Publications by authors named "Maria Auxiliadora Parreiras Martins"

43 Publications

Mechanisms and interactions in concomitant use of herbs and warfarin therapy: An updated review.

Biomed Pharmacother 2021 Aug 30;143:112103. Epub 2021 Aug 30.

Department of Pharmaceutical Products, Faculty of Pharmacy, Universidade Federal de Minas Gerais, Av. Antônio Carlos 6627, Belo Horizonte, Minas Gerais, Brazil; Consórcio Acadêmico Brasileiro de Saúde Integrativa, CABSIN, Brazil. Electronic address:

This review is an updated and expanded version published in this journal in 2016. Warfarin pharmacotherapy is extremely complex, since in addition to being a low therapeutic index drug, it does not follow the dose-response pattern and has characteristics that predispose the occurrence of interactions, such as high binding rate to plasma proteins, metabolization by cytochrome P450 enzymes, further to acting in the complex process of blood coagulation, platelet activation, and inflammation. For these reasons, warfarin has great potential for interaction with drugs, foods, and herbal medicines. Herb-warfarin interactions, however, are still not very well studied; thus, the objective of this update is to present new information on the subject aiming to provide a scientific basis to help health professionals in the clinical management of these interactions. A literature review was performed from May to June 2021 in multiple databases and articles published in 2016 to 2021 were included. A total of 59 articles describing 114 herbal medicines were reported to interact with warfarin. Of the plants mentioned, 84% had the potential to increase warfarin effect and the risk of bleeding. Targets possibly involved in these interactions include the processes of blood coagulation, platelet activation, and inflammation, in addition to the pharmacokinetics and pharmacodynamics of warfarin. Despite these alarming numbers, however, the clinical management of interactions is known to be effective. Thus, it is important that the use of these herbal medicines be done with caution in anticoagulated patients and that studies of herb-drug interactions be encouraged in order to generate information to support the clinical management of patients.
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http://dx.doi.org/10.1016/j.biopha.2021.112103DOI Listing
August 2021

Self-report instruments for assessing adherence to warfarin therapy: a systematic review.

Eur J Clin Pharmacol 2021 Jul 22. Epub 2021 Jul 22.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, 31270-901, Brazil.

Background: The assessment of adherence to warfarin therapy is useful in clinical practice due to its wide variability in dose-response and risks of complications. The aim of this study was to investigate validated instruments used to assess adherence to warfarin therapy.

Methods: Information was collected from the MEDLINE (PubMed), LILACS, EMBASE, and Cochrane Library databases. Search strategies were applied for each database, with no time limit or language restriction. Inclusion criteria consisted of study participants of ≥ 18 years of age, from both sexes, on chronic anticoagulation with warfarin for any indication and the use of validated instruments to assess adherence to warfarin therapy. Exclusion criteria consisted of duplicate articles, narrative or systematic reviews, and meta-analyses, as well as case reports/series and experimental studies involving animals. Two independent reviewers performed the following steps: evaluation of titles/abstracts, selection of studies after full reading, data extraction, and evaluation of potential bias. Discrepancies were resolved by a third reviewer.

Results: Overall, 19 articles were selected for this systematic review, including 17 cross-sectional studies, one cohort study, and one quasi-experimental study, published from 2009 to 2019. The validated instruments identified in this review were Morisky Medication Adherence Scale (MMAS), the eight-item Morisky Medication Adherence Scale (MMAS-8), Measurement of Treatment Adherence (MTA), and Brief Medication Questionnaire (BMQ). Only MMAS-8 was tested for reliability, using the internal consistency assessment, with Cronbach's α range 0.56-0.71.

Conclusions: This review highlighted a gap in knowledge regarding the scarcity of validated instruments to assess adherence to warfarin therapy. Limitations were found in instruments that comprised the assessment of the isolated use of medication and the lack of analysis of other relevant therapeutic aspects. Future studies are needed to develop and validate more comprehensive instruments in an attempt to assess adherence to warfarin therapy.

Prospero: Registration number CRD42019128324.
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http://dx.doi.org/10.1007/s00228-021-03168-zDOI Listing
July 2021

Medication literacy: A conceptual model.

Res Social Adm Pharm 2021 Jun 7. Epub 2021 Jun 7.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, 6627 Presidente Antônio Carlos Ave., Pampulha, Belo Horizonte, Minas Gerais, Brazil.

Background: Medication literacy reflects the specific literacy skills necessary to act on medication-related information. A comprehensive and clear conceptual model that reflects medication literacy is lacking. Conceptual models describe the components that represent a construct, allowing for its understanding and providing a rationale for its measurement.

Objectives: To propose a conceptual model to support the development of an instrument to measure medication literacy.

Methods: This is a three-phase methodological study. A literature review was conducted to identify the components that should be part of the preliminary conceptual model. Subsequently, the importance of its components was judged on a Likert-5 scale. Then, the model was refined, and the dimensions and subdimensions of medication literacy were defined.

Results: Forty-five experts were included, with a mean age of 39.9 (SD = 10.5) years, most of them females (86.7%) and pharmacists (80%). All components of the preliminary conceptual model were considered important to extremely important by most experts. "Dosing information", "medication name", and "processing the information received about their medication and acting upon medication instructions" were the components considered most important. In the refinement phase, we identified that the construct has four dimensions - functional literacy, communicative literacy, critical literacy, and numeracy, which include the subdimensions to access, understand, evaluate, calculate, and communicate medication-related information.

Conclusions: The conceptual model allowed identifying the components that represent medication literacy, which will support the development of an instrument for measuring the construct in Brazil.
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http://dx.doi.org/10.1016/j.sapharm.2021.06.003DOI Listing
June 2021

Effectiveness and usability of mobile health applications to medication adherence for heart failure: a systematic review protocol.

JBI Evid Synth 2021 Jun 1. Epub 2021 Jun 1.

Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil Centro de Ciências da Saúde, Universidade Federal do Recôncavo da Bahia, Santo Antônio de Jesus, Brazil Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

Objective: This review will assess the effectiveness and usability of mobile health applications to improve medication adherence in patients with heart failure.

Introduction: Inadequate medication adherence by heart failure patients is a major cause of negative clinical outcomes, high rates of hospital readmissions, and death, thus increasing the costs to patients and the health care system. Several studies have shown that the use of mobile health applications improves self-care by heart failure patients, including medication adherence. Therefore, gathering evidence on these studies will help researchers and clinicians understand the impact of such interventions on patient care.

Inclusion Criteria: Eligible studies will evaluate medication adherence and include participants aged ≥18 years diagnosed with heart failure who are using app-based (software) interventions. Experimental and observational studies will be included. We will exclude studies with interventions that used mobile applications without functionality to assist the user in organizing and taking their medications.

Methods: Articles published to the present day, without restrictions of language, will be selected from Embase, MEDLINE, LILACS, Scopus, Web of Science, CINAHL, and Cochrane Library. Two independent reviewers will perform article screening, assessment of methodological quality, and data extraction using JBI assessment and extraction instruments. Discrepancies will be solved by consensus and a third reviewer will be consulted if necessary. A narrative synthesis of findings will be presented, and statistical analysis will be used only when appropriate.

Systematic Review Registration Number: PROSPERO CRD42020147816.
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http://dx.doi.org/10.11124/JBIES-20-00399DOI Listing
June 2021

Primary cutaneous histoplasmosis difficult to treat in immunocompetent patient: case report and literature review.

Einstein (Sao Paulo) 2021 24;19:eRC5488. Epub 2021 May 24.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.

Histoplasmosis is an infection caused by the dimorphic fungus Histoplasma capsulatum. The disease is endemic in several regions of tropical and temperate climate. The fungus presents opportunistic behavior, causing widespread infection in immunocompromised patients, resulting from complication of primary pulmonary infection, due to exogenous reinfection or reactivation of a quiescent source. In immunocompetent individuals, approximately 95% of pulmonary infections are asymptomatic. However, prolonged exposure to high amount spores may lead to acute or chronic lung infection. Due to the low amount of inoculum, primary cutaneous histoplasmosis caused by traumatic implantation is extremely rare and effectively treated with triazoles. Thus, the present study aims to report a case of primary cutaneous histoplasmosis that is difficult to treat in an immunocompetent patient, and to review the literature on the incidence of drug-resistant Histoplasma capsulatum strains in clinical practice.
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http://dx.doi.org/10.31744/einstein_journal/2021RC5488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8121373PMC
May 2021

Effectiveness of local hemostatic to prevent bleeding in dental patients on anticoagulation: A systematic review and network meta-analysis.

J Craniomaxillofac Surg 2021 Jul 29;49(7):570-583. Epub 2021 Apr 29.

School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

This study aimed to determine the effectiveness of hemostatic protocols to prevent bleeding in dental procedures among individuals undergoing oral anticoagulation therapy. A systematic review and network meta-analysis were accomplished. Searches of literature and grey literature were performed in different electronic databases. Clinical trials were considered as part of the inclusion criteria. Data extraction and assessment of the risk of bias of the included articles were performed. Assessment of the certainty of evidence was also performed. As results we find that the N-butyl-2-cyanoacrylate [RR -35.00 (95% CI - 107.12, -5.78)], calcium sulfate (CaSO) [RR -5.62 (95% CI -11.41, -1.03)], and tranexamic acid (TXA) [RR -3.46 (95% CI -7.63, -0.77)] showed beneficial effects compared to placebo. However, only TXA presented beneficial effects with moderate certainty evidence. N-butyl-2-cyanoacrylate and CaSO presented very low certainty evidence. In the comparisons between the hemostatic agents, no differences were observed. For the mean bleeding time, no significant difference in the comparisons was observed as well. Concluding, bleeding events in individuals on oral anticoagulation decreased with the use of TXA compared to placebo. N-butyl-2-cyanoacrylate and CaSO were also superior to placebo, but the certainty of evidence was low. For the mean bleeding time, no significant difference in hemostatic agents was observed.
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http://dx.doi.org/10.1016/j.jcms.2021.04.014DOI Listing
July 2021

Sex-influence on the time in therapeutic range (TTR) during oral anticoagulation with coumarin derivatives: Systematic review and meta-analysis.

Br J Clin Pharmacol 2021 May 11. Epub 2021 May 11.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627, Pampulha, Belo Horizonte, Minas Gerais, 31270-901, Brazil.

Aims: We sought to investigate the association between sex and oral anticoagulation control employing coumarin derivatives.

Methods: Electronic sources were MEDLINE, Biblioteca Virtual em Saúde (BVS), The Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, Cochrane Central and Web of Science. Inclusion criteria were: observational and experimental studies; age ≥18 years; both sexes; treatment with any coumarin derivative for ≥3 months; any indication of long-term use; quality of oral anticoagulation measured by time in therapeutic range (TTR). The meta-analysis was developed with odds ratios (OR) for binary variables and mean differences (MD) for continuous variables, using random-effects models (DerSimonian and Laird) with 95% confidence intervals (CI).

Results: Overall, 22 articles were selected, comprising 16 cohort studies, four cross-sectional studies and two clinical trials. The number of participants ranged from 110 to 104 505 (183 612; women: 45%). The main indication of oral anticoagulation was atrial fibrillation. Most studies reported the use of warfarin. In the meta-analysis, 15 studies were analysed using TTR as a binary variable (OR = 0.87; 95% CI = 0.78, 0.96; z = -2.75; P = .006.; I  = 67%) and seven studies as a continuous variable (MD = -2.97; 95% CI = -4.80, -1.14; z = -3.19; P = .0014; I  = 75%). The pooled estimates indicated that women were associated with lower TTR than men.

Conclusions: Our findings revealed an association between female sex and worse oral anticoagulation control. Further studies are needed with primary design to investigate sex-related factors influencing oral anticoagulation control with coumarin derivatives. Innovative strategies focused on women's health may be useful to improve patient-centred care.
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http://dx.doi.org/10.1111/bcp.14892DOI Listing
May 2021

Oral Health-Related Quality of Life in Anticoagulated Patients with Warfarin Treatment: A Cross-Sectional Study.

Int J Environ Res Public Health 2021 04 2;18(7). Epub 2021 Apr 2.

School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte CEP 31270-901, Brazil.

To evaluate factors associated with oral health-related quality of life (OHRQoL) in patients under oral anticoagulant therapy with warfarin, a cross-sectional study was conducted. Validated questionnaires assessed self-reported periodontal disease, demographic variables, and OHRQoL using the short version of the Oral Health Impact Profile (OHIP-14) instrument. After calibration (Kappa > 0.60), an examiner evaluated patients' experience with dental caries and the need for dental prostheses. Statistical analysis involved proportions and measures of central tendency. Negative binomial regression models were used to estimate the rate ratios (RR) and the corresponding 95% confidence interval (CI). The sample consisted of 158 individuals, with a mean age of 58.8 years (SD = 12.1), of which 62.7% of the participants were women. The OHIP-14 mean was 10.62 (SD = 10.92). A higher OHIP-14 total score (worse OHRQoL) was associated with ethnic group, age, periodontal disease self-report, dental caries, and oral health self-report. Demographic and clinical factors can negatively influence the perception of anticoagulated patients on OHRQoL.
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http://dx.doi.org/10.3390/ijerph18073714DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037600PMC
April 2021

Relationship of health literacy and adherence to oral anticoagulation therapy in patients with atrial fibrillation: a cross-sectional study.

J Thromb Thrombolysis 2021 Apr 15. Epub 2021 Apr 15.

Faculdade de Medicina, Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 190, Santa Efigênia, Belo Horizonte, Minas Gerais, CEP 30130-100, Brazil.

Oral anticoagulant therapy (OAT) has increased substantially due to the aging population and prevalence rise of atrial fibrillation (AF). Medication adherence is important to achieve effectiveness and safety of OAT. The study aim was to investigate the relationship between health literary (HL) and the adherence to OAT in patients with atrial fibrillation (AF). This is a cross-sectional study conducted in a public cardiology clinic in Brazil, 2019. Sociodemographic and clinical data were collected by the review of medical records and interviews with patients. The relation between health literacy (HL) and adherence to OAT was investigated by a multiple logistic regression model. Overall, 100 AF patients were included in this study, with average age of 68.8 ± 13.8 years and predominance of women (54 %). Inadequate HL was found in 79 % of the patients and non-adherence was identified in 66 % of the participants. Sex was the only variable with a statistically significant association with non-adherence to OAT. Men presented a 2.54-fold greater chance of non-adherence to OAT, when compared to the women (Odds ratio (OR) = 2.54; 95 % confidence interval (CI): 1.03-6.62; p = 0.047). No statistically significant relationship was found between inadequate HL and non-adherence to OAT (OR 1.48; 95 % CI, 0.47-4.61; p = 0.49). High rates of inadequate HL and non-adherence to OAT were identified in this study; however, this relationship did not prove to be statistically significant. Further studies are needed to investigate factors associated with non-adherence to OAT in large samples of vulnerable populations and strategies for its improvement in public health.
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http://dx.doi.org/10.1007/s11239-021-02432-4DOI Listing
April 2021

Empowerment-oriented strategies to identify behavior change in patients with chronic diseases: An integrative review of the literature.

Patient Educ Couns 2021 04 15;104(4):689-702. Epub 2021 Jan 15.

Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil. Electronic address:

Background: Chronic diseases in the Americas account for about 80 % (5.2 million) of all deaths. Instruments are needed to enhance knowledge, skills, behavior change and self-care attitudes drawing on patient autonomy.

Objective: To identify empowerment-oriented strategies focused on behavioral change in patients with chronic diseases.

Patient Involvement: None.

Methods: This is an integrative review of articles published from any period until June 2020 by journals indexed in the following databases: National Library of Medicine National Institutes of Health (PubMed), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Biblioteca Virtual em Saúde (BVS).

Results: Out of 1,287 articles, 25 met our selection criteria. Reported health interventions were based on self-management and behavior change, shared decisions and a personalized collaborative process, peer support and self-confidence, as well as strategies involving educational media and health literacy.

Discussion: Over 80 % of health interventions were patient-centered and focused on patient knowledge and skill development towards personal goal setting, including effective problem-solving strategy development. Behavior change is not only an outcome of education, but also implicates revisiting values, attitudes, and experiences. Knowledge is important to facilitate decision-making leading to positive outcomes in chronic disease management.

Practical Value: Empowerment-oriented strategies are important tools for providing trust and motivation to people with chronic diseases. Healthcare professionals should support and encourage patient empowerment as a strategy for behavior change and able to offer qualified care for shared decision making. Thus, patients will be able to participate more actively in their own health condition management and to make decisions to promote self-care.
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http://dx.doi.org/10.1016/j.pec.2021.01.011DOI Listing
April 2021

Influence of sex-based differences on oral anticoagulation control in patients taking coumarin derivatives: a systematic review protocol.

JBI Evid Synth 2021 02;19(2):477-483

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

Objective: This review will aim to assess the influence of sex-based differences on oral anticoagulation control in patients taking coumarin derivatives.

Introduction: Coumarin derivatives, such as warfarin, have a narrow therapeutic index, requiring frequent monitoring to achieve adequate anticoagulation control, which can be assessed by the time in therapeutic range. Differences in the quality of oral anticoagulation control between men and women have been reported, although the current evidence is controversial. A systematic review on this topic would provide results that could be incorporated into clinical practice to enhance oral anticoagulation control and treatment outcomes.

Inclusion Criteria: Observational and experimental studies were assessed for eligibility, with participants aged ≥18 years of either sex taking oral anticoagulation or other coumarin derivatives for ≥3 months, for any indication of chronic use, who had oral anticoagulation control evaluated by time in therapeutic range.

Methods: Electronic databases to be searched include MEDLINE, BVS, CINAHL, Embase, Cochrane CENTRAL, and Web of Science. Two reviewers will independently perform title/abstract selection and screening, and then full text retrieval and screening of articles that meet the inclusion criteria. The evaluation of methodological quality and data extraction will also be performed by two independent reviewers. Data will be synthesized in tables and then the compiled results will be meta-analyzed. In the presence of subgroup differences, meta-regression methods will be used to investigate the effects of categorical or continuous covariates. If statistical pooling is not possible, a narrative synthesis will be presented.

Systematic Review Registration Number: PROSPERO (CRD42019128329).
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http://dx.doi.org/10.11124/JBIES-20-00168DOI Listing
February 2021

Effectiveness of hemostatic protocols for the prevention of bleeding during oral procedures among individuals receiving anticoagulation therapy: a systematic review protocol.

JBI Evid Synth 2020 11;18(11):2409-2415

Department of Community and Preventive Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

Objective: The objective of this review is to determine the effectiveness of hemostatic protocols for the prevention of bleeding during dental procedures among individuals receiving oral anticoagulation therapy.

Introduction: Dental procedures may increase the chance of bleeding in individuals receiving oral anticoagulation therapy. The literature suggests different hemostatic protocols for the prevention of bleeding in these individuals but offers no consensus regarding their effectiveness.

Inclusion Criteria: Randomized controlled clinical trials comparing the effectiveness of different hemostatic protocols for the prevention of bleeding during oral procedures among individuals 18 years or older receiving oral anticoagulation therapy will be included.

Methods: Computerized searches will be conducted in seven electronic databases. Gray literature and searches in the reference lists of the included articles will also be screened. Two independent reviewers will assess titles/abstracts for potential inclusion against the eligibility criteria. References that meet the eligibility criteria will be included without restriction on the language or date of publication. Assessment of the methodological quality of the included articles and data extraction will be performed. Statistical heterogeneity of meta-analysis will be assessed. In the event of high statistical heterogeneity, sensitivity analysis will be performed. Subgroup analysis will be planned. The certainty of the evidence will be evaluated with the Grading of Recommendations, Assessment, Development and Evaluation.

Systematic Review Registration Number: PROSPERO CRD42019136744.
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http://dx.doi.org/10.11124/JBISRIR-D-19-00342DOI Listing
November 2020

Assessment of the complexity of drug therapy and psychosocial and behavioral aspects in people living with type 2 diabetes mellitus.

Int J Clin Pharm 2021 Jun 30;43(3):743-747. Epub 2020 Oct 30.

Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

Background Type 2 diabetes mellitus is a public health problem worldwide. The complexity of drug therapy and behavioral aspects are important factors in its management. Objective To characterize the complexity of drug therapy, attitudes, empowerment and self-care in people with type 2 diabetes mellitus. Methods Observational descriptive study involving people with type 2 diabetes mellitus recruited in eight public primary care settings in Brazil, 2018. We used validated instruments to determine the complexity of drug therapy employing the Medication Regimen Complexity Index, and to describe the behavioral aspects, encompassing Diabetes Attitudes Questionnaires, Diabetes Empowerment Scale-Short Form and Diabetes Mellitus Care Self-Management. Results The 119 participants showed median age of 64 years (Quartile 1 57.0; Quartile 3 71.0) with predominance of women (68.1%). We found high percentages of participants with low scores on attitudes (87.9%) and self-care (84.8%) questionnaires, but with high scores on empowerment questionnaire (81.8%) in groups with high complexity of drug therapy. Conclusion High complexity of drug therapy concentrated low scores for attitudes and self-care, even though presenting elevated empowerment scores. Further studies are needed to investigate the effect of these aspects on the behavior of people with type 2 diabetes mellitus on drug therapies of high complexity.
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http://dx.doi.org/10.1007/s11096-020-01183-1DOI Listing
June 2021

Preparedness of pharmacists to respond to the emergency of the COVID-19 pandemic in Brazil: a comprehensive overview.

Drugs Ther Perspect 2020 Jul 31:1-8. Epub 2020 Jul 31.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627, Campus Pampulha, Belo Horizonte, Minas Gerais 31270-901 Brazil.

The outbreak of COVID-19 in low- and middle-income countries is worrisome due to the social inequalities in these countries, their limited health budgets and the significant burden of other acute and chronic diseases. The leap in the number of cases in Brazil has imposed a huge strain on the healthcare system. We sought to provide a comprehensive overview of the challenges encountered by pharmacy services in responding to the COVID-19 pandemic emergency in Brazil and discuss the role of clinical pharmacists in this context. Pharmaceutical services play a key role in the emergency response to the pandemic. The pharmacy workforce has been actively working to manage drug shortages, redesign workflow, and review drug formularies/protocols to improve safety for patients and healthcare professionals (HCPs). COVID-19 patients may present high risk in the use of medications and clinical pharmacists can contribute substantially as part of a multidisciplinary team to improve outcomes in drug therapy in severe and critical illness. The participation of pharmacists as members of antimicrobial stewardship programs should be enhanced to ensure appropriate and safe use of antibiotics in this context. HCPs should be encouraged to seek improvements in the performance of pharmaceutical services and innovative practices to respond to the pandemic. Further studies are needed to generate knowledge on COVID-19 to improve patient care in vulnerable populations.
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http://dx.doi.org/10.1007/s40267-020-00761-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393336PMC
July 2020

A simple and sensitive HPLC-FL method for simultaneous determination of angiotensin II receptor antagonists in human plasma.

J Pharm Biomed Anal 2020 Sep 4;188:113403. Epub 2020 Jun 4.

Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos 6627, 31270-901, Belo Horizonte, MG, Brazil. Electronic address:

Angiotensin II receptor antagonists are one of the most widely used classes of antihypertensive drugs. In this study, an HPLC fluorescence method after protein precipitation (PPT) extraction was developed and validated for determination of olmesartan, losartan, irbesartan, and valsartan in human plasma. The separation was carried out on a Luna cyano (250 × 4.6 mm i.d.; 5 μm particle size) column and the mobile phase was composed of acetonitrile and 0.1 % phosphoric acid in gradient elution, at a flow rate of 1.2 mL min. A PPT method was optimized by a two-level factorial design with triplicate at the central point. The parameters that could affect the extraction (sample volume and acetonitrile/plasma volume ratio) were evaluated and the method was compared to microextraction by packed sorbent (MEPS) and liquid-liquid extraction (LLE). The developed method allowed the simultaneous quantification of the analytes employing a simple and cheap sample preparation method and a short chromatographic run (13 min). This method was fully validated showing selectivity, precision, accuracy, and linearity over the range of 25.0-1500.0 ng mL for olmesartan and valsartan, 25.0-2500.0 ng mL for irbesartan, and 35.0-2500.0 ng mL for losartan. Finally, the method was successfully applied in the analysis of human plasma from volunteers.
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http://dx.doi.org/10.1016/j.jpba.2020.113403DOI Listing
September 2020

Acute kidney injury biomarkers in the critically ill.

Clin Chim Acta 2020 Sep 12;508:170-178. Epub 2020 May 12.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627, Pampulha, Belo Horizonte, Minas Gerais 31270-901, Brazil; Faculdade de Medicina da Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 190, Bairro Santa Efigênia, Belo Horizonte, Minas Gerais 30130-100, Brazil; Hospital das Clínicas da Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 110, Bairro Santa Efigênia, Belo Horizonte, Minas Gerais 30130-100, Brazil. Electronic address:

Acute kidney injury (AKI) is a highly common complication in intensive care units (ICUs). Novel biomarkers might accelerate the detection and management of AKI. We performed a systematic review aiming to evaluate the performance of biomarkers for early AKI diagnosis in ICUs. MEDLINE, BVS, CINAHL, COCHRANE and EMBASE were searched for studies (2006-2019) on the use of biomarkers for AKI diagnosis. Preselected biomarkers were cystatin C, chitinase-3-like protein-1 (UCHI3L1), neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1) and interferon-gamma-inducible protein 10 (IP-10/CXCL-10), measured in plasma or urine. Eleven articles with total of 2,289 patients were included. The most cited biomarker was NGAL (n = 7 studies; 63.6%). Biomarkers with the highest sensitivity (se) and specificity (sp) were urinary heat shock protein (HSP-72) (se = 100%; sp = 90%) and urinary IL-18 (se = 92%; sp = 100%). All biomarkers' performance was influenced by the presence of comorbidities or AKI etiology. Although some biomarkers showed good performance, there was no externally validated biomarker for early AKI diagnosis. Thus, from this review, we did not indicate a novel biomarker to be promptly used in clinical practice. Prospective studies with a large number of patients are needed to expand knowledge in this field. PROSPERO registration number CRD42016037325.
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http://dx.doi.org/10.1016/j.cca.2020.05.024DOI Listing
September 2020

Assessment of patient knowledge on warfarin: An item response theory approach.

J Clin Pharm Ther 2020 Aug 27;45(4):698-706. Epub 2020 Apr 27.

Faculty of Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

What Is Known And Objective: There are no instruments to assess the patient's knowledge of oral anticoagulation with warfarin, in which the performance of the items has been evaluated through the item response theory. To evaluate psychometric properties of the Brazilian version of the Oral Anticoagulation Knowledge Test, using the item response theory.

Methods: This methodological study was developed in an anticoagulation clinic of a university hospital with a sample of 201 patients treated with warfarin. The item response theory was used to evaluate questions regarding psychometric properties and the performance of the Brazilian version of the Oral Anticoagulation Knowledge Test items. The unidimensionality hypothesis was analysed by decomposing the polychoric correlation and the Cronbach's alpha coefficient. An item characteristic curve of the 20 items of the instrument was made to identify the discrimination power of each item of the performance scale.

Results And Discussion: Correlations were positive and statistically significant among the 20 items, with a Cronbach's alpha coefficient of 0.82. The difficulty parameter ranged from -4.14 to 0.42. The discrimination parameter ranged from 0.41 to 1.89. The items regarding drug-drug/drug-food interactions were able to differentiate knowledge about oral anticoagulation with greater accuracy.

What Is New And Conclusion: This study is the first that uses this methodology to evaluate the knowledge on oral anticoagulation therapy with warfarin. The evaluation using item response theory showed that the Brazilian version of the Oral Anticoagulation Knowledge Test is suitable for assessing the patient's knowledge of oral anticoagulation with warfarin. Thus, our findings confirmed the utility of this instrument and provided an essential point of reference for the structuring of health education activities that ensure the individualization of educational interventions in patients on warfarin.
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http://dx.doi.org/10.1111/jcpt.13147DOI Listing
August 2020

Audit of pre-operative antibiotic prophylaxis usage in elective surgical procedures in two teaching hospitals, Islamabad, Pakistan: An observational cross-sectional study.

PLoS One 2020 7;15(4):e0231188. Epub 2020 Apr 7.

Department of Microbiology, Faculty of Chemical and Life Sciences, Abdul Wali Khan University, Mardan, Pakistan.

An audit of the antibiotic prophylaxis in surgical procedures is the basic area of antimicrobial stewardship programme. The current research aimed to evaluate the adherence-proportion of the pre-operative antibiotic prophylaxis (PAP) practices in common elective surgical procedures. It was an eight-month (January 2017 to August 2017) observational cross-sectional patients' treatment record-based study conducted at two tertiary care teaching hospitals of Islamabad, Pakistan. We investigated the three most commonly performed elective general surgical procedures at the hospitals in adults aged > 18 years with no previous infection or surgery. The required data were extracted from the medical charts. Current prescribing practices were compared with the standard prescribing guidelines. A total of 660 (Government Hospital (GH), n = 330 and Private Hospital (PH), n = 330) procedures were observed. The most commonly performed elective general surgical procedures were laparoscopic cholecystectomy 307/660 (46.5%), followed by direct inguinal hernia 197/660 (29.8%) and total thyroidectomy 156/660 (23.6%). Non-use of PAP was observed in 64/660 (9.7%) cases. PAP was given to 90.3% (n = 596/660) cases (300/330 (90.9%) patients in GH and 296/330 (89.7%) in PH; P = 0.599). Based on the existing guidelines, the choice of antibiotics was correct in only 4.2% (25/596) patients (10/300; 3.3% cases at GH and 15/296; 5% at PH). The appropriate use of antibiotics was significantly greater in direct inguinal hernia (n = 19/193; 9.8%) cases compared with that in total thyroidectomy (n = 4/152; 2.6%) and laparoscopic cholecystectomy (n = 2/251; 0.8%) cases; P = 0.001. Compliance to the timing was only 51% (n = 304/596) of the total patients received PAP which was significantly lower in GH 97/300 (32.3%) as compared with that in PH 207/296 (69.9%); P = 0.001. Administration timing of antibiotics was observed to be more appropriate in total thyroidectomy (n = 79/152; 51.9%) cases than in laparoscopic cholecystectomy (n = 130/251; 51.8%) and direct inguinal hernia (n = 95/193; 49.2%) cases; P = 0.001. The route and dose were appropriate in accordance with the guidelines in all cases (100%). Most of the patients received ceftriaxone, a third-generation cephalosporin that is no longer recommended by the latest international guidelines. The current analysis revealed an alarmingly poor adherence rate with the guidelines in the three elective surgical procedures at both hospitals. To improve the situation, training and awareness programs about the antimicrobial stewardship interventions on the institutional level may be valuable.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0231188PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7138312PMC
July 2020

Adverse reactions to meglumine antimoniate in Brazilian inpatients with visceral leishmaniases: A case series.

J Clin Pharm Ther 2020 Jun 2;45(3):573-576. Epub 2019 Dec 2.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

What Is Known And Objectives: Adverse drug reactions (ADR) related to the treatment of visceral leishmaniasis (VL) can cause severe clinical complications. We report a case series of ADR in hospitalized VL patients on meglumine antimoniate (MA).

Case Description: Seven cases of patients taking MA had at least one objective evidence for suspected ADR, including electrocardiographic, laboratory or clinical alteration.

What Is New And Conclusion: Meglumine antimoniate is highly toxic. Adherence to treatment guidelines is important. Pharmacists working in multidisciplinary teams may contribute to early detection and management of MA therapy-related ADR.
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http://dx.doi.org/10.1111/jcpt.13089DOI Listing
June 2020

Instruments for the assessment of patient adherence to oral anticoagulation with warfarin protocol for a systematic review.

Medicine (Baltimore) 2019 Oct;98(42):e17323

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte.

Background: Non-adherence can be highlighted as one of the main contributors to the occurrence of adverse events in patients treated with warfarin. The usefulness of self-reporting measures of drug adherence could be improved by following psychometric properties in the development of the measurement scales. Thus, we aimed to describe the protocol of a systematic literature review designed to investigate and describe validated instruments used to assess adherence to warfarin therapy.

Methods: We will perform a systematic review will include observational and experimental studies involving the use of validated instruments to assess adherence to warfarin therapy. Dimensions of adherence raised by the selected studies will be extracted to be compared. We will systematically search electronic databases including MEDLINE, LILACS, EMBASE, and Cochrane Library using a comprehensive strategy from inception to June 31, 2019. Two reviewers will revise the literature independently using a standardized form and assess the potential bias. After the comparison of results, discrepancies will be solved after the analysis of a third reviewer.

Result: The development of the present systematic will help to summarize and evaluate the validated instruments that have been previously published to assess adherence to warfarin therapy.

Conclusion: This review will substantiate the discussion of relevant topics that should be assessed while providing care to patients taking warfarin. This knowledge will enable a comprehensive approach for healthcare professionals to improve treatment outcomes and the design of future investigations.

Registration: The systematic review is registered in the PROSPERO international prospective register of systematic review (PROSPERO# CRD42019128324).
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http://dx.doi.org/10.1097/MD.0000000000017323DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824815PMC
October 2019

Vancomycin-associated nephrotoxicity in non-critically ill patients admitted in a Brazilian public hospital: A prospective cohort study.

PLoS One 2019 5;14(9):e0222095. Epub 2019 Sep 5.

Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.

Introduction: Vancomycin is widely used to treat infections caused by Gram positive bacteria, mostly methicillin-resistant strains. Despite its therapeutic effectiveness, vancomycin is a nephrotoxic drug that has been associated with the occurrence of acute kidney injury (AKI). In this study, we sought to evaluate the variability of serum trough concentrations of vancomycin and to determine the incidence and risk factors of vancomycin-associated nephrotoxicity (VAN) in non-critically ill patients.

Methods: This was a prospective cohort including Brazilian public hospital inpatients from April 2017 to June 2018. The participants received intravenous vancomycin therapy for at least 48 hours for any suspected or confirmed infection by Gram positive bacteria. Demographic, clinical and laboratory data were collected. Information on vancomycin therapy and concomitant use of other nephrotoxic drugs were also recorded. Patients were followed up until discontinuation of vancomycin treatment or death, whatever occurred first. The primary outcome was the occurrence of AKI. We performed a Poisson regression to determine risk factors for AKI.

Results: Overall, 98 participants were included in the study. Median age was 55.9 (interquartile range [IQR] 40.6-66.8) years and 58 (59.2%) were men. Most of them showed subtherapeutic (<10mg/L) or supratherapeutic (>20mg/L) trough levels of vancomycin; 42.9% and 15.3%, respectively. A total of 19 (19.4%) patients developed AKI. Poisson regression showed that male sex (odds ratio [OR] 2.90; confidence interval [CI] 95% 1.28-6.53; p = 0.011), concomitant use of piperacillin-tazobactam (OR 4.66; CI 95% 2.26-9.58; p <0.001) and vancomycin trough levels above 20mg/mL (OR 4.21; CI 95% 1.57-11.278; p = 0.004) were independently associated with AKI.

Conclusions: Our study showed that usual doses of vancomycin did not reach recommended therapeutic serum trough levels of vancomycin in non-critically ill patients. Besides that, nephrotoxicity was common in this population, being associated with male sex, concomitant use of piperacillin-tazobactam and supra-therapeutic trough serum levels of vancomycin.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0222095PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728013PMC
March 2020

A national study on the use of opioid analgesics in dentistry.

Braz Oral Res 2019 Aug 15;33:e076. Epub 2019 Aug 15.

Universidade Federal de Minas Gerais - UFMG, School of Dentistry, Department of Community and Preventive Dentistry, Belo Horizonte, MG, Brazil.

The aim of this study was to assess the frequency of opioid analgesics prescribed by Brazilian dentists, potential regional differences and their association with socioeconomic and health-related factors. Data for all opioid prescriptions by dentists was obtained from the 2012 database of the National Controlled Substances Management System, regulated by the Brazilian Health Surveillance Agency. The number of defined daily doses (DDD) and DDDs per 1,000 inhabitants per day for each Brazilian state were calculated as the primary outcomes. DDDs were compared by regions and Brazilian states. Spearman's rho correlation coefficient was used to determine the influence of the states' characteristics, such as the Human Development Index; poverty; education; number of dentists per 100,000 inhabitants; visit to the dentist; dental care plan; good or very good oral health; number of pharmaceutical establishments per 100,000/inhabitants; and ability to get all prescribed medications. Data analysis was performed using IBM SPSS Statistics 25.0. A total of 141,161 prescriptions for opioids analgesics by 36,929 dentists were recorded, corresponding to 658,855 doses of opioids dispensed in 2012. The most commonly dispensed opioids were codeine associated with paracetamol (83.2%; n = 117,493). The national DDDs per 1,000 inhabitants per day was 0.0093 (range: 0.0002-0.0216). DDD per 1,000 inhabitants per day was positively associated to visits to dentists (rs = 0.630; P < 0.001) and inversely associated to poverty (rs = -0.624; p = 0.001). There are significant differences in opioid prescriptions in dentistry among the Brazilian states. These differences may be associated with non-clinical factors.
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http://dx.doi.org/10.1590/1807-3107bor-2019.vol33.0076DOI Listing
August 2019

Algorithm for predicting low maintenance doses of warfarin using age and polymorphisms in genes CYP2C9 and VKORC1 in Brazilian subjects.

Pharmacogenomics J 2020 02 9;20(1):104-113. Epub 2019 Aug 9.

Faculdade de Medicina, Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 190, Santa Efigênia, Belo Horizonte, Minas Gerais, 30130-100, Brazil.

Warfarin exhibits a wide variation in dose requirements. We sought to evaluate the association of polymorphisms CYP2C9*2 (rs1799853), CYP2C9*3 (rs1075910), and VKORC1-G1639A (rs9923231) and nongenetic factors with maintenance doses of warfarin <17.5 mg/week and to create an algorithm to predict drug sensitivity. This is a retrospective cohort study including 312 patients assisted at an anticoagulation clinic in Brazil. The mean age of participants was 60.4 ± 13.5 years and 59.9% were female. The logistic regression model included: age [odds ratio (OR) 1.03, 95% confidence interval (CI) 1.01-1.06], genotype VKORC1 AA (OR 31.61, 95% CI 11.20-100.15) and genotype CYP2C9 2/2, 2/3 or 3/3 (OR 16.48, 95% CI 3.37-81.79). The creation of our algorithm involved warfarin-experienced patients on stable doses, identifying factors associated with drug sensitivity. The validation of this algorithm allows its use in future populations to determine the initial dose distinguishing patients with dose requirements <17.5 mg and reducing time to achieve stable doses.
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http://dx.doi.org/10.1038/s41397-019-0091-3DOI Listing
February 2020

Protocol of a clinical trial study involving educational intervention in patients treated with warfarin.

Medicine (Baltimore) 2019 May;98(22):e15829

Faculdade de Farmácia.

Background: Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. Oral anticoagulation is an effective strategy for primary and secondary prevention of stroke in patients with AF. Warfarin is an oral anticoagulant widely prescribed and, despite its benefits, the achievement of the goals of drug therapy depends on patient involvement, among other factors. Educational interventions can contribute for effectiveness and safety of oral anticoagulation therapy. We sought to describe the protocol of a clinical trial designed to evaluate the effect of a patient-centered educational strategy focused on low-income patients with AF and poor anticoagulation control.

Methods: Patients ≥18 years with AF, on warfarin for at least 6 months and time in therapeutic range (TTR) <60% will be recruited at 2 anticoagulation clinics (ACs) in Brazil. Patients from 1 AC will be allocated to the intervention group and patients from the other AC will be allocated to the control group. Intervention group will attend educational sessions based on a patient-centered care approach, and the control group will receive usual care. The intervention will be based on Paulo Freire's theory and tailored according to practices involving health empowerment and techniques applied to individuals with limited socioeconomic status. The intervention is estimated to last 5 months. We will consider TTR as the primary outcome and knowledge and self-reported non-adherence to warfarin therapy as secondary outcomes. TTR values and non-adherence will be measured before intervention (T0) and at times immediately after (T1), and 3 (T2), 6 (T3), 9 (T4), and 12 (T5) months after intervention. Knowledge will be measured at times T0, T1 e T5. The calculated sample size indicated 85 patients in each group.

Discussion: The proposed study aims to investigate whether an innovative educational approach to deliver care to a low-income population on warfarin improves anticoagulation control. Once our hypothesis is confirmed, our findings are expected to help improving anticoagulation control, knowledge on warfarin therapy and adherence to drug therapy. Thus, we believe our results may contribute to improve oral anticoagulation effectiveness in a low-income population.

Trial Registration: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR- 9cy6py and UTN: U1111-1217-0151 (March, 2019).
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http://dx.doi.org/10.1097/MD.0000000000015829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709162PMC
May 2019

Suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups.

Einstein (Sao Paulo) 2018 Nov 8;16(4):eAO4354. Epub 2018 Nov 8.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.

Objective: To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups.

Methods: A descriptive study of drugs with pediatric indication included in a retrospective cohort of new drugs registered in Brazil. The evaluation of drug suitability for the pediatric age group was performed using the following criteria: suitability of dosage form and capacity to deliver the recommended dose. The drugs were considered adequate for the pediatric age groups when they met both criteria. The statistical analysis included calculation of frequencies and proportions.

Results: Suitability due to the drug capacity to deliver the recommended dose was greater than 80% across all age groups. Regarding suitability of the dosage form, we identified that the older the age group, the greater suitability for pediatric use. Concerning the drugs presented in solid dosage form, we showed that half were classified as inadequate for one or more pediatric age groups to whom they were indicated. The adequacy of drugs to the pediatric age group was 64.3% for preschool children, 66.7% for full-term newborns, 66.7% for premature newborns, and over 70% for other age groups.

Conclusion: Drugs for children aged under 6 years were less often adequate, considering the dosage form and capacity to provide the recommended dose. The availability and proportional suitability of medicines for pediatric use are greater for older age groups, according to age groups the drug is registered for.
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http://dx.doi.org/10.31744/einstein_journal/2018AO4354DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223947PMC
November 2018

Predictive ability of scores for bleeding risk in heart disease outpatients on warfarin in Brazil.

PLoS One 2018 19;13(10):e0205970. Epub 2018 Oct 19.

Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.

Introduction: Bleeding is a common complication in patients taking warfarin. We sought to compare the performance of nine prediction models for bleeding risk in warfarin-treated Brazilian outpatients.

Methods: The dataset was derived from a clinical trial conducted to evaluate the efficacy of an anticoagulation clinic at a public hospital in Brazil. Overall, 280 heart disease outpatients taking warfarin were enrolled. The prediction models OBRI, Kuijer et al., Kearon et al., HEMORR2HAGES, Shireman et al., RIETE, HAS-BLED, ATRIA and ORBIT were compared to evaluate the overall model performance by Nagelkerke's R2 estimation, discriminative ability based on the concordance (c) statistic and calibration based on the Hosmer-Lemeshow goodness-of-fit statistic. The primary outcomes were the first episodes of major bleeding, clinically relevant non-major bleeding and non-major bleeding events within 12 months of follow-up.

Results: Major bleeding occurred in 14 participants (5.0%), clinically relevant non-major bleeding in 29 (10.4%), non-major bleeding in 154 (55.0%) and no bleeding at all in 115 (41.1%). Most participants with major bleeding had their risk misclassified. All the models showed low overall performance (R2 0.6-9.3%) and poor discriminative ability for predicting major bleeding (c <0.7), except Shireman et al. and ORBIT models (c 0.725 and 0.719, respectively). Results were not better for predicting other bleedings. All models showed good calibration for major bleeding.

Conclusions: Only two models (Shireman et al. and ORBIT) showed at least acceptable performance in the prediction of major bleeding in warfarin-treated Brazilian patients. Accurate models warrant further investigation to be used in similar populations.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0205970PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6195286PMC
April 2019

Drug therapy and other factors associated with the development of acute kidney injury in critically ill patients: a cross-sectional study.

PeerJ 2018 14;6:e5405. Epub 2018 Aug 14.

Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.

Background: Acute kidney injury (AKI) is associated with a significant increase in morbidity, mortality, and health care costs. In intensive care units (ICU), AKI is commonly multifactorial and frequently involves diverse factors, such as hypovolemia, sepsis, and the use of nephrotoxic drugs. We aimed to investigate drug therapy and other factors associated with the development of AKI in a Brazilian public hospital.

Methods: This is a cross-sectional study involving critically ill patients at an ICU of a tertiary hospital. All data on sequential serum creatinine (S) level, glomerular filtration rate (GFR), and urine output were collected during ICU stay. The primary outcome was the occurrence of AKI assessed by the Acute Kidney Injury Network (AKIN) criterion. Sociodemographics, clinical data and drug therapy were considered as covariates. Factors associated with AKI were assessed using logistic regression.

Results: Overall, 122 participants were included in the study. Median age was 46.0 (interquartile range, IQ = 29.0-69.0) years, with a predominance of men (58.2%). Mean number of prescribed drugs throughout ICU stay was 22.0 ± 9.4. The number of potentially nephrotoxic drugs ranged from two to 24 per patient. A total of 29 (23.8%) ICU patients developed AKI. In the AKI-group, patients were older and showed higher Acute Physiology and Chronic Health Evaluation II (APACHE II) scores at admission, higher rates of sedation, mechanical ventilation, and infection. More drugs in general and specifically more vasoactive drugs were prescribed for AKI group. Patients who developed AKI tended to have extended stays in the ICU and a lower probability of being discharged alive than patients with no AKI development. Model adjustments of logistic regression showed that the number of medications (OR 1.15; 95% CI [1.05-1.27]) was the only factor associated with AKI in this study. This association was independent of drug nephrotoxicity.

Discussion: Intensive care is characterized by its complexity that combines unstable patients, severe diseases, high density of medical interventions, and drug use. We found that typical risk factors for AKI showed statistical association on bivariate analysis. The contribution of drug therapy in the occurrence of AKI in medical ICUs reinforces the need for prevention strategies focused on early recognition of renal dysfunction and interventions in drug therapy. These actions would help improve the quality of patient care and ensure progress towards medication safety.
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http://dx.doi.org/10.7717/peerj.5405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097492PMC
August 2018

Evaluation of accuracy of IHI Trigger Tool in identifying adverse drug events: a prospective observational study.

Br J Clin Pharmacol 2018 10 8;84(10):2252-2259. Epub 2018 Jul 8.

Hospital das Clínicas, Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 110, Santa Efigênia, Belo Horizonte, Minas Gerais, 30130-100, Brazil.

Aims: Adverse drug events (ADEs) can seriously compromise the safety and quality of care provided to hospitalized patients, requiring the adoption of accurate methods to monitor them. We sought to prospectively evaluate the accuracy of the triggers proposed by the Institute for Healthcare Improvement (IHI) for identifying ADEs.

Methods: A prospective study was conducted in a public university hospital in 2015 with patients over the age of 18. Triggers proposed by IHI and clinical alterations suspected to be ADEs were searched daily. The number of days in which the patient was hospitalized was considered as unit of measure to evaluate the accuracy of each trigger.

Results: A total of 300 patients were included in this study. Mean age was 56.3 years (standard deviation (SD) 16.0), and 154 (51.3%) were female. The frequency of patients with ADEs was 24.7% and with at least one trigger was 53.3%. From those patients who had at least one trigger, the most frequent triggers were antiemetics (57.5%) and 'abrupt medication stop' (31.8%). The sensitivity of triggers ranged from 0.3 to 11.8% and the positive predictive value ranged from 1.2 to 27.3%. Specificity and negative predictive value were greater than 86%. Most patients identified by the presence of triggers did not have ADEs (64.4%). No triggers were identified in 40 (38.5%) ADEs.

Conclusions: IHI Trigger Tool did not show good accuracy in detecting ADEs in this prospective study. The adoption of combined strategies could enhance effectiveness in identifying patient safety flaws. Further discussion might contribute to improve trigger usefulness in clinical practice.
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http://dx.doi.org/10.1111/bcp.13665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6138496PMC
October 2018

Analysis of new drugs registered in Brazil in view of the Unified Health System and the disease burden.

Cien Saude Colet 2018 Jan;23(1):215-228

Programa de Pós-Graduação em Medicamentos e Assistência Farmacêutica, Faculdade de Farmácia, Universidade Federal de Minas Gerais. Av. Antônio Carlos 6627, Pampulha. 31270-901 Belo Horizonte MG Brasil.

The most important aspect of a new drug in terms of public health is its therapeutic value and benefit it provides for the patient and for the society. The aim of this study was to analyze new drugs registered in Brazil between 2003 and 2013 with respect to Pharmaceutical Assistance programs within the Brazilian health system and to the disease burden in the country. In our retrospective cohort study, new drugs registered in Brazil were identified through document analysis of databases and publicly available documents from National Health Surveillance Agency. The data on disease burden in Brazil was obtained from the Global Burden of Disease Study 2012, published by the World Health Organization. The level of therapeutic innovation was determined using the Motola algorithm. Although a total of 159 new medicines were used in the cohort, only 28 (17.6%) were classified as important therapeutic innovations. There is a disproportionate relationship between the percentage of new drugs and the burden of disease, with an under-representation of drugs for infectious respiratory diseases, heart disease, and digestive diseases. Incentive strategies for research and development of medicines should be prioritized to reduce the disparity regarding the burden of disease and to help develop innovative medicines necessary to improve health throughout the country.
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http://dx.doi.org/10.1590/1413-81232018231.21672015DOI Listing
January 2018

Health Literacy and Atrial Fibrillation: Relevance and Future Directions for Patient-centred Care.

Eur Cardiol 2017 ;12(1):52-7

Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.

Atrial fibrillation (AF) is a common cardiac arrhythmia with significant clinical outcomes, and is associated with high medical and social costs. AF is complicated for patients because of its specialised terminology, long-term adherence, symptom monitoring, referral to specialty care, array of potential interventions and potential for adversity. Health literacy is a frequently under-recognised, yet fundamental, component towards successful care in AF. Health literacy is defined as the capacity to obtain, process and understand health information, and has had markedly limited study in AF. However, health literacy could contribute to how patients interpret symptoms, navigate care, and participate in treatment evaluation and decision-making. This review aims to summarise the clinical importance and essential relevance of health literacy in AF. We focus here on central aspects of AF care that are most related to self-care, including understanding the symptoms of AF, shared decision-making, adherence and anticoagulation for stroke prevention. We discuss opportunities to enhance AF care based on findings from the literature on health literacy, and identify important gaps. Our overall objective is to articulate the importance and relevance of integrating health literacy in the care of individuals with AF.
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http://dx.doi.org/10.15420/ecr.2017:2:2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603910PMC
January 2017
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