Pharmaceutical Care Practice and Consequences on Quality of Life and Satisfaction of Diabetic Patients: A Randomized Clinical Trial

Abstract The pursuit of quality of life, which has become marked in recent years, has translated into important population health benefits. This study assessed the quality of life of patients with type 2 diabetes (T2DM) who received pharmaceutical care, and their satisfaction with the service provided in community pharmacies. This single blind, randomized controlled clinical trial included 100 patients. The intervention group (N=47) received pharmaceutical care by a clinical pharmacist and the control group (N=42) received standard care. The Quality of Life Diabetes Questionnaire (DQOL) was used to measure all participants´ quality of life at study enrollment and six months later. Satisfaction of the participants in the intervention group was measured using a validated 14-items questionnaire. At the end of the study, participants in the intervention group had a statistically significant improvement in DQOL scores ( -0.62 x 1.57, p < 0.001) and were highly satisfied with the intervention (96% excellent satisfaction scores). Pharmaceutical care practice was associated with high satisfaction and increased quality of life scores in T2DM patients. These results underscore the important role of pharmacists to improve the health of diabetic patients.

Development and validation of a clinical instrument to predict risk of an adverse drug reactions in hospitalized patients.

OBJECTIVE: Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. METHODOLOGY: Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution's research ethics committee. RESULTS: In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure <79 mmHg, diabetes mellitus, serum urea ≥ 67 mg/dL, serum sodium ≥141 mmol/L, serum potassium ≥4.9 mmol/L, main diagnosis of neoplasia, prescription of ≥3 ATC class B drugs, prescription of ATC class R drugs, prescription of intravenous drugs and ≥ 6 oral drugs. In the validation sample, the ADR risk tool based on those variables showed sensitivity 61%, specificity 73% and area under the ROC curve 0.73. CONCLUSION: We report a clinical tool for ADR risk stratification in patients hospitalized in general wards based on 14 variables.

Risk factors for drug-related problems in a general hospital: A large prospective cohort.

OBJECTIVE: To identify risk factors for potential Drug-Related Problems (DRP) at admission in hospitalized patients. METHODOLOGY: Prospective cohort study conducted in adults patients hospitalized (May 2016 to May 2018) in a general tertiary care hospital in Brazil. Potential DRP were detected by daily review of 100% of electronic medication orders by hospital pharmacists and classified by the Pharmaceutical Care Network Europe classification system (PCNE version 6.2). For the identification of risk factors of potential DRP, backward stepwise logistic regression was used to identify the set of independent predictors among over 120 variables collected in the initial 48 hours after admission in a training set consisting of 2/3 of the study population. The model was validated in the remaining sample. RESULTS: The study population consisted of 1686 patients aged 52.0+/- 18.3 years-old, 51.4% females, with a median length of stay of 3.24 days, and 4.5% in-hospital mortality. The cumulative incidence of potential DRP was 14.5%. Admission for elective surgery and main diagnosis of disease of the circulatory system were associated with reduced risk of DRP (OR 0.41 and 0.57, respectively, p<0.05). The independent risk factors of DRP are heart rate ≥ 80 bpm (OR 1.41, p = 0.05), prescription of more than seven drugs in day 2 (OR 1.63, p = 0.05), prescription in day 1 of drugs of the Anatomical Therapeutic Chemical Code (ATC) class A (alimentary tract and metabolism, OR 2.24, p = 0.003), prescription in day 2 of two or more ATC class A drugs (OR = 3.52, p<0.001), and in day 1 of ATC class J drugs (antiinfectives for systemic use, OR 1.97, p = 0.001). In the validation set, the c-statistic of the predictive model was 0.65, the sensitivity was 56.1% and the specificity was 65.2%. CONCLUSION: This study identified seven independent risk factors of potential DRP in patients hospitalized in a general hospital that have fair predictive performance for utilization in clinical practice.

Analgesic efficacy of lidocaine and multimodal analgesia for chest tube removal: A randomized trial study / Eficácia analgésica da lidocaína e analgesia multimodal na remoção do dreno torácico: Um estudo randomizado controlado / Eficacia analgésica de la lidocaína y la analgesia multimodal para la remoción del tubo torácico: Un estudio con ensayo aleatorio

Objective: to assess the analgesic efficacy of subcutaneous lidocaine and multimodal analgesia for chest tube removal following heart surgery. Methods: sixty volunteers were randomly allocated in two groups; 30 participants in the experimental group were given 1% subcutaneous lidocaine, and 30 controls were given a multimodal analgesia regime comprising systemic anti-inflammatory agents and opioids. The intensity and quality of pain and trait and state anxiety were assessed. The association between independent variables and final outcome was assessed by means of the Chi-squared test with Yates' correction and Fisher's exact test. Results: the groups did not exhibit significant difference with respect to the intensity of pain upon chest tube removal (p= 0.47). The most frequent descriptors of pain reported by the participants were pressing, sharp, pricking, burning and unbearable. Conclusion: the present study suggests that the analgesic effect of the subcutaneous administration of 1% lidocaine combined with multimodal analgesia is most efficacious.

Objetivo: avaliar a eficiência analgésica de lidocaína subcutânea e analgesia multimodal na remoção do dreno torácico após cirurgia cardíaca. Método: sessenta voluntários foram alocados aleatoriamente em dois grupos; 30 participantes no grupo experimental receberam lidocaína subcutânea 1%, e outros 30 do grupo controle receberam o regime de analgesia multimodal compreendendo agentes anti-inflamatórios e opióides sistêmicos. A intensidade e qualidade da dor e Ansiedade Traço Estado foram avaliados. A associação entre variáveis independentes e desfecho final foi avaliada através do Teste Qui-quadrado com correção de Yates e o Teste exato de Fisher. Resultados: os grupos não apresentaram diferenças significante, no que diz respeito à intensidade da dor na remoção do dreno torácico (p= 0,47). Os descritores de dor mais comuns relatados pelos participantes foram dor: de pressão, aguda, como uma picada, queimar/arder e intolerável. Conclusão: o presente estudo sugere que o efeito analgésico da administração de lidocaína 1% combinada com a analgesia multimodal é mais eficiente.

Objetivo: evaluar la eficacia analgésica de la lidocaína subcutánea y la analgesia multimodal para la remoción del tubo torácico después de la cirugía cardíaca. Métodos: sesenta voluntarios fueron asignados aleatoriamente en dos grupos; 30 participantes en el grupo experimental recibieron lidocaína subcutánea al 1%, y 30 controlos recibieron un régimen de analgesia multimodal que comprende agentes antiinflamatorios sistémicos y opioides. La intensidad y calidad del dolor y rasgo y estado de ansiedad se evaluaron. La asociación entre las variables independientes y el resultado final han sido evaluados por medio de la prueba de Chi-cuadrado con corrección de Yates y la prueba exacta de Fisher. Resultados: los grupos no mostraron diferencias significativas con respecto a la intensidad del dolor después de la retirada del tubo torácico (p= 0,47). Los descriptores de dolor más frecuentes informados por los participantes fueron apretado, agudo, punzante, ardiente e insoportable. Conclusión: el presente estudio sugiere que el efecto analgésico de la administración subcutánea de lidocaína al 1% combinada con la analgesia multimodal es eficaz.

How can micelle systems be rebuilt by a heating process?

The aim of this work was to evaluate how an aqueous micellar system containing Amphotericin B (AmB) and sodium deoxycholate (DOC) can be rebuilt after heating treatment. Also, a review of the literature on the physicochemical and biological properties of this new system was conducted. Heated (AmB-DOC-H) and unheated (AmB-DOC) micelles were then diluted at four different concentrations (50 mg · L(-1), 5 mg · L(-1), 0.5 mg · L(-1), and 0.05 mg · L(-1)) to perform physicochemical studies and a pharmacotoxicity assay, in which two cell models were used for the in vitro experiments: red blood cells (RBC) from human donors and Candida parapsilosis (Cp). While potassium (K(+)) and hemoglobin leakage from RBC were the parameters used to evaluate acute and chronic toxicity, respectively, the efficacy of AmB-DOC and AmB-DOC-H were assessed by K(+) leakage and cell survival rate from Cp. The spectral study revealed a slight change in the AmB-DOC aggregate peak from 327 nm to 323 nm, which is the peak for AmB-DOC-H. Although AmB-DOC and AmB-DOC-H exhibited different behavior for hemoglobin leakage, AmB-DOC produced higher leakage than AmB-DOC-H at high concentrations (from 5 mg · L(-1)). For K(+) leakage, both AmB-DOC and AmB-DOC-H showed a similar profile for both cell models, RBC and Cp (P < 0.05). AmB-DOC-H and AmB-DOC also revealed a similar profile of activity against Cp with an equivalent survival rate. In short, AmB-DOC-H showed much less toxicity than AmB-DOC, but remained as active as AmB-DOC against fungal cells. The results highlight the importance of this new procedure as a simple, inexpensive, and safe way to produce a new kind of micelle system for the treatment of systemic fungal infections.