Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil

Detalhes bibliográficos
Autor(a) principal: Lopes, Luciane Cruz
Data de Publicação: 2010
Outros Autores: Barberato-Filho, Silvio, Costa, Augusto Chad, Osorio-de-Castro, Claudia Garcia Serpa
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Revista de Saúde Pública
Texto Completo: https://www.revistas.usp.br/rsp/article/view/32812
Resumo: OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.
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spelling Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo Antineoplásicos^i1^sprovisão & distribuiDecisões judiciaisLegislação de MedicamentosGastos em SaúdeAssistência FarmacêuticaAgentes Antineoplásicos^i3^sprovisión & distribucDecisiones JudicialesLegislación de MedicamentosGastos en SaludServicios FarmacéuticosAntineoplastic Agents^i2^ssupply & distributJudicial DecisionsLegislationDrugHealth ExpendituresPharmaceutical Services OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology. OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17% de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones. CONCLUSIONES: Los resultados refuerzan la necesidad de calificación técnica para tratar las demandas judiciales y exige capacitación de los profesionales en el manejo de la literatura científica, en la selección adecuada de los fármacos y en la escogencia de la mejor conducta terapéutica para cada condición clínica. De esta forma será posible garantizar el acceso a tecnologías eficaces y seguras, y así perfeccionar el modelo de asistencia farmacéutica en oncología. OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17% dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões. CONCLUSÕES: Os resultados reforçam a necessidade de qualificação técnica para tratar as demandas judiciais e exige capacitação dos profissionais no manejo da literatura científica, na seleção adequada dos fármacos e na escolha da melhor conduta terapêutica para cada condição clínica. Dessa forma será possível garantir o acesso a tecnologias eficazes e seguras, e assim aprimorar o modelo de assistência farmacêutica em oncologia. Universidade de São Paulo. Faculdade de Saúde Pública2010-08-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://www.revistas.usp.br/rsp/article/view/3281210.1590/S0034-89102010000400005Revista de Saúde Pública; Vol. 44 No. 4 (2010); 620-628 Revista de Saúde Pública; Vol. 44 Núm. 4 (2010); 620-628 Revista de Saúde Pública; v. 44 n. 4 (2010); 620-628 1518-87870034-8910reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USPporenghttps://www.revistas.usp.br/rsp/article/view/32812/35330https://www.revistas.usp.br/rsp/article/view/32812/35331Copyright (c) 2017 Revista de Saúde Públicainfo:eu-repo/semantics/openAccessLopes, Luciane CruzBarberato-Filho, SilvioCosta, Augusto ChadOsorio-de-Castro, Claudia Garcia Serpa2012-07-10T02:23:17Zoai:revistas.usp.br:article/32812Revistahttps://www.revistas.usp.br/rsp/indexONGhttps://www.revistas.usp.br/rsp/oairevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2012-07-10T02:23:17Revista de Saúde Pública - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil
Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo
title Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
spellingShingle Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
Lopes, Luciane Cruz
Antineoplásicos^i1^sprovisão & distribui
Decisões judiciais
Legislação de Medicamentos
Gastos em Saúde
Assistência Farmacêutica
Agentes Antineoplásicos^i3^sprovisión & distribuc
Decisiones Judiciales
Legislación de Medicamentos
Gastos en Salud
Servicios Farmacéuticos
Antineoplastic Agents^i2^ssupply & distribut
Judicial Decisions
Legislation
Drug
Health Expenditures
Pharmaceutical Services
title_short Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
title_full Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
title_fullStr Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
title_full_unstemmed Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
title_sort Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil
author Lopes, Luciane Cruz
author_facet Lopes, Luciane Cruz
Barberato-Filho, Silvio
Costa, Augusto Chad
Osorio-de-Castro, Claudia Garcia Serpa
author_role author
author2 Barberato-Filho, Silvio
Costa, Augusto Chad
Osorio-de-Castro, Claudia Garcia Serpa
author2_role author
author
author
dc.contributor.author.fl_str_mv Lopes, Luciane Cruz
Barberato-Filho, Silvio
Costa, Augusto Chad
Osorio-de-Castro, Claudia Garcia Serpa
dc.subject.por.fl_str_mv Antineoplásicos^i1^sprovisão & distribui
Decisões judiciais
Legislação de Medicamentos
Gastos em Saúde
Assistência Farmacêutica
Agentes Antineoplásicos^i3^sprovisión & distribuc
Decisiones Judiciales
Legislación de Medicamentos
Gastos en Salud
Servicios Farmacéuticos
Antineoplastic Agents^i2^ssupply & distribut
Judicial Decisions
Legislation
Drug
Health Expenditures
Pharmaceutical Services
topic Antineoplásicos^i1^sprovisão & distribui
Decisões judiciais
Legislação de Medicamentos
Gastos em Saúde
Assistência Farmacêutica
Agentes Antineoplásicos^i3^sprovisión & distribuc
Decisiones Judiciales
Legislación de Medicamentos
Gastos en Salud
Servicios Farmacéuticos
Antineoplastic Agents^i2^ssupply & distribut
Judicial Decisions
Legislation
Drug
Health Expenditures
Pharmaceutical Services
description OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.
publishDate 2010
dc.date.none.fl_str_mv 2010-08-01
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.revistas.usp.br/rsp/article/view/32812
10.1590/S0034-89102010000400005
url https://www.revistas.usp.br/rsp/article/view/32812
identifier_str_mv 10.1590/S0034-89102010000400005
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/rsp/article/view/32812/35330
https://www.revistas.usp.br/rsp/article/view/32812/35331
dc.rights.driver.fl_str_mv Copyright (c) 2017 Revista de Saúde Pública
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2017 Revista de Saúde Pública
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Saúde Pública
publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Saúde Pública
dc.source.none.fl_str_mv Revista de Saúde Pública; Vol. 44 No. 4 (2010); 620-628
Revista de Saúde Pública; Vol. 44 Núm. 4 (2010); 620-628
Revista de Saúde Pública; v. 44 n. 4 (2010); 620-628
1518-8787
0034-8910
reponame:Revista de Saúde Pública
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Revista de Saúde Pública
collection Revista de Saúde Pública
repository.name.fl_str_mv Revista de Saúde Pública - Universidade de São Paulo (USP)
repository.mail.fl_str_mv revsp@org.usp.br||revsp1@usp.br
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