Elevated calprotectin levels are associated with mortality in patients with acute decompensation of liver cirrhosis.

BACKGROUND: Acute decompensation (AD) of cirrhosis is related to systemic inflammation and elevated circulating cytokines. In this context, biomarkers of inflammation, such as calprotectin, may be of prognostic value. AIM: To evaluate serum calprotectin levels in patients hospitalized for complications of cirrhosis. METHODS: This is a prospective cohort study that included 200 subjects hospitalized for complications of cirrhosis, 20 outpatients with stable cirrhosis, and 20 healthy controls. Serum calprotectin was measured by enzyme-linked immunosorbant assay. RESULTS: Calprotectin levels were higher among groups with cirrhosis when compared to healthy controls. Higher median calprotectin was related to Child-Pugh C, ascites, and hepatic encephalopathy. Higher calprotectin was related to acute-on-chronic liver failure (ACLF) and infection in the bivariate, but not in multivariate analysis. Calprotectin was not associated with survival among patients with ACLF; however, in patients with AD without ACLF, higher calprotectin was associated with a lower 30-d survival, even after adjustment for chronic liver failure-consortium (CLIF-C) AD score. A high-risk group (CLIF-C AD score ≥ 60 and calprotectin ≥ 580 ng/mL) was identified, which had a 30-d survival (27.3%) similar to that of patients with grade 3 ACLF (23.3%). CONCLUSION: Serum calprotectin is associated with prognosis in patients with AD without ACLF and may be useful in clinical practice to early identify patients with a very low short-term survival.

Benzodiazepines utilization in Brazilian older adults: a population-based study.

OBJECTIVE: To evaluate the utilization of benzodiazepines (BZD) in Brazilian older adults, based on the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey of Access, Use and Promotion of Rational Use of Medicines). METHODS: The PNAUM is a cross-sectional study conducted between 2013 and 2014, representing the Brazilian urban population. In the present study, we included 60 years or older (n = 9,019) individuals. We calculated the prevalence of BZD utilization in the 15 days prior to survey data collection according to independent variables, using a hierarchical Poisson regression model. A semistructured interview performed empirical data collection (household interview). RESULTS: The prevalence of BZD utilization in the older adults was 9.3% (95%CI: 8.3-10.4). After adjustments, BZD utilization was associated with female sex (PR = 1.88; 95%CI: 1.52-2.32), depression (PR = 5.31; 95%CI: 4.41-6, 38), multimorbidity (PR = 1.44; 95%CI: 1.20-1.73), emergency room visit or hospitalization in the last 12 months (PR = 1.42; 95%CI: 1.18-1.70 ), polypharmacy (PR = 1.26; 95%CI: 1.01-1.57) and poor or very poor self-rated health (PR = 4.16; 95%CI: 2.10-8.22). Utilization was lower in the North region (PR = 0.18; 95%CI: 0.13-0.27) and in individuals who reported abusive alcohol consumption in the last month (PR = 0.42; 95%CI: 0.19-0.94). CONCLUSION: Despite contraindications, results showed a high prevalence of BZD utilization in older adults, particularly in those with depression, and wide regional and sex differences.

Acciones judiciales que exigen tecnologías en salud en Brasil: una revisión sistemática de métodos mixtos / Lawsuits demanding health technologies in Brazil: a systematic review of mixed methods / Ações judiciais que demandam tecnologias em saúde no Brasil: uma revisão sistemática de métodos mistos

Objetivos: conocer el perfil y comprender el contexto descrito en las publicaciones sobre la judicialización del acceso a tecnologías en salud en Brasil. Metodología: revisión sistemática de métodos mixtos. Se consultaron 5 bases de datos y se incluyeron artículos que presentaran datos de procesos judiciales demandando tecnologías en salud del SUS en Brasil, o que analizaran este fenómeno, publicados en portugués, inglés y español, hasta 2019. La calidad metodológica fue evaluada con un enfoque convergente segregado. La caracterización de los datos de los estudios y el análisis e integración de la evidencia cuali-cuantitativa se realizó usando la síntesis realista. Resultados: 27 estudios fueron incluidos en la revisión. Se identificaron 76.666 procesos judiciales en que se solicitaba alguna tecnología en salud, en su mayoría medicamentos (65%); la mayoría de los procesos presentaron una representación jurídica privada (68%) y la mayoría de las acciones fue contra los estados (65%). Los enfoques de análisis de judicialización más frecuentes fueron Social Positivo (32%) y Normativo Negativo (32%), seguidos de 29% para el abordaje de Normativo Positivo. El abordaje Social Negativo (7%) fue el menos frecuente. Conclusiones: se identificó que existen evidencias cuantitativas que soportan las evidencias cualitativas. Estas demuestran que el desconocimiento del Poder Judicial sobre las políticas de salud lleva a un aumento de las desigualdades en salud; al fomento del paternalismo del Estado, así como que el aumento de acciones judiciales explica la necesidad de la búsqueda de alternativas para acceder a tecnologías en salud.

Objectives: to know the profile and understand the context described in publications on the judicialization of access to health technologies in Brazil. Methods: systematic review of mixed methods. Five databases were consulted, and articles were included that presented data from lawsuits demanding health technologies from the SUS in Brazil, or that analyzed this phenomenon, published in Portuguese, English and Spanish, until 2019. The methodological quality was evaluated using the convergent segregated approach. The characterization of data from the studies and the analysis and integration of qualitative-quantitative evidence were conducted through realistic synthesis. Results: 27 studies were included in the review. A total of 76,666 lawsuits were identified in which some health technology was requested, mainly medicines (65%); most lawsuits had private legal representation (68%) and most lawsuits were against the states (65%). The most frequent judicialization analysis approaches were Positive Social (32%) and Negative Normative (32%), followed by 29% for the Positive Normative approach. The Social Negative approach (7%) was the least frequent. Conclusions: it was identified that there is quantitative evidence that supports qualitative evidence. These demonstrate that the Judiciary's lack of knowledge about health policies leads to an increase in health inequalities; to the promotion of state paternalism, as well as the fact that the increase in lawsuits explains the need to seek alternatives for accessing health technologies.

Objetivos: conhecer o perfil e compreender o contexto descrito nas publicações sobre a judicialização do acesso às tecnologias em saúde no Brasil. Metodologia: Revisão sistemática de métodos mistos. Foram consultadas cinco bases de dados e incluídos artigos que apresentassem dados de processos judiciais demandando tecnologias em saúde do SUS no Brasil, ou que analisassem esse fenômeno, publicados em português, inglês e espanhol, até 2019. A qualidade metodológica foi avaliada com a abordagem convergente segregada. A caracterização dos dados dos estudos e a análise e integração das evidências qualitativos-quantitativas foram realizadas por meio da síntese realista. Resultados: 27 estudos foram incluídos na revisão. Foram identificados 76.666 processos judiciais em que foi solicitada alguma tecnologia em saúde, principalmente medicamentos (65%); a maioria dos processos apresentou representação legal privada (68%) e a maioria das ações foi contra os estados (65%). As abordagens de análise de judicialização mais frequentes foram Social Positiva (32%) e Normativa Negativa (32%), seguidas de 29% para a abordagem Normativa Positiva. A abordagem Social Negativa (7%) foi a menos frequente. Conclusões: identificou-se que há evidências quantitativas que sustentam as evidências qualitativas. Estes demonstram que o desconhecimento do Judiciário sobre as políticas de saúde leva ao aumento das desigualdades em saúde; à promoção do paternalismo estatal, bem como o fato de que o aumento das ações judiciais explica a necessidade de buscar alternativas de acesso às tecnologias em saúde.

Benzodiazepines utilization in Brazilian older adults: a population-based study / Utilização de benzodiazepínicos em idosos brasileiros: um estudo de base populacional

ABSTRACT OBJECTIVE To evaluate the utilization of benzodiazepines (BZD) in Brazilian older adults, based on the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey of Access, Use and Promotion of Rational Use of Medicines). METHODS The PNAUM is a cross-sectional study conducted between 2013 and 2014, representing the Brazilian urban population. In the present study, we included 60 years or older (n = 9,019) individuals. We calculated the prevalence of BZD utilization in the 15 days prior to survey data collection according to independent variables, using a hierarchical Poisson regression model. A semistructured interview performed empirical data collection (household interview). RESULTS The prevalence of BZD utilization in the older adults was 9.3% (95%CI: 8.3-10.4). After adjustments, BZD utilization was associated with female sex (PR = 1.88; 95%CI: 1.52-2.32), depression (PR = 5.31; 95%CI: 4.41-6, 38), multimorbidity (PR = 1.44; 95%CI: 1.20-1.73), emergency room visit or hospitalization in the last 12 months (PR = 1.42; 95%CI: 1.18-1.70 ), polypharmacy (PR = 1.26; 95%CI: 1.01-1.57) and poor or very poor self-rated health (PR = 4.16; 95%CI: 2.10-8.22). Utilization was lower in the North region (PR = 0.18; 95%CI: 0.13-0.27) and in individuals who reported abusive alcohol consumption in the last month (PR = 0.42; 95%CI: 0.19-0.94). CONCLUSION Despite contraindications, results showed a high prevalence of BZD utilization in older adults, particularly in those with depression, and wide regional and sex differences.

RESUMO OBJETIVO Avaliar a utilização de benzodiazepínicos (BZD) em idosos brasileiros,a partir de dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). MÉTODOS A PNAUM é um estudo transversal, conduzido entre 2013 e 2014, com representatividade da população urbana brasileira. No presente estudo, foram incluídos indivíduos com 60 anos ou mais (n = 9.019). Foi calculada a prevalência de utilização de BZD nos 15 dias anteriores à coleta dos dados da pesquisa, geral e segundo as variáveis independentes, por meio de análise bruta e ajustada, utilizando modelo hierárquico de regressão de Poisson. A coleta de dados foi realizada por meio de entrevista domiciliar. RESULTADOS A prevalência de utilização de BZD em idosos foi de 9,3% (IC95%: 8,3-10,4). Após análise ajustada, foram associados à maior utilização de BZD: sexo feminino (RP = 1,88; IC95%: 1,52-2,32), depressão (RP = 5,31; IC95%: 4,41-6,38), multimorbidade (RP = 1,44; IC95%: 1,20-1,73), visita à emergência ou internação hospitalar nos últimos 12 meses (RP = 1,42; IC95%: 1,18-1,70), polifarmácia (RP = 1,26; IC95%: 1,01-1,57) e autopercepção de saúde ruim ou muito ruim (RP = 4,16; IC95%: 2,10-8,22). A utilização foi menor na região Norte (RP = 0,18; IC95%: 0,13-0,27) e em indivíduos que relataram consumo abusivo de álcool no último mês (RP = 0,42; IC95%: 0,19-0,94). CONCLUSÃO Apesar das recomendações contrárias ao uso, os resultados demonstraram elevada prevalência de utilização de BZD em idosos, particularmente naqueles que apresentam depressão, além de amplas diferenças em relação às regiões do país e ao sexo do indivíduo.

The clinical pharmacist's role in a high-cost medicine pharmacy: Patient-centered care

Abstract In Brazil, medicine dispensing is a pharmacy service provided within the national health system that allows the pharmacist to interact directly with the patient in order to prevent, detect and solve problems related to pharmacotherapy and health needs. However, it is known that most dispensing services provided in the country are still limited to supplying medications and, at their finest, offering advice on medication utilization. Attempts to change this scenario present new challenges the area of pharmacy, which involve the need for a patient-centered pharmaceutical service model. This paper describes the patient-centered pharmaceutical service of high-cost medicine dispensing performed at a pharmacy linked to the Brazilian Unified Health System. In the model described here, the medicine-dispensing activity is the pharmacist's main field of practice, which consists of identifying patient needs related to health care itself and medication utilization. It also aims to introduce the instrument developed (a Pharmaceutical Care Protocol) that contributed to implementing this clinical service provided by the pharmacist. The protocols guide and qualify the service by providing information that helps in evaluating the effectiveness and safety of treatments and in the preparation of the care plan and can be used as a basis for other services that intend to adopt clinical pharmacy practices.

Health regulation and technological development: innovative strategies for accessing medicines in the SUS. / Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS.

Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV "Efavirenz", which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental, foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral "efavirenz", objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropolíticas ou políticas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.

Access to high-priced medicines: inequalities in the organization and the results among Brazilian states. / Acesso a medicamentos de alto preço: desigualdades na organização e resultados entre estados brasileiros.

This case study aimed to characterize the Specialized Component of Pharmaceutical Services (CEAF) organization in four Brazilian states from diverse regions of the country. Data were collected with representatives of CEAF management from states in different regions, who answered a 21-question questionnaire on scope, organization, financing, hurdles, and facilitators. This information was complemented with data from national health surveys, DataSUS, the applied resources, and socioeconomic indicators. Differences were observed between states on issues such as the proportion of users and the decentralization of services. These characteristics seem to be related to the level of development concerning the socioeconomic indicators used. Advances in access to medicines were highlighted, despite the difficulties complying with the CEAF's objectives, such as insufficient resources, the qualification of human resources, and the provision of necessary visits and exams. The results point to advances, different forms of organization and highlight the need for more in-depth studies on the clinical and economic outcomes achieved as a strategy to outline solutions to achieve the comprehensive and equal care for users.

Este estudo de caso visou caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) em quatro estados, de diferentes regiões do país. A coleta de dados foi realizada junto a representantes da gestão do CEAF, os quais responderam um questionário com 20 perguntas sobre: abrangência, organização, financiamento, barreiras e facilitadores. Essas informações foram complementadas com dados de inquéritos nacionais de saúde, do DataSUS, os valores investidos e indicadores socioeconômicos. Observaram-se diferenças entre os estados em questões como a proporção de usuários e a descentralização dos serviços. Estas características parecem estar relacionadas com o grau de desenvolvimento em termos dos indicadores socioeconômicos utilizados. Destacaram-se avanços no acesso a medicamentos, apesar das dificuldades para o cumprimento dos objetivos do CEAF, como a insuficiência de recursos, de qualificação da força de trabalho e da oferta de consultas e exames necessários. Os resultados indicam avanços, diferentes formas de organização e destacam a necessidade de estudos mais aprofundados relativos aos resultados clínicos e econômicos alcançados, como uma estratégia para traçar soluções para o atendimento integral e equânime dos usuários.

Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System. / Vacinas no Brasil: análise histórica do registro sanitário e a disponibilização no Sistema de Saúde.

Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI in Portuguese), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed vaccine registration procedureswith the Brazilian Health Regulatory Agency (ANVISA, in Portuguese) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by ANVISA; a document analysis of official/normative publications; and data from published literature. The data shows the incorporation of vaccines into the PNI, evidencing that Brazil is a country with industrial potential for vaccine production but that is still focused on the transfer of technologies and in need of public attention and investments for developing new technologies as a way to ensure the sector's independence.

Com a pandemia da COVID-19 e a importância das políticas públicas de proteção social, questões sanitaristas incluindo as imunizações se tornaram destaque. O estudo tem o objetivo de analisar a dinâmica dos registros sanitários de vacinas no país e as vacinas disponibilizadas por meio do Programa Nacional de Imunização (PNI), com destaque para o calendário vacinal no período entre 2004 e 2018. Realizou-se um estudo descritivo, documental e exploratório dos processos de registro sanitário na Agência Nacional de Vigilância Sanitária (Anvisa) e a incorporação dos produtos no PNI. Como base da pesquisa foram utilizados o banco de dados de registro sanitário disponibilizado pela Anvisa, a análise documental de publicações oficiais/normativas e os dados da literatura. Os dados demonstram a incorporação das vacinas no PNI, assim como um país com potencial industrial para a produção das vacinas, no entanto ainda centrado na transferência de tecnologias, necessitando de investimentos e atenção pública no desenvolvimento de novas tecnologias, garantindo a independência do setor.

Acesso a medicamentos de alto preço: desigualdades na organização e resultados entre estados brasileiros / Access to high-priced medicines: inequalities in the organization and the results among Brazilian states

Resumo Este estudo de caso visou caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) em quatro estados, de diferentes regiões do país. A coleta de dados foi realizada junto a representantes da gestão do CEAF, os quais responderam um questionário com 20 perguntas sobre: abrangência, organização, financiamento, barreiras e facilitadores. Essas informações foram complementadas com dados de inquéritos nacionais de saúde, do DataSUS, os valores investidos e indicadores socioeconômicos. Observaram-se diferenças entre os estados em questões como a proporção de usuários e a descentralização dos serviços. Estas características parecem estar relacionadas com o grau de desenvolvimento em termos dos indicadores socioeconômicos utilizados. Destacaram-se avanços no acesso a medicamentos, apesar das dificuldades para o cumprimento dos objetivos do CEAF, como a insuficiência de recursos, de qualificação da força de trabalho e da oferta de consultas e exames necessários. Os resultados indicam avanços, diferentes formas de organização e destacam a necessidade de estudos mais aprofundados relativos aos resultados clínicos e econômicos alcançados, como uma estratégia para traçar soluções para o atendimento integral e equânime dos usuários.

Abstract This case study aimed to characterize the Specialized Component of Pharmaceutical Services (CEAF) organization in four Brazilian states from diverse regions of the country. Data were collected with representatives of CEAF management from states in different regions, who answered a 21-question questionnaire on scope, organization, financing, hurdles, and facilitators. This information was complemented with data from national health surveys, DataSUS, the applied resources, and socioeconomic indicators. Differences were observed between states on issues such as the proportion of users and the decentralization of services. These characteristics seem to be related to the level of development concerning the socioeconomic indicators used. Advances in access to medicines were highlighted, despite the difficulties complying with the CEAF's objectives, such as insufficient resources, the qualification of human resources, and the provision of necessary visits and exams. The results point to advances, different forms of organization and highlight the need for more in-depth studies on the clinical and economic outcomes achieved as a strategy to outline solutions to achieve the comprehensive and equal care for users.

Vacinas no Brasil: análise histórica do registro sanitário e a disponibilização no Sistema de Saúde / Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System

Resumo Com a pandemia da COVID-19 e a importância das políticas públicas de proteção social, questões sanitaristas incluindo as imunizações se tornaram destaque. O estudo tem o objetivo de analisar a dinâmica dos registros sanitários de vacinas no país e as vacinas disponibilizadas por meio do Programa Nacional de Imunização (PNI), com destaque para o calendário vacinal no período entre 2004 e 2018. Realizou-se um estudo descritivo, documental e exploratório dos processos de registro sanitário na Agência Nacional de Vigilância Sanitária (Anvisa) e a incorporação dos produtos no PNI. Como base da pesquisa foram utilizados o banco de dados de registro sanitário disponibilizado pela Anvisa, a análise documental de publicações oficiais/normativas e os dados da literatura. Os dados demonstram a incorporação das vacinas no PNI, assim como um país com potencial industrial para a produção das vacinas, no entanto ainda centrado na transferência de tecnologias, necessitando de investimentos e atenção pública no desenvolvimento de novas tecnologias, garantindo a independência do setor.

Abstract Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI in Portuguese), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed vaccine registration procedureswith the Brazilian Health Regulatory Agency (ANVISA, in Portuguese) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by ANVISA; a document analysis of official/normative publications; and data from published literature. The data shows the incorporation of vaccines into the PNI, evidencing that Brazil is a country with industrial potential for vaccine production but that is still focused on the transfer of technologies and in need of public attention and investments for developing new technologies as a way to ensure the sector's independence.

Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS / Health regulation and technological development: innovative strategies for accessing medicines in the SUS

Resumo A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental, foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral "efavirenz", objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropolíticas ou políticas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.

Abstract Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV "Efavirenz", which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

Vaccines in Brazil: a Historical Analysis of Sanitary Registration and Vaccine Availability in the National Health System / Vacinas no Brasil: Análise Histórica do Registro Sanitário e a disponibilização no Sistema de Saúde

Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed processes of vaccine registration with the Brazilian Health Regulatory Agency (Anvisa) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by Anvisa, a document analysis of official/normative publications, and the published literature. The data do demonstrate the incorporation of vaccines into the PNI, evincing a country with industrial potential for vaccine production, but still focused on the transfer of technologies, and in need of public attention and investments in new technologies as a way to ensure the sector's independence.

Com a pandemia da COVID-19 e a importância das políticas públicas de proteção social, questões sanitaristas incluindo as imunizações se tornaram destaque. O estudo tem o objetivo de analisar a dinâmica dos registros sanitários de vacinas no país e as vacinas disponibilizadas por meio do Programa Nacional de Imunização (PNI), com destaque para o calendário vacinal no período entre 2004 e 2018. Realizou-se um estudo descritivo, documental e exploratório dos processos de registro sanitário na Agência Nacional de Vigilância Sanitária (Anvisa) e a incorporação dos produtos no PNI. Como base da pesquisa foram utilizados o banco de dados de registro sanitário disponibilizado pela Anvisa, a análise documental de publicações oficiais/normativas e dados da literatura. Os dados demonstram a incorporação das vacinas no PNI, assim como um país com potencial industrial para a produção das vacinas, no entanto ainda centrado na transferência de tecnologias, necessitando de investimentos e atenção pública no desenvolvimento de novas tecnologias, garantindo a independência do setor.

Attending a Blended In-Service Management Training in a Public Health System: Constraints and Opportunities for Pharmacists and Health Services.

Management and public health are important domains of competency for pharmacists. In about 90% of Brazilian health departments, pharmacists manage the selection and purchase of medicines. The Pharmaceutical Services and Access to Medicines Management Course (PSAMM) was offered to pharmacists working in the public health system. The aim of this study is to analyze the impacts of the course as perceived by the students (pharmacists). Two thousand five hundred pharmacists completed the course. It is a mixed-methods study, including subscribing forms (n = 2500), evaluation questionnaire (n = 1500), focus groups (n = 10), and semi-structured interviews (n = 31). Participants reported a high level of satisfaction with the course; they considered to have developed competencies related to leadership and management, competencies needed to enhance and sustain their practices in health services. Data analyses showed important barriers to complete the course: high course workload, poor quality of Internet access, lack of support from the health services. Participants highlighted crucial features of the course that helped them develop key competencies: practical in-service activities, useful and realistic contents, tutoring. These features helped participants overcome some important constraints described by them. The educational model described in this study was perceived as having a long-term impact on their behaviors and management practices in health services.

Analysis of a Blended, In-Service, Continuing Education Course in a Public Health System: Lessons for Education Providers and Healthcare Managers.

Introduction: To train pharmacists working in the public health system, the Brazilian Ministry of Health developed a specialization course called Pharmaceutical Service and Access to Medicine Management (PSAMM) between 2010 and 2016. The course was free of charge and used e-learning as its main approach. In the end, 2,500 pharmacists were trained. The purpose of this study was to identify and analyze the strengths, weaknesses, opportunities, and threats of an in-service and e-learning course for pharmacists working in a public health system. Materials and Methods: Three workshops involving 67 participants were conducted at the conclusion of the course to analyze the perspective of the PSAMM course's faculty (tutors, regional coordinators, professors, and management committee) and students (pharmacists). Strengths, weaknesses, opportunities, and threats analysis and qualitative analysis methods were used. Results and Discussion: The strength dimension had the greatest number of items. The qualitative analysis resulted in six categories: the category "E-learning in continuing education" had the most cited items. Internal elements such as in-service hands-on activities directly related to the professionals' roles, course contents, faculty, and the methods to offer the course (the mixed methods and materials) were positively assessed. Nonetheless, external elements were considered critical for the course's outcomes such as investments in the infrastructure of pharmaceutical services, access to the internet, local managers' support for continuing education and innovation implementation, practice of interprofessional collaboration, and political stability. The continuing education course in the public health system was affected by internal elements such as its project and structure as well as external elements such as the sociopolitical scenario. Continuing education investment must be accompanied by infrastructure investment and coordination of services.

Cost and Effectiveness of the Treatment of Chronic Hepatitis C in Brazil: Real-World Data.

OBJECTIVES: To introduce and discuss the cost and effectiveness of using sofosbuvir, daclatasvir, and simeprevir antivirals, in combination or not with peginterferon alfa and ribavirin, for the treatment of hepatitis C, as based on real-world data. METHODS: We analyzed the treatment and outcomes of 253 patients from a retrospective cohort held in a specialized assistance service in the municipality of Porto Alegre, Brazil. Regarding costs, we considered only the direct costs of the antiviral medications per unit (pills), according to the financial receipts of the public procurements. We calculated the total cost of treatment per individual and the cost per cure expressed in sustained virologic response (SVR). RESULTS: Most patients (66.8%) were carriers of the genotype 1 of hepatitis, and 92.9% reached the SVR. The average cost of the treatment for genotype-1 patients was $5,862.31 USD per patient and $6,310.34 for the cure; for genotype-3 patients, on the other hand, the cost was $5,144.27 per patient and $5,974.76 for the cure. The drugs purchasing cost was around 40% less than was estimated for the process of incorporating them into the public health system. CONCLUSION: The results indicated that good rates of effectiveness were achieved with different combinations of the medicines. The costs of the medicines were still deemed too high for the Brazilian reality, however. Therefore the results contribute to support the formulation and review of public policies based on strong evidence and on real-world data for the treatment of hepatitis C.

The benefits of a public pharmacist service in chronic hepattis C treatment: The real-life results of sofosbuvir-based therapy.

BACKGROUND: In Brazil, the sofosbuvir-based therapy was introduced in the public health system (SUS) in 2015 to treat Chronic Hepatitis C (CHC). This drug and other direct-acting antiviral agents (DAAs) represent a major advance in the HCV-infection treatment due to their high effectiveness and tolerability. However, the drug safety profile is limited by significant drug interactions and its use is restricted for their high cost. Pharmacists have the opportunity to improve patient care by monitoring the therapy, recommending strategies to guarantee treatment adherence, effectiveness and safety, preventing complications of the disease, and drug-related problems, thus reducing the cost for patients and payers. OBJECTIVE: This study aimed to assess the results of the one of the first patient group treated with sofosbuvir in Brazil and their opinions about the benefits of clinical pharmacist services in the achievement of the cure for CHC and in the management of their therapy difficulties. METHODS: This cohort study (November 2015-January 2017) enrolled 240 patients followed up by the clinical pharmacists at the University Pharmacy (UPh) of the Federal University of Santa Catarina, Brazil, during the CHC treatment. The therapeutic schemes used were sofosbuvir + daclatasvir or + simeprevir associated or not with ribavirin. At the end of the therapy, the patients provided qualitative feedback about the clinical pharmacist services. RESULTS: The study demonstrated high levels of treatment adherence (99.2% of completion rates) and effectiveness rates (Sustained Virological Response rates) (92.1%). Patients reported high levels of satisfaction with the care provided on account of the good rapport built with their pharmacist, the counseling and education on HCV-infection and on sofosbuvir-based therapy utilization, motivation for adherence, and convenient access to the pharmacist. CONCLUSIONS: The clinical pharmacist services provided by the UPh was beneficial to patients treated for CHC with the sofosbuvir-based therapy.

[Use of artificial sweeteners in Brazil: a household survey approach]. / Utilização de adoçantes no Brasil: uma abordagem a partir de um inquérito domiciliar.

The objective was to estimate the prevalence of artificial sweetener use by the adult Brazilian population and users' characteristics. Analysis of data from the Brazilian National Survey on Access, Utilization, and Promotion of Rational Use of Medicines (PNAUM, 2014), a nationwide population-based survey. The target outcome was self-reported use of sweeteners by Brazilians 20 years and older. The independent variables were sex, age, major geographic region of Brazil, schooling in complete years, and economic status according to the Brazilian Economic Classification Criterion of the Brazilian Association of Research Companies (ABEP). The health condition indicators were: self-reported noncommunicable diseases (NCDs), number of NCDs, and body mass index (BMI). Prevalence of sweetener use in the Brazilian adult population was 13.4% (95%CI: 12.5-14.3), and it was higher in females and in persons 60 years or older, in the Northeast and Southeast, among individuals from economic classes A and B, and among obese individuals. Persons with chronic diseases (especially diabetes) showed the highest prevalence of use of sweeteners, and their use increased with the number of reported comorbidities. Prevalence of use of artificial sweeteners was 13.4% and was associated with sociodemographic and health characteristics.

O objetivo foi estimar a prevalência do uso de adoçantes pela população adulta brasileira e características dos usuários. Análise de dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM, 2014), um inquérito nacional de base populacional. O desfecho de interesse foi o uso autorreferido de adoçantes entre brasileiros com 20 anos ou mais. As variáveis analisadas foram sexo, idade em anos completos, região do Brasil, escolaridade em anos completos e classificação econômica segundo o Critério Classificação Econômica Brasil da Associação Brasileira de Empresas de Pesquisa (ABEP). Os indicadores das condições de saúde foram: relato de doença crônica não transmissíveis (DCNT), número de DCNT e índice de massa corporal (IMC). A prevalência do uso de adoçantes na população adulta brasileira foi de 13,4% (IC95%: 12,5-14,3), sendo maior entre as pessoas do sexo feminino e no grupo com 60 anos ou mais, nas regiões Nordeste e Sudeste, entre pessoas da classe econômica A/B e entre indivíduos obesos. As pessoas com doenças crônicas (em especial diabetes) foram as que mostraram maior prevalência de uso de adoçantes, sendo o uso maior quanto maior o número de comorbidades relatadas. A prevalência de uso de adoçantes foi de 13,4% e mostrou-se associada a características sociodemográficas e de saúde.

El objetivo fue estimar la prevalencia del uso de edulcorantes por parte de la población adulta brasileña y las características de los usuarios. Análisis de datos de la Encuesta Nacional de Acceso, Utilización y Promoción del Uso Racional de Medicamentos (PNAUM, 2014), una encuesta nacional de base poblacional. El resultado de interés fue el uso autoinformado de edulcorantes entre brasileños con 20 años o más. Las variables analizadas fueron: sexo, edad (años completados), región de Brasil, escolaridad (años completados), así como la clasificación económica según el Criterio Clasificación Económica Brasil de la Asociación Brasileña de Empresas de Investigación (ABEP). Los indicadores de las condiciones de salud fueron: informe de enfermedades crónicas (DCNT), número de DCNT e índice de masa corporal (IMC). La prevalencia del uso de edulcorantes en la población adulta brasileña fue de un 13,4% (IC95%: 12,5-14,3), siendo mayor entre las personas de sexo femenino y en el grupo con 60 años o más, en las regiones Nordeste y Sudeste, entre personas de clase económica A/B y entre individuos obesos. Las personas con enfermedades crónicas (en especial diabetes) fueron las que mostraron una mayor prevalencia de uso de edulcorantes, siendo el uso mayor, cuanto mayor fuera el número de comorbilidades informadas. Conclusiones: la prevalencia de uso de edulcorantes fue de un 13,4% y se mostró asociada a características sociodemográficas y de salud.

Judicialization of access to medicines in four Latin American countries: a comparative qualitative analysis.

BACKGROUND: The valuation of medicines as health needs vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations. These factors modulate the role of medicines as a health need and influence access to medicines, and could be useful to explain the rising of Judicialization of access to medicines. AIM: To conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia and Chile from the perspective of medicines as health needs. METHODS: A qualitative, cross-country study was carried out in these 4 countries. Semi-structured interviews were conducted with 50 representatives of the different stakeholders involved in the judicialization of access to medicines, including Executive branch, Judiciary, health system managers, patient organizations. The interviews were audio-recorded and transcribed verbatim. Thematic analysis used a framework approach based on the theoretical model for medicines as health needs. FINDINGS: Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries. Meanwhile in Chile, the respondents highlighted that most lawsuits related to the right to health were filed against private insurers because of unjustified increases in the insurance premiums. The comparative analysis showed that judicialization of access to medicines emerged in the four countries regardless of the constitutional protection or the health system population coverage. Among the causes were mentioned difficulties in guaranteeing access to covered medicines and the influence of pharmaceutical marketing on needs assessment and prescription behaviours. The interviewees highlighted the pressure to health system managers to fulfil their responsibilities as a positive impact of litigation. In contrast, the funding of medicines without evidence of efficacy or safety was considered a negative impact. Only in Brazil, judicialization has had impact on R&D policies. In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right and the development of policies for controlling medicines prices. CONCLUSION: The results suggest that applying the adopted theoretical model creates the possibility of identifying critical points to guide policy makers to improve the health systems performances and to control lawsuits for access to medicines.