Massachusetts shut down another compounding pharmacy after a surprise
inspection last week found conditions that called into question the sterility
of its products, state officials said Sunday.
The pharmacy, Infusion Resource in Waltham, voluntarily surrendered its
license over the weekend, said Dr. Madeleine Biondolillo, director of the
Bureau of Health Care Safety and Quality at the Massachusetts Public Health
Department. Inspectors who visited Infusion Resource on Tuesday found
“significant issues with the environment in which medications were being
compounded,” Dr. Biondolillo said during a news conference here. She would not
disclose details, but said that in another troubling discovery, patients had
apparently been receiving intravenous medications at the pharmacy, against
state regulations.
The findings led the state to immediately issue a cease-and-desist
order, Dr. Biondolillo said, preventing Infusion Resource from dispensing any
drugs. But she added that as of yet, there was no evidence of any contaminated
drugs produced there. The latest shutdown comes amid a continuing investigation
of New England Compounding Pharmacy, the company believed responsible for a
national meningitis outbreak in which 25 people have died, at least 344 others
have fallen ill and as many as 14,000 people are thought to have been exposed.
State and federal inspections in recent weeks found unsanitary conditions at
New England Compounding, from surfaces coated with mold and bacteria to residue
on sterilization equipment. New England Compounding has suspended operations
and laid off most of its employees.
Gov. Deval Patrick last week directed the state’s Board of Registration
in Pharmacy to immediately start unannounced inspections of compounding
pharmacies that prepare sterile, injectable medications. There are 25 such
pharmacies in Massachusetts, and Mr. Patrick has acknowledged that the state
rules governing them were insufficient. Although the Food and Drug
Administration can inspect compounding pharmacies and issue warnings, the
agency says states have ultimate jurisdiction.
At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner
of the Massachusetts Department of Public Health, said the state was bringing
on five additional inspectors to help with unannounced visits to compounding
pharmacies. The goal is to inspect all of them by Jan. 1, she added. Dr. Smith
also said the state had asked Sophia Pasedis, a member of the pharmacy board
who works at Ameridose, a sister company to New England Compounding that is
also under investigation and currently shut down, to resign from the board.
State officials said earlier this month that Ms. Pasedis had recused herself
from any board actions concerning New England Compounding and Ameridose. But on
Sunday, Dr. Smith said there was “no definitive proof” that Ms. Pasedis, the
vice president of regulatory affairs and compliance at Ameridose, had
consistently done so.
Ms. Pasedis has so far declined to step down, Dr. Smith said, but her
term expires next month. She has been on the pharmacy board since 2004. Dr.
Biondolillo said the manager of record at Infusion Resource used to work at
Ameridose. Infusion Resource was last inspected by the state when it opened in
December 2009, she said, and was found to be in compliance at the time. The
state has not received any complaints about the pharmacy since then, she added.
In an e-mailed statement, Bernard F. Lambrese, the chief executive of
Infusion Resource, said, “No issues were cited relating to the integrity of our
products nor to the quality of our compounding practices.” He added that the
pharmacy was working to address concerns cited by the inspectors, including the
condition of the flooring in the room where the pharmacy mixes drugs, and would
then seek to be relicensed.
Dr. Biondolillo said that Infusion Resource supplies specialized
medications to patients after they have been discharged from a hospital.
According to its Web site, Infusion Resource is part of a company based in East
Providence, R.I. Also on Sunday, Representative Edward J. Markey, a
Massachusetts Democrat in whose district New England Compounding is located,
issued a report on the practice of compounding that stated there had been
“adverse medical incidents” related to compounding in at least 34 states.
Citing F.D.A. records, the report said there had been 23 deaths and at
least 86 serious illnesses associated with the practice of compounding. The
statistics did not include the current meningitis outbreak. The report also
included a review of state pharmacy boards and found that they do not generally
undertake enforcement actions that relate to the safety or scope of compounding.
Instead, the report said, their focus tends to be more on traditional pharmacy
activities, including licensing and controlled substances.
Massachusetts officials have said that tracking volume from compounding
pharmacies was not part of their regulatory mandate. But Dr. Smith said the
state would soon issue emergency rules requiring compounding pharmacies to
submit frequent reports on production and distribution of injectable drugs. “I
know that we face great challenges,” she said. “At the same time, though, we
have a rare opportunity to create meaningful change.”
NY Times
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