ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1: Background and Adult Considerations.

Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations used as a source of energy and essential fatty acids in parenteral nutrition. Issues associated with ILE use are distinctly different from oral fat and arise from emulsion stability, dose, and infusion tolerance. Since 1975, soybean oil has been the consistent source oil used in ILE formulations in the US. Partly because of safety concerns with the soybean-based ILE and frequent and long-standing problems with product inventory shortages, new ILE products have become available. Gaps in ILE best practices create a risk for ILE safety errors in prescribing, compounding, and administration of these products. This paper provides information on appropriate indications, dosing, and methods to avoid potential errors with ILE products in the US. This paper (Part 1) will focus on ILE background, information, and recommendations for adult patients, whereas Part 2 of this series will focus on neonatal and pediatric patient-specific information.

Single High-dose Vitamin D3 Supplementation in Pediatric Patients With Inflammatory Bowel Disease and Hypovitaminosis D.

OBJECTIVES: The primary aim was to determine the effectiveness of a single high-dose of oral vitamin D3 (stoss therapy) in children with inflammatory bowel disease (IBD) and hypovitaminosis D. Our secondary aim was to examine the safety of stoss therapy. METHODS: We conducted a randomized, prospective study of 44 patients, ages 6 to 21 years, with IBD and 25-hydroxyvitamin D (25-OHD) concentrations <30 ng/mL. Patients were randomized to receive 50,000 IU of vitamin D3 once weekly for 6 weeks (standard of care, SOC group) or 300,000 IU once (stoss group). Serum 25-OHD levels were obtained at baseline, 4 and 12 weeks. Safety monitoring labs were performed at week 4. RESULTS: Thirty-nine of 44 enrolled patients (19 stoss, 20 SOC) completed the study. Baseline vitamin D levels were not significantly different between the groups. Stoss therapy resulted in a substantial rise in 25-OHD levels at week 4, equivalent to the weekly regimen (53.6 ±â€Š17.3 vs 54.6 ±â€Š17.5 ng/mL). At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ±â€Š7.1 vs 40.4 ±â€Š11.9 ng/mL, P = 0.04). A significant interaction with treatment group over time was observed (P = 0.0003). At the week-4 time point, all patients who received stoss therapy had normal serum calcium and PTH levels. Eighty percentage of patients preferred stoss therapy to the weekly regimen. CONCLUSIONS: Stoss therapy was safe and effective in raising 25-OHD in children with IBD commensurate to that of the weekly regimen.

Follow-Up Survey on Functionality of Nutrition Documentation and Ordering Nutrition Therapy in Currently Available Electronic Health Record Systems.

BACKGROUND: This is a follow-up survey to reassess the safety and efficacy of nutrition content in the available electronic health record (EHR) systems. MATERIALS AND METHODS: Members of the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), American Society for Nutrition, and the Academy for Nutrition and Dietetics were asked to participate in an online survey. The survey included questions from a 2012 EHR survey on the safety and efficacy in 5 nutrition content areas as well as questions from previous 2003 and 2011 A.S.P.E.N. parenteral nutrition (PN) surveys. RESULTS: Percent of respondents using an EHR and using the EHR for less than 1 year increased between 2012 and 2014 (86%-94%, P < .05; 11%-16%, P < .05, respectively). However, there was no improvement in the safety and efficacy of the 5 nutrition content areas, with a significant decrease in 2 of these areas, ordering oral nutrition supplements and ordering PN. The top-rated EHR vendors had a higher average favorable response rate in regards to safety and efficacy in the nutrition content areas but even the top-rated EHR vendor had only a 60% average in favorable responses. Reported use of electronic PN ordering and a direct interface between the EHR and the automated compounding device (ACD) significantly increased from 2003 to 2011 to 2014 (29% to 33% to 63% and 16% to 19% to 28%, respectively, P < .05). CONCLUSIONS: This is a call to action to nutrition support clinicians, societies, and organizations to proactively be involved in initiatives to educate clinicians and collaborate with EHR vendors to enhance the EHR systems to improve the safety and efficacy of providing nutrition therapy in hospitalized patients.