"State halts drug production at Woburn pharmacy; Firm recalls products deemed tainted" by Chelsea Conaboy and Kay Lazar | Globe Staff, March 25, 2013
Government inspectors found foreign matter in vials of injectable drugs made by a Woburn compounding pharmacy that regulators had previously cited for a series of problems, prompting the state last week to order a halt to production and request a recall of products, state officials announced Monday....
Pallimed Solutions Inc. was cited last year for producing an overly potent painkiller that caused two patients to be hospitalized, a top state health regulator said. The company also was ordered to stop making a generic form of Viagra last November after a surprise inspection found it was being made with “improper components.”
There were contaminants in the Viagra?
Related: Doped Up on This Supreme Court Post
We will see if they can get it up.
The latest action, coming a week after wide-scale recalls by two compounders in other states, highlights the continuing concerns about lack of oversight of these specialty pharmacies after 51 deaths and hundreds of cases of fungal meningitis and other serious infections were linked to New England Compounding Center of Framingham....
See: A Compounding Crisis
So six more have died over the last six weeks?
Chronic shortages of various medications nationwide have forced many hospitals and doctors to rely on compounding companies to produce hard-to-find drugs, but the recent spate of recalls has prompted many to rethink that policy, said Michael Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania nonprofit that has long tracked compounders.
How can that be when we seem awash in pills?
Related: Drug shortage pushing some EMTs to extremes
Hey, don't worry about that expiration date that means decreased potency. It's the same with the food we feed to kids, so....
“Just in the last couple of days, I have heard from pharmacists that have written to us letting us know that their hospital leadership has banned them from using outside compounders,” Cohen said. “We need better oversight, and something has to be done quickly.”
I agree. Someone is dying each week.
Btw, when are the arrests and lawsuits going to begin?
State legislative and congressional hearings last fall after the nationwide fungal meningitis outbreak underscored gaps in regulatory oversight between state pharmacy boards and the FDA, which allowed companies like New England Compounding to operate largely unnoticed.
Massachusetts lawmakers plan a State House hearing next Tuesday to review proposals submitted by Governor Deval Patrick and others for improving state oversight of compounders, said Representative Jeffrey Sanchez, a Jamaica Plain Democrat and chairman of the legislature’s Joint Committee on Public Health.
Related: Dookhan the Deceiver
They say they need more money in this age of austerity after conflicts-of-intere$t and other things sabotaged the preexisting structure. This from a state that is all tied up with anxiety about writing medical marijuana regulations.
“This conundrum that exists is pretty profound,” said Sanchez, who has been meeting with industry and regulatory officials. “Whatever we do can have an adverse reaction on the patient drug supply.”
Already has. People are waiting. If this is the greatest system in the world it sure does suck.
The Globe reported in December that the state had ordered Pallimed to stop producing one drug, sildenafil citrate, known by the brand name Viagra, because the product was being made with “improper components.”
Prior to that, state regulators cited Pallimed for producing a super-potent batch of the painkiller lidocaine, which resulted in two patients being hospitalized, Biondolillo disclosed for the first time Monday. State regulators have still not resolved that issue, and recently requested more information from the company, she said.
The FDA said little Monday about the nature and scope of the recall. It was unclear, for example, how many patients could be affected or precisely where the drugs were distributed. FDA spokesman Steven Immergut said the inspection of Pallimed is ongoing.
How can that be? These are not illegal drugs.
Related: Report cites need for drug tracker
Why?
"Most companies have moved their operations overseas to take advantage of cheaper labor and materials"
Weren't those the good jobs you were promised, and the jobs cited as driving our economic boom by the Boston Globe?
As for finding the drugs, they can never found the source of drug money laundered through banks either, so....
Also see: Time to Take a Pill
I think I'll pass on it, thanks.
Pallimed spokesman Scott Farmelant declined to answer specific questions about the recall.
Working with the FDA, companies often issue recall notices that include detailed information about the drugs affected, including lot numbers or the states in which drugs were distributed, information that patients or doctors would need in order to know whether the drug they received should be used. None of that information was included in Pallimed’s news release.
I've started to think that the FDA should be called the Fatality and Death Administration because all they are is a clearing path for corporate intere$t$.
In August, a post on the company’s blog portrayed Pallimed as the state’s largest sterile compounding pharmacy accredited by the national Pharmacy Compounding Accreditation Board. The board suspended Pallimed’s accreditation March 8. Douglas Hoey, the accrediting group’s president, said the board had decided to reexamine Pallimed’s practices after a pharmacist at the company reported receiving a cease-and-desist order.
Hoey said the problems did not present a threat to patients.
Yeah, thanks, doc.
--more--"
NEXT DAY UPDATE:
You understand what a blank space means, right?
Yeah, the threats we should be worried about di$appear from my paper while all the conjured up and created bogeyman appear day after day after day.
And yet on the website I find:
"The development highlights the continuing concerns about specialty pharmacies after 51 deaths and hundreds of cases of fungal meningitis and other serious infections were linked to New England Compounding Center of Framingham.
Separately on Tuesday, Attorney General Bill Schuette of Michigan sought permission in that state to launch a criminal investigation of New England Compounding, which has been hit with several lawsuits stemming from the outbreak."
I haven't seen much on the lawsuits in my Globe, and I've been scouring them.
UPDATE: Legislature to hold hearing on new regulations for compounding pharmacies
They just compound the problem.
