PROBLEM: The complexity of parenteral nutrition (PN) coupled with the heightened risk of causing significant patient harm when used in error, calls for targeted safeguards throughout the medication-use process. In Part I, published in our March 13, 2025 newsletter, we shared results from a recent survey completed by 280 practitioners who prescribe, dispense, compound, and/or administer multi-chamber bag parenteral nutrition (MCB-PN) or patient-specific compounded (i.e., custom) PN. The survey revealed that whether an organization purchases MCB-PN, compounds custom PN, or provides a combination of formulations, errors are common and organizations should take action to enhance systems and processes to prevent harm. Responses also highlighted an urgent need for focused PN-related pharmacy education.

SAFE PRACTICE RECOMMENDATIONS: Organizations should evaluate PN-related systems and processes and consider the following risk-reduction strategies.

Conduct an FMEA. The results revealed a common opportunity for organizations to evaluate their current PN practices by conducting a proactive risk evaluation, such as a failure mode and effects analysis (FMEA). During the analysis, be sure to review the labeling and packaging of products and identify how mix-ups will be prevented; how MCB-PN bags and/or custom PN will be ordered in your electronic health record (EHR) and displayed on your medication administration records (MARs); and the method that will be used to remind practitioners to activate MCB-PN bags. Consider if there should be any restrictions for MCB-PN use, such as in fluid-restricted patients. Incorporate clinical guidelines and refer to recommendations such as those provided by the American Society for Parenteral and Enteral Nutrition (ASPEN).

Implement standard times. Establish cutoff times when PN orders need to be entered or transmitted to the pharmacy. Designate specific times (e.g., 10 am until 2 pm) when staff should prepare and dispense PN. These times should be when adequate pharmacy staff are available to manage PN orders without being interrupted. If outsourcing to a compounding pharmacy to prepare PN solutions, the order should be transmitted to the pharmacy during the day shift so it can be checked by a hospital pharmacist with PN expertise before it is sent to be compounded. Pharmacy staff should be aware of all patients who are receiving PN and check if orders have not been received by the established time.

Prevent transcription errors. The ISMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology calls for organizations to implement automated compounding devices that are interfaced with the EHR to eliminate transcription errors. If an interface is not available, a process must be in place for transcribed orders/prescriptions to be verified by a second individual using an independent double-check and the technology should prompt for the second check. Build order templates with standardized units for defined patient populations (i.e., dose per day for adults, dose/kg/day for pediatric and neonatal patients).¹

Evaluate system functionality. Test EHR functionality (e.g., compatibility, drug-drug interaction checking, duplicate therapy alerts, cyclic PN titration rates, central versus peripheral line administration, MAR warning to confirm the MCB-PN is activated) to determine how key information is displayed to end users. Work with vendors to enhance these functions, if needed. Whether your systems are interfaced or not, evaluate what clinical decision support is available (in the EHR and/or automated compounding device) and ensure there are soft warnings and hard stops to warn practitioners when approaching or exceeding limits (e.g., single dose, daily dose, infusion rate, maximum solubility of calcium and phosphate, osmolarity). Regularly review alert overrides to determine appropriateness and to improve the safety of PN practices.

Conduct effective verification processes in the pharmacy. A pharmacist should be required to verify the initial PN order entry. If a compounder is used for preparation, and transcription of the order into the compounder is required, an independent double-check by a second pharmacist must occur and should include a check of all components, as well as dose calculations and compatibility checks. When setting up the compounder, scan the barcodes of all products for verification and ensure proper line tracing. Conduct quality control checks and verification of replacement solutions on the compounder, if used. All source containers used should be presented to the pharmacist for verification, not just a representative vial when multiple vials are used. An intravenous workflow management system (IVWMS) with barcode scanning should be used to verify the vials and syringes that contain all manually prepared additives before they are injected into the PN admixture. Additionally, using gravimetric analysis of the PN admixture ingredients for verification can help detect errors before reaching the patient. A pharmacist should review the final compounded PN prior to dispensing.

Gather stability data. Contact manufacturers and document stability data for any pharmacy additives, and make this information readily available to prescribers, pharmacists, and nurses. Based on the literature on PN compatibility and stability,² ASPEN recommends PN generally have an expiration date of 30 hours at room temperature and 9 days refrigerated,^3,4 unless there is specific extended stability data for the components used in the PN formulation. Additionally, the hang time for PN should not exceed 24 hours, and the hang time for a separate injectable lipid emulsion (ILE) infusion should not exceed 12 hours.⁵ The ASPEN PN Committee authored an article about this important topic.⁶ Ensure your organization's policy and procedures related to PN follow these updated standards and include an appropriate beyond-use date (sterility), expiration date (stability), and hang time for PN to avoid patient harm. For additional MCB-PN-specific information, refer to ASPEN's resources.

Store MCB-PN safely. Store MCB-PN products separately in the pharmacy, away from similar-looking bags. Avoid storing MCB-PN in an ADC, as nurses may not be familiar with the need to activate all chambers. Storing MCB-PN in the ADC also poses safety risks if additives (e.g., multivitamins, trace elements) are required (e.g., additives are omitted, additives not added in a sterile environment).

Require pharmacy activation and compounding. Require the pharmacy to activate all MCB-PN bags, and add any prescribed additives, such as multivitamins and trace elements, in a sterile environment. Then dispense the activated PN (with additives, if required) to patient care units.

Apply auxiliary labels. Consider applying auxiliary labels to the overwrap of MCB-PN bags upon procurement in the pharmacy to differentiate similar-looking products with and without electrolytes. After pharmacy activation, consider applying auxiliary labels directly on MCB-PN bags for nurses to confirm that pharmacy has activated the product prior to administration.

Employ barcode technology. Use barcode scanning technology prior to compounding, dispensing, and administration to ensure the correct PN product is being used.

Trace infusion lines and confirm the programming. When PN and ILE infusions are started, reconnected, or changed (i.e., new bag), trace the tubing by hand from the solution container to the pump (and channel), to the connection port, and then to the patient to verify the proper infusion, pump/channel, and route of administration. Confirm that the infusion dose and rate are programmed accurately in the smart pump; verify that the order in the MAR and the medication label match what is programmed in the pump when performing line tracing before starting the infusion. During handoffs, nurses should round on the patient together to check medications that are infusing on the pump. During shift changes, oncoming nurses should trace the lines and verify the pump settings and infusion labels paying particular attention to the risk of inadvertent PN versus ILE rate swaps.

Administer PN using a 1.2-micron filter. ASPEN recommends using a 1.2-micron in-line filter for the administration of total nutrient admixtures (TNAs), dextrose-amino acid admixtures, and ILEs. For TNAs, place the filter as close to the catheter hub as possible. For dextrose-amino acid admixtures, place the filter below the Y-site where the dextrose-amino acid admixture and ILE co-infuse.⁷

Reconcile medications including home PN. Add scripting to your medication reconciliation procedures that specifically ask patients about prescription medications, over-the-counter medications (including herbals and dietary supplements), and non-enteral medications (e.g., infusions, including PN). Obtain a copy of their home PN order and share this with the applicable practitioners (e.g., prescriber, pharmacist, dietitian). During transitions of care, work with home infusion pharmacies to determine if orders need to be converted from MCB-PN to patient-specific compounded PN. Require an independent double-check of all calculations to verify accuracy. Confirm the patient’s weight is accurate or clarify any discrepancies. For additional information, refer to Safe care transitions for patients receiving parenteral nutrition.

Document and communicate. Changes to the PN order (e.g., rate change, ingredient amounts, held order) must be documented in the EHR and communicated to applicable practitioners. During interdisciplinary team rounding, discuss the plan of care for the patient's PN therapy including any laboratory monitoring.

Educate practitioners. Provide initial and annual competency assessments for any practitioners who prescribe, activate, compound, dispense, or administer PN. Educate practitioners about how to calculate the amount of macronutrients, electrolytes, and additives patients will be provided from the PN bag, based on the ordered rate of infusion. Educate prescribers about how to enter orders for PN in the EHR. Teach practitioners how to review stability data for pharmacy additives. Establish a formal training process and validate competency for pharmacy technicians who compound PN, and for pharmacists who check the compounded PN solution. If compounding services are provided for neonatal and pediatric patients, include age-specific training emphasizing weight-based dosing, and validate the competency of all who may prepare or check pediatric PN. Ensure pharmacy staff know how to activate MCB-PN bags and add necessary additives (e.g., multivitamins, trace elements) prior to dispensing, and educate nurses to confirm the bag has been activated prior to administration. Since MCB-PN products are commercially standardized, alert nurses to the likely waste of excess PN volume since each bag may contain more than required for a particular patient (e.g., the patient may receive only 1,500 mL from a 2,000 mL bag in 24 hours) and communicate this during handoffs.

Report errors and share lessons learned. It is only when practitioners, like those who participated in our survey, share stories of PN-related errors that learnings can be distributed widely. Please report PN-related medication errors and close calls internally and to ISMP so that we can continue to share lessons learned.

References
1. Ayers P, Adams S, Boullata J, et al. A.S.P.E.N. parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014;38(3):296-333.
2. Boullata JI, Mirtallo JM, Sacks GS, et al. Parenteral nutrition compatibility and stability: a comprehensive review. JPEN J Parenter Enteral Nutr. 2022;46(2):273-99.
3. Boullata JI, Gilbert K, Sacks G, et al. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenter Enteral Nutr. 2014;38(3):334-77.
4. Mays A, Ayers P, Monczka J, Cober MP. Safety in parenteral nutrition compounding. Nutr Clin Pract. 2023;38(6):1253-62.
5. Nickel B, Gorski L, Kleidon T, et al. Infusion therapy standards of practice, 9th edition. J Infus Nurs. 2024;47(1S Suppl 1):S1-S285.
6. Cogle SV, Mulherin DW, Sacks GS, Mirtallo JM. Beyond-use dates for parenteral nutrition must take compatibility and stability into consideration. Pharmacy Practice News. Published June 23, 2023. Accessed January 23, 2025.
7. Worthington P, Gura KM, Kraft MD, et al. Update on the use of filters for parenteral nutrition: an ASPEN position paper. Nutr Clin Pract. 2021;36(1):29-39.

Citation:
Institute for Safe Medication Practices (ISMP). Action needed to address risk with custom and multi-chamber bag parenteral nutrition – part II. ISMP Medication Safety Alert! Acute Care. 2025;30(6):1-4.

Action Needed to Address Risk With Custom and Multi-Chamber Bag Parenteral Nutrition—Part II