Silvio Barberato-Filho

Análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial

OBJECTIVE To analyze judicial requests for medications that are covered by the pharmaceutical assistance components of the Sistema Único de Saúde (SUS - Brazilian Unified Health System). METHODS We analyzed 81 judicial requests for medications in the State of São Paulo between 2005 and 2009. The details of these cases were obtained electronically from the Court of Justice of the State of São Paulo. Directives that regulate pharmaceutical assistance were consulted to identify judicially requested medications that are covered by the SUS. To assess the level of evidence supporting the use of these medications to treat the clinical indications described, we consulted the Thomson Micromedex® database. RESULTS The number of individual medications requested in each case ranged from 1 to 7; in total, 77 different pharmaceuticals agents were identified. Of the medications requested, 14.3% should have been available through SUS primary care, 19.5% were classified under the exceptionally dispensed medications component of the SUS, and 66.2% were not on any official list. Medications of the exceptionally dispensed medications component showed better clinical evidence when indicated for the treatment of medical conditions covered by the Clinical Protocols and Therapeutic Guidelines of Brazils Ministry of Health. CONCLUSIONS The judicial process has been used to ensure access to medications that are covered by the SUS and to request access to those that are not covered. Our assessment of the level of available evidence reinforces the need for technical analysis in the decision-making process in cases of judicially requested medications.OBJETIVO: Analisar a solicitacao judicial de medicamentos previstos nos componentes da assistencia farmaceutica no Sistema Unico de Saude. METODOS: Foram analisados 81 processos judiciais para fornecimento de medicamentos no Estado de Sao Paulo, entre 2005 e 2009. As informacoes dos processos foram obtidas do Tribunal de Justica do Estado de Sao Paulo. Portarias que regulamentam a assistencia farmaceutica foram consultadas para identificar a solicitacao judicial de medicamentos incorporados pelo Sistema Unico de Saude. Para analise do nivel de evidencia dos medicamentos nas indicacoes clinicas referidas, foi consultada a base de dados Thomson Micromedex®. RESULTADOS: O numero de medicamentos solicitados em cada processo variou entre um e sete itens, nos quais foram identificados 77 farmacos diferentes. Dos medicamentos solicitados, 14,3% deveriam estar disponiveis na atencao basica do Sistema Unico de Saude, 19,5% no componente de medicamentos de dispensacao excepcional e 66,2% nao pertenciam a nenhuma lista oficial. Medicamentos do componente de dispensacao excepcional apresentaram melhor evidencia clinica quando indicados no tratamento de doencas cobertas pelos Protocolos Clinicos e Diretrizes Terapeuticas do Ministerio da Saude. CONCLUSOES: A via judicial tem sido utilizada para garantir o acesso a medicamentos cujo fornecimento esta previsto no Sistema Unico de Saude e para solicitar aqueles nao incorporados por ele. A avaliacao do nivel de evidencia reforca a necessidade de analise tecnica para a tomada de decisao do fornecimento de medicamentos pela via judicial.

Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo segun evidencias cientificas de eficacia y seguridad. METODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplasicos solicitados por via judicial, con mayor impacto financiero para el Sistema Unico de Salud en 2006 y 2007. Los farmacos fueron evaluados considerando las evidencias clinicas de eficacia y seguridad, con base en la clasificacion de Micromedx®, metanalisis y revisiones sistematicas. 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

Perfil de prescrições e uso de antibióticos em infecções comunitárias

40 millones para atender 1.220 solicitudes, con costo promedio de R

A technical analysis of medicines request-related decision making in Brazilian courts

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 tenian evidencia para la indicacion mencionada en el pleito, lo que equivale a un gasto inadecuado de, minimo, R

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

6,8 millones. CONCLUSIONES: Los resultados refuerzan la necesidad de calificacion tecnica para tratar las demandas judiciales y exige capacitacion de los profesionales en el manejo de la literatura cientifica, en la seleccion adecuada de los farmacos y en la escogencia de la mejor conducta terapeutica para cada condicion clinica. De esta forma sera posible garantizar el acceso a tecnologias eficaces y seguras, y asi perfeccionar el modelo de asistencia farmaceutica en oncologia.

Vitamin D and respiratory infections

INTRODUCTION: The aim of this study was to find out about the patterns of antibiotic use in the municipality of Sorocaba, through evaluating the reported diagnosis and the therapy used. METHODS: An evaluation tool was applied among antibiotic users over a 12-month period. Sociodemographic data and information relating to health, diagnosis and therapeutics were gathered in relation to 403 users. RESULTS: Great present use and the greatest previous use was found in the 0-10 year-old age group (p < 0.05). Infections with lung involvement were the ones most mentioned (p < 0.05) and penicillins were the drugs most used, present in 45.1% of the prescriptions. The mean duration of therapy for otitis (8.9 days) was below the recommendation. For sinusitis, 22% of the prescriptions did not give guidance regarding recommended use (10 days). CONCLUSIONS: The lack and/or nonuse of therapeutic protocols resulted in great differences in prescription patterns, thereby leading to therapeutic failure and recurrence of infections, which were situations frequently found in this study.

Evaluation of the prescription and use of antibiotics in Brazilian children

OBJECTIVE To analyze judicial requests for medications that are covered by the pharmaceutical assistance components of the Sistema Único de Saúde (SUS - Brazilian Unified Health System). METHODS We analyzed 81 judicial requests for medications in the State of São Paulo between 2005 and 2009. The details of these cases were obtained electronically from the Court of Justice of the State of São Paulo. Directives that regulate pharmaceutical assistance were consulted to identify judicially requested medications that are covered by the SUS. To assess the level of evidence supporting the use of these medications to treat the clinical indications described, we consulted the Thomson Micromedex® database. RESULTS The number of individual medications requested in each case ranged from 1 to 7; in total, 77 different pharmaceuticals agents were identified. Of the medications requested, 14.3% should have been available through SUS primary care, 19.5% were classified under the exceptionally dispensed medications component of the SUS, and 66.2% were not on any official list. Medications of the exceptionally dispensed medications component showed better clinical evidence when indicated for the treatment of medical conditions covered by the Clinical Protocols and Therapeutic Guidelines of Brazils Ministry of Health. CONCLUSIONS The judicial process has been used to ensure access to medications that are covered by the SUS and to request access to those that are not covered. Our assessment of the level of available evidence reinforces the need for technical analysis in the decision-making process in cases of judicially requested medications.OBJETIVO: Analisar a solicitacao judicial de medicamentos previstos nos componentes da assistencia farmaceutica no Sistema Unico de Saude. METODOS: Foram analisados 81 processos judiciais para fornecimento de medicamentos no Estado de Sao Paulo, entre 2005 e 2009. As informacoes dos processos foram obtidas do Tribunal de Justica do Estado de Sao Paulo. Portarias que regulamentam a assistencia farmaceutica foram consultadas para identificar a solicitacao judicial de medicamentos incorporados pelo Sistema Unico de Saude. Para analise do nivel de evidencia dos medicamentos nas indicacoes clinicas referidas, foi consultada a base de dados Thomson Micromedex®. RESULTADOS: O numero de medicamentos solicitados em cada processo variou entre um e sete itens, nos quais foram identificados 77 farmacos diferentes. Dos medicamentos solicitados, 14,3% deveriam estar disponiveis na atencao basica do Sistema Unico de Saude, 19,5% no componente de medicamentos de dispensacao excepcional e 66,2% nao pertenciam a nenhuma lista oficial. Medicamentos do componente de dispensacao excepcional apresentaram melhor evidencia clinica quando indicados no tratamento de doencas cobertas pelos Protocolos Clinicos e Diretrizes Terapeuticas do Ministerio da Saude. CONCLUSOES: A via judicial tem sido utilizada para garantir o acesso a medicamentos cujo fornecimento esta previsto no Sistema Unico de Saude e para solicitar aqueles nao incorporados por ele. A avaliacao do nivel de evidencia reforca a necessidade de analise tecnica para a tomada de decisao do fornecimento de medicamentos pela via judicial.

Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo segun evidencias cientificas de eficacia y seguridad. METODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplasicos solicitados por via judicial, con mayor impacto financiero para el Sistema Unico de Salud en 2006 y 2007. Los farmacos fueron evaluados considerando las evidencias clinicas de eficacia y seguridad, con base en la clasificacion de Micromedx®, metanalisis y revisiones sistematicas. 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

Adherence to guidelines in the use of biological agents to treat psoriasis in Brazil

40 millones para atender 1.220 solicitudes, con costo promedio de R

Paracoccidioidomycosis: evaluation of treatment and patient profile

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 tenian evidencia para la indicacion mencionada en el pleito, lo que equivale a un gasto inadecuado de, minimo, R