O objetivo desta pesquisa foi mapear e caracterizar as iniciativas institucionais implementadas no setor público para abordar a judicialização da saúde no Brasil por meio de uma revisão sistemática de escopo. A busca sistemática na literatura foi realizada, sem restringir idioma, status de publicação ou desenho do estudo, em bases de dados indexados e de literatura cinzenta, até março de 2019. A seguir, dois revisores independentes avaliaram a elegibilidade dos textos e incluíram os documentos que relatavam sobre qualquer iniciativa implementada no setor público para abordar a judicialização da saúde e excluíram aquelas que promoviam a judicialização. A partir dos 101 documentos incluídos na revisão de escopo, identificou-se 78 iniciativas implementadas, das quais: 72 (92,3%) foram implementadas a partir de 2007, 37 (47,4%) pertenciam à região sudeste, 61 (78,2%) em nível estadual e 59 (75,6%) estão em atividade. Concluiu-se que, de modo geral, as iniciativas são desenvolvidas e implementadas quando as instituições conseguem utilizar os recursos humanos e/ou a infraestrutura existentes (93,6%), possuem sistema informatizado para o controle de dados (61,5%), formam equipes multiprofissionais e celebram acordos interinstitucionais (71,8%). As iniciativas identificadas e caracterizadas nesta revisão, e que estão sendo utilizadas pelos setores saúde e jurídico para abordar a judicialização da saúde no Brasil, podem servir como referencial aos gestores na tomada de decisão sobre a implementação de práticas para abordar a judicialização da saúde. No entanto, não se pode afirmar que tais iniciativas sejam efetivas, o que poderia ser apropriado para um futuro estudo.
BACKGROUND: The judicialization of health care is a social claim concerning the right to the access to health care. It usually occurs due to gaps in public policy or failures in its application. In Brazil, several public institutions have implemented strategies to approach this phenomenon. However, these strategies have not yet been systematized into functional categories. OBJECTIVE: To categorize and analyze the strategies implemented by public institutions in Brazil to approach the judicialization of health care. METHOD: A systematic scoping review was developed following the method proposed by the Joanna Briggs Institute. The descriptor 'judicialization of health' was used to conduct the searches for studies in 18 electronic databases and other types of documents in the gray literature until March 2019. Documents containing the reports of strategies implemented in public institutions to approach the judicialization of health care in Brazil were included. Two independent reviewers assessed the eligibility of the documents and extracted the data. The strategies identified were categorized using definitions from the World Health Organization and existing Brazilian legislation. RESULTS: Seventy eight implemented strategies were identified and organized into nine categories: i. Technical support to the judiciary; ii. State health committees; iii. Organization of assistance; iv. Compliance with court orders, v. Computerized information systems; vi. Administrative proceeding; vii. Defense of the public authority; viii. Pharmacy and therapeutics committee; ix. Alternative dispute resolution. These categories are not mutually exclusive and often act in concert or complement each other's activities. They represent services either existing or provided for in legal provisions by the public administration to meet various types of demands. CONCLUSIONS: The categories proposed to approach the judicialization of health care represent some of the recommendations for qualifying public administration or are provided for in ...
OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17% dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões. CONCLUSÕES: Os resultados reforçam a necessidade de qualificação técnica para tratar as demandas judiciais e exige capacitação dos profissionais no manejo da literatura científica, na seleção adequada dos fármacos e na escolha da melhor conduta terapêutica para cada condição clínica. Dessa forma será possível garantir o acesso a tecnologias eficazes e seguras, e assim aprimorar o modelo de assistência farmacêutica em oncologia. ; OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17% de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones. CONCLUSIONES: Los resultados refuerzan la necesidad de calificación técnica para tratar las demandas judiciales y exige capacitación de los profesionales en el manejo de la literatura científica, en la selección adecuada de los fármacos y en la escogencia de la mejor conducta terapéutica para cada condición clínica. De esta forma será posible garantizar el acceso a tecnologías eficaces y seguras, y así perfeccionar el modelo de asistencia farmacéutica en oncología. ; OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy 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 scientific 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.
Para realizar un inventario de fuentes de datos nacionales sobre utilización de medicamentos en Argentina y verificar las fuentes de datos disponibles públicamente, llevamos a cabo un estudio transversal que investiga la existencia de bases de datos nacionales y provinciales sobre utilización de medicamentos. En julio de 2020, realizamos una búsqueda en sitios web de instituciones gubernamentales, una búsqueda sistemática en bases de datos bibliográficas sobre "drug utilization research" en Argentina y una encuesta de expertos. Se identificaron 31 fuentes de datos de utilización de medicamentos, solo una era de acceso público y conveniente, cinco publicaban datos agregados y proporcionaban un acceso más detallado mediante solicitud formal, solo siete fuentes (23%) informaban datos nacionales, y la mayoría de ellas (n=29) incluían solo datos del sector público de salud. Aunque se han encontrado fuentes de datos de utilización de medicamentos en Argentina, el acceso a investigadores y legisladores sigue siendo una barrera importante. Aumentar la transparencia de los datos de salud a través de fuentes disponibles públicamente para analizar la información de salud pública es crucial para construir un sistema de salud más sólido. ; In order to compile an inventory of national data sources for drug utilization research (DUR) in Argentina and to verify publicly available data sources, we performed a cross-sectional study that sought to identify national and provincial databases of drug use. In July 2020, we searched the websites of government institutions, carried out a systematic query of bibliographic databases for "drug utilization research" conducted in Argentina, and conducted a survey with local experts. Data collected included: the institution responsible for the database, population covered, accessibility, source of the data, healthcare setting, geographic information, and whether data were individual or aggregated. Descriptive analyses were then performed. We identified 31 data sources for DUR; only one was publicly and conveniently accessible. Five published aggregated data and provide more detailed access by formal request. Only seven sources (23%) reported national data, and most (n=29) included only data from the public healthcare sector. Although data sources for DUR have been found in Argentina, limited access by researchers and policymakers is still an significant obstacle. Increasing health data transparency by making data sources publicly available for the purpose of analyzing public health information is crucial for building a stronger health system. ; Facultad de Ciencias Médicas
Background: The deinstitutionalization process is complex, long-term and many countries fail to achieve progress and consolidation. Informing decision-makers about appropriate strategies and changes in mental health policies can be a key factor for it. This study aimed to develop an evidence brief to summarize the best available evidence to improve care for deinstitutionalized patients with severe mental disorders in the community. Methods: We used the SUPPORT (Supporting Policy Relevant Reviews and Trials) tools to elaborate the evidence brief and to organize a policy dialogue with 24 stakeholders. A systematic search was performed in 10 electronic databases and the methodological quality of systematic reviews (SRs) was assessed by AMSTAR 2. Results: Fifteen SRs were included (comprising 378 studies and 69,736 participants), of varying methodological quality (3 high-quality SRs, 2 moderate-quality SRs, 7 low-quality SRs, 3 critically low SRs). Six strategies were identified: (i). Psychoeducation; (ii). Anti-stigma programs, (iii). Intensive case management; (iv). Community mental health teams; (v). Assisted living; and (vi). Interventions for acute psychiatric episodes. They were associated with improvements on a global status, satisfaction with the service, reduction on relapse, and hospitalization. Challenges to implementation of any of them included: stigma, the shortage of specialized human resources, limited political and budgetary support. Conclusions: These strategies could guide future actions and policymaking to improve mental health outcomes.
Background: In 2019, a new type of coronavirus emerged and spread to the rest of the world. Numerous drugs were identified as possible treatments. Among the candidates for possible treatment was azithromycin alone or in combination with other drugs. As a result, many clinicians in Brazil have prescribed azithromycin in an attempt to combat or minimize the effects of COVID19. Aim: This study analyzed the sales data of the main antibiotics prescribed in Brazil to verify the change in consumption trends of these drugs during the COVID-19 pandemic. Methods: This is an interrupted time series that analyzed antimicrobial sales data between January 2014 and July 2021, publicly accessible information obtained from the Brazilian government's website. Monthly means of "defined daily doses of DDDs" (DDDs per 1,000 inhabitants per day) of antibiotics were compared by analysis of variance, followed by the Dunnett Multiple Comparisons Test. Monthly trend changes in antibiotic use were verified using Joinpoint regression. Results: Amoxicillin (31.97%), azithromycin (18.33%), and cefalexin (16.61%) were the most sold antibiotics in Brazil during the evaluation period. Azithromycin consumption rose from 1.40 DDDs in February 2020 to 3.53 DDDs in July 2020. Azithromycin sales showed a significant increase in the pandemic period [Monthly Percent Change (MPC) 5.83%, 95% 1.80; 10.00], whereas there was a fall in amoxicillin sales (MPC −9.00%, 95% CI −14.70; −2.90) and cefalexin [MPC-2.70%, 95% (CI −6.30; −1.10)] in this same period. Conclusion: The COVID-19 pandemic changed the pattern of antibiotic consumption in Brazil, with a decrease in the use of amoxicillin and cefalexin and an increase in the consumption of azithromycin.
OBJETIVO Analisar o acesso e o perfil de utilização, por via judicial, de medicamentos biológicos para o tratamento de psoríase. MÉTODOS Estudo transversal descritivo. Foram entrevistados 203 pacientes com psoríase que demandaram medicamentos biológicos, por via judicial, ao Estado de São Paulo, entre 2004 e 2010. Informações sobre características sociodemográficas, médico-sanitárias e político-administrativas foram complementadas com dados obtidos das respectivas ordens de dispensação quanto a medicamento biológico para tratamento de psoríase e autos correspondentes. Os dados foram analisados em banco eletrônico e as variáveis sumarizadas por frequência simples. As prescrições contidas nos processos foram analisadas quanto aos preceitos legais contidos na lei. RESULTADOS Foram analisados 190 autos referentes aos medicamentos biológicos: adalimumabe, efalizumabe, etanercepte e infliximabe. Os proponentes obtiveram o medicamento por mandado de segurança (59,5%), sem nunca ter solicitado o medicamento biológico para outra instituição (86,2%), por sistema de saúde público ou privado. Utilizaram-se da prerrogativa de gratuidade de justiça (72,6%), embora fossem representados por advogado particular (91,1%) e atendidos em consultórios médicos privados (69,5%). Utilizaram o medicamento biológico por período >; 13 meses (66,0%) e 44,9% faziam uso do medicamento no momento da entrevista. Quase um terço daqueles que deixaram de usar os medicamentos abandonou o tratamento por piora do quadro (26,6%), efeitos adversos (20,5%), falta de eficácia ou suspensão pelo médico (13,8%). Nenhuma prescrição médica atendeu aos preceitos legais; 70,3% dos pacientes não haviam realizado exames laboratoriais (hemograma, função hepática e renal) para controle do tratamento. CONCLUSÕES Os demandantes recorreram à via judicial para obtenção de medicamentos biológicos por desconhecimento ou por dificuldades de acesso pelas vias institucionais do sistema público de saúde O acesso facilitado pela via judicial favorece o uso do medicamento por tempo prolongado por meio de prescrições não conformes, frequência elevada de efeitos adversos e monitoramento clínico inadequado. ; OBJECTIVE To analyze the access and utilization profile of biological medications for psoriasis provided by the judicial system in Brazil. METHODS This is a cross-sectional study. We interviewed a total of 203 patients with psoriasis who were on biological medications obtained by the judicial system of the State of Sao Paulo, from 2004 to 2010. Sociodemographics, medical, and political-administrative characteristics were complemented with data obtained from dispensation orders that included biological medications to treat psoriasis and the legal actions involved. The data was analyzed using an electronic data base and shown as simple variable frequencies. The prescriptions contained in the lawsuits were analyzed according to legal provisions. RESULTS A total of 190 lawsuits requesting several biological drugs (adalimumab, efalizumab, etanercept, and infliximab) were analyzed. Patients obtained these medications as a result of injunctions (59.5%) or without having ever demanded biological medication from any health institution (86.2%), i.e., public or private health services. They used the prerogative of free legal aid (72.6%), even though they were represented by private lawyers (91.1%) and treated in private facilities (69.5%). Most of the patients used a biological medication for more than 13 months (66.0%), and some patients were undergoing treatment with this medication when interviewed (44.9%). Approximately one third of the patients discontinued treatment due to worsening of their illness (26.6%), adverse drug reactions (20.5%), lack of efficacy, or because the doctor discontinued this medication (13.8%). None of the analyzed medical prescriptions matched the legal prescribing requirements. Clinical monitoring results showed that 70.3% of the patients had not undergone laboratory examinations (blood work, liver and kidney function tests) for treatment control purposes. CONCLUSIONS The plaintiffs resorted to legal action to get access to biological medications because they were either unaware or had difficulty in accessing them through institutional public health system procedures. Access by means of legal action facilitated long-term use of this type of medication through irregular prescriptions and led to a high rate of adverse drug reactions as well as inappropriate clinical monitoring.
Background: In Brazil, studies that map electronic healthcare databases in order to assess their suitability for use in pharmacoepidemiologic research are lacking. We aimed to identify, catalogue, and characterize Brazilian data sources for Drug Utilization Research (DUR). Methods: The present study is part of the project entitled, "Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries." A network of Brazilian health experts was assembled to map secondary administrative data from healthcare organizations that might provide information related to medication use. A multi-phase approach including internet search of institutional government websites, traditional bibliographic databases, and experts' input was used for mapping the data sources. The reviewers searched, screened and selected the data sources independently; disagreements were resolved by consensus. Data sources were grouped into the following categories: 1) automated databases; 2) Electronic Medical Records (EMR); 3) national surveys or datasets; 4) adverse event reporting systems; and 5) others. Each data source was characterized by accessibility, geographic granularity, setting, type of data (aggregate or individual-level), and years of coverage. We also searched for publications related to each data source. Results: A total of 62 data sources were identified and screened; 38 met the eligibility criteria for inclusion and were fully characterized. We grouped 23 (60%) as automated databases, four (11%) as adverse event reporting systems, four (11%) as EMRs, three (8%) as national surveys or datasets, and four (11%) as other types. Eighteen (47%) were classified as publicly and conveniently accessible online; providing information at national level. Most of them offered more than 5 years of comprehensive data coverage, and presented data at both the individual and aggregated levels. No information about population coverage was found. Drug coding is not uniform; each data source has its own coding system, ...
