Evaluation of demands of inclusion, exclusion and alteration of technologies in the Brazilian Health System submitted to the National Committee on Technology Incorporation

ABSTRACT The steady increase in the number of health technologies and advances in associated research generate management challenges in the choice of technologies to be made available to the public. From 2011, the process of inclusion, exclusion and alteration of technologies to the Brazilian Unified Health System (SUS) has undergone major transformations, such as the creation of the National Committee on Technology Incorporation (CONITEC). This study analyzed the decisions of CONITEC since its inception until July 2015. The analyzed variables were: type of technology, reason for application, name of the technology, indication, claimant and CONITEC decision status. We found that the Government was the main claimant, accounting for 58.1% of the 420 cases. The most frequent request was inclusion (93.8%) and the technology type was medicine (61.4%). Of the incorporated medicines, the classes of antineoplastic/immunomodulatory were the most frequent (39.47%). Society's desire for inclusion of an increasing amount of health technology contrasts with the limited resources available to management, which causes budget concerns. Using Health Technology Assessment (HTA), advances resulting from these innovations in the process were highlighted, and challenges were identified for the management and the academic community

A model for drug dispensing service based on the care process in the Brazilian health system

Access to medication emphasizes the availability of the product at the expense of providing a service. The goal of this paper is to propose a theoretical model for a drug dispensing service, beginning with a reflection on the current realities of the Unified Health System and drug dispensation in Brazil. A conceptual analytical research made by a methodological course called disciplined imagination was mainly the approach applied to develop the model. The drug dispensing service is part of the care process, which considers access as an attribute; reception, connection and accountability, management, and clinical pharmaceutical aspects as components; and the rational use of drugs as the purpose. The proposed model addresses access to the dispensing service and demands a reorientation of routines, instruments, and practices.O acesso a medicamentos enfatiza a disponibilidade do produto em detrimento da provisão de um serviço. O objetivo deste trabalho é propor um modelo teórico para um serviço de dispensação de medicamentos, iniciando com uma reflexão sobre a realidade atual do Sistema Único de Saúde e a dispensação de medicamentos no Brasil. Uma pesquisa analítica conceitual realizada por meio de um percurso metodológico chamado de imaginação disciplinada constituiu a estratégia principal para o desenvolvimento do modelo. O serviço de dispensação é parte do processo de cuidado, o qual considera o acesso como um atributo; os aspectos acolhimento, vínculo e responsabilização, gestão e clínica farmacêutica como componentes e o uso racional de medicamentos como o propósito. O modelo proposto direciona o acesso para o serviço de dispensação e demanda a reorientação de rotinas, instrumentos e práticas

Understanding the political framework of biopharmaceutical development in Brazil: the case of monoclonal antibodies

Over the last three decades, some industrialized countries have implemented a set of scientific, technological, and industrial policies to improve the economic landscape of the new emerging biopharmaceutical industry. Biopharmaceuticals generally refers to medicines developed using biotechnological methods (such as the culture of cells from mice and other mammals, cultivated under rigorous quality controls and best practices), as well as drugs produced using DNA technologies and genomic and proteomic techniques (Ecker et al., 2015). This article aims to provide an introductory analysis of the political framework under implementation for the development and manufacturing of the so-called Monoclonal Antibodies (mAbs) in Brazil. We conducted a documental research on articles available in the Web of Science and reports and website information of federal governmental agencies. We also applied 28 interviews with the main stakeholders involved in the Brazilian mAbs biopharmaceutical development agenda

Incomplete Medical Record In Emergency Service: A Barrier For The Quality In Health [prontuário Incompleto No Pronto-socorro: Uma Barreira Para A Qualidade Em Saúde]

Purpose: scrutinize the filling of medical records in Ophthalmology emergency services, in order to provide grounds for the evaluation of the service quality. Materials and methods: we have analyzed the filling of medical records (administrative forms) by the residents of the Emergency Service of the "Hospital das Clínicas" of the Medical School of São Paulo University, during a regular week on duty. Results: the sample was composed of 584 medical records. In 57 (9,8%) the destination of the patients was not mentioned; in 16 (2,7%) the name of the medical doctor who attended the patient was not mentioned; in 15 (2,6%) the attending medical doctor did not provide the respective enrollment number at the Regional Medicine Council. As regards the diagnosis, to 6,0% the handwriting of the attending medical doctor was illegible and to 6,3% only the Disease International Code was mentioned. To 33,4% the anamnesis was not mentioned at the medical record (including eye trauma cases). Conclusion: we have found mistakes at the filling of medical records in an ophthalmology urgency college service, that may cause problems to the hospital and even to the medical doctor, by lack of payment of the services rendered, by decreasing patterns of quality of the medical care, by the impossibility of defense in case of litigation founded on medical malpractice and by deficiencies on education and research. © Copyright Moreira Jr. Editora.667218222Schout, D., Novaes, H.M.D., Do registro ao indicador: Gestão da produção da informação assistencial nos hospitais (2007) Ciência & Saúde Coletiva, 12 (4), pp. 935-944Silva, F.G., Tavares-Neto, J., Avaliação dos prontuários médicos de hospitais de ensino do Brasil (2007) Rev Bras de Educação Médica, 31 (2), pp. 113-126Resolução no 1331 de 21 de setembro de 1989. Dispõe sobre o prontuário médico Diário Oficial Da União, p. 17145. , Conselho Federal de Medicina. Brasília - DFOs Prontuários Dos Pacientes No HC-FMUSP, , Comissão de Análise de Prontuários e Óbitos - CAPO/ Diretoria Clinica. Comissões Executivas de Análise de Prontuários e Óbitos - CEAPOs dos InstitutosBittar, O.J.N.U., Aspectos legais do prontuário médico no Brasil (1980) Rev Paulista de Hospitais, , agosto deNovaes, H.M.D., Avaliação de Programas, Serviços e Tecnologias em Saúde (2000) Rev Saúde Pública, 34 (5), pp. 547-559Damasceno, M.C.T., Aspectos Ético-Legais no Pronto-Socorro (2006) Pronto Socorro - Condutas Do Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo, pp. 16-22. , Martins HS, Damasceno MCT, Awada SB. São Paulo: Manoele Ltda;Rotta, G.S.C., Palocci, P.A., Rocha, F.L.R., Pereira, R.M., Bittar, O.J.N.V., Diretrizes: Metas e medidas para a obtenção da qualidade do prontuário (2003) Rev Adm Saúde, 5 (20), pp. 17-23Kara Jr., N., Zanatto, M.C., Villaça, V.T.N., Nagamati, L.T., Kara-José, N., Aspectos médicos e sociais no atendimento oftalmológico de urgêneia (2001) Arq. Bras. Oftalmol., 64, pp. 39-43Carvalho, R.S., (2007) Conduta Leiga e Assistência Médica Em Pacientes Do Pronto-Socorro de Oftalmologia Do Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo, [Tese], , São Paulo: Faculdade de Medicina, Universidade de São Paulo;Tanaka, O.U., Melo, C., (2001) Avaliação de Programas de Saúde Do Adolescente. Um Modo de Fazer, , São Paulo: EDUSP;Parecer Sobre Demanda Crescente Do Atendimento No Pronto-socorro e Ambulatório Frente à Assistência Adequada [On Line], , http://www.hcnet.usp.br/adm/dc/cobi/parecer/parecer_04_2004.pdf, Universidade de São Paulo. Faculdade de Medicina. Parecer CoBi no. 004/2004. São Paulo: HCnet2004 [citado08/01/2007]. Disponível emEstatística, , http://www.ichc.hcnet.usp.br/subportais/raiz/Arquivos/Estatistica/2006/ ps2006.xls, Universidade de São Paulo. Faculdade de Medicina. Hospital das Clinicas. [portal on line] citado em 21 de abril de 2007. Disponível emBrasil. Ministério da Educação e Cultura - Ministério da Saúde - Portaria Interministerial MEC/ MS no 50- 30/01/2005Westphalen, M.E.A., Carraro, T.E., (2001) Metodologias para a Assistência de Enfermagem: Teorizaç ões, Modelos e Subsídios para a Prática, , Goiânia: Ed AB;(1988) Código de Etica Médica, , artigo 69Publicação do CREMESP;Bechara, S.J., Aspectos Médico-Legais do Trauma Ocular (2003) Traumatismos e Urgências Oculares, 5, pp. 241-246. , Takahashi W. São Paulo: RocaSérie Oftalmologia - USPHossne, W.S., Prontuário médico- aspectos éticos (1992) Rev Ass Med Brasil, 38 (2), pp. 75-79Resolução No 1246 de 8 de Fevereiro de 1988. Resolve Aprovar O Código de Ética Médica, , Conselho Federal de Medicina. Disponível em: [email protected] (22/01/08)(2003) O Prontuário Eletrônico Do Paciente Na Assistência, Informação e Conhecimento Médico [On Line], , http://www.netsim.fm.usp.br/dim/livrosdim/prontuario.pdf, Massad EMarin HFAzevedo Neto RS, eds. São Paulo: H. de F. MarinDisponivel em em 03/01/08Resolução No CFM 1.638, de 10 de Julho de 2002. Define Prontuário Médico e Torna Obrigatória a Criação Da Comissão de Revisão de Prontuários Nas Instituições de Saúde, , http://www.cremesp.orgbr/legislacao/resolucoes/rescfm/1638_02.htm, Conselho Regional de Medicina do Estado de São Paulo (Cremesp). Internet. [citado 09 de junho de 2007]. Disponivel emCarazo, V., Velasco, J.R., Beltranena, F., Quesada, T., Evaluating yhe conditions of efficiency (1986) Guías para Gerencia de Servicios de Atención Ocular, , Carazo V, Velasco JR, Beltranena F, Quesada T. Washington, DC: Organizacion Panamericana de la Salu