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| 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, Tuesday, Oct. 23, 2012. 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. |
BOSTON (AP) -- State officials investigating a pharmacy linked to a deadly outbreak of meningitis said Tuesday they found shoddy sterilization practices and unclean conditions there, including debris-covered floor mats and standing water from a leaking boiler.
State
officials also said the New England Compounding Center shipped steroids
from the possibly contaminated batches suspected in the outbreak before
it received its own test results confirming the drugs were sterile.
Gov.
Deval Patrick said he's ordered state pharmacy regulators to conduct
surprise inspections - the first of which happened Tuesday - at
companies similar to the NECC and take other steps to tighten oversight.
The state also has moved to revoke the company's operating license and
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 clean room left an
unsanitary pool of water around it and the adjacent walls, she said.
None
of what's been found is enough to definitively determine what caused
the contamination, and the investigation is ongoing, Biondolillo said.
Meanwhile, Patrick's moves to increase oversight at the state's 25 compounding pharmacies have already started.
The
first of the unannounced inspections, to take place at least annually,
was done on Tuesday, health department spokesman Alec Loftus said. He
wouldn't give the inspected facility's name and said the results are
being reviewed.
Patrick said compounding
pharmacies will now be required to file annual compliance reports that
could help regulators determine if they are acting as manufacturers.
