Lung Cancer Screening in Brazil Comparing the 2013 and 2021 USPSTF Guidelines.

Importance: It is estimated that, from 2023 to 2025, lung cancer (LC) will be the second most frequent cancer in Brazil, but the country does not have an LC screening (LCS) policy. Objective: To compare the number of individuals eligible for screening, 5-year preventable LC deaths, and years of life gained (YLG) if LC death is averted by LCS, considering 3 eligibility strategies by sociodemographic characteristics. Design, Setting, and Participants: This comparative effectiveness research study assessed 3 LCS criteria by applying a modified version of the LC-Death Risk Assessment Tool (LCDRAT) and the LC-Risk Assessment Tool (LCRAT). Data are from the 2019 Brazilian National Household Survey. Participants included ever-smokers aged 50 to 80 years. Data analysis was performed from February to May 2023. Exposures: Exposures included ever-smokers aged 50 to 80 years, US Preventive Services Task Force (USPSTF) 2013 guidelines (ever-smokers aged 55 to 80 years with ≥30 pack-years and <15 years since cessation), and USPSTF 2021 guidelines (ever-smokers aged 50 to 80 years with 20 pack-years and <15 years since cessation). Main Outcomes and Measures: The primary outcomes were the numbers of individuals eligible for LCS, the 5-year preventable deaths attributable to LC, and the number of YLGs if death due to LC was averted by LCS. Results: In Brazil, the eligible population for LCS was 27 280 920 ever-smokers aged 50 to 80 years (13 387 552 female [49.1%]; 13 249 531 [48.6%] aged 50-60 years; 394 994 Asian or Indigenous [1.4%]; 3 111 676 Black [11.4%]; 10 942 640 Pardo [40.1%]; 12 830 904 White [47.0%]; 12 428 536 [45.6%] with an incomplete middle school education; and 12 860 132 [47.1%] living in the Southeast region); 5 144 322 individuals met the USPSTF 2013 criteria for LCS (2 090 636 female [40.6%]; 2 290 219 [44.5%] aged 61-70 years; 66 430 Asian or Indigenous [1.3%]; 491 527 Black [9.6%]; 2 073 836 Pardo [40.3%]; 2 512 529 [48.8%] White; 2 436 221 [47.4%] with an incomplete middle school education; and 2 577 300 [50.1%] living in the Southeast region), and 8 380 279 individuals met the USPSTF 2021 LCS criteria (3 507 760 female [41.9%]; 4 352 740 [51.9%] aged 50-60 years; 119 925 Asian or Indigenous [1.4%]; 839 171 Black [10.0%]; 3 330 497 Pardo [39.7%]; 4 090 687 [48.8%] White; 4 022 784 [48.0%] with an incomplete middle school education; and 4 162 070 [49.7%] living in the Southeast region). The number needed to screen to prevent 1 death was 177 individuals according to the USPSTF 2013 criteria and 242 individuals according to the USPSTF 2021 criteria. The YLG was 23 for all ever-smokers, 19 for the USPSTF 2013 criteria, and 21 for the USPSTF 2021 criteria. Being Black, having less than a high school education, and living in the North and Northeast regions were associated with increased 5-year risk of LC death. Conclusions and Relevance: In this comparative effectiveness study, USPSTF 2021 criteria were better than USPSTF 2013 in reducing disparities in LC death rates. Nonetheless, the risk of LC death remained unequal, and these results underscore the importance of identifying an appropriate approach for high-risk populations for LCS, considering the local epidemiological context.

Factors associated with late-stage diagnosis and overall survival for lung cancer: An analysis of patients treated in a Brazilian hospital and a US-hospital from 2009 to 2019.

BACKGROUND: Lung cancer is a major public health problem due to its high incidence and mortality rates worldwide. Histology, socioeconomic conditions, access, quality of healthcare, and regional aspects are associated with lung cancer stages at diagnosis and survival outcomes. This paper aims to examine and contrast the factors associated with late-stage diagnosis of lung cancer and overall survival rates in two different settings: a Brazilian hospital and a US hospital, spanning from 2009 to 2019. METHODS: This is a retrospective cohort study of the incidence of lung cancer cases at the institution's cancer registry from a Brazilian and a US-based cohort. Descriptive analyses are presented using either the mean and standard deviation or the median and interquartile interval. Frequency is used to present categorical variables. Factors associated with late-stage lung cancer diagnosis were identified through bivariate and multivariable forward stepwise logistic regression. One-year overall survival and its associated factors were identified by Kaplan-Meier curves and Cox's proportional hazards model. RESULTS: Between January 2009 and December 2019, a total of 5286 individuals were diagnosed with LC in the Brazilian cohort, and out of these cases, 85.6% were diagnosed with late-stage disease. The US-cohort consisted of 3594 individuals, of whom 60.3% were diagnosed with late-stage disease in lung cancer. The one-year overall survival was 8.6 months for the US cohort and 6.4 months for the Brazilian cohort. In both cohorts, late-stage diagnosis emerged as the most significant factor influencing overall survival. However, the factors associated with late-stage diagnosis differed between the US and Brazilian cohorts. In the Brazilian cohort, being male and belonging to black or brown ethnic groups, along with having a lower education level, were linked to late-stage diagnosis. On the other hand, in the US-based cohort, the factors related to late-stage diagnosis were being male, having been diagnosed before 2015, and possessing private insurance coverage. CONCLUSION: Late-stage diagnosis was associated with the worst survival in both the US and Brazilian cohorts. This study provides valuable information on inequities and barriers to access for lung patients with cancer from upper-middle-income and high-income countries.

Registros Hospitalares de Câncer: Proposta Metodológica para Correção do Estadiamento de Câncer de Pulmão / Hospital-Based Cancer Registry: Methodological Proposal for Correction of Lung Cancer Staging / Registros Hospitalarios de Cáncer: Propuesta Metodológica para la Corrección de la Estadificación del Cáncer de Pulmón

Introdução: Um grande desafio para a utilização de registros e bases de dados secundárias é a qualidade do registro e o percentual de perdas em variáveis estratégicas e necessárias à plena utilização do banco. Objetivo: Propor um método de correção para a variável de estadiamento no âmbito dos Registros Hospitalares de Câncer (RHC), a fim de aprimorar sua completude e qualidade. Método: Estudo descritivo, abrangendo as Unidades da Federação, utilizando-se como fonte de informação o RHC, de janeiro de 2013 a dezembro de 2019. O câncer de pulmão foi escolhido como caso para a correção do banco, em razão da sua alta taxa de mortalidade no Brasil e no mundo. As análises foram realizadas com o software de análises estatísticas SAS Studio e a base de dados organizada em Excel. Resultados: O total de casos registrados no RHC foi de 86.026, e a variável de interesse, o estadiamento, teve um total de 32,0% de perda. Ao final de todas as etapas de correção, a perda foi de 9,8%, correspondendo a 22,2% de recuperação. Conclusão: A metodologia proposta representa um avanço na correção do banco do RHC, possibilitando a utilização dos dados de base secundária, com melhor representatividade das diferentes Regiões do país, sobre o tratamento de câncer de pulmão, com possibilidade de expansão de seu uso para outras topografias

Introduction: A major challenge to utilize the registries and secondary databases is the quality of the data and the percentage of losses in strategic and necessary variables for better effectiveness of the database. Objective: To propose a correction method for the cancer staging variable of the HospitalBased Cancer Registry (HBCR), to improve its completeness and quality. Method: HBCR-based descriptive analysis covering Brazil's Federation Units from January 2013 to December 2019. Due to its high mortality in Brazil and worldwide, lung cancer was selected as case for database correction. The analyzes were performed with the software SAS Studio for statistical analyzes and the data were organized in Excel. Results: The total number of cases registered at the HBCR was 86,026, and 32% the variable of interest, staging, were missed. At the end of the correction process, the missed data reached 9.8%, corresponding to a recovery of 22.2%. Conclusion: The proposed methodology is an advance for the correction of the HBCR database on the treatment of lung cancer, allowing a more extensive use, with better representativeness of different country regions, and potential utilization in other topographies

Introducción: Un gran desafío para el uso de registros y bases de datos secundarias es la calidad del registro en sí, el porcentaje de pérdidas en variables estratégicas y necesarias para el pleno uso de la base de datos. Objetivo: Proponer un método de corrección de la variable estadificación en el ámbito de los Registros Hospitalarios de Cáncer (RHC), con el fin de mejorar su exhaustividad y calidad. Método: Análisis descriptivo, abarcando las Unidades de la Federación. Se utilizó el RHC como fuente de información, de enero de 2013 a diciembre de 2019. El cáncer de pulmón fue elegido como caso para la corrección de la base de datos, debido a su alta tasa de mortalidad en el Brasil y en el mundo. Los análisis se realizaron con el software de análisis estadístico SAS Studio y los datos se organizaron en Excel. Resultados: El total de casos registrados en el RHC fue de 86.026, y la variable de interés, la estadificación, tuvo una pérdida total del 32,0% Al final de todas las etapas esta fue de 9,8%, es decir el 22,2% de recuperación. Conclusión: La metodología propuesta representa un avance en la corrección del RHC, permitiendo una mejor utilización de la base de datos, con una mejor representatividad de las diferentes regiones del país, sobre el tratamiento del cáncer de pulmón, con la posibilidad de expandir su uso a otras topografías

Desempenho das Unidades Básicas de Saúde e uso do Programa Farmácia Popular / Performance of Basic Health Unitsand use ofthe Popular PharmacyProgram

Resumo Introdução O Brasil conta com dois programas de financiamento governamental para a provisão de medicamentos, o Programa Farmácia Popular do Brasil (PFPB) e a provisão em Unidades do Sistema Único de Saúde, ambos possuindo itens em comum. Objetivo Explorar a relação entre o uso do PFPB por hipertensos e diabéticos com fatores relacionados ao atendimento nas Unidades Básicas de Saúde, à estrutura da farmácia destas Unidades e à disponibilidade dos anti-hipertensivos e antidiabéticos comuns ao PFPB e ao SUS em municípios brasileiros de médio e grande porte populacional. Método Delineamento ecológico transversal utilizando dados secundários do PFPB e do Programa Nacional de Melhoria do Acesso e Qualidade na Atenção Básica (PMAQ-AB), com dados referentes ao ano de 2012. Resultados Municípios de médio porte apresentaram uma proporção de Unidades de Saúde com disponibilidade de anti-hipertensivos e antidiabéticos superior aos de grande porte. A maioria dos respondentes do PMAQ-AB relataram disponibilidade dos anti-hipertensivos e antidiabéticos nos serviços públicos. A análise multivariada mostrou que o uso da Farmácia Popular pela população está mais relacionado às situações emergenciais e ocasionais. Conclusão Na ausência do SUS, o PFPB supre a necessidade da população para obter medicamentos, evidenciando o seu importante papel para a continuidade do tratamento de muitos indivíduos com hipertensão e diabetes.

Abstract Background Brazil has two government-funded drug supply programs, the Popular Pharmacy Program of Brazil (PFPB), and the provision in Unified Health System (SUS) units, which have items in common. Objective To explore the relationship between the use of PFPB by hypertensive and diabetic patients and factors related to care in basic health units, the pharmacy structure of units, and the availability of antihypertensive and antidiabetic agents common to PFPB and SUS in Brazilian municipalities of medium and large population sizes. Method A cross-sectional ecological study was carried out using secondary data from PFPB and the National Program for Improving Access and Quality in Primary Care (PMAQ-AB) for 2012. Results Municipalities of medium population showed a greater proportion of health units with antihypertensive and antidiabetic availability than those of large size. Most respondents at PMAQ-AB affirmed that hypertension and diabetes medications are available in public health services. The multivariate analysis showed that the use of Popular Pharmacy by the population is more related to emergency and occasional situations. Conclusion PFPB supplies the need for the population to obtain medications in the absence of SUS, evidencing an important role in the continuity of drug treatment for many individuals suffering from hypertension and diabetes.

Effect of municipal and state regulation on access and outcomes for cervical cancer patients in Rio de Janeiro, Brazil: An interrupted time series analysis.

BACKGROUND: Cervical cancer (CC) is one of Brazil's most prevalent neoplasms, and organizing health care flows that guarantee adequate and timely referral is a challenge. This paper analyzes the effect of municipal and state regulation on access and outcomes for CC patients treated in Rio de Janeiro. METHODS: Retrospective, quasi-experimental study, applying interrupted time series, using data from Cancer Registry from January-2012 to December-2017. We analyzed the implementation of the municipal (August-2013) and state (June-2015) regulation systems for the treatment of CC. The primary outcomes were 1. Time from diagnosis to the first Specialist Visit (TSV); 2. Time from a specialist visit to Treatment Initiation (TSV-TTI); 3. Time from diagnosis to treatment initiation (DTTI); 4. Percentage of patients with adequate Time to Treatment Initiation (PATTI); 5. Percentage of patients with a positive outcome (PPO). RESULTS: were included 4119 women. 71.04 % were between 30 and 59 years old, 55.57 % were black or brown, and 50.52 % had completed elementary school. The monthly average TSV was 43 days in 2012. After the first intervention, TSV increased by seven days, with a decreasing trend of 1 day per month until December-2017. Similarly, after June-2015, DTTI increased to 63 days, decreasing by one day per month until December-2017. After both interventions, there was an increase of 11.98 % in PATTI, with an increasing monthly trend of 0.18 %. PPO remained stable throughout the analyzed period. CONCLUSION: the results suggest that regulation organized access flow for specialized care. However, other relevant issues must be addressed, such as an internal backlog at the institutions, which compromises a timely start of treatment. POLICY SUMMARY: To improve access to the diagnosis and treatment of CC in its early stages, it is necessary to invest in health policies to adjust the supply to the required demand and thus reduce mortality from this pathology.

Impact of the National Lung Screening Trial (NLST) publication and Medicare Lung cancer screening payment on lung cancer incidence rates: An interrupted time series analysis.

INTRODUCTION: Explore the impact of the Lung Cancer Screening Trial (NLST-September-2011) and the Medicare approval for CT-screening (CT-LCS-AP-February-2015) on lung cancer incidence rates, mortality, and the percentage of early-stage lung cancer diagnosis (ESLCD-T1-T2N0M0). METHODS: Retrospective interrupted time series analysis using SEER-18 database. All individuals with lung cancer (LC) diagnosis from 2006 to 2016 were included. The effect of NLST and CT-AP-2015 on the monthly percentage of early-stage ESLCD was the primary outcome, additionally LC incidence and mortality rates were calculated. The analysis was performed by age, sex, race, marital status, insurance status, and household income. Bivariate and multivariate models were used to identify predictors of ESLCD. RESULTS: The study cohort was composed by 388,207 individuals, 69 years old in average, 46.6 % female, and 81.1 % white. LC incidence and mortality rates declined from 2006 to 2016 without association with NLST-September-2011 and CT-LCS-AP-February-2015. The percentage of ESLCD increased over time for all groups. Overall rates of ESLCD started at 18 % in January-2006 and increased to 25 % by December-2016. The intervention NLST-2011 did not show an impact in the ESLCD while the CT-AP-2015 showed a significant impact in the ESLCD trend (p < 0.001). ESLCD was associated with female, white, insurance, and household incomes above median. Medicare expansion was a significant factor for insured group, married patients and those from households under the median income level. CONCLUSION: Medicare approval for CT screening was found to have a statistically significant effect on the diagnosis of early-stage lung cancer and neither NLST-September-2011 nor CT-AP-2015-February-2015 impacted the incidence nor mortality rates. POLICY SUMMARY: To improve early-stage lung cancer diagnosis, it is vital to invest in health policies to increase Lung Cancer Screening implementation and to reduce disparities in access to diagnosis. Furthermore, policies that facilitate access to diagnosis and treatment are crucial to reduce lung cancer mortality.

Factors associated with diagnosis of stages I and II lung cancer: a multivariate analysis.

OBJECTIVE: To present the overall survival rate for lung cancer and identify the factors associated with early diagnosis of stage I and II lung cancer. METHODS: This is a retrospective cohort study including individuals diagnosed with lung cancer, from January 2009 to December 2017, according to the cancer registry at UMass Memorial Medical Center. Five-year overall survival and its associated factors were identified by Kaplan-Meier curves and Cox's proportional hazards model. Factors associated with diagnosing clinical stage I and II lung cancer were identified by bivariate and multivariate backward stepwise logistic regression (Log-likelihood ratio (LR)) at 95% confidence interval (CI). RESULTS: The study was conducted with data on 2730 individuals aged 67.9 years on average, 51.5% of whom female, 92.3% white, and 6.6% never smoked. Five-year overall survival was 21%. Individuals diagnosed with early-stage disease had a 43% five-year survival rate compared to 8% for those diagnosed at late stages. Stage at diagnosis was the main factor associated with overall survival [HR = 4.08 (95%CI: 3.62-4.59)]. Factors associated with early diagnosis included patients older than 68 years [OR = 1.23 (95%CI: 1.04-1.45)], of the female gender [OR = 1.47 (95%CI: 1.24-1.73)], white [OR = 1.63 (95%CI: 1.16-2.30)], and never-smokers [OR = 1.37 (95%CI: 1.01-1.86)]; as well as tumors affecting the upper lobe [OR = 1.46 (95%CI: 1.24-1.73)]; adenocarcinoma [OR = 1.43 (95%CI: 1.21-1.69)]; and diagnosis after 2014 [OR = 1.61 (95%CI: 1.37-1.90)]. CONCLUSIONS: Stage at diagnosis was the most decisive predictor for survival. Non-white and male individuals were more likely to be diagnosed at a late stage. Thus, promoting lung cancer early diagnosis by improving access to health care is vital to enhance overall survival for individuals with lung cancer.

Increased Use of Antibiotics in the Intensive Care Unit During Coronavirus Disease (COVID-19) Pandemic in a Brazilian Hospital.

Background: Microbial drug resistance is one of the biggest public health problems. Antibiotic consumption is an essential factor for the emergence and spread of multiresistant bacteria. Therefore, we aimed to analyze the antibiotics consumption in the Intensive Care Unit (ICU), identifying trends in the antibiotics use profile and microbiological isolates throughout the COVID-19 pandemic. Methods: We performed this retrospective observational study in intensive care units of a Brazilian tertiary hospital from January 2019 to December 2020. The primary outcome was antimicrobial consumption in the ICU, measured by defined daily doses (DDDs) per 100 bed-days. As a secondary outcome, bacterial infections (microbiological isolates) were calculated in the same fashion. Outcomes trends were analyzed using Joinpoint regression models, considering constant variance (homoscedasticity) and first-order autocorrelation assumptions. A monthly percent change (MPC) was estimated for each analyzed segment. Results: Seven thousand and nine hundred fifty-three patients had data available on prescribed and received medications and were included in the analyses. Overall, the use of antibiotics increased over time in the ICU. The reserve group (World Health Organization Classification) had an increasing trend (MPC = 7.24) from February to April 2020. The azithromycin consumption (J01FA) increased rapidly, with a MPC of 5.21 from January to April 2020. Polymyxin B showed a relevant increase from March to June 2020 (MPC = 6.93). The peak of the antibiotic consumption of Reserve group did not overlap with the peak of the pathogenic agents they are intended to treat. Conclusion: Overall antimicrobial consumption in ICU has increased in the context of the COVID-19 pandemic. The peaks in the antimicrobial's use were not associated with the rise of the pathogenic agents they intended to treat, indicating an empirical use, which is especially concerning in the context of treating multidrug-resistant (MDR) infections. This fact may contribute to the depletion of the therapeutic arsenal for MDR treatment.

Oral cancer patient's profile and time to treatment initiation in the public health system in Rio de Janeiro, Brazil.

BACKGROUND: This paper aims to describe the profile of oral cancer (OC) patients, their risk classification and identify the time between screening and treatment initiation in Rio de Janeiro Municipality. METHOD: Data were obtained from the healthcare Regulation System (SISREG) regarding the period January 2013 to September 2015. Descriptive, bivariate and multivariate analysis were performed identifying the factors associates with a diagnosis of OC as well as the time to treatment initiation (TTI) differences between groups. RESULTS: From 3,862 individuals with a potential OC lesion, 6.9 % had OC diagnosis. OC patients were 62.3 y.o. (mean), 64.7 % male, 36.1 % were white and 62.5 % of the records received a red/yellow estimated risk classification. Being older, male, white and receiving a high-risk classification was associated with having an OC diagnosis. OC TTI was in average 59.1 days and median of 50 days significantly higher than non-OC individuals (p = 0.007). TTI was higher for individuals older than 60 years old, male, and white individuals and for risk classification red and yellow, nevertheless while in average none of these differences were statistically significant, the median of individuals classified as low risk was significantly (p = 0.044) lower than those with high risk. CONCLUSIONS: Time to treatment initiation (TTI) was higher for OC patients related to non OC. Despite OC confirmed was associated with risk at screening classified as urgent or emergent, a high percentage of OC patients had their risk classified for elective care when specialized care was requested.

Factors associated with diagnosis of stages I and II lung cancer: a multivariate analysis

ABSTRACT OBJECTIVE To present the overall survival rate for lung cancer and identify the factors associated with early diagnosis of stage I and II lung cancer. METHODS This is a retrospective cohort study including individuals diagnosed with lung cancer, from January 2009 to December 2017, according to the cancer registry at UMass Memorial Medical Center. Five-year overall survival and its associated factors were identified by Kaplan-Meier curves and Cox's proportional hazards model. Factors associated with diagnosing clinical stage I and II lung cancer were identified by bivariate and multivariate backward stepwise logistic regression (Log-likelihood ratio (LR)) at 95% confidence interval (CI). RESULTS The study was conducted with data on 2730 individuals aged 67.9 years on average, 51.5% of whom female, 92.3% white, and 6.6% never smoked. Five-year overall survival was 21%. Individuals diagnosed with early-stage disease had a 43% five-year survival rate compared to 8% for those diagnosed at late stages. Stage at diagnosis was the main factor associated with overall survival [HR = 4.08 (95%CI: 3.62-4.59)]. Factors associated with early diagnosis included patients older than 68 years [OR = 1.23 (95%CI: 1.04-1.45)], of the female gender [OR = 1.47 (95%CI: 1.24-1.73)], white [OR = 1.63 (95%CI: 1.16-2.30)], and never-smokers [OR = 1.37 (95%CI: 1.01-1.86)]; as well as tumors affecting the upper lobe [OR = 1.46 (95%CI: 1.24-1.73)]; adenocarcinoma [OR = 1.43 (95%CI: 1.21-1.69)]; and diagnosis after 2014 [OR = 1.61 (95%CI: 1.37-1.90)]. CONCLUSIONS Stage at diagnosis was the most decisive predictor for survival. Non-white and male individuals were more likely to be diagnosed at a late stage. Thus, promoting lung cancer early diagnosis by improving access to health care is vital to enhance overall survival for individuals with lung cancer.

Complications of Covid-19: developments for the Unified Health System / Complicações da Covid-19: desdobramentos para o Sistema Único de Saúde

Resumo Covid-19 is an infectious severe acute respiratory syndrome, caused by Coronavirus, which quickly reached pandemic levels. In July/2020, Brazil was the second country most affected by the disease, exceeding two million cases. Despite the increasing scientific literature on Covid-19, its containment is still compromised by the lack of understanding about its determinants and complications. This article presents a discussion on aspects related to Covid-19 complications and its effects on Unified Health System (SUS), aiming at planning new coping strategies. Additionally, it is pointed out that the overload of the health system does not result only from aspects associated with the assistance to Covid-19, but adds to the pre-existing health needs, whose care strategies were postponed and/or changed due to the actions transmission control. It is evident, then, the need to reinforce the action of Primary Health Care as the ordering of care in SUS, acting in the management of the reorganization of flows and in the improvement of the physical structures of the units. To this end, the end of measures to limit health resources is essential, since not only does the success of coping with Covid-19 depend on this, but also the future of SUS and Brazilian's health.

Resumo A Covid-19 é uma síndrome respiratória aguda grave, infecciosa, causada por coronavírus, que rapidamente alcançou níveis pandêmicos. Em julho 2020, o Brasil era o segundo país mais afetado pela doença, superando dois milhões de casos. Apesar da eclosão de literatura científica sobre Covid-19, o planejamento de ações para sua contenção ainda é comprometido pelo alto grau de desconhecimento sobre seus determinantes e complicações. Este artigo considera aspectos relativos às complicações associadas a Covid-19 e seus efeitos no Sistema Único de Saúde (SUS), visando ao planejamento de novas estratégias de enfrentamento. Adicionalmente, aponta-se que a sobrecarga do sistema de saúde não resulta apenas dos aspectos associados a assistência à Covid-19, mas se somam às necessidades de saúde preexistentes, cujas estratégias de cuidado foram postergadas e/ou alteradas devido às ações de controle da transmissão. Evidencia-se a necessidade de reforçar a ação da Atenção Primária à Saúde, enquanto ordenadora do cuidado no SUS, atuando na gerência da reorganização dos fluxos e na melhoria das estruturas físicas das unidades. Para tal, o fim de medidas de contingenciamento de recursos da saúde é imprescindível, visto que não só o sucesso do enfrentamento à Covid-19 depende disso, mas também o futuro do SUS e a saúde dos brasileiros.

Burden of disease from COVID-19 and its acute and chronic complications: reflections on measurement (DALYs) and prospects for the Brazilian Unified National Health System. / Carga de doença da COVID-19 e de suas complicações agudas e crônicas: reflexões sobre a mensuração (DALY) e perspectivas no Sistema Único de Saúde.

COVID-19 is an acute infectious respiratory distress syndrome (ARDS) caused by the novel coronavirus SARS-CoV-2. The disease is highly communicable and produces mild to severe symptoms, generating a high demand for intensive care and thousands of deaths. In March 2020, COVID-19 was declared a pandemic and has already surpassed five million cases and 300,000 deaths in the world. The natural history of the disease has still not been fully established, hindering the elaboration of effective clinical protocols and preventive measures. Nevertheless, the disease requires a systemic approach, since there is evidence of acute and chronic complications, in addition to the catastrophic effects on the population's mental health. This highlights the need for a methodology that more effectively captures the effect of COVID-19, considering such aspects as severity, duration, and the potential to generate chronic complications that will increase the demands on Brazilian Unified National Health System (SUS). DALYs, or disability-adjusted life years, are thus an extremely useful indictor that adds mortality, an estimate of years of life lost (YLLs), and morbidity, an estimate of years of life lived with disability (YLDs). This article discusses the relevance and difficulties of studying the burden of COVID-19 and its complications in the Brazilian context, highlighting the natural history of the disease and estimating indicators such as YLDs, considering the high burden of disease in planning strategies to deal with the consequences of COVID-19 after the pandemic. The article also discusses the future challenges to deal with the disease in the SUS and the effects on the calculation of DALYs.

A COVID-19 é uma síndrome respiratória aguda grave (SRAG) infecciosa, causada por coronavírus. A doença tem alta transmissibilidade e ocasiona sintomas leves a graves, gerando elevada demanda por cuidados intensivos e milhares de óbitos. Em março de 2020, a COVID-19 foi caracterizada como pandemia e já soma mais de 5 milhões de casos e 300 mil óbitos pelo mundo. A história natural da doença ainda não é bem estabelecida, dificultando a elaboração de protocolos clínicos eficazes e medidas de prevenção. Apesar disso, pode-se afirmar que é uma doença de abordagem sistêmica, já que há evidências de complicações agudas e crônicas, além de efeitos catastróficos na saúde mental da população. Destaca-se então a necessidade de uma metodologia que capte de forma mais efetiva os efeitos da COVID-19, considerando aspectos como sua gravidade, duração e potencial de gerar complicações crônicas que aumentarão as demandas no Sistema Único de Saúde (SUS). Nesse sentido, é de extrema utilidade o indicador DALY, ou anos de vida perdidos por morte prematura ajustados por incapacidade (DALY), que agrega a (1) mortalidade - estimativa dos anos de vida perdidos (YLL) e (2) morbidade - estimativa dos anos vividos com incapacidade (YLD). Este artigo discute a relevância e as dificuldades de estudar a carga da COVID-19 e de suas complicações, no contexto brasileiro, ressaltando a importância de caracterizar a história natural da doença e estimar indicadores como o YLD, que considerem a alta carga de morbidade no planejamento de estratégias para lidar com as consequências da COVID-19 pós-pandemia. Discute-se também os desafios futuros para o enfrentamento da doença no SUS e reflexões sobre o cálculo do DALY.

La COVID-19 es un síndrome respiratorio agudo grave (SRAG) infeccioso, causado por coronavirus. La enfermedad posee una alta transmisibilidad y ocasiona de síntomas leves a graves, generando una elevada demanda de cuidados intensivos y millares de fallecimientos. En marzo de 2020, la COVID-19 se caracterizó como pandemia y ya suma más de 5 millones de casos y 300 mil fallecimientos por el mundo. La historia natural de la enfermedad todavía no ha sido bien establecida, dificultando la elaboración de protocolos clínicos eficaces y medidas de prevención. A pesar de eso, se puede afirmar que es una enfermedad de abordaje sistémico, ya que existen evidencias sobre complicaciones agudas y crónicas, además de efectos catastróficos en la salud mental de la población. Se destaca entonces la necesidad de una metodología que capte de forma más efectiva los efectos de la COVID-19, considerando aspectos como su gravedad, duración, potencial de generar complicaciones crónicas que aumentarán las demandas en el Sistema Único de Salud (SUS). En este sentido, es de extrema utilidad el indicador DALY o años de vida perdidos por muerte prematura ajustados por incapacidad, que agrega la (1) mortalidad - estimación de los años de vida perdidos (YLL) y (2) morbilidad - estimación de los años vividos con incapacidad (YLD). Este artículo discute la relevancia y las dificultades de estudiar la carga de la COVID-19 y sus complicaciones, en el contexto brasileño, resaltando la importancia de caracterizar la historia natural de la enfermedad y estimar indicadores como el YLD, que consideren la alta carga de morbilidad en la planificación de estrategias para lidiar con las consecuencias de la COVID-19 pospandemia. Se discuten también los desafíos futuros para el combate de la enfermedad en el SUS y reflexiones sobre el cálculo del DALY.

Longevity and cost of care: the challenge of a self-managed health plan. / Longevidade e custo da assistência: o desafio de um plano de saúde de autogestão.

This paper aims to analyze the relationship between the cost of health care and the aging of the population assisted by a self-managed plan, reflecting on the ways to address the challenge arising from this conjunction of population demographic changes. This is a descriptive study of the 1997-2016 period based on secondary data from the management operator of the health plan under study and from another administrative database of a self-managing provider with broad nationwide coverage. Older adults (over 60 years) increased 55% during the study period. On the other hand, the so-called "very old" (over 80 years) grew 332.8%. The population above 60 years corresponds to 25.7% of the total, and accounts for 68.8% of expenses. Most of the population covered (84,6%) is located in the State of Rio de Janeiro, which has the highest per capita health care cost in Brazil. We found a relationship between aging of the beneficiary population and increased expenditure. It is imperative to invest in health promotion and disease prevention initiatives as a way of improving the quality of life and financial sustainability of the plan, and define a subsystem that delimits and regulates access to the network and is accepted by the beneficiaries.

O objetivo deste artigo é analisar a relação entre o custo da assistência e o envelhecimento da população assistida por um plano de autogestão, refletindo sobre possibilidades de enfrentamento do desafio advindo dessa conjunção de fatores. Trata-se de um estudo descritivo do período 1997 a 2016, efetivado a partir de dados secundários provenientes da operadora do plano de saúde em estudo, e outro banco administrativo de operadora de autogestão de grande abrangência nacional. Os idosos (mais de 60 anos) aumentaram no período do estudo 55,5%. Já os chamados "muito idosos" (acima de 80 anos) cresceram em quantidade 332,8%. A população acima de 60 anos corresponde a 25,7% do total sendo responsável por 68,8% das despesas. A grande maioria da população atendida (84,6%) está localizada no Estado no Rio de Janeiro, o qual tem o mais alto custo per capita em saúde no País. Foi encontrada relação entre o envelhecimento da população beneficiária e o aumento das despesas. É imperioso investir em iniciativas de promoção da saúde e prevenção de doenças como forma de melhora da qualidade de vida e viabilidade financeira do plano, além de definir um sub-sistema que delimite e discipline o acesso à rede e seja aceito pelos beneficiários.

Hypertension and diabetes treatment affordability and government expenditures following changes in patient cost sharing in the "Farmácia popular" program in Brazil: an interrupted time series study.

BACKGROUND: Increasing medicines availability and affordability is a key goal of Brazilian health policies. "Farmácia Popular" (FP) Program is one of the government's key strategies to achieve this goal. Under FP, antihypertension (HTN) and antiglycemic (DM) medicines have been provided at subsidized prices in private retail settings since 2006, and free of charge since 2011. We aim to assess the impact of sequential changes in FP benefits on patient affordability and government expenditures for HTN and DM treatment under the FP, and examine their implications for public financing mechanisms and program sustainability. METHODS: Longitudinal, retrospective study using interrupted time series to analyze: HTN and DM treatment coverage; total and per capita expenditure; percentage paid by MoH; and patient cost sharing. Analyzes were conducted in the dispensing database of the FP program (from 2006 to 2012). RESULTS: FP has increased its coverage over time; by December 2012 FP covered on average 13% of DM and 11.5% of HTN utilization, a growth of over 600 and 1500%, respectively. The overall cost per treatment to the MoH declined from R$36.43 (R$ = reais, the Brazilian currency) to 18.74 for HTN and from R$33.07to R$15.05 for DM over the period analyzed, representing a reduction in per capita cost greater than 50%. The amount paid by patients for the medicines covered increased over time until 2011, but then declined to zero. We estimate that to treat all patients in need for HTN and DM in 2012 under FP, the Government would need to expend 97% of the total medicines budget. CONCLUSIONS: FP rapidly increased its coverage in terms of both program reach and proportion of cost subsidized during the period analyzed. Costs of individual HTN and DM treatments in FP were reduced after 2011 for both patients (free) and government (better negotiated prices). However, overall FP expenditures by MoH increased due to markedly increased utilization. The FP is sustainable as a complementary policy but cannot feasibly substitute for the distribution of medicines by the SUS.

Carga de doença da COVID-19 e de suas complicações agudas e crônicas: reflexões sobre a mensuração (DALY) e perspectivas no Sistema Único de Saúde / Carga de enfermedad de la COVID-19 y de sus complicaciones agudas y crónicas: reflexiones sobre la medición (DALY) y perspectivas en el Sistema Único de Salud de Brasil / Burden of disease from COVID-19 and its acute and chronic complications: reflections on measurement (DALYs) and prospects for the Brazilian Unified National Health System

A COVID-19 é uma síndrome respiratória aguda grave (SRAG) infecciosa, causada por coronavírus. A doença tem alta transmissibilidade e ocasiona sintomas leves a graves, gerando elevada demanda por cuidados intensivos e milhares de óbitos. Em março de 2020, a COVID-19 foi caracterizada como pandemia e já soma mais de 5 milhões de casos e 300 mil óbitos pelo mundo. A história natural da doença ainda não é bem estabelecida, dificultando a elaboração de protocolos clínicos eficazes e medidas de prevenção. Apesar disso, pode-se afirmar que é uma doença de abordagem sistêmica, já que há evidências de complicações agudas e crônicas, além de efeitos catastróficos na saúde mental da população. Destaca-se então a necessidade de uma metodologia que capte de forma mais efetiva os efeitos da COVID-19, considerando aspectos como sua gravidade, duração e potencial de gerar complicações crônicas que aumentarão as demandas no Sistema Único de Saúde (SUS). Nesse sentido, é de extrema utilidade o indicador DALY, ou anos de vida perdidos por morte prematura ajustados por incapacidade (DALY), que agrega a (1) mortalidade - estimativa dos anos de vida perdidos (YLL) e (2) morbidade - estimativa dos anos vividos com incapacidade (YLD). Este artigo discute a relevância e as dificuldades de estudar a carga da COVID-19 e de suas complicações, no contexto brasileiro, ressaltando a importância de caracterizar a história natural da doença e estimar indicadores como o YLD, que considerem a alta carga de morbidade no planejamento de estratégias para lidar com as consequências da COVID-19 pós-pandemia. Discute-se também os desafios futuros para o enfrentamento da doença no SUS e reflexões sobre o cálculo do DALY.

La COVID-19 es un síndrome respiratorio agudo grave (SRAG) infeccioso, causado por coronavirus. La enfermedad posee una alta transmisibilidad y ocasiona de síntomas leves a graves, generando una elevada demanda de cuidados intensivos y millares de fallecimientos. En marzo de 2020, la COVID-19 se caracterizó como pandemia y ya suma más de 5 millones de casos y 300 mil fallecimientos por el mundo. La historia natural de la enfermedad todavía no ha sido bien establecida, dificultando la elaboración de protocolos clínicos eficaces y medidas de prevención. A pesar de eso, se puede afirmar que es una enfermedad de abordaje sistémico, ya que existen evidencias sobre complicaciones agudas y crónicas, además de efectos catastróficos en la salud mental de la población. Se destaca entonces la necesidad de una metodología que capte de forma más efectiva los efectos de la COVID-19, considerando aspectos como su gravedad, duración, potencial de generar complicaciones crónicas que aumentarán las demandas en el Sistema Único de Salud (SUS). En este sentido, es de extrema utilidad el indicador DALY o años de vida perdidos por muerte prematura ajustados por incapacidad, que agrega la (1) mortalidad - estimación de los años de vida perdidos (YLL) y (2) morbilidad - estimación de los años vividos con incapacidad (YLD). Este artículo discute la relevancia y las dificultades de estudiar la carga de la COVID-19 y sus complicaciones, en el contexto brasileño, resaltando la importancia de caracterizar la historia natural de la enfermedad y estimar indicadores como el YLD, que consideren la alta carga de morbilidad en la planificación de estrategias para lidiar con las consecuencias de la COVID-19 pospandemia. Se discuten también los desafíos futuros para el combate de la enfermedad en el SUS y reflexiones sobre el cálculo del DALY.

COVID-19 is an acute infectious respiratory distress syndrome (ARDS) caused by the novel coronavirus SARS-CoV-2. The disease is highly communicable and produces mild to severe symptoms, generating a high demand for intensive care and thousands of deaths. In March 2020, COVID-19 was declared a pandemic and has already surpassed five million cases and 300,000 deaths in the world. The natural history of the disease has still not been fully established, hindering the elaboration of effective clinical protocols and preventive measures. Nevertheless, the disease requires a systemic approach, since there is evidence of acute and chronic complications, in addition to the catastrophic effects on the population's mental health. This highlights the need for a methodology that more effectively captures the effect of COVID-19, considering such aspects as severity, duration, and the potential to generate chronic complications that will increase the demands on Brazilian Unified National Health System (SUS). DALYs, or disability-adjusted life years, are thus an extremely useful indictor that adds mortality, an estimate of years of life lost (YLLs), and morbidity, an estimate of years of life lived with disability (YLDs). This article discusses the relevance and difficulties of studying the burden of COVID-19 and its complications in the Brazilian context, highlighting the natural history of the disease and estimating indicators such as YLDs, considering the high burden of disease in planning strategies to deal with the consequences of COVID-19 after the pandemic. The article also discusses the future challenges to deal with the disease in the SUS and the effects on the calculation of DALYs.

Brazilian generics market change after Farmácia Popular program.

OBJECTIVE: To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS: This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS: Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS: Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

The Brazilian private pharmaceutical market after the first ten years of the generics law.

OBJECTIVES: To describe changes in the private market for selected originators, branded generics ('similares'), and generic products during the 10 years following passage of the Brazilian Generics Law. METHODS: We analyzed longitudinal data collected by IQVIA® on quarterly sales by wholesalers to retail pharmacies in Brazil from 1998 through 2010, grouped by originators, branded generics, and generic products in three therapeutic classes (antibiotics, antidiabetics, and antihypertensives). Outcomes included market share (proportion of the total private market volume), sales volume per capita, prices and number of manufacturers by group. RESULTS: In the private market share, generics became dominant in each therapeutic class but the speed of uptake varied. Originators consistently lost most market share while branded generics varied over time. By the end of the study period, generics were the most sold product type in all classes, followed by branded generics. The number of generic manufacturers increased in all classes, while branded generics increased just after the policy but then decreased slowly through the end of 2010. For approximately 50% of the antibiotics analyzed, branded generics and generics had lower prices than originators. For antidiabetics, branded generic and generic prices were quite similar during the period analyzed. Price trends for the various subclasses of antihypertensive exhibited very different patterns over time. CONCLUSION: Sales of branded generics and originators decreased substantially in the three therapeutic classes analysed following the introduction of the generics policy in Brazil, but the time to market dominance of generics varied by class.

Brazilian generics market change after Farmácia Popular program

ABSTRACT OBJECTIVE To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

[Sources of medicines for chronic patients using the Brazilian Unified National Health System]. / Fontes de obtenção de medicamentos por pacientes diagnosticados com doenças crônicas, usuários do Sistema Único de Saúde.

The article aimed to identify the sources of medicines for users of the Brazilian Unified National Health System (SUS) that reported chronic non-communicable diseases, characterizing the group according to demographic, socioeconomic, and health variables in the different regions of Brazil. Data were analyzed from the National Survey on Access, Use, and Promotion of Rational Use of Medicines in Brazil (PNAUM), a cross-sectional population-based study. The dependent variable was "source of medicines", and the associations were analyzed with demographic, socioeconomic, and health status variables. Users that obtained care and medicines solely in the SUS were designated here as SUS-exclusive. Some 39% of persons obtained their medicines from SUS pharmacies and 28.5% from other sources. The study found 42.9%, 41.8%, 40.2%, and 31% of exclusive SUS users in the Southeast, South, North, and Northeast regions of Brazil, respectively. SUS users have the SUS as their primary source of medicines, but there is also a relevant share from other sources, suggesting problems with access in the SUS. In the South and Southeast regions, the population relies less on private pharmacies than in the Northeast and North.

Este artigo teve como objetivo identificar as fontes de obtenção de medicamentos utilizadas por usuários do Sistema Único de Saúde (SUS) com relato de doenças crônicas, caracterizando tal população quanto a variáveis demográficas, socioeconômicas e de saúde nas diferentes regiões do Brasil. Foram analisados dados da Pesquisa Nacional sobre o Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM), um estudo transversal de base populacional. A variável dependente foi a "fonte de obtenção de medicamentos" e foram analisadas associações com variáveis demográficas, socioeconômicas e com o estado de saúde. Os usuários que obtiveram cuidado e medicamentos unicamente no SUS foram aqui designados como SUS-exclusivos. Cerca de 39% das pessoas obtiveram seus medicamentos exclusivamente em farmácias do SUS e 28,5% recorreram a outras fontes. Foram encontrados 42,9%, 41,8%, 40,2%, 31%, usuários SUS-exclusivos, respectivamente, no Sudeste, Sul, Norte, e Nordeste. Os usuários do SUS têm como fonte primária de medicamentos o próprio SUS, entretanto há uma participação relevante de outras fontes de obtenção, indicando problemas no acesso dentro do SUS. No Sul e Sudeste, a população busca menos a farmácia privada do que no Nordeste e Norte do país.

El objetivo de este artículo fue identificar las fuentes de obtención de medicamentos, utilizados por usuarios del Sistema Único de Salud brasileño (SUS), con antecedentes de enfermedades crónicas, caracterizando tanto a la población, como las variables demográficas, socioeconómicas y de salud, en las diferentes regiones del país. Se analizaron los datos de la Encuesta Nacional sobre el Acceso, Utilización y Promoción del Uso Racional de Medicamentos en Brasil (PNAUM), un estudio transversal de base poblacional. La variable dependiente fue la 'fuente de obtención de medicamentos' y se analizaron asociaciones con variables demográficas, socioeconómicas y con el estado de salud. Los usuarios que recibieron cuidados y medicamentos únicamente en el SUS fueron designados aquí como SUS exclusivos. Cerca de un 39% de las personas obtuvieron sus medicamentos exclusivamente en farmacias del SUS y un 28,5% recurrieron a otras fuentes. Se encontraron un 42,9%, 41,8%, 40,2%, 31%, usuarios SUS exclusivos, respectivamente, en el Sudeste, Sur, Norte, y Nordeste. Los usuarios del SUS tienen como fuente primaria de medicamentos el propio SUS, no obstante, existe una participación relevante de otras fuentes de obtención, indicando problemas en el acceso dentro del SUS. En el Sur y Sudeste, la población busca menos la farmacia privada que en el Nordeste y Norte del país.