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S P E C I A L
R E P O R T :
T A I N T E D
S T E R O I D S
Operating as a mass manufacturer
Compounding pharmacies are licensed to fill individual prescriptions
for individual doctors, but officials say NECC illegally operated as a
mass manufacturer, mixing huge batches of drugs and sending them
around the country. This was a clear violation of its state license. A
Nashville, Tenn., surgical center reportedly received more than 2,000
vials of contaminated steroids from NECC and had to close temporarily to deal with the fallout.
"Compounded medications ready for distribution were not labeled
with patient-specific identifiers, as is required under Massachusetts
licensing regulations," says the state in a report. "With this violation,
NECC was operating beyond the scope of their compounding license."
The meningitis outbreak centers on 3 contaminated lots containing
17,000 vials of methylprednisolone acetate steroid product manufactured at NECC. But that's just the start. The FDA has now advised
providers and facilities to pull all NECC products from their shelves.
In addition, the agency is asking that providers and facilities follow up
with all patients who received the steroid injections, or NECC-compounded injectable or surgery-related ophthalmic drugs (calling them
"of significant concern") or cardioplegic solution (responsible for 1
infection) after May 21.
"We've had probably 4 patients a day calling," says Shawn M.
Herman, RN, BSN, the clinical director at the Eye Center of Columbus
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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