects that impact the pharmaceutical services. Methods: descriptive and exploratory study using data from lawsuits received by a reference cancer care facility between January 2009 and December 2018, and which resulted in the supply of antineoplastic drugs. The variables were analyzed in the clinical-sanitary and regulatory-institutional dimensions and correlated to its effects on pharmaceutical services in oncology, from regulatory, logistical, technical, and clinical perspectives. Results: a total of 41 lawsuits demanded 14 different antineoplastic drugs in the period. All medicines had a valid Brazilian National Health Surveillance Agency registration, monoclonal antibodies were the most demanded and the total expenditure in the period exceeded R$ 3 million. Non-compliance with normative aspects, technical and logistical implications for the preparation of antineoplastic drugs purchased by patients with resources from lawsuits and lack of scientific evidence to support adequate decision-making were discussed as some of the judicialization effects for pharmaceutical services. Conclusion: the results made it possible to broaden the debate on the effects of health judicialization considering the basic aspects of pharmaceutical care imbricated in the routine of health services. |
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Judicialization effects of antineoplastic drugs in a public cancer care facilityEfectos de la judicialización de los fármacos antineoplásicos en un servicio público de atención oncológicaEfeitos da judicialização de medicamentos antineoplásicos nos serviços farmacêuticos em oncologiaHealth's judicializationPharmaceutical servicesRight to healthAntineoplasticsJudicialización de la saludServicios farmacéuticosDerecho a la saludAntineoplásicosJudicialização da saúdeServiços de assistência farmacêutica Direito à saúdeAntineoplásicosObjective: to analyze the effects of lawsuits regarding the regulatory, technical, logistical and clinical aspects that impact the pharmaceutical services. Methods: descriptive and exploratory study using data from lawsuits received by a reference cancer care facility between January 2009 and December 2018, and which resulted in the supply of antineoplastic drugs. The variables were analyzed in the clinical-sanitary and regulatory-institutional dimensions and correlated to its effects on pharmaceutical services in oncology, from regulatory, logistical, technical, and clinical perspectives. Results: a total of 41 lawsuits demanded 14 different antineoplastic drugs in the period. All medicines had a valid Brazilian National Health Surveillance Agency registration, monoclonal antibodies were the most demanded and the total expenditure in the period exceeded R$ 3 million. Non-compliance with normative aspects, technical and logistical implications for the preparation of antineoplastic drugs purchased by patients with resources from lawsuits and lack of scientific evidence to support adequate decision-making were discussed as some of the judicialization effects for pharmaceutical services. Conclusion: the results made it possible to broaden the debate on the effects of health judicialization considering the basic aspects of pharmaceutical care imbricated in the routine of health services.Objetivo: analizar los efectos de los juicios sobre los aspectos regulatorios, técnicos, logísticos y clínicos que impactan los servicios farmacéuticos. Metodología: estudio descriptivo y exploratorio con datos de los juicios recibidos por un centro oncológico de referencia entre enero de 2009 y diciembre de 2018 y que resultaron en el suministro de fármacos antineoplásicos. Las variables fueron analizadas en las dimensiones médico-sanitaria y político-administrativa, y correlacionado con sus efectos sobre los servicios farmacéuticos en oncología, desde las perspectivas regulatoria, logística, técnica y clínica. Resultados: un total de 41 demandas demandaron 14 antineoplásicos diferentes en el período. Todos los medicamentos tenían un registro válido de la Agencia Nacional de Vigilancia Sanitaria de Brasil, los anticuerpos monoclonales fueron los más demandados y el gasto total en el período superó los R$ 3 millones. El incumplimiento de aspectos normativos, las implicaciones técnicas y logísticas para la preparación de fármacos antineoplásicos adquiridos por pacientes con recursos de litigios y la falta de evidencia científica que sustente una adecuada toma de decisiones se discutieron como algunos de los efectos de judicialización para los servicios farmacéuticos. Conclusión: los resultados permitieron ampliar el debate sobre los efectos de la judicialización de la salud, considerando los aspectos básicos de la atención farmacéutica imbricados en la rutina de los servicios de salud.Objetivo: analisar como os efeitos das demandas judiciais quanto aos aspectos regulatório, técnico, logístico e clínico impactam os serviços farmacêuticos em oncologia. Metodologia: estudo descritivo e exploratório, utilizando dados de processos judiciais recebidos pelo Instituto Nacional do Câncer (INCA), entre janeiro de 2009 e dezembro de 2018, e que resultaram no fornecimento de antineoplásicos. As variáveis foram analisadas nas dimensões médico-sanitária e político-administrativa, e correlacionadas aos seus efeitos nos serviços farmacêuticos em oncologia, nas perspectivas regulatória, logística, técnica e clínica. Resultados: foram identificados 41 processos judiciais que demandaram 14 antineoplásicos diferentes no período. Todos os medicamentos possuíam registro válido na Agência Nacional de Vigilância Sanitária; os anticorpos monoclonais foram os mais demandados; e o gasto total no período ultrapassou R$ 3 milhões. O descumprimento de aspectos normativos; as implicações técnicas e logísticas para preparo de antineoplásicos adquiridos pelos pacientes com recursos advindos de demandas judiciais; e a insuficiência de evidências científicas que suportem a adequada tomada de decisão foram alguns dos efeitos da judicialização para os serviços farmacêuticos em oncologia. Conclusão: os resultados permitiram ampliar o debate sobre os efeitos da judicialização da saúde, considerando aspectos basilares da assistência farmacêutica imbricados na rotina dos serviços de saúde.Fundação Oswaldo Cruz Brasília2022-03-15info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/80210.17566/ciads.v11i1.802Iberoamerican Journal of Health Law; Vol. 11 No. 1 (2022): (JAN./MAR. 2022); 163-182Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 11 Núm. 1 (2022): (ENE./MAR. 2022); 163-182Cadernos Ibero-Americanos de Direito Sanitário; v. 11 n. 1 (2022): (JAN./MAR. 2022); 163-1822358-18242317-839610.17566/ciads.v11i1reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/802/884Copyright (c) 2022 Felipe Felizardo Mattos Vieira, Thais Jeronimo Vidal, Mario Jorge Sobreira da Silva, Luiz Eduardo Chauvet, Elaine Lazzaroni Moraes (Autor)https://creativecommons.org/licenses/by-nc-sa/4.0info:eu-repo/semantics/openAccessVieira, Felipe Felizardo Mattos Vidal, Thais Jeronimoda Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni Vieira, Felipe Felizardo Mattos Vidal, Thais Jeronimoda Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni Vieira, Felipe Felizardo Mattos Vidal, Thais Jeronimoda Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni 2022-10-17T17:54:16Zoai:ojs.cadernos.prodisa.fiocruz.br:article/802Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2022-10-17T17:54:16Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.none.fl_str_mv |
Judicialization effects of antineoplastic drugs in a public cancer care facility Efectos de la judicialización de los fármacos antineoplásicos en un servicio público de atención oncológica Efeitos da judicialização de medicamentos antineoplásicos nos serviços farmacêuticos em oncologia |
| title |
Judicialization effects of antineoplastic drugs in a public cancer care facility |
| spellingShingle |
Judicialization effects of antineoplastic drugs in a public cancer care facility Vieira, Felipe Felizardo Mattos Health's judicialization Pharmaceutical services Right to health Antineoplastics Judicialización de la salud Servicios farmacéuticos Derecho a la salud Antineoplásicos Judicialização da saúde Serviços de assistência farmacêutica Direito à saúde Antineoplásicos |
| title_short |
Judicialization effects of antineoplastic drugs in a public cancer care facility |
| title_full |
Judicialization effects of antineoplastic drugs in a public cancer care facility |
| title_fullStr |
Judicialization effects of antineoplastic drugs in a public cancer care facility |
| title_full_unstemmed |
Judicialization effects of antineoplastic drugs in a public cancer care facility |
| title_sort |
Judicialization effects of antineoplastic drugs in a public cancer care facility |
| author |
Vieira, Felipe Felizardo Mattos |
| author_facet |
Vieira, Felipe Felizardo Mattos Vidal, Thais Jeronimo da Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni |
| author_role |
author |
| author2 |
Vidal, Thais Jeronimo da Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni |
| author2_role |
author author author author |
| dc.contributor.author.fl_str_mv |
Vieira, Felipe Felizardo Mattos Vidal, Thais Jeronimo da Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni Vieira, Felipe Felizardo Mattos Vidal, Thais Jeronimo da Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni Vieira, Felipe Felizardo Mattos Vidal, Thais Jeronimo da Silva, Mario Jorge Sobreira Chauvet, Luiz Eduardo Moraes, Elaine Lazzaroni |
| dc.subject.por.fl_str_mv |
Health's judicialization Pharmaceutical services Right to health Antineoplastics Judicialización de la salud Servicios farmacéuticos Derecho a la salud Antineoplásicos Judicialização da saúde Serviços de assistência farmacêutica Direito à saúde Antineoplásicos |
| topic |
Health's judicialization Pharmaceutical services Right to health Antineoplastics Judicialización de la salud Servicios farmacéuticos Derecho a la salud Antineoplásicos Judicialização da saúde Serviços de assistência farmacêutica Direito à saúde Antineoplásicos |
| description |
Objective: to analyze the effects of lawsuits regarding the regulatory, technical, logistical and clinical aspects that impact the pharmaceutical services. Methods: descriptive and exploratory study using data from lawsuits received by a reference cancer care facility between January 2009 and December 2018, and which resulted in the supply of antineoplastic drugs. The variables were analyzed in the clinical-sanitary and regulatory-institutional dimensions and correlated to its effects on pharmaceutical services in oncology, from regulatory, logistical, technical, and clinical perspectives. Results: a total of 41 lawsuits demanded 14 different antineoplastic drugs in the period. All medicines had a valid Brazilian National Health Surveillance Agency registration, monoclonal antibodies were the most demanded and the total expenditure in the period exceeded R$ 3 million. Non-compliance with normative aspects, technical and logistical implications for the preparation of antineoplastic drugs purchased by patients with resources from lawsuits and lack of scientific evidence to support adequate decision-making were discussed as some of the judicialization effects for pharmaceutical services. Conclusion: the results made it possible to broaden the debate on the effects of health judicialization considering the basic aspects of pharmaceutical care imbricated in the routine of health services. |
| publishDate |
2022 |
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2022-03-15 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/802 10.17566/ciads.v11i1.802 |
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https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/802 |
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10.17566/ciads.v11i1.802 |
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por |
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por |
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https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/802/884 |
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https://creativecommons.org/licenses/by-nc-sa/4.0 info:eu-repo/semantics/openAccess |
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https://creativecommons.org/licenses/by-nc-sa/4.0 |
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Fundação Oswaldo Cruz Brasília |
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Fundação Oswaldo Cruz Brasília |
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Iberoamerican Journal of Health Law; Vol. 11 No. 1 (2022): (JAN./MAR. 2022); 163-182 Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 11 Núm. 1 (2022): (ENE./MAR. 2022); 163-182 Cadernos Ibero-Americanos de Direito Sanitário; v. 11 n. 1 (2022): (JAN./MAR. 2022); 163-182 2358-1824 2317-8396 10.17566/ciads.v11i1 reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ) |
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