The CVS representative popped into Lisa Trumble’s third-floor Berkshire Medical Center hospital room in Pittsfield, Massachusetts, to announce that everything was arranged for Trumble to return home, where she relies on IV nutrition because of severe intestinal problems that leave her unable to eat.
That was on Tuesday, Oct. 8. The next morning a social worker and a doctor woke Trumble to say her discharge was canceled. CVS would no longer provide her home nutrition, and she had to stay in the hospital. A week later, “I’m still here,” she said by telephone Wednesday. “I was dropped between Tuesday night and Wednesday morning with no care for my life or my health.”
Trumble is not the only one in crisis. She’s among 25,000 U.S. patients who depend on parenteral nutrition, or PN — IV bags containing life-sustaining amino acids, sugars, fats, vitamins, and electrolytes. Hurricane Helene wrecked a factory in North Carolina that produced 60% of the fluids their sustenance is mixed from. About two weeks later, CVS announced that its Coram division, a leading infusion pharmacy, was exiting the PN and IV antibiotics business.
The hurricane led Baxter International to ration its dwindling supplies. Pharmacies that supply Trumble and other patients like her were already plagued by shortages, and the rationing means the remaining infusion pharmacies can’t take on the customers cut off by CVS, said David Seres, director of medical nutrition at Columbia University Medical Center in New York.
At the Mayo Clinic in Rochester, Minnesota, seven or eight patients were ready to go home Tuesday but couldn’t be discharged because no infusion company would accept them, said Manpreet Mundi, a Mayo endocrinologist. The patients would fall ill within a day or two without this nutrition, he said.
Although the FDA is allowing emergency imports of IV fluids wiped out by Helene, as well as production of some of the fluids by U.S. compounding pharmacies, it’s unclear how long it will take to replenish supplies, said Mundi, who is a board member of the American Society for Parenteral and Enteral Nutrition and medical adviser to the Oley Foundation, which advocates for PN patients. “We’re trying to raise awareness that this could get worse before it gets better,” he said.
The patients who rely on PN have a variety of conditions that render them unable to digest food. Some have congenital abnormalities or disorders like Crohn’s disease that led to surgical removal of bowel sections. Others were scarred by cancer, car accidents, or gunfire, or are preemies born with underdeveloped intestines. In most patients, the fluid is pumped through a catheter into a large vein near the heart.
A crisis hit this community two years ago when CVS Health announced that it was shutting half of the 71 Coram pharmacies.
CVS, which recently announced nearly 3,000 layoffs amid reports of a possible restructuring, on Oct. 8 began telling its remaining 800 to 1,000 PN customers that they would have to find other infusion pharmacies. A news release provided to KFF Health News suggested the phaseout would last into January, but for patients like Trumble, the impact was immediate.
Highly specialized infusion medicine is “a challenging environment” for all companies “and Coram has not been immune to these challenges,” the CVS release said. “As such, we have reevaluated our service offerings.”
As far as Trumble, CVS Health spokesperson Mike DeAngelis said, “We’ll look into this matter and try to resolve it.”
It’s hard enough normally for such patients to find new suppliers for their materials, which can include 120 pounds of IV fluid per week.
Coram’s departure “made a big crisis that much worse,” Mundi said. “It’s become kind of a double whammy.”
The Baxter International North Cove plant produced most of the country’s high-concentration dextrose, a major source of energy for PN patients, as well as saline solution and sterile water, also vital supplies. A week after Helene hit, Hurricane Milton threatened sterile IV fluid supplier B. Braun Medical’s facility in Daytona Beach, Florida. The federal government helped truck 60 loads of the company’s inventory to a safe location, but the plant was spared the storm’s worst. It restarted production on Oct. 11.
That was a huge relief for Beth Gore, CEO of the Oley Foundation. She, her husband, and their six adopted children braved the storm’s seven hours of lashing wind in their home near Ruskin, Florida. Milton wrecked a car and part of the roof, but the family prayed through it all and somehow never lost power, though their neighbors did, Gore said. That kept the IV fluids fresh and the internet on, which calmed the kids.
Coram has supplied her youngest son, 15-year-old Manny, with PN for 13 years, and the family will need to find another supplier, she said.
“There’s been no relief” since Coram reduced its services in 2022, Gore said. “Now there’s this new twist.”
Her son gets care through Medicaid, whose reimbursement provides barely break-even margins for many infusion pharmacies, she said. Insurance limits, state licensing differences, and highly specific nutritional needs pose challenges for patients seeking new IV suppliers in the best of times, she said.
The FDA announced Oct. 9 that it would allow Baxter to import emergency supplies from Canada, China, Ireland, and the U.K. In the meantime, Baxter is prioritizing hospital patients over the home infusion companies — which lack backup supplies, Mundi said.
“We’re all on the phone 24/7,” said Kathleen Gura, president-elect of the American Society for Parenteral and Enteral Nutrition and pharmacy clinical research program manager at Boston Children’s Hospital. Her team is struggling to find new suppliers of IV nutrition at home for the 20 Coram patients among the 150 she sees.
“Some kids have a situation where they can’t absorb at all through their intestines and will die of dehydration if they can’t get IV,” Gura said.
The IV fluids lost in the Baxter disaster are key to all kinds of inpatient care. Many U.S. hospitals are conserving fluid by giving some patients oral hydration instead of IVs, or by delaying surgeries, said Soumi Saha, senior vice president of government affairs at Premier, which negotiates group hospital purchases.
President Joe Biden has invoked the Defense Production Act, which will enable the government to order companies to prioritize rebuilding the Baxter plant.
The military is flying in supplies from Baxter plants overseas, Saha said. Premier has also asked the FDA to put several more PN ingredients on its shortage list, which would allow large compounding facilities to produce the materials.
Ellie Rogers, 17, of Simpsonville, South Carolina, fears the worst if she can’t get her supplies. She suffers from a host of immunological and neurological ailments that require her to get four liters of IV fluid daily to stay alive, she said.
Her supplier, an Option Care Health pharmacy in South Carolina, informed the family Oct. 14 that instead of her weekly supply it was sending her enough bags for a day or two. “They really don’t know when they’re going to get what they need,” she said. Reducing the infusions in the past has led to dizziness, nausea, and pooling of her blood that “felt like my veins were going to explode.”
On Oct. 7, Crohn’s disease patient Hannah Hale’s infusion pharmacy called and said it couldn’t fill her standing weekly order of IV bags, urging her to find a new pharmacy.
“I called 14 infusion pharmacies and haven’t been able to find anyone to take me,” said the Dallas 37-year-old. She suffers from weight loss and low blood sugar, and rationing her supplies raises dangers of seizures or coma, she said.
Trumble, 52, who started on PN 13 months ago because of colon cancer and severe intestinal issues, said she’s grateful to the hospital and gets excellent care but misses her mother, son, and 8-year-old grandson, Jordan — and her cats.
What’s worse, Trumble said, her mother and son, who get Medicaid payments to care for her, haven’t been paid the two weeks she has been in the hospital.
But without IV nutrition at home, she said, “I’d starve.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
from KFF Health News https://ift.tt/CkgLXl9
0 comments:
Post a Comment