• Mirtallo J, Canada T, Johnson D, Kumpf V, Petersen C, Sacks G, Seres D, Guenter P, Task Force for the Revision of Safe Practices for Parenteral Nutrition. Sterile compounding of parenteral nutrition formulations. In: Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr 2004 Nov-Dec;28(6):S57-61. [11 references]

This is the current release of the guideline.

Screening the Parenteral Nutrition (PN) Order

1. The calorie, protein, fluid, electrolyte, vitamin, trace element and medication content is reviewed for each and every PN prescription to assure that a complete and balanced nutrient formulation is provided. Balanced is defined as the presence of the proper proportion of calories, protein, fluid, electrolytes, vitamins and trace elements, to assure adequate use by and assimilation into the body.
2. Each of the PN components should be assessed for appropriateness of dose and for the potential of a compatibility or stability problem.
3. Any dose of a nutrient outside a normal range that is not explained by a specific patient condition or history shall be questioned and clarified before the PN is compounded.

PN Compounding

1. The additive sequence in compounding shall be optimized and validated as a safe and efficacious method.
2. If the manual method currently in use at an institution has not been recently reviewed, or if the contract with a particular manufacturer of macronutrients is about to change, then a review of the compounding method is strongly recommended. This review shall include an evaluation of the most current literature as well as consultation with the manufacturer when necessary.
3. Manufacturers of automated methods of PN compounding shall provide an additive sequence that ensures the safety of the compounding device. This compounding sequence should be reviewed with the manufacturer of the parenteral nutrient products used by the institution. As most institutions in the U.S. are represented by buying groups with many participants, such buying groups should not only ensure the safety and support of the automated compounding device, but should avoid splitting PN contracts (mixing brands of amino acids, dextrose and Intravenous Fat Emulsion (IVFE) unless such combinations have adequate physicochemical data that ensures the stability, compatibility and safety of the final formulations commensurate with the data for single source PN products.
4. Each PN formulation compounded should be visually inspected for signs of gross particulate contamination, particulate formation and/or phase separation of Total Nutrient Admixtures (TNA).

Quality Assurance of the Compounding Process

1. Gravimetric analyses that indirectly assess the accuracy of the individual additives delivered or the final contents of the PN can be readily applied in the pharmacy practice setting. Particular attention should be focused on the most dangerous additives that tolerate the least margin of error, such as the potassium salts.
2. Chemical analyses that directly measure the final content of the individual additives can be incorporated into the PN compounding operations of the pharmacy. The accuracy of the PN dextrose content is an example of an additive that may be associated with significant morbidity and mortality.
3. Refractometric analysis is an alternative, as well as an indirect measure of the final additive concentration. For example, dextrose concentration is frequently assessed by this technique. However, this method is limited to PN formulations that do not contain IVFE.
4. In-process or end-product testing of PN formulations is recommended daily so as to assure a safe, final formulation is dispensed to the patient.
5. End-product testing of PN formulations prepared with automated compounding devices is recommended to verify compounding accuracy.
6. The aseptic sterile preparation of intravenous admixtures intended for patient administration should adhere to the USP (797) Pharmaceutical Compounding-Sterile Preparations Chapter and the American Society for Health-System Pharmacists (ASHP) Guideline on Quality Assurance for Pharmacy- Prepared Sterile Products.

None provided

The recommendations are supported by a review of the literature as well as results from the 2003 American Society for Parenteral and Enteral Nutrition Survey.

• Mirtallo J, Canada T, Johnson D, Kumpf V, Petersen C, Sacks G, Seres D, Guenter P, Task Force for the Revision of Safe Practices for Parenteral Nutrition. Sterile compounding of parenteral nutrition formulations. In: Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr 2004 Nov-Dec;28(6):S57-61. [11 references]

Not applicable: The guideline was not adapted from another source.

2004 Dec

American Society for Parenteral and Enteral Nutrition - Professional Association

American Society for Parenteral and Enteral Nutrition

Task Force for the Revision of Safe Practices for Parenteral Nutrition

Task Force Members: Jay Mirtallo, MS, RPh, BCNSP, Chair; Todd Canada, PharmD, BCNSP; Deborah Johnson, MS, RN; Vanessa Kumpf, PharmD, BCNSP; Craig Petersen, RD, CNSD; Gordon Sacks, PharmD, BCNSP; David Seres, MD, CNSP; Peggi Guenter, PhD, RN, CNSN

Not stated

This is the current release of the guideline.

This NGC summary was completed by ECRI Institute on July 8, 2008. The information was verified by the guideline developer on July 30, 2008.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Reprint request/permissions should be sent to: Permissions Department, ASPEN; 8630 Fenton St. #412; Silver Spring, MD 20910; Fax: 301-587-2365.