Medicamentos de dispensação excepcional: histórico e gastos do Ministério da Saúde do Brasil

OBJECTIVE: To describe the technical aspects of the Exceptional Circumstance Drug Dispensing Program of the Brazilian Ministry of Health, especially with respect to the cost of dispensed medication. METHODS: Technical information was obtained from the ordinances that regulate the Program. Expenditure from 2000 to 2007 was obtained from the Sistema Único de Saúde's (Unified Healthcare System) Outpatient Information System. All drugs dispensed between 1993 and 2009 and the amount and cost of each procedure were evaluated, based on information from the high-complexity procedure authorization of each of the country's states. RESULTS: The Program changed with the increase in the number of pharmacological agents and presentations distributed by, and the number of diseases contemplated in the program. In 1993, the program distributed 15 pharmacological agents in 31 distinct presentations. This number increased to 109 agents in 243 presentations in 2009. Total Ministry of Health expenditure with medications was R$1,410,181,600.74 in 2007, almost twice the amount spent in 2000, R$684,975,404.43. Diseases whose expenditure increased in the period included chronic renal insufficiency, transplantation, and hepatitis C. CONCLUSIONS: The Exceptional Circumstance Drug Dispensing Program is in constant transformation, aimed at building instruments and strategies that can ensure and expand access to medication among the population. Alternatives should be sought to decrease the financial impact of the Program to a level that does not impact other sectors of the health care system, given the high cost associated with novel interventions.OBJETIVO: Describir aspectos técnicos del Programa de Medicamentos de Dispensación en Carácter Excepcional del Ministerio de Salud de Brasil, especialmente con relación a los gastos con los medicamentos distribuidos. MÉTODOS: Los aspectos técnicos fueron obtenidos por medio de consulta a todas los reglamentos que rigen el Programa. Gastos en el período de 2000 a 2007 fueron obtenidos del Sistema de Informaciones Ambulatorias del Sistema Único de Salud. Se analizaron los medicamentos dispensados de 1993 a 2009, cantidades y valor de cada procedimiento, informado en las autorizaciones de procedimientos de alta complejidad para cada estado. RESULTADOS: El Programa cambió, con aumento del número de fármacos y presentaciones farmacéuticas distribuidas y de enfermedades contempladas. Eran distribuidos 15 fármacos en 31 diferentes presentaciones farmacéuticas en 1993, pasando para 109 fármacos en 243 presentaciones en 2009. Los gastos totales del Ministerio de Salud con medicamentos sumaron, en 2007, R$1.410.181.600,74, casi el doble del valor gastado en el año 2000: R$ 684.975.404,43. Algunas enfermedades que representaron mayor gastos en ese período fueron: insuficiencia renal crónica, trasplante y hepatitis C. CONCLUSIONES: El Programa de Medicamentos de Dispensación en Carácter Excepcional está en constante transformación, buscando mejorar los instrumentos y estrategias que aseguren y amplíen el acceso de la población a los medicamentos. Se deben buscar alternativas para reducir el impacto financiero del Programa para que no exista prejuicio hacia las otras áreas del sistema de salud, dado el costo elevado de las nuevas tecnologías.OBJETIVO: Descrever aspectos técnicos do Programa de Medicamentos de Dispensação em Caráter Excepcional do Ministério de Saúde do Brasil, especialmente em relação aos gastos com os medicamentos distribuídos. MÉTODOS: Os aspectos técnicos foram obtidos por meio de consulta a todas as portarias que regulamentaram o Programa. Gastos no período de 2000 a 2007 foram obtidos do Sistema de Informações Ambulatoriais do Sistema Único de Saúde. Foram analisados os medicamentos dispensados de 1993 a 2009, quantidades e valor de cada procedimento informados nas autorizações de procedimentos de alta complexidade para cada estado. RESULTADOS: O Programa mudou, com aumento do número de fármacos e apresentações farmacêuticas distribuídas e de doenças contempladas. Eram distribuídos 15 fármacos em 31 diferentes apresentações farmacêuticas em 1993, passando para 109 fármacos em 243 apresentações em 2009. Os gastos totais do Ministério da Saúde com medicamentos somaram, em 2007, R$1.410.181.600,74, quase o dobro do valor gasto em 2000: R$ 684.975.404,43. Algumas das doenças que representaram maiores gastos nesse período foram: insuficiência renal crônica, transplante e hepatite C. CONCLUSÕES: O Programa de Medicamentos de Dispensação em Caráter Excepcional está em constante transformação, visando aprimorar os instrumentos e estratégias que assegurem e ampliem o acesso da população aos medicamentos. Devem-se buscar alternativas para reduzir o impacto financeiro do Programa para que não haja prejuízos às outras áreas do sistema de saúde, dado o custo elevado das novas tecnologias.Universidade Federal de São Paulo (UNIFESP) Centro Paulista de Economia da SaúdeMinistério da SaúdeUNIFESP, Centro Paulista de Economia da SaúdeSciEL

Racionalidade terapêutica: elementos médico-sanitários nas demandas judiciais de medicamentos

OBJETIVO: Caracterizar os principais elementos processuais, médico-científicos e sanitários que respaldam as decisões das demandas judiciais individuais por medicamentos consideradas essenciais. MÉTODOS: Estudo descritivo retrospectivo com base em 27 ações julgadas em 2ª instância no Estado do Rio de Janeiro em 2006. Os processos originais foram solicitados ao Arquivo Central do Tribunal de Justiça do Estado do Rio de Janeiro, fotografados e analisados na íntegra. RESULTADOS: Todas as ações incluíram prescrição e atestado médicos. As prescrições estavam em desacordo com a legislação. Não houve perícia médica em nenhuma das ações e em 7,4% constavam exames complementares. Apesar da escassa informação médica contida nos autos, todos os pedidos foram deferidos. CONCLUSÕES: O acolhimento de demandas judiciais carentes de subsídios clínicos e diagnósticos traz embaraços de ordem gerencial e sanitária ao sistema de saúde, pois comprometem a assistência farmacêutica regular e fomentam o uso irracional de medicamentos.OBJETIVO: Caracterizar los principales elementos procesales, medico-científicos y sanitarios que respaldan las decisiones de las demandas judiciales individuales por medicamentos consideradas esenciales. MÉTODOS: Estudio descriptivo retrospectivo con base en 27 acciones juzgadas en 2ª instancia en el estado de Rio de Janeiro, Sureste de Brasil, en 2006. Los procesos originales fueron solicitados al Archivo Central del Tribunal de Justicia del Estado de Rio de Janeiro, fotografiados y analizados de forma íntegra. RESULTADOS: Todas las acciones incluyeron prescripción y atestados médicos. Las prescripciones estaban en desacuerdo con la legislación. No hubo pericia médica en ninguna de las acciones y en 7,4% constaban exámenes complementarios. A pesar de la escasa información médica contenida en los autos, todos los pedidos fueron deferidos. CONCLUSIONES: El acogimiento de demandas judiciales carentes de subsidios clínicos y diagnósticos trae complicaciones de tipo gerencial y sanitaria al sistema de salud, ya que comprometen la asistencia farmacéutica regular y fomentan el uso irracional de medicamentos.OBJECTIVE: To characterize the main medical, scientific and health-related procedural elements upon which decisions are made in individual lawsuits demanding medicines that are considered essential to the Court of Justice. METHODS: Retrospective descriptive study based on 27 cases ruled on by the Court of Appeals in Rio de Janeiro, Southeastern Brazil, in 2006. The original proceedings were solicited from the Central Archive of the Court of Justice of the State of Rio de Janeiro and were photographed and analyzed in full. RESULTS: Prescriptions and medical certificates were present in 100% of the lawsuits. All prescriptions lacked conformity to legislation. No expert medical reports were added, and only 7.4% of the lawsuits presented complementary examinations. In spite of the scarcity of medical information present in the records, all of the demands were granted. CONCLUSIONS: The admission of judicial demands devoid of clinical and diagnostic substantiation results in managerial and health-related constraints on the health system. Besides creating havoc in standard pharmaceutical services, badly justified medicine demands may compromise rational drug use

Inducible Nitric Oxide Synthase in Heart Tissue and Nitric Oxide in Serum of Trypanosoma cruzi-Infected Rhesus Monkeys: Association with Heart Injury

Chagas disease, a neglected tropical disease caused by the protozoan Trypanosoma cruzi, afflicts from 8 to 15 million people in the Latin America. Chronic chagasic cardiomyopathy (CCC) is the most frequent manifestation of Chagas disease. Currently, patient management only mitigates CCC symptoms. The pathogenic factors leading to CCC remain unknown; therefore their comprehension may contribute to develop more efficient therapies. In patients, high nitric oxide (NO) levels have been associated with CCC severity. In T. cruzi-infected mice, NO, mainly produced via inducible nitric oxide synthase (iNOS/NOS2), is proposed to work in parasite control. However, the participation of iNOS/NOS2 and NO in T. cruzi control and heart injury has been questioned. Here, infected rhesus monkeys and iNOS/NOS2-deficient mice were used to explore the participation of iNOS/NOS2-derived NO in heart injury in T. cruzi infection. Chronically infected monkeys presented electrical abnormalities, myocarditis and fibrosis, resembling the spectrum of human CCC. Moreover, cardiomyocyte lesion correlated with iNOS/NOS2+ cells infiltrating the cardiac tissue. Our findings support that parasite-driven iNOS/NOS2+ cells accumulation in the cardiac tissue and NO overproduction contribute to cardiomyopathy severity, mainly disturbing the pathway involved in electrical synchrony in T. cruzi infection

Influence of design and material characteristics on 3D printed flow-cells for heat transfer-based analytical devices

Redesigning 3D-printed flow cells is reported used for heat transfer based detection of biomolecules from a flow-through system to an addition-type measurement cell. The aim of this study is to assess the performance of this new measurement design and critically analyse the influence of material properties and 3D printing approach on thermal analysis. Particular attention is paid to reduce the time to stabilisation, the sample volume in order to make the technique suitable for clinical applications, and improving the sensitivity of the platform by decreasing the noise and interference of air bubbles. The three different approaches that were studied included a filament polylactic acid cell using only fused filament fabrication (FFF), a resin cell printed using stereolitography (SLA), and finally a design made of copper, which was manufactured by combining metal injection moulding (MIM) with fused filament fabrication (FFF). Computational fluid dynamic (CFD) modelling was undertaken using ANSYS Fluent V18.1 to provide insight into the flow of heat within the measurement cell, facilitating optimisation of the system and theoretical response speed. It was shown that the measurement cells using SLA had the lowest noise (~ 0.6%) and shortest measurement time (15 min), whereas measurement cells produced using other approaches had lower specificity or suffered from voiding issues. Finally, we assessed the potential of these new designs for detection of biomolecules and amoxicillin, a commonly used beta lactam antibiotic, to demonstrate the proof of concept. It can be concluded that the resin addition-type measurement cells produced with SLA are an interesting affordable alternative, which were able to detect amoxicillin with high sensitivity and have great promise for clinical applications due to the disposable nature of the measurement cells in addition to small sample volumes