Oops is now a pharmaceutical term

Sabrina Tavernise and Andrew Pollack have an article in The New York Times about the recent meningitis disaster:

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 twelve 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 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.
Paul Cirel, a lawyer representing Ameridose, declined to discuss the statements made by the former employees. “What some anonymous, maybe disgruntled, ex-employees say to you that is not said to us by the FDA or any regulator, I just can’t go there right now,” he said. “If it becomes a claim that a regulator puts to us, then we will address it.” Cirel, of Boston-based Collora LLP, added that the suspension was voluntary and would be in place until 22 October.
In all, eight former employees were interviewed, three from New England Compounding and five from Ameridose. Three of those former workers said the companies were run with good attention to safety.
Thomas DiAdamo, who was a salesman for New England Compounding for about two years, said: “When I heard about this I was shocked, because they were meticulous about safety.” He said Barry Cadden, New England Compounding’s chief pharmacist, who is also a shareholder in Ameridose and who lost his pharmacist license this week, told him, “‘We do not make mistakes.’ Something must have happened that was out of his control.”
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.
New England Compounding declined to comment on specific accusations, saying in a statement that its “intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations.”
The investigation into New England Compounding and its associated companies is happening as the number of deaths climbed to fourteen in the meningitis outbreak linked to its tainted medicine. Health officials estimate that fourteen thousand patients across the country might have been exposed to the drug, and announced this week that they had contacted about twelve thousand of them.
The sheer magnitude of the potential exposure has drawn attention to the large-scale compounding pharmacies, many of which have become mini-drug companies, overstepping the bounds of traditional pharmacy activity and taking advantage of a legal no-man’s land between state and federal authorities. Lawmakers and federal regulators called this week for stronger rules. “It is really unfortunate that it takes a crisis to bring this kind of change, but that is often the case,” said Deborah Autor, a Food and Drug Administration deputy commissioner. Ameridose has FDA approval as a manufacturer, but it also produces compounded drugs, the Massachusetts health department said. It has emphasized that it a separate entity from New England Compounding.
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. “I expressed my concern to the management,” said the pharmacist, who worked there in 2008 and 2009. “I said: ‘This isn’t right. These people don’t even know anything about the drugs.’” 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.’ ”
Both employees attributed the pressure to increase production speed to an aggressive new operations manager focused on the bottom line.
In 2008, an FDA inspector found that Ameridose did not do appropriate testing to determine potency of a drug, according to a 2010 summary of the inspection report in an industry newsletter, Validation Times. The company was also shipping drugs without waiting the fourteen days it took for the sterility test results to come back from an outside lab, the newsletter said.
Not long after that inspection, Ameridose issued a recall of 155 bags of the powerful drug fentanyl from five states because the doses were too potent, according to the FDA website.
Another Ameridose worker, Anwar Kabir, said the company followed strict safety rules. Hired in 2008 to help develop a quality control lab, he said the people he worked with on that project were all experts in their field. “They were very nice people, very qualified,” he said.
A former New England Compounding salesman was less charitable. The man, who worked for the company from 2008 to 2011, said it was standard practice to sell large quantities of medicine to buyers without patients’ names. Buyers would later fax the names as the medicine was dispensed, and the names would be put in their file, he said. According to state law, compounding pharmacies are permitted to ship medicines only for specific patients. “Honestly, there’s no way you could sell anything of quantity otherwise,” he said.
But some potential clients, like a pharmacy director from a Nevada hospital, balked at working that way. He said: "I’m on the pharmacy board in Nevada, and that won’t fly here.”

Rico says he got some heavy doses of steroids when he was in the hospital but, fortunately, not this stuff. That's good, too, because he would've been forced to visit some of these people and do them harm... (And where the fuck was the FDA in all this? Sleeping?)