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Pharmacy in meningitis outbreak flouted rules, officials say

BOSTON — The compounding pharmacy responsible for a deadly national meningitis outbreak repeatedly failed to follow standard procedures to keep its facility clean and its products sterile, Massachusetts officials said Tuesday, painting a harrowing picture of a company that flouted crucial rules as it hurried to ship drugs around the country.

One finding in particular stands out: The pharmacy, New England Compounding Center, shipped some orders of the drug implicated in the outbreak without waiting for the final results of sterility testing. And while company records indicate that the tests found no contamination, regulators said they were skeptical of the company's methods.

Records suggest that the company failed to sterilize products for "even the minimum amount of time necessary to ensure sterility," said Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department.

The findings raise questions about whether the outbreak could have been averted, or reduced in magnitude, had proper procedures been followed.

"This was preventable," said Eric Kastango, president of Clinical IQ, a consulting firm that counsels compounding pharmacies. "They failed to properly sterilize this medicine that had to be sterilized. That's huge."

Mats used to trap dust and dirt just outside the company's clean rooms were "visibly soiled with assorted debris," according to a report released Tuesday by the state's Board of Registration in Pharmacy, and hoods in the sterile compounding area were not properly cleaned. A leaking boiler next to a clean room "created an environment susceptible to contaminant growth," Biondolillo said during a news conference at the state House.

Investigators are also looking into "the environmental conditions surrounding the business," she said, including a recycling center on the same property in Framingham, Mass., and owned by the same family. At the same time, the state and the Food and Drug Administration are investigating two related drug companies, Ameridose of Westborough and Alaunus Pharmaceutical of Framingham, which have many of the same owners.

New England Compounding has suspended operations and laid off most of its employees.

The meningitis outbreak has been tied to three lots of a steroid, methylprednisolone acetate, produced at New England Compounding that were contaminated with a fungus. In all, it shipped more than 17,000 vials of the suspect drug, which was used mainly for spinal injections aimed at easing back and neck pain.

So far, 304 people in 17 states, including Florida, have contracted meningitis, and 23 have died.

Biondolillo stressed that the root cause of the outbreak has yet to be determined

Gov. Deval Patrick, speaking at the news conference, said he had directed the state pharmacy board to "immediately start periodic, unannounced inspections of compounding pharmacies that prepare sterile and injectable medication."

Although the FDA can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.

Patrick said the state was moving to permanently revoke the licenses of New England Compounding and its three principle pharmacists.

Pharmacy in meningitis outbreak flouted rules, officials say 10/23/12 [Last modified: Tuesday, October 23, 2012 10:52pm]
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