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

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

Medications used in paediatric intensive care by continuous infusion: Do the technical aspects of the package inserts corroborate scientific evidence?

WHAT IS KNOWN AND OBJECTIVE: Hospitalized paediatric patients are three times more likely to experience medication errors with the potential to cause harm, when they are compared to adults. The lack of research in paediatrics, difficulties that are derived as indications and the parameters of safety and effectiveness of pharmacological therapy in children. To analyse whether the technical and legal aspects of the package insert for medicines used in paediatric intensive care units (ICU) using a continuous infusion (CI) pump corroborate the recommendations of clinical protocols and legal provisions. METHODS: A documentary study, in which technical and legal information contained in the package inserts of medications commonly used via CI in neopediatric ICUs was analysed. The consultation of the medication package insert was carried out through the electronic portal of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA). Information on the use of medications in the neonatal and paediatric populations via CI was sought in the medication package insert. To analyse the legal aspects, ANVISA's RDC no. 47/2009 was used. In order to compare the technical information, the Micromedex NeoFax®, Micromedex Paediatrics®, and Lexicomp® databases were consulted. RESULTS AND DISCUSSION: Of the 13 medications analysed, 46% (n = 6) had some non-compliance with RDC 47/2009. Only 46% (n = 6) of the medications are indicated for paediatric use and only the medication package insert for midazolam (7.7%) contained the information considered essential for use via CI in paediatrics. WHAT IS NEW AND CONCLUSION: This is an innovative study that identifies the weaknesses of the medication package inserts for medications used by CI in paediatric ICUs. Failure to comply with legal recommendations can make medication administration difficult and increase the probability that errors will occur; and the absence of specific technical information can make care difficult and compromise patient safety. It is important that there is supervision by regulatory agencies and the contribution of health professionals so that non-conformities are reported and corrected, to guarantee safe care for paediatric patients in intensive care.

Drug-resistant epilepsy and topiramate: Plasma concentration and frequency of epileptic seizures.

Topiramate (TPM) is a second-generation antiepileptic drug (AED), acting on drug-resistant epilepsy. The aim of the study was to evaluate the influence of the dose, use of other AEDs on TPM plasma concentration (Cp ), and frequency of epileptic seizures. A cross-sectional analytical study was developed with patients aged 18-60 years, for diagnosis of drug-resistant epilepsy, using TPM in monotherapy or associated with other AEDs. The following variables were analyzed: age, frequency of epileptic seizures, pharmacotherapeutic regimen with its respective doses, adherence to medication treatment, and adverse events score. Thirty-seven patients were included, 83.8% of the patients presented Cp below the therapeutic range. Multiple linear regression estimated that the increase of 1.0 mg/kg/d promoted an increase of 0.68 µg/mL in TPMCp , while the use of inducers predicted a reduction of 2.97 µg/mL (P < .001). Multiple Poisson regression predicts that an increase of 1.0 µg/mL in TPMCp decreased the patient's chance of presenting seizures, and patients using AED inducers were about ten times more likely to present seizures than those who do not use (P < .001). In addition, for patients using AED inducers with Cp below the therapeutic range, the mean number of seizures per month was greater than those with Cp within the therapeutic range. The prescribed dose and the use of AED inducers influence Cp of TPM, likewise the low Cp of first-line AEDs and of the adjuvant in the treatment, TPM, as well as low TPM dose seem to affect the control of epileptic seizures.

An investigation of the influence of patient-related factors and comedications on lamotrigine clearance in patients with epilepsy.

Lamotrigine (LTG) is one of the most widely used antiepileptic drugs. Confusion still exists in the literature as to the relative influence of age, body weight, and concomitant drug therapy on LTG pharmacokinetics. So, the objective of this study is to evaluate the influence of patient-related factors and comedication on LTG apparent oral clearance (CL/F). A therapeutic drug-monitoring database was used to identify steady-state plasma LTG concentrations in 210 patients. LTG CL/F values were calculated for each patient according to the equation CL/F (L/h per kg) = LTG daily dose (mg/kg)/Css (steady state concentration) (mg/L) × 24 h. A linear-regression model was used to assess the influence of gender, dose, age, and body weight in LTG CL/F. The influence of comedication on LTG CL/F was investigated by applying the Bonferroni post-test. The lowest LTG CL/F was found in patients comedicated with valproate (VPA) (mean, 0.0183 L/h per kg), followed by patients receiving VPA + enzyme inducers (0.0271 L/h per kg), patients on LTG monotherapy (0.0298 L/h per kg) and patients comedicated with enzyme inducers (0.056 L/h per kg) LTG CL/F correlated significantly with LTG dose (P < 0.01), but showed no significant relationship with gender, weight, and age. LTG CL/F is influenced by the type of antiepileptic comedication. The correlation with dose may be a spurious finding related to the fact that physicians, in adjusting dosage according to clinical response, are more likely to use larger doses in patients with high clearance values.

Evaluation of Immunobiological Cold Chain Costs.

Background and Purpose: Studies assessing the costs of the immunobiological cold chain (CC) are scarce. Therefore, the factors that influence the allocation of resources in this process are not known. The objective of this study is to determine the cost of the immunobiological CC. Methods: The Health Economic Assessment study was carried out in Minas Gerais, Brazil, between 2021 and 2022. The unit of analysis was the municipal level of the CC. The perspective of the Public Health System (Sistema Único de Saúde) was considered as a funder, the year 2021 was considered as the time frame, and the period of 1 year was considered as the time horizon of the analysis. Direct medical, nonmedical, and indirect costs were included. A mixed technique was used involving micro- and macrocosting and sensitivity analysis to identify the influence of the main categories on the final cost. Results: The total cost was USD 20,014,545, with nonmedical direct costs being the most representative (61.24%). Human resources were the most influential items, representing 76.43% of the total cost. Conclusions: The most influential items should be those of greatest concern and planned by managers to make the CC more efficient.

Is screening for chronic kidney disease in patients with diabetes mellitus being properly conducted in primary care?

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.

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia.

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.

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.

Antimicrobial stewardship for surgical antibiotic prophylaxis and surgical site infections: a systematic review.

Background Surgical site infections account for 14-17% of all healthcare-associated infections. Antimicrobial stewardship (AMS) are complementary strategies developed to optimize the use of antimicrobials. Aim to evaluate the effectiveness of AMS in promoting adherence to surgical antibiotic prophylaxis protocols in hospitalized patients, reducing surgical site infection rate and cost-benefit ratio. Method This systematic review of randomized clinical trials, non-randomized clinical trials and before and after studies was performed using Pubmed, Cochrane, Web of Science, Scopus, Embase, Google Scholar and ClinicalTrials.gov, in addition to reference lists of included studies. The risk of bias of studies was measured by the ROBINS-I checklist and the quality of the evidence synthesis by GRADE. Results Fourteen before and after design studies were included. In 85.7% of the studies, AMS was effective in increasing adherence to surgical antibiotic prophylaxis protocols and in 28.5%, there was reduction in surgical site infection rate. Three studies evaluated cost-benefit ratio and found a favorable impact. Eight (57%) studies were at risk of moderate bias and six had severe bias. The evaluation of the synthesis of evidence showed quality ranging from low to very low. Conclusion AMS, such as audit, feedback, education, implementation of a protocol, and a computer-assisted decision support methodology, appear to be effective in promoting adherence to surgical antibiotic prophylaxis protocols, reducing surgical site infection rate with a positive economic impact. However, more studies, particularly randomized clinical trials, are needed to improve the level of evidence of available information on AMS in order to favor decision-making.

Deprescribing clonazepam in primary care older patients: a feasibility study.

Background Inappropriate use of clonazepam by older adults is associated with cognitive impairment, delirium, and falls. Strategies to optimize its use are important to increase patient safety. Objective To evaluate the feasibility of a clonazepam deprescription protocol in the elderly. Methods This is a quasi-experimental study. Elderly people with chronic use of clonazepam and attended in primary care units in two Brazilian municipalities were selected. A deprescription protocol was used, which included five fortnightly meetings between the older adults and the research team, to reduce the dose by 25%. Patients received instructions on sleep hygiene behaviors and the advantages of clonazepam deprescription; family physicians followed a flowchart for gradual dose reduction. In the 1st and 5th meetings, there were medical appointments for anamnesis and discharge. The monitoring of patients and the application of tests were carried out by the research team. Results Of the 35 elderly people included in the study, 27 reached the end; 81.5% achieved deprescription: 22.2% stopped completely and 59.3% decreased the dose. At the last meeting, 20% of elderly patients reported an increase in blood pressure. Conclusion The high rate of deprescription and the little relevance of clonazepam withdrawal reactions, showed that the use of the protocol was effective. However, the increase in blood pressure and the worsening of sleep quality in the last meeting show the need for adjustment in the last stage of the deprescription process.

Racial Differences in Blood Pressure Control from Users of Antihypertensive Monotherapy: Results from the ELSA-Brasil Study. / Diferenças Raciais no Controle da Pressão Arterial em Usuários de Anti-Hipertensivos em Monoterapia: Resultados do Estudo ELSA-Brasil.

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.

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.

Implementation of a text messaging intervention to patients on warfarin therapy in Brazilian primary care units: a quasi-experimental study.

BACKGROUND: Warfarin remains the most affordable oral anticoagulant in many countries. However, it may have serious side effects, and the success of the therapy depends on the patient's understanding of the medication and their adherence to treatment. The use of short messages services (SMS) is a strategy that can be used to educate patients, but there are no studies evaluating this intervention in patients taking warfarin. Therefore, we aimed to develop, implement, and assess the feasibility of an intervention using SMS to primary care patients taking warfarin in a medium-sized Brazilian city. METHODS: A bank of 79 SMS was drafted and validated by an expert panel. During 6 months, three times a week, patients received messages about anticoagulation with warfarin. At baseline and after 3 months, we assessed their knowledge and adherence with validated instruments. At the end of the follow-up, participants answered a satisfaction questionnaire. Subsequently, a scale-up phase was conducted, with another round of the intervention including 82 participants (29 from the first phase and 53 newly recruited). Seven months after the end of the scale-up, we asked the patients for their insights about the long-term effects of this program. All patients signed informed consent. The study was approved by the Research and Ethics committee of the Universidade Federal de Minas Gerais. RESULTS: In the pilot, 33 (89.2%) patients completed the follow-up. Among the participants who answered the satisfaction questionnaire (n = 29), 86.2% considered that the intervention motivated a healthy lifestyle and improved their understanding of warfarin therapy. All patients were willing to continue receiving the messages. Adherence measured by the Measure of Adherence to Treatment (MAT) test was high in the pre-intervention assessment and remained high (96.7% vs. 93.3%; p = 1.0000). The proportion of patients who achieved > 75% correct answers on the Oral Anticoagulation Knowledge (OAK) test increased from 6.5% to 25.6, p = 0.0703. In the scale-up, 23 patients answered the long-term assessment questionnaire. The main long-term knowledge reported was dietary information. Nine patients received the messages but did not remember their content. CONCLUSION: The intervention was well-accepted and had a positive impact on patient's knowledge about oral anticoagulation therapy. The scale-up assessment reinforced the need to constantly monitor digital interventions.

Thirteen years of medication alerts issued by the Brazilian Health Regulatory Agency (ANVISA): What is the profile?

RATIONALE, AIMS, AND OBJECTIVES: As a pharmacovigilance measure, the Brazilian Health Regulatory Agency (ANVISA) monitors the postmarketing events of medication and issues alerts on actions to be taken and information updates. The present study has the objective of analysing the profile of all the alerts on medication issued by ANVISA between 2006 and 2018. METHODS: A descriptive documentary analysis was carried out through the ANVISA website and double checked with two researchers in order to avoid discrepancies in data collection and interpretation of information. RESULTS: A total of 79 alerts available in the period were analysed, the mean being 6.07 alerts/year and standard deviation of 3.81. The medications most cited in the alerts were antivirals (9.7%), followed by antidiabetics (7.3%) and contraceptives (7.3%). The main problems identified were adverse reactions (50%) and other problems related to safety (15%). The main actions directed by ANVISA were generation of a new contraindication (37.3%) and alteration in the package insert (22.3%). CONCLUSION: Alerts are an important means of communicating new information to health professionals and to society. However, they need better standardization in order to facilitate understanding, dissemination in order to broaden access to information, and studies to corroborate the current literature and improve current pharmacovigilance.

Storage and disposal of expired medicines in home pharmacies: emerging public health problems.

OBJECTIVE: To characterize storage and disposal practices associated with expired medicines in home pharmacies of Primary Care users. METHODS: Cross-sectional study based on data collected from 423 users of 15 Primary Care units located in a Brazilian city, between August 2014 and July 2016. Data were collected via face-to-face interviews. Categorical (demographic and socioeconomic characteristics) and continuous variables were expressed as proportions and means and standard deviations, respectively . Storage behaviors and disposal practices associated with unused and expired medicines were described as frequencies. RESULTS: Most (83%) interviewees were female and approximately 70% had completed high school. The kitchen was the most common medicine storage place (58.6%). Approximately 75% of participants reported inappropriate medicine disposal practices. CONCLUSION: This study revealed high rates of inappropriate medicine disposal practices with direct impacts on pharmacological treatment and the environment. Continuing education of healthcare professionals and the general public is required to raise awareness about proper medicine use and disposal.

Omeprazole use and risk of chronic kidney disease evolution.

RATIONALE, AIMS AND OBJECTIVES: In recent years, the use of proton pump inhibitors (PPI), especially omeprazole, has been associated with development of chronic kidney disease (CKD). These drugs are widely used worldwide. Although some studies have found an association between the use of PPI and the onset of acute renal failure and CKD. This study aims to analyze the association between the continuous use of omeprazole and the progression of CKD in adult and elderly individuals. METHOD: A retrospective cohort study was conducted with patients followed up at a nephrology clinic in Brazil, in 2016 and 2017. Information about clinical and sociodemographic data, health behaviors, and medication use were collected from all patients diagnosed with CKD through consultation of medical charts and the Brazilian health information system (SIS). The participants were allocated into two groups: users and non-users of omeprazole, and the progression of CKD was then evaluated for each group. In the bivariate analysis, the Mann-Whitney U test to compare the quantitative variables between groups, and the Pearson/Fisher two-tailed chi-square test to compare the categorical variables were applied. Multivariate analysis was performed using Cox regression. RESULTS: A total of 199 CKD patients were attended in the polyclinic, and of these, 42.7% were omeprazole users. There was a higher percentage of CKD progression in users (70.6%) compared to non-users (10.5%). The hazard ratio was 7.34 (CI: 3.94-13.71), indicating a higher risk of progression to worse stages of CKD in omeprazole users than in non-users. As for the other variables, no statistically significant difference was found between groups (p > 0.05). CONCLUSION: An association between omeprazole use and progression of CKD stage was identified, showing a higher risk of disease evolution among omeprazole users.

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.

Pharmacotherapeutic empowerment and its effectiveness in glycemic control in patients with Diabetes Mellitus.

AIMS: To develop an intervention and evaluate its effectiveness in pharmacotherapeutic empowerment of patients with type 2 diabetes mellitus (T2DM). METHOD: This is an intervention study with before and after evaluation. The intervention was conducted between 2015 and 2016 with users of the Unified Health System (SUS) in Brazil. The study was divided into six stages: initial evaluation, three individual patient-pharmacist meetings every 15 days over 6 weeks, clinical discussion between pharmacists, and final evaluation. At each meeting with the patient, specific themes for empowerment were addressed using educational booklets and pharmaceutical care. Clinical and laboratory evaluations and questionnaires on self-efficacy (IMDSES), self-care (QAD) and distress (PAID-5) were conducted before and three months after the intervention. RESULTS: 47 patients completed the intervention. Glycated hemoglobin of patients had a median reduced from 7.0% to 6.6% after the intervention (p = 0.02). There was a significant difference (p < 0.01) in the reduction in total cholesterol, fasting glycemia, creatinine and blood pressure. Participants showed significant improvements (p < 0.01) in scores related to self-efficacy and self-care and less distress related to T2DM. CONCLUSION: The results of the study suggest that the strategy developed is effective in promoting the empowerment of T2DM patients, improved glycemic control and self-care.

Patients with chronic kidney disease and diabetes mellitus: How is health care?

OBJECTIVE: To evaluate if the recommendations of appropriate health care for Chronic Kidney Disease (CKD) are implemented in patients with Diabetes Mellitus (DM) and Systemic Arterial Hypertension (SAH). METHODS: This is a descriptive study conducted between January and March 2019 in Divinópolis, in the Brazilian state of Minas Gerais. Patients aged 18 years or older with CKD, DM and/or SAH were followed up at the municipal nephrology outpatient clinic. An interview was conducted using a structured questionnaire to assess care, which was categorized as adequate or inadequate, based on the health care recommendations of the national guidelines for care of patients with CKD. RESULTS: 42 participants with CKD participated in the study. All participants had SAH and 42.9% (n = 18) also had DM. It was evidenced that 81.0% (n = 34) of the individuals with CKD had adequate health care, especially among patients in earlier stages (3A and 3B) and those who progressed to renal replacement therapy. However, 80.0% (n = 8) of the participants in the intermediate stage (stage 4) were inadequately followed up by the nephrologist and multidisciplinary team. CONCLUSIONS: Patients in intermediate stages do not receive follow-up with a multidisciplinary team at the recommended frequency. The preventive approach of the progression of renal disease in the intermediate stage in the studied municipality was not within the recommendations of the Ministry of Health.

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.