“If you’re not conserving IV fluids now, start conserving immediately. This is going to last for months.”
That was 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.
Although some of shortages have started to ease up (sidebar), the following conservation strategies Dr. Ganio offered are ones that every health system should have in their toolbox, he noted, given the heightened risk for superstorms that has been playing out in the past few years.
- Increase 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.
- Maintain 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,” 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. “That can’t happen [during severe shortages].”
- Only use 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.”
- Put some elective surgeries on hold. Even with the above conservation strategies in place, Dr. Ganio noted that, based on real-world experience after Helene, some hospitals may need to postpone 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,” he said.
- Keep in touch with your suppliers. Nicolette Louissaint, PhD, the senior vice president of policy and strategic planning at Healthcare Distribution Alliance, advised health-system pharmacies to review their own continuity plans, to maintain open communication with their supply chain partners, and to consider whether—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 a storm is important, given that infrastructure such as water, power and roads may be disrupted,” Dr. Louissaint said. “Ensuring that you have sufficient plans to be able to operate for 72 to 96 hours without getting a resupply is incredibly important.”
- Look to regulatory agencies for compounding relief. After Hurricane Helene caused significant damage to Baxter International’s manufacturing facility in North Carolina, which produces about 60% of IV fluids used in U.S. hospitals, the FDA issued a temporary guidance giving compounding pharmacies that are not licensed as 503A outsourcing facilities flexibility in compounding certain drugs, including certain dextrose formulations, sodium chloride, sterile water, lactated Ringer’s solution and peritoneal dialysis solutions. The policy was intended to remain in place for the duration of the public health emergency (PHE) related to Hurricane Helene, which was declared on Oct. 10, 2024. (As of late November, the PHE for Helene as well as Hurricane Milton were still in place.)
Baxter Resumes IV Production, Gets BUD Extension
According to a Nov. 21 update from Baxter, the company resumed releasing 1-liter IV solutions manufactured at its North Cove, N.C. facility damaged by Hurricane Helene (bit.ly/3V7UYUp). The company also resumed production on two additional manufacturing lines that represent about 85% of the total production of 1-liter IV solutions (the size most commonly used by hospitals). Baxter projected that it will restart peritoneal dialysis solutions and irrigations manufacturing lines in early December, and that all lines will be restarted by the end of the year, but said it doesn’t have a timeline for when everything will be back to pre-hurricane levels.
Baxter added that is “has received FDA authorization to extend the beyond-use dates of 50+ IV and irrigation codes to provide up to an additional 12 months of expiry. Products now have a 24-month expiry period from the date of manufacture. This extension only applies to products manufactured prior to the end of September 2024.”
On Nov. 26, Baxter noted that, “barring any unanticipated developments, [it] expects to share details on planned, phased increases in allocations again in mid-December and at year-end, which includes reaching 100% allocation across several IV product codes by the end of 2024.”
In the meantime, employees have returned to work at the North Cove facility. The Baxter International Foundation has donated more than $4 million to support employees and communities impacted by Hurricane Helene, including $1.5 million in grants to three humanitarian partners and more than $2.5 million in funding to employees through Baxter’s Employee Disaster Relief Fund, the company noted.
ISMP Steps In
With the FDA also authorizing the importation of some fluid products to meet demand, the Institute for Safe Medication Practices (ISMP) has created an Imported Fluid Product Checklist for evaluating imported product safety while the IV fluid product shortage continues (bit.ly/3Z6deih).
“Consider gathering an interdisciplinary team (e.g., pharmacy, nursing, prescribers, dietitians, central supply/materials management) and use the Checklist as a tool for completing a gap analysis to determine potential failure points and mitigation strategies,” ISMP recommended in a new alert on product safety during the shortage.
ISMP also cautioned that some of these imported products will have different concentrations, packaging and labeling than U.S. products. “Educate practitioners about product differences and emphasize that they must confirm the product’s identity prior to dispensing and administration.”
ISMP suggested these added strategies:
- gather staff feedback about safety concerns related to imported products during huddles;
- consider including a field in your error reporting program to designate if the event was related to a shortage so you can track such issues; and
- report errors and close calls internally and to ISMP to share lessons learned.
The FDA guidance noted that the agency will not take action against a licensed pharmacy that provides a compounded drug without a patient-specific prescription or for compounding an essential copy of a commercially available drug, as long as it met certain requirements, including:
- the drug must be on its temporary drug shortage list;
- it must be labeled with a default beyond-use date;
- the pharmacy has to notify the relevant state authority of its intention; and
- the compounder must comply with certain sanitary, strength, quality and purity requirements.
During the next weather-related PHE, health systems may be given similar relief.
ASHP has established a resource page on management of fluid shortages, summarizing the status of current shortages and suggested strategies for management (bit.ly/3OlfDAU). It will be a “living document” with frequent updates, Dr. Ganio said.
The sources reported no relevant financial disclosures.
This article is from the December 2024 print issue.