Baxter International’s North Carolina manufacturing facility is currently closed following damage caused by Hurricane Helene. The North Carolina site is the largest U.S. manufacturer of intravenous (IV) solutions, including saline, dextrose, and sterile water.
NASPGHAN is monitoring the situation and has been participating in regular updates from federal administration officials.
Products manufactured at the Baxter North Carolina facility are on allocation to manage inventory. Effective October 9, Baxter announced it had increased allocations for IV solutions and nutrition products for designated children’s hospitals to 100%. Additionally, Baxter increased the current U.S. allocation levels of its highest demand IV fluids for direct customers from 40% to 60%, and for distributors the allocation was increased from 10% to 60%. Baxter is also increasing high concentration dextrose and sterile water for injection allocations and expects to be in a position to make additional increases for certain product codes by early November.
To meet patient needs, the Food and Drug Administration (FDA) is working to temporarily import some products, including products that were in shortage prior to Hurricane Helene. The FDA provides guidance on compounding drugs when they are on the FDA’s shortage list. The FDA has also asked manufacturers to give the agency data that would allow extension of the shelf life of affected products and is asking those with supply to not dispose of expired products at this time.
Federal officials are calling for modest conservation of products in a manner that does not impact patient care. The American Society of Health System Pharmacists has published suggestions for fluid conservation and management.
Baxter has set up an email (hurricanehelenesupport@baxter.com) that existing customers should use for inquiries.
NASPGHAN members who are having difficulty accessing IV solution products impacted by the hurricane, or know of patients who cannot access product, should share information directly with Camille Bonta, NASPGHAN policy advisor, at cbonta@summithealthconsulting.com. Please be as specific as possible with the problem and location. Please write in the subject line of your email “NASPGHAN IV Solution Case Report.”
Resources:
American Society of Health System Pharmacists Suggestions for Fluid Conservation and Management
Baxter Hurricane Helene Clinical Resources
Food and Drug Administration Updates and Information
Food and Drug Administration Guidance on Drug Compounding
HHS Letter to Health Care Leaders and Stakeholders
HHS Document on IV Fluid Shortage Strategies
Olympus Letter on Sterile Water and Saline Shortage
Vizient Memo on IV Solutions Produced at Baxter North Carolina Facility
