"More problems found at compounding pharmacies" Associated Press, April 13, 2013
WASHINGTON — The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected following a recent outbreak of meningitis caused by contaminated drugs....
The wave of inspections comes in response to a deadly fungal meningitis outbreak linked to contaminated steroids from the New England Compounding Center, a Massachusetts pharmacy. The company’s injections, mainly used to treat back pain, have been linked to 53 deaths and 733 illnesses since last summer....
Well, that's two more added to the tally since we last communicated.
The FDA has stepped up its oversight of the pharmacies since the outbreak was identified in September, but agency officials say they have been slowed by the complex overlap of state and federal laws that govern the industry. Pharmacies are licensed and overseen by state boards, though the FDA sometimes intervenes when major safety issues arise.
In a blog post to the FDA’s website Thursday, FDA Commissioner Margaret Hamburg noted that four pharmacies initially refused to admit the agency’s inspectors. In two cases the agency had to return with search warrants and US marshals....
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Related: : Compounding Woes For Woburn's Pallimed
Woburn drug maker may stop making sterile injections
Been put out of business, have they?
Also see:
Compounding pharmacy that recalled drugs had ... - Boston.com
www.boston.com/...notes/.../compounding...not-licensed/.../blog.html
3 days ago ... The company would not comment this week on how many patients might ... but a
Globe review found the company lacked the required license to ... Regulators
have said New England Compounding was acting more like a ...
Like a what?
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-- Your friends at Boston.com
Whose friend?
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I looked for it in other places on the Globe web site, and I found nothing.
Just found something:
"Compounder sold drugs illegally in seven states" by Chelsea Conaboy | Globe Staff, March 30, 2013
A Woburn compounding pharmacy that recalled two dozen drugs this week has said it distributed directly to patients and doctors in up to 21 states, but a Globe review found the company lacked the required license to operate as a pharmacy in at least a third of those states.
The California pharmacy board on Wednesday ordered Pallimed Solutions Inc. to stop shipping prescription drugs into that state because it had no license. Texas will consider taking similar action, the pharmacy board director said. State officials in Illinois, Maine, Wisconsin, Vermont, and Virginia — all listed on the distribution list in Pallimed’s recall notice — said the company was not properly licensed to operate within their borders.
The possibility that the pharmacy was operating in states where it is not licensed points to continued gaps in the oversight of compounding pharmacies exposed last year when tainted steroids produced at New England Compounding Center caused a national crisis.
The Framingham pharmacy’s drugs sickened hundreds of people and have been linked to 51 deaths. Regulators have said New England Compounding was acting more like a drug manufacturer, shipping products in bulk to providers nationwide though it didn’t have a federal license.
While manufacturers are overseen by the Food and Drug Administration, it is the responsibility of compounding pharmacies to secure proper licenses for the states in which they do business....
It is unclear at what scale Pallimed, which has a small staff and is located in the back of an office building in West Cummings Park, was operating. The state has said it is looking into whether the company has stayed within the scope of its Massachusetts license.
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said the system of making pharmacies responsible for securing their state licenses seemed to work until the fungal meningitis outbreak linked to New England Compounding.
Because no one knew about the deplorable conditions.
“It wasn’t troubling before, but it is troubling now,” he said. “The whole game has changed.”
It's not a game. People have died.
**************************
Massachusetts wasn’t making routine pharmacy inspections prior to the New England Compounding case. Governor Deval Patrick’s administration has recently expanded oversight efforts, ordering surprise inspections of sterile compounding pharmacies and planning to hire more staff.
Proposals before state and federal lawmakers could further tighten regulation of the pharmacies. A federal proposal would require compounders that are acting as manufacturers to register with the FDA.
Massachusetts is one of just three states that do not require pharmacies located out of state to be licensed in Massachusetts in order to serve patients here. That means if Pallimed were based in another state, for example, it could distribute drugs here without a Massachusetts license. A bill scheduled for a legislative hearing Tuesday would change that.
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You know, since I'm checking the drug labs:
"More signs of disarray in closed state drug lab" by Scott Allen and Andrea Estes | Globe Staff, April 02, 2013
State investigators have found at least a half-dozen drug samples scattered about the state lab in Jamaica Plain, documents show, raising questions about the integrity of all testing where indicted state chemist Annie Dookhan worked.
Thought that was/is kind of important.
Investigators for the state inspector general, who have been combing through the closed lab for months, found a plastic bag containing “a white rock substance” and test tubes “containing unknown substances” in one supervisor’s office. They found pills taped to a lab bench cabinet and old samples, including marijuana submitted in 1996.
Related(?): Drug Addict Worked at State Drug Lab
Oh, that's rich!
The findings, in a confidential report by the attorney general, add fuel to defense lawyers’ arguments that virtually all drug tests done there since 2003 are suspect, expanding the number of cases that could be affected by the scandal from the 34,000 handled by Dookhan to the 190,000 cases processed by the entire lab.
Thought that was/is kind of important.
A leading authority on crime labs said that failing to secure and track all evidence is a fundamental failure in a crime lab....
Thought that was/is kind of important.
Unlike hundreds of other crime labs nationwide, including the Boston police crime lab, the Massachusetts lab was not accredited....
Are you f***ing s***ting me?
Matthew Segal of the American Civil Liberties Union of Massachusetts said the illegal drugs found lying about the lab reflects labwide problems that undermine the credibility of all drug testing there....
Thought that was/is kind of important.
Hey, government is ONE LONG PARTY these days, or haven't you heard?!
But prosecutors said they believe the inspector general’s discoveries will not jeopardize cases handled by other chemists in the lab.
They can't be serious.
“People at my office aren’t overly alarmed,” said Norfolk District Attorney Michael W. Morrissey. “We can’t point to any cases that were directly affected. You’re trying to find out if the other shoe is going to drop. That’s everyone’s question. What they did or didn’t do. How bad is the problem? We’ll have to wait for the result of the forensic investigation.”
Jake Wark, spokesman for Suffolk District Attorney Daniel F. Conley, said that the samples that were discovered may have no bearing on cases that were actually tried. “They could be linked to closed cases or no cases at all,” he said.
Doesn't matter. Anything that came out of that lab is tainted "evidence" now.
Have you ever noticed that prosecuting authorities in the U.S. rarely, if ever, admit a mistake.
Never heard back on the fires, either. I rest my case.
Inspector General Glenn A. Cunha sent investigators to the drug lab in January and February as part of a sweeping investigation of the lab’s practices that is not expected to be completed until later this year. While Attorney General Martha Coakley is handling the criminal investigation, Cunha is looking at the lab’s procedures and whether problems extend beyond Annie Dookhan.
The investigators’ visits, described in memos written by State Police officials who accompanied them, found the lab exactly as workers left it on the evening of Aug. 29. The next morning, State Police closed the lab and did not allow employees back in.
The field reports contain little analysis, and it is clear, in some instances, that investigators did not know exactly what they found....
The union that represents the 11 chemists in the lab, out on paid leave since the lab was closed, defended their expertise and said they are eager to return to work.
Wow.
“Make no mistake, these people want to get back to work, preferably with the State Police crime lab,“ said Joe Dorant, president of the Massachusetts Organization of State Engineers and Scientists.
Dorant would not comment on the inspector general’s reports.
But defense lawyer Michael Tumposky said the inspector general’s discoveries should bolster the motion he filed for a new trial in a case that involved a chemist other than Dookhan at the Hinton lab.
“Who are the adults at this lab or was it a case of the inmates running the asylum?” said Tumposky. “You know there’s a problem when the guy who is supposed to be in charge has a bag of crack on his desk for no apparent reason.”
Anybody find a pipe?
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Related:
Dookhan the Deceiver
Looks like she not the only one.
