Parenteral nutrition preparations are considered a high-alert medication according to ISMP Medication Safety Self-Assessment® for High-Alert Medications. The chances for errors, contamination, and complications related to PN therapy are high. Standardization is a suggested strategy to ensure patient safety associated with PN therapy. As mentioned in the 2007 American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), position statement on PN standardization, a standardized, commercial PN product available from a manufacturer requires limited compounding.1− 2
Ready-made PN formulations are prepared in single-container or multi-chamber bags, usually cited as “premixed” despite the fact that they need mixing in the pharmacy before administration. Ready-made formulations have been marketed as safer and more efficient delivery systems for nutrients compared with traditional formulations compounded manually or by automated compounder machines.3 The marketed two-chamber bag contains amino acids in one chamber and dextrose in the other chamber. Bags with and without added electrolytes in final volumes of 1 L and 2 L have been available in markets over past years.1 The lipid can be given through a Y-connector inserted in the IV catheter. While three- chamber bags contain the same elements of the two-chamber bags, the third chamber contains lipids.1 Multichambered PN with compounded formulations are an available formulation choice for hospitalized patients to best meet an institution’s patient needs.3 The benefits of using the ready-made parenteral solutions compared to the customized solutions include reduced medication error throughout the whole preparation process, reduced incidents of bloodstream infections (BSIs), and possible lower cost.4–5 To accommodate particular patient demands for electrolytes, vitamins, and minerals, these positive impacts must be weighed against the need for individual adaptation.6
The ready-made parenteral solutions are made with a fixed number of calories and electrolytes designed to fit the majority of the population. Thus, there are major limitations, including that ready-made solutions cannot be used in populations requiring higher protein requirements (e.g., obese, underweight, and CRRT patients), a possible inability to maintain electrolyte balances in patients who require higher or lower requirements (e.g., HF patients, CKD or AKI, and post bone marrow transplant), and difficulty achieving target calories/day while maintaining the patient’s hydration status.7 In conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism, and sepsis, SmofKabiven should be prescribed with caution.8 SmofKabiven® is a premixed PN available on the market. Approved by the FDA in August 2014 to be used in patients 2 years and older, SmofKabiven® is the first premixed PN added to King Faisal Specialist Hospital’s formulary in 2015. SmofKabiven is a three-chamber container available in different pack sizes: 960 ml, 1080 ml, 1200 ml, 1320 ml, 1440 ml, 1560 ml, 1680 ml, 1800 ml, and 1920 ml. Each bag contains amino acids (3.2 g/100 mL), dextrose anhydrous (7.1 g/100 mL), and lipids (2.8 g/100 mL) with electrolytes. Each component is located in a separate chamber. These components must be mixed before administration and should be administered via a central line, as the maximum allowed peripheral osmolarity is 900 mOsmol/L for adults.7− 8 Contraindications for use, as defined by the manufacturer, are hypersensitivity to fish-, egg-, soya-, or peanut protein or corn (maize) and corn products or to any of the active substances or excipients; severe hyperlipidemia; severe liver insufficiency; severe blood coagulation disorders; congenital errors of amino acid metabolism; severe renal insufficiency without access to hemofiltration or dialysis; unstable conditions (such as extreme post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma); uncontrolled hyperglycemia; and elevated serum levels of any of the included electrolytes. In addition, the manufacturer includes uncontrolled hyperglycaemia contraindications to infusion therapy, such as acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency. Previous literature compared the use of compounded monobags with industrially manufactured three-chamber bags. MCB-PN had proven benefits compared to customized PN in terms of reduced cost and reduced risk of BSIs. This study was conducted to evaluate the nutritional efficacy and safety of MCB-PN. In terms of efficacy, the percentage of patients who achieved calculated target calories and protein and the percentage of patients who developed electrolyte imbalances were evaluated. In terms of safety, the incidence of BSI and MCB-associated complications developed during the treatment period were evaluated.