U.S. hospitals are taking steps to conserve their supplies of intravenous (IV) fluids after Hurricane Helene took down a major manufacturing plant in North Carolina and the supplier said it will reduce product shipments as part of its mitigation strategy.
Baxter International—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—said a week ago that it would temporarily shut down production at its North Cove, North Carolina-based facility as a result of the fallout of Hurricane Helene. The company said Thursday that the plant was "significantly impacted by the rain and storm surge from Hurricane Helene."
While progress is already being made after the storm, which resulted in water “permeating” Baxter’s plant, the company cautioned Thursday that it does not yet have a timeline for when operations at the North Cove site will be back online, Fierce Pharma reported.
In addition to the flooding at the site, which is the largest in Baxter’s global manufacturing network, bridges leading to the site were damaged in the hurricane, hampering transportation of remediation equipment going into the facility and some finished products unaffected by the storm that Baxter is seeking to get out to customers and patients, according to Fierce Pharma.
The plant in question primarily manufactures intravenous (IV) and peritoneal dialysis (PD) solutions and is the largest producer of those critical drugs in the U.S. The North Cove facility, which employs about 2,500 workers, manufactures 60% of the country's supply of IV solutions and produces 1.5 million bags per day. Baxter has seven manufacturing sites within North America and 13 plants globally.
A list of the impacted products manufactured at the Baxter North Cave plant can be found here.
The Food and Drug Administration (FDA) said it is actively working with Baxter and HHS to confirm how much product was recently released for distribution or may be available at wholesalers, and provide any resources and assistance. "This could include reviewing potential temporary imports or expediting reviews of the cleaned and restored manufacturing lines," the FDA said in a statement posted to its site.
"While Baxter is taking new steps to manage inventory of their North Cove presentations to assure equitable access, FDA is also working with Baxter’s additional facilities to increase supply and reduce the risk of new shortages until Baxter can resume manufacturing the impacted products. FDA will also be working with alternative suppliers, as needed, to manage gaps/shortages in supply of critical products," the FDA said.
"Supporting our employees in the impacted communities, bringing the North Cove facility back online and helping to ensure ongoing supply to patients are our top priorities," Baxter said in a statement posted online.
The company is now reducing shipments to hospitals to "help limit stockpiling and increase the likelihood of equitable access to available products," the company announced Thursday.
"We have implemented allocations to help ensure we are appropriately managing our inventory and minimizing disruption to patient care. That means that after review and consideration of available inventory and the medical necessity of the impacted products, a specific limit on what a customer can order has been implemented," the company said in statement on its website.
The current allocation includes saline, dextrose and PD solution products manufactured in all sizes, the company said. The company said in a letter to customers that additional information on peritoneal dialysis products will be coming soon.
As of October 1, the FDA has not declared any shortages related to the products produces at the North Cove plant.
Working with the FDA, Baxter is leveraging its global manufacturing network to help mitigate potential supply impact as it continue efforts to restore North Cove’s manufacturing operations.
Another major manufacturer, B. Braun Medical is taking "immediate steps to increase production" at its pharmaceutical manufacturing sites in Irvine, CA and Daytona Beach, FL, focusing on critical IV fluids," the company said in a statement to Fierce Healthcare on Sunday.
"We are anticipating that there will be major constraints on the U.S. supply of I.V. fluids as a result of the production outage at Baxter’s North Cove plant," the B. Braun spokesperson said.
The company also has placed products on a "protective allocation" and encourages providers to "practice conservation, including alternative hydration methods."
"These products are the building blocks of healthcare and are relied upon by patients across the country. We are working with industry partners, government officials and other stakeholder organizations to take steps that are available to us to help mitigate this anticipated shortage," B. Braun said.
The American Hospital Association said in a statement that it is "coordinating with Baxter and proactively engaging with federal agencies with regard to the disruption and to convey our concerns about the impact on patient care."
"We will continue to actively monitor the situation and provide hospitals and health systems with updated information. To continue to meet their mission of caring, hospitals are exploring alternative sources and considering conservation efforts," an AHA spokesperson said in a statement to Fierce Healthcare.
Hospitals take steps to conserve supplies
Hospitals across the country are taking steps to maximize supplies.
Baxter sent letters to hospitals telling them that future shipments of IV fluids would be about 40% of what they normally receive due to the North Carolina plant closure, according to Dr. Paul Biddinger, chief preparedness and continuity officer at Mass General Brigham in Boston, The Wall Street Journal reported.
During a conference call with reporters Thursday, Biddinger said hospital operations continue as normal and patient care has not been affected, according to media reports. The hospital system is conserving its fluid supplies, including switching to oral hydration—Gatorade or water—for patients who are healthy enough for it, and not discarding partially used IV fluid bags when patients are moved to a different part of the hospital, Biddinger said, as the WSJ reported.
“I would characterize this as one of the bigger shortages that we’ve been through in the last decade or so,” Biddinger said, as reported by the Washington Post. “We acted early to make sure we’re conserving as quickly as we possibly can.”
Hospitals also experienced IV fluid shortages in 2017, when Hurricane Maria disrupted manufacturing.
"Having experienced similar challenges in the wake of Hurricane Maria in 2017, we continue to be mindful of how we manage the supply of these medications to ensure minimal impact on our patients. Hospital operations continue as normal and patient care remains unaffected," Biddinger said in a statement, as reported by CBSNews.
RWJBarnabas Health, based in New Jersey, is taking “appropriate conservation measures” across its health system as it assesses the supply affected by Baxter, NBC News reported.
Oregon Health & Science University Hospital, which was also affected by the Baxter closure, is using oral hydration options when possible, as well as evaluating each patient for the discontinuation of continuous IV fluids, the organization told NBC News.
ECRI, a healthcare quality and safety group, released a report designed to provide guidance to healthcare providers to help navigate shortages caused by the Baxter facility shutdown. Medical facilities may experience shortages of normal saline, dialysis solutions, and additional IV products that are critical for patient care, the organization said.
“Our hearts are with those who experienced tragedy and loss from the devastating storm and flooding caused by Hurricane Helene,” said Tim Browne, Vice President of ECRI’s Global Supply Chain Solutions. “We extend our gratitude to the healthcare staff and frontline workers tirelessly providing support and care in medical facilities in the hardest-hit communities along the southeast.”
The report (Excel file) identifies up to the top three alternatives from other manufacturers to the IV and irrigation solutions affected by the plant closure.
The American Society of Health-System Pharmacists (ASHP) published suggestions for management and conservation of IV solutions.
Baxter International also offered steps healthcare providers can take to manage and conserve IV solutions and products:
- Evaluate inventory, look at current stock levels, expiration dates and the distribution of IV solutions
- Collaborate with clinical teams to identify which patients are in critical need of impacted IV solutions
- Identify alternative sources of solutions and medications such as oral rehydration for non-critically ill patients
- Implement evidence-based fluid management protocols to optimize IV fluid administration and minimize waste
- Assess pharmacy operational strategies
- Engage clinical teams on managing fluid restrictions, medication changes and potential risks
- Document and monitor fluid usage, patient needs and any shortages encountered
Lessons learned for supply chain resiliency from previous natural disasters
Healthcare leaders say the industry has learned some valuable lessons from responding to past natural disasters and supply chain disruptions.
"Having experienced similar challenges in the wake of Hurricane Maria in 2017, we continue to be mindful of how we manage the supply of these medications to ensure minimal impact on our patients. Hospital operations continue as normal and patient care remains unaffected," Mass General Brigham's Biddinger said in a statement.
Nicolette Louissaint, senior vice president of policy and strategic planning at the Healthcare Distribution Alliance (HDA), told Fierce Healthcare there are now more tools in place ready to be deployed to help mitigate supply shortages.
"I think in 2017 when there was an ongoing saline shortage that was then exacerbated by Hurricane Maria, we saw that there were a lot of concerns related to the availability of saline, and really testing what we could do regarding flexibilities to be able to respond to a saline shortage. I think that lesson from that hurricane a few years ago has both created a certain level of concern, because I think the healthcare community remembers that it's still something that feels fairly recent, and there's no desire to go back there again. I also think there are a lot of lessons that were learned from that particular incident, specifically existing shortages exacerbated by catastrophic hurricane, which is what we're seeing here. This need for a medical surge related to just a regular fall season and then the situation created by a hurricane," Louissaint said in an interview on Friday.
She added, "While there are things that could happen, like concerns regarding availability of supply, there are a lot of tools that are being explored and a lot of other strategies that are currently in place and have been in place since it was clear that the facility went down that are going to really mitigate against that."
There is ongoing communication between the FDA, the Administration for Strategic Preparedness and Response and Baxter to ensure the continuity of supply can continue, she noted.
"We aware that [Baxter] is ramping up production in other facilities. There are facilities that were originally at five lines, five-day operation consistent lines that are going to 24-hour operations. There are competitors that are also doing the same thing to ensure that there's availability of supply," Louissaint said. "I think where we are right now is looking at within the range of existing manufacturers that are able to move product into the market, how can they ensure that they're bumping up what they're able to do while Baxter is working diligently to get the resumption of this plant back online as soon as possible."
In 2017, the federal government and the industry learned the value of strategic partnerships. "The faster that our federal partners can be engaged directly with the company, the faster they're able to determine should they should think about releasing product that may be available in a stockpile. Should the FDA use regulatory flexibilities to be able to allow for temporary importation, for example. Should the FDA and ASPR begin conversations with other manufacturers of that product to see if they can bump up production sooner rather than later?" Louissaint said.
Those conversations are happening faster in the wake of Hurricane Helene, she noted.
"I think there's just a better understanding of what to do, so it's happening quicker, and there's a much more open line of communication, and I think that's something that Baxter should really be applauded for."
HDA is not hearing that hospitals or health systems are having issues with constraints or shortages. "We are hearing concern that there might be issues with constraints or shortages," she noted.
"There are facilities that are rightly looking at the type of time of year and saying, this is flu season, and the last few years we've seen this tripledemic that relies on saline and similar products to be able to treat acute respiratory illnesses. There are systems and public health departments that are starting to say, 'OK, if we're trying to order 3x the product that we normally order, and we're not getting 3x and what happens when we can't get that full amount?' The reality is that the product is not yet in shortage," Louissaint said.
"She added, "We are not seeing an indication that the product would be in shortage, but this is being tracked day by day, including from the lens of the fact that there's a response to a catastrophic hurricane going on, so there are going to be additional medical surgical needs associated with that. And we're aware that we're in this time of year where we may see surges related to flu and RSV and COVID."
HDA encouraged its members to maintain ordering product based on historical levels of their supply needs and what they believe they can utilize. "That ensures that we will continue to support the entire healthcare community, and that we don't run into these issues of potential spot shortages," she said.
Supply chain leaders also were keeping an eye on the port workers' strike announced last week, which could have significantly escalated the urgency and logistics of supply movements. On Thursday, the longshoremen’s union on the East and Gulf Coasts agreed to suspend its strike and major ports have rushed to reopen.