Nearly 90% of professionals surveyed by hospital group-purchasing alliance Premier Inc. reported experiencing shortages of sterile intravenous (IV) fluids in the aftermath of Hurricane Helene that halted production at a Baxter International manufacturing facility in North Cove, North Carolina.
Of the 250-plus survey respondents—those working with health care organizations with acute-care beds, nonacute-care beds, surgery centers and in physician offices and other settings—who reported shortages, 53.9% said they only had enough supply on hand to last up to 10 days. Nearly 20% of respondents said they had to postpone elective and other procedures, while 58% said they were considering taking that step.
“Baxter is the largest manufacturer of IV fluid and peritoneal dialysis and intravenous solution in the U.S.,” Andrea Garcia, MPH, the AMA’s vice president of science, medicine and public health, said during an episode of “AMA Update” that covered the news. “This closure caused massive supply disruptions. We know that hospitals and government agencies are now scrambling to cope with these shortages.”
The Food and Drug Administration (FDA) has added three IV fluids to its drug-shortage database, but the shortage problem in this area is not entirely new, Garcia noted.
“Even prior to Helene, supplies of several IV fluid products had been declared in shortage. And that goes back at least a couple of years,” she said. “But the closure of this North Cove facility has been particularly devastating and has had major repercussions for the supply chain. We know that—according to the American Hospital Association—the site produces about 60%, or 1.5 million bags, of the IV fluid used by U.S. hospitals. And that's really a staggering amount.”
The AMA is closely monitoring the situation and has assembled a devoted webpage to help physicians address and manage drug shortages. Among other things, the resource page outlines:
- Clinical guidance for practices on substitutions and practice changes, ordering and alternate product sourcing, and temporary importation sources and compounding guidelines.
- AMA communications on the impact of Hurricane Helene.
- Updates and resources on the ongoing drug shortage.
- General background and policy considerations.
- Resources from the Department of Health and Human Services (HHS).
- AMA advocacy efforts on drug shortages.
The Biden administration has invoked the Defense Production Act “to help speed up recovery efforts and get that North Cove plant back up and running,” Garcia noted. Hospitals, meanwhile, are turning to alternative options such as hydration tablets and sports drinks while prioritizing IV fluids for the higher-acuity and higher-risk patients.
The FDA, meanwhile, has “released new guidance that eases up on rules regarding the compounding of IV solutions,” she added. “That's to make it easier for hospitals and other facilities to do this during the shortage period.”
At this article’s deadline, Baxter also moved to extend the expiration dates for some products manufactured before Sept. 30 (product codes and new expiration dates, in PDF).
HHS also has started airlifting additional sterile products into the country. By the end of 2024, that effort will encompass 200 flights, each carrying 150,000–200,000 units of IV fluid.
For physician practices struggling to source product, Baxter has a dedicated inbox for triage: [email protected]. Pediatric hospitals can use the subject line “Pediatric Allocation Request” for expedited response.
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Don’t wait for disaster to act
In a letter to HHS Secretary Xavier Becerra earlier this month (PDF), the AMA applauded the administration’s “quick action” to address the immediate crisis.
But AMA Executive Vice President and CEO James L. Madara, MD, urged a more proactive approach “to ensure that supply chains for drugs at risk of shortages are bolstered before shortages actually occur.”
The nation “should not let drugs fall into predictable shortages before we take action to maintain their availability,” he wrote.
“The shortages of essential drug products have been a persistent issue that shows no sign of abating. Sterile injectables and intravenous solutions have seen supply constraints lasting years, frequently exacerbated by severe weather events directly impacting manufacturing facilities,” Dr. Madara added. “Given the serious impacts of recent storms on the drug manufacturing and supply chains, the AMA urges the administration to pull every available lever to help mitigate any potential shortages and ensure adequate supplies of drug products at risk of shortage.”
The AMA has previously declared drug shortages to be an urgent public health crisis and a national security threat. In a Leadership Viewpoints column published ahead of the Helene-related problems, AMA President Bruce A. Scott, MD, outlined the multifaceted approach that is needed to combat drug shortages.
“Reform should begin,” he wrote, “with far greater transparency of the drug-supply chain and all those who operate within it.”
The IV fluid shortage underscores the need to additional action to build resiliency and redundancy into the domestic supply chain. The AMA also is engaged in ongoing advocacy on this pressing public health issue, participating in a coalitition with U.S. Pharmacopeia on drug shortages.
At the most recent AMA Interim Meeting, the House of Delegates adopted new policy to:
- Support activities which may lead to the stabilization of the generic drug market by nonprofit or public entities. Stabilization of the market may include, but is not limited to, activities such as government-operated manufacturing of generic drugs, the manufacturing or purchasing of the required active pharmaceutical ingredients, or fill-finish. Nonprofit or public entities should prioritize instances of generic drugs that are actively, at-risk of, or have a history of being, in shortage, and for which these activities would decrease reliance on a small number of manufacturers outside the United States.
- Encourage government entities to stabilize the generic drug supply market by piloting innovative incentive models for private companies which do not create artificial shortages for the purposes of obtaining said incentives.
Delegates also modified existing policy to support:
- Innovative approaches for diversifying the generic drug manufacturing base to move away from single-site manufacturing, increasing redundancy, and maintaining a minimum number of manufacturers for essential medicines.
- The public availability of FDA facility inspection reports to allow purchasers to better assess supply-chain risk.
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