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cies like manufacturers in 2007, it backed off after professional pharmacy groups protested.
This isn't the first time New England Compounding has been implicated in below-standard compounding procedures. In 2006, NECC
received a warning letter from the FDA regarding concerns about the
scale of production and potential health risks, particularly with
injectable sterile drugs. It's also not the first time contaminated solutions from compounding pharmacies have been behind patient deaths.
Steven Gayer, MD, MBA, a professor of anesthesia and ophthalmology at the University of Miami (Fla.) School of Medicine, speaking at
last month's OR Excellence conference, pointed out that
• in 2001, 38 patients were exposed to meningitis in a similar case;
• in 2002, 4 patients developed fungal meningitis (from a different fungus) after steroid injections; and
• a Michigan pharmacy recalled 900-plus vials of contaminated
steroids recently.
"We've had 2 separate compounding pharmacy issues just in the last
year here in Florida, including 33 fungal endophthalmitis cases in one
of them," says Dr. Gayer. "What I'm saying is: We've been here before."
More to come
However, no contamination issue has ever been so big, so widespread
and so baffling. Experts say it's as yet unclear why some patients have
succumbed to the tainted vials and many others haven't. The CDC is
N O V E M B E R 2012 | O U T PAT I E N T S U R G E R Y M A G A Z I N E O N L I N E
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