The impact of a lipid injectable emulsion (SMOF) on conjugated bilirubin levels in children receiving prolonged parenteral nutrition: A large single center experience.

BACKGROUND: The SMOFlipid is a composite emulsion that has showed benefits, but limited data is available on children receiving prolonged parenteral nutrition (PN). This study aimed to compare conjugated bilirubin (CB) levels at the end of ILE administration in this population. METHODS: Medical charts of all infants treated with Intralipid (Jan 2012-Sep 2013) or SMOFlipid (Oct 2013-Dec 2016) were reviewed. Only infants that received PN for ≥28 consecutive days were included. Laboratory data were extracted from the closest day of initiation and discontinuation of the ILE (±7 days). For the primary objective, an analysis of covariance was employed, adjusting for initial CB values and total days of ILE administration. CB values were log-transformed to normalize distribution. Statistical tests were two-sided and performed at the significance level <0.05. RESULTS: A total of 150 infants were included: 72 used Intralipid for 82 times and 88 received SMOFlipid in 92 occasions. The incidence of cholestasis was 20% (Intralipid) and 4.5% (SMOFlipid). Infants treated with SMOFlipid had significantly lower CB levels at the end of ILE administration with geometric mean ratio between groups of 1.7 (95% CI:1.0, 2.8; p < 0.05). CONCLUSION: In a large and heterogenous group of infants receiving PN for ≥28 consecutive days the final levels of CB were significantly lower with SMOFlipid when compared to Intralipid suggesting a protective role of this type of ILE in this high-risk population. CLINICAL RELEVANCY STATEMENT: SMOFlipid is an emulsion that has showed benefits, but limited data is available on children receiving prolonged parenteral nutrition (PN). This study compared conjugated bilirubin (CB) levels at the end of ILE administration in infants that received PN for ≥28 consecutive days with either SMOFlipid or Intralipid. In a large number of patients with several gastrointestinal diseases lower CB levels were observed with the use of SMOFlipid with geometric mean ratio between groups of 1.7 (95% CI:1.0, 2.8; p < 0.05). Our results demonstrate a protective role of this type of ILE in this high-risk population.

Impact and appreciation of two methods aiming at reducing hazardous drug environmental contamination: The centralization of the priming of IV tubing in the pharmacy and use of a closed-system transfer device.

OBJECTIVES: The main objective was to evaluate the impact of two methods aiming at reducing hazardous drug environmental contamination: the centralization of the priming of IV tubing in the pharmacy and the use of a closed-system transfer device. The secondary objective was to evaluate the satisfaction of pharmacy technicians using a survey. METHODS: Sites in the hematology-oncology satellite pharmacy and care unit were analyzed for the presence of cyclophosphamide, ifosfamide and methotrexate before and after the centralization of the priming of IV tubing in the pharmacy and before and after using a closed-system transfer device. The limits of detection for cyclophosphamide, ifosfamide and methotrexate were, respectively, of 0.0015 ng/cm(2), 0.0012 ng/cm(2) and 0.0060 ng/cm(2). The pharmacy technician satisfaction was evaluated using a questionnaire. RESULTS: A total of 225 samples was quantified. After the centralization of priming in the pharmacy, no significant difference was found in the proportion of positive samples for cyclophosphamide, ifosfamide and methotrexate. Traces of cyclophosphamide found on the floor in patient care areas was significantly reduced (median[min-max] 0.08[0.06-0.09]ng/cm(2) vs. 0.03[0.02-0.05], p < 0.0001). After using a closed-system transfer device, a significant difference was found for the proportion of cyclophosphamide positive samples (15/45(33%) vs. 0/45(0%), p < 0.0001), but no significant difference was found for ifosfamide (12/45(27%) vs. 5/45(11%), p = 0.059) and methotrexate (1/45(2%) vs. 2/45(4%), p = 0.557). Pharmacy technicians raised issues following the centralization of priming (e.g. workload) and the use of closed-system transfer devices (e.g. spills, particles, workload and handling difficulties). CONCLUSION: The centralization of the priming of IV tubing in the pharmacy reduced floor contamination in patient care areas without increasing surface contamination in the pharmacy. Closed-system transfer devices reduced contamination in pharmacy, but handling issues were raised by pharmacy technicians.