NEW YORK The pharmacy linked to a deadly fungal meningitis outbreak repeatedly failed to follow standard safety and quality procedures, including waiting for results of sterility tests on its injectable steroid before shipping them to doctors and maintaining sterile conditions, health officials said on Tuesday.
Massachusetts-based New England Compounding Center is being investigated for its role in the meningitis outbreak that has killed 23 people and infected 304 who received injections of its preservative-free methylprednisolone acetate, a steroid used for back pain and other conditions.
State health regulators said their probe has turned up "substantial evidence" of problematic procedures, record-keeping and work conditions inside NECC.
Vowing to regulate compounding pharmacies more strictly, they also announced that they had voted to permanently revoke NECC's license and that of its three principle pharmacists, including owner Barry Cadden.
"Examination of NECC records indicated a failure of the facility to sterilize products for even the minimum amount of time necessary to ensure sterility," said Dr. Madeleine Biondolillo, director of the Bureau of Healthcare Safety at the state public health department.
Paul Cirel, an attorney for NECC, said in a statement that Massachusetts regulators "had numerous opportunities, including as recently as last summer, to make first-hand observations of the NECC's facilities and operations." As a result, he said, it is "hard to imagine" that Massachusetts "has not been fully apprised of both the manner and scale of the company's operations."
Details of the investigation followed the disclosure that NECC had escaped harsh punishment from regulators several times in the years leading up to the outbreak, despite repeated complaints about its business practices and sterilization procedures.
The company reached a 2006 settlement with the Massachusetts Board of Registration in Pharmacy and the U.S. Food and Drug Administration that spared it disciplinary action. On Monday, state health officials called the agreement "troubling" and said they were investigating how it came about.
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 NECC case has drawn national scrutiny to the industry, which is only loosely regulated by FDA and state pharmacy boards.
DIRTY MATS, LEAKY BOILER
The Massachusetts Department of Public Health's investigation, launched in September, found that NECC shipped orders of methylprednisolone as much as 11 days before obtaining results of sterility testing.
In addition, 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, said Biondolillo.
Conditions at the pharmacy suggested numerous ways the steroid could have become contaminated with fungus. Floor mats that technicians and pharmacists were supposed to use 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 NECC was "acting as a manufacturer" and not a traditional compounder as its state license required.
Governor Deval Patrick said Massachusetts will regulate compounding pharmacies more strictly in the wake of the meningitis outbreak, including requiring them to submit annual reports on the quantities of medications they are producing so "we can identify those acting like manufacturers" rather than traditional compounders.
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.
"In this administration, we're going to take a different tack," Patrick said. "No one should live in fear that their medicine is unsafe."