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.

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.

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.

Abstract Introduction: Screening patients with diabetes mellitus (DM) for chronic kidney disease (CKD) enables early diagnosis and helps to establish adequate treatment and avoid possible damages to health associated with disease progression. This study aimed to verify whether screening for CKD has been properly conducted in populations with diabetes mellitus seen at primary care clinics. Methods: This descriptive study included 265 individuals with DM seen at Basic Healthcare Clinics in Divinópolis, MG, Brazil. Clinical and laboratory data were collected from the Integrated Health System. Frequency of testing and kidney function evaluations performed within the last 12 months were calculated along with the proportion of patients with increased urinary albumin excretion (UAE) and decreased glomerular filtration rate (GFR) to determine the proportion of patient with kidney involvement. Results: We found that 41.2% of the patients had kidney involvement and that 61.2% of the individuals with kidney involvement were on nephroprotective medication. Of the 21.9% tested for isolated albuminuria, 46.5% had increased UAE. The albumin-to-creatinine ratio (ACR) was measured in 12.1% of the patients, with 43.8% having an increased ACR. We found that 89.0% of the patients had their serum creatinine levels measured, and that 33.1% had a decreased GFR. Conclusion: CKD screening was more frequently performed via the GFR than UAE, a parameter analyzed only in a small proportion of patients. Therefore, CKD screening for patients with diabetes is not being performed properly in primary care.

Resumo Introdução: O rastreio da doença renal crônica (DRC) em pacientes com diabetes (DM) possibilita o diagnóstico precoce e ajuda a estabelecer um tratamento adequado, evitando possíveis danos à saúde pela progressão da doença. O objetivo deste trabalho foi verificar se o rastreio da DRC está sendo feito de maneira adequada entre diabéticos acompanhados na atenção primária à saúde. Métodos: Estudo descritivo com 265 pacientes com DM atendidos nas Unidades Básicas de Saúde de Divinópolis, MG. A coleta de dados clínicos e laboratoriais foi realizada por meio de consulta ao Sistema Integrado de Saúde. Foram calculadas a frequência de realização dos exames de avaliação da função renal nos últimos 12 meses e a frequência de pacientes com excreção urinária de albumina (EUA) aumentada e a taxa de filtração glomerular (TFG) reduzida, e assim determinada a frequência de pacientes com comprometimento renal. Resultados: Foi observado que 41,2% dos pacientes têm comprometimento renal; dentre esses, 61,2% utilizam algum medicamento nefroprotetor. Apenas 21,9% realizaram o exame de albuminúria isolada, dos quais 46,5% apresentaram albuminúria aumentada. O exame de relação albumina/creatinina (RAC) foi realizado por 12,1% dos pacientes, dos quais 43,8% apresentaram RAC aumentada. Foi observado que 89,0% dos pacientes realizaram o exame de creatinina sérica, dos quais 33,1% apresentaram TFG reduzida. Conclusão: Foi observado maior índice de rastreio da DRC por meio da TFG em relação ao rastreio por meio da EUA, o qual foi realizado por pequeno número de pacientes. Portanto, o rastreio da DRC não está sendo realizado adequadamente na atenção básica ao diabético.

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.

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.

Resumo Fundamento Aparentemente, a pior resposta a algumas classes de anti-hipertensivos, especialmente inibidores da enzima conversora da angiotensina e bloqueadores de receptor de angiotensina, pela população negra, explicaria, pelo menos parcialmente, o pior controle da hipertensão entre esses indivíduos. Entretanto, a maioria das evidências vêm de estudos norte-americanos. Objetivos Este estudo tem o objetivo de investigar a associação entre raça/cor da pele autorrelatadas e controle de PA em participantes do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) utilizando várias classes de anti-hipertensivos em monoterapia. Métodos O estudo envolveu uma análise transversal, realizada com participantes da linha de base do ELSA-Brasil. O controle de pressão arterial foi a variável de resposta, participantes com valores de PA ≥140/90 mmHg foram considerados descontrolados em relação aos níveis de pressão arterial. A raça/cor da pele foi autorrelatada (branco, pardo, negro). Todos os participantes tiveram que responder perguntas sobre uso contínuo de medicamentos. A associação entre o controle de PA e raça/cor da pele foi estimada por regressão logística. O nível de significância adotado nesse estudo foi de 5%. Resultados Do total de 1.795 usuários de anti-hipertensivos em monoterapia na linha de base, 55,5% se declararam brancos, 27,9%, pardos e 16,7%, negros. Mesmo depois de padronizar em relação a variáveis de confusão, negros em uso de inibidores da enzima conversora de angiotensina (IECA), bloqueadores de receptor de angiotensina (BRA), diuréticos tiazídicos (DIU tiazídicos) e betabloqueadores (BB) in monoterapia tinham controle de pressão arterial pior em comparação a brancos. Conclusões Os resultados deste estudo sugerem que, nesta amostra de brasileiros adultos utilizando anti-hipertensivos em monoterapia, as diferenças de controle de pressão arterial entre os vários grupos raciais não são explicadas pela possível eficácia mais baixa dos IECA e BRA em indivíduos negros.

Abstract Background It seems that the worst response to some classes of antihypertensive drugs, especially angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, on the part of the Black population, would at least partially explain the worse control of hypertension among these individuals. However, most of the evidence comes from American studies. Objectives This study aims to investigate the association between self-reported race/skin color and BP control in participants of the Longitudinal Study of Adult Health (ELSA-Brasil), using different classes of antihypertensive drugs in monotherapy. Methods The study involved a cross-sectional analysis, carried out with participants from the baseline of ELSA-Brasil. Blood pressure control was the response variable, participants with BP values ≥140/90 mmHg were considered out of control in relation to blood pressure levels. Race/skin color was self-reported (White, Brown, Black). All participants were asked about the continuous use of medication. Association between BP control and race/skin color was estimated through logistic regression. The level of significance adopted in this study was of 5%. Results Of the total of 1,795 users of antihypertensive drugs in monotherapy at baseline, 55.5% declared themselves White, 27.9% Brown, and 16.7% Black. Even after adjusting for confounding variables, Blacks using angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blocker (ARB), thiazide diuretics (thiazide DIU), and beta-blockers (BB) in monotherapy had worse blood pressure control compared to Whites. Conclusions Our results suggest that in this sample of Brazilian adults using antihypertensive drugs in monotherapy, the differences in blood pressure control between different racial groups are not explained by the possible lower effectiveness of ACEIs and ARBs in Black individuals.

Abstract The present study proposes and evaluates the test-retest reliability of indicators of the correct use of sodium alendronate in elderly patients. This is a test-retest reliability study for use of sodium alendronate. Six questions to evaluate the correct use of this medicine were elaborated after analysis of information in the literature. Data collection was performed through questionnaires in face-to-face in-home interviews by previously trained interviewers. The participants were initially interviewed (test) when they agreed to participate in the study, and secondly (retest), after a period of 7 to 14 days from the first interview. The reliability of the questions was evaluated by means of the agreement percentage and the Kappa coefficient. Fifty-seven pairs (test-retest) were obtained. The mean age was 69.3 (SD = 6.9) years, the majority (92.5%) completed elementary education, and declared themselves white (50.9%). All the questions presented high concordance ranging from 79.0% to 98.3%. The Kappa values ranged from 0.1 (low) to 0.83 (very good). The agreement percentage and the Kappa values suggest adequate reliability of the proposed questions. We suggest that they can be used as a simple and quick way to evaluate the quality of sodium alendronate use among the elderly.

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.

ABSTRACT Objective To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. Methods Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. Results Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. Conclusion The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies.

Abstract The treatment of epilepsy is complex and a matter of concern is the interchangeability among different formulations available for antiepileptic drugs. To evaluate the effects of interchangeability among carbamazepine formulations on patients with epilepsy. This is a prospective cohort study that included adult outpatients diagnosed with epilepsy and under pharmacological treatment with carbamazepine. Before switching the brand/manufacturer, the “Interchangeable Pharmaceutical Product in the Treatment of Epilepsies” questionnaire was applied. The questionnaires “Adverse Events Profile” and Quality of Life in Epilepsy-31, so as the plasma carbamazepine concentrations, were evaluated before and after the brand/ manufacturer switch. Physical-chemical tests aiming to assess tablets quality were performed in accordance with the Brazilian Pharmacopoeia 5th edition. The study population was composed by 14 patients (mean age: 44.6 years), with 10 of females. From those interviewed, 10 had no knowledge about the three antiepileptic drugs formulations available. The frequency of adverse event “problems with skin” incresead (p=0.023) and “upset stomach” decreased (p=0.041) after the changeover. The adverse events profile was associated with only two quality of life domains: “energy/fatigue” (p=0.048) and “total score” (p=0.018). Divergent results between generic and reference formulations were observed in purity-water test (reference: 1.96%, generic: 4.84%) and dissolution test, in which the generic formulation presented 66.27 to 85.77% of carbamazepine dissolved after the third level. Conclusions: Objective differences before and after the brand/manufacturer switch were not observed, in spite of patients’ perceptions. Despite that, more studies in the field are necessary, especially on the interchangeability among generic antiepileptics, in order to better elucidate switching consequences on patients’ life.

Abstract Evidence on factors associated with the progression of chronic kidney disease (CKD) is still under construction. The present study aimed to evaluate sociodemographic, clinical, and drug use factors associated with the progression of CKD. A retrospective cohort study was conducted with 193 patients with CKD stages 3A to 5- non-dialysis followed for three years in a Brazilian city. The outcome was the evolution to renal replacement therapy (RRT) or death. A total of 52.3 % (n = 101) were men and 83.4 % (n = 161) elderly. The median age was 72.0 years, and 22.3 % (n = 44) progressed to RRT or death, and the three-year mortality rate was 20.2 %. Participants exposed to angiotensin converting enzyme inhibitors or angiotensin II receptor blockers had a lower risk of progressing to the outcome (hazard ratio (HR) 0.25; p = 0.003) and higher survival (p = 0.022) when compared to those not exposed to these drugs. Age (HR 1.06;) and use of omeprazole (HR 6.25; CI; p <0.01) and hydrochlorothiazide (HR 2.80; p = 0.028) increased the risks of RRT or death. The results highlight the importance of rational management of pharmacotherapy for patients with CKD.

Resumo Introdução Medicamentos vencidos em farmácias caseiras são potenciais agentes causadores de danos à saúde humana e ao meio ambiente. Neste sentido, são essenciais estudos que subsidiem políticas de intervenção para minimização dos riscos. Objetivo Estimar a prevalência e os fatores associados aos medicamentos vencidos em estoques caseiros. Método O estudo transversal foi realizado por meio de entrevistas nas residências dos usuários da atenção primária à saúde (APS) de uma cidade do centro-oeste mineiro, Brasil. As estimativas de prevalência e suas associações foram realizadas por meio de modelos lineares generalizados (MLGs). Resultados Nos 423 estoques caseiros, foram encontrados 4.203 medicamentos, com uma média de 10 medicamentos/residência (DP = 5,87). A prevalência de residências com medicamentos vencidos foi de 45,4%, sendo os antimicrobianos e analgésicos os mais prevalentes. A presença de medicamentos vencidos está associada à presença de medicamentos isentos de prescrição (MIPs) e antimicrobianos nas residências e ao comportamento de guardar o medicamento em desuso em seu estoque caseiro. Conclusão Aproximadamente metade das residências possui medicamentos vencidos, e a presença deles está associada à classe terapêutica e ao comportamento do usuário.

Abstract Background The storage of expired medications at home can cause potential damage to human health and the environment. Thus, studies that support intervention policies to minimize risks are essential. Objective To estimate the prevalence and factors associated with storage of expired medications at home. Method The cross-sectional study was conducted through interviews in the homes of Primary Health Care (PHC) users of a city in the center-west of Minas Gerais, Brazil. Prevalence estimates and their associations were performed using generalized linear models (MLGs). Results We found 4,203 medications stored in 423 homes, with an average of 10 medication/residence (SD=5.87). The prevalence of homes with expired medications was 45.4%, with antimicrobials and analgesics being the most prevalent. The presence of expired medications is associated with the presence of Over the Counter drugs (OTC) and antimicrobials at homes, and the behavior of keeping the unused drug in their home pharmacy. Conclusion Almost half of the homes have expired medications. And the presence of these drugs is associated with the therapeutic class and the behavior of the PHC user.

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.