HIDA FAQ: IV Solution Supplies Following Hurricane Helene

Yes. Although manufacturers are working diligently to resume production of IV solutions, and the federal government has relaxed import restrictions to fill stocks from other countries, supplies of IV solutions are not expected to return to pre-disruption levels before the end of the year. Providers should continue their conservation strategies for the foreseeable future. The American Society of Health-System Pharmacists has published one resource – Suggestions for Management and Conservation of Small- and Large-Volume Fluid Shortages – on its website. See additional resources at the end of this FAQ.

That is unclear. Although manufacturers have announced allocation increases, these decisions are being made on a product-by-product basis. It may take days or weeks for these products to be manufactured and arrive at distributors’ distribution centers.

The FDA has declared shortages of three IV drugs, dextrose 70% IV solution, lactated ringers IV solution, and peritoneal dialysis solution.

The agency is working to temporarily import some products in shortage to help meet patient needs. Click here for more information about imports of 19 products from China, Canada, Ireland, and the United Kingdom.

FDA’s shortage declaration also gives hospital pharmacies the flexibility to compound their own IV solutions.

Hurricane Milton had minimal impact on the medical supply chain. IV solutions that were stored at a manufacturer in Daytona Beach were moved out-of-state before the hurricane made landfall, the manufacturer has resumed production as of the morning of Friday, October 11. All 15 medical distribution facilities identified by the Supply Chain Control Tower as being in the path of Hurricane Milton had resumed operations.

The Baxter International manufacturing facility in North Cove, North Carolina was significantly impacted by the rain and storm surge from Hurricane Helene. Production has been halted until the situation is resolved.

Regular updates about the status of the North Cove facility, allocation strategies, and efforts to mitigate shortages of IV solution are available from Baxter International at a Hurricane Helene Updates page at Baxter.com – refresh the page frequently for the most recent updates.

The North Cove facility primarily manufactures intravenous (IV) and peritoneal dialysis (PD) solutions and is the largest producer of those products in the United States. The facility employs about 2,500 workers, manufactures 60% of the U.S supply of IV solutions, and produces 1.5 million bags per day. A full list of product codes manufactured by the North Cove facility is available here.

B. Braun has advised the media that the company will close its Florida factory today in advance of Hurricane Milton, and is hoping to reopen Friday. “In partnership with ASPR, [B.Braun is] taking immediate steps to increase production of critical IV fluids at our plant in Irvine, CA, and will resume this plan at Daytona Beach following Hurricane Milton’s departure.”

The American Hospital Association has warned that “our members are already reporting substantial shortages of these lifesaving and life-supporting products. Patients across America are already feeling this impact, which will only deepen in the coming days and weeks unless much more is done to alleviate the situation and minimize the impact on patient care.”

HIDA has published a white paper – Allocations: Best Practices For Conserving Medical Supplies During Shortages – which offers guidance on how to manage end-to-end supply chain challenges. This guidance is also available in a one-page infographic.

The U.S. Department of Health and Human Services has released a Letter to Health Care Leaders and Stakeholders on Impacts of Hurricane Helene from Secretary Becerra that outlines the status of IV solution supply chain.

Baxter International has advised providers to take steps to evaluate inventory and clinical needs, identify alternative sources of solutions and medications, and optimize fluid management.

The American Society of Health-System Pharmacists has linked to Suggestions for Management and Conservation of Small- and Large-Volume Fluid Shortages on its website.

The American Hospital Association has called on the Biden Administration to take immediate actions to increase the supply of IV solutions for the nation’s hospitals, health systems, and other healthcare providers. These proposed actions include:

• Direct the Food and Drug Administration (FDA) to declare a shortage of sterile IV solutions, which will permit the use of certain flexibilities not otherwise available to healthcare providers.
• Declare a national emergency under the National Emergencies Act and/or the Stafford Act and request that Department of Health and Human Services Secretary Xavier Becerra declare a national Public Health Emergency in order to allow for waivers of Medicare/Medicaid rules and regulations.
• Invoke the Defense Production Act to require appropriate manufacturers to prioritize and accept contracts for materials and services necessary to produce sterile IV solutions and their containers.
• Incentivize appropriate manufacturers to expand the production and supply of the critical materials and goods needed to produce sterile IV solutions and their containers.
• Direct the Department of Defense to make transportation available for emergency supplies from other international sources identified by the FDA.
• Remove any barriers to the importation of sterile IV and peritoneal dialysis solutions from abroad that are approved by the European Union.
• Secure transport to domestic distribution centers for such supplies to be allocated to hospitals and other healthcare providers in need.
• Direct the Federal Trade Commission and the Department of Justice to be on alert for and intervene in matters related to price gouging.
• Appoint a person within the Administration to serve as the point of contact for matters related to the IV solution shortage.