Originally published by our sister publication Specialty Pharmacy Continuum

By Gina Shaw

“If you’re not conserving IV fluids now, start conserving immediately. This is going to last for months.” That’s the message from Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP, regarding the possible shortage of bags of IV fluids as a result of damage to a major Baxter facility in North Carolina due to flooding from Hurricane Helene in late September.

Still unknown—any additional impact on either demand or supply from Hurricane Milton, which is headling toward Florida.

Historic inland flooding in the aftermath of Helene shut down the Baxter plant in Marion, N.C., which manufactures approximately 60% of the IV solutions for the United States. “The scope and length of the shutdown is unknown at the moment,” Dr. Ganio said. “A facility taking in water is really not something you want to hear about at a sterile manufacturing facility. So it is likely going to take months to clean that site up and do all the testing and revalidation. It’s not going to be an overnight fix.”

On Oct. 1, Baxter halted all orders of IV fluids for 48 hours to evaluate the situation. “On Oct. 3rd, they started allowing orders again but changed allocation to 40% of what you usually order,” said Erin Fox, PharmD, the associate chief pharmacy officer at University of Utah Health and a professor (adjunct) in the Department of Pharmacotherapy at the University of Utah College of Pharmacy, in Salt Lake City. “For many hospitals, we are talking about thousands and thousands of IV bags; the average hospital uses about 40,000 of these a month, and because they are so large, compared with other drugs, nobody is maintaining a massive inventory.”

Baxter also has been working with the federal government on multiple solutions to restore supply, including restoration of the production plant and the surrounding facilities as well as alternative supply sources, said Nicolette Louissaint, PhD, the senior vice president of policy and strategic planning at Healthcare Distribution Alliance. “There are some bridges out and other barriers near the plant that will make access difficult, so there has also been a lot of tracking of what the additional capabilities are within Baxter and their competitors. The FDA has reported in some of their updates that there are plants that are doing continuous production of product, and that there is no immediate shortage, although we are seeing that health systems are starting to report that while they are getting a resupply, they are not getting all of the product that they’ve ordered.”

In addition Baxter has announced increases in allocations to adult and pediatric hospitals. The company expects those allocation increases to endure and hopes to continue increasing them toward the end of the year. For more about Helene updates, click here.

Conservation strategies include the following steps:

  • Increased use of oral hydration. “If you come in to the ED [emergency department] and need hydration, you may be asked to drink some Gatorade or Pedialyte instead before immediately starting an IV,” Dr. Ganio said.
  • Maintaining an existing IV rather than starting a new one. “For example, often a patient will come from the ED up to the floor, and the floor will discard the IV they received in the ED and start another,” Dr. Fox said. “That can’t happen now.”
  • Only using fluids to start IV access when necessary. “There are instances where a patient may need IV access but not actually need fluids, but an IV bag might be started just for the sake of having that IV running,” Dr. Ganio said. “Instead, you can place a catheter and leave it unattached to an IV until it’s absolutely necessary.”

ASHP has established a resource page on management of fluid shortages, summarizing the status of current shortages and suggested strategies for management. It will be a “living document” with frequent updates, Dr. Ganio said.

Even with these conservation strategies in place, Dr. Ganio reported that some hospitals are already considering postponing certain elective surgeries because of the volume of fluids that can be used during those procedures. “Larger institutions might have a little bit more on hand if they have the storage capacity, but it really doesn’t take long to start depleting some of these supplies.”

ASHP has been in close communication with the FDA, and Dr. Ganio said the agency is “acutely aware of how emergent the situation can become.” “For additional resources, they are looking at Baxter facilities located in other countries that may not be registered with the FDA, but are registered with EMA [the European Medicines Agency] or other agencies, so maybe the FDA can expedite inspections or approvals for those products,” he said. “They may also be able to expedite inspections and approvals for other U.S. manufacturers that need to scale up. Lots of things are on the table.”

The impending impact on the supply chain is unknown. At press time, a category 4 hurricane was expected to double in size before making landfall somewhere on Florida’s central Gulf Coast on Oct. 9. “One of the other major suppliers of sterile fluids is B. Braun, and they have a large facility in Daytona Beach, Florida,” Dr. Ganio said. “While that is on the other side of the peninsula, it is unknown how Milton will affect that area. They have proactively moved all finished product out of their warehouses there, so now it is just watch and wait.” He also noted that supply chains are likely to be disrupted in the immediate area affected by Milton, as well as the larger region.

“We expect that there will be significant medical surge considerations,” Dr. Louissaint said. “Based on the storm’s current path, we anticipate that the priority is going to be those emergent medical needs and those hospital facilities, clinics and dialysis centers that are in the region, and ensuring that those who have evacuated who have medical needs and hospitalized patients who are not able to evacuate can maintain a stabilized level of care. The latter end of this week will be focused on dealing with those emergent needs, and then continuing to make sure that the supply chain can provide the product that is necessary for that region, in a way that doesn’t disrupt continuity of care in other regions as well.”

Dr. Louissaint advised hospital and health-system pharmacies to review their own continuity plans, to maintain open communication with their supply chain partners, and to consider whether or not—without hoarding—they need to order additional product.

“Making sure you have what you need on hand and not relying on placing an order after the storm is important, given that infrastructure such as water, power and roads may be disrupted. Based on the composition of this storm, ensuring that you have sufficient plans to be able to operate for 72 to 96 hours without getting a resupply is incredibly important,” she said.

The sources reported no relevant financial disclosures.