Introduction: Oral anticoagulants are the treatment of choice for diverse types of coagulation disorders. Warfarin is widely used by the Brazilian population, possibly due to its lower cost than other oral anticoagulants. However, it has a high risk of serious adverse effects if used incorrectly. The Anticoagulation Knowledge Tool (AKT) can assess a patient's knowledge about her/his oral anticoagulant therapy and can assist health professionals in identifying patients with difficulties in adherence. This study aimed to translate, culturally adapt, and validate the AKT into Brazilian Portuguese. Methods: After a standard forward-backward procedure to translate the AKT into Brazilian Portuguese (AKT-Br), a version of the instrument was applied in three groups (patients, pharmacists, and the general population). The reliability of the AKT-Br was tested using an internal consistency measure and test-retest. The validity of the instrument was confirmed with data from the contrasted groups. All statistical analyses were performed with RStudio. Results: The median scores obtained with the AKT-Br were 29.0, 17.0, and 7.5 for pharmacists, patients, and the general population, respectively (maximum score of 35 points). There was moderate internal consistency for the instrument and test-retest reliability was satisfactory. Analysis of variance for validity of the groups revealed a significant relationship between the total score and the evaluated groups. Conclusion: The ATK-Br is a reliable and valid tool to assess knowledge about oral anticoagulants. AKT-Br can be used in clinical practice as an auxiliary tool to improve patient care through personalised educational interventions.
Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine.This puts the pharmacist in a position of authority that should be harnessed for the benefit of health.Thus, this professional is strategic for performing pharmacovigilance.Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores.The information was collected through an online questionnaire via Survey Monkey®.The data were analyzed statistically using SPSS software.Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail.81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa.More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care.The main barriers to making notifications were the lack of access and knowledge about Notivisa.Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process.Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance.Simplification of the system and training on it are likely to increase notifications.
Aims: According to a recent national diabetes screening performed by our group in 2018, 18.4% of the Brazilians were found to have high blood glucose. The objective of the present study was to estimate the risk of developing type 2 DM (T2DM) in the next ten years in Brazilian population. Methods: A cross-sectional study was carried out in community pharmacies across Brazil, in 2018, where pharmacists applied the FINDRISC questionnaire to estimate the population's risk of developing T2DM within a ten-year period. Results: The study included 977 pharmacists from 345 municipalities distributed across the five geographical regions of Brazil. Of the 17,580 people evaluated, the South region was found to have the highest frequency (59.6%) among people at very low and/or low risk of developing T2DM, while the North region, the most underserved, presented the highest and/or very highest T2DM risk (24.1%). The factors that mostly and importantly impacted these regional differences were body mass index; the highest daily consumption of vegetables and fruits; history of high blood glucose and family history of T1DM/T2DM. Conclusion: These results showed an impressive change of direction concerning diabetes numbers between the most underserved region in public health care and one of the most developed and best organized regions concerning health assistance, the North and the South, respectively. (c) 2021 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
The safety and effectiveness of main anti-obesity drugs are controversial, and there is no consensus among regulatory agencies regarding anti-obesity drugs. We undertook an overview of systematic reviews (SR) of randomized controlled trials (RCT) to summarize the quality of evidence related to anti-obesity drugs. Data sources included Medline, Scopus, The Cochrane Library and PROSPERO. Twenty-one SR (564 RCT; average of 2,356 participants per review) satisfied the inclusion criteria. Ten SR presented a high level of heterogeneity, and only five SR included sensitivity analyses. The most important limitations reported by the SR were a high level of attrition, a small sample size, and a short follow-up. Eight different outcomes for efficacy were used, 15 different outcomes for biomarkers were used, and nine different outcomes for safety were used. Conclusions: In conclusion, the quality of SR pertaining to anti-obesity drugs is low, and these reviews have a high level of heterogeneity. Future SR should present more detailed population inclusion criteria, larger sample sizes, and focus variables reported in a predefined anti-obesity core outcome set.
Background: Brazil is one of top 10 countries with the highest number of people with diabetes mellitus (DM), affecting 16.8 million peoples. It is estimated that 7.7 million people (20–79 years) in the country have not yet been diagnosed, representing an under-diagnosis rate of 46.0%. Herein we aimed to screen people for high blood glucose or risk for developing type 2 DM (T2DM) through community pharmacies in Brazil.Methods: A cross-sectional study was carried out in November 2018, involving 977 pharmacists from 345 municipalities in Brazil. The study evaluated people between 20 and 79 years old without a previous diagnosis of DM. Glycemia was considered high when its value was ≥100 mg/dL fasting and ≥ 140 mg/dL in a casual feeding state. The FINDRISC (Finnish Diabetes Risk Score) was used to estimate the risk for developing T2DM. The prevalence of high blood glucose was estimated and the associated factors were obtained using Poisson's multivariate analysis with robust variance.Results: During the national screening campaign, 17,580 people were tested with the majority of the consultations (78.2%) being carried out in private pharmacies. The population was composed mainly of women (59.5%) and people aged between 20 and 45 years (47.9%). The frequency of participants with high blood glucose was 18.4% (95% CI 17.9–19.0). Considering the FINDRISC, 22.7% of people had a high or very high risk for T2DM. The risk factors associated with high blood glucose were: Body Mass Index > 25 kg/m 2 , abdominal circumference> 94 cm for men and> 80 cm for women; education level below 15 years of study, no daily intake of vegetables and fruits; previous diagnosis of arterial hypertension; history of high blood glucose and family history of DM.Conclusions: This is the largest screening study that evaluated the frequency of high blood glucose and its associated factors in a population without a previous diagnosis ever performed in community pharmacies in Brazil. These results may help to improve public health policies and reinforce the role of pharmacists in screening and education actions aimed at this undiagnosed population in a continent-size country such as Brazil.
Background The Cochrane collaboration risk of bias assessment (RoB) tool is used in several fields to evaluate the methodological quality of studies. Its strengths and challenges are discussed. Objective To assess the sensitivity of the RoB tool in studies of pharmacist interventions. Setting DEPICT database was used to pool randomized controlled trials (RCTs) of complex interventions. Method A Guide for RoB Judgment in Pharmacy Services was created to help in the interpretation and judgment of bias criteria. The evaluation of bias (low, unclear, high risk) was performed by RCT. Sensitivity analyses were performed to assess the influence of different interpretations of eight elements of judgment in the RoB tool. Paired analysis and estimations of the effect size (95% confidence interval) of the criteria modifications compared to the original analyses were calculated. Main outcome measure Changes in the interpretations of judgment in the RoB tool. Results Overall, 8.3, 45.4, and 46.3% of the studies were determined to have low, unclear, and high risk of bias, respectively. High risk of bias was caused by attrition and detection domains. The number of studies classified with high risk of bias significantly increased for five of the eight interpretations, while unclear risk of bias increased for three interpretations (with a negligible effect size in all of them). Lack of blinding, loss of participants, and the use of subjective and self-reported outcomes were the main elements resulting in high risk of bias. Conclusion The RoB tool is useful for evaluating RCTs of pharmacist interventions if adapted criteria for judgment are used. Ignoring these adjustments produces a floor-effect with studies classified with high risk of bias.
Objective: Medication errors extend inpatient stay, increase costs and double the risk of death. Identify patients more likely to present prescription errors would be one manner that could be used to decrease the impact of such events. Thus, the present study identified the prevalence of prescription errors with patients with oncohematologic diseases and the factors associated with these events. Methods: A cross-sectional study was performed in a Brazilian tertiary hospital. Data regarding service, patients and their clinical condition, drug therapy and prescription errors were retrieved and analyzed. Results: Of 344 drug prescriptions identified, 26.2% showed at least one prescription error, mainly involving a wrong drug (48.3%). According to the logistic regression, the factors associated with errors include: presence of neutropenia OR 1.92 (95% CI 1.10–3.35), physicians on holiday or weekend shifts OR 0.40 (95% CI 0.18–0.86) and prescriptions with higher proportion of parenteral administration route OR 1.05 (95% CI 1.03–1.08). Conclusion: In conclusion, identify the factors associated with errors can be useful in developing clinical tools for predicting patients at higher risk for the occurrence of prescribing errors, as well as to contribute to the optimization of health professionals’ clinical performance.
INTRODUCTION:Despite the significant impact of cardiovascular disease (CVD), there is not yet an analytical decision tool for assessing efficiency of interventions to prevent primary CVD events in Brazil. Therefore, we sought to adapt a Scottish CVD Policy Model to be used in the proposed population.METHODS:Calibration consisted of identifying multiplicative factors for linear predictors of existing survival analysis models to produce predictions that closely match observed data (Life-table and Brazilian cohort study). Target data were life expectancy (LE) and cumulative incidence of coronary heart disease (CHD), cerebrovascular disease (CBVD), fatal CVD and fatal non-CVD. Root-Mean-Square-Error (RMSE) was used to estimate differences between predictions and observations. Acceptance criteria were defined as a fit of less than one year for LE and 1% for cumulative incidence. Male and female models were built separately.RESULTS:The original model underestimated LE (RMSE=2.85 for men and 1.91 for women), CHD and CBVD for women (RMSE=0.044 and 0.041, respectively). The calibration process identified multiplicative factors to reach acceptance criteria for the four target data mentioned above (RMSE=0.61, 0.21, 0.016 and 0.017, respectively). Over prediction was identified only for CHD events in men (RMSE=0.031) being further calibrated (RMSE=0.008). All other target data met the acceptance criteria. Overall, the calibrated model predicts properly to individuals aging 35-80 years old, diabetics or not, smokers or not, with or without family history of CVD, and presenting at least one of the risk factors uncontrolled: Systolic Blood Pressure, Total Cholesterol or HDL-Cholesterol.DISCUSSION:This is the first decision analytic model capable of assessing efficiency of interventions that prevent primary CVD events in Brazil. In future research, independent external validation should be carried out to corroborate the reliability of the model outputs.
Objective: Pharmacists have adopted an active role in asthma management. This review aimed to analyze the intervention dose, understood as the "amount of program delivered," and core components of the intervention provided by pharmacists in asthma management. Data sources: A literature search was conducted in December 2016 using PubMed. Study selection: A 2-stage approach was used. At the first stage, systematic reviews of pharmacists' interventions in asthma management were identified. At the second stage, primary studies included in the systematic reviews were selected. Data extraction: The DEPICT-2 (Descriptive Elements of Pharmacist Intervention Characterization Tool) was used for data extraction. In addition GINA (Global Initiative for Asthma) guidelines were used as a reference to classify the interventions' core components. Results: Thirty-one studies were included. In most of the studies, the pharmacistepatient intervention occurred at the community pharmacy setting (n = 22). The most common core components used in pharmacists' interventions were the provision of drug information and patient counseling (n = 27). Pharmacists' interventions frequently were targeted at assessing and improving the use of patient's inhaler technique (n = 27). Educational materials and written action plans were the materials most commonly used in the interventions (n = 20). The duration (n = 13) and the frequency (n = 16) of the intervention were the most frequent information about the intervention dose measure reported. Conclusion: Pharmacists' interventions in asthma management are complex. Structured educational programs and patient counseling appear to be the most frequent core components of pharmacists' interventions. Interventions were focused on providing information about the condition and on inhaler technique assessment and training. However, most studies failed to report the intervention dose sufficiently to be reproduced. The reporting of this indicator is crucial to ensure the reproducibility of the interventions assessed and their implementation in practice. (C) 2018 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Brazilian version was self-applied in 500 psychiatric and 50 non-psychiatric patients in an outpatient medical centre. The instrument was reapplied in 50 psychiatric patients whose treatment with psychotropics was not altered, and in 100 whose it was altered. Confirmatory factor analysis confirmed the theoretical dimensional model proposed by the WHO for the WHODAS 2.0 36- item scale, and a simpler alternative model for the WHODAS 2.0 12-item scale. All the items of the WHODAS 2.0 was proven to be valid and reproducible for use in people with mental disorders from Brazil. The WHODAS 2.0 scores differentiate psychiatric from non-psychiatric patients and exhibited a significant correlation with the Global Assessment of Functioning scale. However, the 12-item scale was more responsive to changes in the patients’ treatment than the 36-item scale, and this should be considered for Diagnostic and Statistical Manual of Mental Disorders.
Objective: The purpose of this overview (systematic review of systematic reviews) is to evaluate the impact of clinical decision support systems (CDSS) applied to medication use in the care process. Methods: A search for systematic reviews that address CDSS was performed on Medline following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane recommendations. Terms related to CDSS and systematic reviews were used in combination with Boolean operators and search field tags to build the electronic search strategy. There was no limitation of date or language for inclusion. We included revisions that investigated, as a main or secondary objective, changes in process outcomes. The Revised Assessment of Multiple Systematic Reviews (R-AMSTAR) score was used to evaluate the quality of the studies. Results: The search retrieved 954 articles. Five articles were added through manual search, totaling an initial sample of 959 articles. After screening and reading in full, 44 systematic reviews met the inclusion criteria. In the medication-use processes where CDSS was used, the most common stages were prescribing (n=38 (86.36%) and administering (n=12 (27.27%)). Most of the systematic reviews demonstrated improvement in the health care process (30/44 – 68.2%). The main positive results were related to improvement of the quality of prescription by the physicians (14/30 – 46.6%) and reduction of errors in prescribing (5/30 - 16.6%). However, the quality of the studies was poor, according to the score used. Conclusion: CDSSs represent a promising technology to optimize the medication-use process, especially related to improvement in the quality of prescriptions and reduction of prescribing errors, although higher quality studies are needed to establish the predictors of success in these systems.
ABSTRACT Pharmacists and their pharmacies have been evolving in their roles as health promoters in Brazil. Some examples are the recent legislation reaffirming the role of Brazilian pharmacies as health institutions, rather than having only a commercial profile, giving greater clarity to pharmacists about their roles as health care providers. This evolution came with the recognition that is already seen in other developed countries, confirming the need for the pharmacist as a health promoter, and not simply a dispenser of drugs in society. This study has obtained the profile and activities of community pharmacists, as well as the quality indicators of private community pharmacies throughout the State of Paraná through the application of an online survey sent to pharmacists in the state. Out of all pharmacists surveyed, 533 were part of the final analysis, being the pharmacists to complete the survey in full. Participants were mostly female (69.4%) and were, on average, 35.2 ± 9.2 years old. Of these, 60% worked in pharmacy chains and just 37% of all pharmacist respondents were issuing the Declaration of Pharmaceutical Services. The current study showed that many pharmaceutical services are not adopted by pharmacies as these services bring no significant financial reward. Regarding the structure, the Paraná State showed that pharmacies present a good overall structure. The kind of pharmacy (chain or independent) influenced the pharmaceutical services provided and the available structure, where the independent pharmacies provide a wider range of services and have better structure. This study was able to identify the profile and behaviors of pharmacists and also the quality indicators of pharmacies in Paraná State.
Antiobesity pharmacotherapy remains the main point of disagreement among both scientists and regulators. This is probably due to small sample sizes, high levels of heterogeneity, and low methodological quality. For many years, Brazil was one of the largest consumers of appetite suppressants worldwide, with evidence of irrational use of this drug class. Therefore, the country was the scene of a debate that divided the Brazilian Health Surveillance Agency (Anvisa - Agência Nacional de Vigilância Sanitária) and medical societies over the maintenance record of diethylpropion, mazindol and fenproporex. In this context, this commentary presents new arguments to contribute to the discussion, as well as recommendations for future studies.
The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term (<180 days; mean difference (MD) -1.281 kg; p<0.05; I2: 0.0%; p=0.379) and long-term (≥180 days; MD -6.518 kg; p<0.05; I2: 0.0%; p=0.719). Only studies with long-term follow up reported efficacy in terms of abdominal circumference and 5-10% weight reduction. These results corroborated the finding that the efficacy of amfepramone is greater than that of placebo. Treatment with mazindol showed greater short-term weight loss than that with placebo (MD -1.721 kg; p<0.05; I2: 0.9%; p=0.388). However, metabolic outcomes were poorly described, preventing a meta-analysis. A mixed treatment comparison corroborated the direct meta-analysis. Considering the high level of risk of bias and the absence of important published outcomes for anti-obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status.
Background and purpose: The aim of this study was to analyze the implementation of an active methodology in a blended model of education in the teaching-learning processes of students enrolled in two disciplines: Pharmaceutical Care I and Pharmaceutical Care II, both part of the undergraduate Bachelor of Pharmacy program at the Federal University of Parana. Educational activity and setting: The study design was quasi-experimental, prospective, comparative, following a pre/posttest format, where Pharmaceutical Care classes were the intervention. Identical pre- and post-intervention tests were designed based on Anderson and Krathwohl's (2001) revision of Bloom's taxonomy, and according to the three levels of the cognitive domain: remember and understand; apply and analyze; evaluate and create. Findings: Participants were 133 students enrolled in the two Pharmaceutical Care classes. A significant difference between pre- and posttest results was observed, showing an increase in students' performance in the applied tests at all cognitive levels. This is the first study of its kind involving Pharmaceutical Care and Blended Learning. Discussion and summary: By comparing the results of the diagnostic and summative assessments based on Bloom's taxonomy at all levels of the cognitive domain, positive results were observed regarding the students' performance in the two disciplines (Pharmaceutical Care I and II).
The chronic care model (CCM) uses a systematic approach to restructure health care systems. The aim of this systematic review was to examine studies that evaluated different elements of the CCM in patients with type 2 diabetes mellitus (T2DM) and to assess the influence of the CCM on different clinical outcomes. There view was performed in the Medline and Cochrane Library electronic databases. The search was limited to randomized controlled trials conducted with T2DM patients. Studies were eligible for inclusion if they compared usual care with interventions that use done or more elements of the CCM and assessed the impact on clinical outcomes. After applying the eligibility criteria, 12 studies were included for data extraction. Of these, six showed evidence of effectiveness of the CCM for T2DM management in primary care as well as significant improvements in clinical outcomes. In the other six studies, no improvements regarding clinical outcomes were observed when comparing the intervention and control groups. Some limitations, such as a short follow-up period and a low number of patients, were observed. Some studies showed that the reorganization of health systems can improveT2DM care. However, it is possible that greater benefits could be obtained through combing all 6 elements of CCM.
Background Adherence to prescribed drug therapy is associated with lower rates of cardiovascular causes of death. In view of the relevance for public health, it is important to understand the relation between medication adherence tools’ scores, especially in low literacy patients discharged from a cardiology ward. Objectives We aimed to assess: (a) the association between number of controlled clinical conditions and adherence tools scores, and (b) the correlation between the scores of three instruments to assess adherence. Methods We conducted a prospective study and included patients discharged from a specialized cardiovascular ward in Brazil. The results of the Beliefs about Medicines questionnaire (BMQ), the Adherence to Refills and Medication Scale (ARMS) and the MedTake test were compared. Results Of 53 included patients, most of them were elderly, and did not complete primary school. On average, there were six health conditions per patient, where two of them were not controlled. ARMS was the only tool that was associated with number of controlled health conditions (r = −0.312, p < 0.05). Moreover, ARMS (average score 15.6 ± 3.4) had significant correlation with MEDTAKE (r = 0.535, p < 0.01) and BMQ (r = 0.38, p < 0.01). BMQ and MEDTAKE were also positively correlated (r = 0.311, p < 0.05). Conclusions Clinically, higher ARMS scores (>12) suggest assumed non-adherence. It is also negatively correlated with the number of controlled clinical conditions in low literacy elderlies with cardiovascular diseases.