Pharmacotherapeutic follow-up in patients with type 1 diabetes in context of judicialization: possibility optimize costs

Abstract In Brazil, insulin analogs stand out as one of the most demanded medications by judicial means. However, the guarantee of judicial access does not guarantee rational use. In context, pharmacotherapeutic follow-up (PF) is shown to be clinical effective strategy for patients with diabetes. To evaluate direct medical costs one year after performing PF in patients with type 1 diabetes mellitus using insulin analogs ordered by court in Public Health System (Sistema Único de Saúde - SUS). This is a partial economic analysis, nested within a quasi-experimental study. Patients with T1DM who receive insulin analogs by judicialization in a medium-sized Brazilian city participated. The PF was conducted following the method adapted from the Pharmacotherapy workup (PW). Data were collected considering the period of one year before the start of the intervention and one year after the start of the intervention. Direct medical costs were evaluated and the difference in costs was calculated. 28 patients participated in the intervention. After PF, direct costs were -$3,696.78. Sensitivity analysis showed that there is a 33.4 % chance for PF to present cost savings when compared to baseline. The PF has the potential to reduce direct medical costs from the perspective of the SUS.

Perception of pharmacists regarding human resources, training, and development of a national hospital pharmacy: a preliminary report on Basel Statements

Abstract The hospital pharmacy needs a constant process of evaluation and monitoring of its activities. In Brazil, several agencies establish tasks and duties for pharmacists, but little is known about the compliance and the perception of the professional regarding these policies. The present study aims to characterize the pharmacist's perception of Brazilian hospital pharmacy policies according to the Basel Statements. A search was performed for the contacts of all medium and high complexity hospitals in the country. Subsequently, a questionnaire elaborated following the Basel Statements was sent by e-mail to hospital pharmacists throughout the country. The domain analyzed was "Human Resources, Training, and Development". Statistical analyses were performed using SPSS 19.0. Pharmacists representing a total of 111 hospitals from all Brazilian regions answered the survey questionnaire and showed that more than half of the hospital pharmacists perceive themselves as not complying, whether in the service of local, national, or pharmaceutical education. Besides updating the professionals in relation to national policies, it is necessary that the representative bodies of the pharmaceutical class be more present in the elaboration and evaluation of the policies directed to human resources, seeking uniformity and the possibility of carrying out the activities required.

Polypharmacy, socioeconomic indicators and number of diseases: results from ELSA-Brasil.

OBJECTIVE: To estimate the prevalence of polypharmacy, describe the pharmacotherapeutic classes used, and investigate whether polypharmacy is associated with demographic and socioeconomic indicators, regardless of the number of diseases, among participants in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) baseline (2008-2010). METHOD: In this analysis, 14,523 adults and elderly (35-74 years) participated. Polypharmacy was characterized as regular use of five or more medicines. The demographic and socioeconomic indicators analyzed were: gender, age, education level, per capita family income, and access to private health insurance. The independent association between demographic and economic indicators and polypharmacy was estimated by binary logistic regression. RESULTS: The prevalence of polypharmacy was 11.7%. The most used drugs were those with action on the cardiovascular system. After adjustments, including by number of diseases, the chances of being on polypharmacy treatment were significantly higher among women, older participants and those with greatest number of diseases. Individuals without health insurance had lower chance to be under polypharmacy, as well as those with lower income. CONCLUSION: The occurrence of polypharmacy among ELSA-Brasil baseline participants was mainly due to drugs for the treatment of chronic diseases. The relation between polypharmacy and the female gender, as well as its association with old age, are in consonance with the results obtained in other studies. Despite the absence of an association between polypharmacy and education level, the income and health insurance results reinforce the existence of social inequalities regarding drug use.

Pacientes com diabetes mellitus tipo 2 em uso de medicamentos via judicial: há monitorização clínica e laboratorial? / Patients with type 2 diabetes mellitus using drugs by filing lawsuits: is there clinical and laboratory monitoring? / Pacientes con diabetes mellitus tipo 2 en uso de medicamentos vía judicial: ¿hay monitoreo clínico y laboratorial?

Introdução: O aumento contínuo do número de processos de judicialização da saúde, a relevância epidemiológica do diabetes mellitus tipo 2 (DM2), a escassez de recursos utilizados para monitorar os investimentos dos processos judiciais e do seu alto custo para a saúde pública, diante disso torna-se necessário estudos que analisem o perfil da judicialização dos antidiabéticos, que é a principal classe de medicamentos alvo dos processos judiciais. Objetivo: Analisar se os pacientes com DM2 atendidos via judicial, foram acompanhados e monitorados no Sistema Único de Saúde (SUS) antes e após os processos judiciais. Além de analisar o perfil de medicamentos judicializados para tratamento da DM2. Métodos: Trata-se de um estudo longitudinal retrospectivo, que utilizou dados secundários, prontuários e arquivos de processos judiciais, de 56 pacientes com DM2 que adquiriram pelo menos um de seus medicamentos por meio da judicialização, no ano de 2019, em um município mineiro. Os dados foram analisados 12 meses antes e 12 meses após a judicialização. Resultados: Dentre as 56 ações judiciais, 39% se concentraram em apenas três unidades de saúde do município. Somente 30 pacientes (53%) antes e 29 (51%) após a judicialização tiveram consultas no SUS. Além disso, apenas 15 (26%) e 13 (23%) pacientes, respectivamente antes e após a judicialização, apresentaram algum exame laboratorial realizado pelo SUS. As insulinas Levemir Flex Pen® (13%), Novo Rapid® (11%) e Lantus® (7%) foram os medicamentos mais judicializados. Conclusão: Observou-se que apesar do SUS prover o insumo terapêutico de elevado custo por meio de uma porta de entrada não convencional, não há monitorização clínica e laboratorial para avaliação da efetividade do uso da tecnologia, conforme recomendam os protocolos clínicos e dispositivos legais brasileiros sobre acesso a medicamentos.

Introducción: El aumento continuo en el número de procesos de judicialización de la salud, la relevancia epidemiológica de la diabetes mellitus tipo 2 (DM2), la escasez de recursos utilizados para monitorear las inversiones en procesos judiciales y de su alto costo para la salud pública, se vuelven necesarios estudios que analicen el perfil de la judicialización de los antidiabéticos, que es la principal clase de medicamentos a las que se dirigen los procesos judiciales. Objetivo: Analizar si los pacientes con DM2 atendidos vía judicial, fueron acompañados y monitoreados en el Sistema Único de Salud (SUS) antes y después de los procesos judiciales. Además de analizar el perfil de las drogas legalizadas para el tratamiento de la DM2. Métodos: Se trata de un estudio retrospectivo longitudinal, que utilizó datos secundarios, registros médicos y archivos de demandas, de 56 pacientes con DM2 que adquirieron al menos uno de sus medicamentos a través de la judicialización, en el año 2019, en un municipio de Minas Gerais. Los datos fueron analizados 12 meses antes y 12 meses después de la judicialización. Resultados: Entre las 56 acciones judiciales, el 39% se concentró en solo tres unidades de salud en el municipio. Solo 30 pacientes (53%) antes y 29 (51%) después de la judicialización tuvieron consultas en el SUS. Además, solo 15 (26%) y 13 (23%) pacientes, respectivamente antes y después de la judicialización, se sometieron a pruebas de laboratorio realizadas por el SUS. Las insulinas Levemir Flex Pen® (13.0%), Novo Rapid® (11%) y Lantus® (7%) fueron los medicamentos más judicializadas. Conclusión: Se observó que a pesar de que el SUS proporciona un recurso terapéutico de alto costo a través de una puerta de entrada no convencional, no hay monitoreo clínico y laboratorial para la evaluación de la efectividad del uso de la tecnología, según lo recomendado por los protocolos clínicos y dispositivos legales brasileros sobre el acceso a medicamentos.

Introduction: The continuous increase in the number of health judicialization processes, the epidemiological relevance of type 2 diabetes mellitus (DM2), the scarcity of resources used to monitor the investments of lawsuits, and their high cost to public health, that said there is a need for studies that analyze the profile of the judicialization of antidiabetics, which is the main class of drugs targeted by lawsuits. Objective: To analyze whether patients with DM2 attended by judicial system, are followed up and monitored in Brazilian Public Health System (SUS) before and after judicial proceedings. In addition to analyzing the profile of drugs legalized for the treatment of DM2. Methods: A retrospective observational study, which secondary database, medical records and judicial files, was conducted with 56 patients with DM2 who have acquired at least one of their medicines through lawsuits, in 2019, in a city in Minas Gerais. The data were analyzed 12 months before and 12 months after judicialization process. Results: Among the 56 lawsuits, 39% were concentrated in only three health units. Only 30 patients (53%) before and 29 (51%) after judicialization had appointments in SUS. Furthermore, only 15 (26%) and 13 (23%) patients, respectively before and after judicialization, had some laboratory test performed by SUS. The insulins Levemir Flex Pen® (13%), Novo Rapid® (11%), and Lantus® (7%) were the most judicialized drugs. Conclusion: It was observed that despite the SUS providing the high-cost therapeutic input through an unconventional gateway, there is no clinical and laboratory monitoring to evaluate the effectiveness of the technology, as recommended by clinical protocols and Brazilian laws about access to medicines.

Efeito das "promessas terapêuticas" sobre os preços de medicamentos em tempos de pandemia / Effect of "therapeutic promises" on drug prices in times of pandemic

Objetivo: Analisar o preço real de aquisição de medicamentos anunciados como promessas terapêuticas para tratamento da COVID-19 no Brasil. Métodos: Identificaram-se os medicamentos que estão sendo estudados e/ou noticiados como promissores e, posteriormente, analisaram-se os custos de aquisição desses medicamentos por uma drogaria do interior do estado de Minas Gerais, entre janeiro e junho de 2020. Resultados: Sete (87,5%) medicamentos apresentaram aumento do valor de compra no período estudado. Dexametasona e ivermectina apresentaram elevação de mais de 200% no preço. A menor elevação foi o polivitamínico, 5,44%. A hidroxicloroquina foi o único medicamento (12,5%) que não sofreu variação no preço e só foi adquirida nos três primeiros meses do ano de 2020. Conclusão: O preço de aquisição da maioria dos medicamentos anunciados como "promessas terapêuticas" para tratamento da Covid-19 no Brasil sofreu aumento significativo no período da pandemia.

Objective: To analyze the real purchase price of drugs announced as therapeutic promises for the treatment of Coronavirus disease in Brazil. Methods: The drugs that are being studied and/or announced as promising were identified and, subsequently, the costs of purchasing these drugs by a drugstore in the countryside of the state of Minas Gerais were analyzed between January and June 2020. Results: A total of seven (87.5%) drugs showed an increase in the purchase price in the period studied. Dexamethasone and ivermectin showed an increase of more than 200% in price. The lowest increase was the multivitamin, 5.44%. Hydroxychloroquine was the only drug (12.5%) that did not change its price and was only purchased in the first three months of 2020. Conclusion: The purchase price of the vast majority of drugs announced as "therapeutic promises" for the treatment of Covid-19 in Brazil suffered a significant increase during the pandemic period.

Polypharmacy, socioeconomic indicators and number of diseases: results from ELSA-Brasil / Polifarmácia, indicadores socioeconômicos e número de doenças: resultados do ELSA-Brasil

ABSTRACT: Objective: To estimate the prevalence of polypharmacy, describe the pharmacotherapeutic classes used, and investigate whether polypharmacy is associated with demographic and socioeconomic indicators, regardless of the number of diseases, among participants in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) baseline (2008-2010). Method: In this analysis, 14,523 adults and elderly (35-74 years) participated. Polypharmacy was characterized as regular use of five or more medicines. The demographic and socioeconomic indicators analyzed were: gender, age, education level, per capita family income, and access to private health insurance. The independent association between demographic and economic indicators and polypharmacy was estimated by binary logistic regression. Results: The prevalence of polypharmacy was 11.7%. The most used drugs were those with action on the cardiovascular system. After adjustments, including by number of diseases, the chances of being on polypharmacy treatment were significantly higher among women, older participants and those with greatest number of diseases. Individuals without health insurance had lower chance to be under polypharmacy, as well as those with lower income. Conclusion: The occurrence of polypharmacy among ELSA-Brasil baseline participants was mainly due to drugs for the treatment of chronic diseases. The relation between polypharmacy and the female gender, as well as its association with old age, are in consonance with the results obtained in other studies. Despite the absence of an association between polypharmacy and education level, the income and health insurance results reinforce the existence of social inequalities regarding drug use.

RESUMO: Objetivo: Estimar a prevalência de polifarmácia, descrever as classes farmacoterapêuticas utilizadas e investigar se a polifarmácia está associada a indicadores demográficos e socioeconômicos, independentemente do número de morbidades, entre os participantes na linha de base do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) (2008-2010). Métodos: Participaram desta análise 14.523 adultos e idosos (35-74 anos). A polifarmácia foi caracterizada como uso regular de cinco ou mais medicamentos. Os indicadores demográficos e socioeconômicos analisados foram: sexo, idade, escolaridade, renda familiar per capita e acesso a plano de saúde particular. A associação independente entre os indicadores demográficos e econômicos e polifarmácia foi estimada por meio de regressão logística binária. Resultados: A prevalência de polifarmácia foi de 11,7%. Os medicamentos mais utilizados foram aqueles com ação no sistema cardiovascular. Após ajustes, incluindo número de doenças, a chance de estar sob tratamento com polifarmácia foi significativamente maior entre mulheres, participantes mais velhos e aqueles com maior número de doenças. Participantes de baixa renda e aqueles sem plano privado de saúde, no entanto, tiveram menor chance de estar sob polifarmácia. Conclusão: A ocorrência de polifarmácia entre os participantes da linha de base do ELSA-Brasil deveu-se principalmente a medicamentos para o tratamento de doenças crônicas. A relação entre polifarmácia e sexo feminino, bem como sua associação com maior idade, estão em consonância com os resultados obtidos em outros estudos. Apesar da ausência de associação entre a polifarmácia e a escolaridade, os resultados de renda e plano privado de saúde reforçam a existência de desigualdades sociais em relação ao uso de medicamentos.

Primary health care as assessed by health professionals: comparison of the traditional model versus the Family Health Strategy.

INTRODUCTION: The Family Health Strategy (FHS) should be first-contact care in the Brazilian Health System. However, Primary Health Care (PHC) still encompasses two models: the FHS and the traditional health care facilities. The expansion of the FHS has been slow and heterogeneous in many cities, rendering a comparative evaluation of key quality-related elements of PHC models crucial. OBJECTIVE: To compare the performance of PHC models as perceived by health professionals. METHODS: A cross-sectional study involving managers and health professionals from PHC of a medium-size city in South-eastern Brazil. Data were collected by applying the Primary Care Assessment Tool. The performance was estimated through primary health care indexes (general and partial PHCI by attributes). Univariate polytomous logistic regression was performed to compare care model performances according to their attributes. Strength of association was estimated by odds ratio with 95% confidence interval. RESULTS: Three managers and 81 health professionals participated in the study. The FHS had a better index rating than the traditional care model for general PHCI and for the attributes longitudinality, comprehensiveness, family focus and professional level. CONCLUSION: Although the FHS attained higher scores compared to the traditional model, it has not yet achieved the performance expected. This scenario points to the need for increased FHS cover and quality improvements at the existing units.

Primary health care as assessed by health professionals: comparison of the traditional model versus the Family Health Strategy / Avaliação da atenção primária à saúde por profissionais de saúde: comparação entre modelo tradicional versus Estratégia Saúde da Família

ABSTRACT: Introduction: The Family Health Strategy (FHS) should be first-contact care in the Brazilian Health System. However, Primary Health Care (PHC) still encompasses two models: the FHS and the traditional health care facilities. The expansion of the FHS has been slow and heterogeneous in many cities, rendering a comparative evaluation of key quality-related elements of PHC models crucial. Objective: To compare the performance of PHC models as perceived by health professionals. Methods: A cross-sectional study involving managers and health professionals from PHC of a medium-size city in South-eastern Brazil. Data were collected by applying the Primary Care Assessment Tool. The performance was estimated through primary health care indexes (general and partial PHCI by attributes). Univariate polytomous logistic regression was performed to compare care model performances according to their attributes. Strength of association was estimated by odds ratio with 95% confidence interval. Results: Three managers and 81 health professionals participated in the study. The FHS had a better index rating than the traditional care model for general PHCI and for the attributes longitudinality, comprehensiveness, family focus and professional level. Conclusion: Although the FHS attained higher scores compared to the traditional model, it has not yet achieved the performance expected. This scenario points to the need for increased FHS cover and quality improvements at the existing units.

RESUMO: Introdução: A Estratégia de Saúde da Família (ESF) deve ser o primeiro contato do Sistema Único de Saúde (SUS). Contudo dois modelos de atenção operam concomitantemente no âmbito da Atenção Primária à Saúde (APS): a ESF e o modelo tradicional. A expansão da ESF tem sido lenta e heterogênea em muitos municípios, tornando fundamental a condução de avaliações comparativas de atributos relacionados à qualidade dos modelos da APS. Objetivo: Comparar o desempenho dos modelos de atenção da APS de acordo com a percepção dos profissionais de saúde. Métodos: Estudo transversal com gestores e profissionais de saúde da APS do município de Divinópolis, Minas Gerais. Dados foram coletados por meio do Primary Care Assessment Tool. O desempenho dos modelos foi estimado por meio do Índice de Atenção Primária à Saúde (IAPS geral e específico). Regressão logística politômica univariada foi conduzida para comparação do desempenho dos modelos da APS de acordo com os atributos. A força da associação foi estimada por meio do odds ratio com intervalo de confiança de 95%. Resultados: Três gestores e 81 profissionais de saúde participaram do estudo. A ESF obteve melhor avaliação do que o modelo tradicional com relação ao IAPS geral e aos atributos vínculo, elenco de serviços, enfoque familiar e formação profissional. Conclusão: A ESF obteve escores superiores aos do modelo tradicional, entretanto ainda não atingiu o seu desempenho esperado. Esse cenário aponta para a necessidade de ampliação da cobertura da ESF e para a melhoria da qualidade das unidades de ESF existentes no Brasil.