Disruption in Production of Intravenous (IV) Fluid Due to Impacts from Hurricane Helene—Update #2

Disruption in Production of Intravenous (IV) Fluid Due to Impacts from Hurricane Helene—Update #2 

October 21, 2024

Dear Colleague:

This letter provides an update to the Clinician Letter that the Virginia Department of Health (VDH) sent on October 8, 2024, regarding the disruption in production of IV solutions as a result of Hurricane Helene on the Baxter International Inc. North Cove manufacturing facility in Marion, North Carolina.

Per an update from the manufacturer on October 17, 2024, in close coordination with Food and Drug Administration (FDA), Baxter International Inc. is scaling and ramping up production across its global manufacturing network to help support their customers. Baxter’s allocation levels remain the same as reported on October 9, 2024. With the expectation of increased capacity from other Baxter facilities, initiation of temporary importation of certain products, and efforts to reopen the North Carolina facility, Baxter’s goal remains to return to 90-100% allocation of certain IV solutions by the end of 2024. For the most current updates on the product availability, please contact the manufacturer directly.

VDH is requesting all health care providers continue to implement temporary conservation measures to mitigate the potential impacts of this manufacturing disruption. To support these decisions, Baxter has provided a webinar and resources for clinical and operational IV fluids conservation strategies. On October 11, the FDA announced a guidance document for Temporary Policies for Compounding Certain Parenteral Drug Product along with a list of parenteral drug products in shortage. American Society of Health-System Pharmacists updated Suggestions for Management and Conservation of Small-and Large-Volume Fluid Shortages on October 17, 2024.

VDH activated the Virginia Disaster Medical Advisory Committee to ensure cross-sector communication and awareness. For additional information on the post-storm response to Hurricane Helene, including clinical information and resources, please visit the VDH Hurricane Helene Response page. In anticipation of the respiratory season and its potential impacts, VDH recommends facilities plan accordingly to mitigate further gaps regarding IV solutions with clinical and operational conservation strategies.

Virginia is experiencing supply impact and conservation of IV solutions is helping; however, these efforts need to be increased and sustained. VDH continues to work closely with the Virginia Hospital & Healthcare Association (VHHA), Virginia Health Care Association (VHCA), Quality Insights Renal Network, Virginia’s EMS Councils, and other health care organizations, and alongside our federal partners, to closely monitor this situation and will continue to provide updates as soon as available.

Resources:

• https://meded.baxter.com/hurricane-helene-clinical-resources
• https://www.fda.gov/news-events/press-announcements/fda-roundup-october-11-2024
• https://www.vdh.virginia.gov/news/hurricane-helene-post-storm-response/#Clinician
• Fact Sheet: HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene | HHS.gov
• https://www.vdh.virginia.gov/news/hurricane-helene-post-storm-response/#Clinician

Dialysis Management and Conservation:

• https://www.baxter.com/sites/g/files/ebysai3896/files/2024-10/10-1_RenalMedical%20Information%20Letter.pdf

List of Parenteral Drug Products in Shortage

• Hurricane Helene: Baxter’s manufacturing recovery in North Carolina | FDA

Additional Resources:

• https://www.ashp.org/drug-shortages/shortage-resources/publications/fluid-shortages-suggestions-for-management-and-conservation?loginreturnUrl=SSOCheckOnly

Sincerely,

Karen Shelton, MD

State Health Commissioner