Association of Medication Regimen Complexity With Clinical Endpoints in Pediatric Patients With Cystic Fibrosis.

OBJECTIVE: Cystic fibrosis (CF) patients and caregivers are impacted by the number of pharmacological agents and unique administration needs; however, no data currently assesses how medication regimen complexity impacts clinical outcomes in this population. The objective of this study is to evaluate if an association exists between increased medication regimen complexity and clinical endpoints in pediatric patients with CF. METHODS: This retrospective analysis included all pediatric patients with CF (ages 5-20 years) with at least 2 pharmacist encounters and acceptable pulmonary function tests at our pediatric pulmonary clinic during 2017. Each patient's medication regimen was scored using the validated Medication Regimen Complexity Index (MRCI) tool. The primary outcome was the correlation between MRCI score and lung function. Secondary endpoints included growth, number of infections requiring antibiotics, and hospitalizations. RESULTS: MRCI scores of the 113 included patients ranged from 2 to 101 points. A negative correlation was found between initial and final MRCI score and initial and final forced expiratory volume in 1 second (FEV1; r = -0.323, p = 0.0005 and r = -0.287, p = 0.0021, respectively). MRCI scores were negatively correlated with BMI percentile for both encounters (r = -0.162 and r = -0.125) but were not significant. Higher MRCI scores were associated with increased use of oral and intravenous antibiotics and hospital admissions. CONCLUSIONS: Higher MRCI scores are correlated with a significant decrease in FEV1, increased need for antibiotic therapy, and more hospital admissions in pediatric patients with CF. Larger studies are needed to determine if a correlation exists between MRCI score and growth.

Evaluation of the Safety of Intravenous Thiamine Administration in a Large Academic Medical Center.

BACKGROUND/OBJECTIVE: Previous literature describes increased incidence of infusion-related reactions when administering thiamine doses greater than 100 mg as an intravenous (IV) push. The purpose of this evaluation was to assess the safety of administering higher doses of thiamine as IV push compared to infusion. METHODS: A single-center, retrospective review was performed from June to October 2017. Included patients were aged 18 years or older and received 1 dose of IV thiamine 200 mg or greater. Patients were divided into 2 groups: group 1 included patients who received 200-mg IV push and, group 2 included patients who received any dose greater than 200 mg. The primary objective was to quantify and compare rate of adverse reactions between the 2 groups. Institutional thiamine prescribing practices were examined. Wilcoxon Rank Sum and Fischer exact tests were performed. RESULTS: Sixty-six percent of patients were male, and the median age was 55 years (interquartile range [IQR]: 44-63). Fifty percent received 200-mg IV push, 20% received a combination of IV infusion and IV push, and 30% received IV infusion. Adverse reactions possibly due to thiamine administration occurred in 4 (2.0%) patients. One patient received 200 mg via IV infusion, while 3 received 200 mg via IV push. There was no significant difference in adverse reaction rate between IV push and IV infusion administrations (P = .640). CONCLUSION: Our results support administering thiamine doses of 200 mg or less as an IV push. Given lack of robust safety data, it is recommended to continue to dilute doses greater than 200 mg and infuse over 30 minutes.

Safety and tolerability of high-intensity statin therapy in heart transplant patients receiving immunosuppression with tacrolimus.

BACKGROUND: Following heart transplantation (HT), HMG CoA reductase inhibitors (statins) have been shown to reduce total and low-density lipoprotein (LDL) cholesterol, development of cardiac allograft vasculopathy (CAV), and mortality. Studies in HT patients have demonstrated the safety of low/moderate intensity statins; however, little data exist using high-intensity (HI) statins. The study aim was to evaluate the safety and efficacy of HI statins in HT recipients receiving tacrolimus. METHODS: This single-center, retrospective analysis included adult HT recipients from January 1, 2005, to December 31, 2015, who received HI statin therapy during posttransplant follow-up. The primary outcome, tolerability, was defined as the absence of myalgias, hepatotoxicity, rhabdomyolysis, or HI statin dose reduction/discontinuation. The secondary end point was the mean reduction in total and LDL cholesterol. RESULTS: Among the 24 patients included, one experienced myalgias and therapy discontinuation (4%; P > 0.99). No other HI statin dose reduction/discontinuation occurred, and no instances of rhabdomyolysis or hepatotoxicity were observed. The average reduction in total and LDL cholesterol after conversion to HI statin was 35 mg/dL (P = 0.02) and 19 mg/dL (P = 0.10), respectively. CONCLUSIONS: High-intensity statin therapy appears safe and efficacious in HT recipients receiving tacrolimus and is a reasonable option for the treatment of refractory hyperlipidemia.