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Laboratory Linked to Meningitis was Filthy
Thu, 10/25/2012 - 8:36am
Associated Press, Jay Lindsay

Mass. Gov. Deval Patrick gestures during a news conference regarding the Massachusetts pharmacy responsible for the meningitis outbreak during a news conference at the Statehouse in Boston. The outbreak of meningitis, an inflammation of the lining of the brain and spinal cord, has sickened nearly 300 people, including 23 who died, in more than a dozen states. Image: AP Photo, Charles KrupaWater from a leaking boiler collected just outside a room that was supposed to be sterile. Floor mats used by technicians were filled with dirt and debris. Drugs were shipped out before the company even confirmed they were sterile.

State officials say that they found these and other problems at the New England Compounding Center during a preliminary investigation into the company, linked to a deadly outbreak of meningitis.

The probe can't yet conclusively prove what caused the outbreak, a top health official says. In the meantime, Massachusetts Gov. Deval Patrick says he wants to tighten oversight at similar companies, including with surprise inspections — the first of which happened earlier this week.

The state has also moved to permanently revoke the company's operating license, as well as the licenses of its top three pharmacists.

"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," Patrick says.

The outbreak of fungal meningitis, an inflammation of the lining of the brain and spinal cord, has sickened 308 people, including 23 who have died, in 17 states. The outbreak has been linked to a steroid made by the NECC and taken mainly for back pain. Compounding pharmacies like NECC custom mix solutions in doses or forms generally not commercially available.

The federal government is conducting a criminal investigation.

The state says that its preliminary investigation, which began last month after the company was first suspected in the growing outbreak, found batches of drugs ready for general distribution but not labeled for specific patients.

Its state license permits the company to fill out only specific prescriptions for specific patients, and distributing drugs in batches like a manufacturer would violate that, says Madeleine Biondolillo, director of the state Department of Public Health's Bureau of Healthcare Safety.

But company attorney Paul Cirel says it's "hard to imagine" state regulators weren't previously aware of the scale of its operations because they've worked so closely together. The state Board of Registration in Pharmacy has always had complete access to the facility, and board members were there as recently as last summer, he says.

"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license," Cirel says.

Besides possible state license violations, Biondolillo says the inspections also revealed "several health and safety deficiencies" at the NECC facility in Framingham, just west of Boston.

Three lots of steroids produced by the company are suspected in the outbreak, and the company shipped orders from those lots 13 times before receiving the results of its own tests to confirm those lots were sterile, Biondolillo says. Some medication was shipped as many as 11 days before the company received test results, she says.

Biondolillo also detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.

Investigators found the company didn't sterilize its products long enough and didn't adequately test whether its sterilization equipment was working, she says.

In addition, mats on which people wiped their shoes to remove contamination before entering a sterile environment were "visibly dirty and soiled with assorted debris," she says. And a leaking boiler adjacent to a pharmacy clean room left an unsanitary pool of water around it and the adjacent walls, she says.

As the investigation continues, Patrick's moves to increase oversight at the state's 25 compounding pharmacies have started.

The first of the unannounced inspections, to take place at least annually, was done this week, health department spokesman Alec Loftus says. He wouldn't give the inspected facility's name and says the results are being reviewed.

Patrick also says compounding pharmacies will now be required to file annual compliance reports that could help regulators determine if they are acting as manufacturers.

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