Baxter International Inc. has increased allocations of IV fluids to children’s hospitals to 100% but other facilities continue to struggle with supply disruptions caused by Hurricane Helene.
Baxter’s North Cove plant in North Carolina produces a significant portion of the country’s IV fluid and peritoneal dialysis solutions but closed in late September due to flooding from the hurricane. Supply disruptions caused by the closure came on top of existing shortages of several IV solutions.
Baxter has been increasing production at other sites including global locations and working with the Food and Drug Administration (FDA) on temporary importation of certain products. The FDA on Wednesday announced temporary importation sources in Canada, Ireland, China and the United Kingdom. In addition, it released the guidance Temporary Policies for Compounding Certain Parenteral Drug Products.
The manufacturer also has been limiting orders to prevent stockpiling. On Wednesday, it increased allocations of its most in-demand IV fluids from 40% to 60% for direct customers and to 100% for children’s hospitals “due to the vulnerable patient population they serve.” The company said it also is increasing allocations for high concentration dextrose and sterile water for injection.
In an Oct. 7 letter to federal officials, the American Hospital Association (AHA) noted “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,” AHA President and CEO Richard J. Pollack, M.P.A., wrote.
He urged several steps to increase supply including providing flexibilities in rules around IV solution preparation, extending the shelf-life of solutions nearing expiration, allowing waivers of certain Medicare and Medicaid rules, invoking the Defense Production Act and removing barriers to importation of products approved by the European Union.
U.S. Department of Health and Human Services Secretary Xavier Becerra, J.D., said Wednesday the department is working with public and private partners to support the supply chain. The FDA also will expedite consideration of shelf-life extension requests that manufacturers submit.
HHS is encouraging health care providers to conserve IV fluid products. Both Baxter and the American Society of Health-System Pharmacists (ASHP) have provided advice on doing so.
Baxter expects to make additional allocation increases in early November. It hopes to return allocations of certain IV solutions to 90% to 100% by the end of the year.
“We will spare no resource — human or financial — to restart operations and help ensure patients and providers have the products they need,” Baxter Chairman, President and CEO José (Joe) E. Almeida said in a statement.
Resources
- Information from Baxter on IV solution supply disruptions related to Hurricane Helene
- Information from Baxter and managing and conserving fluids
- Information from the ASHP on managing and conserving fluids
- Letter from HHS to health care leaders
- Information from the FDA on Baxter’s manufacturing recovery and on compounding