Isoniazid use, effectiveness, and safety for treatment of latent tuberculosis infection: a systematic review.

BACKGROUND: The treatment strategy for latent tuberculosis infection is to reduce the number of tuberculosis cases and consequently reduce the transmission of pathogenic bacteria. This study aimed to determine the safety, effectiveness, and adherence of isoniazid use for latent tuberculosis infection treatment. METHODS: To identify studies on isoniazid use for latent tuberculosis infection, five electronic databases were searched. The methods and results are presented in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Most studies (53) used isoniazid for 9 months. The prevalence of use and adherence to treatment varied considerably (18% to 100%), and were evaluated by participant completion of isoniazid treatment for latent tuberculosis infection. The adverse events most frequently reported were hepatotoxicity, gastric intolerance, and neuropathy; the rates of occurrence ranged from < 1% to 48%. In the studies that evaluated the effectiveness of isoniazid for latent tuberculosis infection, the rate varied from 0 to 19.7% for patients who did not have active tuberculosis after the follow-up period. CONCLUSIONS: The importance of maintaining follow up for patients using isoniazid should be emphasized due to the risk of developing adverse events. Despite the treatment challenges, the rates of patients who used isoniazid and developed active tuberculosis during the follow-up period were low. We believe that isoniazid continues to contribute to tuberculosis control worldwide, and better care strategies are required.

Prevalence of trachoma in indigenous and non-indigenous areas, Northeastern Brazil, 2019–2021 / Prevalencia del tracoma en zonas de población indígena y no indígena del nordeste de Brasil, 2019-2021 / Prevalência de tracoma em áreas indígenas e não indígenas, Nordeste do Brasil, 2019-2021

[ABSTRACT]. Objective. To estimate the prevalence of trachoma in indigenous and non-indigenous populations in selected areas of the state of Maranhão, in northeastern Brazil. Methods. This was a population-based survey with probabilistic sampling. For the diagnosis of trachoma, external ocular examination was performed using head magnifying loupes, at 2.5X magnification. The prevalence of trachomatous inflammation – follicular (TF) in children aged 1–9 years and the prevalence of trachomatous trichiasis (TT) in the population aged ≥15 years were estimated. Relative frequencies of sociodemographic and environmental characteristics were obtained. Results. The study included 7 971 individuals, 3 429 from non-indigenous populations and 4 542 from indigenous populations. The prevalence of TF in non-indigenous and indigenous populations was 0.1% and 2.9%, respectively, and the prevalence of TT among indigenous populations was 0.1%. Conclusions. The prevalence of TF and TT in the two evaluation units in the state of Maranhão were within the limits recommended for the elimination of trachoma as a public health problem. However, the prevalence of TF was higher in the indigenous evaluation unit, indicating a greater vulnerability of this population to the disease. The prevalence of TF of below 5.0% implies a reduction in transmission, which may have resulted from improved socioeconomic conditions and/or the implementation of the World Health Organization SAFE strategy.

[RESUMEN]. Objetivo. Estimar la prevalencia del tracoma en poblaciones indígenas y no indígenas en determinadas zonas del estado de Maranhão, en el nordeste de Brasil. Métodos. Se trató de una encuesta de ámbito poblacional con muestreo probabilístico. Para el diagnóstico del tracoma, se realizó un examen ocular externo con una lupa frontal de 2,5X aumentos. Se estimó la prevalencia de la inflamación tracomatosa folicular (TF) en la población infantil de 1 a 9 años y la prevalencia de la triquiasis tracomatosa (TT) en la población de 15 años o más. Se obtuvieron las frecuencias relativas de las características sociodemográficas y ambientales. Resultados. En el estudio participaron 7 971 personas, 3 429 de poblaciones no indígenas y 4 542 de poblaciones indígenas. La prevalencia de la TF en las poblaciones no indígenas e indígenas fue de 0,1% y 2,9%, respectivamente, en tanto que la de la TT en las poblaciones indígenas fue de 0,1%. Conclusiones. La prevalencia de la TF y la TT en las dos unidades de evaluación del estado de Maranhão estuvo dentro de los límites recomendados para la eliminación del tracoma como problema de salud pública. Sin embargo, la prevalencia de la TF fue mayor en la unidad de evaluación indígena, lo que indica una mayor vulnerabilidad de esta población a la enfermedad. La prevalencia de la TF inferior al 5,0% implica una reducción de la transmisión, que puede haber sido consecuencia tanto de la mejora de las condiciones socioeconómicas como de la aplicación de la estrategia SAFE de la Organización Mundial de la Salud.

[RESUMO]. Objetivo. Estimar a prevalência do tracoma em populações indígenas e não indígenas em áreas selecionadas do estado do Maranhão, na região Nordeste do Brasil. Métodos. Inquérito de base populacional com amostragem probabilística. Para o diagnóstico de tracoma, foi realizado exame ocular externo com o auxílio de lupas binoculares com ampliação de 2,5×. Foram estimadas a prevalência de inflamação tracomatosa folicular (TF) em crianças de 1 a 9 anos de idade e a prevalência de triquíase tracomatosa (TT) na população com idade ≥15 anos. Foram obtidas as frequências relativas das características sociodemográficas e ambientais. Resultados. O estudo incluiu 7 971 indivíduos (3 429 de populações não indígenas e 4 542 de populações indígenas). A prevalência de TF nas populações não indígenas e indígenas foi de 0,1% e 2,9%, respectiva- mente, e a prevalência de TT entre as populações indígenas foi de 0,1%. Conclusões. A prevalência de TF e TT nas duas unidades de avaliação no estado do Maranhão ficou dentro dos limites recomendados para a eliminação do tracoma como problema de saúde pública. No entanto, a prevalência de TF foi maior na unidade de avaliação indígena, indicando uma maior vulnerabilidade dessa população à doença. A prevalência de TF abaixo de 5,0% implica uma redução na transmissão, que pode ter sido resultado de melhores condições socioeconômicas e da implementação da estratégia SAFE da Organização Mundial da Saúde.

Prevalence of trachoma in indigenous and non-indigenous areas, Northeastern Brazil, 2019-2021.

Objective: To estimate the prevalence of trachoma in indigenous and non-indigenous populations in selected areas of the state of Maranhão, in northeastern Brazil. Methods: This was a population-based survey with probabilistic sampling. For the diagnosis of trachoma, external ocular examination was performed using head magnifying loupes, at 2.5X magnification. The prevalence of trachomatous inflammation - follicular (TF) in children aged 1-9 years and the prevalence of trachomatous trichiasis (TT) in the population aged ≥15 years were estimated. Relative frequencies of sociodemographic and environmental characteristics were obtained. Results: The study included 7 971 individuals, 3 429 from non-indigenous populations and 4 542 from indigenous populations. The prevalence of TF in non-indigenous and indigenous populations was 0.1% and 2.9%, respectively, and the prevalence of TT among indigenous populations was 0.1%. Conclusions: The prevalence of TF and TT in the two evaluation units in the state of Maranhão were within the limits recommended for the elimination of trachoma as a public health problem. However, the prevalence of TF was higher in the indigenous evaluation unit, indicating a greater vulnerability of this population to the disease. The prevalence of TF of below 5.0% implies a reduction in transmission, which may have resulted from improved socioeconomic conditions and/or the implementation of the World Health Organization SAFE strategy.

Barriers to medication adherence by caregivers of children with leukemia: an observational study / Barreiras de adesão medicamentosa por cuidadores de crianças com leucemia: um estudo observacional

ABSTRACT Objective: To identify barriers to adherence to home oral maintenance chemotherapy in children with leukemia treated at a specialized cancer center. Methods: We used the Brief Medication Questionnaire (BMQ) as a tool for screening barriers to adherence. The level of adherence was calculated considering at least one positive response in each BMQ domain, defined as Regimen Screen, Belief Screen, and Recall Screen. A positive screening for belief barriers (PSB) indicates that the caregiver reports not understanding the medication's mechanism of action and adverse effects. Results: Three important barriers to adherence were identified: beliefs, number of children of the caregiver, and age of the caregiver. The primary caregivers included 32 mothers (80%), four fathers (10%), three grandmothers (7.5%), and one unrelated caregiver (2.5 %). Most caregivers with a PSB were mothers. A PSB indicates that the caregiver reports not understanding the medication's mechanism of action and adverse effects. Caregivers with two or more children (median, three) had more barriers to adherence. Caregivers with potential non-adherence tended to be older than those with potential adherence, although without statistical significance (p=0.079, Mann-Whitney U test). Conclusions: The main barriers to adherence to home oral maintenance chemotherapy in children with leukemia identified through interviews with their caregivers, most often mothers, were lack of understanding of the treatment regimen, a greater number of children, and older age.

RESUMO Objetivo: Identificar barreiras de adesão ao tratamento de manutenção da quimioterapia via oral domiciliar, em uma amostra de crianças diagnosticadas com leucemia atendidas em um serviço especializado em oncologia. Métodos: O Brief Medication Questionnaire (BMQ) foi utilizado como instrumento de coleta para a identificação de barreiras de adesão. O nível de adesão foi calculado considerando-se pelo menos uma resposta positiva no domínio do BMQ, definido como regime, crença e recordação. Uma crença positiva mostra que o cuidador reporta não entender o mecanismo de ação e os efeitos adversos. Resultados: Três importantes barreiras de adesão foram identificadas, incluindo crença, o número de filhos do casal e a idade dos cuidadores. A mãe como principal responsável pelo tratamento da criança apresentou frequência maior entre as pessoas com rastreamento positivo para barreiras de crenças (BPC). Crença positiva significa que o cuidador relata não entender o mecanismo de ação dos medicamentos e os efeitos adversos. Quanto ao número de filhos, o estudo mostrou que quanto mais filhos (dois filhos ou mais, mediana=três) maior a barreira de adesão. Houve tendência de responsáveis com potencial não adesão serem mais velhos que os responsáveis com potencial adesão, embora sem significância estatística ao nível de significância de 5% (p=0,079, teste U de Mann-Whitney). Conclusões: As principais barreiras de adesão dos cuidadores de crianças com leucemia ao tratamento medicamentoso de manutenção foram dificuldades relatadas pelos cuidadores, na maioria das vezes as mães, que não entenderam como o medicamento funcionava, o número de filhos — quanto mais filhos menor a adesão — e a idade dos cuidadores. Cuidadores mais velhos aderiram menos ao tratamento prescrito.

Isoniazid use, effectiveness, and safety for treatment of latent tuberculosis infection: a systematic review

ABSTRACT Background: The treatment strategy for latent tuberculosis infection is to reduce the number of tuberculosis cases and consequently reduce the transmission of pathogenic bacteria. This study aimed to determine the safety, effectiveness, and adherence of isoniazid use for latent tuberculosis infection treatment. Methods: To identify studies on isoniazid use for latent tuberculosis infection, five electronic databases were searched. The methods and results are presented in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: Most studies (53) used isoniazid for 9 months. The prevalence of use and adherence to treatment varied considerably (18% to 100%), and were evaluated by participant completion of isoniazid treatment for latent tuberculosis infection. The adverse events most frequently reported were hepatotoxicity, gastric intolerance, and neuropathy; the rates of occurrence ranged from < 1% to 48%. In the studies that evaluated the effectiveness of isoniazid for latent tuberculosis infection, the rate varied from 0 to 19.7% for patients who did not have active tuberculosis after the follow-up period. Conclusions: The importance of maintaining follow up for patients using isoniazid should be emphasized due to the risk of developing adverse events. Despite the treatment challenges, the rates of patients who used isoniazid and developed active tuberculosis during the follow-up period were low. We believe that isoniazid continues to contribute to tuberculosis control worldwide, and better care strategies are required.

Prevalence of trachoma in indigenous and non-indigenous areas, Northeastern Brazil, 2019-2021 / Prevalencia del tracoma en zonas de población indígena y no indígena del nordeste de Brasil, 2019-2021 / Prevalência de tracoma em áreas indígenas e não indígenas, Nordeste do Brasil, 2019-2021

ABSTRACT Objective. To estimate the prevalence of trachoma in indigenous and non-indigenous populations in selected areas of the state of Maranhão, in northeastern Brazil. Methods. This was a population-based survey with probabilistic sampling. For the diagnosis of trachoma, external ocular examination was performed using head magnifying loupes, at 2.5X magnification. The prevalence of trachomatous inflammation - follicular (TF) in children aged 1-9 years and the prevalence of trachomatous trichiasis (TT) in the population aged ≥15 years were estimated. Relative frequencies of sociodemographic and environmental characteristics were obtained. Results. The study included 7 971 individuals, 3 429 from non-indigenous populations and 4 542 from indigenous populations. The prevalence of TF in non-indigenous and indigenous populations was 0.1% and 2.9%, respectively, and the prevalence of TT among indigenous populations was 0.1%. Conclusions. The prevalence of TF and TT in the two evaluation units in the state of Maranhão were within the limits recommended for the elimination of trachoma as a public health problem. However, the prevalence of TF was higher in the indigenous evaluation unit, indicating a greater vulnerability of this population to the disease. The prevalence of TF of below 5.0% implies a reduction in transmission, which may have resulted from improved socioeconomic conditions and/or the implementation of the World Health Organization SAFE strategy.

RESUMEN Objetivo. Estimar la prevalencia del tracoma en poblaciones indígenas y no indígenas en determinadas zonas del estado de Maranhão, en el nordeste de Brasil. Métodos. Se trató de una encuesta de ámbito poblacional con muestreo probabilístico. Para el diagnóstico del tracoma, se realizó un examen ocular externo con una lupa frontal de 2,5X aumentos. Se estimó la prevalencia de la inflamación tracomatosa folicular (TF) en la población infantil de 1 a 9 años y la prevalencia de la triquiasis tracomatosa (TT) en la población de 15 años o más. Se obtuvieron las frecuencias relativas de las características sociodemográficas y ambientales. Resultados. En el estudio participaron 7 971 personas, 3 429 de poblaciones no indígenas y 4 542 de poblaciones indígenas. La prevalencia de la TF en las poblaciones no indígenas e indígenas fue de 0,1% y 2,9%, respectivamente, en tanto que la de la TT en las poblaciones indígenas fue de 0,1%. Conclusiones. La prevalencia de la TF y la TT en las dos unidades de evaluación del estado de Maranhão estuvo dentro de los límites recomendados para la eliminación del tracoma como problema de salud pública. Sin embargo, la prevalencia de la TF fue mayor en la unidad de evaluación indígena, lo que indica una mayor vulnerabilidad de esta población a la enfermedad. La prevalencia de la TF inferior al 5,0% implica una reducción de la transmisión, que puede haber sido consecuencia tanto de la mejora de las condiciones socioeconómicas como de la aplicación de la estrategia SAFE de la Organización Mundial de la Salud.

RESUMO Objetivo. Estimar a prevalência do tracoma em populações indígenas e não indígenas em áreas selecionadas do estado do Maranhão, na região Nordeste do Brasil. Métodos. Inquérito de base populacional com amostragem probabilística. Para o diagnóstico de tracoma, foi realizado exame ocular externo com o auxílio de lupas binoculares com ampliação de 2,5×. Foram estimadas a prevalência de inflamação tracomatosa folicular (TF) em crianças de 1 a 9 anos de idade e a prevalência de triquíase tracomatosa (TT) na população com idade ≥15 anos. Foram obtidas as frequências relativas das características sociodemográficas e ambientais. Resultados. O estudo incluiu 7 971 indivíduos (3 429 de populações não indígenas e 4 542 de populações indígenas). A prevalência de TF nas populações não indígenas e indígenas foi de 0,1% e 2,9%, respectivamente, e a prevalência de TT entre as populações indígenas foi de 0,1%. Conclusões. A prevalência de TF e TT nas duas unidades de avaliação no estado do Maranhão ficou dentro dos limites recomendados para a eliminação do tracoma como problema de saúde pública. No entanto, a prevalência de TF foi maior na unidade de avaliação indígena, indicando uma maior vulnerabilidade dessa população à doença. A prevalência de TF abaixo de 5,0% implica uma redução na transmissão, que pode ter sido resultado de melhores condições socioeconômicas e da implementação da estratégia SAFE da Organização Mundial da Saúde.

[The evolution of Brazilian human health policies for the prevention and control of antimicrobial resistance: a scoping reviewEvolución de las políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana en Brasil: revisión exploratoria]. / Evolução das políticas brasileiras de saúde humana para prevenção e controle da resistência aos antimicrobianos: revisão de escopo.

Objective: To map the policies related to the prevention and control of antimicrobial resistance from a human health perspective in Brazil and systematize the historical course of these policies. Method: A scoping review was performed following Joana Briggs Institute and PRISMA guidelines. A literature search was performed in December 2020 in the LILACS, PubMed and EMBASE databases. The terms "antimicrobial resistance" AND "Brazil" as well as their synonyms were used. Using the same keywords, Brazilian government websites were searched for documents published until December 2021. Studies of all designs were included, with no language or date restrictions. Clinical documents, reviews and epidemiological studies that did not focus on antimicrobial resistance management policies in Brazil were excluded. Categories based on World Health Organization documents were used for data systematization and analysis. Results: In Brazil, policies related to antimicrobial resistance such as the National Immunization Program and hospital infection control programs can be traced back to before the creation of the Unified Health System. In the late 1990s and 2000s, the first specific policies on antimicrobial resistance (surveillance networks and programs) and education strategies were established; especially noteworthy is The National Action Plan for the Prevention and Control of Antimicrobial Resistance in the Single Health Scope (PAN-BR) of 2018. Conclusions: Despite the long history of policies related to antimicrobial resistance in Brazil, gaps were identified, particularly in monitoring the use of antimicrobials and surveillance of antimicrobial resistance. The PAN-BR, the first government document prepared from a One Health perspective, represents an important milestone.

Objetivo: Determinar qué políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana se han adoptado en Brasil y sistematizar su evolución histórica. Método: Se hizo una revisión exploratoria según las directrices del Instituto Joana Briggs y de PRISMA. La búsqueda bibliográfica se realizó en diciembre del 2020 en las bases de datos LILACS, PubMed y EMBASE. Se utilizaron los términos "antimicrobial resistance" AND "Brazil" y sinónimos. Se efectuó una investigación documental con los mismos términos en los sitios web del gobierno brasileño hasta diciembre del 2021. Se incluyeron estudios de todos los diseños, sin restricciones de idioma ni de fecha. Se excluyeron los documentos clínicos, revisiones y estudios epidemiológicos que no hicieran referencia a las políticas de gestión de la resistencia a los antimicrobianos en Brasil. Para la recolección y el análisis de datos se establecieron categorías basadas en documentos de la Organización Mundial de la Salud. Resultados: Desde antes de la creación del Sistema Único de Salud, Brasil tenía políticas de resistencia a los antimicrobianos, como el Programa Nacional de Inmunización y los programas de control de infecciones hospitalarias. A finales de las décadas de 1990 y 2000 se establecieron las primeras políticas específicas de resistencia a los antimicrobianos (redes y programas de vigilancia) y estrategias de educación. Entre ellas se destaca el Plan de Acción Nacional de Prevención y Control de la Resistencia a los Antimicrobianos en el marco del enfoque de "Una salud" (PAN-BR) del 2018. Conclusiones: A pesar de la larga historia de las políticas de resistencia a los antimicrobianos en Brasil, se encontraron lagunas, particularmente en el seguimiento del uso de antimicrobianos y la vigilancia de la resistencia a los mismos. El PAN-BR, primer documento gubernamental elaborado desde la perspectiva de "Una salud", marca un hito en las políticas formuladas en Brasil.

Evolução das políticas brasileiras de saúde humana para prevenção e controle da resistência aos antimicrobianos: revisão de escopo

[RESUMO]. Objetivo. Mapear políticas relacionadas à prevenção e ao controle da resistência aos antimicrobianos na perspectiva da saúde humana no Brasil e sistematizar a evolução histórica dessas políticas. Método. Desenvolveu-se uma revisão de escopo conforme as diretrizes do Instituto Joana Briggs e PRISMA. A busca na literatura foi realizada em dezembro de 2020 nas bases de dados LILACS, PubMed e EMBASE. Utilizaram-se os termos “antimicrobial resistance” AND “Brazil” e sinônimos. Uma pesquisa documental com os mesmos termos foi conduzida nos sites eletrônicos do governo brasileiro até dezembro de 2021. Foram incluídos estudos de todos os desenhos, sem restrição de idioma ou data. Excluíram-se documentos clínicos, revisões e estudos epidemiológicos que não referenciavam políticas de gestão da resistência aos antimicro- bianos no Brasil. Para coleta e análise de dados, estabeleceram-se categorias baseadas em documentos da Organização Mundial da Saúde. Resultados. Desde antes da criação do Sistema Único de Saúde, o Brasil possuía políticas relacionadas à resistência aos antimicrobianos, como o Programa Nacional de Imunização e programas de controle de infec- ção hospitalar. No final das décadas de 1990 e 2000, estabeleceram-se as primeiras políticas específicas sobre resistência aos antimicrobianos (redes e programas de vigilância) e estratégias de educação. Desta- ca-se o Plano de Ação Nacional de Prevenção e Controle da Resistência aos Antimicrobianos no Âmbito da Saúde Única (PAN-BR), de 2018. Conclusões. Apesar do longo histórico de políticas relacionadas à resistência aos antimicrobianos no Brasil, foram identificadas lacunas, sobretudo no monitoramento da utilização de antimicrobianos e na vigilância da resistência aos antimicrobianos. O PAN-BR, primeiro documento de governo elaborado na perspectiva One Health, é um marco nas políticas brasileiras.

[ABSTRACT]. Objective. To map the policies related to the prevention and control of antimicrobial resistance from a human health perspective in Brazil and systematize the historical course of these policies. Method. A scoping review was performed following Joana Briggs Institute and PRISMA guidelines. A literature search was performed in December 2020 in the LILACS, PubMed and EMBASE databases. The terms “anti- microbial resistance” AND “Brazil” as well as their synonyms were used. Using the same keywords, Brazilian government websites were searched for documents published until December 2021. Studies of all designs were included, with no language or date restrictions. Clinical documents, reviews and epidemiological studies that did not focus on antimicrobial resistance management policies in Brazil were excluded. Categories based on World Health Organization documents were used for data systematization and analysis. Results. In Brazil, policies related to antimicrobial resistance such as the National Immunization Program and hospital infection control programs can be traced back to before the creation of the Unified Health System. In the late 1990s and 2000s, the first specific policies on antimicrobial resistance (surveillance networks and programs) and education strategies were established; especially noteworthy is The National Action Plan for the Prevention and Control of Antimicrobial Resistance in the Single Health Scope (PAN-BR) of 2018. Conclusions. Despite the long history of policies related to antimicrobial resistance in Brazil, gaps were identified, particularly in monitoring the use of antimicrobials and surveillance of antimicrobial resistance. The PAN-BR, the first government document prepared from a One Health perspective, represents an important milestone.

[RESUMEN]. Objetivo. Determinar qué políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana se han adoptado en Brasil y sistematizar su evolución histórica. Método. Se hizo una revisión exploratoria según las directrices del Instituto Joana Briggs y de PRISMA. La búsqueda bibliográfica se realizó en diciembre del 2020 en las bases de datos LILACS, PubMed y EMBASE. Se utilizaron los términos "antimicrobial resistance" AND "Brazil" y sinónimos. Se efectuó una investigación documental con los mismos términos en los sitios web del gobierno brasileño hasta diciembre del 2021. Se incluyeron estudios de todos los diseños, sin restricciones de idioma ni de fecha. Se excluyeron los docu- mentos clínicos, revisiones y estudios epidemiológicos que no hicieran referencia a las políticas de gestión de la resistencia a los antimicrobianos en Brasil. Para la recolección y el análisis de datos se establecieron categorías basadas en documentos de la Organización Mundial de la Salud. Resultados. Desde antes de la creación del Sistema Único de Salud, Brasil tenía políticas de resistencia a los antimicrobianos, como el Programa Nacional de Inmunización y los programas de control de infecciones hospitalarias. A finales de las décadas de 1990 y 2000 se establecieron las primeras políticas específicas de resistencia a los antimicrobianos (redes y programas de vigilancia) y estrategias de educación. Entre ellas se destaca el Plan de Acción Nacional de Prevención y Control de la Resistencia a los Antimicrobianos en el marco del enfoque de “Una salud” (PAN-BR) del 2018. Conclusiones. A pesar de la larga historia de las políticas de resistencia a los antimicrobianos en Brasil, se encontraron lagunas, particularmente en el seguimiento del uso de antimicrobianos y la vigilancia de la resis- tencia a los mismos. El PAN-BR, primer documento gubernamental elaborado desde la perspectiva de “Una salud”, marca un hito en las políticas formuladas en Brasil.

Difficulties in the use of medications by elderly people followed up in a cohort study in Southern Brazil. / Dificuldades no uso de medicamentos por idosos acompanhados em uma coorte do Sul do Brasil.

OBJECTIVE: This study aimed to assess the need for help by elderly people to take their medications, the difficulties related to this activity, the frequency of forgotten doses, and factors associated. METHODS: Cross-sectional study conducted with a cohort of elderly people (60 years and over - "COMO VAI?" [How do you do?] study), where the need for help to properly take medication and the difficulties faced in using them were evaluated. The Poisson regression model was used to estimate the crude and adjusted prevalence ratios (PR) of the outcomes and respective 95% confidence intervals according to the characteristics of the sample. RESULTS: In total, 1,161 elderly people were followed up. The prevalence of participants who reported requiring help with medication was 15.5% (95%CI 13.5-17.8), and the oldest subjects, with lower educational levels, in worse economic situations, on four or more medications and in bad self-rated health were the ones who needed help the most. Continuous use of medication was reported by 83.0% (95%CI 80.7-85.1) of the sample and most participants (74.9%; 95%CI 72.0-77.5) never forgot to take their medications. CONCLUSION: The need for help to use medications was shown to be influenced by social and economic determinants. Studies assessing the difficulties in medication use by the elderly are important to support policies and practices to improve adherence to treatment and the rational use of medications.

OBJETIVO: Este estudo visou avaliar a necessidade de ajuda dos idosos para tomar seus medicamentos, bem como as dificuldades relacionadas com a sua utilização, e a frequência de esquecimento de doses. Ainda, avaliar fatores associados à necessidade de ajuda dos idosos com os medicamentos. MÉTODOS: Corte transversal em uma coorte de idosos (60 anos ou mais ­ estudo "COMO VAI?"), em que foi avaliada a necessidade de ajuda para tomar medicamentos de forma adequada e as dificuldades apresentadas na sua utilização. Utilizou-se regressão de Poisson para estimar as razões de prevalência (RP) brutas e ajustadas dos desfechos e seus intervalos de confiança de 95% (IC95%) de acordo com as características da amostra. RESULTADOS: Participaram 1.161 idosos. A prevalência de idosos que relataram necessidade de ajuda com os medicamentos foi de 15,5% (IC95% 13,5­17,8), sendo que os mais idosos, com menor escolaridade e em pior situação econômica, em uso de quatro medicamentos ou mais e com pior autoavaliação de saúde foram os que mais necessitaram de ajuda. O uso contínuo de medicamentos foi referido por 83,0% (IC95% 80,7­85,1) e a maioria (74,9%; IC95% 72,0­77,5) nunca se esqueceu de tomar seus medicamentos. CONCLUSÃO: Observou-se a influência de determinantes sociais e econômicos e de saúde sobre a necessidade de ajuda para a utilização dos medicamentos. Estudos que estimem as dificuldades no uso de medicamentos por idosos são importantes para subsidiar políticas e práticas norteadoras de ações para melhorar a adesão e o uso racional de medicamentos.

Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation.

INTRODUCTION: It is essential to strengthen the treatment of latent tuberculosis infection (LTBI) to break the chain of transmission. The drug used worldwide for the treatment of LTBI is Isoniazid. A clinical trial conducted in Brazil has demonstrated the bioequivalence of Isoniazid in the 300 mg formulation with 3 tablets in the 100 mg formulation. Further studies are needed to evaluate the completion of treatment with Isoniazid 300 mg single tablet. OBJECTIVE: Describing a protocol for a clinical trial to evaluate the completion of treatment of LTBI with the drug Isoniazid in 300 mg tablet formulation compared to the use of Isoniazid in 100 mg tablet formulation. METHODS: This is a pragmatic, multicenter, randomized, open-label clinical trial registered on the Rebec RBR-2wsdt6 platform. Individuals 18 years of age or older with an indication for treatment of LTBI will be included, with only 1 individual per family nucleus. Individuals whose index case of active TB is categorized as retreatment, multidrug-resistant and extremely resistant, individuals transferred from the original center two or more weeks after the onset of treatment, and persons deprived of liberty will be excluded. The study intervention will be the treatment of LTBI with 1 tablet of Isoniazid 300 mg. The control group will receive the treatment of LTBI with 3 tablets of Isoniazid 100 mg. Follow-up will be performed at month 1, month 2 and at the end of treatment. The primary outcome will be completion of treatment. CONCLUSION: It is expected that with the treatment with the 300 mg formulation, more patients will complete the treatment based on the complexity index of pharmacotherapy. Our study intends to substantiate theoretical and operational strategies that respond to the demand for incorporation of a new formulation of the drug for the treatment of LTBI in the Unified Health System network.

Compounded drugs as an alternative to the therapeutical gaps of inborn errors of metabolism

Abstract Inborn errors of metabolism are rare disorders with few therapeutic options for their treatments, which can make patients suffer with complications. Therefore, compounded drugs might be a promising option given that they have the ability of meeting the patient's specific needs, (i) identification of the main drugs described in the literature; (ii) proposal of compounding systems and (iii) calculation of the budgetary addition for the inclusion of these drugs into the Brazilian Unified Health System. The research conducted a literature review and used management data as well as data obtained from official Federal District government websites. The study identified 31 drugs for the treatment of inborn errors of metabolism. Fifty eight percent (58%) (18) of the medicines had their current demand identified, which are currently unmet by the local Health System. The estimated budget for the production of compounded drugs was of R$363,16.98 per year for approximately 300 patients. This estimated cost represents a budgetary addition of only 0.17% from the total of expenditures planned for drug acquirement. There is a therapeutic gap for inborn errors of metabolism and compounding pharmacies show potential in ensuring access to medicine therapy with a low-cost investment.

Dificuldades no uso de medicamentos por idosos acompanhados em uma coorte do Sul do Brasil / Difficulties in the use of medications by elderly people followed up in a cohort study in Southern Brazil

RESUMO Objetivo: Este estudo visou avaliar a necessidade de ajuda dos idosos para tomar seus medicamentos, bem como as dificuldades relacionadas com a sua utilização, e a frequência de esquecimento de doses. Ainda, avaliar fatores associados à necessidade de ajuda dos idosos com os medicamentos. Métodos: Corte transversal em uma coorte de idosos (60 anos ou mais — estudo "COMO VAI?"), em que foi avaliada a necessidade de ajuda para tomar medicamentos de forma adequada e as dificuldades apresentadas na sua utilização. Utilizou-se regressão de Poisson para estimar as razões de prevalência (RP) brutas e ajustadas dos desfechos e seus intervalos de confiança de 95% (IC95%) de acordo com as características da amostra. Resultados: Participaram 1.161 idosos. A prevalência de idosos que relataram necessidade de ajuda com os medicamentos foi de 15,5% (IC95% 13,5-17,8), sendo que os mais idosos, com menor escolaridade e em pior situação econômica, em uso de quatro medicamentos ou mais e com pior autoavaliação de saúde foram os que mais necessitaram de ajuda. O uso contínuo de medicamentos foi referido por 83,0% (IC95% 80,7-85,1) e a maioria (74,9%; IC95% 72,0-77,5) nunca se esqueceu de tomar seus medicamentos. Conclusão: Observou-se a influência de determinantes sociais e econômicos e de saúde sobre a necessidade de ajuda para a utilização dos medicamentos. Estudos que estimem as dificuldades no uso de medicamentos por idosos são importantes para subsidiar políticas e práticas norteadoras de ações para melhorar a adesão e o uso racional de medicamentos.

ABSTRACT Objective: This study aimed to assess the need for help by elderly people to take their medications, the difficulties related to this activity, the frequency of forgotten doses, and factors associated. Methods: Cross-sectional study conducted with a cohort of elderly people (60 years and over — "COMO VAI?" [How do you do?] study), where the need for help to properly take medication and the difficulties faced in using them were evaluated. The Poisson regression model was used to estimate the crude and adjusted prevalence ratios (PR) of the outcomes and respective 95% confidence intervals according to the characteristics of the sample. Results: In total, 1,161 elderly people were followed up. The prevalence of participants who reported requiring help with medication was 15.5% (95%CI 13.5-17.8), and the oldest subjects, with lower educational levels, in worse economic situations, on four or more medications and in bad self-rated health were the ones who needed help the most. Continuous use of medication was reported by 83.0% (95%CI 80.7-85.1) of the sample and most participants (74.9%; 95%CI 72.0-77.5) never forgot to take their medications. Conclusion: The need for help to use medications was shown to be influenced by social and economic determinants. Studies assessing the difficulties in medication use by the elderly are important to support policies and practices to improve adherence to treatment and the rational use of medications.

Evolução das políticas brasileiras de saúde humana para prevenção e controle da resistência aos antimicrobianos: revisão de escopo / The evolution of Brazilian human health policies for the prevention and control of antimicrobial resistance: a scoping review / Evolución de las políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana en Brasil: revisión exploratoria

RESUMO Objetivo. Mapear políticas relacionadas à prevenção e ao controle da resistência aos antimicrobianos na perspectiva da saúde humana no Brasil e sistematizar a evolução histórica dessas políticas. Método. Desenvolveu-se uma revisão de escopo conforme as diretrizes do Instituto Joana Briggs e PRISMA. A busca na literatura foi realizada em dezembro de 2020 nas bases de dados LILACS, PubMed e EMBASE. Utilizaram-se os termos "antimicrobial resistance" AND "Brazil" e sinônimos. Uma pesquisa documental com os mesmos termos foi conduzida nos sites eletrônicos do governo brasileiro até dezembro de 2021. Foram incluídos estudos de todos os desenhos, sem restrição de idioma ou data. Excluíram-se documentos clínicos, revisões e estudos epidemiológicos que não referenciavam políticas de gestão da resistência aos antimicrobianos no Brasil. Para coleta e análise de dados, estabeleceram-se categorias baseadas em documentos da Organização Mundial da Saúde. Resultados. Desde antes da criação do Sistema Único de Saúde, o Brasil possuía políticas relacionadas à resistência aos antimicrobianos, como o Programa Nacional de Imunização e programas de controle de infecção hospitalar. No final das décadas de 1990 e 2000, estabeleceram-se as primeiras políticas específicas sobre resistência aos antimicrobianos (redes e programas de vigilância) e estratégias de educação. Destaca-se o Plano de Ação Nacional de Prevenção e Controle da Resistência aos Antimicrobianos no Âmbito da Saúde Única (PAN-BR), de 2018. Conclusões. Apesar do longo histórico de políticas relacionadas à resistência aos antimicrobianos no Brasil, foram identificadas lacunas, sobretudo no monitoramento da utilização de antimicrobianos e na vigilância da resistência aos antimicrobianos. O PAN-BR, primeiro documento de governo elaborado na perspectiva One Health, é um marco nas políticas brasileiras.

ABSTRACT Objective. To map the policies related to the prevention and control of antimicrobial resistance from a human health perspective in Brazil and systematize the historical course of these policies. Method. A scoping review was performed following Joana Briggs Institute and PRISMA guidelines. A literature search was performed in December 2020 in the LILACS, PubMed and EMBASE databases. The terms "antimicrobial resistance" AND "Brazil" as well as their synonyms were used. Using the same keywords, Brazilian government websites were searched for documents published until December 2021. Studies of all designs were included, with no language or date restrictions. Clinical documents, reviews and epidemiological studies that did not focus on antimicrobial resistance management policies in Brazil were excluded. Categories based on World Health Organization documents were used for data systematization and analysis. Results. In Brazil, policies related to antimicrobial resistance such as the National Immunization Program and hospital infection control programs can be traced back to before the creation of the Unified Health System. In the late 1990s and 2000s, the first specific policies on antimicrobial resistance (surveillance networks and programs) and education strategies were established; especially noteworthy is The National Action Plan for the Prevention and Control of Antimicrobial Resistance in the Single Health Scope (PAN-BR) of 2018. Conclusions. Despite the long history of policies related to antimicrobial resistance in Brazil, gaps were identified, particularly in monitoring the use of antimicrobials and surveillance of antimicrobial resistance. The PAN-BR, the first government document prepared from a One Health perspective, represents an important milestone.

RESUMEN Objetivo. Determinar qué políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana se han adoptado en Brasil y sistematizar su evolución histórica. Método. Se hizo una revisión exploratoria según las directrices del Instituto Joana Briggs y de PRISMA. La búsqueda bibliográfica se realizó en diciembre del 2020 en las bases de datos LILACS, PubMed y EMBASE. Se utilizaron los términos "antimicrobial resistance" AND "Brazil" y sinónimos. Se efectuó una investigación documental con los mismos términos en los sitios web del gobierno brasileño hasta diciembre del 2021. Se incluyeron estudios de todos los diseños, sin restricciones de idioma ni de fecha. Se excluyeron los documentos clínicos, revisiones y estudios epidemiológicos que no hicieran referencia a las políticas de gestión de la resistencia a los antimicrobianos en Brasil. Para la recolección y el análisis de datos se establecieron categorías basadas en documentos de la Organización Mundial de la Salud. Resultados. Desde antes de la creación del Sistema Único de Salud, Brasil tenía políticas de resistencia a los antimicrobianos, como el Programa Nacional de Inmunización y los programas de control de infecciones hospitalarias. A finales de las décadas de 1990 y 2000 se establecieron las primeras políticas específicas de resistencia a los antimicrobianos (redes y programas de vigilancia) y estrategias de educación. Entre ellas se destaca el Plan de Acción Nacional de Prevención y Control de la Resistencia a los Antimicrobianos en el marco del enfoque de "Una salud" (PAN-BR) del 2018. Conclusiones. A pesar de la larga historia de las políticas de resistencia a los antimicrobianos en Brasil, se encontraron lagunas, particularmente en el seguimiento del uso de antimicrobianos y la vigilancia de la resistencia a los mismos. El PAN-BR, primer documento gubernamental elaborado desde la perspectiva de "Una salud", marca un hito en las políticas formuladas en Brasil.

An analysis of the essential medicines policy in primary care: Findings from MedMinas project.

Background: Essential Medicines Policy (EMP) has been adopted in Brazil to improve the provision and use of pharmaceuticals. This mixed methods study aims to bring evidence of the EMP implemented in municipalities in the context of primary care in Minas Gerais (20,997,560 inhabitants), Southeast Brazil. Methods: We analysed the core output of the EMP, i.e., the municipal essential medicines lists (MEML) and the effects of the policy on the procurement and availability of medicines. Data sources included a sample of 1,019 individuals (patients, health managers and health professionals), 995 prescriptions, 2,365 dispensed medicines and policy documents from 26 municipalities. Data were collected between April and October 2019. Document analysis and thematic content analysis were performed, and four availability indexes were estimated. Results: The findings suggest an overall lack of standardised and methodologically sound procedures to elaborate the MEML. Funding and public purchasing processes were found to be the major obstacles to medicine procurement. Only 63% of medicines were available at public community pharmacies and just 46.2% of patients had full access to their pharmaceutical treatment. Conclusion: This study reveals weaknesses in the implementation of EMP and a clear disconnection between medicines selection, procurement, and availability, the three core elements of the supply system. These findings contribute to informing future policy improvement actions to strengthen this system. Other countries aiming to advance towards universal health coverage may learn from the challenges that primary care in Brazil still needs to address.

Sources of medicines for hypertension and diabetes in Brazil: results from the National Health Survey.

This study aims to analyze the sources people over 18 years of age use to obtain medication for the treatment of hypertension and diabetes, according to sociodemographic characteristics from 2013 to 2019. Data from the Brazilian National Health Survey were analyzed. Most individuals with diagnosis and prescription to pharmacological treatment reported obtaining medicines exclusively from one type of source. The percentage of people who acquired hypertension medicine exclusively from public pharmacies decreased, from 24.5% in 2013 to 16.2% in 2019; while there was an increase in those obtaining from the Popular Pharmacy program, from 23.5% to 31.4%; as well as for out-of-pocket payment, which rose from 30.9% to 35.5% The percentage of people who acquired diabetes medication exclusively from public pharmacies increased from 7.4% to 18.6% and with out-of-pocket payment increased from 21.6% to 26.8%, while the percentage of those who acquired from the Popular Pharmacy program decreased from 47.2% to 36.4%. The percentage of those who acquired medication from various sources decreased for both hypertension and diabetes. For men, white, and those with higher education, the source of medication acquisition, for both conditions, was mostly by out-of-pocket payment. The high number of medicine acquisition from public sources represents an advance in Brazil's response to the treatment of these conditions, but reducing regional differences still represents a challenge to be overcome by the healthcare system.

A lacuna regulatória de medicamentos órfãos impacta na disponibilidade de alternativas terapêuticas no Brasil?

Introdução: A regulação de registros específicos para os chamados "medicamentos órfãos" tem sido uma estratégia das maiores agências de medicamentos do mundo para fomentar o acesso e monitoramento de tratamento para doenças e agravos de pouca prevalência ou interesse mercadológico. Objetivos: Esse estudo visou identificar o perfil dos medicamentos que se enquadram nessa categoria internacionalmente explorar possíveis lacunas de registro gerados pela ausência de uma norma sanitária específica no Brasil. Métodos: Foram analisadas as bases de dados de registro de medicamentos órfãos de países da União Europeia e dos Estados Unidos da América e os resultados foram comparados com a base registros da Agência brasileira. Resultados: Foram identificados 369 medicamentos registrados como órfãos nos órgãos europeu e estadunidense totalizando 801 indicações clínicas. A maior parte dos medicamentos registrados no âmbito internacional era de agentes anti-neoplásicos e imunomoduladores (N=135; 36,59 %) e de medicamentos que agiam no aparelho digestivo e metabolismo (N=48; 13,01 %). Dos medicamentos órfãos registrados e comercializados no âmbito internacional, quase metade, 177 (47,97 %), não apresentavam registros ativos no Brasil e atendem a 327 indicações clínicas (40,82 %). Conclusão: O Brasil deve analisar afundo os impactos da ausência de um fluxo de registro medicamentos órfãos, que pode afetar diretamente no acesso de tratamento para determinadas doenças raras e negligenciadas.

SUMMARY Introduction: The regulation of specific registrations for the so-called "orphan drugs" has been a strategy of the largest drug agencies in the world to promote access and monitoring of treatment for diseases and conditions of low prevalence or market interest. Aims: This study aimed to identify the profile of drugs that fall into this category internationally and explore possible gaps in registration generated by the absence of a specific health standard in Brazil. Methods: Orphan drug registration databases from countries of the European Union and the United States of America were analyzed and the results were compared with the database of the Brazilian Agency. Results: A total of 369 drugs registered as orphans in European and US agencies were identified, totaling 801 clinical indications. Most of the drugs registered internationally were antineoplastic agents and immunomodulators (N=135; 36.59 %) and drugs that acted on the digestive system and metabolism (N=48; 13.01 %). Of the orphan drugs registered and marketed internationally, almost half, 177 (47.97 %), did not have active registrations in Brazil and meet 327 clinical indications (40.82 %). Conclusion: Brazil must analyze in depth the impacts of the absence of an orphan drug registration flow, which can directly affect access to treatment for certain rare and neglected diseases.

Introducción: La regulación de registros específicos para los denominados "medicamentos huérfanos" ha sido una estrategia de las agencias de drogas más grandes del mundo promover el acceso y seguimiento del tratamiento de enfermedades y condiciones de poca prevalencia o interés de mercado. Objetivos: Identificar el perfil de las drogas que entran en esta categoría a nivel internacional explorar posibles lagunas en los registros generadas por la ausencia de un estándar sistema de salud específico en Brasil. Métodos: Las bases de datos de registro de medicamentos huérfanos de países de la Unión Europea y Estados Unidos da América y los resultados fueron comparados con la base de registros de la Agencia Brasileña. Resultados: Se identificaron 369 medicamentos registrados como huérfanos en órganos europeos y americanos, totalizando 801 indicaciones clínicas. La mayor parte de los medicamentos registrados a nivel internacional fueron agentes antineoplásicos e inmunomoduladores (N=135; 36,59%) y fármacos que actuaron en el aparato digestivo y metabolismo (N=48; 13,01%). De medicamentos huérfanos registrados y vendidos internacionalmente, casi la mitad, 177 (47,97 %), no tenía registros activos en Brasil y atendió 327 indicaciones clínicas (40,82%). Conclusión: Brasil debe analizar en profundidad los impactos de la ausencia de un flujo de registro de medicamentos huérfanos, que puede afectar directamente el acceso al tratamiento para ciertas enfermedades raras y desatendidas.

National Health Survey 2019: medication obtainment through the Brazilian Popular Pharmacy Program by adults being treated for hypertension and diabetes. / Pesquisa Nacional de Saúde 2019: obtenção de medicamentos por adultos em tratamento para hipertensão e diabetes no Programa Farmácia Popular do Brasil.

OBJECTIVE: To describe the proportion of adults with hypertension and diabetes who obtained medication through the Brazilian Popular Pharmacy Program (Programa Farmácia Popular). METHOD: Population-based descriptive study, using data from the 2019 Brazilian National Health Survey. The proportion of individuals who obtained at least one type of medication for hypertension and diabetes in the Program was analysed according to socioeconomic and demographic characteristics, by regions and federative units. RESULTS: The proportion of individuals who obtained medication for hypertension was 45.1% (95%CI 43.7;46.5), and, for diabetes, 51.5% (95%CI 49.5;53.6). Respectively for both conditions, medication obtainment was higher in the South region (54.3%; 95%CI 51.3;57.2 and 59.1%; 95%CI 54.6;63.7) and lower in the higher strata level of education (30.9%; 95%CI 27.7;34.2 and 40.7%; 95%CI 35.1;46.3) and income (24.0%; 95%CI 19.7;28.2 and 28.9%; 95%CI 22.1;35.7). CONCLUSION: Regional and socioeconomic inequalities were identified in obtaining medication for hypertension and diabetes through the Program.

Parents' satisfaction with information received on psychotropic drugs used by adolescents in a Mental Health Unit.

OBJECTIVE: To analyze the satisfaction of those responsible for adolescents with information received for the use of psychotropic drugs. METHODS: Cross-sectional study carried out in a reference outpatient clinic in Brasília between 2017 and 2019. It involved 173 legal representatives of adolescents diagnosed with Mental and Behavioral Disorders using psychotropic drugs. In order to identify the level of satisfaction about the information received on psychotropic drugs, the Satisfaction with Information about Medicines Scale (SIMS) was used. RESULTS: Most guardians were dissatisfied with the information received on psychotropic drugs (n=112; 64.7%). The dissatisfaction with information about potential problems of medication was the one that stood out the most (n=127; 73.4%) when compared to information about action and usage (n=89; 51.5%). Participants considered information on the impact of medication on the adolescent's sexual life unsatisfactory or nonexistent. CONCLUSIONS: The parents' satisfaction with the information received about psychotropic drugs was low. Participants showed dissatisfaction with the information about potential problems, especially related to the impact on the sexual life of their tutored.

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.

MedMinas project: design and use of mixed methods in the evaluation of pharmaceutical services in primary health care in Minas Gerais, Brazil.

BACKGROUND: The main purposes of primary care-based pharmaceutical services (PHCPS) in Brazil are to provide free access to medicines and pharmaceutical care to patients. Several obstacles hinder achieving their goals; thus, MedMinas Project aimed to evaluate the PHCPS, the supply system, and the use of medicines. This paper reflects on our experience designing, planning, and conducting the project, describing the issues yielded in the field and lessons learned. METHODS: This work consists of a mixed-methods study conducted in Minas Gerais, Southeastern Brazil. We adopted the principles of Rapid Evaluation Methods, employing a multistage stratified sampling for the quantitative and a purposeful sampling for the qualitative components, respectively, and a documentary research. Data sources included individuals (patients and professionals), prescriptions, dispensed medicines, and policy documents collected between April and October 2019. The quantitative data described in this paper were analysed by descriptive statistics and the qualitative by Thematic Content Analysis. RESULTS: A total of 26 municipalities varying from 37,784 to 409,341 inhabitants were included. The field team spent, on average, 16 days in each location. We interviewed 1019 respondents, of which 127 were professionals and 892 patients. The participation rate varied from 92 to 100%, depending on the respondent subgroup. Most interviews lasted between 45 min and one hour. Fieldwork challenges included participants' enrolment, field team, interview processes, and project budget. The participants provided positive feedback and five main themes emerged from the interview experience (self-awareness, sense of gratitude, research value, access to findings, and benefits of the research). Additionally, we collected copies of 1072 documents and 2070 pieces of data from prescriptions filled and medicines dispensed at the PCP. CONCLUSION: We demonstrated the viability of conducting the MedMinas Project in an extensive geographic area within effective time frames that provided meaningful, high-quality data from multiple actors. The methods and lessons learned are valuable for researchers across various disciplines in similar urban settings in Brazil and other countries of low- and middle-income (LMIC).