Bryce Vickmark for The New York Times
A recycling center is on the same property as the New England Compounding Center. They are owned by the same family.
BOSTON — The compounding pharmacy blamed 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, the 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 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 Dr. 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 meningitis outbreak could have been averted, or reduced in magnitude, had proper procedures been followed.
"This was preventable," said Eric S. 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," Dr. Biondolillo said during a news conference at the State House here.
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.
All three companies list Barry Cadden, the chief pharmacist, and his brother-in-law, Gregory Conigliaro, as managers, according to company filings with the state. Mr. Conigliaro's brother, Douglas, is also involved in the business and, through his wife, Carla, appears to be a major shareholder in the companies, according to state records.
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, New England Compounding 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 have contracted meningitis, and 23 have died.
Dr. Biondolillo stressed that the root cause of the outbreak has yet to be determined
Gov. Deval Patrick, speaking at the news conference here, said he had directed the state pharmacy board to "immediately start periodic, unannounced inspections of compounding pharmacies that prepare sterile and injectable medication." There are 25 such pharmacies in Massachusetts, he said, adding that state rules governing them "have not kept pace with an industry that's changing rapidly." Although the F.D.A. can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.
Mr. Patrick said that from now on, compounding pharmacies in the state would be required to submit annual reports on "production, volume and distribution of medication." That way, he said, the state could better identify compounders that were acting more like manufacturers.
Mr. Patrick added that the state was moving to permanently revoke the licenses of New England Compounding and its three principal pharmacists, including Mr. Cadden.
Sabrina Tavernise contributed reporting from Washington, and Andrew Pollack from Los Angeles.
Anda sedang membaca artikel tentang
Sterility Found Lacking at Drug Site in Meningitis Outbreak
Dengan url
http://healtybodyguard.blogspot.com/2012/10/sterility-found-lacking-at-drug-site-in.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
Sterility Found Lacking at Drug Site in Meningitis Outbreak
namun jangan lupa untuk meletakkan link
Sterility Found Lacking at Drug Site in Meningitis Outbreak
sebagai sumbernya
0 komentar:
Posting Komentar