Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil.

BACKGROUND AIMS: The marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. METHODS: A survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. RESULTS: We invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. CONCLUSIONS: Considering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS.

Clinical effectiveness of screening for age-related macular degeneration: A systematic review.

INTRODUCTION: Age-related macular degeneration (AMD) is an eye disease that occurs in patients over 50 years old. Early diagnosis enables timely treatment to stabilize disease progression. However, the fact that the disease is asymptomatic in its early stages can delay treatment until it progresses. As such, screening in specific contexts can be an early detection tool to reduce the clinical and social impact of the disease. OBJECTIVE: Assess the effectiveness of screening methods for early detection of AMD in adults aged 50 years or older. METHODS: A systematic review of comparative observational studies on AMD screening methods in those aged 50 years or older, compared with no screening or any other strategy. A literature search was conducted in the MEDLINE (via PubMed), Embase, Cochrane Library and Lilacs database. RESULTS: A total of 5,290 studies were identified, three of which met the inclusion criteria and were selected for the systematic review. A total of 8,733 individuals (16,780 eyes) were included in the analysis. The screening methods assessed were based on optical coherence tomography (OCT) compared with color fundus photography, and OCT and telemedicine testing compared to a standard eye exam. CONCLUSION: The systematized data are limited and only suggest satisfactory performance in early screening of the population at risk of developing AMD. OCT and the telemedicine technique showed promising results in AMD screening. However, methodological problems were identified in the studies selected and the level of evidence was considered low.

The care pathway of individuals with spinal disorders in a Health Care Network in the Federal District, Brazil: a retrospective study.

BACKGROUND: Understanding the care pathway is essential to identify how to effectively treat spinal disorders. However, there is no specific data on the pathway of these individuals in the Health Care Networks (HCN) in Brazil. OBJECTIVE: To investigate the pathway of individuals with non-specific spinal disorders (NSD) in the HCN in the Federal District, Brazil, and verify the interventions adopted, and to test whether sociodemographic and clinical variables predict the number of imaging tests, prescribed medication, and the first HCN access. METHODS: Retrospective study that analysed electronic records of 327 individuals with NSD between 2012 and 2018. Generalized linear models estimated the association between sociodemographic and clinical data and number of drugs prescribed and imaging tests requested. Multinomial logistic regression estimated the association between clinical and demographic variables and setting of first access. RESULTS: The median age was 57 years, and 75.5% were women. Emergency Department (ED) was the most accessed setting (43.7%), and back pain was the most prevalent condition (84.5%). Most individuals underwent imaging tests (60%) and drug prescriptions (86%). Physical exercises were prescribed to 13%, and 55% were referred to physical therapy. Women were more likely to first access the ED. CONCLUSION: The ED was the most used setting by people with NSD. Few participants received exercise prescriptions and half were referred to physical therapists. Individuals who used outpatient clinics and primary care received less drug prescriptions, and women were more likely to first access the ED. Increasing age was associated with greater chance of first accessing Outpatient Clinics.

Determining Medication Errors in an Adult Intensive Care Unit.

INTRODUCTION: Research addressing the costs of Medication errors (MEs) is still scarce despite issues related to patient safety having significant economic and health impacts, making it imperative to analyze the costs and adverse events related to MEs for a better patient, professional, and institutional safety. AIM: To identify the number of medication errors and verify whether this number was associated with increased hospitalization costs for patients in an Intensive Care Unit (ICU). METHOD: This retrospective cross-sectional cohort study evaluated secondary data from patients' electronic medical records to compile variables, create a model, and survey hospitalization costs. The statistical analysis included calculating medication error rates, descriptive analysis, and simple and multivariate regression. RESULTS: The omission error rate showed the highest number of errors per drug dose (59.8%) and total errors observed in the sample (55.31%), followed by the time error rate (26.97%; 24.95%). The omission error had the highest average when analyzing the entire hospitalization (170.40) and day of hospitalization (13.79). Hospitalization costs were significantly and positively correlated with scheduling errors, with an increase of BRL 121.92 (about USD $25.00) (95% CI 43.09; 200.74), and to prescription errors, with an increase of BRL 63.51 (about USD $3.00) (95% CI 29.93; 97.09). CONCLUSION: We observed an association between two types of medication errors and increased hospitalization costs in an adult ICU (scheduling and prescription errors).

Financiamento de pesquisas sobre dengue no Brasil, 2004-2020 / Funding for research on dengue in Brazil, 2004-2020

RESUMO A dengue representa um importante problema de saúde pública no Brasil devido às constantes epidemias causadas pela doença no País. Este estudo objetivou analisar o financiamento de pesquisas sobre dengue pelo Departamento de Ciência e Tecnologia do Ministério da Saúde e parceiros no período de 2004 a 2020. Analisou-se a tendência do financiamento por regressão linear generalizada do tipo Prais-Winster e sua distribuição entre as regiões e Unidades Federadas brasileiras, modalidades de contratação das pesquisas, instituições beneficiadas e temas estudados. Entre 2004 e 2020, financiaram-se 232 pesquisas (R$ 164,03 milhões), realizadas, em sua maioria, em instituições da região Sudeste (77,55%), abordando especialmente a temática controle vetorial (37,93%). A tendência de financiamento foi estacionária nos anos estudados. As chamadas estaduais foram a principal forma de modalidade de contratação das pesquisas (65,95%). Houve diferença estatisticamente significante na distribuição do valor financiado entre as modalidades de contratação, bem como no número de pesquisas financiadas e valor financiado entre as regiões brasileiras. Esses achados demonstram a importância de monitorar o financiamento de pesquisas sobre dengue no Brasil e de implementar estratégias de avaliação das pesquisas financiadas, para subsidiar e aprimorar a política de enfrentamento da doença e de seu vetor.

ABSTRACT Dengue represents an important public health problem in Brazil, due to the constant epidemics caused by the disease in the country. This study aimed to analyze the funding of research on dengue by the Department of Science and Technology of the Ministry of Health of Brazil and partners between 2004 to 2020. Was analyzed the trend of the funding by generalized linear regression using Prais-Winster and its distribution between Brazilian regions and Federated Units, research contracting modalities, benefited institutions, and studied themes. Between 2004 and 2020, 232 research studies were funded (R$ 164.03 million), carried out mostly in institutions in the Southeast Region (77.55%), addressing especially the vector control theme (37.93%). The funding trend was stationary in the years studied. The state calls were the main form of contracting modality for the research (65.95%). There was a statistically significant difference in the distribution of the loan amount between the contracting modalities, and in the number of researches funded and loan amount among Brazilian regions. These findings demonstrate the importance of monitoring the research funding on dengue in Brazil and of implementing strategies to evaluate the research funded, to support and improve the policy to combat the disease and its vector.

Consumption of alcoholic beverages in Brazil: estimation of prevalence ratios - 2013 and 2019.

OBJECTIVES: To estimate the prevalence of weekly, monthly and abusive alcohol consumption in Brazil in 2013 and 2019, compare the period estimates, and verify the magnitude of the differences. METHODS: Analysis of data on alcohol consumption in the adult population (18 years or older) from the National Health Survey (PNS), 2013 and 2019. The number of interviewees in 2013 was 60,202 and 88,531 in 2019. The samples were characterized according to demographic, socioeconomic, health, and alcohol consumption variables and differences in proportions in the period were compared using Pearson's c2 test, with Rao-Scott approximation and a 5% significance level. Multivariate Poisson regression models were estimated for the outcome variables of monthly, weekly and abusive consumption of alcoholic beverages, in order to estimate the magnitude of the differences between the 2013 and 2019 PNS estimates, using the prevalence ratio (PR). Models were adjusted per sex and age group and stratified per sex and demographic region. RESULTS: There was a difference in the distribution of the population according to race, occupation, income, age group, marital status, and education. There was an increase in alcohol consumption for all outcome variables, with the exception of weekly consumption in males. The PR of weekly consumption was 1.02 (95%CI 1.014-1.026), and in females the PR was 1.05 (95%CI 1.04-1.06). The highest PRs in the general population and per sex occur for abusive consumption. The increase in weekly consumption per region occurred in the South, Southeast, and Central-West regions. CONCLUSIONS: Males are the main alcohol consumers in Brazil; the PRs for both males and females show that there was an increase in monthly, weekly and abusive consumption in the research period; it is noteworthy that females have increased their consumption pattern with greater intensity than males.

Evolution of research funding for neglected tropical diseases in Brazil, 2004-2020.

Neglected tropical diseases are a global public health problem. Although Brazil is largely responsible for their occurrence in Latin America, research funding on the subject does not meet the population's health needs. The present study analyzed the evolution of research funding for neglected tropical diseases by the Ministry of Health and its partners in Brazil, from 2004 to 2020. This is a retrospective study of data from investigations registered on Health Research (Pesquisa Saúde in Portuguese), a public repository for research funded by the Ministry of Health's Department of Science and Technology. The temporal trend of funding and the influence of federal government changes on funding were analyzed using Prais-Winster generalized linear regression. From 2004 to 2020, 1,158 studies were financed (purchasing power parity (PPP$) 230.9 million), with most funding aimed at biomedical research (81.6%) and topics involving dengue, leishmaniasis and tuberculosis (60.2%). Funding was stationary (annual percent change of -5.7%; 95%CI -54.0 to 45.0) and influenced by changes to the federal government. Research funding was lacking for chikungunya, Chagas disease, schistosomiasis, malaria and taeniasis/cysticercosis, diseases with a high prevalence, burden or mortality rates in Brazil. Although the Ministry of Health had several budgetary partners, it was the main funder, with 69.8% of investments. The study revealed that research funding for neglected tropical diseases has stagnated over the years and that diseases with a high prevalence, burden and mortality rate receive little funding. These findings demonstrate the need to strengthen the health research system by providing sustainable funding for research on neglected tropical diseases that is consistent with the population's health needs.

Prevented cases of neural tube defects and cost savings after folic acid fortification of flour in Brazil.

Anencephaly, encephalocele, and spina bifida are congenital neural tube defects and are the main causes of neonatal morbidity and mortality and impose a heavy economic burden on health systems. This study to estimates the direct costs of neural tube defects from the perspective of the Brazilian Ministry of Health, and the prevented cases and cost savings during the period in which mandatory folic acid fortification was in effect in the country (2010-2019). It is a top-down cost-of-illness oriented study based on the prevalence of the disorders in Brazil. Data were collected from the Brazilian Ministry of Health's outpatient and hospital information system databases. The direct cost was estimated from the total patient-years, allocated by age and type of disorder. Prevented cases and cost savings were determined by the difference in the prevalence of the disorders in the pre- and post-fortification periods based on the total number of births and the sum of outpatient and hospital costs during the period. The total cost of outpatient and hospital services for these disorders totaled R$ 92,530,810.63 (Int$ 40,565,896.81) in 10 years; spina bifida accounted for 84.92% of the total cost. Hospital costs were expressive of all three disorders in the first year of the patient's life. Between 2010 and 2019, mandatory folic acid fortification prevented 3,499 live births with neural tube defects and resulted in R$ 20,381,586.40 (Int$ 8,935,373.25) in hospital and outpatient cost savings. Flour fortification has proved to be a valuable strategy in preventing pregnancies with neural tube defects. Since its implementation, there has been a 30% decrease in the prevalence of neural tube defects and a 22.81% decrease associated in hospital and outpatient costs.

Pay-for-performance for primary health care in Brazil: A comparison with England's Quality Outcomes Framework and lessons for the future.

Pay-for-performance (P4P) has been widely applied in OECD countries to improve the quality of both primary and secondary care, and is increasingly being implemented in low- and middle-income countries. In 2011, Brazil introduced one of the largest P4P schemes in the world, the National Programme for Improving Primary Care Access and Quality (PMAQ). We critically assess the design of PMAQ, drawing on a comparison with England's quality and outcome framework which, like PMAQ, was implemented at scale relatively rapidly within a nationalised health system. A key feature of PMAQ was that payment was based on the performance of primary care teams but rewards were given to municipalities, who had autonomy in how the funds could be used. This meant the incentives felt by family health teams were contingent on municipality decisions on whether to pass the funds on as bonuses and the basis upon which they allocated the funds between and within teams. Compared with England's P4P scheme, performance measurement under PMAQ focused more on structural rather than process quality of care, relied on many more indicators, and was less regular. While PMAQ represented an important new funding stream for primary health care, our review suggests that theoretical incentives generated were unclear and could have been better structured to direct health providers towards improvements in quality of care.

Consumption of alcoholic beverages in Brazil: estimation of prevalence ratios - 2013 and 2019 / Consumo de bebidas alcoólicas no Brasil: estimativa de razões de prevalências - 2013 e 2019

ABSTRACT OBJECTIVES To estimate the prevalence of weekly, monthly and abusive alcohol consumption in Brazil in 2013 and 2019, compare the period estimates, and verify the magnitude of the differences. METHODS Analysis of data on alcohol consumption in the adult population (18 years or older) from the National Health Survey (PNS), 2013 and 2019. The number of interviewees in 2013 was 60,202 and 88,531 in 2019. The samples were characterized according to demographic, socioeconomic, health, and alcohol consumption variables and differences in proportions in the period were compared using Pearson's c2 test, with Rao-Scott approximation and a 5% significance level. Multivariate Poisson regression models were estimated for the outcome variables of monthly, weekly and abusive consumption of alcoholic beverages, in order to estimate the magnitude of the differences between the 2013 and 2019 PNS estimates, using the prevalence ratio (PR). Models were adjusted per sex and age group and stratified per sex and demographic region. RESULTS There was a difference in the distribution of the population according to race, occupation, income, age group, marital status, and education. There was an increase in alcohol consumption for all outcome variables, with the exception of weekly consumption in males. The PR of weekly consumption was 1.02 (95%CI 1.014-1.026), and in females the PR was 1.05 (95%CI 1.04-1.06). The highest PRs in the general population and per sex occur for abusive consumption. The increase in weekly consumption per region occurred in the South, Southeast, and Central-West regions. CONCLUSIONS Males are the main alcohol consumers in Brazil; the PRs for both males and females show that there was an increase in monthly, weekly and abusive consumption in the research period; it is noteworthy that females have increased their consumption pattern with greater intensity than males.

RESUMO OBJETIVOS Estimar as prevalências de consumo de bebidas alcoólicas semanal, mensal e abusivo no Brasil em 2013 e 2019, comparar as estimativas do período e estimar a magnitude das diferenças. MÉTODOS Análise dos dados do consumo de bebidas alcoólicas na população adulta (18 anos ou mais) da Pesquisa Nacional de Saúde (PNS), 2013 e 2019. O número de entrevistados em 2013 foi de 60.202 e, em 2019, de 88.531. As amostras foram caracterizadas segundo variáveis demográficas, socioeconômicas, de saúde e de consumo de bebidas alcoólicas; e foram comparadas as diferenças de proporções no período, por meio do teste do c2 de Pearson, com aproximação de Rao-Scott e nível de significância de 5%. Foram estimados modelos multivariados de regressão de Poisson para as variáveis de desfecho de consumo mensal, semanal e abusivo de bebidas alcoólicas, com o intuito de estimar a magnitude das diferenças entre as estimativas da PNS 2013 e 2019, por meio da razão de prevalência (RP). Os modelos foram ajustados por sexo e faixa etária e estratificados por sexo e região demográfica. RESULTADOS Houve diferença da distribuição da população segundo raça, ocupação, renda, faixa etária, estado civil e escolaridade. Houve aumento do consumo de álcool para todas as variáveis desfecho, com exceção do consumo semanal em homens. A razão de prevalência do consumo semanal foi de 1,02 (IC95% 1,014-1,026), nas mulheres a RP foi de 1,05 (IC95% 1,04-1,06). As maiores razões de prevalência na população geral e por sexo ocorrem para o consumo abusivo. O aumento do consumo semanal por região ocorreu no Sul, Sudeste e Centro-Oeste. CONCLUSÕES O homem é o principal consumidor de álcool no Brasil, as razões de prevalência tanto em homens quanto em mulheres demonstram que houve aumento do consumo mensal, semanal e abusivo no período pesquisado, destaca-se que as mulheres têm aumentado o padrão de consumo com maior intensidade do que os homens.

Conflito distributivo: análise do Programa de Melhoria do Acesso e Qualidade da Atenção Básica (PMAQ-AB) em duas capitais nordestinas / Conflicto distributivo: análisis del Programa de Mejora del Acceso y Calidad de la Atención Básica (PMAQ-AB) en dos capitales del nordeste de Brasil / Distributive conflict: analysis of the Program for Improving Access and Quality of Primary Care (PMAQ-AB) in two Brazilian northeastern capitals

Este artigo analisa a execução do PMAQ-AB a partir de sua contextualização em um cenário político nacional de profundas transformações, desde o reformismo fraco que promoveu lenta extensão de direitos até o contrarreformismo forte da restauração neoliberal. Para debater os elementos relacionados ao trabalho e às disputas pela distribuição dos recursos públicos, foi realizado estudo de caso com trabalhadores, gestores e conselheiros de saúde em duas capitais do nordeste brasileiro. Os resultados evidenciam o acirramento do conflito distributivo e o resultado desfavorável aos trabalhadores no contexto pós-golpe parlamentar de 2016. As dinâmicas locais expõem processos de contração salarial e individualização das relações de trabalho e a reafirmação da meritocracia como justificativa ideológica da precarização. A isso, trabalhadores se contrapõem pela reafirmação de sua condição coletiva de classe, em favor de benefícios derivados do PMAQ, como recomposição salarial para todos.(AU)

Este artículo analiza la realización del PMAQ-AB a partir de su contextualización en un escenario político nacional de profundas transformaciones, desde el reformismo débil que promovió una lenta extensión de derechos contra el reformismo fuerte de la restauración neoliberal. Para discutir los elementos relacionados al trabajo y a las disputas por la distribución en los recursos públicos se realizó un estudio de caso con trabajadores, gestores y consejeros de salud en dos capitales del nordeste brasileño. Los resultados ponen en evidencia el recrudecimiento del conflicto distributivo y el resultado desfavorable para los trabajadores en el contexto post-golpe parlamentario de 2016. Las dinámicas locales exponen procesos de contracción salarial e individualización de las relaciones de trabajo y la reafirmación de la meritocracia como justificativa ideológica de la precarización. A eso se contraponen los trabajadores por medio de la reafirmación de su condición colectiva de clase, en favor del beneficio derivado del PMAQ con la recomposición salarial para todos.(AU)

This article analyzes the implementation of the Program for Improving Access and Quality of Primary Care (PMAQ-AB) in the context of a national political scenario of deep transformations, from the weak reformism that promoted slow extension of rights to the strong counter-reformism of neoliberal restoration. It is a case study with health workers, managers, and counselors in two capital cities in northeastern Brazil, discussing matters of work and distributive disputes of public resources. Results show the intensification of these conflicts in health and the unfavorable outcome for workers after the parliamentary coup in 2016 political context. Local dynamics expose the wage contraction and individualization of labor relations and the reassertion of meritocracy as an ideological ground for precariousness. Workers oppose this, reaffirming their collective class condition, favoring the benefit derived from PMAQ for fully regaining their group wages.(AU)

Big Data e Inteligência Artificial para pesquisa translacional na Covid-19: revisão rápida / Big Data and artificial intelligence for translational research in COVID-19: a rapid review

RESUMO O objetivo deste estudo foi identificar como a Inteligência Artificial (IA) vem sendo utilizada para a pesquisa translacional no contexto da Covid-19. Foi realizada uma revisão rápida para identificar o uso de técnicas de IA na translação de tecnologias para o enfrentamento da Covid-19. Empregou-se estratégia de busca com base em termos MeSH e seus respectivos sinônimos em sete bases de dados. Dos 59 artigos identificados, oito foram incluídos. Foram identificadas 11 experiências que usaram IA para a pesquisa translacional em Covid-19: predição de eficácia medicamentosa; predição de patogenicidade do Sars-CoV-2; diagnóstico de imagem para Covid-19; predição de incidência de Covid-19; estimativas de impacto da Covid-19 na sociedade; automatização de sanitização de ambientes hospitalares e clínicos; rastreio de pessoas infectadas e possivelmente infectadas; monitoramento do uso de máscaras; predição de gravidade de pacientes; estratificação de risco do paciente; e predição de recursos hospitalares. A pesquisa translacional pode ajudar no desenvolvimento produtivo e industrial em saúde, especialmente quando apoiada em métodos de IA, uma ferramenta cada vez mais importante, sobretudo quando se discute a Quarta Revolução Industrial e suas aplicações na saúde.

ABSTRACT The objective of this study was to identify how Artificial Intelligence (AI) has been used for translational research in the context of COVID-19. A rapid review was carried out to identify the use of AI techniques in the translation of technologies to face COVID-19. A search strategy was used based on MeSH terms and their respective synonyms in seven databases. Of the 59 articles identified, eight were included. We identified 11 experiments that used AI for translational research in Covid-19: prediction of drug efficacy; predicting the pathogenicity of SARS-CoV-2; imaging diagnosis for COVID-19; predicting the incidence of COVID-19; estimates of the impact of COVID-19 on society; automation of sanitizing hospital and clinical environments; screening of infected and possibly infected people; monitoring the use of masks; prediction of patient severity; patient risk stratification; and prediction of hospital resources. Translational research can help in productive and industrial development in health, especially when supported by AI methods, an increasingly important tool, especially when discussing the Fourth Industrial Revolution and its applications in health.

Direct and indirect costs attributed to alcohol consumption in Brazil, 2010 to 2018.

INTRODUCTION: Alcohol consumption is the main risk factor for death and disability in the world population between 15 to 49 years old, is related to more than 200 causes of death, and has an important economic impact on the health and social security systems. In 2016, three million deaths were attributable to alcohol worldwide and 131.4 million DALYs. In Brazil, alcohol consumption per inhabitant was 7.8 liters in 2016; and the prevalence of abusive consumption was 17.1% in 2019. OBJECTIVE: Estimate the costs attributable of alcohol consumption in the Brazilian population 18 years-old and over, in the period 2010 to 2018. METHODS: This is a prevalence-based cost-of-illness study, with a top-down and retrospective approach, including direct costs (hospital and outpatient) and indirect costs (absenteeism from work) related to alcohol consumption. A list of diseases and conditions for which alcohol is a risk factor was used, and the Population Attributable Risk (PAR) was calculated to estimate what portion of the cost of these diseases is attributable to alcohol consumption. Prevalence was calculated by sex and level of alcohol consumption, based on data from the 2019 National Health Survey. Relative risk data were identified by disease/injury and level of daily consumption obtained from the Global Burden Disease study in 2017. The cost data used are from the Brazilian Unified Health System and social security system. All costs were adjusted for inflation for the period and converted to purchasing power parity. RESULTS: Prevalence data revealed that 73.6% of the Brazilian population reported not consuming alcoholic beverages, which included 62.9% of men and 83.0% of women. The lowest values for the PAR were found at the consumption range of 60 grams per day. Although the 12 grams per day consumption category is the least in terms of the quantity of alcohol consumed, it is one of the main ones in terms of PAR, given the higher prevalence of consumption. The total cost attributable to alcohol between 2010 and 2018 was Int$ 1,487,417,115.43, of which Int$ 737,834,696.89 was for hospital expenses, Int$ 416,052,029.75 for outpatient care, and Int$ 333,530,388.79 due to absenteeism from work. CONCLUSION: Few comprehensive studies of alcohol-related costs have been developed, which suggests a knowledge gap in Brazil and worldwide and indicates the need for more research in this area. Understanding the economic impact of alcohol consumption is essential to help measure this public health problem in all its aspects and encourage implementation of public policies.

Landscape of Brazilian research and development public funding in advanced therapies: lessons learned and a roadmap for middle-income economies.

BACKGROUND AIMS: Advanced therapy medicinal products (ATMPs) have reached the forefront of biotechnological innovation, partly due to public funders' efforts in the early stages of research and development (R&D). Data on investment in R&D of ATMPs are recognized as scarce, particularly in developing countries. Because of the numerous peculiarities of the Brazilian health system and the science and technology (S&T) system, the country is a good example for the evaluation of public investments in R&D of ATMPs. The aim of this study is to analyze the evolution of investments made by the Ministry of Health (MoH) of Brazil and partners in the ATMP field between 2004 and 2020. METHODS: A descriptive analysis was performed based on secondary data. The analysis was based on S&T and innovation research and support for research infrastructure in the field. The database was stratified by year of funding, ATMP type, type of study or research infrastructure project, amount invested in the project, targeted disease for which clinical trials in ATMPs were developed and financing sector (health, education, S&T and economic). RESULTS: The investments coordinated by MoH (61.5%) in partnership with the S&T, education and economic sectors (38.5%) consisted of Int$137.35 million in 282 ATMP projects. Funding included S&T and innovation research (67% of the total amount) and projects to implement or maintain infrastructure in selected research centers (32.98%). With regard to global convergence, cell therapy was the type of ATMP that most benefited from public investment, totaling 82.23% of the total funding in the analyzed period. Cardiology (29%) and neurology (21%) were the main focus of clinical trials. Following the global trend of public sector R&D funding, the number of basic and pre-clinical research projects represented 78.06% of the total number of projects. CONCLUSIONS: Despite the need to implement improvements in ATMP R&D financing policy in Brazil, the country has made important steps in the field and can serve as a benchmark for other countries with socioeconomic similarities. Among the main lessons are the prioritization of research aligned with the health needs of the population, cross-sector articulation by the health policymaker to coordinate R&D efforts of the sector and formulation of a specific sector policy (Programa Genomas Brasil, the Brazilian National Program of Genomic and Precision Medicine) to promote knowledge translation.

Analysis of the Financial Costs of a Health Promotion Program for Sexually Exploited Adolescents and Youngsters: The Case of the Vira Vida Program in Brazil.

The Vira Vida program promotes the health of adolescents and young adults, ages 16 to 24, who have been sexually exploited. It has served more than 3000 individuals in 18 Brazilian states. The objective of this research was to estimate the costs of Vira Vida and compare them with the costs of detention policies for juveniles under 18. This program cost study considers two periods: 2008 to 2012 (Cycle 1) and 2013 to 2014 (Cycle 2). The System S perspective and time horizon for one year were adopted. Direct costs incurred by the National Council of Industry Social Services, which coordinates Vira Vida, and by the Regional Departments (RD), responsible for the direct execution of Vira Vida, were analyzed. The cost of detention measures for adolescents and youngsters under the age of 18 was obtained from the literature. The annual cost per student enrolled in Vira Vida varied between US$ 3754.93 and US$27,244.48, depending on the cycle and the state. Most of the costs of the program were lower than those reported for detention measures for adolescents in Brazilian states. Evidence indicates that health promotion interventions targeting sexually exploited children and adolescents can help their recovery; on the other hand, studies indicate that detention measures do not help adolescents recover.

Development of an Index to Assess COVID-19 Hospital Care Installed Capacity in the 450 Brazilian Health Regions.

OBJECTIVE: The article seeks to assess the Brazilian health system ability to respond to the challenges imposed by the coronavirus disease 2019 (COVID-19) pandemic by measuring the capacity of Brazilian hospitals to care for COVID-19 cases in the 450 Health Regions of the country during the year 2020. Hospital capacity refers to the availability of hospital beds, equipment, and human resources. METHODS: We used longitudinal data from the National Register of Health Facilities (CNES) regarding the availability of resources necessary to care for patients with COVID-19 in inpatient facilities (public or private) from January to December 2020. Among the assessed resources are health professionals (certified nursing assistants, nurses, physical therapists, and doctors), hospital beds (clinical, intermediate care, and intensive care units), and medical equipment (computed tomography scanners, defibrillators, electrocardiograph monitors, ventilators, and resuscitators). In addition to conducting a descriptive analysis of absolute and relative data (per 10,000 users), a synthetic indicator named Installed Capacity Index (ICI) was calculated using the multivariate principal component analysis technique to assess hospital capacity. The indicator was further stratified into value ranges to understand its evolution. RESULTS: There was an increase in all selected indicators between January and December 2020. It was possible to observe differences between the Northeast and North regions and the other regions of the country; most Health Regions presented low ICI. The ICI increased between the beginning and the end of 2020, but this evolution differed among Health Regions. The average increase in the ICI was more evident in the groups that already had considerably high baseline capacity in January 2020. CONCLUSIONS: It was possible to identify inequalities in the hospital capacity to care for patients affected by COVID -19 in the Health Regions of Brazil, with a concentration of low index values in the Northeast and North of the country. As the indicator increased throughout the year 2020, inequalities were also observed. The information here provided may be used by health authorities, providers, and managers in planning and adjusting for future COVID-19 care and in dimensioning the adequate supply of hospital beds, health-care professionals, and devices in Health Regions to reduce associated morbidity and mortality. We recommend that the ICI continue to be calculated in the coming months of the pandemic to monitor the capacity in the country's Health Regions.

Direct costs of prematurity and factors associated with birth and maternal conditions.

OBJECTIVE: To estimate the direct costs due to hospital care for extremely, moderate, and late preterm newborns, from the perspective of a public hospital in 2018. The second objective was to investigate whether factors associated with birth and maternal conditions explain the costs and length of hospital stay. METHODS: This is a cost-of-illness study, with data extracted from hospital admission authorization forms and medical records of a large public hospital in the Federal District, Brazil. The association of characteristics of preterm newborns and mothers with costs was estimated by linear regression with gamma distribution. In the analysis, the calculation of the parameters of the estimates (B), with a confidence interval of 95% (95%CI), was adopted. The uncertainty parameters were estimated by the 95% confidence interval and standard error using the Bootstrapping method, with 1,000 samples. Deterministic sensitivity analysis was performed, considering lower and upper limits of 95%CI in the variation of each cost component. RESULTS: A total of 147 preterm newborns were included. We verified an average cost of BRL 1,120 for late preterm infants, BRL 6,688 for moderate preterm infants, and BRL 17,395 for extremely preterm infants. We also observed that factors associated with the cost were gestational age (B = -123.00; 95%CI: -241.60 to -4.50); hospitalization in neonatal ICU (B = 6,932.70; 95%CI: 5,309.40-8,556.00), and number of prenatal consultations (B = -227.70; 95%CI: -403.30 to -52.00). CONCLUSIONS: We found a considerable direct cost resulting from the care of preterm newborns. Extreme prematurity showed a cost 15.5 times higher than late prematurity. We also verified that a greater number of prenatal consultations and gestational age were associated with a reduction in the costs of prematurity.

The disruption of elective procedures due to COVID-19 in Brazil in 2020.

Elective procedures were temporarily suspended several times over the course of the pandemic of COVID-19. Monthly data from the Unified Health System (SUS) were used for the period between January 2008 and December 2020 and the interrupted time series method was used to estimate the effect of the pandemic on the number of elective surgeries and elective procedures that were not performed. Considering a 9-month period, a reduction of 46% in the number of elective procedures carried out in the SUS could be attributed to COVID-19, corresponding to about 828,429 elective procedures cancelled, ranging from 549,921 to 1,106,936. To a full recovery of pre-pandemic performance, SUS would need to increase about 21,362 hospital beds, ranging from 12,370 to 36,392 hospital beds during a 6 month-period. This effort would represent an increase of 8.48% (ranging from 4.91 to 14.45%) in relation to the total number of SUS's hospital beds in 2019. As a result, the pandemic will leave a large number of elective procedures to be carried out, which will require efforts by health agencies to meet this demand.

Impact of COVID-19 on the mental health of public university hospital workers in Brazil: A cohort-based analysis of 32,691 workers.

BACKGROUND: In early 2020, the COVID-19 pandemic paralyzed the world and exposed the fragility of health systems in the face of mass illness. Health professionals became protagonists, fulfilling their mission at the risk of physical and mental illness. The study aimed to evaluate absenteeism indirectly related to SARS-CoV-2 infection in a large population of health care professionals. METHODS: An observational longitudinal repeated measures study was performed, including workers linked to 40 public university hospitals in Brazil. All causes of absenteeism were analyzed, focusing on those not directly attributed to COVID-19. Results for the same population were compared over two equivalent time intervals: prepandemic and during the pandemic. FINDINGS: A total of 32,691 workers were included in the study, with health professionals comprising 82.5% of the sample. Comparison of the periods before and during the pandemic showed a 26.6% reduction in work absence for all causes, except for COVID-19 and mental health-related absence. Concerning work absence related to mental health, the odds ratio was 39.0% higher during the pandemic. At the onset of the pandemic, there was an increase in absenteeism (all causes), followed by a progressive reduction until the end of the observation period. INTERPRETATION: Work absence related to mental illness among health care professionals increased during the COVID-19 pandemic, highlighting the need for health care managers to prioritize and implement support strategies to minimize absenteeism.

Association of the new zero-tolerance drinking and driving law with hospitalization rate due to road traffic injuries in Brazil.

We investigated the association of the new zero-tolerance drinking and driving law (Law 12,760, Dec. 2012) with hospital admissions due to road traffic injuries in Brazil by using interrupted time series from 2008 to 2019. We used linear regression designed to adjust for autocorrelation and Cumby-Huizinga test for residual autocorrelation. Newey-West standard errors was used to handle heteroscedasticity. We used ICD-10 codes for land transport accidents (V01-V89). The hospitalization rate was calculated per 100,000 inhabitants. The sources were the Hospital Information System and the Brazilian Institute for Geography and Statistics. Pre- and postintervention consist of 59 and 85 months, respectively. For Brazil, the hospitalization rate was associated with a reduction of 0.34 (p = 0.097; 95% CI - 0.74 to 0.06) in the first month of the intervention (Dec. 2012), followed by a significant change in the hospitalization trend. Compared to the period prior to the intervention, the monthly trend was associated with a reduction of 0.05 (p < 0.01; 95% CI - 0.06 to - 0.04) in the post period. These results stand in agreement with subgroup analyses for the Brazilian regions, although North and Northeast regions did not immediately reduce hospitalization rates (level change). Our results suggested that 440,599 hospitalizations for land transport accidents would be averted by the new zero-tolerance drinking and driving law from Dec. 2012 to Dec. 2019 in Brazil. Even using a quasi-experimental approach, our findings must be interpreted with caution due to observational design and registration flaws surrounding our data.