Bryce Vickmark for The New York Times
The building housing the New England Compounding Center and the nearby recycling center.
WASHINGTON — A federal inspection of a company whose tainted pain medicine has caused one of the worst public health drug disasters since the 1930s found greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company's own environmental limits, and an air-conditioner that was shut off nightly despite the importance of controlling temperature and humidity.
The findings, made public on Friday by the Food and Drug Administration, followed a report from Massachusetts regulators on Tuesday and offered disturbing new details in an emerging portrait of what went wrong inside the New England Compounding Center, the pharmacy at the heart of a national meningitis outbreak in which 25 people have died, 313 more have fallen ill and as many as 14,000 people are believed to have been exposed.
Instead of producing tailor-made drugs for individual patients, as the law allowed, the company turned into a major drug maker that supplied some of the most prestigious hospitals in the country, including ones affiliated with Harvard, Yale and the Mayo Clinic, all with minimal oversight from federal regulators.
Federal officials also drew attention to the company's proximity to a recycling plant where excavators and freight trucks heaped old mattresses, plastics and other materials, generating large amounts of dust. The plant, which is owned by one of the same people as the pharmacy, has not always complied with regulations and has drawn complaints, according to records in Framingham, Mass., where the company is located.
And as the death toll continues to rise, the F.D.A.'s commissioner, Dr. Margaret Hamburg, who was appointed by President Obama, has stayed mostly silent.
Some observers said that weighing in loudly and publicly on a contentious issue was simply not Dr. Hamburg's style. Others said that it was because the agency was preparing a criminal case and would not want to endanger that with statements construed to be prejudicial. David Kessler, a former F.D.A. commissioner, pointed to the impending presidential election and efforts to keep the outbreak from becoming a political issue.
"Everyone is closed down right now," he said. "People are being very careful. No one wants to make a mistake."
The inspection report offered the clearest indication yet that the fungus that contaminated the company's vials of methylprednisolone acetate, an injectable pain medicine, may have gotten there because of the company's own practices.
Inspectors said that 83 out of 321 vials from one of the lots linked to the meningitis outbreak that they observed contained "greenish black foreign matter" and another 17 vials had "white filamentous material."
The report said the company had tested only one sample from that lot, and it had proved sterile. When the F.D.A. tested 50 vials from that same lot, all of them contained some microbial growth.
Experts said that perhaps the most worrisome finding was that the company's own testing between January and September found surfaces in the clean rooms contaminated with either bacteria or mold exceeding the levels at which the company's own procedures called for remedial measures. In some cases, there were so many bacteria or fungi in a sample that the whole testing dish was overrun with a so-called overgrowth.
"Think of a plant just growing out of control," said Steven Lynn, director of the Office of Manufacturing and Product Quality at the F.D.A. Yet, according to the agency, there was no evidence the company took remedial actions.
"This is pretty heinous stuff," said Lou Diorio of LDT Health Solutions, a consultant to compounding pharmacies. "This just shows a general lack of basic clean-room principles."
Russell E. Madsen, a consultant on sterility issues to the pharmaceutical industry, said of the inspection report: "In all my time in the pharmaceutical industry, which is 45 years, I've never seen one this bad."
Another problem was the company's air-conditioning system, which employees said was switched off between 8 p.m. and 5:30 a.m. in the room where sterile drugs were made. Maintaining proper temperature and humidity is important for retarding the growth of microbes.
Sabrina Tavernise reported from Washington, and Andrew Pollack from Los Angeles. Abby Goodnough contributed reporting from Boston, and Denise Grady from New York. Sheelagh McNeill contributed research.
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