Determining the optimal vancomycin daily dose for pediatrics: a meta-analysis.

OBJECTIVE: The objective of this study was to check which initial dose of vancomycin is needed to achieve the therapeutic target that is currently used in pediatrics. METHODS: The search was conducted in the following data sources: Pubmed (1980-2017), the Cochrane Library, and Embase (1986-2017) and the references of the published studies; searches were performed using the key terms: child, children, pediatrics, infants and adolescents, vancomycin, pharmacokinetics, and pharmacodynamics. The data extracted from the studies were analyzed and grouped using RevMan V 5.2 software. The confidence interval (CI) 95% and the odds ratio (OR) were calculated considering the Mantel-Haenszel random effect. RESULTS: From the 704 studies identified, 40 revealed eligibility for this review and only 20 presented enough data to be included in the statistical analysis. The articles found in this review were published between 1980 and 2017. The vancomycin doses varied between 40 mg/kg/day to 120 mg/kg/day. The statistical tests demonstrated significant clinical heterogeneity of I2 (84%). CONCLUSIONS: The meta-analysis study revealed in the majority of studies that doses lower than 60 mg/kg/day were not enough to achieve desirable vancomycin plasma concentrations "area under the curve in 24 h/minimum inhibitory concentration >400 (AUC0-24/MIC>400) or trough 10-20 mg/L" to control bacterial infections in pediatrics.

Comparison of Two Methods of Capillary Sampling in Blood Pre-Donation Anemia Screening in Brazil.

BACKGROUND: The laboratory tests most used by blood banks to diagnose anemia are the hemoglobin (Hb) and microhematocrit (Hct) tests, measured from capillary samples. OBJECTIVE: To analyze the two capillary screening methods for pre-donation anemia by comparing their agreement in diagnosing anemia. METHOD: A cross-sectional study in a population of 15,521 blood donation candidates for whom information was available on Hb and Hct, performed from capillary blood samples. Hb was determined using the HemoCue® test and Hct by the centrifugation method. The Kappa coefficient was calculated to assess the agreement between the methods. Pearson's correlation tests and gender-adjusted linear regression were used to assess the change in the response variable (Hb) as a function of the explanatory variable (Hct). RESULTS: The majority of the study population were men (70.4%), aged between 18 and 44 years (72.1%), who declared themselves white or mixed skin color (85.6%), and had undergone at least 11 years of complete education (72.4%). The Kappa coefficient found was 92.7 and 99.2 for women and men, respectively. Pearson's correlation showed a correlation coefficient of 0.98 and the linear regression graph showed an adequate relationship between the tests with R2 = 0.97. CONCLUSIONS: Comparing the Hb and Hct capillary tests, it was found that Hct can be safely used to screen for anemia in pre-blood donation.

Prevalence and predictors of potential drug-drug interactions in the elderly: a cross-sectional study in the brazilian primary public health system.

PURPOSE: The primary objective of this study was to investigate the prevalence of clinically important potential drug-drug interactions (DDIs) in elderly patients attending the public primary health care system in Brazil. The secondary objective was to investigate possible predictors of potential DDIs. METHODS: A cross-sectional study was carried out in 5 Brazilian cities located in the Ourinhos Micro-region, Sao Paulo State, between November 2010 and April 2011. The selected sample was divided according to the presence (exposed) or absence (unexposed) of one or more potential DDIs (defined as the presence of a minimum 5-day overlap in supply of an interacting drug pair). Data were collected from medical prescriptions and patients' medical records. Potential DDIs (rated major or moderate) were identified using 4 DDI-checker programs. Logistic regression analysis was used to study potential DDI predictors. RESULTS: The prevalence of clinically important potential DDIs found during the study period was 47.4%. Female sex (OR = 2.49 [95% CI 2.29-2.75]), diagnosis of ≥ 3 diseases (OR = 6.43 [95% CI 3.25-12.44]), and diagnosis of hypertension (OR = 1.68 [95% CI 1.23-2.41]) were associated with potential DDIs. The adjusted OR increased from 0.90 [95% CI 0.82-1.03] in patients aged 60 - 64 years to 4.03 [95% CI 3.79 - 4.28] in those aged 75 years or older. Drug therapy regimens involving ≥ 2 prescribers (OR = 1.39 [95% CI 1.17-1.67]), ≥ 3 drugs (OR = 3.21 [95% CI 2.78-3.59]), ≥ 2 ATC codes (OR = 1.19 [95% CI 1.12-1.29]), ≥ 2 drugs acting on cytochrome P450 (OR = 2.24 [95% CI 2.07-2.46]), and ATC codes B (OR = 1.89 [95% CI 1.05-2.08]) and C (OR = 4.01 [95% CI 3.55-4.57]) were associated with potential DDIs. CONCLUSION: Special care should be taken with the prescription and therapeutic follow-up of patients who present characteristics identified as predictors. Knowledge of potential DDI predictors could aid in developing preventive practices and policies that allow public health services to better manage this situation.

[The use of anticholinergic drugs and associated factors in middle-aged adults and the elderly]. / O uso de fármacos anticolinérgicos e fatores associados em adultos de meia-idade e idosos.

The objective of this article was to describe the use of anticholinergic drugs and possible factors associated with their use, in middle-aged adults and in the elderly. This is a cross-sectional study, based on data from a population-based study called VIGICARDIO. All respondents aged 44 or older interviewed in 2015 were included. Anticholinergic Drug Scale (ADS) was used to determine anticholinergic burden (ACB), categorized as significant (≥3) and non-significant (< 3). Poisson regression was conducted with crude and adjusted analysis to investigate the factors associated with ACB. There was a prevalence of 20.7% of significant ACB among respondents, higher among middle-aged adults (24.1%). After adjusted analysis, significant ACB (≥ 3) remained in the non-elderly age group with polypharmacy and sporadic use of two or more drugs. In the elderly, sporadic use of two or more medications and hospitalization in the last year continued to be associated with significant ACB. The results indicate a higher prevalence of ACB among middle-aged adults, polymedicated and in sporadic use of medications, which suggests that the investigation of the use of anticholinergicsin this age group requires greater attention.

O objetivo deste artigo foi descrever o uso de medicamentos anticolinérgicos e possíveis fatores associados ao seu uso em adultos de meia idade e idosos. Trata-se de um estudo transversal em que foram incluídos todos os respondentes de 44 anos ou mais entrevistados em 2015. Foi utilizada a Anticholinergic Drug Scale (ADS) para determinação da carga anticolinérgica (CAC), categorizada em elevada (≥ 3) e não-elevada (< 3). Conduziu-se regressão de Poisson com análise bruta e ajustada para investigar os fatores associados à CAC, com cálculo da razão de prevalência (RP) e intervalo de confiança 95% (IC95%). Constatou-se prevalência de 20,7% de CAC elevada entre os respondentes, maior entre adultos de meia idade (24,1%). Após análise ajustada, mantiveram-se associadas à CAC elevada na faixa etária não idosa a polifarmácia e uso esporádico de dois ou mais medicamentos. Nos idosos, continuaram associados à CAC elevada o uso esporádico de dois ou mais medicamentos e internação no último ano. Os resultados indicam maior prevalência de CAC entre adultos de meia-idade, polimedicados e em uso esporádico de medicamentos, o que sugere que a investigação do uso de anticolinérgicos nessa faixa etária demanda maior atenção.

Population Pharmacokinetic Model of Piperacillin in Critically Ill Patients and Describing Interethnic Variation Using External Validation.

Objectives: This study aimed to develop a piperacillin population PK model for critically ill Brazil-ian patients and describe interethnic variation using an external validation. Methods: Plasma samples were obtained from 24 ICU patients during the fifth day of piperacillin treatment and assayed by HPLC-UV. Population pharmacokinetic modelling was conducted using Pmetrics. Empiric dose of 4 g IV 6- and 8-hourly were simulated for 50 and 100% fT > MIC and the probabil-ity of target attainment (PTA) and the fractional target attainment (FTA) determined. Results: A two-compartment model was designed to describe the pharmacokinetics of critically ill Brazillian patients. Clearance and volume of distribution were (mean ± SD) 3.33 ± 1.24 L h−1 and 10.69 ± 4.50 L, respectively. Creatinine clearance was positively correlated with piperacillin clearance and a high creatinine clearance was associated with lower values of PTA and FTA. An external vali-dation was performed using data from two different ethnic ICU populations (n = 30), resulting in acceptable bias and precision. Conclusion: The primary pharmacokinetic parameters obtained from critically ill Brazilian patients were similar to those observed in studies performed in critically ill patients of other ethnicities. Based on our results, the use of dose adjustment based on creati-nine clearance is required in Brazilian patients.

Professional practice of pharmacists in private community pharmacies of Minas Gerais, Brazil

Abstract Considering the wide accessibility of population to private community pharmacies, Pharmaceutical Services must be provided comprehensively in such establishments. This research aims to understand how pharmaceutical practice is developed by pharmacists in private community pharmacies of Minas Gerais, Brazil. Qualitative descriptive research was performed. Data were collected through online questionnaires (n=113) and interviews (n=12) with pharmacists working in such institutions and they were analyzed according to Bardin's Content Analysis, with the contribution of software IRAMUTEQ. Two main categories of analysis were formed: "Professional training of pharmacists and the working conditions in private community pharmacies" and "Pharmaceutical Services in private community pharmacies of Minas Gerais". Pharmacists understood the population's healthcare as the main purpose of their professional practice. However, the routine focused on the technical management of medicines and the lack of private rooms hindered the provision of qualified assistance. Furthermore, commercial strategies were identified as motivators for ethical dilemmas and conflicts among the work team. It is suggested that the growth of the pharmaceutical retail market in Minas Gerais should be accompanied by favorable conditions for the production of care, so that pharmaceutical practice in these institutions can be developed in an ethical and responsible way.

Atitudes dos profissionais da saúde em relação ao cuidado em diabetes tipo 2 na atenção primária / Actitudes de los profesionales de la salud hacia elcuidado a la diabetes tipo 2 en la atención primaria / Attitudes of health professionals towards type 2 diabetes care in primary care

RESUMO Objetivo: analisar as atitudes de profissionais que atuam na Atenção Primária à Saúde em relação ao cuidado de pessoas com diabetes mellitus tipo 2 (DM2). Método: estudo transversal realizado com 56 profissionais da atenção primária à saúde em Divinópolis, município do centro-oeste mineiro. As atitudes dos profissionais foram medidas por meio do instrumento Escala de Atitudes dos profissionais em relação ao diabetes Mellitus (EAP-DM) aplicado via plataforma web e-Surv. Os dados foram coletados entre maio e julho de 2019. Para análise, utilizaram-se os testes Mann Whitney e de Kruskal Wallis. Resultados: dos 56 profissionais, 36 (64,3%) possuíam menos de 10 anos de atuação na atenção primária e 40 (71,4%) concluíram especialização na área de atuação. Os participantes apresentaram atitudes positivas em relação ao diabetes, com pontuação média de 4,37 (DP: 0.22), variando entre 3,76 e 4,85. Médicos e psicólogos demonstraram atitudes menos favoráveis em relação aos cuidados em DM2, quando comparados aos enfermeiros e fisioterapeutas (valor de p <0,05). Conclusão: todos os profissionais apresentaram atitudes positivas e o nível destas atitudes variou conforme categoria profissional.

RESUMEN Objetivo: analizar las actitudes de profesionales que actúan en la Atención Primaria de Salud con relación al cuidado de personas con diabetes mellitus tipo 2 (DM2). Método: estudio transversal realizado con 56 profesionales de la atención primaria a la salud en Divinópolis, municipio del centro-oeste del Estado de Minas Gerais-Brasil. Las actitudes de los profesionales fueron medidas a través del instrumento Escala de Actitudes de los profesionales respecto al diabetes Mellitus (EAP-DM) aplicado vía plataforma web e-Surv. Los datos fueron recogidos entre mayo y julio de 2019. Para el análisis, se utilizaron las pruebas Mann Whitney y de Kruskal Wallis. Resultados: de los 56 profesionales, 36 (64,3%) poseían menos de 10 años de actuación en la atención primaria y 40 (71,4%) concluyeron especialización en el área de actuación. Los participantes presentaron actitudes positivas con relación a la diabetes, con puntuación media de 4,37 (DP: 0.22), variando entre 3,76 y 4,85. Médicos y psicólogos demostraron actitudes menos favorables hacia los cuidados en DM2, cuando comparados a los enfermeros y fisioterapeutas (valor de p <0,05). Conclusión: todos los profesionales presentaron actitudes positivas y el nivel de estas actitudes varió según categoría profesional.

ABSTRACT Objective: to analyze the attitudes of professionals working in Primary Health Care in relation to the care of people with type 2 diabetes mellitus (T2DM). Method: cross-sectional study conducted with 56 primary health care professionals in Divinópolis, a city in the center-west of Minas Gerais. The attitudes of professionals were measured through the instrument Scale of Attitudes of professionals in relation to diabetes Mellitus (EAP-DM) applied via e-Surv web platform. Data were collected between May and July 2019. For analysis, the Mann Whitney and Kruskal Wallis tests were used. Results: of the 56 professionals, 36 (64.3%) had less than 10 years of experience in primary care and 40 (71.4%) completed specialization in the area of activity. Participants showed positive attitudes towards diabetes, with a mean score of 4.37 (SD: 0.22), ranging from 3.76 to 4.85. Physicians and psychologists showed less favorable attitudes towards T2DM care when compared to nurses and physical therapists (p-value <0.05). Conclusion: all professionals showed positive attitudes and the level of these attitudes varied according to professional category.

Relationship between anticholinergic load and self-perceived health in a population aged 44 years or older / Relação entre carga anticolinérgica e autopercepção de saúde em população com mais de 44 anos

OBJECTIVE: To investigate the relationship between anticholinergic load (ACL) and self-perceived general health in adults in a medium-sized municipality in southern Brazil. METHODS: This cross-sectional study was based on 2015 data from a medium-sized municipality in southern Brazil. All respondents aged 44 years or older who reported using drugs in the 2 weeks before the interview were included (n = 662). The Anticholinergic Drug Scale was used to measure the ACL. Self-perceived health was categorized as positive self-perception (PSP) or negative self-perception (NSP). Crude and adjusted Poisson regression analyses were conducted to investigate the association between ACL and self-perceived health. RESULTS: NSP was found in 50.91% of 662 respondents. Significant ACL, older age, lower economic status, lower education, polypharmacy, and depression correlated with a higher frequency of NSP. Individuals with significant ACL had a prevalence of NSP of 1.27 (95% confidence interval: 1.02 ­ 1.58), and each additional ACL level represented a 6.10% higher chance of worse self-perceived health, regardless of confounding factors. CONCLUSIONS: An association was found between significant ACL and NSP, with an effect dependent on ACL level

OBJETIVO: Investigar a relação entre carga anticolinérgica (CAC) e autopercepção de saúde em adultos de um município de médio porte do sul do Brasil. METODOLOGIA: Trata-se de um estudo transversal com dados de 2015, realizado em um município de médio porte do sul do Brasil. Todos os entrevistados com 44 anos ou mais que relataram uso de drogas nas duas semanas anteriores à entrevista foram incluídos (n = 662). A Anticholinergic Drug Scale (ADS) foi utilizada para medir a CAC. A autopercepção da saúde foi categorizada em autopercepção positiva (APP) ou autopercepção negativa (APN). Análises de regressão de Poisson bruta e ajustada foram realizadas para investigar a associação entre CAC e autopercepção de saúde. RESULTADOS: Entre os 662 participantes, a CAC foi encontrada em 50,91% dos respondentes. CAC significativa, idade avançada, situação econômica mais baixa, menor escolaridade, polifarmácia e depressão foram correlacionados com maior frequência de APN. Indivíduos com CAC significativo apresentaram prevalência de APN de 1,27 (intervalo de confiança de 95%: 1,02 ­ 1,58), e cada nível adicional de CAC representou uma chance 6,10% maior de pior autopercepção de saúde, independentemente de fatores de confusão. CONCLUSÕES: Encontrou-se associação entre ACL significativo e APN, com efeito dependente do valor do CAC

Análise da qualidade das evidências científicas sobre a eficácia e segurança nas bulas de anticoagulantes orais diretos comercializados no Brasil / Analysis of the quality of scientific evidence on efficacy and safety in the package leaflets of direct oral anticoagulants marketed in Brazil

Objetivo: Identificar e analisar a qualidade das evidências científicas sobre a eficácia e segurança dos anticoagulantes orais direto (DOAC) disponíveis nos ensaios clínicos referenciados nas bulas dos medicamentos comercializados no Brasil. Método: Trata-se de um descritivo documental dividido em duas etapas, sendo elas: (i) identificação e análise da disponibilidade das referências bibliográficas contidas nas bulas dos DOAC e (ii) análise da qualidade dos estudos contidos nas bulas através da ferramenta da Cochrane Risk of Bias RevMan versão 5.4. Foram analisados setes domínios de importâncias para ensino clínico, sendo que cada domínio foi classificado como alto, incerto ou baixo risco de viés, segundo a avaliação dos colaboradores. Resultados: Foram analisadas 10 bulas destinadas aos profissionais da saúde. Sendo que destas, foram avaliados 25 ensaios clínicos. A análise da qualidade das evidências científicas, referenciadas nas bulas para profissionais dos DOAC, mostrou que os estudos citados apresentaram consistência metodológica. Entretanto, na maioria dos estudos, os domínios foram classificados como viés incerto, ou seja, não foi possível identificar como esses pontos foram abordados nos estudos. Conclusão: Portanto, o presente estudo evidenciou que a qualidade dos ensaios clínicos referenciados nas bulas dos DOAC apresentou incertezas metodológicas em seus ensaios. Sugere-se a necessidade de normativas que estabeleçam atualizações do conteúdo informativo presente nas bulas profissionais e estabeleçam descrição dos métodos de forma clara e coesa (AU).

Objective: Identify and analyze the quality of scientific evidence on the efficacy and safety of direct oral anticoagulants (DOAC) available in clinical trials referenced in the package leaflets of drugs marketed in Brazil. Method: This is a descriptive documentary study divided into two stages: (i) identification and analysis of the availability of the bibliographic references contained in the package leaflets of DOACs and (ii) analysis of the quality of the studies contained in the package leaflets through the Cochrane Risk of Bias RevMan tool version 5.4. Seven domains of importance for clinical teaching were analyzed, and each domain was classified as high, uncertain or low risk of bias, according to the assessment of the collaborators. Results: Ten package leaflets intended for health professionals were analyzed. Of these, 25 clinical trials were evaluated. The analysis of the quality of the scientific evidence referenced in the package leaflets for health professionals showed that the cited studies presented methodological consistency. However, in most studies, the domains were classified as uncertain bias, i.e., it was not possible to identify how these points were addressed in the studies. Conclusion: Therefore, the present study evidenced that the quality of clinical trials referenced in the package leaflets of DOACs presented methodological uncertainties in their trials. It is suggested the need for regulations that establish updates of the information content present in the professional package inserts and establish a description of the methods in a clear and cohesive way (AU).

Perfil dos pacientes em uso de anticoagulantes orais diretos atendidos via judicial em um município de médio porte do estado de Minas Gerais / Profile of patients in the use of direct oral anticoagulants assisted judicially in a medium-sized municipality of the state of Minas Gerais

Fundamentos: O sistema de saúde brasileiro é embasado nos princípios estabelecidos na Constituição Federal, que in-cluem igualdade, universalidade, equidade e participação popular, em um modelo de saúde totalmente gratuito. O Brasil vive um grande desafio para ofertar assistência de qualidade para toda população. Muitas vezes, é necessário solicitar à justiça um suporte para conseguir acesso à saúde pública. Entre os processos judiciais envolvendo questões de saúde, a maioria são referentes ao fornecimento de medicamentos. Dentre os medicamentos solicitados, destacam-se os anticoagulantes orais diretos (DOACs), cujos estudos apontam que apresentam melhor segurança e eficácia similar em relação à varfarina, medicamento padronizado no SUS para o tratamento do tromboembolismo venoso e fibrilação atrial. Objetivo: Avaliar o perfil dos pacientes e das solicitações dos DOACs atendidos por via judicial. Métodos: Estudo documental descritivo realizado em Divinópolis/MG a partir de todos os processos julgados com parecer favorável pela justiça referentes à solicitação dos DOACs. A coleta de dados foi realizada em três fontes secundárias: os pro-cessos judiciários, prontuários dos pacientes nas unidades básicas de saúde e no Sistema de Informações em Saúde. Resultados: Foram incluídos no estudo um total de 74 processos referentes à solicitação dos DOACs no município de Divinópolis-MG. Observou-se que 74,3% dos indivíduos eram do sexo feminino, com média de idade de 70 anos. O diagnóstico mais observado foi a fibrilação atrial (36,5%). Cerca de 52,7% dos médicos registraram que houve tenta-tiva terapêutica com varfarina antes da introdução dos DOACs e a comodidade (24,3%) foi a justificativa mais utilizada por optar pelos DOACs seguida por dificuldade em controlar a RNI (20,3%). Outro dado encontrado foi que 25,7% dos pacientes nunca obtiveram na farmácia do SUS o medicamento solicitado por via judicial. Conclusão: Concluímos que a demanda judicial que afoga tanto o sistema judiciário como o sistema de saúde, poderia ser evitada se fossem seguidas as recomendações da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde para estabelecer a distribuição dos insumos de saúde. Além disso, nos processos judiciais faltam informações importantes para auxiliar o juiz a emitir um parecer, sendo baseadas, na maioria das vezes, em apenas uma opinião médica. (AU)

Fundamentals: The Brazilian health system is based on the principles established in the Federal Constitution, which include equality, universality, equity, and popular participation in a completely free health model. Brazil is under great challenge to offer quality care to the entire population. It is often necessary to ask the court for support to gain access to public health.Among the court proceedings involving health issues, the majority refer to the supply of medicines. Among the drugs requested, direct oral anticoagulants (DOACs) stand out, which indicate that they have better safety and similar efficacy concerning warfarin, a standardized medication in the SUS to treat venous thromboembolism (VTE) and atrial fibrillation (AF). Objective: Assess the profile of patients and requests for direct oral anticoagulants (DOACs) served by the court. Methods: Descriptive documental study carried out in Divinópolis/MG from all cases judged with a favorable opinion by the court regarding the request of DOACs. Data collection was carried out from three secondary sources: court proceedings, medical records of patients in basic health units, and the Health Information System (SIS). Results:A total of 74 lawsuits referring to the DOACs request in the city of Divinópolis-MG were included in the study. It was observed that 74.3% of the individuals were female, with a mean age of 70 years. The most common diagnosis was atrial fibrillation (36.5%). About 52.7% of physicians reported that there was a therapeutic attempt with warfarin before the introduction of DOACs, and convenience (24.3%) was the most used justification for choosing DOACs, followed by difficulty in controlling the INR (20.3%). Another finding was that 25.7% of the patients never obtained the medication requested through the courts at the SUS pharmacy. Conclusion: We concluded that the judicial demand that drowns both the judicial system and the health system could be avoided if the recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System were followed to establish the distribution of health education. In addition, in court proceedings, important information is lacking to assist the judge in issuing an opinion and is most often based on only one medical opinion. (AU)

O uso de fármacos anticolinérgicos e fatores associados em adultos de meia-idade e idosos / The use of anticholinergic drugs and associated factors in middle-aged adults and the elderly

Resumo O objetivo deste artigo foi descrever o uso de medicamentos anticolinérgicos e possíveis fatores associados ao seu uso em adultos de meia idade e idosos. Trata-se de um estudo transversal em que foram incluídos todos os respondentes de 44 anos ou mais entrevistados em 2015. Foi utilizada a Anticholinergic Drug Scale (ADS) para determinação da carga anticolinérgica (CAC), categorizada em elevada (≥ 3) e não-elevada (< 3). Conduziu-se regressão de Poisson com análise bruta e ajustada para investigar os fatores associados à CAC, com cálculo da razão de prevalência (RP) e intervalo de confiança 95% (IC95%). Constatou-se prevalência de 20,7% de CAC elevada entre os respondentes, maior entre adultos de meia idade (24,1%). Após análise ajustada, mantiveram-se associadas à CAC elevada na faixa etária não idosa a polifarmácia e uso esporádico de dois ou mais medicamentos. Nos idosos, continuaram associados à CAC elevada o uso esporádico de dois ou mais medicamentos e internação no último ano. Os resultados indicam maior prevalência de CAC entre adultos de meia-idade, polimedicados e em uso esporádico de medicamentos, o que sugere que a investigação do uso de anticolinérgicos nessa faixa etária demanda maior atenção.

Abstract The objective of this article was to describe the use of anticholinergic drugs and possible factors associated with their use, in middle-aged adults and in the elderly. This is a cross-sectional study, based on data from a population-based study called VIGICARDIO. All respondents aged 44 or older interviewed in 2015 were included. Anticholinergic Drug Scale (ADS) was used to determine anticholinergic burden (ACB), categorized as significant (≥3) and non-significant (< 3). Poisson regression was conducted with crude and adjusted analysis to investigate the factors associated with ACB. There was a prevalence of 20.7% of significant ACB among respondents, higher among middle-aged adults (24.1%). After adjusted analysis, significant ACB (≥ 3) remained in the non-elderly age group with polypharmacy and sporadic use of two or more drugs. In the elderly, sporadic use of two or more medications and hospitalization in the last year continued to be associated with significant ACB. The results indicate a higher prevalence of ACB among middle-aged adults, polymedicated and in sporadic use of medications, which suggests that the investigation of the use of anticholinergicsin this age group requires greater attention.

Cost-effectiveness analysis of different dipeptidyl-peptidase 4 inhibitor drugs for treatment of type 2 diabetes mellitus.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) has burdened health systems in the world to the value of 500 billion dollars/year. Dipeptidyl peptidase 4 inhibitors (DPP-4 Inhibitors) have been strongly associated with spending on the treatment of T2DM by the courts in Brazil. The aim of this study was to estimate the most cost-effective DPP-4 Inhibitor for T2DM treatment. A pharmacoeconomic study of cost-effectiveness was performed in a medium-sized municipality in Minas Gerais state, Brazil. METHODS: The data are from legalization in municipal health in 2013. The effectiveness of DPP-4 Inhibitors was measured by the reduction in glycated hemoglobin (A1c). The direct medical costs of drug and adverse drug reactions were identified. With these data, a cost-effectiveness ratio (CER) and construction of the decision tree for sensitivity analysis were performed. RESULTS: The representative of the most effective in reducing A1c gliptins was sitagliptin in combination with metformin, it was able to reduce A1c by 1.16% (1.09 to 1.22, CI 95%). The drug with the lowest cost was linagliptin, with a cost per patient/year of US$ 481.42. Sensitivity analysis performed by the decision tree shows that sitagliptin in association with metformin had the CER of US$ 1,506.75 per patient/year, to reduce A1c by 1%. CONCLUSION: The most cost-effective DPP-4 Inhibitor was sitagliptin with metformin.

Factors associated with the occurrence of adverse events to antiretroviral therapy in adults and elderly living with HIV

Objectives: This study identifies the factors associated with the occurrence of adverse events in adults and elderly on antiretroviral therapy. Methods: This is a cross-sectional study carried out with adults and elderly patients, attended by the Specialized Assistance Service between September 2016 and August 2017. Adverse events were measured through self-reports collected in interviews, information collected in medical records, and changes identified in laboratory tests, with the degree of causality being assessed using the Naranjo Algorithm. Univariate analysis, with results expressed as odds ratio (OR) and their respective confidence intervals (CI 95%), was performed to estimate the association between sociodemographic, pharmacotherapeutic, and clinical characteristics (explanatory variables) with the occurrence of four or more adverse events to antiretroviral therapy (response variable). For multivariate analysis, multiple logistic regression was considered in order to verify the permanence or absence of associations previously found in the univariate analysis. Results: Prevalence of adverse events to antiretroviral therapy was 92.6%, with the median of adverse events being four (IQR 25%: 2 ; IQR 75%: 5) and two (IQR 25%: 2 ; IQR 75%: 4), respectively, among adults and elderly (p <0.05). Additionally, 340 adverse events were identified, among which nightmares (15.0%) and vertigo (13.5%) were the most frequent. Most of the adverse events identified were classified as possible (96.2% / n = 327). In the initial univariate analysis, factors such receipt of guidance on adverse events and age were associated with a higher occurrence of adverse events to antiretroviral therapy. Contrary to expectations, the elderly were considered less susceptible to have adverse events when compared to adults (OR = 0.363; CI 95% = 0.164-0.801). However, the final multivariate analysis model revealed "receipt of guidance on adverse events" as the only variable significantly associated with the presence of four or more adverse events to antiretroviral therapy (OR = 4.183 ; CI 95% = 1.775-9.855). Conclusions: Results suggest difference in perception of adverse events between patients who received and those who did not receive guidance in this regard, which indicates the importance of health professionals to provide specific information to their patients regarding adverse events to antiretroviral therapy. Thus the patient can understand the effects generated by the treatment and inform these professionals for the notification of adverse events, in order to improve pharmacovigilance actions and promote patient safety.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

BACKGROUND: Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. OBJECTIVE: To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. METHODS: A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. RESULTS: No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). CONCLUSIONS: While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

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.

Adherence and discontinuation of oral hormonal therapy in patients with hormone receptor positive breast cancer.

BACKGROUND: Oral treatment in women with breast cancer has been increasingly used. However, a potentially negative side of oral medication is poor patient adherence and/or discontinuation, which reduces the treatment effectiveness, accelerating progression of the disease and reducing the patient survival rate. AIM OF THE REVIEW: To compare the rates of adherence and/or discontinuation and the methodologies used to assess these outcomes. It was conducted an integrative review of original articles published from 2000 to 2012, in which their primary outcome was to quantify medication adherence and/or discontinuation of oral hormonal therapy in patients with hormone receptor positive breast cancer. METHODS: Original studies were searched in the PubMed/MEDLINE, Scopus, Embase and SciELO databases. The Medical Subject Heading was used to define descriptors. The descriptor "breast neoplasms" was used in all combinations. Each of the descriptors "medication adherence" and "patient compliance" were combined with each of the following descriptors "tamoxifen", "aromatase inhibitors", "selective estrogen receptor modulators", or the terms "letrozole", "anastrozole", and "exemestane". RESULTS: Twenty-four original articles were included. Our study showed a wide range of adherence and discontinuation rates, ranging from 45-95.7 and 12-73 %, respectively. Regarding the methodological development of the selected articles, a high prevalence (87.5 %) of prospective and/or retrospective longitudinal studies was found. In addition, there was a high prevalence of studies using a database (70.8 %). Among some of the studies, it was shown that patient adherence to hormonal therapy gradually reduces, while discontinuation increases during the treatment. CONCLUSIONS: It was observed a great diversity among rates of adherence and/or discontinuation of hormonal therapy for breast cancer, which may be due to a lack of methodology standardization. Therefore, adequate and validated methods to ensure reliability of the results and allow comparison in the literature are needed. Furthermore, adherence decreases and discontinuation increases over time, suggesting the need for patient continuous education and a pharmacotherapeutic follow up by health professionals to improve these clinical outcomes.

Factors associated with potentially inappropriate medications use by the elderly according to Beers criteria 2003 and 2012.

BACKGROUND: Potentially inappropriate medications (PIMs) should be avoided by the elderly because they possess a significant high risk for this population when a safer alternative is available. Therefore, the identification of prevalence and factors associated with PIMs should be considered as they provide valuable information that can be used to develop strategies to ensure patients' safety. OBJECTIVE: To identify the prevalence and the clinical and socioeconomic-demographic factors that may be associated with PIMs use in the elderly, according to Beers criteria 2003 and its updated version 2012. And, as a secondary objective, a comparison between both criteria was performed. SETTING: Pharmacy of the Basic Health District Unit of the western district of Ribeirão Preto. METHODS: This cross-sectional observational study was conducted with the elderly, assisted by the Brazilian public health system. Data from patients were collected through a structured interview form. Beers criteria 2003 and 2012 were used to classify PIMs. The association between PIMs used and independent variables were analyzed by odds ratios. The differences between PIMs use according to Beers criteria 2003 and 2012 were analyzed by McNemar's test and the agreement by kappa coefficient. MAIN OUTCOME MEASURE: Prevalence and factors associated with PIMs use in Brazilian elderly outpatients. RESULTS: One thousand elderly patients were interviewed. High prevalence of PIMs use was observed, 48.0 and 59.2 % according to Beers criteria 2003 and 2012, respectively. The factors associated with PIMs use, common for both criteria, are female gender, self-medication, use of over the counter drugs, complaints related to adverse drug event, psychotropic medication, polypharmacy and some categories of drugs. PIMs use is different between Beers criteria 2003 and 2012 (McNemar's test, p < 0.01), although a substantial agreement between these classifications was observed (kappa coefficient 0.635, 95% confidence intervals (0.588, 0.681). CONCLUSIONS: Our study showed a high prevalence of PIMs use, which is associated with various clinical and social-demographic factors. When comparing both criteria through McNemar's test, PIMs use was considered different. The differences may have occurred because medications with high prevalence of use in Brazil were included in Beers criteria 2012 .

How much to invest in glycemic control of a patient with diabetes mellitus type 2? A constant dilemma for the Brazilian Public Health System (SUS)

Diabetes mellitus type 2 (DM2) affects millions of people worldwide and causes several complications for the patient, consuming large sums of financial resources from the health services. This study aims to estimate the financial investment of DM2 treatment for glycemic control of the patient, from the point of view of the municipal Public Health System (SUS). The Delphi technique was used to validate the opinion of a team of judges, specialists in DM2, and health service managers, on the investment necessary for glycemic control of patients with DM2 through the application of questionnaires. In order for the patient to achieve glycated hemoglobin (A1c) < 7%, an investment of US$ 2,419.06 (value/patient/year) is necessary. As the value of A1c increases, investment is reduced. This result reveals the intention to allocate resources for the prevention of DM2 and its complications

Drug utilization profile in adult patients with refractory epilepsy at a tertiary referral center.

OBJECTIVE: To evaluate the utilization profile of antiepileptic drugs in a population of adult patients with refractory epilepsy attending a tertiary center. METHOD: Descriptive analyses of data were obtained from the medical records of 112 patients. Other clinical and demographic characteristics were also registered. RESULTS: Polytherapies with ≥3 antiepileptic drugs were prescribed to 60.7% of patients. Of the old agents, carbamazepine and clobazam were the most commonly prescribed (72.3% and 58.9% of the patients, respectively). Among the new agents, lamotrigine was the most commonly prescribed (36.6% of the patients). At least one old agent was identified in 103 out of the 104 polytherapies, while at least one new agent was prescribed to 70.5% of the population. The most prevalent combination was carbamazepine + clobazam + lamotrigine. The mean AED load found was 3.3 (range 0.4-7.7). CONCLUSION: The pattern of use of individual drugs, although consistent with current treatment guidelines, is strongly influenced by the public health system.

Qualidade de vida e eventos adversos de pacientes com epilepsia farmacorresistente em uso de lamotrigina / Quality of life and adverse events of patients with drug-resistant epilepsy using lamotrigine

Modelo do estudo: Estudo transversal. Introdução: O tratamento farmacológico é a primeira opção para o tratamento da epilepsia, e cerca de 40% dos pacientes necessitam de politerapia para melhor controle das crises epilépticas, o que pode estar associado ao aumento de eventos adversos e comprometimento da qualidade de vida. Objetivos: Avaliar a qualidade de vida de pacientes com epilepsia farmacoresistente em uso de lamotrigina (LTG), bem como verificar a associação dos eventos adversos dos antiepilépticos com a qualidade de vida. Metodologia: Este estudo transversal foi realizado com 75 pacientes com epilepsia farmacorresistente em uso LTG atendidos em um Ambulatório de Epilepsia de Difícil Controle de Ribeirão Preto-SP, no período de maio/2011 a abril/2012. As variáveis clínicas analisadas foram a qualidade de vida (Quality of Life in Epilepsy - Qolie-31) e o perfil de eventos adversos (AEP ­ Adverse Events Profile Questionnaire). Dados sociodemográficos e farmacoterapêuticos foram coletados através dos prontuários dos pacientes. Este trabalho foi aprovado pelo Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP), cujo número do processo é 8791/2010. Resultados: Os eventos adversos mais frequentes foram sonolência e dificuldade de concentração. Além disso, observou-se baixos escores em todos os domínios relacionados à qualidade de vida (Qolie-31). Conclusão: A qualidade de vida possui associação inversamente significativa com os eventos adversos, nos pacientes em uso de antiepilépticos (p<0,01). (AU)

Study design: Cross-sectional study. Introduction: Pharmacological treatment is the first option to treat epilepsy, and about 40% of patients require polytherapy to better control epileptic seizures, which may be associated with an increase in adverse events and impairment of quality of life. Objective: To evaluate the quality of life of patients with pharmacoresistant epilepsy using lamotrigine (LTG), as well as to verify the association of adverse events with antiepileptic drugs with quality of life. Methods: This cross-sectional study was carried out with 75 patients with drugresistant epilepsy using LTG, in a Clinic of Epilepsy of Difficult Control of Ribeirão Preto-SP, from May/2011 to April / 2012. The clinical variables analyzed were Quality of Life in Epilepsy (QOLIE31) and the Adverse Events Profile Questionnaire (AEP). Socio-demographic and pharmacotherapeutic data were collected through patient records. This study was approved by the Research Ethics Committee of the General Hospital of the Medical School of Ribeirão Preto of the University of São Paulo (HCFMRP-USP), whose case number is 8791/2010. Results: The most frequent adverse events were somnolence and difficulty concentrating. In addition, low scores were observed in all domains related to quality of life (Qolie-31). Conclusion: Quality of life has an inverse association with adverse events in patients using antiepileptic drugs (p <0.01). (AU)