Oct. 23, 2012 at 6:31 PM ETBy Sharon Begley, Reuters
NEW YORK - At least 13 times, the Massachusetts pharmacy linked to a deadly fungal meningitis outbreak shipped orders of injectable steroid before it obtained the results of sterility testing, Massachusetts health officials announced on Tuesday. Officials in that state have also voted to permanently revoke the pharmacy's license.
Twenty-three people have died and more than 300 have become ill with fungal meningitis linked to steroid shots from the New England Compounding Center in Framingham, Massachusetts. Medical experts say the outbreak is not over and there will be more cases in the coming weeks or months.
In at least one case, NECC shipped methylprednisolone acetate, the steroid linked to the meningitis outbreak, 11 days before obtaining sterility results from an outside lab, Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said.
Her department launched an investigation of NECC in September, soon after the compounding pharmacy was linked to cases of fungal meningitis from the injectable steroid. A compounding pharmacy prepares prescriptions for patients when a drug from a pharmaceutical manufacturer is unavailable or when the patient cannot take the standard medication because of allergies or other reasons.
The investigation produced "substantial evidence" of problematic procedures, record-keeping and conditions inside NECC, Biondolillo said.
Crucial sterilization procedures were not followed, and on 13 occasions NECC's pharmacists did not allow "even the minimum amount of time" to confirm that a batch of medication was sterile, she said.
The pharmacy did not properly test its own sterilizing equipment, she said, and when it sent batches of drugs to an outside lab for sterility testing, it did not wait for the results to come back before shipping medication from the same lot to patients or physicians.
Conditions at the pharmacy suggested numerous ways the contaminated methylprednisolone acetate could have become contaminated with fungus. Mats that technicians and pharmacists were supposed to use on their shoes before entering work areas "were soiled with assorted debris," Biondolillo said, and there was a leaky boiler next to a "clean room" that was supposed to maintain the highest barriers against contamination.
Still, she warned, none of these problems has yet been "conclusively" linked to the fatal contamination.
Another red flag, said Biondolillo, was that compounded medications ready for shipment "were not labeled with patient-specific identifiers, as is required under Massachusetts licensing regulations." That meant that NECC was "acting as a manufacturer" and not a traditional compounder as its state license required.
The Massachusetts Board of Registration in Pharmacy, she said, voted to permanently revoke NECC's license and that of its three principle pharmacists, including owner Barry Cadden.
Governor Deval Patrick said Massachusetts will regulate compounding pharmacies more strictly in the wake of the meningitis outbreak.
It will require them to submit annual reports on the quantities of medications they are producing and shipping so that "we can identify those acting like manufacturers" rather than traditional compounders, Patrick said.
Massachusetts also will conduct annual inspections of the 25 compounding pharmacies in the state, Patrick said, and require them to report to state public health officials all interactions with federal authorities. NECC had received warning letters from the U.S. Food and Drug Administration.
The pharmacy was also the subject of investigations by the Massachusetts pharmacy board. Those probes culminated in a 2006 consent agreement in which NECC agreed to rectify problems in its record-keeping and other procedures to escape more onerous sanctions.
"In this administration, we're going to take a different tack," Patrick said. "No one should live in fear that their medicine is unsafe."
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