Massachusetts closes third pharmacy since meningitis outbreak

BOSTON Sun Oct 28, 2012 9:03pm EDT

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BOSTON (Reuters) - 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 October 3, and a sister company of NECC, called Ameridose, which closed voluntarily for inspections on October 19.

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 U.S. 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.

(Editing by Alex Dobuzinskis, Dan Whitcomb and Stacey Joyce)

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Comments (1)
tyg wrote:
Massachusetts is a bit late to the scene, now trying to limit their people’s and country’s perception as an advanced, educated state that does not tolerate placing the public health at risk. Massachusetts with the “best” Universities could not have an educated government and public health department that takes greedy pharmacists, doctors, lawyers, hospitals, and HMOs to task for placing the state and national public health at risk. The private, state, and any government official who has watched compounders grow to compete with established, modern, safer drug approvals should take the heat for the 25 dead, hundreds injured, and thousands who may yet suffer from this fiasco. Focusing on the “sterile” manufacturers will not make it a safer place for the public health at risk due to greedy compounders and their outlets. This is the tip of the iceberg in compounding, look at the dermatologists, the firms buying drugs for compounding and putting it in our food in the guise of supplements, hair loss treatment compounding, weight loss treatment compounding, menopause treatment compounding, androgen treatment compounding, allergy treatment compounding. It seems the FDA is not approving the drugs the public needs most, and having the highest drug prices in the world makes it that much easier for those who purchase cheap, manufacture big, and have no regulations. Sounds like any of the countries around that world that produce dangerous goods with little oversight, manufacturing right here in the United States. The sad thing is that people won’t know the true effects unless these tragedies occur periodically. The FDA, Public Health Departments, and Governments who sit around watching compounding out of control are just as responsible as the compounders that will be eventually featured in American Greed.

Oct 29, 2012 1:16am EDT  --  Report as abuse
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