BOSTON – State officials said Tuesday they found un´ clean conditions including vis´ ible black specks of fungus in steroids and a leaking boiler near what was supposed to be a clean room at a pharmacy linked to a deadly outbreak of meningitis.
Dr. Madeleine Biondolillo, Director of the Mass. Bureau of Healthcare Safety, addresses reporters 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. (AP Photo/Charles Krupa)
By BOB SALSBERGÂ
Associated Press
BOSTON – State officials
said Tuesday they found un´
clean conditions including vis´
ible black specks of fungus in
steroids and a leaking boiler
near what was supposed to be
a clean room at a pharmacy
linked to a deadly outbreak of
meningitis.
ù Gov. Deval Patrick said the
state has moved to revoke the
licenses of the New England
Compounding Center and
three pharmacists there. He
also has ordered the state
pharmacy board that oversees
similar companies to conduct
surprise inspections and take
other steps to tighten over´
sight.
ù The first such unannounced
inspection was done at a com´
pounding pharmacy on Tues´
day, state health department
spokesman Alec Loftus said.
He would not reveal the name
of the facility and said results
of the inspection were being
reviewed.
ù State officials said a prelimi´
nary investigation found that
the NECC shipped orders
from the lots of steroid shots
suspected in the meningitis
outbreak before its own tests
came back confirming the lots
were sterile. In some cases,
they said, drugs went out up to
11 days before test results
came back.
ù Officials also said the com´
pany, in Framingham, just
west of Boston, operated as a
drug manufacturer by produc´
ing drugs for broader use,
rather than filling out specific
prescriptions for specific doc´
tors, which is all its license al´
lowed.
ù “Over the years and for a va´
riety of reasons, some phar´
macists have transformed
from your neighborhood drug´
store into large-scale manu´
facturers that sell products
across state lines,” Patrick
said.
ù The outbreak of meningitis,
an inflammation of the lining
of the brain and spinal cord,
has sickened nearly 300 peo´
ple, including 23 who died, in
more than a dozen states.
Each victim had received a
steroid shot, mostly for back
pain. Federal health officials
matched the shots produced
by the company to the out´
break after finding a deadly
fungus in more than 50 un´
opened vials there but have
not said how the shots were
contaminated.
ù New state documents re´
leased this week detailed
problems an outside firm hired
to do an assessment found
there years ago.
ù The state documents, ob´
tained by The Associated
Press under a public records
request, say investigators in
2006 found inadequate con´
tamination control and no
written standard operating
procedures for using equip´
ment, among other problems.
The problems were corrected
that year, and a state inspec´
tion in May 2011 as the compa´
ny prepared to update its
facilities found no such issues.
ù In a letter sent Monday to a
lawyer for NECC, the U.S.
House Committee on Energy
and Commerce sought nearly
10 years of documents about
safety and quality issues at the
company. It indicated that as
far back as 2002 and 2003 offi´
cials from the Food and Drug
Administration and the state
conducted joint probes of the
company after receiving a re´
port about a steroid shot.
Those probes preceded a 2004
joint investigation of the cen´
ter by the FDA and the Massa´
chusetts Board of Registration
in Pharmacy.
ù In January 2006, based on
several complaints, the com´
pany signed with state regula´
tors a consent agreement in
which it agreed to a full in´
spection of its drug com´
pounding practices by
investigators.
ù The company’s encounters
with regulators have been re´
ported since the outbreak be´
gan, but state pharmacy board
documents released Monday
offer a new level of detail.
They show the inspection by
Illinois-based Pharmaceutical
Systems Inc. found “signifi´
cant gaps” in procedures and a
lack of required documenta´
tion at the NECC facility.
ù NECC spokesman Andrew
Paven said he hadn’t seen the
committee’s letter but the
company continues to cooper´
ate with the ongoing investiga´
tion.
ù “NECC worked coopera´
tively with the Massachusetts
Board of Registration in Phar´
macy to resolve to the Board’s
satisfaction any issues
brought to the company’s at´
tention,” he said by email.