Scientists say 16 kidney patients at a Colorado dialysis center developed severe blood infections after the staff tried to shave costs by double-dipping into single-dose vials of an anti-anemia drug called epoetin alfa, or Epogen. Ten patients had blood infections, and six had fever reactions.
Tests showed the patients were infected with Serratia liquefaciens, a rare bacterium that until the outbreak had not been associated with dialysis, a procedure to clean the blood of people with kidney failure. An investigation turned up traces of the germ on vials of Epogen and containers of soap and hand lotion.A report on the 1999 outbreak in the May 17 issue of the New England Journal of Medicine says that while the source of the unusual bugs isn't clear, tainted tap water is the likely culprit. The report says the clinic did what many similar facilities have done to save money: It inappropriately used single-dose bottles of a medication for more than one patient or combined the remnants of nearly drained vials.
"This isn't a new occurrence. Over the last 20 years there have been episodic reports of multi-dose or single-dose medications getting contaminated, but this is the first one we know of with this particular organism," says Dr. Lisa Grohskopf, an epidemiologist at the Centers for Disease Control and Prevention (CDC) and lead author of a new study of the practice.
Grohskopf and her colleagues surveyed 103 dialysis centers nationwide. Of the 71 that responded, 45 said they punctured single-use vials of the drug more than once to draw as much of the medication as possible, and nine said they pooled the contents of mostly empty bottles.
"The potential is there for some pretty severe illness," Grohskopf says.
Dialysis patients are at a heightened risk of serious infection from the machines. Eighteen percent of deaths of people on dialysis are the result of infection. An estimated 200,000 Americans now undergo the procedure.
The Colorado outbreak drew the attention of the Food and Drug Administration, which posted a letter from California drug-maker Amgen warning dialysis centers in March 2000 not to use single-use vials of Epogen twice or to pool the drug. "Once a syringe has entered a single dose vial, the sterility of the product can no longer be guaranteed," the letter says.
Amgen makes both multi-use and single-use vials of Epogen, a blood-cell stimulating protein prescribed to kidney patients and people with anemia linked to cancer treatment. The vials come in doses ranging from 2,000 to 10,000 units. In some cases, 10 to 20 percent of the liquid inside can be left behind.
That waste can add up. A facility serving 150 patients that uses 10,000-unit vials only once might spend up to $1.1 million a year for the drug, while the same clinic that recovers the leftover drug from smaller doses might be save $180,000, Grohskopf says.
David Kaye, an Amgen spokesman, says the company hasn't received any more reports of infections linked to misuse of Epogen vials. However, Kaye says Amgen is aware of the financial pressures on dialysis clinics to get the most from their drugs.
"Centers may elect to store it up and see if they can get another full injection out of it, but there is a risk to patients," Kaye says. "This is a protein that's injected, so if there's any contamination, it goes right into the bloodstream."
The multi-dose form of Epogen contains a preservative that kills bacteria. It can also be injected underneath the skin, which further minimizes its risk of blood-borne illness, Kaye says.
Dr. Jay Wish, who runs the dialysis center at University Hospitals of Cleveland, says low reimbursement rates by Medicare encourages clinics to look for ways to maximize profit margins, including mining Epogen vials for leftover medication.
Wish says, "Nobody really knew that it was harmful until a study like this came out. People thought that with the appropriate safeguards," including not keeping the drug overnight and not allowing the vials to sit out, patients wouldn't be at risk. Wish is board president of ERSD Networks, a national dialysis group that works with the U.S. Health Care Financing Administration to monitor dialysis care.
Wish says dialysis centers will continue to have a perverse incentive to trim costs as long as the government reimburses the treatment at its current rate.
Medicare recently raised its payment for the procedure to $125, the first adjustment in 15 years, Wish says. That's not enough to compensate for increases in the cost of the machines, labor and other expenses. "It's still not keeping pace," he says.
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