Hurricane Helene is gone but its ripple effects continue all across the U.S., with tens of thousands of dialysis patients now at risk of losing access to life-saving care due to a shocked supply chain.
Hospitals warned that when Baxter International’s North Carolina facility was shut down by Helene, the U.S. health system would acutely feel the impact. These harms are now becoming evident nearly three weeks after the storm.
Baxter’s North Cove manufacturing plant supplied roughly 60 percent of IV fluids used by U.S. hospitals, including half of all peritoneal dialysis (PD) fluids for the country; the Food and Drug Administration (FDA) declared PD fluids in shortage last week.
PD is used to treat kidney failure, when a patient’s kidney can no longer effectively filter their blood. There are two types of dialysis, peritoneal and hemodialysis, with the former able to be done at home, while the latter is usually done at a dialysis center.
Hemodialysis involves blood being removed from a patient’s body and filtered through a hemodialysis machine, essentially operating as an external, artificial kidney. PD involves a patient filling their abdomen daily with a cleansing fluid called dialysate, keeping it in their body for about four to six hours, draining it and then replacing it with fresh dialysate.
In the absence of dialysis or a kidney transplant, a patient with kidney failure is certain to die.
For most patients, access is relatively easy when supply is normal. Dialysis is federally covered, regardless of age, and the vast majority of dialysis patients are covered by Medicare for the service.
“Over half a million people get dialysis in this country — like 550,000 — and about 15 percent of them get dialysis at home,” said Suzanne Watnick, health policy scholar-in-residence at the American Society of Nephrology (ASN) and professor of medicine at the University of Washington.
“Most get it through peritoneal dialysis so, like 80,000 patients get peritoneal dialysis. And it’s lifesaving therapy. You don’t get it, you die.”
Options are available for PD patients if they’re unable to access solutions. They can switch to hemodialysis, or they can use less of their supply of PD solution, but both courses of action have drawbacks.
Nancy Colobong Smith, national president of the American Nephrology Nurses Association, told The Hill that PD patients using less fluid will have to be more careful about their diet, behaving more like hemodialysis patients who typically only get filtered three times a week. PD patients often say they prefer the at-home option as it affords them more flexibility in their diet.
“Let’s say that they’re using 15 liters. We might say, ‘Oh, let’s try to use less in your therapy tonight, you know. Instead of using 15 liters, let’s use 10 liters.’ So, it can be rationed in a way that at that point then we’re changing prescriptions,” said Smith.
“If we’re making small adjustments, it’s not as noticeable,” Smith added. “But if we’re really either telling people that they can only have PD, you know, instead of every night, every other night, then that would be more of a concern.”
Patients who significantly reduce their use of PD solution risk extra electrolytes, fluid and waste collecting in their bodies.
Watnick noted that PD typically offers a higher quality of life as patients don’t have to visit a doctor’s office multiple times a week.
While hemodialysis clinics are spread throughout much of the country, Smith noted that rural areas are less likely to have access, so patients who live in these areas may be more reliant on PD.
The best option for patients with kidney failure is a kidney transplant. But waitlists are long, and most patients wait several years if they don’t have a donor.
How manufacturers are responding
Though the shortage was just recently declared by the FDA, the Baxter plant has been closed for several weeks patients are already seeing differences. According to Watnick, patients are being told to expect between 50 and 90 percent of the PD fluids they normally receive.
In an update released Thursday, Baxter said it was “closely partnering with the kidney care community to promote conservation of peritoneal dialysis (PD) solutions supplies.”
“We continue to actively deliver supplies to current PD patients, in close coordination with dialysis care teams to help meet patients’ therapeutic needs,” said the company, noting it is “partnering with healthcare professionals to limit new PD patient starts to pediatric patients (those under 18 years old).”
The FDA has approved temporary importation from five Baxter facilities abroad, with the company stating the imported fluid is being factored into allocation levels.
Watnick stressed that because PD fluid goes directly into a patient’s abdomen, the product must be sterile and “of the highest quality.”
During times of shortage, compounders have the flexibility to prepare FDA-regulated products, but Watnick noted that PD fluid is significantly more complex than saline. Additionally, PD fluid isn’t a moneymaker.
“It’s probably why there’s only, you know, one plant that’s out there,” Watnick said. “It’s not a big moneymaker for them, but it is a good community service. So, the compounders are probably going to preferentially make the saline over PD solutions. That will play out. We’ll figure it out.”
There is one other major manufacturer of PD fluids, Fresenius Medical Care. The company said in a statement last week it is “working to ramp up its production capacity of PD and IV solutions to create additional supply.”
“In the short term this is being done by maximizing the use of existing production capacity at our international sites. At the request of the Department of Health & Human Services, FME is further exploring all opportunities to ensure patients’ needs for both IV fluids and PD products are met during this period of critical need,” Fresenius stated.
For the time being, Smith says patients do not need to change prescriptions or ration product.
“At this point, it is really planning ahead and reallocating the fluids we do have because there are supply delays,” said Smith.
