KLIMAWIRE | Doctors are being forced to change treatment plans for American patients with kidney failure – and blocking some patients from starting dialysis – three weeks after Hurricane Helene severely damaged a medical supply manufacturer in Marion, North Carolina.
The Baxter International-owned plant manufactures half of the nation’s supply of a fluid called peritoneal dialysis, a critical component of the treatment used by about 80,000 kidney patients nationwide.
Baxter International is one of two companies in the United States that produce peritoneal dialysis fluid. The other company, Fresenius Medical Care, owns dialysis centers and supplies only its own patients.
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Due to storm damage at the Baxter facility, the Food and Drug Administration over the weekend declared an official shortage of three types of fluids manufactured by the plant, including peritoneal dialysis solution.
And since Baxter said it likely won’t start its North Carolina plant until the end of the year, “that means half of the people on home dialysis can’t get fluids,” said researcher Suzanne Watnick. Headquarters of the Nephrology Association.
Watnick last week led a group of kidney-related organizations to write guidance for doctors and patients on how to manage the shortage.
Many patients who rely on Baxter’s dialysis fluids receive 50 to 90 percent of their prescriptions.
“It’s a terrible place for a patient to be, and the doctor has to be the one making the changes and writing the prescriptions to respond to that, and it’s not easy,” Watnick told POLITICO’s E&E News.
The kidneys act as special filters for the body, removing waste and excess fluid from the blood and producing urine. When the kidneys stop working, a special treatment called dialysis is needed to keep someone alive. Without it, they will suffer seizures, go into a coma and eventually die.
There are two types of dialysis. Hemodialysis is when patients are attached to machines that take blood from the body, wash it, and put it back. Often, this type of dialysis requires the patient to go to a hospital or dialysis clinic for hours, three to four days a week.
Peritoneal dialysis, on the other hand, is less harmful to the patient’s life and is often done at home. There, a bag of special fluid is attached to a catheter in the lining of the abdomen. The solution drains into the lining of the abdomen, absorbs waste products and extra fluid, and drains into the pouch.
The eight-page guidance document Watnick worked on helps doctors navigate medicine where patients undergo dialysis fewer days a week, pump less fluid into the abdominal lining, or where that fluid may stay in the abdominal lining for less time than usual. would be
The guideline states that doctors or nurses should only consider changing patients’ dialysis prescriptions or treatment plans if patients still have normal kidney function.
He also urges patients who change dialysis plans to adhere to strict diets that reduce the amount of sodium, sugar and fluids they eat to put less stress on the body.
Although the guidelines are carefully written to limit treatment to only relatively healthy patients, Watnick said there is always concern that the deficiency could lead to side effects.
The guidance follows a notice sent by Baxter to healthcare professionals earlier this month, notifying them of the plant’s damage and directing doctors to review their current stock and try to save their existing peritoneal dialysis solution.
Baxter also told doctors to “delay initiation of dialysis” for new patients “if clinically possible.”
“During a (peritoneal dialysis) fluid shortage, Baxter’s primary goal is to ensure patient safety while maintaining effective treatment for existing patients,” the company wrote on Oct. 1.
The company is actively working to restore its manufacturing plant that was flooded during Hurricane Helene. The storm also blew down a local bridge to access the site.
In an update Thursday, Baxter said two temporary bridges are being put in place to increase access to the site and “current priorities are to complete a deep clean of the facility, including floors and equipment.”
The company’s current goal is to restart production by the end of this year. But Baxter cautioned that he had no timeline for when production would “fully recover to pre-hurricane levels.”
In the meantime, the FDA and the Department of Health and Human Services’ Strategic Response and Preparedness Administration have been working to obtain other solutions produced by the North Carolina plant.
In addition to the peritoneal dialysis fluid, the facility produces other intravenous fluidsfor example, salt, which is used to treat patients undergoing surgery or who are dehydrated.
To address other shortages, the FDA has temporarily authorized the importation of some intravenous fluids from international Baxter plants. Thanks to this, the company has made some progress.
Now, customers can get 60 percent of their regular orders, up from 40 percent. And some IV solution products, the company says, will return to 100 percent by the end of the year thanks to imports.
But no such changes have been reported for dialysis fluids. Baxter says it is “working closely with our partners” to “identify alternative sources of supply”.
Many kidney patients who currently rely on peritoneal dialysis may switch to hemodialysis, which is much more common in the United States.
But medical officials have so far warned against that strategy because hemodialysis itself relies on other fluids from Hurricane Helene.
Sterile intravenous fluids are used to flush the tubes used to circulate blood in and out of the patients’ body before dialysis begins, and rehydration of the fluids is also sometimes necessary if the patients’ blood pressure drops during dialysis.
“Transition to hemodialysis should be avoided as much as possible,” the Centers for Disease Control and Prevention wrote in guidance issued over the weekend.
Watnick noted that transitioning someone to hemodialysis too quickly can make them more vulnerable to infection.
When patients are prescribed long-term hemodialysis, they first operate on the blood vessels in the arm to create a perfect place for blood to flow in and out of the body.
But if patients need to undergo hemodialysis quickly, doctors insert a plastic tube into the skin of the neck. Such catheters leave patients vulnerable to infection and are “much less safe,” Watnick said.
Further such transitions may be necessary depending on whether the FDA is able to certify an additional peritoneal dialysis solution.
“That’s the real question, how long is this going to last?” Watnick said.
reprinted E&E News Courtesy of POLITICO, LLC. Copyright 2024. E&E News provides essential news for energy and environmental professionals.
