Does patient and public involvement impact public health decision-making? A 10 year retrospective analysis of public consultation in Brazil.

BACKGROUND:  The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil, and to identify factors associated with changes in Conitec's recommendations following these PC. METHODS:  This cross-sectional study analysed all processes related to the adoption of technologies that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec's recommendations following PC. RESULTS:  A total of 479 technical reports were published, of which 83% (n = 400) were submitted to PC. Demands were made mainly by applicants from the government (n = 262; 55%), regarding the adoption of medicines (n = 366; 76%), in which context neoplasms and infectious diseases were the most frequent indications (n = 66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196 483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n = 99 082; 50%), females (122 895; 67%), white individuals (129 165; 71%) and individuals between the ages of 25 and 59 years (145 364; 80%). Alteration of the preliminary recommendation occurred in 13% (n = 53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (odds ratio 3.87, 95% CI 1.33-13.35, p = 0.02). CONCLUSIONS: Increased engagement of patients and their families and caregivers in PC was associated with changing the preliminary recommendation of Conitec about the adoption of technologies into the public health system in Brazil.

Evaluation of mobile emergency service with the use of mixed method.

This is an evaluative study, with sequential explanatory mixed methods, aimed at evaluating the performance of the Brazilian Mobile Emergency Medical Service (SAMU) in the Grande ABC region, located in the state of São Paulo, Brazil. In the quantitative approach, an analysis of interrupted time series was performed to evaluate the immediate and gradual effects of the SAMU on hospital mortality due to acute myocardial infarction. The qualitative approach was conducted via semi-structured interviews and a thematic analysis was applied for the interpretation of the results, exploring the attitudes and values of the interviewees regarding the performance of SAMU in the Grande ABC region. Interrupted time series analysis showed a -0.04% reduction in the underlying mortality rate since SAMU implementation (95%CI: -0.0816; -0.0162; p-value = 0.0040) and a reduction in the mortality level, -2.89 (95%CI: -4.3293; -1.4623; p-value = 0.0001), both with statistical significance. To improve the robustness of the results, a control region was used, showing a statistically significant difference in the post-intervention result of -0.0639 (95%CI: -0.1060; -0.0219; p-value = 0.0001). The interviews revealed that the SAMU has the potential to intervene in the prognosis of transported cases, however, challenges related to the availability of beds, expansion of telemedicine, and continuous training of professionals for qualified emergency care in the event of a heart attack must be overcome. The results indicate that the studied intervention is part of a set of factors that, together, generate more conditions to achieve a better result.

[Performance of the mobile emergency care service from the perspective of managers and professionals: case study in a region of the state of São Paulo, Brazil]. / Desempenho do serviço de atendimento móvel de urgência na perspectiva de gestores e profissionais: estudo de caso em região do estado de São Paulo, Brasil.

This article aims to analyze the perspective of managers and professionals about the performance of the Mobile Emergency Care Service (SAMU) in the Grande ABC region. This is a qualitative case study based on the formulation of a theoretical-logical model of intervention and semi-structured interviews. The Theoretical-Logical Model translated the dimensions of SAMU analysis: regulation, care and management. The regulation process was understood as a strategic space where the judgment of the patient's need and the ambulance dispatch time have the potential to influence the outcomes of the cases transported. In health care, the main themes that emerged were investment in the qualification of the team and in telemedicine with the perspective of improving the quality of care and making the diagnosis more accurate. In management, challenges such as integrating SAMU with tertiary centers, improving the information system, and monitoring and evaluation were highlighted aiming to qualify the regulatory processes by aligning them with the objectives proposed in the health policy. The set of data analyzed reinforces the capacity of the SAMU in emergency care in the region; however, the intervention needs to overcome important challenges in order to improve the prognosis of the cases transported.

Este artigo tem como objetivo analisar a perspectiva de gestores e profissionais sobre o desempenho do SAMU na região do Grande ABC. Trata-se de estudo de caso, de abordagem qualitativa, baseado na formulação de modelo teórico-lógico da intervenção e entrevistas semiestruturadas. O Modelo teórico-lógico traduziu as dimensões de análise do SAMU: regulação, assistência e gestão. O processo de regulação foi entendido como espaço estratégico onde o julgamento da necessidade do paciente e o tempo de despacho da ambulância tem potencial de influenciar nos desfechos dos casos transportados. Na assistência os principais temas que emergiram foram investimento na qualificação da equipe e em telemedicina com a perspectiva de melhorar a qualidade do cuidado e tornar o diagnóstico mais preciso. No âmbito da gestão desafios como integração do SAMU com centros terciários, aperfeiçoamento do sistema de informação e monitoramento e avaliação foram destacados visando qualificar os processos regulatórios alinhando-os aos objetivos propostos na política de saúde. O conjunto de dados analisados reforça a capacidade do SAMU na atenção de urgência na região, no entanto a intervenção precisa superar importantes desafios em busca de melhor prognóstico entre os casos transportados.

Desempenho do serviço de atendimento móvel de urgência na perspectiva de gestores e profissionais: estudo de caso em região do estado de São Paulo, Brasil / Performance of the mobile emergency care service from the perspective of managers and professionals: case study in a region of the state of São Paulo, Brazil

Resumo Este artigo tem como objetivo analisar a perspectiva de gestores e profissionais sobre o desempenho do SAMU na região do Grande ABC. Trata-se de estudo de caso, de abordagem qualitativa, baseado na formulação de modelo teórico-lógico da intervenção e entrevistas semiestruturadas. O Modelo teórico-lógico traduziu as dimensões de análise do SAMU: regulação, assistência e gestão. O processo de regulação foi entendido como espaço estratégico onde o julgamento da necessidade do paciente e o tempo de despacho da ambulância tem potencial de influenciar nos desfechos dos casos transportados. Na assistência os principais temas que emergiram foram investimento na qualificação da equipe e em telemedicina com a perspectiva de melhorar a qualidade do cuidado e tornar o diagnóstico mais preciso. No âmbito da gestão desafios como integração do SAMU com centros terciários, aperfeiçoamento do sistema de informação e monitoramento e avaliação foram destacados visando qualificar os processos regulatórios alinhando-os aos objetivos propostos na política de saúde. O conjunto de dados analisados reforça a capacidade do SAMU na atenção de urgência na região, no entanto a intervenção precisa superar importantes desafios em busca de melhor prognóstico entre os casos transportados.

Abstract This article aims to analyze the perspective of managers and professionals about the performance of the Mobile Emergency Care Service (SAMU) in the Grande ABC region. This is a qualitative case study based on the formulation of a theoretical-logical model of intervention and semi-structured interviews. The Theoretical-Logical Model translated the dimensions of SAMU analysis: regulation, care and management. The regulation process was understood as a strategic space where the judgment of the patient's need and the ambulance dispatch time have the potential to influence the outcomes of the cases transported. In health care, the main themes that emerged were investment in the qualification of the team and in telemedicine with the perspective of improving the quality of care and making the diagnosis more accurate. In management, challenges such as integrating SAMU with tertiary centers, improving the information system, and monitoring and evaluation were highlighted aiming to qualify the regulatory processes by aligning them with the objectives proposed in the health policy. The set of data analyzed reinforces the capacity of the SAMU in emergency care in the region; however, the intervention needs to overcome important challenges in order to improve the prognosis of the cases transported.

Evaluation of mobile emergency service with the use of mixed method / Avaliação do serviço móvel de urgência com o uso de método misto / Evaluación de la atención móvil de urgencias con el uso del método mixto

This is an evaluative study, with sequential explanatory mixed methods, aimed at evaluating the performance of the Brazilian Mobile Emergency Medical Service (SAMU) in the Grande ABC region, located in the state of São Paulo, Brazil. In the quantitative approach, an analysis of interrupted time series was performed to evaluate the immediate and gradual effects of the SAMU on hospital mortality due to acute myocardial infarction. The qualitative approach was conducted via semi-structured interviews and a thematic analysis was applied for the interpretation of the results, exploring the attitudes and values of the interviewees regarding the performance of SAMU in the Grande ABC region. Interrupted time series analysis showed a -0.04% reduction in the underlying mortality rate since SAMU implementation (95%CI: -0.0816; -0.0162; p-value = 0.0040) and a reduction in the mortality level, -2.89 (95%CI: -4.3293; -1.4623; p-value = 0.0001), both with statistical significance. To improve the robustness of the results, a control region was used, showing a statistically significant difference in the post-intervention result of -0.0639 (95%CI: -0.1060; -0.0219; p-value = 0.0001). The interviews revealed that the SAMU has the potential to intervene in the prognosis of transported cases, however, challenges related to the availability of beds, expansion of telemedicine, and continuous training of professionals for qualified emergency care in the event of a heart attack must be overcome. The results indicate that the studied intervention is part of a set of factors that, together, generate more conditions to achieve a better result.

Estudo avaliativo com uso de métodos mistos na tipologia explanatória sequencial cujo objetivo foi avaliar o desempenho do Serviço de Atendimento Móvel de Urgência (SAMU) na região do Grande ABC, Estado de São Paulo, Brasil. Na abordagem quantitativa, foi realizada análise de séries temporais interrompidas para testar os efeitos imediatos e graduais da intervenção sobre a mortalidade hospitalar por infarto agudo do miocárdio. A abordagem qualitativa foi realizada através de entrevistas semi-estruturadas, e a análise temática foi aplicada para a interpretação dos resultados, explorando as atitudes e valores dos entrevistados em relação ao desempenho do SAMU no Grande ABC. A análise de série temporal interrompida mostrou uma redução de -0,04% na taxa de mortalidade subjacente desde a implementação do SAMU (IC95%: -0,0816; -0,0162; p = 0,0040) e uma redução no nível de mortalidade, de -2,89 (IC95%: -4,3293; -1,4623; p = 0,0001), ambas estatisticamente significativas. Para melhorar a robustez dos resultados, foi utilizada uma região de controle, o que mostrou uma diferença estatisticamente significativa na tendência pós-intervenção de -0,0639 (IC95%: -0,1060; -0,0219; p = 0,0001). De acordo com as entrevistas, o SAMU tem o potencial de intervir no prognóstico dos pacientes transportados; entretanto, em casos de infarto agudo do miocárdio, diversos desafios precisam ser superados, relacionados à disponibilidade de leitos, expansão da telemedicina e capacitação permanente das equipes de atendimento qualificado em emergências. Os resultados indicam que a intervenção faz parte de um conjunto de fatores que, conjuntamente, geram mais condições para alcançar melhores resultados.

Investigación evaluativa, utilizando métodos mixtos explicativos secuenciales, cuyo objetivo fue evaluar el desempeño del Servicio de Atención Móvil de Urgencia (SAMU) en una región de Brasil, denominada Grande ABC, estado de São Paulo, Brasil. En el enfoque cuantitativo, se realizó un análisis de series temporales interrumpidas para comprobar los efectos inmediatos y graduales de la intervención sobre la mortalidad intrahospitalaria por infarto agudo de miocardio. El enfoque cualitativo se llevó a cabo a través de entrevistas semiestructuradas y para la interpretación de los resultados se aplicó un análisis temático, investigando las actitudes y valores de los entrevistados sobre el desempeño del SAMU en la región Grande ABC. Los análisis de series de tiempo interrumpido mostraron una reducción -0,04% en la tasa de mortalidad subyacente desde la implementación del SAMU (IC95%: -0,0816; -0,0162; p = 0,0040) y una reducción en el nivel de mortalidad, -2,89 (IC95%: -4,3293; -1,4623; p = 0,0001), ambos con significación estadística. Con el fin de mejorar la solidez de los resultados, se utilizó un control de región, que mostró una diferencia estadísticamente significativa en la tendencia del resultado post intervención de -0,0639 (IC95%: -0,1060; -0,0219; p = 0,0001). Las entrevistas revelaron que el SAMU tiene el potencial de intervenir en la prognosis de los casos trasportados, sin embargo, deben superarse los desafíos relacionados con la disponibilidad de camas, expansión de la telemedicina y el entrenamiento continuo de profesionales para la asistencia cualificada en emergencias, en caso de un ataque al corazón. Los resultados indican que la intervención estudiada es parte de un conjunto de condiciones que, juntas, generan más condiciones para alcanzar un mejor resultado.

COVID-19 and the medicines regulation challenges in times of pandemic. / COVID-19 e os desafios para a regulação de medicamentos em tempos de pandemia.

The SARS-CoV-2 pandemic has brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in the number of intensive care beds, provision of human resources and equipment are necessary actions. However, there are yet no specific effective and safe medicines that justify their use. The challenge imposed on the regulatory framework for medicines is aimed at providing timely access to medicines capable of modifying the course of the disease and leading to better treatment outcomes, with health safety. Regulatory agencies must protect the health by assessing the actual benefits and harms of the medicines under these specific conditions. The article discusses the main regulatory challenges and response of regulatory agencies to the demands imposed by the COVID-19 pandemic, especially, drug development strategies and regulatory strategies related to off-label use. Emergency drug use authorization and alternatives for extended/compassionate use are addressed, as well as clinical trials, safety assessment and monitoring of adverse events.

A pandemia de SARS-CoV-2 trouxe desafios relacionados à prevenção, proteção e cuidado. Estratégias de enfrentamento, como distanciamento social, medidas de proteção individual da população e trabalhadores, ampliação dos leitos de terapia intensiva, disponibilização de recursos humanos e equipamentos são ações necessárias. Não há, ainda, medicamentos específicos com eficácia e segurança que justifiquem sua utilização. O desafio imposto ao marco regulatório de medicamentos volta-se para o acesso tempestivo a medicamentos capazes de modificar o curso da doença e conduzir a melhores desfechos no tratamento, com segurança sanitária. Cabe às agências reguladoras a proteção da saúde com a atribuição de avaliar os reais benefícios e malefícios dos medicamentos nestas condições especificas. O artigo apresenta as ações das agências reguladoras e discute os desafios na implementação da política regulatória de medicamentos frente às exigências impostas pela pandemia de COVID-19. São abordadas, especialmente, estratégias de desenvolvimento de fármacos e estratégias regulatórias sobre a indicação de uso off label, do uso emergencial de medicamentos e das alternativas de uso extendido/compassivo, bem como da realização de ensaios clínicos e da avaliação da segurança e monitoramento de eventos adversos.

COVID-19 e os desafios para a regulação de medicamentos em tempos de pandemia / COVID-19 and the medicines regulation challenges in times of pandemic

Resumo A pandemia de SARS-CoV-2 trouxe desafios relacionados à prevenção, proteção e cuidado. Estratégias de enfrentamento, como distanciamento social, medidas de proteção individual da população e trabalhadores, ampliação dos leitos de terapia intensiva, disponibilização de recursos humanos e equipamentos são ações necessárias. Não há, ainda, medicamentos específicos com eficácia e segurança que justifiquem sua utilização. O desafio imposto ao marco regulatório de medicamentos volta-se para o acesso tempestivo a medicamentos capazes de modificar o curso da doença e conduzir a melhores desfechos no tratamento, com segurança sanitária. Cabe às agências reguladoras a proteção da saúde com a atribuição de avaliar os reais benefícios e malefícios dos medicamentos nestas condições especificas. O artigo apresenta as ações das agências reguladoras e discute os desafios na implementação da política regulatória de medicamentos frente às exigências impostas pela pandemia de COVID-19. São abordadas, especialmente, estratégias de desenvolvimento de fármacos e estratégias regulatórias sobre a indicação de uso off label, do uso emergencial de medicamentos e das alternativas de uso extendido/compassivo, bem como da realização de ensaios clínicos e da avaliação da segurança e monitoramento de eventos adversos.

Abstract The SARS-CoV-2 pandemic has brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in the number of intensive care beds, provision of human resources and equipment are necessary actions. However, there are yet no specific effective and safe medicines that justify their use. The challenge imposed on the regulatory framework for medicines is aimed at providing timely access to medicines capable of modifying the course of the disease and leading to better treatment outcomes, with health safety. Regulatory agencies must protect the health by assessing the actual benefits and harms of the medicines under these specific conditions. The article discusses the main regulatory challenges and response of regulatory agencies to the demands imposed by the COVID-19 pandemic, especially, drug development strategies and regulatory strategies related to off-label use. Emergency drug use authorization and alternatives for extended/compassionate use are addressed, as well as clinical trials, safety assessment and monitoring of adverse events.

Rethinking approaches of science, technology, and innovation in healthcare during the COVID-19 pandemic: the challenge of translating knowledge infrastructures to public needs.

The coronavirus disease 2019 (COVID-19) outbreak made it clear that despite the potential of science, technology, and innovation (ST&I) to positively impact healthcare systems worldwide, as shown by the rapid development of SARS-CoV-2 test diagnostics and new mRNA vaccines, healthcare stakeholders have faced significant challenges in responding to the crisis through well-integrated ST&I-oriented health initiatives and policies. Therefore, the pandemic has mobilized experts, industry, and governments to evaluate alternative trajectories to promote a more efficient dialogue between ST&I and public health. This article presents a critical thinking about the contemporary asymmetries in the technical and political infrastructures available for particular approaches in ST&I in health, such as precision medicine, and for public health systems worldwide, uncovering a persistent gap in the translation of knowledge and technologies to adequately coordinated responses to the pandemic. We stimulate the understanding of this process as a matter of translation between platforms of knowledge and policy rationales shaped by different institutionalized frames of organizational practices and agendas. We draw attention to the need to strengthen governance tools for the promotion of ST&I as a strategic component of the post-pandemic agenda in public health, to prepare societies to respond efficiently to future emergencies.

Patient and public involvement in health technology decision-making processes in Brazil.

OBJECTIVE: The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS: This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS: The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS: There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.

[National Pharmacovigilance Systems in Brazil and Portugal: similarities, differences, and challenges]. / Sistema Nacional de Farmacovigilância no Brasil e em Portugal: semelhanças, diferenças e desafios.

National Pharmacovigilance Systems (PVS) manage health risks and identify, assess, and act to minimize them, contributing to adequate use of medicines, patient safety, and improved quality of care. Fast-track drug registration, which has become increasingly frequent, hinders assessment of the efficacy and safety of new drugs, adding difficulties to current regulation and health protection. The article applies indicators proposed by the World Health Organization to analyze the National PVS of Portugal and Brazil. Brazil's PVS was established later than that of Portugal, generates fewer safety signals, has a lower notification rate for suspected adverse drug events (ADEs), and displays difficulty in producing and disseminating information to health professionals and the population. Portugal has the advantage of being a member state of the European Medicines Agency. The article also suggests that the differences are related to the political and social context that hinders the implementation of public policies and compromises the effectiveness of the Brazilian PVS. Challenges for PVS include awareness-raising of health professionals, the adoption of methods to complement voluntary notification, pharmacovigilance of biological and genetic drugs, and assessment of the system's impact. An additional challenge for the Brazilian PVS is to improve the notifications' uptake and quality, including from industry, generate safety signals in the national context, and communicate risk in timely fashion to health professionals and the population.

Income and out-of-pocket health expenditure in living arrangements of families with older adults in Brazil.

The main objective of this study was to characterize household sociodemographic and economic patterns of different living arrangements of families with older adults in Brazil and their relationship with income and out-of-pocket health expenditure. Data were extracted from the 2008-2009 Brazilian Household Budget Survey (POF, in Portuguese) database of the Brazilian Institute of Geography and Statistics. Families with older adults represented 28% of all families, being smaller and having higher average income when compared to families without older adults. Older adults were head of the household in 85% of the families, with income based mainly on social protection policies. The families with older adult or couple as head of the household had significantly higher average monthly income. The proportion of out-of-pocket health expenditure per income quintile per capita was higher for families with one older adult or couple as head of the household, when compared to families without older adult as head of the household and even more in families without older adults at all. These findings allow the identification of potential positive impacts on the quality of life of families with older adults in Brazil. The higher household income of families with older adults is a consequence of the expansion of inclusive social protection policies for this population in the 2000s in Brazil, especially for families with lower average income levels, representing 4/5 of this population. The economic and political crisis in the 2010s have probably reduced these families' relative advantage, and this study will compare with results of the next survey.

Cost-effectiveness analysis of universal adult immunization with tetanus-diphtheria-acellular pertussis vaccine (Tdap) versus current practice in Brazil.

BACKGROUND: A pertussis outbreak occurred in Brazil from 2011 to 2014, despite high coverage of whole-cell pertussis containing vaccines in early childhood. Infants were the most affected. This study aimed to evaluate the cost-effectiveness of introducing universal adult vaccination with Tdap into the National Immunization Program in Brazil. METHODS: Economic evaluation using a dynamic model to compare two strategies: (1) universal vaccination with single dose of Tdap at 20 years of age and (2) current practice (only pregnant women pertussis vaccination). The health system perspective was adopted. Temporal horizon was 10 years. Discount rate of 5% was applied to costs and benefits. Vaccine effectiveness (VE) was obtained from a population-based observational study. Epidemiological, resource utilization and cost estimates were obtained from the Brazilian Health Information Systems. The primary outcome was cost per life year saved (LYS), based on life expectancy at birth in Brazil in 2015. Univariate and multivariate sensitivity analysis were performed. RESULTS: Adult vaccination with VE of 82.6% and coverage of 40%, at price of US$7.01 per dose, and assuming herd protection would avoid 167 infant deaths by pertussis, saving 12,325 years of life and costing a total of US$105495891.61, from the health system perspective. The universal immunization would result in ICER of US$8459.13. The results were highly sensitive to disease incidence. CONCLUSIONS: The results suggest that universal adult vaccination with Tdap would not be a cost-effective intervention for preventing pertussis cases and deaths in infants in Brazil.

Patient and public involvement in health technology decision-making processes in Brazil / Participação social na gestão de tecnologias em saúde em âmbito federal no Brasil

ABSTRACT OBJECTIVE The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.

RESUMO OBJETIVO Caracterizar e discutir os processos formais de participação social previstos e implementados pelas instituições Agência Nacional de Vigilância Sanitária (Anvisa), Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) e Agência Nacional de Saúde Suplementar (ANS). MÉTODOS Estudo exploratório, descritivo, comparativo, conduzido por meio de análise de documentos publicados até 2018 no sítio eletrônico e da legislação específica de cada instituição. RESULTADOS Os espaços de participação social identificados incluem a representação em colegiados e participação direta por meio de uma demanda inicial ou em consultas públicas, audiências públicas e ouvidorias. A Anvisa conduziu 187 consultas públicas entre 1999 e 2018, e contabilizou 10.699 contribuições. Em 76 (41%) consultas públicas não há informações sobre as contribuições recebidas. A Conitec conduziu 234 consultas públicas, e recebeu 53.174 contribuições entre 2011 e 2018. Identificou-se que 70 (23%) recomendações da Conitec foram emitidas sem consulta pública, e 26 (8%) recomendações preliminares foram alteradas após consulta pública. As alterações de recomendação aconteceram especialmente em casos com grande volume de contribuições. A ANS conduziu 8 consultas públicas sobre o rol de procedimentos e eventos em saúde entre 2000 e 2018, e recebeu pelo menos 31.498 contribuições. Em três consultas públicas não há informações sobre o número de contribuições recebidas. CONCLUSÕES Observa-se recente avanço normativo e de desempenho institucional em favor da participação social em espaços decisórios notadamente técnicos, embora de forma bastante heterogênea entre as instituições analisadas. O poder deliberativo da participação social de influenciar as decisões em saúde ainda necessita de estudo aprofundado, incluindo a caracterização dos participantes e a legitimidade das decisões subsequentes.

Sistema Nacional de Farmacovigilância no Brasil e em Portugal: semelhanças, diferenças e desafios / National Pharmacovigilance Systems in Brazil and Portugal: similarities, differences, and challenges / Sistema Nacional de Farmacovigilancia en Brasil y en Portugal: semejanzas, diferencias y desafíos

Resumo: Os Sistemas Nacionais de Farmacovigilância (SINAF), ao realizar a gestão do risco sanitário, identificam, avaliam e atuam na sua minimização, contribuindo para o uso adequado dos medicamentos, a segurança do paciente e a melhor qualidade do cuidado. O registro acelerado, cada vez mais frequente, dificulta a avaliação da eficácia e segurança de novas substâncias, agregando dificuldades para a regulação contemporânea e para a proteção da saúde. O artigo analisa, por meio da aplicação de indicadores propostos pela Organização Mundial da Saúde, os SINAF de Portugal e do Brasil. O SINAF brasileiro foi institucionalizado mais tardiamente, gera menos sinais de segurança, apresenta menor taxa de notificação de suspeitas de eventos adversos a medicamentos (EAM) e demonstra dificuldade na produção e disseminação de informação a profissionais e população. Portugal se favorece da condição de estado membro da Agência Europeia de Medicamentos. Sugere-se, ainda, que as diferenças se relacionem ao contexto político-social que dificulta a implantação das políticas públicas e compromete a efetividade do SINAF brasileiro. São desafios para os SINAF a sensibilização dos profissionais, a adoção de métodos complementares à notificação voluntária, a farmacovigilância de medicamentos biológicos e de base genética, e a avaliação do impacto de suas ações. O SINAF brasileiro tem como desafio complementar aprimorar a captação e qualidade das notificações, inclusive da indústria, gerar sinais de segurança no contexto nacional e comunicar o risco, de forma tempestiva, a profissionais e população.

Abstract: National Pharmacovigilance Systems (PVS) manage health risks and identify, assess, and act to minimize them, contributing to adequate use of medicines, patient safety, and improved quality of care. Fast-track drug registration, which has become increasingly frequent, hinders assessment of the efficacy and safety of new drugs, adding difficulties to current regulation and health protection. The article applies indicators proposed by the World Health Organization to analyze the National PVS of Portugal and Brazil. Brazil's PVS was established later than that of Portugal, generates fewer safety signals, has a lower notification rate for suspected adverse drug events (ADEs), and displays difficulty in producing and disseminating information to health professionals and the population. Portugal has the advantage of being a member state of the European Medicines Agency. The article also suggests that the differences are related to the political and social context that hinders the implementation of public policies and compromises the effectiveness of the Brazilian PVS. Challenges for PVS include awareness-raising of health professionals, the adoption of methods to complement voluntary notification, pharmacovigilance of biological and genetic drugs, and assessment of the system's impact. An additional challenge for the Brazilian PVS is to improve the notifications' uptake and quality, including from industry, generate safety signals in the national context, and communicate risk in timely fashion to health professionals and the population.

Resumen: Los Sistemas Nacionales de Farmacovigilancia (SINAF), cuando realizan la gestión del riesgo sanitario, identifican, evalúan y actúan en su minimización, contribuyendo al uso adecuado de los medicamentos, la seguridad del paciente y una mejor calidad del cuidado. El registro acelerado, cada vez más frecuente, dificulta la evaluación de la eficacia y seguridad de nuevas sustancias, agregando dificultades para la regulación contemporánea y para la protección de la salud. El artículo analiza, mediante la aplicación de indicadores propuestos por la Organización Mundial de la Salud, los SINAF de Portugal y de Brasil. El SINAF brasileño se institucionalizó más tardíamente, genera menos señales de seguridad, posee una menor tasa de notificación de sospechas de efectos adversos relacionados con medicamentos (EAM) y demuestra dificultad en la producción y difusión de información a profesionales y población. Portugal se favorece de la condición de estado miembro de la Agencia Europea de Medicamentos. Se sugiere, incluso, que las diferencias se relacionan con el contexto político-social que dificulta la implementación de las políticas públicas y compromete la efectividad del SINAF brasileño. Son desafíos para los SINAF: la sensibilización de los profesionales, la adopción de métodos complementarios a la notificación voluntaria, la farmacovigilancia de medicamentos biológicos y de base genética y la evaluación del impacto de sus acciones. El SINAF brasileño tiene como desafío complementario perfeccionar la captación y calidad de las notificaciones, inclusive de la industria, generar señales de seguridad en el contexto nacional y comunicar el riesgo, de forma adecuada, a profesionales y población.

Income and out-of-pocket health expenditure in living arrangements of families with older adults in Brazil / Renda e gastos diretos em saúde de acordo com diferentes arranjos de moradia em famílias com idosos no Brasil / Ingresos y gastos personales en salud dentro de hogares familiares conviviendo con ancianos en Brasil

Abstract: The main objective of this study was to characterize household sociodemographic and economic patterns of different living arrangements of families with older adults in Brazil and their relationship with income and out-of-pocket health expenditure. Data were extracted from the 2008-2009 Brazilian Household Budget Survey (POF, in Portuguese) database of the Brazilian Institute of Geography and Statistics. Families with older adults represented 28% of all families, being smaller and having higher average income when compared to families without older adults. Older adults were head of the household in 85% of the families, with income based mainly on social protection policies. The families with older adult or couple as head of the household had significantly higher average monthly income. The proportion of out-of-pocket health expenditure per income quintile per capita was higher for families with one older adult or couple as head of the household, when compared to families without older adult as head of the household and even more in families without older adults at all. These findings allow the identification of potential positive impacts on the quality of life of families with older adults in Brazil. The higher household income of families with older adults is a consequence of the expansion of inclusive social protection policies for this population in the 2000s in Brazil, especially for families with lower average income levels, representing 4/5 of this population. The economic and political crisis in the 2010s have probably reduced these families' relative advantage, and this study will compare with results of the next survey.

Resumo: O estudo teve como principal objetivo caracterizar os padrões domiciliares sociodemográficos e econômicos em diferentes arranjos de moradia em famílias com idosos no Brasil e a associação com renda e gastos diretos em saúde. Os dados foram extraídos da base de dados da Pesquisa de Orçamentos Familiares (POF) de 2008/2009 do Instituto Brasileiro de Geografia e Estatística. As famílias com idosos representavam 28% do total, eram menores e tinha uma média de renda mais elevada, comparado a famílias sem idosos. Os adultos idosos eram chefes de família em 85% do total, e com renda originária principalmente das políticas de proteção social. As famílias chefiadas por um adulto ou casal idoso tinham média de renda mensal mais elevada. A proporção de gastos diretos em saúde de acordo com o quintil de renda per capita era mais alta em famílias chefiadas com um adulto ou casal idoso, comparado a famílias com um idoso não chefe de domicílio, e mais ainda em famílias sem idosos. Os achados permitem a identificação de impactos positivos potenciais sobre a qualidade de vida de famílias com idosos no Brasil. A renda domiciliar mais alta das famílias com idosos é consequência da expansão das políticas inclusivas de políticas de proteção social para idosos no Brasil nos anos 2000, especialmente para famílias com renda mais baixa, que representam 80% dessa população. É provável que a crise econômica e política dos anos 2010 tenha reduzido a vantagem relativa dessas famílias, e o estudo atual permitirá comparações com os resultados da próxima POF.

Resumen: El objetivo principal de este estudio fue caracterizar los patrones sociodemográficos y económicos de los hogares en los que conviven familias con ancianos en Brasil, y su relación con los ingresos y gastos personales en salud. Los datos se extrajeron de la base de datos de la Encuesta de Presupuestos Familiares (POF, por sus siglas en portugués) en 2008-2009 del Instituto Brasileño de Geografía y Estadística. Las familias con ancianos representaron un 28% de todas las familias, eran pequeñas y contaban con ingresos promedio altos, cuando se compararon con las familias sin ancianos en el hogar. Los ancianos eran los cabeza de familia en un 85% de las familias, con ingresos basados principalmente en políticas de protección social. Las familias con ancianos o parejas de ancianos cabezas del hogar contaban con un promedio de ingresos significativamente más alto. La proporción de gasto personal en salud por quintil de ingresos per cápita fue mayor en las familias con una pareja o un anciano como cabeza de familia, cuando se comparó con las familias sin ancianos cabeza de familia, e incluso mayor respecto a las familias sin ancianos en el hogar. Estos resultados permitieron la identificación de potenciales impactos positivos en la calidad de vida de las familias con ancianos en Brasil. Los ingresos más altos por hogar de familias con ancianos son una consecuencia de la expansión de la protección social inclusiva en Brasil durante la primera década del 2000, especialmente para familias con niveles promedio más bajos de ingresos, representando un 4/5 de esta población. La crisis política y económica a partir del año 2010 ha reducido probablemente la ventaja relativa de estas familias, lo que permitirá comparaciones entre este estudio y los resultados de posteriores.

Systematic review of health economic evaluation studies of dengue vaccines.

OBJECTIVES: To review the literature on economic evaluation of dengue vaccination to produce evidence to support a local cost-effectiveness study and to subsidize the decision to introduce a dengue vaccine in the Brazilian National Immunization Program. METHODS: We systematically searched multiple databases (MEDLINE (via PubMed), EMBASE, SCOPUS, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination - CRD) and LILACS), selecting full HEEs of dengue vaccine. Two independent reviewers screened articles for relevance and extracted the data. The methodology for the quality reporting was assessed using CHEERS checklist. We performed a qualitative narrative synthesis. RESULTS: Thirteen studies conducted in Asian and Latin America countries were reviewed. All studies were favorable to the incorporation of the vaccine. However, the assumptions and values assumed for vaccine efficacy, safety and duration of protection, as well as the choice of the study population and the type of model used in the analyses, associated to an insufficient reporting of the methodological steps, affect the validity of the studies' results. The quality reporting appraisal showed that the majority (8/13) of the studies reported less than 55% of the CHEERS checklists' items. CONCLUSIONS: This systematic review shows that the economic evaluation of dengue vaccination did not adhere to key recommended general methods for economic evaluation. The presented cost-effectiveness results should not be transferred to other countries. It is recommended to conduct studies with local epidemiological and cost data, as well as assumptions about vaccination that reflect the results observed in clinical trials.