Report: Drug Site of Meningitis Outbreak Found Unsterile

Wednesday, 24 Oct 2012 12:07 PM

By Bill Hoffmann

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Disturbing new evidence of unclean conditions at the lab blamed for the deadly meningitis outbreak was revealed yesterday as Massachusetts officials continued to probe the health menace that has killed 23 people and sickened more than 300.

Investigators say that the New England Compounding Center, which manufactured the tainted steroids at the center of the outbreak, was found to have repeatedly failed to keep its facility sterile.

The unsanitary conditions included black specks of fungus and a leaky boiler believed to have promoted bacterial growth and contamination.

As the state raced to contain the mushrooming crisis, officials moved to revoke the licenses of the compounding center and three pharmacists who work there.

The state pharmacy board will also begin to “immediately start unannounced inspections of compounding pharmacies that prepare sterile and injectable medication,’’ Gov. Deval Patrick announced at a news conference in Boston. Massachusetts has 25 such pharmacies.

Federal officials say that at least 304 people in 17 states have been hit with meningitis and 23 of those victims have died.

The latest victim is a 66-year-old woman who was injected with a single dose of the steroid for back pain at the Forsyth Street Ambulatory Surgery Center in Macon, Ga. Her condition was reported as stable today.

Meningitis is a bacterial infection of the membranes covering the brain and spinal cord and can cause severe headaches, neck pain, fever, confusion, and death. The diagnosis of meningitis is considered a medical emergency and is often treated by a regimen of powerful antibiotics.

State health officials found the New England Compounding Center, in its hurry to ship the drugs it manufactured, sometimes shipped orders before tests revealing whether they were sterile had been completed.

“This was preventable,’’ Eric Kastango, president of Clinical IQ, which consults compounding pharmacies, told The New York Times. “They failed to properly sterilize this medicine that had to be sterilized. That’s huge.’’

Documents obtained by the Associated Press revealed that in 2006, investigators found inadequate contamination control and no standard operating procedures for the use of equipment. The problems were corrected after the investigators issued their report.

The Food and Drug Administration has launched an investigation into two drug companies related to the New England Compounding Center. The firms, Ameridose and Alaunus Pharmaceutical, have some of the same owners.

Investigators are focusing on three lots of the steroid methylprednisolone which they say are at the root of the outbreak. More than 17,000 vials of the drug were shipped nationwide. The steroid is injected into the spine and can help ease excruciating back and neck pain.

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