Eli Iola Gurgel Andrade

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em acoes judiciais. METODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saude e a representacao dos autores junto ao Poder Judiciario. Os medicamentos foram descritos segundo registro na Agencia Nacional de Vigilância Sanitaria, essencialidade, inclusao programatica no Sistema Unico de Saude e evidencias de eficacia. RESULTADOS: Mais de 70% dos autores foram atendidos no sistema privado de saude e 60,3% foram representados por advogados particulares. O diagnostico mais frequente foi o de artrite reumatoide (23,1%) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5% dos medicamentos pleiteados nao eram registrados na Agencia, 19,6% estavam presentes na Relacao Nacional de Medicamentos Essenciais, 24,3% compunham o Programa de Medicamentos de Alto Custo e 53,9% apresentavam evidencia consistente de eficacia. Dentre os medicamentos nao disponiveis no sistema publico, 79,0% apresentavam alternativa terapeutica nos programas de assistencia farmaceutica. CONCLUSOES: O fenomeno da judicializacao na saude pode indicar falhas do sistema publico de saude, uma vez que ha solicitacoes de medicamentos constantes de suas listas. Todavia, constitui um obstaculo para a pratica do uso racional de medicamentos e para a consolidacao das premissas da Politica Nacional de Medicamentos, principalmente quando sao solicitados medicamentos sem comprovacao de eficacia e nao padronizados pelo Sistema Unico de Saude.OBJECTIVE To analyze the profile of claimants and medicines demanded in lawsuits. METHODS Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.

Avanços e desafios do acolhimento na operacionalização e qualificação do Sistema Único de Saúde na Atenção Primária: um resgate da produção bibliográfica do Brasil

The public policies adopted by the Unified Health System (SUS) in Brazil have gone through successive transformations, striving to reassert health as a universal right. The user acceptance of the guidelines of the National Humanization Policy for Care and Management of the SUS - Humanize SUS - is taking shape and relevance in Primary Healthcare (PHC) to ensure humanized access and resolution of the health demands of users and communities in Brazil. A critical analysis of the bibliographical output in Brazil from 1989 to 2009 was conducted regarding acceptance of implementation and qualification of SUS in PHC. The databases consulted were SciELO, Lilacs and Medline. The results revealed progress in broadening access to PHC services and health professionals more sensitive to the needs of users and communities. However, lack of coordination in integrated networks, excess demand, the hegemonic biomedical model, lack of training and democratic and reflexive spaces to reorganize the work process have been raising increasingly more incisive questions about the potential of this guideline for the implementation and qualification of SUS.

Perfil epidemiológico dos pacientes em terapia renal substitutiva no Brasil, 2000-2004

OBJECTIVE To describe the clinical and epidemiological profile of patients under renal replacement therapies, identifying risk factors for death. METHODS This is a non-concurrent cohort study of data for 90,356 patients in the National Renal Replacement Therapies Database. A deterministic-probabilistic linkage was performed using the Authorization System for High Complexity/Cost Procedures and the Mortality Information System databases. All patients who started dialysis between 1/1/2000 and 12/31/2004 were included and followed until death or the end of 2004. Age, sex, region of residence, primary renal disease and causes of death were analyzed. A proportional hazards model was used to identify factors associated with risk of death. RESULTS The prevalence of patients under renal replacement therapies increased an average of 5.5%, while incidence remained stable during the period. Hemodialysis was the predominant initial modality (89%). The patients were majority male with mean age 53 years, residents of the Southeast region and presented unknown causes as the main cause of chronic renal disease, followed by hypertension, diabetes and glomerulonephritis. Of these patients, 42% progressed to death and 7% underwent kidney transplantation. The patients on peritoneal dialysis were older and had higher prevalence of diabetes. The death rate varied from 7% among transplanted patients to 45% among non-transplanted patients. In the final Cox proportional hazards model, the risk of mortality was associated with increasing age, female sex, having diabetes, living in the North and Northeast region, peritoneal dialysis as a first modality and not having renal transplantation. CONCLUSIONS There was an increased prevalence of patients on renal therapy in Brazil. Increased risk of death was associated with advanced age, diabetes, the female sex, residents of the North and Northeast region and lack of renal transplant.OBJETIVO: Describir el perfil epidemiologico y clinico de pacientes en terapia renal substitutiva, identificando factores asociados al riesgo de muerte. METODOS: Estudio de observacion, prospectivo no concurrente, a partir de datos de 90.356 pacientes de la Base Nacional en Terapias Renales Substitutivas, en Brasil. Fue realizado reracionamiento deterministico-probabilistico del Sistema de Informacion de Mortalidad. Fueron incluidos todos los pacientes incidentes que iniciaron dialisis entre 1/1/2000 y 31/12/2004, acompanados hasta la muerte o final de 2004. Edad, sexo, region de residencia, enfermedad renal primaria, causa del obito fueron analizados. Se ajusto un modelo de riesgos proporcionales para identificar factores asociados al riesgo de muerte. RESULTADOS: Ocurrio un aumento promedio de 5,5% en la prevalencia de pacientes en terapia, con relacion a la incidencia se mantuvo estable en el periodo. Hemodialisis fue la modalidad inicial predominante (89%). La mayoria de los pacientes era del sexo masculino, con edad promedio de 53 anos, residente en la region Sureste y presentaba causa indeterminada como principal causa basica de la enfermedad renal cronica, seguida de la hipertension, diabetes y glomerulonefritis. De esos pacientes, 7% realizaron transplante renal y 42% evolucionaron a obito. Los pacientes en dialisis peritoneal eran mas ancianos y presentaban mayor prevalencia de diabetes. Entre los no transplantados, 45% fueron a obito y, entre los transplantadas 7%. En el modelo final de riesgos proporcionales de Cox, el riesgo de mortalidad estuvo asociado con el aumento de la edad, sexo femenino, tener diabetes, residir en la region Norte y Noreste, dialisis peritoneal como modalidad de entrada y no haber realizado transplante renal. CONCLUSIONES: Hubo aumento de la prevalencia de pacientes en terapia renal en Brasil. Pacientes con edad avanzada, diabetes, del sexo femenino, residentes en la region Norte y Noreste y sin transplante renal presentan mayor riesgo de muerte.

A construção da base de dados nacional em Terapia Renal Substitutiva (TRS) centrada no indivíduo: aplicação do método de linkage determinístico-probabilístico

Os sistemas de informação em saúde são ferramentas fundamentais para subsidiar a tomada de decisões e auxiliar a organização dos serviços, por meio do planejamento das ações e do acompanhamento e avaliação dos objetivos propostos. O sistema de saúde brasileiro tem larga experiência com a captura e o uso de informações. No entanto, Morais e Gómez (2007) fazem uma reflexão de que os atuais pressupostos, práticas e saberes de informação e informática em saúde não mais dão conta da complexidade do processo saúde/doença/cuidado, apontando algumas questões: a fragmentação dos indivíduos entre diversas bases de dados em saúde, o que acar-

Fatores associados com a qualidade de vida relacionada à saúde de idosos em hemodiálise

OBJETIVO: Identificar fatores associados a qualidade de vida relacionada a saude de pacientes idosos em hemodialise. METODOS: Estudo transversal com 223 pacientes com idade > 60 anos em hemodialise nas unidades de dialise do municipio de Belo Horizonte, MG, em 2008. A qualidade de vida foi avaliada utilizando o Kidney Disease and Quality of Life - Short Form (KDQOL-SF) e o Medical Outcome Survey - Short Form 36 (SF-36). Os tres escores do KDQOL-SF medidos foram: componente da doenca renal sumarizado (11 subescalas), componente fisico sumarizado (quatro subescalas) e componente mental sumarizado (quatro subescalas). RESULTADOS: Foram observadas associacoes negativas significativas e independentes do componente da doenca renal e mental com numero de doencas cronicas e tempo de tratamento (ambas). O componente fisico foi menor entre os mais velhos, as mulheres, aqueles com maior numero de internacoes e com tres ou mais doencas cronicas. CONCLUSOES: A associacao consistente com presenca de doencas cronicas mostra a importância do perfil de morbidade para a qualidade de vida dessa populacao. A identificacao dos fatores associados, como aumento da idade, sexo feminino, numero de internacoes e tempo de tratamento, pode favorecer o planejamento adequado das acoes de saude para melhor atender a esse grupo.

Factors associated with health-related quality of life in elderly patients on hemodialysis

OBJETIVO: Identificar fatores associados a qualidade de vida relacionada a saude de pacientes idosos em hemodialise. METODOS: Estudo transversal com 223 pacientes com idade > 60 anos em hemodialise nas unidades de dialise do municipio de Belo Horizonte, MG, em 2008. A qualidade de vida foi avaliada utilizando o Kidney Disease and Quality of Life - Short Form (KDQOL-SF) e o Medical Outcome Survey - Short Form 36 (SF-36). Os tres escores do KDQOL-SF medidos foram: componente da doenca renal sumarizado (11 subescalas), componente fisico sumarizado (quatro subescalas) e componente mental sumarizado (quatro subescalas). RESULTADOS: Foram observadas associacoes negativas significativas e independentes do componente da doenca renal e mental com numero de doencas cronicas e tempo de tratamento (ambas). O componente fisico foi menor entre os mais velhos, as mulheres, aqueles com maior numero de internacoes e com tres ou mais doencas cronicas. CONCLUSOES: A associacao consistente com presenca de doencas cronicas mostra a importância do perfil de morbidade para a qualidade de vida dessa populacao. A identificacao dos fatores associados, como aumento da idade, sexo feminino, numero de internacoes e tempo de tratamento, pode favorecer o planejamento adequado das acoes de saude para melhor atender a esse grupo.

Quality of life of patients in renal replacement therapy in Brazil: comparison of treatment modalities

PurposeThis study aimed to analyze and compare the quality of life of renal replacement therapy patients undergoing hemodialysis, peritoneal dialysis and those with renal transplantation in Brazil. In addition, we aimed to verify factors associated with patients’ quality of life and the relationship between quality of life and treatment modality, socioeconomic and demographic conditions as well as aspects related to the disease and health services.MethodsA representative sample of the dialysis units and transplant centers was obtained. Structured questionnaires were used to interview 3,036 patients in one of three treatment modalities: hemodialysis, peritoneal dialysis and renal transplant. Information was collected about socioeconomic and demographic characteristics and quality of life measures.ResultsThere were significant differences between renal transplants and both forms of dialysis for all dimensions of the SF-36. Hemodialysis patients showed better results in the dimensions of functional capacity, physical aspects and social aspects, compared to peritoneal dialysis patients. Renal transplant patients had the best mean score in the physical component of quality of life. There were no significant differences among treatment groups regarding the mental component of quality of life. The physical and mental components were associated with comorbidities and age; however, older patients had better mental quality of life but worse physical quality of life. Patients in a higher socioeconomic class and patients that were not hospitalized also reported better quality of life. Unmarried and male patients presented better physical quality of life. The dialysis units and transplant centers influenced the patients’ quality of life.ConclusionsRenal transplant patients have the best quality of life of the three treatment modalities. It is necessary to increase access to renal transplants.

Médicos, advogados e indústria farmacêutica na judicialização da saúde em Minas Gerais, Brasil

OBJETIVO: Descrever as relacoes entre medico prescritor, advogado e industria farmaceutica em acoes judiciais contra o Estado. METODOS: Estudo descritivo retrospectivo com base nas informacoes dos expedientes administrativos dos processos judiciais com demandas por medicamentos contra o Estado de Minas Gerais movidos entre outubro de 1999 e outubro de 2009. As variaveis estudadas foram: sexo, idade e doenca dos beneficiarios das acoes, origem do atendimento medico (publico ou privado), medico prescritor, tipo de representacao juridica e medicamento solicitado. Foi realizada analise descritiva das variaveis com a distribuicao de frequencias. RESULTADOS: Foram analisadas 2.412 acoes judiciais referentes a 2.880 medicamentos solicitados, com 18 farmacos diferentes. Entre esses, 12 sao fornecidos pelas politicas de assistencia farmaceutica do Sistema Unico de Saude (SUS). Os medicamentos mais solicitados foram adalimumabe, etanercepte, infliximabe e insulina glargina. As principais doencas dos beneficiarios foram artrite reumatoide, espondilite anquilosante, diabetes mellitus e doencas pulmonares obstrutivas cronicas. Houve predominio de representacao por advogados particulares e atendimento por medicos do setor privado. Entre as acoes representadas pelo escritorio A, 43,6% tiveram um unico medico prescritor para o adalimumabe e 29 medicos foram responsaveis por 40,2% dos pedidos do mesmo farmaco. Apenas um medico foi responsavel por 16,5% das prescricoes de adalimumabe, solicitado por apenas um escritorio particular de advocacia, em 44,8% dos pedidos. CONCLUSOES: A maior representatividade de medicos do setor privado e advogados particulares pode trazer prejuizo a equidade. Os dados sugerem associacao entre medicos e escritorios de advocacia nas solicitacoes dos medicamentos. Esse quadro e um indicio de que a Justica e a medicina tem sido utilizadas para atender aos interesses da industria farmaceutica.OBJECTIVE To describe the relationship between the prescribing doctor, lawyer and pharmaceutical industry in lawsuits against the state. METHODS Retrospective descriptive study based on data from administrative files, relating to lawsuits involving medicine demands, in the state of Minas Gerais, Southeastern Brazil, from October 1999 to October 2009. RESULTS A total of 2,412 lawsuits were analyzed with 2,880 medicine requests, including 18 different drugs, 12 of them provided through Pharmaceutical Policies of the Brazilian National Health System (SUS). The most frequent medicines requested included were adalimumab, etanercept, infliximab, insulin glargine and tiotropium bromide. The main diseases were rheumatoid arthritis, ankylosing spondylitis, diabetes mellitus, and chronic obstructive pulmonary disease. Private lawyers and doctors were predominant. The results revealed the association between doctors and law offices on drug requests. Among the lawsuits filed by the office A, 43.6% had a single prescriber to adalimumab, while 29 doctors were responsible for 40.2% of the same drug prescriptions. A single doctor was responsible for 16.5% of the adalimumab prescriptions, being requested through lawsuits filed by a single private law office in 44.8% of legal proceedings. CONCLUSIONS A greater representation of doctors and lawyers from the private sector can hinder equity in health. The results revealed the association between doctors and law offices on drug requests. This is an indication that justice and medical practice have been used, at certain times, to serve the interests of the pharmaceutical industry.

Acesso aos procedimentos de media e alta complexidade no Sistema Unico de Saude: uma questao de judicializacao

Lawsuits in healthcare have increased exponentially in Brazil. However, the judicialization of healthcare procedures has not been sufficiently discussed, although such a discussion could broaden the scope of healthcare assessment. This study aimed to analyze the use of court action to ensure access to outpatient and hospital procedures from 1999 to 2009 in the State of Minas Gerais, Brazil. This was a retrospective descriptive study. Procedures were classified according to the Brazilian Unified National Health System (SUS) and the Table on Unified Terminology for Private Healthcare. Coverage by the SUS was 93.5%. The largest proportions of beneficiaries of such lawsuits lived in the Central and Western regions of the country (26.4% and 24%, respectively). The most common procedures involved in such cases were clinical admissions, admission to intensive care, and cardiovascular surgery. The study highlights the emerging need for access to medium and high-complexity procedures through extensive rules for coverage.Os processos judiciais na area da saude tem crescido de forma exponencial. A judicializacao de procedimentos, no entanto, ainda nao foi discutida e pode ampliar o escopo de avaliacao da atencao a saude. O objetivo deste estudo e investigar as acoes judiciais para acesso a procedimentos ambulatoriais e hospitalares do Estado de Minas Gerais, Brasil, no periodo de 1999 a 2009. E um estudo descritivo retrospectivo. Os procedimentos foram classificados pela Tabela Unificada do SUS e pela Tabela de Terminologia Unificada da Saude Suplementar. Observou-se cobertura pelo SUS de 93,6%. A residencia dos beneficiarios localiza-se, principalmente, nas macrorregioes Centro (26,4%) e Oeste (24%). Os procedimentos mais solicitados foram internacoes em leitos comuns, Centro de Terapia Intensiva e cirurgias do aparelho circulatorio. Este estudo aponta para as necessidades emergentes de acesso aos procedimentos de media e alta complexidade, mediante uma extensa cobertura normativa.

Determinants of expenditures on dialysis in the Unified National Health System, Brazil, 2000 to 2004

The aim of this study was to compare total outpatient expenditures on hemodialysis and peritoneal dialysis from 2000 to 2004 in patients that began dialysis in 2000 under the Unified National Health System (SUS). A historical cohort was developed, consisting of patients that began dialysis in 2000, identified by probabilistic matching in the database of Authorizations for High-Complexity/High-Cost Procedures (APAC). A multiple linear regression model was used, including individual and clinical attributes and health services supply variables. The cohort included 10,899 patients, 88.5% of whom began hemodialysis and 11.5% peritoneal dialysis. The dialysis modality explains 12% of the variance in expenditures, and patients in peritoneal dialysis showed 20% higher mean annual expenditure. The differences in expenditures are explained according to the State of Brazil and health services supply level. Individual risk variables did not alter the models explanatory power, while age and diabetes mellitus were significant. The study showed the importance of the National Health Systems payment mechanism for explaining differences in expenditures on dialysis treatment in Brazil.