Problem: As most readers are aware, on September 29, 2024, Baxter announced that their North Cove, NC manufacturing plant was temporarily closed due to damage from Hurricane Helene. This facility is the production site for several intravenous (IV), parenteral nutrition (PN), peritoneal dialysis (PD), and cardioplegic fluids/solutions. The closure has resulted in the need for Baxter to invoke product allocations to healthcare organizations. ISMP has been in communication with Baxter, the US Food and Drug Administration (FDA), the American Society of Health-System Pharmacists (ASHP), and several other organizations to advocate for safe fluid conservation practices. ASHP and the University of Utah are providing ongoing updates to their Small- and Large-Volume Fluid Shortages – Suggestions for Management and Conservation resource. In addition, on October 9, 2024, the FDA announced it is working to temporarily import some products to help meet patient needs.
As organizations implement strategies that work best for their institution, we recognize that any change to compounding procedures, workflows, or needing to procure new products because of the shortage may increase the risk of error. The following represent safety concerns and unsafe practices that must be addressed and avoided.
- Manipulating fluid bags (e.g., preparing smaller aliquots from a fluid bag into syringes) outside of the pharmacy's sterile compounding area without IV workflow management systems (IVWMS)
- Storing vials of concentrated 23.4% sodium chloride injection outside of the pharmacy for compounding solutions of 0.9% sodium chloride for injection
- Storing 1,000 mL bags of sterile water outside of the pharmacy
- Lack of understanding of how to administer medications via IV push that were previously administered by infusion (e.g., uncertain rate of antibiotic administration)
- Mix-ups due to look-alike product packaging/labeling when new products are purchased from an alternative manufacturer or imported (which may present unforeseen labeling and nomenclature issues)
- Bypassing barcode medication administration (BCMA) systems due to missing or unscannable barcodes (e.g., imported products)
- Administering an expired product due to confusion about the product’s extended expiration date
Safe Practice Recommendations: When implementing fluid conservation strategies, consider the following recommendations.
Evaluate systems. Evaluate all systems impacted by workflow or product changes due to the shortage. Review order sets and treatment protocols and make changes based on available products (and likewise when shortages end). Review and update order sets to remove automatic orders for fluids, when possible. Consider changes in the electronic health record (EHR) to allow the use of either dextrose or saline for the admixture of drugs compatible with both solutions (considering any critical carbohydrate or sodium restrictions that the patient may have). Use EHR alerts or forcing functions when a drug is compatible with only one diluent. Confirm existing smart infusion pump drug libraries are up to date to ensure safe and consistent practices. If a new medication concentration will be used, evaluate all systems and refer to our previous newsletter article, A comprehensive, proactive plan is needed to mitigate risk when changing drug concentrations, published June 16, 2022.
Maximize the use of IVWMS. Use IVWMS in the pharmacy when manipulating or compounding all products. IVWMS should also be used when aliquoting from large containers to smaller “unit-dose” containers (i.e., large-volume parenteral [LVP] to a syringe).
Conduct a proactive safety analysis. When a new product is procured (i.e., from an alternative manufacturer or imported) conduct a review to identify potential risks with the product’s design, including look-alike labeling and packaging concerns with other products in use within the organization. Store look-alike products separately, and consider the use of signage in storage locations, or other warnings such as auxiliary labels. Do not store 1,000 mL bags of sterile water for injection, irrigation, or inhalation in patient care areas, and follow recommendations in the ISMP Targeted Medication Safety Best Practices for Hospitals, archived Best Practice #10. Test all product barcodes in the pharmacy prior to distribution to identify and mitigate any issues. For more information, see our previous article, Safety considerations during expedited product approval, published in the April 6, 2023 issue.
Safeguard IV push practices. If switching from an infusion to IV push when the patient’s clinical status and drug properties (e.g., pH, osmolarity) allow, follow the recommendations listed in the ISMP Safe Practice Guidelines for Adult IV Push Medications. The pharmacy should prepare and dispense medications that may be administered IV push in ready-to-administer concentrations in appropriate syringes. The syringe of diluted medication should be labeled with the patient’s name, drug name, strength, dose, rate of administration (e.g., slow IV push over 5 minutes), and the beyond-use date/time. The medication administration record (MAR) should also include the rate of administration. Ensure practitioners administering medications have access to IV push policies and guidelines and have been trained and are competent in administering medications via IV push.
Monitor expiration dates. If FDA approves an extended expiration date for a product, 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.
Educate practitioners. Communicate changes to policies and practices, systems, and when new products are purchased, so staff are aware of any potential safety concerns. Be prepared for times like these by providing competency assessments related to impacted technologies (e.g., BCMA, IVWMS), including a broad spectrum of scenarios (e.g., incorrect drug alert upon scanning) that staff might encounter. If a medication barcode will not scan, the practitioner must confirm the product's identity prior to administration. Develop an escalation process when a medication barcode will not scan. The process should include when and how to report close-call events, barcode-related issues, why it is dangerous to use a proxy scan, and who is responsible for monitoring barcode issues. Gather staff feedback about safety concerns related to shortages during huddles.
Report errors and share lessons learned. Report medication errors, close calls, and hazards, including those related to shortages, to ISMP. Share lessons learned within your organization and externally with others.
Additional Resources.
- ECRI: Patient safety nonprofit releases guidance for navigating medical supply chain disruptions caused by Hurricane Helene
- End Drug Shortages Alliance: Resources
