Meningitis outbreak: Massachusetts regulators shut down third pharmacy

http://www.guardian.co.uk/society/2012/oct/29/meningitis-outbreak-massachusetts-investigation

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Massachusetts regulators shut down a pharmacy on Sunday after a surprise inspection raised concerns about the sterility of its drugs, in the third such closure since a deadly meningitis outbreak caused by contaminated drugs from another pharmacy in the state.

The latest pharmacy to be closed, Infusion Resource, is not affiliated with New England Compounding Center, the company linked to the outbreak, officials said.

Infusion Resource in Waltham was closed after inspectors last week found "significant issues" and "expressed concerns for the sterility of products", said Madeleine Biondolillo, director of the state's bureau of healthcare safety and quality.

No contaminated drugs were found at Infusion Resource, but 40 patients and their doctors were asked to return any medications they received from the company, she said.

Massachusetts regulators have come under fire after contaminated drugs from NECC, based in Framingham, were cited as the cause of the outbreak that has killed 25 people and sickened another 337 in 18 states.

The state is conducting inspections of all compounding pharmacies that handle sterile medications in the wake of the deadly national meningitis outbreak.

The two pharmacies shut down earlier were NECC, which was closed on 3 October, and a sister company of NECC, called Ameridose, which closed voluntarily for inspections on 19 October.

Bernard Lambrese, CEO of Infusion Resource, said in a statement he wanted to reassure "patients and the general public of the safety, purity and efficacy" of solutions produced at his company's Waltham pharmacy. "Patient safety is something we take very seriously," he said.

Lauren Smith, interim commissioner of the Massachusetts department of public health, told reporters the ongoing state-wide inspections are part of "a series of aggressive and necessary actions to protect public safety and enhance oversight of this industry" following the national meningitis outbreak.

Separately, Smith said a member of the state's pharmacy oversight board with ties to NECC and Ameridose, Sophia Pasedis, has rejected a request by regulators to step down.

Pasedis sits on the state's Board Registration of Pharmacy and is vice-president of regulatory affairs at Ameridose. Ameridose has said Pasedis recused herself from any board topics that related to NECC or Ameridose

But Smith said a review of the board's minutes "call into question" that defense and fail to provide definitive proof that Pasedis recused herself on certain occasions.

"Given the ongoing investigation, we believe it is in best interest of the board to have Ms Pasedis step down," Smith said. "Thus far, she has declined to do so."

Ameridose representatives did not immediately reply to calls and emails for comment.

The US Food and Drug Administration said on Friday it found "greenish black foreign matter" and other contaminants in an injectable steroid produced by NECC.

It also found that vials from the same bin of the steroid contained what appeared to be a "white filamentous material", according to the report released by the FDA following inspections of the facility in October.