Kidney function decline associated with proton pump inhibitors: results from the ELSA-Brasil cohort.

OBJECTIVE: Investigate the longitudinal association of use and time of use of proton pump inhibitors (PPI) with incidence of chronic kidney disease (CKD) and kidney function change. METHODS: Prospective study with 13,909 participants from baseline (2008-2010) and second wave (2012-2014) of the ELSA-Brasil (mean interval between visits = 3.9 years (1.7-6.0)). Participants answered about use and time use of the PPI in the two weeks prior the interview. Renal function was assessed by glomerular filtration rate estimated by the Collaboration Equation for the Epidemiology of Chronic Kidney Disease. Values below 60ml/min/1.73 m² in wave 2 were considered incident CKD. Associations between PPI use and time of use at baseline and incident CKD and decline in renal function were estimated, respectively, by logistic regression and linear models with mixed effects, after adjusting for confounders. RESULTS: After adjustments, PPI users for more than six months had an increased risk of CKD compared to non-users. Compared to non-users, users PPIs for up to six months and above six months had greater decline in kidney function over time. CONCLUSION: This cohort of adults and elderly, after a mean interval of 3.9 years, PPI use and initial duration were associated with kidney function change between visits.

Patients in insulin analogues use via judicial litigation: do they use the Brazilian Public Health System (SUS)? / Pacientes em uso de análogos de insulina via ação judicial: eles utilizam o Sistema Único de Saúde (SUS)?

Abstract Background Studies show that among the drugs most commonly used in judicial litigation in Brazil, are those used to treat diabetes mellitus, especially insulin analogues. Objective Evaluate the use of the Unified Health System (SUS) by patients with type 1 diabetes mellitus (T1DM), who receive insulin analogues through judicial action, before and after this process. Method In a retrospective longitudinal observational study, secondary data was used from these patients in Minas Gerais, Brazil, in 2018. Socio-demographic information was collected and related to the follow-up of these patients in the SUS. The McNemar χ2 test was used to compare the proportions of the variables. Results Of the 89 patients analyzed, women (53.9%) were predominant. Most patients were aged between 20 and 39 years (52.8%), and more than half, 55.1%, use only a private health system. After the judicial action, there was a significant increase (p <0.05) in the number of patients who had consultations in primary health care (from 19.1% to 30.3%) and emergency medical appointments (from 1.1% to 9.0%). Conclusion It is observed that the majority of patients with T1DM via judicial action in the SUS are not monitored by this health system through examinations, consultations, and hospitalizations.

Resumo Introdução Estudos mostram que, dentre os medicamentos mais adquiridos via ação judicial, estão os utilizados para o tratamento do Diabetes Mellitus, especialmente os análogos de insulina. Objetivo Avaliar a utilização do Sistema Único de Saúde (SUS) pelos pacientes com Diabetes Mellitus tipo 1 (DM1), que recebem insulina por meio de judicialização, antes e após este processo. Método Em um estudo observacional longitudinal retrospectivo, foram utilizados dados secundários de pacientes com DM1, que adquiriram insulinas por processos judiciais em Divinópolis-MG, Brasil, em 2018. Foram coletadas informações sociodemográficas e referentes ao acompanhamento destes pacientes no SUS Realizou-se o teste χ2 de McNemar para a comparação das proporções das variáveis utilizadas para a avaliação do acompanhamento antes e após a judicialização. Resultados Dos 89 pacientes analisados, predominou-se o sexo feminino (53,9%), com idade entre 20 e 39 anos (52,8%). 55,1% destes utilizam apenas o sistema privado de saúde. Após a judicialização, houve um aumento significativo (p< 0,05) no número de pacientes que realizaram consultas na atenção primária à saúde (de 19,1% para 30,3%) e consultas médicas de emergência (de 1,1% para 9,0%). Conclusão A maioria dos pacientes com DM1 que judicializam medicamentos no SUS não são acompanhados por este sistema de saúde através de realização de exames, consultas e hospitalizações.

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.

Frequency of A1C tests undertaken by patients assisted by pharmaceutical care services in Brazil.

BACKGROUND AND AIMS: The test of glycated hemoglobin is used to assess the glycemic control of patients with diabetes mellitus, however is essential that the monitoring is carried out with adequate frequency. In this context, the objective of study is evaluate the frequency of A1C tests undertaken by patients assisted by pharmaceutical care services. METHODS: Descriptive study that included patients with DM treated at pharmaceutical care services in Brazil. This service is provided by pharmacists, for optimizing of patient's drug therapy to achieve outcomes that improve a patient's quality of life. Frequency of A1C tests was collected, with a minimum interval of three and a maximum of six months being considered adequate. Tests performed with a minimum interval of less than three or greater than six months frequency were considered inadequate. The comparison of the mean time between the A1C tests between the groups was investigated by the Student's t-test. The significance level adopted was p < 0.05. The study was conducted using data recorded from March 2018 to December 2019. RESULTS: The study included 66 patients and 67% of these underwent A1C test with inadequate frequency. The mean time between A1C tests was significantly higher (p < 0.0001) in group with inadequate frequency. CONCLUSION: Only one third of DM patients treated by pharmaceutical care services are monitored with adequate A1C frequency. It is necessary to identify the causes of this underutilization and to develop tools to optimize the monitoring.

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.

Alendronato de sódio, levotiroxina e inibidores da bomba de prótons: há interação entre eles? / Sodium alendronate, levothyroxine and proton pump inhibitors: is there an interaction between them? / Alendronato de sodio, levotiroxina e inhibidores de la bomba de protones: ¿hay alguna interacción entre ellos?

Introdução: As interações medicamentosas podem alterar a segurança e/ou efetividade no tratamento das doenças. Alguns medicamentos precisam ser utilizados em jejum e a literatura apresenta informações divergentes sobre o real impacto clínico do uso destes no mesmo horário. Objetivos: Analisar as evidências sobre a relevância clínica de potenciais interações entre inibidores da bomba de prótons (IBPs), levotiroxina e alendronato de sódio. Métodos: Realizou-se uma revisão narrativa de artigos disponíveis na base de dados PubMed, além de consulta de potenciais interações medicamentosas em fontes de informações sobre medicamentos disponíveis na World Wide Web. Resultados: Em apenas três das 17 fontes de informações consultadas foi relatado uma possível redução dos níveis plasmáticos e/ou da efetividade da levotiroxina, quando administrada de forma concomitante com omeprazol ou outro da classe. Somente uma fonte relata leve redução dos níveis plasmáticos de alendronato de sódio por interação com a levotiroxina, e apenas duas fontes evidenciam possível redução do efeito terapêutico do alendronato de sódio por interação com IBPs. Apenas dois estudos relatam resultados significativos relacionados à existência de interação entre levotiroxina ou alendronato no uso concomitante de IBPs. Em todas as fontes consultadas, as interações são descritas como menores, leves, moderadas ou de significado desconhecido. Todas as fontes de informações sugerem a continuidade da terapia para manejo da interação. Conclusão: Até o momento não há evidências robustas que demonstrem impedimento de uso de inibidores da bomba de prótons, levotiroxina e alendronato de sódio no mesmo horário, sendo essencial o acompanhamento dos parâmetros clínicos e laboratoriais.

Introduction: Drug interactions can alter safety and/or effectiveness in the treatment of diseases. Some medications need to be used on an empty stomach and the literature presents divergent information about the real clinical impact of using them at the same time. Objectives: To analyze the evidence on the clinical relevance of potential interactions between proton pump inhibitors, levothyroxine and sodium alendronate. Methods: A narrative review of articles available in the PubMed database was carried out, in addition to consulting potential drug interactions in sources of information on drugs available on the World Wide Web. Results: In only three of the 17 information sources consulted, a report was reported possible reduction in plasma levels and the effectiveness of levothyroxine, when administered concomitantly with omeprazole or another in the class. Only one source reports a slight reduction in plasma sodium alendronate levels due to interaction with levothyroxine, and only two sources show a possible reduction in the therapeutic effect of sodium alendronate through interaction with PPIs. Only two studies report significant results related to the existence of an interaction between levothyroxine or alendronate in concomitant use of PPIs. In all sources consulted, interactions are described as minor, mild, moderate or of unknown significance. All sources of information suggest the continuity of therapy to manage the interaction. Conclusion: To date, there is no robust evidence demonstrating that it is impossible to use proton pump inhibitors, levothyroxine and sodium alendronate at the same time, and it is essential to monitor clinical and laboratory parameters.

Introducción: Las interacciones farmacológicas pueden alterar la seguridad y / o efectividad en el tratamiento de enfermedades. Algunos medicamentos deben usarse con el estómago vacío y la literatura presenta información divergente sobre el impacto clínico real de usarlos al mismo tiempo. Objetivo: Analizar la evidencia sobre la relevancia clínica de las posibles interacciones entre los inhibidores de la bomba de protones, la levotiroxina y el alendronato de sodio. Métodos: Se realizó una revisión narrativa de los artículos disponibles en la base de datos Pubmed, además de la consulta de posibles interacciones farmacológicas en las fuentes de información sobre medicamentos disponibles en la World Wide Web. Resultados: En solo tres de las 17 fuentes de información consultadas, se informó posible reducción en los niveles plasmáticos y la efectividad de la levotiroxina, cuando se administra concomitantemente con omeprazol u otro en la clase. Solo una fuente informa una ligera reducción en los niveles plasmáticos de alendronato de sodio debido a la interacción con levotiroxina, y solo dos fuentes muestran una posible reducción en el efecto terapéutico del alendronato de sodio a través de la interacción con los IBP. Solo dos estudios informan resultados significativos relacionados con la existencia de una interacción entre levotiroxina o alendronato en el uso concomitante de IBP. En todas las fuentes consultadas, las interacciones se describen como leves, moderadas o de significancia desconocida. Todas las fuentes de información sugieren la continuidad de la terapia para gestionar la interacción. Conclusión: Hasta la fecha, no existe evidencia sólida que demuestre que es imposible usar inhibidores de la bomba de protones, levotiroxina y alendronato de sodio al mismo tiempo, y es esencial monitorear los parámetros clínicos y de laboratorio.

Desenvolvimento e validação de cartilhas para cuidado farmacêutico de pacientes com diabetes mellitus em uso de insulinas / Development and validation of educational booklets for pharmaceutical care of patients with diabetes mellitus in insulin use

Objetivo: desenvolver e validar cartilhas para aprimorar o preparo e a utilização de insulinas, bem como o monitoramento da glicemia capilar. Métodos: as cartilhas foram elaboradas considerando a acessibilidade das informações e a compreensibilidade das imagens, a fim de torná-las didáticas ao público-alvo. Posteriormente, foram submetidas à validação. Resultados: por meio da Técnica Delphi, criou-se um questionário contendo 10 perguntas para cada uma das quatro cartilhas validadas, o qual foi enviado para 32 painelistas, especialistas na área. A fim de avaliar o consenso entre as respostas dos painelistas, em cada item, empregou-se o cálculo do Coeficiente de Validade de Conteúdo (CVC), que varia de 0 a 1. Considerou-se validado, o valor de CVC superior a 0,8. Ao final de duas rodadas, foi possível validar as quatro cartilhas. Conclusão: o material possui vasto potencial de contribuição para o uso racional, efetivo e seguro das insulinas, além de poder contribuir com a qualidade de vida dos pacientes e com a redução de custos para o sistema de saúde.

Objective: the present study aimed to develop and validate educational booklets to improve the preparation and use of insulins, as well as the monitoring of capillary blood glucose. Methods: the educational booklets were developed considering the accessibility of information and the comprehensibility of images in order to make them didactic to the target audience. Subsequently, they were submitted to validation. Results: through the Delphi Technique, a questionnaire was created containing 10 questions for each of the four educational booklets, which was sent to 32 expert panelists in the area. In order to assess the consensus among the panelists' answers, in each item the calculation of the Content Validity Coefficient (CVC) was used, which varies from 0 to 1. The CVC above 0.8 was considered valid. At the end of two rounds, it was possible to validate the four educational booklets. Conclusion: the material has a vast potential to contribute to the rational, effective and safe use of insulins, in addition to being able to contribute to the quality of life of patients and the reduction of costs for the health system.

Análise do perfil e da frequência de erros de dispensação de medicamentos em um hospital de médio porte nos anos de 2009 a 2019 / Analysis of the profile and frequency of medication dispensing errors in a medium-sized hospital in the years 2009 to 2019

Objetivo: avaliar o perfil e a frequência de erros de dispensação de medicamentos entre os anos de 2009 e 2019 em um hospital de médio porte. Métodos: neste trabalho descritivo documental de abordagem quantitativa, os medicamentos envolvidos em erros de dispensação foram classificados de acordo com Anatomical Therapeutic Chemical (ATC) e medicamentos potencialmente perigosos. E os erros foram categorizados segundo guia da Política Nacional de Segurança do Paciente (PNSP). Resultados: os resultados demonstraram que os erros aumentaram no decorrer dos anos, apresentando 28 erros/mês no primeiro ano e 58,6 erros/mês no último, e que os tipos de erros mais frequentes são de omissão do envio (n=1532; 39,0%) e dispensação com dose ou quantidade errada (n=827; 21,0%). A classe de medicamento prescrita mais envolvida em erros foi a de agentes anti-infecciosos de uso sistêmico (n=806; 20,5%). Entre os medicamentos potencialmente perigosos, os de ação no sistema nervoso (n=271; 32,8%) foram os mais dispensados de forma errada, tendo, também, como principal tipo de erro, a omissão, e seu principal representante foi o diazepam (n=84; 31,0%). Conclusões: a quantidade de erros de dispensação (mais de um por dia, em média) evidencia a importância do profissional farmacêutico como potencializador para transformar esse cenário, tanto no âmbito gerencial ao propor barreiras de segurança, quanto clínico, ao acompanhar o processo de uso dos medicamentos.

Objetctive: to evaluate the profile and frequency of medication dispensing errors between the years of 2009 to 2019 in a medium-sized hospital. Methods: In this descriptive documentary work of quantitative approach, the drugs involved in dispensing errors were classified according to the Anatomical Therapeutic Chemical (ATC) and potentially dangerous drugs. The errors were categorized according to the guidelines of the National Policy for Patient Safety (NPPS). Results: The results showed that errors increased over the years, presenting 28 errors/month in the first year and 58.6 errors/month in the last, and that the most frequent types of errors are shipment omission (n = 1532; 39.0%) and dispensing with wrong dose or amount (n = 827; 21.0%). The medication class prescribed most involved in errors was anti-infective agents for systemic use (n = 806; 20.5%). Among the potentially dangerous drugs, those with action on the nervous system (n = 271; 32.8%) were the most misdispensed, also having omission as the main type of error, and its main representative was diazepam (n = 84; 31.0%). Conclusions: The amount of dispensing errors (more than one per day, on average) highlights the importance of the professional pharmacist as a potential generator to transform this scenario, both managerially, by proposing safety barriers, and clinically, by monitoring the process of medication use.

Deprescribing benzodiazepines: Do Brazilian package inserts address this issue? / Desprescrição de benzodiazepínicos: As bulas brasileiras abordam essa temática?

OBJECTIVE: To analyze the presence and quality of content on drug deprescribing in Brazilian package inserts for benzodiazepine drugs. METHODS: Documentary study where we analyzed data on deprescribing extracted from electronic package inserts of drugs containing benzodiazepines; these documents were available at the Brazilian Health Surveillance Agency website. Our search was performed independently by 2 researchers who used the following keywords: "deprescription," "withdrawal," and "tapering." The deprescribing plan, when presented by the package insert, was compared to deprescribing protocols for benzodiazepines found in the literature. Moreover, we assessed the presence of guidance on the maximum length of treatment and risks of long-term use. RESULTS: We found 12 package inserts for benzodiazepines and 100% of them suggested gradual withdrawal; only 1 (8.33%) suggested a systematized deprescribing plan. One document (8.33%) did not offer guidance on maximum treatment duration. Eleven (91.67%) had the information on long-term use possibly causing dependence or tolerance, and 1 (8.33%) did not describe the risks of continuous use. CONCLUSIONS: It is known that benzodiazepines should be withdrawn in a gradual and schematized manner, but package inserts do not currently bring this information in detail. It is of utmost importance that health professionals be educated on their conduct, hence the necessity for updating medication package inserts.

OBJETIVO: Analisar a presença e a qualidade do conteúdo sobre desprescrição em bulas brasileiras de benzodiazepínicos. METODOLOGIA:Estudo do tipo documental, em que foram analisados dados sobre a desprescrição extraídos de bulas eletrônicas de medicamentos que contêm benzodiazepínicos disponibilizadas na página eletrônica da Agência Nacional de Vigilância Sanitária. A busca foi realizada de forma independente por dois pesquisadores que utilizaram as palavras-chave "desprescrição", "retirada" e "redução". Para fins de comparação, quando a bula apresentou esquema de desprescrição, este foi comparado com protocolos de desprescrição de benzodiazepínicos encontrados na literatura. Além disso, foi analisada nas bulas a existência de orientações quanto ao tempo máximo de uso e os riscos do uso prolongado. RESULTADOS: Foram encontradas 12 bulas de benzodiazepínicos e 100% delas sugeriram a redução gradual do medicamento; apenas uma (8,33%) sugeria o esquema sistematizado de desprescrição. Uma (8,33%) não apresentou orientações quanto ao tempo máximo de uso. Onze (91,67%) continham a informação de que o uso prolongado pode causar dependência ou tolerância e uma (8,33%) não descrevia os riscos do uso contínuo. CONCLUSÕES: Sabe-se que os benzodiazepínicos devem ser retirados de forma gradual e esquematizada, porém, atualmente, as bulas não trazem essas informações de forma detalhada. É de suma importância que os profissionais de saúde sejam orientados quanto a sua conduta e, por isso, há grande necessidade de atualização das bulas.

Internações por intoxicações medicamentosas em crianças menores de cinco anos no estado de Minas Gerais/Brasil, 2009 ­ 2018 / Hospitalization due to drug poisoning in under-five-year-old children in Minas Gerais/Brazil, 2009 ­ 2018

RESUMO: Objetivo: descrever as internações hospitalares no estado de Minas Gerais devido às intoxicações medicamentosas, em crianças menores de cinco anos de idade, entre os anos de 2009 e 2018. Métodos: estudo descritivo-analítico de levantamento, com dados do Sistema de Internações Hospitalares do Sistema Único de Saúde (SIH/SUS); os diagnósticos foram extraídos conforme a 10ª Revisão da Classificação Estatística Internacional de Doenças e Problemas Relacionados à Saúde (CID-10); os medicamentos envolvidos foram categorizados em classes terapêuticas segundo a Anatomical Therapeutic Chemical (ATC) e os dados obtidos foram analisados por estatística descritiva. Resultados: foram identificadas 1.888 internações com 2358 diagnósticos de intoxicações e três óbitos; as classes terapêuticas mais frequentes foram fármacos não especificados (47,54%), antiepilépticos/sedativo-hipnóticos/antiparkinsonianos (14,72%); fármacos psicotrópicos (6,62%); antibióticos sistêmicos (4,88%); e analgésicos/antitérmicos não opiá-ceos (4,75%). Conclusão: dentre as classes terapêuticas identificadas, os medicamentos que atuam no Sistema Nervoso Central foram os principais agentes causadores de intoxicação medicamentosa. No entanto, mais estudos são necessários para a análise das internações de todo o estado, uma vez que o SIH/SUS apenas contempla as inter-nações subsidiadas pelo SUS. (AU)

ABSTRACT: Objective: Describe hospital admissions in the state of Minas Gerais due to drug intoxications in children under five years old between 2009 and 2018. Methods: descriptive-analytical survey study, with data from the National Hospital Information System (SIH/SUS); the drugs involved were categorized into therapeutic classes (ATC), and the data obtained were analyzed by descriptive statistics. Results: 1,888 hospitalizations were identified with 2,358 diagnoses of poisoning and three deaths; the most common therapeutic classes were unspecified drugs (47.54%); antiepileptic/sedative-hypnotics/antiparkinson drugs (14.72%); psychotropic drugs (6.62%); systemic antibiotics (4.88%); and non-opioid analgesics/antipyretics (4.75%). Conclusion: among the defined therapeutic classes, drugs that act in the Central Nervous System were the main agents causing drug intoxication. However, more studies are needed to analyze hospitalizations across the state since SIH/SUS only contemplates hospitaliza-tions subsidized by SUS. (AU)

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.

Profile of activities developed by community pharmacists: do they corroborate the precepts of the pharmaceutical profession?

Studies that addressed the profile of pharmaceutical activities and behaviors in community pharmacies in the last decades pointed to a gap between community pharmacy practice and the precepts of the profession. Facing the need to analyze whether the new legislation has impacted this scenario, the objective of this study was to describe the general profile and academic profile of community pharmacists, and the profile of the activities they develop, as well as to know their place of work. This is a descriptive study, to which all pharmacists in charge of community pharmacies in the metropolitan area of ​​Belo Horizonte-MG (n = 1624) were invited. Data collection was performed through a questionnaire validated online, from October to December 2017, via Google Docs®. Responses were obtained from 109 pharmacists, most of them female, aged 31-40 years, being general graduates, and in private institutions. Pharmacotherapeutic follow-up, an activity linked to clinical management, is performed by only 37.60% of pharmacists, evidencing that there is still a lag in relation to the provision of clinical services by community pharmacists. Thus, we emphasize the importance of implementing the precepts established by Brazilian curricular guidelines for undergraduate pharmacy courses which focus on the development of clinical skills, since the insertion of the pharmacist into the health team and the provision of clinical services to the community can add new value to the use of medications, and contribute effectively to their rational use in Brazil.

What is the effectiveness of post-discharge pharmacotherapeutic empowerment of patients with diabetes?

The objective of the present article was to evaluate the glycemic control of patients with diabetes mellitus (DM) after discharge from a pharmacotherapeutic empowerment program. The results suggest that the strategy is effective for short-term glycemic control, but the benefits are not maintained after discharge, indicating the need for the pharmacist's continuous role.

Post-marketing Study of Linagliptin: A Pilot Study.

INTRODUCTION: Linagliptin is a high-cost oral antidiabetic that has been widely used, and studies on its effectiveness and safety for the treatment of type 2 diabetes mellitus (DM2) in the real world is rare and necessary. OBJECTIVE: To analyze the values of glycated hemoglobin (HbA1c) and adverse events before and after the use of linagliptin in the post-marketing context of a pilot study. METHODS: This is a descriptive observational and exploratory study with a retrospective longitudinal approach, conducted between January 2014 and December 2016. All patients who participated in the study were over 18 years of age, with DM2, assisted by the Brazilian Public Health System (Sistema Único de Saúde - SUS) and had been indicated for use of linagliptin. The users were followed up and the variables of interest were collected from a computerized health information system (sistema informatizado de saúde - SIS) and patient records. For effectiveness analysis, HbA1c before (T0) and after (T1) the use of linagliptin was considered in patients registered as having collected linagliptin at the pharmacy for at least three consecutive months. For safety analysis, registered adverse events (AE) were verified in patients' records. The sample was stratified according to the pharmacotherapeutic scheme of the users. To compare the means before (T0) and after (T1), a paired t-test (data with normal distribution) and Wilcoxon Signed Rank Sum test (non-normal distribution data) were performed. RESULTS: Considering the total population of the study, in a different pharmacotherapeutic regimen, a median reduction in HbA1c of -0.86% (p < 0.05) was observed. After stratification by pharmacotherapeutic regimen, the most significant reduction of HbA1c was -1.07% (p = 0.014) for the linagliptin group associated with insulins and oral antidiabetic agents (n = 13). On the other hand, patients taking linagliptin in monotherapy had the lowest HbA1c reduction, -0.48% (p > 0.05). AE occurred in 12 (36.4%) patients, and 16.7% were in monotherapy. CONCLUSION: Linagliptin did not presented, in real world, the desired performance as showed in randomized premarketing clinical trials and it should be carefully evaluated in public health services.

Patients participation in pharmaceutical care consultations in Brazil.

Background The effectiveness of pharmaceutical care has already been evidenced in several studies and scenarios; the lack of patient's consultation has been little explored in the literature. Unprovided care is a missed opportunity to offer care to another individual who needs attention to their health. The need for investigation of missed consultations in a Brazilian pharmaceutical care service arises. Objective To evaluate the participation and characteristics of patients in pharmaceutical care consultations in a university outpatient unit in the Brazilian city of Divinópolis. Methods A descriptive study was carried out from a secondary source of information. The socio-demographic profile of the patients who were absent from the pharmacy consultations from January to December 2017 was outlined. Results Of the 832 scheduled appointments from January to December 2017, 501 were not attended by patients, revealing 60.2% missed consultations. The female gender was predominant, corresponding to 67.8% of the patients. A total of 63.8% of the absentees were over 60 years of age. Most of the patients had two comorbidities (32.5%) and came from an active identification by the Outpatient unit pharmacists (86.60%). Furthermore, the patients who were more absent from the consultations had their primary health care units farther away from the outpatient unit, and this could be one of the causes of the high number of absent patients from the pharmaceutical consultations. Conclusion The lack of participation in patient's consultations is high. It is necessary to articulate new strategies aimed at reducing absences from consultations, since this is a source of waste of financial resources and opportunities to improve the patients' health and quality of life.

Linagliptin safety profile: A systematic review.

OBJECTIVE: To describe the safety profile of linagliptin. METHODOLOGY: Systematic review using PubMed/MEDLINE, BVS and Web of Science. The search strategy "Linagliptin" AND "safety" was used. The inclusion criteria were clinical trials with a control group composed of conventional DM2 pharmacotherapy. RESULTS: We identified 16 studies, and the most frequent adverse events (AEs) were nasopharyngitis with linagliptin at 5 and 10mg in monotherapy (31.6% and 29.6%, respectively) and gastrointestinal events (>10.0%) with linagliptin in combination. Of the AEs, 14.9 (±3.1)% were associated with the use of linagliptin in monotherapy, and 17.6 (±6.0)% in combination. The linagliptin AEs have a varied occurrence and frequency, ranging from mild to moderate intensity.

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.