Investigation uncovers unsafe conditions at Mass. pharmacy

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October 23, 2012, 10:55 pm
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(NECN: Josh Brogadir, Framingham, Mass.) - The building and compounding pharmacy has been closed for weeks, and from everything heard on Tuesday, it doesn't appear it will re-open anytime soon, if ever.
 
"Mats used to wipe dirt, dust, and other possible contaminants off of shoes before entering sterile areas were visibly dirty, soiled with assorted debris," said Dr. Madeleine Biondolillo, Director of Mass. DPH Bureau of Healthcare Safety.

So what did investigators find inside the New England Compounding Center in Framingham?

Officials say they found visible black fungus in bottles of the steroid manufactured at NECC, the same steroid injected into thousands of patients suffering from chronic back or joint pain.

More than 300 have gotten sick and 23 have died from fungal meningitis around the nation, which was traced back to NECC.

Mass. Governor Deval Patrick, along with the State Dept. of Public Health, announced what they've found so far in their investigation of NECC.

It includes several violations, starting with a failure to sterilize medication, drugs shipped a week and a half before being properly tested, and the request that the pharmacy board permanently revoke the licenses of NECC and the company's three principal pharmacists.

"You should also know if you don't already that a federal criminal investigation has been launched," Gov. Patrick said.
 
"There was an inspection based on a complaint early this year, in May of 2012," Dr. Biondolillo said.

But the problems at NECC began far before May of this year with this batch of tainted drugs. The timeline goes back at least to 2002, when there were concerns about the very same steroid. And in 2004, investigators recommended NECC and its chief pharmacist be reprimanded.

But an attorney for NECC requested the board do so without imposing discipline which may destroy their business.

The resolution did not include sanctions.

And why not?

"The very questions you're asking, I'm asking and the investigation continues around them," Gov. Patrick said.

He also talked about his concerns that a compounding pharmacy was acting more like a drug manufacturer, instead of filling prescriptions.

NECC's attorney Paul Cirel released a statement saying in part, "The Board had numerous opportunities, including as recently as last summer, to make first-hand observations of the NECC’s facilities and operations. Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company’s operations."

The source of the contamination has still not been identified. There is a recycling center next door that recycles foam and mattresses owned by the same group. Authorities are investigating if there's any connection that could have caused the contamination.

Tags: massachusetts, Deval Patrick, Josh Brogadir, Framingham, New England Compounding Center, fungal meningitis outbreak, Madeleine Biodolillo
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