IV Solutions Shortage Situation Report #2

October 24, 2024  /  TLP:CLEAR 

Healthcare Ready is ENGAGED for this event. We are monitoring potential concerns for supply chain disruptions and impacts on healthcare services on our response page, listing resources and previous situation reports.

Contents

• Situation Overview and Key Updates
• Impacts to Healthcare Supply Chain
• Additional Resources
• About Healthcare Ready

Situation Overview and Key Updates

• Baxter’s North Cove plant located in Marion, North Carolina was significantly impacted by rain and flooding from Hurricane Helene. The facility specializes in the production of intravenous (IV) and peritoneal dialysis solutions and is the leading US manufacturer of these products.
  • Pre-hurricane staffing levels are being seen this week at the North Cove plant. Their teams are working with remediation contractors to engage in site recovery.
  • The temporary bridge has allowed for more than 600 truckloads of finished product to be moved off site and to customers. A second bridge is being installed and will likely be completed in early November. This will allow for even more traffic to and from the North Cove plant.
  • Baxter’s goal is to resume North Cove production in phases by the end of this year however there is no timeline for when production will return to pre-hurricane levels.

Impacts to Healthcare Supply Chain

• The following products are currently in shortage and could be further constrained until the Baxter North Cove facility resumes operations:
  • Dextrose 70% IV Solution (shortage posted on 10/11)
  • Lactated Ringers IV Solution (shortage posted on 10/11)
  • Peritoneal Dialysis Solution (shortage posted on 10/11)
  • Dextrose 5% IV solution
  • Dextrose 10% IV Solution
  • Sodium Chloride 0.9% IV Solution (Normal Saline)
  • Sodium Chloride 0.9% for Irrigation
  • Sterile Water for Injection
  • Sterile Water for Irrigation
• The FDA has provided information on compounding drugs when appropriate if a drug is not available.
  • As of October 11, the FDA issued final guidance, “Temporary Policies for Compounding Certain Parenteral Drug Products,” to help fill the gaps on drug products impacted at the North Cove plant.
• Baxter has activated seven international plants, in Canada, China (two plants), Ireland, UK, Mexico, and Spain, to increase availability of impacted products. The FDA has authorized temporary importation for a variety of product codes from those manufacturing facilities.
  • Baxter is working with the FDA, ASPR, and other government agencies to airlift their products from the international sites to the US. The first flights were scheduled for October 19 and product will continue to be airlifted over the coming weeks.
  • Each flight carries over 100,000 units of Baxter products and ASPR has enabled expedited distribution which can reduce the distribution times from 5-10 days to less than a day.
  • A list of products that are being airlifted can be found here.
• Baxter stated that they are implementing allocations of their highest demand IV fluids for:
  • Direct customers from 40% to 60%
  • Distributors from 10% to 60%
  • Standalone, designated children’s hospitals to 100%
• Baxter implemented an evaluation process for neonatal and pediatric needs for other Baxter customers. Customers should email HurricaneHeleneSupport@baxter.com with the subject line “Pediatric Allocation Request.”

Additional Resources

• The CDC’s Health Alert Network (HAN) Health Advisory summarizes recommendations from multiple government agencies and trade associations which address supply disruptions of PD and IV solutions.

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