In at least one case, the NECC shipped methylprednisolone acetate, the steroid linked to the meningitis outbreak, 11 days before obtaining sterility results from an outside lab, said Madeleine Biondolillo of the Massachusetts Department of Public Health.
Her department launched an investigation of the 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 the NECC, Biondolillo said.
Crucial sterilization procedures were not followed, and on 13 occasions the 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 doctors.
Conditions at the pharmacy suggested numerous ways that the contaminated methylprednisolone acetate could have become contaminated with fungus. Mats that technicians and pharmacists were supposed to have wiped their shoes on 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 said, none of these problems has been “conclusively” linked to the fatal contamination.
Another red flag, Biondolillo said, was that compounded medications ready for shipment “were not labeled with patient-specific identifiers, as is required under state licensing regulations.” That meant that the 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 the NECC’s license and that of its three principal pharmacists, including owner Barry Cadden.
Gov. Deval L. Patrick (D) said the state will now regulate compounding pharmacies more strictly. 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,” Patrick said.
Massachusetts also will conduct annual inspections of the 25 compounding pharmacies in the state, Patrick said, and require them to inform state public-health officials of all interactions with federal authorities. The NECC had received warning letters from the Food and Drug Administration.
The pharmacy had also been the subject of investigations by the Massachusetts pharmacy board. Those probes culminated in a 2006 consent agreement in which the NECC said it would rectify problems in its recordkeeping and other procedures to avoid more onerous sanctions.