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October 23, 2012

Sterility failures found at drug compounder blamed for US meningitis outbreak

A drug compounding company embroiled in the US meningitis outbreak repeatedly failed to uphold basic sterility measures, say officials in Massachusetts.

By Heidi Vella

A drug compounding company embroiled in the US meningitis outbreak repeatedly failed to uphold basic sterility measures, say officials in Massachusetts.

The New England Compounding Center (NECC) – which is believed to be responsible for 23 deaths and 304 diagnoses of meningitis – sacrificed sterility procedures in order to ship drugs around the country more quickly.

The company even failed to wait for drug sterilisation results to come back for a batch of steroids implicated in the meningitis outbreak before shipping them.

The sterilisation results came back as negative after the drugs had already left the laboratory.

Records show that when the NECC sterilised equipment they failed to do so for the minimum recommended amount of time, and mats used to trap dust and dirt were "visibly soiled with assorted debris," according to a report released Tuesday by the state’s Board of Registration in Pharmacy.

"The company failed to wait for drug sterilisation results to come back for a batch of steroids implicated in the meningitis outbreak before shipping them."

A leaking boiler next to a clean room also "created an environment susceptible to contaminant growth," said Massachusetts Department of Public Health representative Dr Madeleine Biondolillo, during a news conference.

Investigators are also looking into the environment of a recycling centre near the building, believed to be owned by the same family as the NECC, and other environmental factors surrounding the area, according to the New York Times.

The ongoing outbreak has been tied to three different batches of a steroid, called methylprednisolone acetate, produced by the NECC and thought to be contaminated with a meningitis fungus. Operations at the company have since been suspended.

The New York Times reported that the Governor Deval Patrick, speaking at a press conference, said the state pharmacy board will be carrying out periodic, unannounced inspections of compounding pharmacies that prepare sterile and injectable medication and that the state was looking to permanently revoke the licenses of the NECC and its three principal pharmacists.

Officials at the press conference also stressed that the root cause of the outbreak had yet to be determined.

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