AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.
Featured topic and speakers
Where did Hurricane Helene hit? Why is there a shortage of intravenous fluids? What can I use instead of IV saline? Where are IV bags made?
AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, discusses the impact of Hurricane Helene, how elective surgery can be delayed after the North Carolina hurricane damage, and addressing drug shortages in the U.S. AMA Chief Experience Officer Todd Unger hosts.
- The AMA is your powerful ally, focused on addressing the issues important to you, so you can focus on what matters most—patients. We will meet this challenge together. Join us.
- AMA resources addressing and managing drug shortages.
- FDA drug shortage list.
- FDA drug shortages FAQ.
- CDC HAN Disruptions in Availability of Peritoneal Dialysis and Intravenous Solutions from Baxter International Facility in North Carolina (CDC HAN 00518).
- If the CDC issues new health warning, get the latest CDC health alert 2024 via the Health Alert Network (HAN CDC website).
- Learn more about American Medical Association councils.
- Learn more about our AMA advocacy priorities, including:
- Reforming Medicare payment
- Fighting scope creep
- Fixing prior authorization
- Reducing physician burnout
- Making technology work for physicians
Speaker
- Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association
Transcript
Unger: Hello and welcome to the AMA Update video and podcast. Today, we have our weekly look at the headlines with the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia. I'm Todd Unger, AMA's chief experience officer. Andrea, it's great to see you.
Garcia: Great to see you, too. And good to be here.
Unger: Well, this week, we've decided to bring everyone out there a special episode focused on something you've been reading a lot about, and that's the shortage of IV fluid in the aftermath of Hurricane Helene and what it means for hospitals and patients. Andrea, Hurricane Helene certainly made headlines for multiple reasons. But for those who may be unaware of this one particular issue, why don't we just start by talking about a brief overview of what happened?
Garcia: Sure, Todd. And we, of course, have seen several catastrophic hurricanes this season. But as a reminder, Helene was a category four hurricane. It made landfall on Florida's Gulf Coast back on September 26. And then it moved throughout the Southeastern U.S., killing more than 200 people across six states and causing extensive damage, really between 30.5 and 47.5 billion in property damage.
In the wake of this destruction, production was halted at a Baxter International manufacturing facility in North Cove, North Carolina. It's located about an hour east of Asheville. And Baxter is the largest manufacturer of IV fluid and peritoneal dialysis and intravenous solution in the U.S. So, this closure caused massive supply disruptions. We know that hospitals and government agencies are now scrambling to cope with these shortages.
Unger: Andrea, have we ever dealt with anything like this before?
Garcia: So according to the FDA, 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. 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.
Last week, the FDA added three IV fluids to its drug shortage database, declaring the products, which were dextrose 70% IV solution, lactated Ringer's IV solution and peritoneal dialysis solution to not be commercially available in adequate supply to meet national demand.
Unger: So first of all, 60% of production kind of sidelined there. That's huge. Who'd have thought that would happen from a hurricane? I know from seeing posts on social media talking with health system leaders that this is really impacting hospitals and patients. Tell us more about what we're seeing out there.
Garcia: Well, there was a survey of more than 220 health care providers that was conducted between October 7 and 8 by the health analytics consulting firm Premier. The survey found that more than 86% of U.S. health care providers are experiencing shortages of IV fluids, approximately 54% reporting supplies of 10 days or less of IV fluids in their inventories.
And as a result of these shortages, we know that nearly 17% of those respondents said that they've already opted to postpone elective surgeries and other procedures. And 58% reported that they were considering taking those measures. Now, this comes at a time where we're heading into respiratory virus season. And we know hospitals are already likely to see higher demand. So any extended shortage of IV fluids can certainly put a further strain on hospital resources.
Unger: So Andrea, what can we do to address the shortage, at least in the short term?
Garcia: Well, the threat of a long-term shortage did prompt the administration to invoke the Defense Production Act to help speed up recovery efforts and get that North Cove plant back up and running. In addition to canceling or postponing elective surgical procedures, hospitals are also turning to alternatives for hydration, like hydration tablets and Gatorade. And they're prioritizing IV fluids for the most acute patients and the most vulnerable, like children.
Some hospitals are even beginning to produce their own solutions. The FDA did release new guidance that eases up on rules regarding the compounding of IV solutions. And that's to make it easier for hospitals and other facilities to do this during the shortage period.
Unger: Andrea, have we heard anything from the CDC about this?
Garcia: We have. And it was October 11 when we saw the CDC issue a health advisory, or a HAN, to urge health care professionals to follow the agency's recommendation on addressing the shortage. That includes strategies on conserving those existing supplies. Health care professionals, pharmacists, health care facility administrators, state, tribal, local and territorial health departments, regardless of supply chain disruptions, were urged to immediately address and assess their supply, develop plans and mitigation strategies to reduce that impact on patient care.
The CDC did say that these strategies must ensure patient safety, timely and effective safety notifications, education of health care personnel and patients. Emergency medical and outpatient services were also to be included in these strategies. And hospitals were asked to report any potential shortages or interruptions to the FDA at drug shortages at fda.hhs.gov. And that's to help better track the situation and to understand the challenges on the ground.
Unger: All right. Well, thank you for that information. Andrea, you mentioned Baxter, the owner of the facility in North Cove, North Carolina, trying to get things back up and running. Have we heard anything from them about how they're responding and where things stand?
Garcia: Yeah, it's been reported that Baxter's more than 2,500 North Cove employees have returned to work across multiple around the clock shifts. And they're currently focused on site remediation. The company's goal is to restart production by the end of this year. They don't have a timeline as to when that production will return to those pre-hurricane levels.
Over the last 10 days, we do know that the company has been able to move more than 450 truckloads of product that was produced prior to the hurricane out of that facility and into the supply chain. But until it can fully ramp up its domestic production, the company's been working with the FDA and ASPR to begin importing supplies from several of its international facilities.
So FDA has conducted scientific and regulatory assessments for that temporary importation of 23 different IV and peritoneal fluid from five Baxter facilities around the world. Those first flights began arriving this past Saturday. And each flight carries over 100,000 units of product.
Unger: Well, that's good news. I'm curious of these efforts. Are they moving the needle, so to speak?
Garcia: Well, this past Friday, we know that HHS shared an update. And although the shortages are still dire, the efforts do seem to be bringing a little relief. According to HHS, hospitals have 50% more product available to them now compared to right after the hurricane.
Baxter's also communicated that supply availability is continually improving. They expect to further increase customer allocations to 90% to 100% of historical levels for many IV solution product codes no later than by the end of this year. The supply improvements combined with increased output from other manufacturers should help hospitals get more product that they need over the coming weeks.
We know that FDA continues to share updates through its dedicated website for essential hurricane Helene response. And Baxter also continues to share updates through its page every Monday and Thursday. Baxter also has created a resource mailbox to track and route inquiries. That mailbox is [email protected].
Unger: Excellent. Andrea, how is the AMA responding to this situation?
Garcia: Well, Todd, the AMA has declared drug shortages to be an urgent public health crisis and a national security threat. And it's been actively working to limit the impact on practice. The AMA's Council on Science and Public Health does an annual report to the House of Delegates on drug shortages, which often includes updated policy recommendations on the IV shortage—IV fluid shortage specifically.
The AMA issued a letter to HHS on October 10 on behalf of physicians and patients. That letter urged the administration to pull every available lever to help mitigate any potential shortages and ensure adequate supplies of drug products that are at risk of shortage. We highlighted the need for continued prioritization of the issue and to provide timely updates to physicians and patients.
On that front, we've also set up a web page that pulls together resources and provides updated information on the fluid shortage and other drug shortages all in one place. On that page, physicians will find clinical guidance, including available substitutions, alternate sourcing and temporary compounding guidelines. And we will share the link to that page in the description of this episode.
Unger: Thank you very much. And again, for that AMA resource page, you can find the link to that page in the description of this episode. So check that out. And we'll continue to update that as there are developments. Well, that's certainly a tragic situation. And we will continue to provide updates as needed, both here and on the site.
Andrea, that wraps up today's episode. As always, thanks so much for being here and providing your perspective. If you found this discussion valuable, you can support more programming like it by becoming an AMA member at ama-assn.org/join. You can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
Subscribe to AMA Update
Get videos with expert opinions from the AMA on the most important health care topics affecting physicians, residents, medical students and patients—delivered to your inbox.
