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

Abstract

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.

ASPEN lipid injectable emulsion safety recommendations part 2: Neonate and pediatric considerations

“…Newer ILE products, such as OO,SO‐ILE, FO‐ILE, and SO,MCT,OO,FO‐ILE, have alpha‐tocopherol added (Table 2) to limit the amount of PUFA peroxidation, 23 whereas SO‐ILE contains the less bioactive gamma‐tocopherol. Lower plasma lipoprotein concentrations of alpha‐tocopherol have been reported in patients receiving prolonged courses of SO‐ILE, which may increase the risk of developing IFALD 1 …”

“…Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations intended as a source of energy and fatty acids (FAs) for parenteral nutrition (PN) therapy. Issues associated with adult ILE use and safety recommendations have been addressed in part 1 of this series 1 . Part 2 addresses the ILE safety issues in neonatal and pediatric patients.…”

“…The paper is organized into the following sections: ILE indications, prescribing, order review, preparation, administration, and monitoring. ILE products approved for use in the United States are provided in Table 1 1 . Those formulations containing more than one oil will be referred to as “Multi‐oil ILE,” whereas single‐oil emulsions will be referred to as soybean oil ILE (SO‐ILE) or fish oil ILE (FO‐ILE) as applicable.…”

Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial

“…Further, research has shown that the energy needs of infants with CHD may be 20-50% higher than that of healthy children. In 2009, the American Society of Parenteral and Enteral Nutrition recommended feeding protocols as standard for pediatric patients in the intensive care unit (ICU), including a feeding protocol for infants with CHD (17,18). Standardized feeding protocols have been shown to decrease the incidence of necrotizing enterocolitis and death, decrease episodes of sepsis, and reduce the overall duration of hospital stays (18).…”

“…In 2009, the American Society of Parenteral and Enteral Nutrition recommended feeding protocols as standard for pediatric patients in the intensive care unit (ICU), including a feeding protocol for infants with CHD (17,18). Standardized feeding protocols have been shown to decrease the incidence of necrotizing enterocolitis and death, decrease episodes of sepsis, and reduce the overall duration of hospital stays (18). Recent studies suggest that protein-and energy-enriched infant formulas may assist in achieving nutrition targets early and promoting anabolism in critically ill infants (19)(20)(21)(22).…”