O crescente número de mandados judiciais impetrados contra a Secretaria de Estado de Saúde do Rio de Janeiro, Brasil, buscando acesso a medicamentos ensejou a condução do estudo. Um desenho seccional foi utilizado para descrever as ações impetradas de janeiro de 1991 a dezembro de 2002, analisando-as frente à definição de competências dentro do Sistema Único de Saúde (SUS). Utilizou-se amostra estratificada de 389 ações, tendo como base o ano de início. Os resultados sugerem demora no julgamento das ações, sendo a maioria conduzida pela defensoria pública para usuários do SUS. Os medicamentos mais solicitados foram os de ação sobre os sistemas nervoso e cardiovascular, muitos de uso contínuo. Notou-se a oficialização de práticas prescritivas, com a inclusão de medicamentos freqüentemente solicitados nas listas de financiamento público, dificultando adesão ao uso racional de medicamentos. Medicamentos da competência de fornecimento dos municípios são solicitados ao Estado, que, por sua vez, falha no repasse. A aparente falta de esclarecimento dos autores e condutores das ações gera desgaste na relação executivo-judiciário e desvio dos recursos para ações coletivas de assistência farmacêutica.
Recognition of the right to health raises two practical issues IntroduçãoAs leis e recomendações internacionais reconhecem o direito à saúde como um direito humano, estando ele incluso nas leis constitucionais de alguns países. O acesso aos medicamentos essenciais é considerado por alguns autores como integrante deste direito 1,2,3 .No Brasil, o direito à saúde está disposto nos artigos 6 o , 196 o a 200 o da Constituição Federal brasileira, como um direito social, a ser garantido por meio de políticas, que, dentre outras tarefas, devem promover e garantir o acesso universal e igualitário às ações e serviços para promoção, proteção e recuperação da saúde dos cidadãos. A Lei Orgânica da Saúde (Lei Federal nº. 8.080/90) 4 , em seus artigos 6 o e 7 o , regulamenta o sistema público de saúde, estabelecido constitucionalmente, e atribuiu ao Sistema Único de Saúde (SUS) a execução de ações de assistência terapêutica integral, inclusive farmacêutica. Desta forma, o reconhecimento da saúde como um direito possui duas importantes repercussões prá-ticas: a responsabilidade ética e legal do poder público de formular e implementar ações que assegurem o acesso da população aos serviços de atenção à saúde; e a possibilidade do cidadão reivindicar judicialmente, de forma individual ou coletiva, o cumprimento desta obrigação estatal. Os chefes dos executivos da saúde têm formulado e implementado políticas e ações de saúde, inclusive de assistência farmacêutica, por meio ARTIGO ARTICLE
A judicialização da saúde e os novos desafios da gestão da assistência farmacêutica
This article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural framework centered on the National Medicines Policy, the past three decades represent a mixture of progress and setbacks, considering the national complexities of the healthcare system and the political, economic and social changes that have influenced policy and access to medicines, which is a key concern even in the world's richest countries, as the forums of discussion on global health have demonstrated. We show that major steps forward have been taken, highlighting that the recent fiscal austerity measures imposed by the government threaten to seriously undermine social progress.
OBJECTIVE:To assess the rationality of legal suits and administrative requests requiring anticancer drugs fi led against and submitted to the São Paulo State Department of Health, in view of scientifi c evidence on effi cacy and safety. METHODS:A descriptive cross-sectional study was carried out based on information on lawsuits fi led by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest fi nancial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on effi cacy 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 scientifi c 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.
Farmacêutica, mestre em Ciências Farmacêuticas (UFRJ), doutoranda em Saúde da Criança e da Mulher (Fiocruz) e pesquisadora do Instituto Fernandes Figueira (IFF/Fiocruz) e do
OBJECTIVE:To characterize the main medical, scientifi c 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 certifi cates 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 justifi ed medicine demands may compromise rational drug use.
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