By JoNel Aleccia, Senior Writer, NBC News
A sharp-eyed nurse at Yale-New
Haven Hospital in Connecticut is being credited with raising a warning last week
about floating mold in vital intravenous drugs, prompting a mass recall -- and
possibly averting serious infections in patients in at least four states.
The nurse spotted the debris in
a bag of magnesium sulfate IV solution as part of a routine safety check,
according to spokesman Rob Hutchison.
“This nurse pulled it and
immediately called the pharmacy,”
said Hutchison, who didn’t identify the employee.
The hospital quickly
quarantined about 40 different types of drugs produced by Med Prep Consulting
Inc., a Tinton Falls, N.J., compounding pharmacy that has recalled all lots of all drugs
and temporarily ceased operations under a consent order imposed by the state
pharmacy board.
Five bags with floating mold
were found at Yale-New Haven Hospital; tests showed the debris was a
still-unidentified fungus. Eighty-eight orders of the magnesium sulfate solution
-- in shipments ranging from 10 to 20 bags up to 500 bags -- were sent to 13
hospitals including Yale-New Haven, according to Angelo J. Cifaldi, a lawyer for
Med Prep.
Hospital officials are reaching
out to doctors and patients who may have received the contaminated drugs,
Hutchison said. Health officials in Connecticut, New Jersey, Pennsylvania and
Delaware all said they are working with federal investigators to determine what
steps to take next. The drugs were produced and delivered between Feb. 18 and
March 13.
The worry is that patients may
have been injected with tainted 50-millileter doses of magnesium sulfate 2 gram
in dextrose 5 percent solution in water.
“Giving a patient a
contaminated injectable drug could result in a life-threatening infection,” Dr.
Janet Woodcock, director of the Center for Drug Evaluation and Research for the
Food and Drug Administration, said in a statement.
So far, no infections or other
problems have been reported, FDA officials said.
But it’s a worrisome -- and
very real -- possibility six months after an outbreak of fungal meningitis tied to contaminated
pain shots that have been tied to 722 illnesses and 50 deaths. The now-bankrupt
compounding pharmacy blamed in that outbreak, New England Compounding Center of
Framingham, Mass., had serious problems with contamination and sterility,
investigations showed.
In addition to the magnesium
sulfate solution -- which is used to replace electrolytes in hospitalized
patients -- Med Prep also makes a wide variety of sterile drugs, including
antibiotics, anesthetics, cardiac, labor and delivery and pain
management medications, according to the FDA.
The firm received FDA warnings
about its sterility practices in 2001 and 2010, agency records showed.
The 1,541-bed Yale-New Haven
hospital has used drugs from compounding pharmacies in order to meet the demand
for the volume of vital medications,
Hutchison said. Drug shortages in recent years -- particularly shortages of
sterile injectables -- have sent many hospitals to compounding pharmacies,
experts say.
Of the 86 drugs affected by the
Med Prep recall, 53 are in short supply, according to Erin Fox, manager of the
Drug
Information Service at the University of Utah , which tracks drug shortages.
After pulling the Med Prep
products, the hospital is trying to find ways to replace the drugs -- and mixing
many of the specialized products themselves.
“We’re working very hard to
source products from other vendors,” Hutchison said.
Many of the drugs will be unavailable,
however, Fox said. And it can be very hard for a hospital to ramp up its own
sterile drug production quickly.
"I think it's concerning
anytime a hospital is completely starting from scratch in a day or two."
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