Psychoactive substance consumption after the Fundão dam mine tailing disaster in Minas Gerais State, Brazil.

Disasters cause changes in morbidity, mortality, and medicine use. Brazil is one of the main producers of mineral ores at great environmental cost. Mine tailings are stored in dams and ruptures have led to major disasters. We investigated the consumption of psychoactive medicines in the municipalities affected by the Fundão dam disaster in Minas Gerais State. An ecological study was carried out on drug consumption, estimated using public purchases in Minas Gerais and dispensing data from private retail pharmacies. Consumption (in number of defined daily doses/100,000 inhabitants per day) was analyzed descriptively in eight municipalities, stratified according to consumption level during a 25-month period. Six comparisons of mean consumption values for both data sets were done for pre- and post-disaster periods. The means of medicine consumption before and after the event were plotted and linear trends were added. Public purchase data evinced high consumption levels. Only pharmaceutical retail showed significant differences between the strata in the pre-disaster versus two post-disaster periods. Smaller municipalities showed an increase in consumption 15 months after the disaster. Clonazepam led the way in pharmaceutical retail consumption, followed by fluoxetine. Medicines showed an upward trend after the disaster. The high public provision may have stifled significant consumption patterns of psychoactive drugs; however, peak consumption were observed in private retail, suggesting a modification in use patterns after the disaster. The decrease in consumption immediately after the event was probably related to lower care-seeking behavior on the part of the population, and significant peaks after the disaster may reflect economic consequences of it.

Psychoactive substance consumption after the Fundão dam mine tailing disaster in Minas Gerais State, Brazil / Consumo de psicoativos após o desastre da Barragem de Fundão, em Minas Gerais, Brasil / Consumo de psicoactivos tras el desastre de la presa Fundão, en Minas Gerais, Brasil

Abstract: Disasters cause changes in morbidity, mortality, and medicine use. Brazil is one of the main producers of mineral ores at great environmental cost. Mine tailings are stored in dams and ruptures have led to major disasters. We investigated the consumption of psychoactive medicines in the municipalities affected by the Fundão dam disaster in Minas Gerais State. An ecological study was carried out on drug consumption, estimated using public purchases in Minas Gerais and dispensing data from private retail pharmacies. Consumption (in number of defined daily doses/100,000 inhabitants per day) was analyzed descriptively in eight municipalities, stratified according to consumption level during a 25-month period. Six comparisons of mean consumption values for both data sets were done for pre- and post-disaster periods. The means of medicine consumption before and after the event were plotted and linear trends were added. Public purchase data evinced high consumption levels. Only pharmaceutical retail showed significant differences between the strata in the pre-disaster versus two post-disaster periods. Smaller municipalities showed an increase in consumption 15 months after the disaster. Clonazepam led the way in pharmaceutical retail consumption, followed by fluoxetine. Medicines showed an upward trend after the disaster. The high public provision may have stifled significant consumption patterns of psychoactive drugs; however, peak consumption were observed in private retail, suggesting a modification in use patterns after the disaster. The decrease in consumption immediately after the event was probably related to lower care-seeking behavior on the part of the population, and significant peaks after the disaster may reflect economic consequences of it.

Resumo: Os desastres provocam alterações na morbidade, mortalidade e no uso de medicamentos. O Brasil é líder na produção de minérios com grande custo ambiental. Os rejeitos de mineração são armazenados em barragens e as rupturas dessas barragens têm causados grandes desastres. Investigamos o consumo de medicamentos psicoativos em municípios atingidos pelo desastre da Barragem de Fundão, em Minas Gerais. Foi realizado um estudo ecológico sobre o consumo de medicamentos, com base em dados de compras públicas e distribuição de farmácias privadas do varejo de Minas Gerais. O consumo (em número de doses diárias definidas/100 mil habitantes por dia) foi analisado descritivamente em oito municípios, estratificados segundo o nível de consumo durante um período de 25 meses. Foram feitas seis comparações de valores médios de consumo para os dois conjuntos de dados dos períodos pré- e pós-desastre. Foram calculadas as médias de consumo de medicamentos antes e depois do evento e adicionadas tendências lineares. Os dados de compras públicas mostraram elevados níveis de consumo. Apenas o varejo farmacêutico apresentou diferenças significativas entre os estratos no período pré-desastre versus dois períodos pós-desastre. Municípios menores apresentaram aumento no consumo a partir do 15º mês após o desastre. Clonazepam liderou o consumo no varejo farmacêutico, seguido pela fluoxetina. Os medicamentos apresentaram tendência de alta após o desastre. A elevada oferta pública pode ter afetado os padrões de consumo significativo de medicamentos psicoativos; no entanto, foram observados aumentos no comércio privado, sugerindo alterações nos padrões de uso após o desastre. A diminuição do consumo imediatamente após o evento estava provavelmente relacionada a um menor comportamento de procura de cuidados por parte da população e os aumentos significativos posteriores podem refletir as consequências econômicas do desastre.

Resumen: Los desastres provocan cambios en la morbilidad, mortalidad y en el uso de medicamentos. Brasil es líder en la producción de minerales con grandes costos ambientales. Los desechos mineros se almacenan en represas y las roturas de dichas represas han causado grandes desastres. Investigamos el consumo de medicamentos psicoactivos en municipios afectados por el desastre de la presa de Fundão, en Minas Gerais. Se realizó un estudio ecológico sobre el consumo de medicamentos, con base en datos de compras públicas y distribución en farmacias privadas minoristas de Minas Gerais. El consumo (en número de dosis diarias definidas/100.000 habitantes por día) se analizó descriptivamente en ocho municipios, estratificados según el nivel de consumo durante un período de 25 meses. Se realizaron seis comparaciones de los valores medios de consumo para los dos conjuntos de datos de los períodos anterior y posterior al desastre. Se calculó el consumo medio de medicamentos antes y después del evento y se añadieron las tendencias lineales. Los datos de compras públicas mostraron altos niveles de consumo. Solo el comercio minorista farmacéutico presentó diferencias significativas entre los estratos en el período anterior al desastre frente a dos períodos posteriores al desastre. Los municipios más pequeños presentaron un aumento en el consumo a partir del 15º mes después del desastre. El clonazepam lideró el consumo en el comercio minorista farmacéutico, seguido de la fluoxetina. Los medicamentos presentaron una tendencia al alza después del desastre. La elevada oferta pública puede haber afectado los patrones de consumo significativo de medicamentos psicoactivos; sin embargo, se observaron aumentos en el comercio privado, lo que sugiere cambios en los patrones de uso después del desastre. La disminución del consumo inmediatamente después del evento probablemente relacionada con un menor comportamiento de búsqueda de cuidados por parte de la población, y los aumentos significativos posteriores pueden reflejar las consecuencias económicas del desastre.

Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

[Data processing of the Brazilian National System of Controlled Product Management for drug utilization research with antimicrobials]. / Tratamento de dados do Sistema Nacional de Gerenciamento de Produtos Controlados para estudos de utilização de medicamentos com antimicrobianos.

The Brazilian National System of Controlled Product Management (SNGPC) stores data on the dispensing of manufactured and compounded drugs and pharmaceutical inputs, whether controlled and antimicrobial, based on the records of private pharmacies and drugstores. This study assessed the quality of SNGPC data from the dispensing records of manufactured antibiotics, aiming to propose their use in drug utilization researchs (DURs), with a descriptive and retrospective design, analyzing the raw dataset of the SNGPC from January 2014 to December 2020. A total of 475,805,207 drug-dispensing records were collected. On average, antibiotics corresponded to 54.5% of the total records. The quality dimension "unreported" was systematically identified in the variables "active ingredient", "sex", "age" and "ICD-10". The amount of vials/bottles and packages ranged from one to 536 units and the amount of pharmaceutical inputs dispensed, from one to 7,500 units. Results show that 25% of the records exceed an individual therapy and the SNGPC has no critical mechanism to avoid dispensations outside the therapeutic standard for the class. Despite vulnerabilities due to data quality, which can be overcome, the SNGPC allows for the construction of different analytical plans, involving time and other aggregations, in the analysis of community use of antimicrobials and controlled drugs, which makes it a powerful source of data for DUR.

O Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC) armazena dados de dispensação de medicamentos industrializados, manipulados e insumos farmacêuticos sob controle especial e antimicrobianos, a partir dos registros de farmácias e drogarias privadas. Este trabalho explorou a qualidade dos dados inseridos no SNGPC, a partir dos registros de dispensação de antibióticos industrializados, com o objetivo de propor seu emprego em estudos de utilização de medicamentos (DUR). A pesquisa foi desenvolvida por meio de desenho descritivo e retrospectivo, examinando o conjunto dados brutos do sistema, para o período de janeiro de 2014 a dezembro de 2020. Um total de 475.805.207 registros de dispensação de medicamentos foi coletado. Os antibióticos corresponderam em média a 54,5% do total de registros. A dimensão de qualidade "não informado" foi identificada, sistematicamente, nas variáveis "princípio ativo", "sexo", "idade" e "CID-10". As quantidades de frascos e caixas variaram de 1 a 536 unidades, e as quantidades de formas farmacêuticas dispensadas de 1 a 7.500 unidades. Os resultados mostram que 25% dos registros extrapolam uma terapia individual e que o sistema não apresenta um mecanismo de crítica para evitar dispensações não conformes ao padrão terapêutico para a classe. Apesar das vulnerabilidades decorrentes da qualidade dos dados, que podem ser superadas, o SNGPC possibilita construir diferentes planos analíticos, envolvendo tempo e outras agregações, na investigação de uso comunitário de antimicrobianos e medicamentos sob controle especial, o que faz dele uma potente fonte de dados para DUR.

El Sistema Nacional de Gestión de Productos Controlados (SNGPC) almacena datos sobre la dispensación de medicamentos industrializados, manipulados, insumos farmacéuticos bajo control especial y de antimicrobianos con base en los registros de farmacias y de boticas privadas. Este trabajo analizó la calidad de los datos ingresados en el SNGPC relacionados a los registros de la dispensación de antibióticos industrializados, para proponer su posible aplicación en estudios sobre el uso de medicamentos (DUR); para ello, realizó un análisis descriptivo y retrospectivo del conjunto de datos brutos para el periodo de enero de 2014 a diciembre de 2020. Se recogieron un total de 475.805.207 registros de dispensación de medicamentos. Los antibióticos correspondieron en promedio al 54,5% del total de los registros. La dimensión de calidad "no informado" se identificó sistemáticamente en las variables "principio activo", "sexo", "edad" y "CIE-10". Las cantidades de viales y cajas oscilaron entre 1 y 536 unidades, y las cantidades de formas farmacéuticas dispensadas entre 1 y 7.500 unidades. Los resultados muestran que el 25% de los registros exceden una terapia individual y que el sistema no tiene un mecanismo crítico para evitar la dispensación que no se ajusta al patrón terapéutico de la clase. A pesar de las vulnerabilidades derivadas de la calidad de los datos, que pueden ser superadas, el SNGPC permite la construcción de diferentes planes analíticos, involucrando tiempo y otras agregaciones, en la investigación del uso comunitario de antimicrobianos y medicamentos bajo control especial, lo que hace que el Sistema sea una potente fuente de datos para DUR.

First use of antineoplastic agents in women with breast cancer in the state of Rio de Janeiro, Brazil.

Context: Breast cancer is the most common cancer, except for non-melanoma skin cancer, among women in Brazil and worldwide. Breast cancer treatment involves surgery, radiotherapy and chemotherapy, which is used in 70% of patients. This study analyzes the utilization of antineoplastic agents among women undergoing their first round of chemotherapy in Brazil's public health system (SUS) in the state of Rio de Janeiro. Methods: Data from the SUS Outpatient Information System's authorizations for high-complexity outpatient procedures (APACs) billed between January 2013 and December 2019 were extracted, and three datasets were created: all type 1 and type 2 APACs (including all chemotherapy procedures performed); all type 1 APACs; and first type 1 APACs (containing data only for the first round of breast cancer chemotherapy). Names of antineoplastic agents were standardized to enable the subsequent classification of therapy regimens, mitigating limitations related to data quality. Absolute and relative frequencies were used to describe sociodemographic, clinical and treatment characteristics, therapy regimen and supportive drugs. Results: We analyzed 23,232 records of women undergoing their first round of chemotherapy. There was a progressive increase in the number of procedures over time. Women were predominantly white, lived in the capital and close to the treatment center. Most had stage 3 cancer at diagnosis (50.51%) and a significant proportion had regional lymph node invasion (37.9%). The most commonly used chemotherapy regimens were TAC (docetaxel, doxorubicine, cyclophosphamide) (21.05%) and and cyclophosphamide (17.71%), followed by tamoxifen (15.65%) and anastrozole (12.94%). Supportive drugs were prescribed to 386 women and zoledronic acid was predominant (59.58%). Conclusion: The findings point to important bottlenecks and possible inequities in access to treatment and medicine utilization for breast cancer patients in Brazil. Efforts to improve breast cancer treatment and prevention should not only focus on interventions at the individual level but address the disease as a public health problem. The study focused on women undergoing their first round of treatment, providing valuable insight into patient and treatment characteristics to inform policy decisions.

Quimioterapia para Câncer de Mama no Estado do Rio de Janeiro durante a Pandemia da Covid-19: Análise de Séries Temporais / Chemotherapy for Breast Cancer in the State of Rio de Janeiro during the COVID-19 Pandemic: Time Series Analysi / Quimioterapia para el Cáncer de Mama en el Estado de Río de Janeiro durante a la Pandemia de Covid-19: Análisis de Series de Tiempo

Introdução: O câncer é uma das principais causas de morte no Brasil e no mundo. Estimam-se 483 mil novos casos no país, para cada ano do triênio 2023-2025, excetuando-se o câncer de pele não melanoma, sendo o câncer de mama o mais incidente em mulheres, com 74 mil novos casos. Após a declaração da pandemia da covid-19 pela Organização Mundial da Saúde, vários Estados brasileiros estabeleceram medidas restritivas, visando à redução da contaminação, e os centros de referência em diagnóstico do câncer foram impactados. Objetivo: Analisar séries temporais das quantidades de procedimentos aprovados de quimioterapia para câncer de mama antes e durante a pandemia da covid-19 nos estabelecimentos habilitados para alta complexidade em oncologia no Estado do Rio de Janeiro. Método: Estudo descritivo com análises de séries temporais e ecológica, usando dados públicos de procedimentos de quimioterapia autorizados pelo Sistema Único de Saúde entre março de 2018 e fevereiro de 2021. Resultados: Foram identificados 394.926 procedimentos, representando um aumento de 47% com tendência linear crescente (R2 =0,5203) no período. Verificou-se um aumento de procedimentos para câncer de mama receptor hormonal positivo (46%) e carcinoma de mama HER-2 positivo (900%). Conclusão: Observou-se um aumento nos procedimentos de quimioterapia, assim como uma diminuição do deslocamento de tratamento dos grandes centros. Os resultados apontam para uma possível resposta efetiva da rede de atendimento e fortalecimento da regionalização durante o primeiro ano da pandemia.

Introduction: Cancer is one of the main causes of death in Brazil and worldwide. For each year of the triennium 2023-2025, 483,000 new cases are estimated for the country, except non-melanoma skin cancer, breast cancer being the most incident in women with 74,000 new cases. After the declaration of the COVID-19 pandemic by the World Health Organization, several Brazilian states determined restrictive measures to reduce the contamination and cancer diagnosis reference centers were impacted. Objective: To analyze the number of approved breast cancer chemotherapy procedures before and during the COVID-19 pandemic in SUS-affiliated cancer-care facilities in the State of Rio de Janeiro, Brazil. Method: Descriptive design, with time series and ecological analyses using publicly available data of chemotherapy procedures authorized by SUS between March 2018 and February 2021. Results: A total of 394,926 procedures were identified, an increase of 47% with a rising linear trend (R2 =0,5203) during the period. Increases in hormonal receptor-positive cancer (46%) and in HER-2 positive carcinoma (900%) were observed. The patients travelled smaller distances for chemotherapy procedures. Conclusion: Results point out a possible effective response by the cancer care network and strengthening of the regionalization during the first pandemic year.

Introducción: El cáncer es una de las principales causas de muerte en el Brasil y en el mundo. Se estiman 483 000 nuevos casos en el país, para cada año del trienio 2023-2025, excluyendo el cáncer de piel no melanoma, siendo el cáncer de mama el más incidente en mujeres, con 74 000 nuevos casos. Luego de la declaración de la pandemia de covid-19 por la Organización Mundial de la Salud, varios Estados del Brasil establecieron medidas restrictivas con el objetivo de reducir la contaminación y los centros de referencia para el diagnóstico del cáncer fueron impactados. Objetivo: Analizar series de tiempo de las cantidades de procedimientos de quimioterapia aprobados para el cáncer de mama, antes y durante la pandemia de covid-19, en los establecimientos calificados para la alta complejidad en oncología en el Estado de Rio de Janeiro, Brasil. Método: Diseño descriptivo con análisis de series de tiempo y ecológico, utilizando datos públicos de procedimientos de quimioterapia aprobados por el Sistema Único de Salud entre marzo de 2018 y febrero de 2021. Resultados: Fueran identificados 394 926 procedimientos, representando un aumento de 47% con una tendencia lineal creciente (R2 =0,5203) en el periodo. Fueron observados aumentos de procedimientos para cáncer de mama receptor hormonal positivo (46%) y carcinoma de mama HER-2 positivo (900%). Conclusión: Los resultados apuntan hacia una posible respuesta efectiva de la red de atención y fortalecimiento de la regionalización durante el primer año pandémico.

The incorporation of the 3HP regimen for tuberculosis preventive treatment in the Brazilian health system: a secondary-database nationwide analysis.

Introduction: The recommendation of rifampin-based shorter - and safer - regimens for tuberculosis preventive treatment (TPT) is progressively replacing monotherapy with isoniazid by different countries. The Brazilian Ministry of Health (MoH) approved the incorporation of the Rifapentine + isoniazid regimen (3HP) at the end of 2020, with free distribution in the Brazilian Unified Health System (SUS) started from the last quarter of 2021. The objectives were to describe the implementation of the IL-TB System (Information System of TPT Notification) and uptake of Rifapentine + isoniazid (3HP) and Isoniazid (6H or 9H) in Brazil. Methods: A quantitative observational and descriptive was performed using the IL-TB National System as the main data source, from January 2018 to December 2022. Results and discussion: There was a steady increase of the number of TPT prescription quarterly throughout the period, which reflects the implementation of the system itself and the progressive adherence of the health system to the non-compulsory notification of new TPT. The substitution of isoniazid (6H or 9H) by 3HP is progressing. The 3HP regimen represented less than 4% of the total administered by the end of 2021, reaching around 30% in the second half of 2022 and 40% in the last quarters of 2022. The study points not only to the need to expand TPT in the country, but also to accelerate 3HP uptake and to encourage the municipalities to notify to the IL-TB system, since there is still a high level of underreporting.

Tratamento de dados do Sistema Nacional de Gerenciamento de Produtos Controlados para estudos de utilização de medicamentos com antimicrobianos / Data processing of the Brazilian National System of Controlled Product Management for drug utilization research with antimicrobials / Procesamiento de datos del Sistema Nacional de Gestión de Productos Controlados para estudios de utilización medicamentos con antimicrobianos

Resumo: O Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC) armazena dados de dispensação de medicamentos industrializados, manipulados e insumos farmacêuticos sob controle especial e antimicrobianos, a partir dos registros de farmácias e drogarias privadas. Este trabalho explorou a qualidade dos dados inseridos no SNGPC, a partir dos registros de dispensação de antibióticos industrializados, com o objetivo de propor seu emprego em estudos de utilização de medicamentos (DUR). A pesquisa foi desenvolvida por meio de desenho descritivo e retrospectivo, examinando o conjunto dados brutos do sistema, para o período de janeiro de 2014 a dezembro de 2020. Um total de 475.805.207 registros de dispensação de medicamentos foi coletado. Os antibióticos corresponderam em média a 54,5% do total de registros. A dimensão de qualidade "não informado" foi identificada, sistematicamente, nas variáveis "princípio ativo", "sexo", "idade" e "CID-10". As quantidades de frascos e caixas variaram de 1 a 536 unidades, e as quantidades de formas farmacêuticas dispensadas de 1 a 7.500 unidades. Os resultados mostram que 25% dos registros extrapolam uma terapia individual e que o sistema não apresenta um mecanismo de crítica para evitar dispensações não conformes ao padrão terapêutico para a classe. Apesar das vulnerabilidades decorrentes da qualidade dos dados, que podem ser superadas, o SNGPC possibilita construir diferentes planos analíticos, envolvendo tempo e outras agregações, na investigação de uso comunitário de antimicrobianos e medicamentos sob controle especial, o que faz dele uma potente fonte de dados para DUR.

Abstract: The Brazilian National System of Controlled Product Management (SNGPC) stores data on the dispensing of manufactured and compounded drugs and pharmaceutical inputs, whether controlled and antimicrobial, based on the records of private pharmacies and drugstores. This study assessed the quality of SNGPC data from the dispensing records of manufactured antibiotics, aiming to propose their use in drug utilization researchs (DURs), with a descriptive and retrospective design, analyzing the raw dataset of the SNGPC from January 2014 to December 2020. A total of 475,805,207 drug-dispensing records were collected. On average, antibiotics corresponded to 54.5% of the total records. The quality dimension "unreported" was systematically identified in the variables "active ingredient", "sex", "age" and "ICD-10". The amount of vials/bottles and packages ranged from one to 536 units and the amount of pharmaceutical inputs dispensed, from one to 7,500 units. Results show that 25% of the records exceed an individual therapy and the SNGPC has no critical mechanism to avoid dispensations outside the therapeutic standard for the class. Despite vulnerabilities due to data quality, which can be overcome, the SNGPC allows for the construction of different analytical plans, involving time and other aggregations, in the analysis of community use of antimicrobials and controlled drugs, which makes it a powerful source of data for DUR.

Resumen: El Sistema Nacional de Gestión de Productos Controlados (SNGPC) almacena datos sobre la dispensación de medicamentos industrializados, manipulados, insumos farmacéuticos bajo control especial y de antimicrobianos con base en los registros de farmacias y de boticas privadas. Este trabajo analizó la calidad de los datos ingresados en el SNGPC relacionados a los registros de la dispensación de antibióticos industrializados, para proponer su posible aplicación en estudios sobre el uso de medicamentos (DUR); para ello, realizó un análisis descriptivo y retrospectivo del conjunto de datos brutos para el periodo de enero de 2014 a diciembre de 2020. Se recogieron un total de 475.805.207 registros de dispensación de medicamentos. Los antibióticos correspondieron en promedio al 54,5% del total de los registros. La dimensión de calidad "no informado" se identificó sistemáticamente en las variables "principio activo", "sexo", "edad" y "CIE-10". Las cantidades de viales y cajas oscilaron entre 1 y 536 unidades, y las cantidades de formas farmacéuticas dispensadas entre 1 y 7.500 unidades. Los resultados muestran que el 25% de los registros exceden una terapia individual y que el sistema no tiene un mecanismo crítico para evitar la dispensación que no se ajusta al patrón terapéutico de la clase. A pesar de las vulnerabilidades derivadas de la calidad de los datos, que pueden ser superadas, el SNGPC permite la construcción de diferentes planes analíticos, involucrando tiempo y otras agregaciones, en la investigación del uso comunitario de antimicrobianos y medicamentos bajo control especial, lo que hace que el Sistema sea una potente fuente de datos para DUR.

Consumption of antidepressants and economic austerity in Brazil.

OBJECTIVE: To describe consumption of antidepressants in Brazil through dispensing data from pharmacy retail outlets, in between 2011 and 2017, and explore the relationship between consumption patterns and changing economic context during this period. METHODS: A time-series analysis of dispensing data from pharmacy retail outlets was carried out considering 10 commonly used antidepressants. DDDs/1000 inhabitants/year for each drug were calculated for each quarter. Ttime-series graphs were constructed to analyze the volumes of drugs purchasedRelationship between economic context and consumption was assessed using the following indicators: annual percent change in Gross Domestic Product (GDP), public debt (% of GDP), and annual net savings (in billions of Brazilian reais - BRL). RESULTS: Overall consumption of antidepressants increased over the study period despite a sharp fall of -3.55% in annual percent change in GDP, negative net annual savings of -53.568 BRL, and an increase in public debt exceeding 32% of the GDP during the economic crisis of 2015. CONCLUSION: Consumption of antidepressants from pharmacy retail outlets increased even within a context of economic crisis, which may be a reflection of the disease burden in Brazil. Health budget cuts due to the economic crisis may be directing users to out-of-pocket expenses, deepening social inequalities.

Public procurement of antineoplastic agents used for treating breast cancer in Brazil between 2013 and 2019.

BACKGROUND: Breast cancer is the most common cancer among women in Brazil and the country's public health care system is the main care provider. Timely treatment can increase the chance of cure, prevent metastasis and improve quality of life. Effective public procurement of antineoplastic agents can therefore improve access to drug therapy. This study investigates patterns in the procurement of selected antineoplastic agents used for treating breast cancer by public bodies and avoidable expenditure on these drugs between January 2013 and December 2019. METHODS: We selected antineoplastic agents used for adjuvant or preoperative chemotherapy listed in the 2018 Breast Cancer Diagnosis and Treatment Guidelines and included in category L of the WHO Anatomical Therapeutic Chemical classification system. We analyzed regular purchases of antineoplastic agents registered in the Integrated General Services Administration System (SIASG), considering purchased quantity, unit price, date of purchase and procuring entity. Prices were inflation-adjusted to July 2019 based on the National Consumer Price Index. RESULTS: A total of 10 antineoplastic agents were selected. Trastuzumab and tamoxifen accounted for the largest share of total spending and largest volume of purchases, respectively. The Ministry of Education was the largest purchaser in volume terms of all the drugs studied, except trastuzumab 440 mg, where the category "Other Institutions" accounted for most purchases, and vinorelbine 20 mg, where the Ministry of Health made most purchases. The category "Other Institutions" accounted for the largest share of total spending. Total avoidable expenditure was R$99,130,645. Prices paid for medicines and avoidable expenditure were highest in the Ministry of Defense. CONCLUSIONS: The differences observed in the performance of different categories of buyers as to amounts purchased and prices practiced for antineoplastic agents could be reduced by employing strategies to expand the centralization of purchases, resulting in expanded access to breast cancer medicines in the public sector.

[Strategies adopted to ensure the rights of people with cancer in the Brazilian Unified Health System (SUS)]. / Estratégias adotadas para a garantia dos direitos da pessoa com câncer no âmbito Sistema Único de Saúde (SUS).

This study was based on Giddens' Structuration Theory and aimed to analyze strategies adopted to ensure the rights of people with cancer in five Brazilian municipalities, anchored on the experience of managers and health professionals within the Brazilian Unified Health System (SUS). A multiple-case study design was conducted. The municipality was the unit of analysis and oncology care-certified facilities were established as analytical sub-units. We analyzed the strategic behavior of ten managers and 15 health professionals from interviews. The results were systematized according to care, legal and social dimensions. The relevant elements expressed were the need to expand and organize the diagnostic and therapeutic cancer care network; the concern with the large number of lawsuits, both in light of economic sustainability of the health system and because of the promotion of inequalities; and the low resoluteness of social benefits, as they do not meet all people's needs. The adopted measures are considered insufficient to ensure the rights of people with cancer in the Brazilian Unified Health System.

Este estudo, fundamentado na Teoria da Estruturação de Giddens, buscou analisar as estratégias adotadas para garantir os direitos das pessoas com câncer em cinco municípios brasileiros, a partir da experiência de gestores e profissionais de saúde no contexto do Sistema Único de Saúde. Foi conduzido um estudo de casos múltiplos. A unidade de análise foi o município e a subunidade foi a unidade habilitada de atenção oncológica. Foi realizada a análise de conduta estratégica de dez gestores e 15 profissionais de saúde, a partir de entrevistas. Os resultados foram sistematizados em três dimensões: assistencial, judicial e social. Destacaram-se: a necessidade de expansão e organização da rede assistencial diagnóstica e terapêutica; a preocupação com o grande número de demandas judiciais, tanto pela sustentabilidade econômica do sistema de saúde, quanto pela promoção de iniquidades; a pouca resolutividade dos benefícios sociais, uma vez que não atendem a todos aqueles que necessitam. A percepção é de que as medidas adotadas são insuficientes para garantir os direitos da pessoa com câncer no sistema de saúde brasileiro.

Estratégias adotadas para a garantia dos direitos da pessoa com câncer no âmbito Sistema Único de Saúde (SUS) / Strategies adopted to ensure the rights of people with cancer in the Brazilian Unified Health System (SUS)

Resumo Este estudo, fundamentado na Teoria da Estruturação de Giddens, buscou analisar as estratégias adotadas para garantir os direitos das pessoas com câncer em cinco municípios brasileiros, a partir da experiência de gestores e profissionais de saúde no contexto do Sistema Único de Saúde. Foi conduzido um estudo de casos múltiplos. A unidade de análise foi o município e a subunidade foi a unidade habilitada de atenção oncológica. Foi realizada a análise de conduta estratégica de dez gestores e 15 profissionais de saúde, a partir de entrevistas. Os resultados foram sistematizados em três dimensões: assistencial, judicial e social. Destacaram-se: a necessidade de expansão e organização da rede assistencial diagnóstica e terapêutica; a preocupação com o grande número de demandas judiciais, tanto pela sustentabilidade econômica do sistema de saúde, quanto pela promoção de iniquidades; a pouca resolutividade dos benefícios sociais, uma vez que não atendem a todos aqueles que necessitam. A percepção é de que as medidas adotadas são insuficientes para garantir os direitos da pessoa com câncer no sistema de saúde brasileiro.

Abstract This study was based on Giddens' Structuration Theory and aimed to analyze strategies adopted to ensure the rights of people with cancer in five Brazilian municipalities, anchored on the experience of managers and health professionals within the Brazilian Unified Health System (SUS). A multiple-case study design was conducted. The municipality was the unit of analysis and oncology care-certified facilities were established as analytical sub-units. We analyzed the strategic behavior of ten managers and 15 health professionals from interviews. The results were systematized according to care, legal and social dimensions. The relevant elements expressed were the need to expand and organize the diagnostic and therapeutic cancer care network; the concern with the large number of lawsuits, both in light of economic sustainability of the health system and because of the promotion of inequalities; and the low resoluteness of social benefits, as they do not meet all people's needs. The adopted measures are considered insufficient to ensure the rights of people with cancer in the Brazilian Unified Health System.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Knowledge and risk perception of vulnerable women on Zika virus infection at primary health care level in Brazil.

Vulnerable low-income groups were most affected by Zika virus (ZIKV)-related neurologic syndrome during the 2014-2016 outbreak in Brazil. Major ZIKV infection response took place in Primary Health Care (PHC), including prevention strategies and risk communication. We aimed to detect knowledge and beliefs, as well as knowledge gaps among vulnerable women at the PHC level. A cross-sectional study was carried out in two low-income urban community settings: a small municipality with few ZIKV infection cases and a large municipality hard-hit by the epidemic. An open-ended data collection instrument centred on ZIKV infection knowledge, sources of information, possible causes, symptoms, risk perception, consequences for pregnant women and PHC point-of-care communication was developed. Interviews were recorded, transcribed and content coded for thematic analysis. Most of the seventy-nine respondents had some knowledge of the disease, acknowledging the vector as the source of infection and associating microcephaly with the disease, but distanced themselves from possible ZIKV infection and related risk. PHC services in both communities did not adequately communicate risk for women and children. In an uncertain future scenario as to disease re-emergence, awareness may be diminished and acquired knowledge lost, configuring a public health challenge that must be overcome.

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

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

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