Lab That Made Tainted Drug In Meningitis Outbreak Was Filthy

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Posted on 27th October 2012 by gjohnson in Uncategorized

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When the Food and Drug Administration (FDA) inspected the pharmacy company that manufactured a contaminated medicine linked to 25 deaths, what it found would make your stomach turn.

Some 83 out of 321 vials contained “what appeared to be a greenish foreign matter,” the FDA said in an eight-page report late last week. Seventeen vials from that bin contained “what appeared to be white filamentous material.” One vial had a fungus.

There was bacteria and mold in a supposedly sterile room where drugs were made. And the air conditioner was put off at night, despite the fact that temperature and humidity were supposed to be carefully controlled at the facility.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf

The New York Times did a Page One story Saturday based on the FDA’s report , called a “483,” on its inspection of the New England Compounding Center (NECC) in Farmingham, Mass. This is the company that manufactured the tainted steroid, injected as a pain killer, that allegedly caused a national outbreak of  fungal meningitis. Two dozen are dead, more than 300 are sick and possibly 14,000 were exposed to the steroid, according to The Times.

http://www.nytimes.com/2012/10/27/health/fda-finds-unsanitary-conditions-at-new-england-compounding-center.html?pagewanted=all&_r=0

“The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass., facility,” the federal agency said in a press release.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325994.htm

“The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination,” the FDA said.

“Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.”

Finally, the press release said, “The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations. The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.”

I think it’s a pretty safe bet that the FDA will ultimately there were violations by NECC, don’t you?

The FDA said it was continuing to work the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate, an injectable steroid.

The problem with compounding centers such as NECC is that they have essentially not been regulated by the FDA, since they are not full-fledged drug makers. As The Times pointed out in its Saturday story about NECC, “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.”

The FDA report also noted that NECC “is abutted to the rear and along the left parking area by a recycling facility that handles such materials as mattresses and plastics … the area was observed to include large equipment (e.g. excavators and freight trucks) producing airborne particulates (e.g. dust). Rooftop units serving the firm’s HVAC system were estimated to be located approximately 100 feet from the recycling facility.”

What did some of the experts say about this mess?

A pharmaceutical sterility expert, Russell Madsen, when asked about the FDA’s inspection report told The Times, “In all my time in the pharmaceutical industry, which is 45 years, I’ve never seen one this bad.”

 

 

 

Fla. lawsuit claims 3 kids died from hospital mold

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Posted on 5th February 2009 by gjohnson in Uncategorized

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Date: 2/4/2009

By CHRISTINE ARMARIO
Associated Press Writer

TAMPA, Fla. (AP) — The families of three pediatric cancer patients sued a Florida hospital this week, claiming their children died after contracting fungal infections from renovations being performed at the facility.

The lawsuit filed by parents against St. Joseph’s Hospital Inc. in Tampa on Tuesday claims the children were exposed to pathogenic fungi because the hospital failed to properly seal off an area under renovation.

Each of the children — ages 2, 5, and 9 — had been previously diagnosed with acute lymphoblastic leukemia, a cancer of white blood cells. Two had recently gone into remission, and a third was still battling the disease.

Attorney Steven Yerrid, who is representing the families, said they believe dust containing the fungus became airborne and invaded the patients’ rooms, “where all these children then were forced to engage in yet another battle.”

“And this one was unnecessary, and could and should have been prevented,” he said.

In a statement, the hospital said patient safety is its top priority, and that they take necessary measures to reduce infections. Those include using barriers around construction areas, filtering the air and monitoring ventilation systems.

All those measures were in place when the infections occurred, spokeswoman Lisa Patterson said. The hospital is part of the BayCare Health System, a network of not-for-profit hospitals in the Tampa Bay region.

“Cancer kills more children than any other disease,” the hospital statement read. “Sometimes, despite all the measures we have in place, all the medical expertise we provide, and all the personal care we deliver, patients do not survive.”

The lawsuit offers the following patient accounts:

Matthew J. Gliddon was first diagnosed with leukemia in 2005. After being treated with chemotherapy, he went into remission. But two and a half years later, his cancer returned. From November of 2007 through February 2008, he spent most of his time as a patient at St. Joseph’s Hospital receiving treatment.

The 5-year-old’s white blood cell count dropped very low, and he was at risk for bacterial and fungal infections.

According to the lawsuit, physicians discovered a spot on his nose, which grew and began destroying tissue. A nose biopsy later determined that he was suffering from a nasal mold infection.

As a result of the infection, Gliddon underwent surgery that removed most of his septum. Still suffering from cancer, and now in the presence of a mold infection, he was not a candidate for a bone marrow transplant. Gliddon died in April.

Around that same time, 2-year-old Kaylie Gunn-Rimes was also taken to St. Joseph’s.

She had been diagnosed with leukemia when she was less than a year old. Last January, the toddler had an allergic reaction to one of her medications and was admitted to the hospital. Though she was cancer-free at the time, she was staying in the pediatric cancer floor and developed a fungal infection in her lungs. She spent 76 days on a ventilator before dying.

The third patient was a 9-year-old girl named Sierra Kesler.

Her leukemia had been in remission, but in March 2008 she went to the hospital and physicians discovered it had returned. She was given chemotherapy and went into remission again. The lawsuit says Sierra returned to the hospital a week later with a fever and coughing. She eventually had to be intubated and died in May.

In each case, tests confirmed the presence of a pathogenic fungi.

The lawsuit says patient rooms were located right above the construction activity, where renovation work would have created a moderate to high level of dust. The air condition systems would have brought air from the outside into patient rooms, it claims.

Sometimes, the patients had to be transported right through the construction area. The parents claim the hospital failed to take common precautions, including sealing the area under construction from non-work areas.

At least one of the parents had raised concerns about the air ventilation in their child’s room, Yerrid said.

The hospital said that aside from using barriers around construction areas, it also conducts regular preventative maintenance rounds throughout the hospital; infection control, nursing, and other departments work together to provide a clean environment; and they educate families about the importance of infection control measures.

Yerrid said the parents are filing the lawsuit in hopes of helping other cancer patients. The parents themselves did not wish to speak publicly, he said. “Every precaution that needs to be taken, should be taken, from the welfare of our most vulnerable, these young weakened children,” he said.

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BayCare Health System: http://www.baycare.org/

Copyright 2009 The Associated Press.
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