Improving Patient Safety in Medication Management by Medication Reconciliation and Pharmaceutical Care Process in Post-Liver Transplant Clinic.

INTRODUCTION: Liver transplant recipients receive many medications for anti-rejection, infection prophylaxis, and treatment of comorbidities. Most of them also receive medications from multiple sources. Therefore, these patients are prone to drug-related problems (DRPs) and medication errors. This study aimed to study the effect of medication reconciliation (MR) and pharmaceutical care processes by transplant pharmacists in the post-liver transplant clinic. METHODS: This study was a retrospective study in Siriraj Liver Transplant Center, Mahidol University, Thailand. Patients who received pharmaceutical care from transplant pharmacists were compared before and after the implementation of MR (October 2020-September 2021 vs October 2021-September 2022) to assess the prevalence of medication errors and identify DRPs between the 2 groups. RESULTS: Before implementation of MR, in a total of 797 visits, 69 medication errors (8.7%) were found. The most errors were medication omissions (44.9%, n = 31). After the implementation of MR, in a total of 879 visits, 44 medication errors (5.0%) were found. Most were medication omission and incorrect strength (31.8%, n = 14). Medication errors significantly decreased by 36.2% (P < .001) after the implementation of MR. Regarding DRPs, transplant pharmacists could significantly detect more DRPs after implementation of MR, 66 DRPs before implementation of MR vs 111 DRPs after implementation of MR (P < .001). The most DRPs were non-adherence (34 vs 41). CONCLUSIONS: MR can reduce medication errors and assist transplant pharmacists in identifying DRPs that will lead to active intervention by attending physicians and/or patients to improve medication management and patient safety in post-liver transplant care.

The effect of the very low dosage diltiazem on tacrolimus exposure very early after kidney transplantation: a randomized controlled trial.

The objective of this study was to assess the effect of the very low dosage of diltiazem on tacrolimus exposure during the first week post-kidney transplantation, among cytochrome P450 (CYP) 3A5 expressers who did not receive diltiazem (EXplb), CYP3A5 expressers who received the very low dose diltiazem (EXdtz), CYP3A5 nonexpressers who did not receive diltiazem (NEplb), and CYP3A5 nonexpressers who received the very low dose diltiazem (NEdtz). Forty kidney recipients who receive tacrolimus-based immunosuppressive regimen were randomly assigned, with stratification on the CYP3A5 genotypes, to receive either diltiazem 30 mg every 12 h or a matched placebo. The observed median dose-adjusted area under the 12-h curve of tacrolimus concentration (AUC/D) at day 7 post-transplantation was lowest in the EXplb group followed by EXdtz, NEplb, and NEdtz at 34.9, 43.6, 49.4, and 71.1 ng*h/mL per mg, respectively. A Kruskal-Wallis test showed a significant difference in the mean ranks of AUC/D among groups. Significant differences between EXplb and NEplb, and between EXplb and NEdtz were demonstrated, whereas no sufficient evidence of significant differences was detected between the other pairs. In conclusion, coadministration of diltiazem 30 mg twice daily may be advantageous for increasing tacrolimus exposure early after kidney transplantation among CYP3A5 expressers.

Medication Adherence, Complementary Medicine Usage and Progression of Diabetic Chronic Kidney Disease in Thais.

PURPOSE: Non-adherence to medication is receiving more attention as a significant problem common to management of chronic diseases including diabetes and chronic kidney disease (CKD). This study was designed to assess the medication adherence and self-medication in a cohort of Thai patients with diabetic kidney disease, and its association with clinical outcomes. PATIENTS AND METHODS: Non-dialysis patients with diabetic CKD visiting outpatient's clinics of Siriraj Hospital, the largest tertiary care in Thailand, were asked for participation. Self-administered questionnaire was given to assess medication adherence (the 6-item-medication-taking-behavior measure in Thai), complementary medicine usage, and personal information. Clinical, pharmaceutical, and relevant laboratory data (at current and the last visit of around 12 months) were abstracted from the medical records. RESULTS: Of the 220 participants eligible (54.1% male, mean age 71.3), 50.9%, 24.1%, and 25% were classified as high-, medium-, and low-medication adherence, respectively. Overall, 24.1% reported self-usage of at least one type of herbal or complementary medicines. The most commonly identified items were cordyceps, cod liver oil, Nan Fui Chao, and turmeric (6 each), with unidentified Thai herbal mixture in 11. On multivariate analysis, late-stage CKD (stage IV-V) was the only independent predictor for low adherence (odds ratio (OR), 5.54; 95% confidence interval (CI), 2.82-10.88). Low adherence was associated with higher blood pressure, lower estimated glomerular filtrate rate (eGFR), and more eGFR decline with greater risk of being rapid CKD progressor (annual eGFR drop >5 mL/min/1.73 m2) [OR, 1.15; 95% CI, 1.06-1.25]. CONCLUSION: Medication taking behavior was a frequently encountered problem in Thai diabetic CKD patients. Increased medication non-adherence was independently predicted by stages of increasing CKD severity, and it was associated with poorer hypertensive control and kidney outcome. Targeting interventions to improve medication adherence should be an important strategy to slow CKD progression among patients with diabetic CKD.

The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism.

BACKGROUND: Secondary hyperparathyroidism (SHPT) is associated with high incidences of cardiovascular disease, bone fracture, and mortality. This study was conducted to demonstrate the effectiveness of cinacalcet treatment on chronic kidney disease-mineral bone disorder (CKD-MBD) markers in chronic hemodialysis patients with severe SHPT. METHODS: In phase 1, 30 adult HD patients were randomized to cinacalcet or control groups for 12 weeks to explore the achievement of >30% reduction of iPTH. In phase 2, 45 patients were participated to further explore the effect of cinacalcet on CKD-MBD parameters for 24-week follow up and 12 additional weeks after cinacalcet discontinuation. RESULTS: In phase 1, the baseline serum iPTH levels were not different [1374 (955, 1639) pg/mL in the control group vs. 1191 (1005, 1884) pg/mL in the cinacalcet group], the percentage of patients achieving iPTH target were significantly higher in the treatment group [80% vs. 13%, p = .001]. In phase 2, the significant reductions of iPTH, FGF-23, tartrate-resistant acid phosphatase 5b, and slightly decreased size of parathyroid gland and stabilized vascular calcification were observed at 24-week follow up and markedly rebounded after discontinuation of cinacalcet. CONCLUSIONS: The effectiveness of cinacalcet were still obviously demonstrated even in chronic HD patients with severe SHPT. In addition, the improvements of bone markers and FGF-23, and stabilization of vascular calcification were observed. Therefore, cinacalcet can provide salutary effects on CKD-MBD in severe SHPT and might be an initially effective PTH-lowering therapy prior to surgical parathyroidectomy as well as an alternative treatment in the patients unsuitable for surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02056730. Date of registration: February 4, 2014.

Validation of a 2-Point Limited Sampling Strategy to Predict the Tacrolimus Area-Under-the-12-Hour-Curve in Kidney Transplant Recipients.

BACKGROUND: Limited sampling strategies (LSS) have been proposed for predicting total exposure of tacrolimus, a widely used immunosuppressant in transplantation. This study aims to validate the equation developed by Wong et al for estimation of the tacrolimus area-under-the-concentration-over-12-hour-curve (AUC0-12) and to assess the effects of hemoglobin and duration of tacrolimus therapy on predictive performance of the equation in adult kidney transplant recipients. METHODS: Seven time point blood concentration profiles were collected from 31 stable kidney transplant recipients who received oral tacrolimus twice daily. The chemiluminescent microparticle immunoassay method was used to determine the tacrolimus concentration. Measured AUC0-12 (AUCm) was calculated by the linear trapezoidal rule. Predicted AUC0-12 (AUCp) was calculated using the equation that used tacrolimus concentrations measured at 2 hours (C2) and 4 hours (C4) after dose: 16.2 + 2.4(C2) + 5.9(C4). Predictive performance of the equation was determined by calculating bias and precision. Agreement between AUCp and AUCm was assessed. The effects of hemoglobin and duration of tacrolimus therapy on bias and precision were also evaluated. RESULTS: The median (interquartile range) of AUCm was 133.00 (98.25, 185.70) ng·h·mL. The AUCp well correlated with the AUCm (r = 0.962, P < 0.001). The equation had a mean percentage prediction error of -2.22% (95% CI, -5.14 to 0.71), mean absolute percentage prediction error of 6.67% (95% CI, 4.92-8.42), and root mean squared error (%CV) of 14.08 (10.29%) ng·h·mL. A Bland-Altman plot showed good agreement between AUCp and AUCm with a mean bias of -5.43 ng·h·mL (95% CI, -10.28 to -0.59). The hemoglobin level and duration of tacrolimus therapy did not influence the predictive performance of the equation. CONCLUSIONS: The equation had low bias and high precision in predicting the AUC0-12 of tacrolimus. The equation is a simple and reliable tool for estimating tacrolimus exposure.