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Contaminated Cleanroom Linked to Meningitis Outbreak

blog:18965:2::0
By Tim Sandle
Posted Oct 25, 2012 in Science
Interesting overview, from Assoicated Press and re-printed in Controlled Environments, in relation to the NECC fungal issue.
Here is the report:
Water 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 said on Oct. 23 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 said. In the meantime, Massachusetts Gov. Deval Patrick said he wants to tighten oversight at similar companies, including with surprise inspections — the first of which happened on Oct. 23.
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 said.
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 said Tuesday 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, said Dr. Madeleine Biondolillo, director of the state Department of Public Health's Bureau of Healthcare Safety.
But company attorney Paul Cirel said 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 said.
"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 said.
Besides possible state license violations, Biondolillo said 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 said. Some medication was shipped as many as 11 days before the company received test results, she said.
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 said.
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 said. And a leaking boiler adjacent to a pharmacy cleanroom left an unsanitary pool of water around it and the adjacent walls, she said.
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 on Oct. 23, health department spokesman Alec Loftus said. He wouldn't give the inspected facility's name and said the results are being reviewed.
Patrick also said compounding pharmacies will now be required to file annual compliance reports that could help regulators determine if they are acting as manufacturers.
Source: CE
Important report in the New England Journal of Medicine 'Fungal Infections Associated withContaminated Methylprednisolone Injections— Preliminary Report'.
Extract:
"This outbreak of fungal meningitis caused by contaminated methylprednisolone used for epidural injections is evolving rapidly and now involves more than 200 patients. The primary pathogen appears to be E. rostratum, but it is possible that other pathogens could emerge, and it remains a mystery as to why the index case is the sole case in which A. fumigatus was detected. It is encouraging to note that clinically apparent disease has developed in only a small percentage of exposed patients. Management recommendations will almost assuredly change as more information becomes available regarding the pathogenesis of these infections."
See: NEJM

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