#1 Meningitis outbreak: workers at firm had concerns
10-13-2012, 12:30 AM
- Join Date
- Jun 2008
Ex-Workers at Firm Tied to Pharmacy Had Safety Fears
BOSTON — One pharmacist said she quit because she was worried that unqualified people were helping prepare dangerous narcotics for use by hospitals. A quality control technician said he tried to stop the production line when he noticed that some labels were missing, but was overruled by management. A salesman said he and his colleagues were brought into the sterile lab to help out with packaging and labeling during rush orders, something they were not trained for.
They all used to work at Ameridose, a drug manufacturing company with many of the same owners as the New England Compounding Center, the pharmacy at the center of a national investigation into a meningitis outbreak now in 12 states.
State and federal health officials say they have no reason to believe that Ameridose sent out contaminated products, and have not recalled any. But regulators asked the company on Wednesday to suspend production to allow them to conduct an on-site investigation, because their inquiry “includes concerns for quality and safety across the corporate entity,” the Massachusetts Department of Public Health said. ...
.... Most former employees declined to speak for attribution because they did not want to be implicated in the current case. Some said they had signed legal agreements not to speak about the company. All left before the current outbreak, which the authorities have traced to thousands of contaminated vials of a steroid made by the New England Compounding Center. All of its products have been recalled, including the steroid, methylprednisolone acetate, that is the source of the current trouble....
....Six former employees, five from Ameridose and one from New England Compounding, described a corporate culture that encouraged shortcuts, even when that meant compromising safety. The former Ameridose pharmacist said she was concerned about a pilot project in which quality control workers, rather than trained pharmacists, did preliminary checks to make sure the correct drugs were present and the pumps were set correctly before filling intravenous bags....
.... She also said that because of pressure to increase output, there were a couple of “near misses.” One was when hydromorphone, a powerful narcotic, was made at twice the potency by a pharmacist who was working late to try to achieve production numbers for the day. The error was caught, however, before the bags left the plant.
“The emphasis was always on speed, not on doing the job right,” said the quality control technician who tried to stop the production line and who said he was eventually fired over disagreements about safety. “One of their favorite phrases was ‘This line is worth more than all your lives combined, so don’t stop it.’ ”
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