[Data processing of the Brazilian National System of Controlled Product Management for drug utilization research with antimicrobials]. / Tratamento de dados do Sistema Nacional de Gerenciamento de Produtos Controlados para estudos de utilização de medicamentos com antimicrobianos.

The Brazilian National System of Controlled Product Management (SNGPC) stores data on the dispensing of manufactured and compounded drugs and pharmaceutical inputs, whether controlled and antimicrobial, based on the records of private pharmacies and drugstores. This study assessed the quality of SNGPC data from the dispensing records of manufactured antibiotics, aiming to propose their use in drug utilization researchs (DURs), with a descriptive and retrospective design, analyzing the raw dataset of the SNGPC from January 2014 to December 2020. A total of 475,805,207 drug-dispensing records were collected. On average, antibiotics corresponded to 54.5% of the total records. The quality dimension "unreported" was systematically identified in the variables "active ingredient", "sex", "age" and "ICD-10". The amount of vials/bottles and packages ranged from one to 536 units and the amount of pharmaceutical inputs dispensed, from one to 7,500 units. Results show that 25% of the records exceed an individual therapy and the SNGPC has no critical mechanism to avoid dispensations outside the therapeutic standard for the class. Despite vulnerabilities due to data quality, which can be overcome, the SNGPC allows for the construction of different analytical plans, involving time and other aggregations, in the analysis of community use of antimicrobials and controlled drugs, which makes it a powerful source of data for DUR.

O Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC) armazena dados de dispensação de medicamentos industrializados, manipulados e insumos farmacêuticos sob controle especial e antimicrobianos, a partir dos registros de farmácias e drogarias privadas. Este trabalho explorou a qualidade dos dados inseridos no SNGPC, a partir dos registros de dispensação de antibióticos industrializados, com o objetivo de propor seu emprego em estudos de utilização de medicamentos (DUR). A pesquisa foi desenvolvida por meio de desenho descritivo e retrospectivo, examinando o conjunto dados brutos do sistema, para o período de janeiro de 2014 a dezembro de 2020. Um total de 475.805.207 registros de dispensação de medicamentos foi coletado. Os antibióticos corresponderam em média a 54,5% do total de registros. A dimensão de qualidade "não informado" foi identificada, sistematicamente, nas variáveis "princípio ativo", "sexo", "idade" e "CID-10". As quantidades de frascos e caixas variaram de 1 a 536 unidades, e as quantidades de formas farmacêuticas dispensadas de 1 a 7.500 unidades. Os resultados mostram que 25% dos registros extrapolam uma terapia individual e que o sistema não apresenta um mecanismo de crítica para evitar dispensações não conformes ao padrão terapêutico para a classe. Apesar das vulnerabilidades decorrentes da qualidade dos dados, que podem ser superadas, o SNGPC possibilita construir diferentes planos analíticos, envolvendo tempo e outras agregações, na investigação de uso comunitário de antimicrobianos e medicamentos sob controle especial, o que faz dele uma potente fonte de dados para DUR.

El Sistema Nacional de Gestión de Productos Controlados (SNGPC) almacena datos sobre la dispensación de medicamentos industrializados, manipulados, insumos farmacéuticos bajo control especial y de antimicrobianos con base en los registros de farmacias y de boticas privadas. Este trabajo analizó la calidad de los datos ingresados en el SNGPC relacionados a los registros de la dispensación de antibióticos industrializados, para proponer su posible aplicación en estudios sobre el uso de medicamentos (DUR); para ello, realizó un análisis descriptivo y retrospectivo del conjunto de datos brutos para el periodo de enero de 2014 a diciembre de 2020. Se recogieron un total de 475.805.207 registros de dispensación de medicamentos. Los antibióticos correspondieron en promedio al 54,5% del total de los registros. La dimensión de calidad "no informado" se identificó sistemáticamente en las variables "principio activo", "sexo", "edad" y "CIE-10". Las cantidades de viales y cajas oscilaron entre 1 y 536 unidades, y las cantidades de formas farmacéuticas dispensadas entre 1 y 7.500 unidades. Los resultados muestran que el 25% de los registros exceden una terapia individual y que el sistema no tiene un mecanismo crítico para evitar la dispensación que no se ajusta al patrón terapéutico de la clase. A pesar de las vulnerabilidades derivadas de la calidad de los datos, que pueden ser superadas, el SNGPC permite la construcción de diferentes planes analíticos, involucrando tiempo y otras agregaciones, en la investigación del uso comunitario de antimicrobianos y medicamentos bajo control especial, lo que hace que el Sistema sea una potente fuente de datos para DUR.

Yellow fever vaccine safety in immunocompromised individuals: a systematic review and meta-analysis.

BACKGROUND: Yellow fever (YF) is an arbovirus with variable severity, including severe forms with high mortality. The vaccination is the most effective measure to protect against the disease. Non-serious and serious adverse events have been described in immunocompromised individuals, but previous studies have failed to demonstrate this association. This systematic review assessed the risk of adverse events after YF vaccination in immunocompromised individuals compared with its use in non-immunocompromised individuals. METHODS: A search was conducted in the MEDLINE, LILACS, EMBASE, SCOPUS, DARE, Toxiline, Web of Science and grey literature databases for publications until February 2021. Randomized and quasi-randomized clinical trials and observational studies that included immunocompromised participants (individuals with HIV infection, organ transplants, with cancer, who used immunosuppressive drugs for rheumatologic diseases and those on immunosuppressive therapy for other diseases) were selected. The methodological quality of observational or non-randomized studies was assessed by the ROBINS-I tool. Two meta-analyses were performed, proportion and risk factor analyses, to identify the summary measure of relative risk (RR) in the studies that had variables suitable for combination. RESULTS: Twenty-five studies were included, most with risk of bias classified as critical. Thirteen studies had enough data to carry out the proposed meta-analyses. Seven studies without a comparator group had their results aggregated in the proportion meta-analysis, identifying an 8.5% [95% confidence interval (CI) 0.07-21.8] risk of immunocompromised individuals presenting adverse events after vaccination. Six cohort studies were combined, with an RR of 1.00 (95% CI 0.78-1.29). Subgroup analysis was performed according to the aetiology of immunosuppression and was also unable to identify an increased risk of adverse events following vaccination. CONCLUSIONS: It is not possible to affirm that immunocompromised individuals, regardless of aetiology, have a higher risk of adverse events after receiving the YF vaccine.

Tratamento de dados do Sistema Nacional de Gerenciamento de Produtos Controlados para estudos de utilização de medicamentos com antimicrobianos / Data processing of the Brazilian National System of Controlled Product Management for drug utilization research with antimicrobials / Procesamiento de datos del Sistema Nacional de Gestión de Productos Controlados para estudios de utilización medicamentos con antimicrobianos

Resumo: O Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC) armazena dados de dispensação de medicamentos industrializados, manipulados e insumos farmacêuticos sob controle especial e antimicrobianos, a partir dos registros de farmácias e drogarias privadas. Este trabalho explorou a qualidade dos dados inseridos no SNGPC, a partir dos registros de dispensação de antibióticos industrializados, com o objetivo de propor seu emprego em estudos de utilização de medicamentos (DUR). A pesquisa foi desenvolvida por meio de desenho descritivo e retrospectivo, examinando o conjunto dados brutos do sistema, para o período de janeiro de 2014 a dezembro de 2020. Um total de 475.805.207 registros de dispensação de medicamentos foi coletado. Os antibióticos corresponderam em média a 54,5% do total de registros. A dimensão de qualidade "não informado" foi identificada, sistematicamente, nas variáveis "princípio ativo", "sexo", "idade" e "CID-10". As quantidades de frascos e caixas variaram de 1 a 536 unidades, e as quantidades de formas farmacêuticas dispensadas de 1 a 7.500 unidades. Os resultados mostram que 25% dos registros extrapolam uma terapia individual e que o sistema não apresenta um mecanismo de crítica para evitar dispensações não conformes ao padrão terapêutico para a classe. Apesar das vulnerabilidades decorrentes da qualidade dos dados, que podem ser superadas, o SNGPC possibilita construir diferentes planos analíticos, envolvendo tempo e outras agregações, na investigação de uso comunitário de antimicrobianos e medicamentos sob controle especial, o que faz dele uma potente fonte de dados para DUR.

Abstract: The Brazilian National System of Controlled Product Management (SNGPC) stores data on the dispensing of manufactured and compounded drugs and pharmaceutical inputs, whether controlled and antimicrobial, based on the records of private pharmacies and drugstores. This study assessed the quality of SNGPC data from the dispensing records of manufactured antibiotics, aiming to propose their use in drug utilization researchs (DURs), with a descriptive and retrospective design, analyzing the raw dataset of the SNGPC from January 2014 to December 2020. A total of 475,805,207 drug-dispensing records were collected. On average, antibiotics corresponded to 54.5% of the total records. The quality dimension "unreported" was systematically identified in the variables "active ingredient", "sex", "age" and "ICD-10". The amount of vials/bottles and packages ranged from one to 536 units and the amount of pharmaceutical inputs dispensed, from one to 7,500 units. Results show that 25% of the records exceed an individual therapy and the SNGPC has no critical mechanism to avoid dispensations outside the therapeutic standard for the class. Despite vulnerabilities due to data quality, which can be overcome, the SNGPC allows for the construction of different analytical plans, involving time and other aggregations, in the analysis of community use of antimicrobials and controlled drugs, which makes it a powerful source of data for DUR.

Resumen: El Sistema Nacional de Gestión de Productos Controlados (SNGPC) almacena datos sobre la dispensación de medicamentos industrializados, manipulados, insumos farmacéuticos bajo control especial y de antimicrobianos con base en los registros de farmacias y de boticas privadas. Este trabajo analizó la calidad de los datos ingresados en el SNGPC relacionados a los registros de la dispensación de antibióticos industrializados, para proponer su posible aplicación en estudios sobre el uso de medicamentos (DUR); para ello, realizó un análisis descriptivo y retrospectivo del conjunto de datos brutos para el periodo de enero de 2014 a diciembre de 2020. Se recogieron un total de 475.805.207 registros de dispensación de medicamentos. Los antibióticos correspondieron en promedio al 54,5% del total de los registros. La dimensión de calidad "no informado" se identificó sistemáticamente en las variables "principio activo", "sexo", "edad" y "CIE-10". Las cantidades de viales y cajas oscilaron entre 1 y 536 unidades, y las cantidades de formas farmacéuticas dispensadas entre 1 y 7.500 unidades. Los resultados muestran que el 25% de los registros exceden una terapia individual y que el sistema no tiene un mecanismo crítico para evitar la dispensación que no se ajusta al patrón terapéutico de la clase. A pesar de las vulnerabilidades derivadas de la calidad de los datos, que pueden ser superadas, el SNGPC permite la construcción de diferentes planes analíticos, involucrando tiempo y otras agregaciones, en la investigación del uso comunitario de antimicrobianos y medicamentos bajo control especial, lo que hace que el Sistema sea una potente fuente de datos para DUR.

A Systematic Review and a Meta-Analysis of the Yellow Fever Vaccine in the Elderly Population.

We conducted a systematic review and a meta-analysis to assess the risk of serious adverse events in the elderly after yellow fever vaccination compared to the non-elderly population. We searched multiple databases and grey literature, and we selected research without language and publication date restrictions. Studies were analyzed in a descriptive way and meta-analyzed and expressed in terms of prevalence ratio and risk ratio with a 95% confidence interval, depending on the degree of heterogeneity found. A total of 18 studies were included and 11 were meta-analyzed. The results obtained through the meta-analysis showed a risk of serious adverse events after yellow fever vaccination three times higher for the elderly when compared to the non-elderly population and five times higher for persons > 70 years. In relation to adverse event types, viscerotropic disease associated with the yellow fever vaccine had a risk that was six times higher when compared to the population < 60 years. The evidence found supports that the vaccine indication in individuals > 60 years of age should be based on a careful analysis of individual benefit-risk assessments. The results found suggest a higher risk of events for individuals > 70 years, especially for viscerotropic and neurotropic disease associated with YFV contraindicating the use of the YFV in this age group.

Theoretical model of sexual and reproductive health care: subsidies for evaluative research.

OBJECTIVE: To elaborate a Theoretical Model of Sexual and Reproductive Health care offered in Primary Health Care. METHOD: Documentary research, with a qualitative approach. Government documents and evaluative studies constituted the data sources, collected between August 2018 and June 2019, and analyzed based on the health evaluation literature. RESULTS: Promotion of Sexual and Reproductive Health and Clinical Care were two structural components of the theoretical model of sexual and reproductive health care in Primary Care. The model includes disease prevention activities, health promotion, treatments, and diagnoses related to sexual and reproductive health. CONCLUSION: The theoretical model developed in this study presents the theory that supports the operationalization of sexual and reproductive health care in primary care according to government regulations in Brazilian scenario and may be useful in future evaluative research on the subject.

Efficacy and costs of nanocrystalline silver dressings versus 1% silver sulfadiazine dressings to treat burns in adults in the outpatient setting: A randomized clinical trial.

BACKGROUND: Nanocrystalline silver dressings can reduce the number of changes, facilitating burn wound management. However, the evidence regarding their efficacy and cost-consequences compared to well-established treatments, such as 1% silver sulfadiazine, is still scarce. OBJECTIVE: To determine the efficacy, safety, and costs of nanocrystalline silver dressings compared to 1% silver sulfadiazine dressings to treat adult patients with burns. STUDY DESIGN AND SETTING: Randomized, single-center, single-blind trial conducted at a referral hospital in São Paulo, Brazil. METHODS: 100 adult patients were randomized 1:1 to nanocrystalline silver (n = 50) or 1% silver sulfadiazine (n = 50). The primary outcome was the proportion of participants with complete re-epithelization at day 15 after randomization. Secondary outcomes included the number of dressing changes, direct medical costs (in international dollars, I$), pain intensity, the incidence of infections, number of patients undergoing surgery, and adverse events. RESULTS: On day 15, the proportion of patients who reached the primary outcome did not differ significantly between participants treated with nanocrystalline silver dressings (24 [48%]) and those treated with 1% silver sulfadiazine dressings (26 [52%]); risk difference of -4.0 percentage points (95% confidence interval [CI], -17 to 9; P = 0.56). The number of patients undergoing surgical intervention was similar between groups (6% vs. 6%), and no local or serious adverse events were reported. The mean (standard deviation, SD) number of dressing changes in the nanocrystalline silver group was 4.1 (2.3), and the corresponding estimate in the 1% silver sulfadiazine group was 9.6 (6.7); mean difference of -5.56 (95% CI), -7.57 to -3.55, P < 0.001). Treatment with nanocrystalline silver dressing incurred significant cost reductions in medical materials, human resources, and administrative labor. However, the mean total cost with nanocrystalline silver dressing was higher compared to 1% silver sulfadiazine dressings: I$496.37 (445.90) vs. I$274.73 (182.76); mean difference = 221.63 (95% CI, 89.04 to 354.23, P = 0.001). The main driver of higher mean total costs among nanocrystalline silver-treated participants was the purchase cost of the dressings, representing 79.3% of the total cost in the nanocrystalline silver group but only 15.2% in the 1% silver sulfadiazine group. CONCLUSION: We found no evidence of a difference between nanocrystalline silver and 1% silver sulfadiazine dressings regarding efficacy and safety outcomes. Nanocrystalline silver dressings were associated with an increase in the total costs, but they could result in important savings for an institution (less changes of dressings, reducing human resources burden), especially if acquisition costs can be decreased. Additional cost-effectiveness studies are warranted. TRIAL REGISTRATION NUMBER: NCT02108535.

Theoretical model of sexual and reproductive health care: subsidies for evaluative research / Modelo teórico de la atención a la salud sexual y reproductiva: subsidios para investigaciones evaluativas / Modelo teórico da atenção à saúde sexual e reprodutiva: subsídios para pesquisas avaliativas

ABSTRACT Objective: To elaborate a Theoretical Model of Sexual and Reproductive Health care offered in Primary Health Care. Method: Documentary research, with a qualitative approach. Government documents and evaluative studies constituted the data sources, collected between August 2018 and June 2019, and analyzed based on the health evaluation literature. Results: Promotion of Sexual and Reproductive Health and Clinical Care were two structural components of the theoretical model of sexual and reproductive health care in Primary Care. The model includes disease prevention activities, health promotion, treatments, and diagnoses related to sexual and reproductive health. Conclusion: The theoretical model developed in this study presents the theory that supports the operationalization of sexual and reproductive health care in primary care according to government regulations in Brazilian scenario and may be useful in future evaluative research on the subject.

RESUMEN Objetivo: Construir el Modelo Teórico de atención en Salud Sexual y Reproductiva ofrecida en la Atención Primaria de Salud como una de las etapas iniciales del proceso de evaluación de implantación. Método: Investigación documental, con enfoque cualitativo. Los documentos gubernamentales y los estudios evaluativos constituyeron las fuentes de datos, recopilados entre agosto de 2018 y junio de 2019 y analizados con base en la literatura de evaluación de la salud. Resultados: La Promoción de la Salud Sexual y Reproductiva y la Atención Clínica fueron los dos componentes estructurantes del modelo teórico de atención de la salud sexual y reproductiva en Atención Primaria. Incluye actividades de prevención de enfermedades, promoción de la salud, tratamientos y diagnósticos relacionados con la salud sexual y reproductiva. Conclusión: El modelo teórico desarrollado en este estudio presenta la teoría que apoya la operacionalización de la atención de la salud sexual y reproductiva en la atención primaria de acuerdo con las normativas gubernamentales en escenario brasileño, y puede ser útil en futuras investigaciones evaluativas sobre el tema.

RESUMO Objetivo: Construir um Modelo Teórico da atenção à saúde sexual e reprodutiva ofertada na Atenção Primária à Saúde. Métodos: Pesquisa documental, com abordagem qualitativa. Documentos governamentais e estudos avaliativos constituíram as fontes de dados, coletadas entre agosto de 2018 e junho de 2019 e analisadas com base na literatura de avaliação em saúde. Resultados: A Promoção da Saúde Sexual e Reprodutiva e a Assistência Clínica foram os dois componentes estruturantes do modelo teórico da atenção à saúde sexual e reprodutiva na Atenção Primária. O modelo contempla atividades de prevenção de doenças, promoção da saúde, tratamentos e diagnósticos relacionados à saúde sexual e reprodutiva. Conclusão: O modelo teórico elaborado apresenta a teoria que subsidia a operacionalização da atenção à saúde sexual e reprodutiva na atenção primária, segundo as normativas governamentais no cenário brasileiro, e poderá ser útil em pesquisas avaliativas futuras sobre o tema.

Testing COVID-19 in Brazil: fragmented efforts and challenges to expand diagnostic capacity at the Brazilian Unified National Health System.

Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

Dynamics of patents, orphan drug designation, licensing, and revenues from drugs for rare diseases: The market expansion of eculizumab.

BACKGROUND: This study examines the dynamics of the eculizumab patenting, orphan designation, and marketing authorization process in different countries and regulatory systems and analyzes drug revenues since its first marketing authorization. METHODS: A retrospective case study was conducted. Multiple information sources were used to: determine the status of eculizumab patents; examine the designation of orphan drug status by US, European, Japanese, and Brazilian regulatory authorities to determine registration status and approved clinical indications; estimate the prevalence of associated clinical conditions; investigate the history of the drug manufacturer, Alexion Pharmaceuticals, Inc., and its financialized business model; and examine global eculizumab sales revenues since its first marketing authorization. RESULTS: Our search yielded 32 patent families divided into 98 applications. The first patent granted was filed in 1995 by Alexion Pharmaceuticals, Inc. in the US. Eculizumab has always been as an orphan drug, except in the Brazilian regulatory agency. All clinical indications approved thus far refer to rare diseases (e.g., paroxysmal nocturnal hemoglobinuria syndrome, atypical hemolytic-uremic syndrome, refractory and generalized myasthenia gravis, and neuromyelitis optica spectrum disorder). Alexion's revenues amounted to more than US$25 billion between 2007 and 2019, showing a growing trend. Eculizumab led sales from the beginning, being the only product in the company's portfolio until 2015. In 2019, the drug accounted for 79.1% of all revenues. DISCUSSION: Our findings show that a strategy focused on obtaining orphan drug designation, expanding therapeutic indications and the geographic range of marketing approvals, extending monopoly periods, and prioritizing public procurement niches has enhanced revenues and helped the company achieve leadership in a highly specific and profitable market.

Testing COVID-19 in Brazil: fragmented efforts and challenges to expand diagnostic capacity at the Brazilian Unified National Health System / A testagem para COVID-19 no Brasil: esforços fragmentados e desafios para ampliar a capacidade diagnóstica no Sistema Único de Saúde / Testar para COVID-19 en Brasil: esfuerzos fragmentados y desafíos para expandir la capacidad diagnóstica en el Sistema Único de Salud

Abstract: Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

Resumo: Desde que o primeiro caso de COVID-19 no Brasil foi notificado, em 26 de fevereiro de 2020, o país assiste a um crescimento exponencial no número de casos e mortes. A estratégia nacional de testagem tem sido insuficiente para usar essa ferramenta corretamente no apoio à contenção da epidemia no país. O artigo discute os esforços e desafios para escalonar a testagem para COVID-19 no Sistema Único de Saúde (SUS). O texto apresenta os resultados iniciais de um projeto de pesquisa sobre os aspectos políticos, industriais, tecnológicos e regulatórios que podem afetar a capacidade diagnóstica e de testagem para COVID-19 no Brasil. O estudo se apoia em revisão da literatura cientifica, artigos publicados na mídia e coleta de dados públicos sobre a compra e regulamentação de testes. O texto faz referência a iniciativas para ampliar a testagem de PCR, a produção nacional e o desenvolvimento de tecnologias, além de medidas regulatórias fast-track para novos testes. Nossa análise sugere alguns pontos para reflexão. Primeiro, a falta de uma estratégia nacional consistente para combater a COVID-19 agravou os problemas de fornecimento de reagentes de diagnostico num primeiro momento. Esta situação foi posteriormente resolvida, embora coloque novamente em pauta a dependência estrutural do país na importação de insumos de saúde estratégicos. Em segundo lugar, financiamento e a distribuição de testes, que ocorreram de forma descontinuada, podem indicar a fragmentação da política sanitária, assim como o papel de governos estaduais, municipais e atores não estatais no combate à epidemia no âmbito do SUS. Por último, iniciativas estabelecidas no segundo semestre de 2020 contribuíram para ampliar a capacidade de testagem molecular no SUS. Contudo, essa capacidade não foi suficiente para controlar a epidemia no Brasil.

Resumen: Desde que se registró el primer caso de COVID-19 el 26 de febrero de 2020, Brasil ha visto un crecimiento exponencial en el número de casos y muertes. La estrategia nacional para preconizar el test de diagnóstico ha sido insuficiente en el uso correcto de esta herramienta, con el fin de ayudar a contener la epidemia en el país. Se presentó los esfuerzos y los desafíos para ampliar la realización de pruebas de COVID-19 en el Sistema Único de Salud brasileño (SUS). Este artículo presenta los resultados iniciales del proyecto de investigación sobre los aspectos políticos, industriales, tecnológicos y regulatorios que pueden afectar la capacidad de diagnóstico para la COVID-19 en Brasil. El grupo de investigación realizó una revisión de la literatura académica, medios de comunicación y recogida de datos públicos respecto a la adquisición de tests y su regulación. Se haz referencia a iniciativas para promover la realización de pruebas de PCR, la producción nacional y el desarrollo de tecnologías, así como las medidas regulatorias fast-track para nuevas pruebas. Nuestro análisis indica algunos puntos de reflexión. Primero, la falta de una estrategia nacional consistente para luchar contra la COVID-19 que exacerbó los problemas de sumistro de los componentes de diagnóstico en un primer momento. Se solucionó posteriormente esta situación, aunque se coloque nuevamente en pauta la dependencia estructural del país en la importación de insumos de salud estratégicos. Segundo, la financiación y la distribución de tests de forma descontinuada pueden indicar la fragmentación de la política de salud, así como los gobiernos estaduales, municipales, y atores no estatales asumiendo un rol preponderante en acciones de combate a la epidemia en el SUS. En último, las iniciativas establecidas en el segundo semestre del 2020 contribuyeron para ampliar la capacidad de realización de tests moleculares en el SUS. Sin embargo, esa capacidad no fue suficiente para controlar la epidemia en Brasil.

Avaliação de Tecnologias em Saúde na saúde suplementar brasileira: revisão de escopo e análise documental / Health Technology Assessment and private health insurance in Brazil: a scoping review and document analysis

RESUMO A Avaliação de Tecnologias em Saúde (ATS) respalda políticas públicas na gestão de tecnologias em diversos países. No Brasil, a institucionalização da ATS se iniciou em 2000, no Ministério da Saúde, e contou com a participação da Agência Nacional de Saúde Suplementar (ANS). Contudo, o sistema público e a saúde suplementar trilharam diferentes caminhos. Processos distintos de ATS podem gerar retrabalho, ineficiência e aumentar as inequidades entre o público e o privado. O objetivo desta pesquisa foi identificar a dualidade entre o público e o privado relativa aos modelos de ATS implantados no País. Realizou-se uma revisão de escopo da literatura no período de 2000 a 2019 nas bases de dados Medline, Scopus, Web of Science e Lilacs. Também se realizou análise de documentos da ANS relativos ao processo de ATS na saúde suplementar. A revisão da literatura constatou a escassez de artigos sobre o tema, enquanto a análise documental permitiu traçar uma linha do tempo com os principais marcos referentes ao processo de ATS da Agência. Concluiu-se que a coordenação nacional de um modelo de ATS é desejada, visando a aumentar a transparência das instituições, a maior credibilidade das suas decisões, maior eficiência do processo e proporcionar maior equidade.

ABSTRACT Health Technology Assessment (HTA) supports public policies on technology management in several countries. In Brazil, the institutionalization of HTA began in 2000 at the Ministry of Health, and had the participation of the National Regulatory Agency for Private Health Insurance (ANS). However, the public and the private systems have taken different paths. Different HTA processes can generate rework, inefficiency and increase inequities between the public and the private sectors. The objective of this research was to identify the duality between those two sectors regarding the current models of HTA implemented in the country. A scoping review of the literature was carried out from 2000 to 2019, in the Medline, Scopus, Web of Science and Lilacs databases. ANS documents were also analyzed, relating to the HTA process in private health insurance sector. The literature review found a shortage of articles on the topic, while the document analysis allowed to draw a timeline with the main milestones related to the Agency's HTA process. It was concluded that the national coordination of an HTA model is desired, aiming at increasing the transparency of the institutions, the greater credibility of their decisions, greater efficiency of the process, and providing greater equity.

Three decades of telemedicine in Brazil: Mapping the regulatory framework from 1990 to 2018.

This study characterized the evolution of Brazilian public telemedicine policy in the Brazilian Unified Health System for 30 years from 1988 to 2019 by analyzing its legal framework. We identified 79 telemedicine-related legislations from the federal government (laws, decrees, and ordinances) and 31 regulations of federal councils of health professionals. Three historical phases were established according to the public policy cycle, and material was classified according to the purpose of the normative documents. The content analysis was based on the advocacy coalition framework model. Of the federal legislations, 8.9% were for the Formulation/Decision-Making phase, 43% for the Organization/Implementation phase, and 48.1% for the Expansion/Maturation phase of telemedicine policy in Brazil. The Federal Council of Medicine was the most active in standardizing telemedicine and was responsible for 21 (67.7%) regulations. The first legislations were passed in 2000; however, the coalitions discussed topics related to telemedicine and created their belief systems from the 1990's. The time cycle which included formulation and decision making for Brazilian telemedicine policy, extended until 2007 with the creation of several technical working groups. The expansion and maturation of telemedicine services began in 2011 with the decentralization of telemedicine policy actions across the country. Telemedicine centers which performed telediagnosis influenced the computerization of primary health care units. We conclude that Brazilian telemedicine field has greatly grown and changed in recent years. However, despite the proliferation of legislations and regulations in the period studied, there is still no fully consolidated process for setting up a wholly defined regulatory framework for telemedicine in Brazil.

Educação e informação em saúde: iniciativas dos núcleos de telessaúde para o enfrentamento da covid-19 / Educação e informação em saúde: iniciativas dos núcleos de telessaúde para o enfrentamento da covid-19 / Health education and information: initiatives of telehealth centers to combat covid-19

Objetivo: Identificar as iniciativas de teleducação e informações em saúde direcionadas ao enfrentamento da pandemia da COVID-19 oferecidas pelos Núcleos Estaduais de Telessaúde vinculados ao Programa Telessaúde Brasil Redes. Método: Estudo exploratório, transversal, de abordagem quali-quantitativa, na forma de casos múltiplos, usando informações disponíveis nos sítios eletrônicos e mídias sociais. Resultados: Informações e iniciativas de tele-educação voltadas à COVID-19 estavam presentes em 15 dos 23 Núcleos existentes. Verificouse produção de amplo leque de materiais diversos, que incluem cursos a distância, webpalestras, webaulas, cartilhas, infográficos e outros materiais informativos. Destaca-se a existência de forte tendência das ações de teleducação com foco nas redes sociais (YouTube, Facebook, Twitter e Instagram), como coadjuvantes na divulgação de produtos e serviços para a população, fortalecendo a democratização e o acesso a informações úteis para usuários, enfermeiros e profissionais dos serviços de saúde. Conclusão: Acesso à informação de forma ágil e transparente, durante o isolamento social é crítico no enfrentamento da pandemia. A web revela-se como importante ferramenta para obter informações sobre a COVID nos Núcleos de Telessaúde. Os resultados mostram papel relevante a ser exercido pelos serviços de telessaúde, considerando a necessidade de qualificação profissional e de acesso à informação de qualidade demandada pela pandemia.(AU)

Objective: To identify the health education and information initiatives aimed at coping with the COVID-19 pandemic, offered by state Telehealth Centers associated with the Brazilian Telehealth Network Program. Method: This is an exploratory, cross-sectional study with a qualitative and quantitative approach, in the form of multiple case study, using information available on websites and social media. Results: COVID-19-related Information and tele-education initiatives were present in 15 of the 23 existing Centers. The production of a wide range of different materials was verified, including online courses, web lectures, manuals, infographics, and other informational material. It is worth mentioning the existence of a strong trend in tele-education actions focused on social networks (YouTube, Facebook, Twitter, and Instagram) as assistants in the disclosure of products and services to the population, strengthening democratization and access to useful information for users, nurses and health service professionals. Conclusions: Access to information in a fast and transparent way during social isolation is critical in facing the pandemic. The websites are an important tool to obtain information about COVID-19 on Telehealth Centers. The results show an important role to be played by telehealth services, considering the need for professional qualification and access to quality information required by the pandemic(AU)

Objetivo: Identificar las iniciativas de teleducación e información de salud destinadas a hacer frente a la pandemia de SARS-CoV-2 ofrecidas por los Centros estaduales de Telesalud vinculados al "Programa Telessaúde Brasil Redes". Método: Estudio exploratorio, transversal, con enfoque cuali-cuantitativo, en forma de casos múltiples, con base en sus páginas web. Resultados: Las iniciativas de información y teleducación dirigidas al nuevo coronavirus estuvieron presentes en 15 centros. Se verificó la producción de una amplia gama de materiales diferentes, incluidos cursos a distancia, conferencias web, folletos, infografías y otros materiales informativos. Se destaca la existencia de una fuerte tendencia en acciones de teleducación centradas en redes sociales (YouTube, Facebook, Twitter e Instagram), como asistentes en la difusión de servicios a la población, fortaleciendo la democratización y el acceso a informaciones útiles para usuarios, enfermeros y profesionales de salud. Conclusión: El acceso a la información ágil y transparente durante el aislamiento social es crítico para enfrentar la pandemia. La web se revela como una herramienta importante para obtener información sobre SARS-CoV-2 en estos centros. Los resultados muestran un papel relevante de los servicios de telesalud, considerando la necesidad de calificación profesional y el acceso a la información de calidad requerida por la pandemia.(AU)

Cost-effectiveness analysis comparing companion diagnostic tests for EGFR, ALK, and ROS1 versus next-generation sequencing (NGS) in advanced adenocarcinoma lung cancer patients.

BACKGROUND: The treatment of choice for advanced non-small cell lung cancer is selected according to the presence of specific alterations. Patients should undergo molecular testing for relevant modifications and the mutational status of EGFR and translocation of ALK and ROS1 are commonly tested to offer the best intervention. In addition, the tests costs should also be taken in consideration. Therefore, this work was performed in order to evaluate the cost-effectiveness of a unique exam using NGS (next generation sequencing) versus other routinely used tests which involve RT-PCR and FISH. METHODS: The target population was NSCLC, adenocarcinoma, and candidates to first-line therapy. Two strategies were undertaken, strategy 1 corresponded to sequential tests with EGFR RT-PCR, then FISH for ALK and ROS1. Strategy 2 differed from 1 in that ALK and ROS1 translocation testing were performed simultaneously by FISH. Strategy 3 considered single test next-generation sequencing, a platform that includes EGFR, ALK and ROS1 genes. A decision tree analysis was used to model genetic testing options. From the test results, a microsimulation model was nested to estimate survival outcomes and costs of therapeutic options. RESULTS: The use of NGS added 24% extra true cases as well as extra costs attributed to the molecular testing. The ICER comparing NGS with sequential tests was US$ 3479.11/correct case detected. The NGS improved a slight gain in life years and QALYs. CONCLUSION: Our results indicated that, although precise, the molecular diagnosis by NGS of patients with advanced stage NSCLC adenocarcinoma histology was not cost-effective in terms of quality-adjusted life years from the perspective of the Brazilian supplementary health system.

Cost-Effectiveness Analysis of Point-of-Care Rapid Testing Versus Laboratory-Based Testing for Antenatal Screening of Syphilis in Brazil.

OBJECTIVES: Severe consequences of mother-to-child transmission of syphilis and high increasing incidence of congenital syphilis remains an important public health problem in Brazil. Our objective was to assess the cost-effectiveness of a rapid point-of-care test (RT) and treatment of positive mothers immediately compared with a laboratory-based standard test (ST) with treatment at next follow-up visit. METHODS: A decision analytic model was developed to estimate the incremental cost-effectiveness ratio (ICER) between antenatal syphilis screening strategies. The model was built with lifetime horizon from Brazilian health system perspective using 3% and 5% discount rates. A hypothetical cohort of pregnant women at reproductive age were used in the model. Health outcomes: low birth weight, stillbirths, neonatal deaths and congenital syphilis were estimated in disability-adjusted life-years (DALYs) lost. Microcosting study and secondary data provided parameters of direct medical costs. Probabilistic sensitivity analysis was undertaken. RESULTS: For base case, the mean cost per pregnant woman screened was $2.63 (RT) and $2.48 (ST), respectively. Maternal syphilis was associated with a loss of 0.0043 DALYs (RT) and 0.0048 DALYs (ST) per mother screened. Expected value of incremental cost per DALY averted was $298.08. After 10 000 probabilistic sensitivity analysis model runs, incremental cost and health benefits were $0.15 (95% credible interval -1.56 to 1.92) and 0.00042 DALYs (95% credible interval -0.0036 to 0.0044), respectively, with a mean ICER of $357.44 per DALY. Screening with RT has a 58% chance of being the optimal strategy at a threshold of $3,200 per DALY. CONCLUSIONS: In Brazil, antenatal screening with syphilis RT and immediate treatment is likely to be cost-effective compared with standard screening and must be prioritized in local settings.

Active and latent tuberculosis in refugees and asylum seekers: a systematic review and meta-analysis.

BACKGROUND: In 2018, there were 70.8 million refugees, asylum seekers and persons displaced by wars and conflicts worldwide. Many of these individuals face a high risk for tuberculosis in their country of origin, which may be accentuated by adverse conditions endured during their journey. We summarised the prevalence of active and latent tuberculosis infection in refugees and asylum seekers through a systematic literature review and meta-analyses by country of origin and host continent. METHODS: Articles published in Medline, EMBASE, Web of Science and LILACS from January 2000 to August 2017 were searched for, without language restriction. Two independent authors performed the study selection, data extraction and quality assessment. Random effect models were used to estimate average measures of active and latent tuberculosis prevalence. Sub-group meta-analyses were performed according to country of origin and host continent. RESULTS: Sixty-seven out of 767 identified articles were included, of which 16 entered the meta-analyses. Average prevalence of active and latent tuberculosis was 1331 per 100 thousand inhabitants [95% confidence interval (CI) = 542-2384] and 37% (95% CI = 23-52%), respectively, both with high level of heterogeneity (variation in estimative attributable to heterogeneity [I2] = 98.2 and 99.8%). Prevalence varied more according to countries of origin than host continent. Ninety-one per cent of studies reported routine screening of recently arrived immigrants in the host country; two-thirds confirmed tuberculosis bacteriologically. Many studies failed to provide relevant information. CONCLUSION: Tuberculosis is a major health problem among refugees and asylum seekers and should be given special attention in any host continent. To protect this vulnerable population, ensuring access to healthcare for early detection for prevention and treatment of the disease is essential.