Shortages of intravenous (IV) fluids, worsened by Hurricane Helene damage at Baxter's Marion, North Carolina, manufacturing plant, are expected to continue for months, although allocations to customers and distributors have increased, the US Department of Health and Human Services (HHS) said in a letter to hospitals yesterday.
Since the hurricane triggered flooding at the plant in late September, many hospitals across the country have been delaying non-urgent surgeries and substituting oral electrolyte fluids (eg, Gatorade, Pedialyte). Baxter supplies about 60% of IV fluids to hospitals in the United States.
In the letter, HHS Secretary Xavier Becerra, JD, noted current shortages of normal saline IV fluids, normal saline irrigation fluid, sterile water irrigation, and dextrose 5% IV fluids.
"In the coming weeks, supply may continue to be constrained, and we understand that certain products are on allocation; however, Baxter reported that they have resumed shipments to hospitals and dialysis providers and patients after the temporary hold last week, based on allocations as previously communicated," he said.
Goal is at least 90% by year's end
In the short-term, the inventory will support current allocations while several global Baxter plants scale up production, other domestic manufacturers step in to fulfill orders within their allocations, and the FDA works with Baxter to identify any products already in the company's system, expedite consideration of any requests for expiration-date extensions, and consider temporary product imports.
Due to the vulnerable patient population they serve, allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%.
HHS's Administration for Strategic Preparedness and Response (ASPR) is working with Baxter and other partners to support infrastructure repairs, the letter said. Based on this, the company's efforts to increase manufacturing capacity at other plants, and anticipation of inbound products and air shipments, the company said yesterday that it has increased allocations of its highest-demand IV fluids from 40% to 60% for direct customers and from 10% to 60% for distributors.
"We are also increasing high concentration dextrose and sterile water for injection allocations and expect to be in a position to make additional increases for certain product codes by early November," Baxter said. "Due to the vulnerable patient population they serve, allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%."
The goal, the company said, is to ramp up production and return to 90% to 100% allocation of certain IV solutions by the end of the year.
Hospitals urged to implement conservation plan
Until supplies are restored to full volume, "HHS is encouraging manufacturers, wholesalers, and distributors to evaluate product allocation and healthcare providers to implement product conservation strategies to maintain safe, quality patient care and maximize available supply," regardless of whether they are experiencing supply disruptions, the letter said.
HHS said hospitals should implement an organization-wide IV-fluid conservation plan and consider strategies such as prioritizing vulnerable populations with specific needs (eg, pediatric and neonatal patients), substituting clinically equivalent products (ie, oral or intramuscular or subcutaneous injection), or compounding drugs on the US Food and Drug Administration (FDA) drug-shortage list.
