High cost drugs in Latin America: access and barriers.

INTRODUCTION: Latin America comprises a large set of culturally diverse middle-income countries sharing an inequality gap and a rapidly aging population. A better informed growing middle class adds to the pressure on fragmented health systems that strive to attain universal coverage. Cost containment becomes crucial for sustainability. AREAS COVERED: Using 'high cost' as free term, together with individual country names, a search was performed in Pubmed and Scopus databases for relevant documents centered on pharmaceutical products. References of selected articles were also reviewed. EXPERT OPINION: In the region as elsewhere improving health information systems has been the starting point. Official health technology assessment agencies have been established in several countries, supporting decisions on best available evidence. A few centralized procurement and price regulation schemes using international reference pricing have been successful. Fast-track approval of generics and biosimilars, or establishing a separate funding source for high cost technologies are other options that, with varying degrees of success, have been. Since Latin America is characterized by its social, geographical and political diversity, each health system needs to recognize its individual priorities, learn from successful experiences elsewhere, and adapt possible alternative interventions to the different local contexts.

Implantação e funcionamento de sala híbrida em hospital privado de São Paulo / Deployment and operation of a hybrid operating room in a private hospital in São Paulo / Despliegue y funcionamento de sala de operaciones híbrida en un hospital privado de São Paulo

Objetivo: Relatar a experiência da implantação de sala operatória híbrida e identificar sua demanda de funcionamento em hospital privado de São Paulo. Método: Estudo retrospectivo, com relato de experiência. Para coleta foram utilizadas informações do banco de dados do centro cirúrgico, registradas em instrumento (caracterização da amostra, informações sobre a cirurgia e utilização da sala híbrida). Resultados: 166 pacientes foram atendidos em 15 meses; a maioria do sexo masculino (109; 65,7%), faixa etária de 71 a 80 anos (42; 25,3%), com diagnóstico de estenose aórtica (25,9%), nas especialidades cardiologia (70,7%) e vascular (16,5%). Os recursos mais utilizados foram: ArtisZeego®, arco C, circulação extracorpórea, equipamentos audiovisuais, softwares, ultrassonografia, ecocardiograma e Robô Da Vinci®. Conclusão: A implantação da sala híbrida é um conceito inovador, com integração de equipes e utilização de recursos de nova geração. A equipe deve estar em constante aprendizado, pois dificuldades na formação dos profissionais e alto custo têm limitado esses procedimentos a poucos centros do mundo.

Objective: To report the experience of the deployment of a hybrid operating room and to identify the demands of its operation in a private hospital in São Paulo, Brazil. Method: Retrospective study, with experience report. The database of the surgical center was used to collect information, which was recorded in an instrument (sample characterization, information on the operation, and use of the hybrid operating room). Results: The hybrid operating room was used for the care of 166 patients in 15 months; most were men (109; 65.7%), aged 71­80 years (42; 25.3%); diagnosed with aortic stenosis (25.9%), in the specialties: cardiology (70.7%) and vascular (16.5%). The most used features were ArtisZeego® arch C, extracorporeal circulation, audiovisual equipment, software, ultrasound, echocardiography, and Da Vinci® Robot. Conclusion: The implementation of the hybrid room is an innovative concept, with the integration of medical teams and the use of next-generation features. The team must be constantly learning, as difficulties in the development of professionals and high costs have limited these procedures to a few centers in the world.

Objetivo: Reportar la experiencia de la implementación del quirófano híbrido e identificar la demanda del funcionamiento en un hospital privado en São Paulo, Brasil. Método: Estudio retrospectivo, con relato de experiencia. Para la recolección de datos, se utilizó las informaciones de la base de datos del quirófano, registradas en instrumento (caracterización de la muestra, información sobre la cirugía y uso del quirófano híbrido). Resultados: 166 pacientes fueron vistos en 15 meses; la mayoría fuera hombres (109; 65,7%), con edades entre 71 y 80 años (42; 25,3%), diagnóstico de estenosis aórtica (25,9%), en cardiología (70,7%) y vascular (16,5%). Los recursos más utilizados fueron: ArtisZeego®, arco C, circulación extracorpórea, equipos audiovisuales, software, ultrasonografía, ecocardiografía y Robot Da Vinci®. Conclusión: La implementación del quirófano híbrido es un concepto innovador, con integración de equipos y uso de los recursos de próxima generación. El equipo debe estar en constante aprendizaje, pues dificultades en la formación de los profesionales y altos costos han limitado estos procedimientos a unos pocos centros en el mundo.

[Access to high-cost drugs in Brazil from the perspective of physicians, pharmacists and patients]. / Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios.

OBJECTIVE: To explore perceptions on access to medication supplied by the Specialized Component of Pharmaceutical Assistance (CEAF) within the Brazilian Unified Health System (which includes high-cost drugs) by the actors involved in the healthcare services of this component. METHOD: A descriptive, qualitative study was carried out by using a focal group with 7 users and 11 semi-structured interviews with health professionals (physicians and pharmacist) in the state of Santa Catarina. RESULTS: According to the participants, access to medicines had improved. Two main perceptions of the CEAF Clinical Guidelines were identified: the requirements constitute a bureaucracy that limits access, and the requisites increase the demand for tests and specialized healthcare services, exceeding the capacity of the healthcare services network. These assumptions generated the search for other means of access that revealed a lack of information and understanding of the right to health among the users. In addition, according to the participants, because of the difficulties of accessing services as a whole, full access to CEAF medicines is a goal that remains to be achieved. CONCLUSION: Although access to CEAF medicines has improved, there are still some difficulties in guaranteeing treatment access and comprehensiveness.

Impacto do uso da pinça seladora ou do bisturi harmônico nos desfechos intra-hospitalares e no custo de procedimentos de tireoidectomia / Impact of the use of vessel sealing or harmonic scalpel on intra-hospital outcomes and the cost of thyroidectomy procedures

OBJETIVOS: Analisar tempo cirúrgico, tempo de internação, sangramento, escore de dor no período pós-operatório e custo referente aos procedimentos de tireoidectomia com utilização de pinça seladora ou bisturi harmônico, comparando-os à técnica convencional. MÉTODOS: Análise retrospectiva das tireoidectomias, realizadas entre 2007 e 2010, pela técnica convencional e com uso de pinça seladora ou bisturi harmônico. Foram analisados: gênero, idade, diagnóstico principal e tipo de procedimento. Os desfechos analisados foram: duração do procedimento, tempo de permanência hospitalar, necessidade de transfusão de hemoderivados, dor e custo da internação. As conclusões foram baseadas em um nível de significância de 5%, e as análises estatísticas foram realizadas utilizando o software R. RESULTADOS: Para o desfecho "duração da cirurgia", o uso da pinça seladora resultou em aumento médio de, aproximadamente, 47 minutos, quando comparado à técnica convencional (p<0,001) e o uso do bisturi harmônico levou à redução média de, aproximadamente, 32 minutos, quando comparado à técnica convencional (p<0,001). Não houve diferença estatisticamente significativa entre os grupos quanto ao uso de hemoderivados e escore de dor. Procedimentos que utilizaram pinça seladora ou bisturi harmônico apresentaram custo superior quando comparados àqueles com a técnica convencional. CONCLUSÃO: O uso do bisturi harmônico mostrou-se favorável na redução do tempo cirúrgico, porém não foi observada redução no tempo de hospitalização. O custo do procedimento foi mais alto em relação à técnica convencional. O uso da pinça seladora não trouxe vantagens com relação aos desfechos, e o custo do procedimento foi maior quando comparado à técnica convencional.

OBJECTIVES: To analyze the operative time, length of hospitalization and cost, as well as the bleeding and pain observed during the postoperative period, of thyroidectomy procedures using vessel sealing, harmonic scalpel or the conventional technique. METHODS: Retrospective analysis of thyroidectomies performed between 2007 and 2010 using either the conventional technique or minimally invasive techniques involving vessel sealing or a harmonic scalpel. Gender, age, primary diagnosis and procedure type were analyzed. The outcomes analyzed included the length of the procedure, length of hospital stay, need for blood product transfusions, pain and cost of hospitalization. The findings were based on a significance level of 5%, and statistical analyses were performed using the R software. RESULTS: The use of the vessel sealing increased the duration of the surgery by approximately 47 minutes compared to the conventional technique (p<0.001), and the use of the harmonic scalpel decreased the duration of the surgery by approximately 32 minutes compared to the conventional technique (p<0.001). No statistically significant difference was found between the groups regarding the use of blood products and pain score. Procedures involving vessel sealing or a harmonic scalpel cost more than those using the conventional technique. CONCLUSION: The use of harmonic scalpel was favorable in terms of reducing the surgical time, but there was no reduction in hospitalization time. The cost of the procedure was higher than that of the conventional technique. The use of vessel sealing offered no advantages in terms of the outcomes assessed, and the cost of the procedure was greater than that of the conventional technique.

Altos custos financeiros do trauma vascular / Expensive therapy of vascular trauma

OBJETIVO: Demonstrar o custo e impacto financeiro referente à primeira abordagem cirúrgica das lesões vasculares em pacientes admitidos no Hospital João XXIII/FHEMIG, entre os anos de 2004 a 2006. MéTODOS: Trata-se de um estudo com aprovação ética, retrospectivo, de coorte e descritivo realizado a partir da auditoria de contas hospitalares referentes a 70 prontuários catalogados pelo Serviço de Trauma Cardiovascular. RESULTADOS: Cinco (7,14 por cento) prontuários foram excluídos por má qualidade técnica. O valor monetário repassado pelo Sistema Único de Saúde e pelo setor privado foram de R$ 103.614,96 (US$ 60.949,97) e de R$ 185.888,21 (US$ 109.346,0, respectivamente, implicando em defasagem potencial de 44 por cento. Houve correlação direta entre custos e topografia anatômica das lesões e exponencial em relação às variáveis hemoderivados e próteses vasculares. CONCLUSÃO: Este estudo corrobora os altos custos do trauma vascular e fortalece a importância da auditoria de contas para as tomadas de decisões médicas.

OBJECTIVE: To analyze all expenses paid to the first surgical approached for vascular lesion patients admitted at Hospital João XXIII/FHEMIG, between years 2004 until 2006. METHOD: It is about an ethical approved study, retrospective and descriptive from audit over 70 eligible patients enrolled by Cardiovascular Service. RESULTS: Five (7,14 percent) patient's files were excluded for bad quality records. The costs were R$ 103.614,96 (US$ 60.949,97) and R$ 185.888,21 (US$ 109.346,0), a 44 percent sliding scale for endowment from Brazilian Public System and private medical assistance estimative, respectively. Indeed, the data showed direct relationship between costs and anatomic topographic and exponential increased expenses when blood and/or vascular prosthesis were utilized. CONCLUSION: Audit in health system is a must to making decision and evidences the expensive therapy for vascular lesions.