
Baxter announced it plans to restart manufacturing intravenous (IV) solutions at its North Cove, North Carolina facility this week. In the interim, as most readers are aware, the US Food and Drug Administration (FDA) has approved the importation of some fluid products due to shortages related to the Hurricane Helene aftermath. Prior to procuring imported products, organizations should ensure the product is included on the FDA-approved list. It is worth noting that some of these products may have different concentrations, packaging, and labeling than US products. For example, Baxter’s Dear Healthcare Professional letter, Temporary importation of 0.9% Sodium Chloride Injection from Shanghai, China, labeled in Chinese, to address drug shortages (Hurricane Helene Clinical Resources for US Healthcare Professionals, scroll to Baxter Resources for Products Authorized for Temporary Importation) states that this imported product has labels written in Mandarin and contains the active pharmaceutical ingredient, concentration, volume, and product code in English. However, the label does not include a barcode, and the letter does not state if the label contains the US national drug code (NDC), lot number, and expiration date in English.
The FDA temporary importation list also includes several glucose and dextrose injections from different countries. It is important to note that glucose injections are not directly interchangeable with FDA-approved dextrose injection USP. Dextrose USP is a hydrated form of glucose. The imported glucose injection product is labeled based on the anhydrous form of glucose. For example, the caloric content of imported 70% glucose injection is 2,800 kcal/L whereas the caloric content of 70% dextrose injection, USP is 2,380 kcal/L. Organizations must consider any differences between glucose and dextrose products (e.g., caloric content, pH, osmolarity) and update protocols and systems (e.g., electronic health records, compounding systems).
Organizations must carefully review the information in the letter accompanying imported products, which can be found on the Baxter Medical Education page. Baxter US Medical Information may have additional product information that can be accessed here. Practitioners are required to register via valid email verification in order to search and access product information.
ISMP has created an Imported Fluid Product Checklist for organizations to use when evaluating imported products’ safety during the current fluid shortage. Consider gathering an interdisciplinary team (e.g., pharmacy, nursing, prescribers, dietitians, central supply/materials management) and use the Checklist as a tool for completing a gap analysis to determine potential failure points and mitigation strategies. The checklist includes factors that should be considered when conducting a review to identify potential risks with the imported product. For example, not having a scannable barcode on any medication or fluid is not an ideal situation, and the potential risks with implementing different strategy options to address the lack of a barcode must be evaluated to determine the safest option for your facility. For imported products that do not have a barcode, consider whether a scannable barcode should be created and how to safeguard the workflow when adding the barcode to the product. Educate practitioners about product differences and emphasize that practitioners must confirm the product's identity prior to dispensing and administration. Gather staff feedback about safety concerns related to imported products during huddles. Consider including a field in your error reporting program to designate if the event was related to a shortage so you can track such issues. Report errors and close calls internally and to ISMP to share lessons learned.
In addition, Baxter is now authorized by FDA to extend the use dates of some products to provide a 24-month expiration from the date of manufacture (Hurricane Helene Clinical Resources for US Healthcare Professionals, scroll to Expiration Dating Extension to 24 Months). Review this information to determine if a product has an extended expiration date, and if so, implement a process (e.g., make staff aware and update the expiration date on the label) to ensure staff know when the product will expire.
Lastly, the American Society for Parenteral and Enteral Nutrition (ASPEN) recently released shortage recommendations for intravenous dextrose and sterile water for injection.
Consider PN compatibility and stability data when applying USP <797> which accounts for sterility only. Parenteral nutrition (PN) is a complex life-sustaining therapy for patients who cannot intake adequate oral or enteral nutrition. It can contain more than 40 ingredients and is considered a high-alert medication.1 PN can be compounded, including neonatal starter PN bags, or delivered using a commercially available multi-chamber bag. PN can also be administered with an intravenous lipid emulsion (ILE) added to the PN bag (total nutrient admixture) or have the ILE co-infuse with the PN (dextrose-amino acid admixture with Y-sited ILE).
The most recent revision of USP General Chapter <797> Pharmaceutical Compounding–Sterile Preparations became official on November 1, 2023.2 The goal of the standard is to reduce the risk of contamination and patient infections from compounded sterile preparations (CSPs). Categories of risk are now assigned as category 1, 2, or 3, and the interpretation of the standards has led PN to be viewed as a category 2 CSP.2 Now, beyond-use dates (BUDs) (i.e., from the time of compounding to administration) for category 2 CSPs are 4 days at room temperature and 10 days if refrigerated.2
The American Society for Parenteral and Enteral Nutrition (ASPEN) has received feedback from practitioners who reported confusion with interpreting the standards, inquiring if PN should now have an extended expiration date (i.e., 4 days or 10 days). In fact, on October 16, 2024, ASPEN released a letter, sharing this concern as it relates to Appendix A, in the US Food and Drug Administration (FDA) temporary guidance during the current fluid shortage, Temporary policies for compounding certain parenteral drug products. It is important to understand that the BUD assigned by USP <797> is based on sterility. USP <797> states a shorter BUD must be assigned when the physical and chemical stability of the CSP is less than the BUD limit. Therefore, practitioners must also consider compatibility and stability data that is specific to each PN's components (amino acid solution, ILE, dextrose, and micronutrients) when determining the PN expiration date (i.e., the date/time the PN should no longer be administered).
Based on the literature on PN compatibility and stability,3,4 ASPEN recommends PN generally have an expiration date of 30 hours at room temperature and 9 days refrigerated,5,6 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 ILE infusion should not exceed 12 hours.7 The ASPEN PN Committee recently authored an article about this important topic.8 Ensure your organization's policy and procedures related to PN follow these updated standards and include an appropriate BUD (sterility), expiration date (stability), and hang time for PN to avoid patient harm.
References
- Buckley B. Parenteral nutrition is a high-alert medication: ISMP President. Pharmacy Practice News. Published May 15, 2024. Accessed July 9, 2024.
- USP-NF (USP 43-NF 38). USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Rockville, MD: USP; November 1, 2023.
- Revised USP 797 guidelines now in effect. American Society for Parenteral and Enteral Nutrition. Accessed July 22, 2024.
- 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.
- 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.
- Mays A, Ayers P, Monczka J, Cober MP. Safety in parenteral nutrition compounding. Nutr Clin Pract. 2023;38(6):1253-62.
- 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.
- 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 July 23, 2024.