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October 23. 2012 8:36PM
Massachusetts moves to shut down pharmacy
The company that made the drugs that gave nine New Hampshire residents fungal meningitis sent out medication despite visible signs of a fungus infection and repeatedly failed to properly sterilize its products and equipment, public health officials charged Tuesday.
Nine New Hampshire residents got fungal meningitis from drugs made by New England Compounding Center (NECC). A tenth suffered a fungus infection to a joint.
Public health officials in Massachusetts, where NECC was operating, have moved to revoke the licenses of the company and its three top physicians and said a federal criminal investigation has been launched.
Dr. Madeleine Biondolillo, director of the Massachusetts Bureau of Healthcare Safety, said medicine shipped by NECC on Oct. 2 and later returned to the company after it was recalled showed visible black particles suspended in the steroid fluid that was supposedly ready for injection.
The Food and Drug Administration tested those vials and found they were positive for the same fungal infection that has afflicted 257 people across the country.
Twenty deaths have been blamed on the contaminated medication.
In addition, some of the drugs in the three lots were confirmed to contain the contaminated drugs were shipped even though the company had not received results of testing on the product's sterility. Thirteen shipments of drugs from the infected lots were sent out without results of the tests intended to confirm their safety.
“A variety of findings shows a lack of basic acceptable standards of pharmacy operations,” Biondolillo said.
Other findings of the Massachusetts investigation include the company's failure to sterilize its products long enough to make sure they were not infected, and its failure to make sure the sterilization equipment itself was not contaminated.
In addition, NECC used contaminated material for wiping shoes of people heading into supposedly sterile environments. Officials also said the company failed to fix a leaky boiler located next to the so-called clean rooms, creating the risk of contamination.
While the investigation into NECC has turned up a long list of sanitary and operational issues, the precise reason why doses given to patients were contaminated has not been pinned down.
In addition to the federal criminal probe, officials have moved to make sure that the offending company and its top pharmacists are put out of business for good.
Massachusetts Board of Pharmacy officials have moved to revoke NECC's license.
Barry Cadden, Glenn Chin, and Lisa Conigliaro-Cadden, who were termed the top pharmacists with the company, have been asked to give up their licenses for life.
If the licenses are not voluntarily surrendered permanently, the state Board of Pharmacy will move to revoke them, Massachusetts Gov. Deval Patrick said.
In New Hampshire, NECC operated under a mail order prescription license and has voluntarily surrendered its permit to do business in the state.
billsmith@unionleader.com
Nine New Hampshire residents got fungal meningitis from drugs made by New England Compounding Center (NECC). A tenth suffered a fungus infection to a joint.
Public health officials in Massachusetts, where NECC was operating, have moved to revoke the licenses of the company and its three top physicians and said a federal criminal investigation has been launched.
Dr. Madeleine Biondolillo, director of the Massachusetts Bureau of Healthcare Safety, said medicine shipped by NECC on Oct. 2 and later returned to the company after it was recalled showed visible black particles suspended in the steroid fluid that was supposedly ready for injection.
The Food and Drug Administration tested those vials and found they were positive for the same fungal infection that has afflicted 257 people across the country.
Twenty deaths have been blamed on the contaminated medication.
In addition, some of the drugs in the three lots were confirmed to contain the contaminated drugs were shipped even though the company had not received results of testing on the product's sterility. Thirteen shipments of drugs from the infected lots were sent out without results of the tests intended to confirm their safety.
“A variety of findings shows a lack of basic acceptable standards of pharmacy operations,” Biondolillo said.
Other findings of the Massachusetts investigation include the company's failure to sterilize its products long enough to make sure they were not infected, and its failure to make sure the sterilization equipment itself was not contaminated.
In addition, NECC used contaminated material for wiping shoes of people heading into supposedly sterile environments. Officials also said the company failed to fix a leaky boiler located next to the so-called clean rooms, creating the risk of contamination.
While the investigation into NECC has turned up a long list of sanitary and operational issues, the precise reason why doses given to patients were contaminated has not been pinned down.
In addition to the federal criminal probe, officials have moved to make sure that the offending company and its top pharmacists are put out of business for good.
Massachusetts Board of Pharmacy officials have moved to revoke NECC's license.
Barry Cadden, Glenn Chin, and Lisa Conigliaro-Cadden, who were termed the top pharmacists with the company, have been asked to give up their licenses for life.
If the licenses are not voluntarily surrendered permanently, the state Board of Pharmacy will move to revoke them, Massachusetts Gov. Deval Patrick said.
In New Hampshire, NECC operated under a mail order prescription license and has voluntarily surrendered its permit to do business in the state.
billsmith@unionleader.com
