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Subscribe to RSSMassachusetts officials said Sunday they had closed another pharmacy as part of a crackdown after an outbreak of fungal disease that has killed 25 people and made 344 sick.
They said a surprise inspection turned up unsanitary conditions at Infusion Resource, a compounding pharmacy in Waltham, Massachusetts that prepares sterile, injectable medications. The facility was also administering injections, something it wasn’t licensed to do, said Dr. Madeleine Biondolillo, director of the state department of health’s Bureau of Healthcare Safety and Quality. Biondolillo did not say any products from the pharmacy were in any way linked to the ongoing outbreak linked to pain injections.
The Centers for Disease Control and Prevention reported six new cases of fungal disease on Saturday in the outbreak traced to steroid injections made by the New England Compounding Center in Massachusetts, bringing the total to 344 cases of infection in 18 states, with 25 deaths. Officials have closed NECC and a separate pharmacy with common ownership, Ameridose, has also closed.
The fungus causes an unusual type of meningitis in some patients who got injections directly into their spines, and patients must undergo weeks or months of treatment with antifungal drugs that themselves can be dangerous, with severe side-effects. State and federal regulators are working to find out how the drugs got contaminated and how the pharmacy managed to operate at such a large scale for so long.
“As our joint investigation with our federal partners into NECC and Ameridose continues, we have launched a series of immediate, on-site inspections of other compounding pharmacies in Massachusetts that prepare sterile injectable medications,” Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, told a news conference Sunday.
“We will continue our aggressive unannounced inspections of compounding pharmacies while also focusing on our ongoing investigations of NECC and Ameridose.” Smith said the department was adding inspectors and other staff to help take on the workload.
NECC was licensed as a compounding pharmacy, which is supposed to custom-make drugs to order on a per-prescription basis. Instead, officials say, it was mass-producing and distributing drugs to hundreds of clinics treating tens of thousands of patients in two dozen states.
On Friday, the Food and Drug Administration released details of some of its inspections of NECC, and said it found greenish black matter growing in some of the products. The FDA doesn’t regulate compounding pharmacies like it does drug manufacturers, but can look for unclean conditions. The FDA said it found dirt, puddles of water and improper sterilization practices at NECC.
State health agencies are supposed to regulate compounding pharmacies but Massachusetts officials say they didn’t have the power they needed to keep tabs on NECC, which had received several state and federal warnings in recent years. Smith said her department was preparing regulations to require compounding pharmacies to submit frequent reports about sterile, injectable medications -- especially how much they are making and distributing. “This reporting will allow us to better identify large-scale operations acting more as a manufacturer, which requires federal licensure and additional scrutiny,” she said.
“We are also launching a special commission to examine best practices in other states and potential changes to state law or regulations to help us keep pace with an evolving industry and close the regulatory gray area that exists between state and federal oversight."
Infusion Resource, the pharmacy that was closed Sunday, has a branch in Rhode Island, also. "Our patients’ infusion solution needs are being serviced out of our Rhode Island pharmacy located within our main headquarters building in East Providence," Infusion Resource LLC CEO Bernard Lambrese said in a statement.
Biondolillo said inspectors found “significant issues with the environment in which medications were being compounded, which has called into question the company's compliance with nationally accepted pharmacy standards and Massachusetts regulations.” She said while no products have been found to be contaminated, the state has closed the facility because of worries about sterility.
“Additionally, there was an adjacent space set up for giving patients intravenous medications on-site. Infusion Resource does not have an appropriate clinic license to conduct these activities, which is a violation of state regulations,” Biondolillo said.
Infusion Resource said the issues uncovered by the inspectors did not involve its products.
"The compliance issues involve such physical plant issues as a hairline crack discovered in a 4-pane window caused by settling of the anteroom, the condition of the standard clean room flooring, and a leak in a refrigerator drain hose," the company said in a statement.
"The company provides infusion therapy services to patients in home, ambulatory suite or hospital locations, with approximately 80 patients in Massachusetts served from its Waltham location. It does not provide batch compounding services -- rather it compounds for individual patient dosing needs." A spokeswoman added that the on-site space flagged by the researchers was for education, not for delivering infusions.
In a separate matter, Smith also said state pharmacy board member Sophia Pasedis, who is also a manager at Ameridose, had been asked to resign but said she had refused. Smith said Pasedis should have recused herself from any matters concerning Ameridose and NECC but it wasn’t in fact clear that she had. “Given the ongoing investigation, we believe it is in the best interest of the board to have Ms. Pasedis step down," Smith said. “We are considering what actions to take in the interim. “
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Obama's job-killing regulations. We shouldn't worry about a few people-killing companies, now should we?
Newsgirl, all politics aside... it's a shame that a compounding pharmacy operates to squeeze out more profit at the expense of human life.
Carry on my wayward son. There will be peace when you are done. GWAR is cute. http://www.youtube.com/watch?v=sIl7d1VVwOc
Yes, as long as we can cut millionaire's taxes, we can skip monitoring murdering companies- Go Romney and let carnage reign!!.
Romney leaves a really nasty, filthy rash on my bum. And, Lord how it itches!!! http://www.youtube.com/watch?v=sIl7d1VVwOc
I want to call this a victory for regulation, but then one has to ask where were the surprise inspections at the other facility?
If regulation happens AFTER a problem becomes public then it doesn't seem that effective.
The problem does not appear to be a lack of regulations. The problem appears to be a lack of enforcement. It's like raising a toddler. Rules don't mean anything if there is no consequence.
Pragmatic-3918582, when republicans practice years of "starving the beast"- underfunding government- enforcement becomes impossible. THAT is the problem- you don't enforce the regulations by magic, but rather with a well-funded enforcement agency paid for by sufficient taxation. Cut taxes= cut enforcement, it's a simple equation that seems beyond TeaParty Republicans intellectual abilities.
Which creates an opportunity of ideological advancement. If government fails, then there's an argument to be made for "privatization" of government functions. See, when the talking point "government isn't the solution" didn't work, it became "government doesn't work" and now they're trying to make it a self-fulfilling prophecy.
Obama did not have any part in this fiasco. Republicans are the ones for that are killing health and safety Regulations. In fact, Regulations MUST be tightened so that "Companies for excess profits" are inspected more frequently and have more standards to adhere to.
If Republicans gain control of the White House and stay in control in Congress you can expect such occurrences to increase tenfold because Republicans don't like the EPA, OSHA, FDA, etc. in the first place.
And PS: If they get away with killing off these Regulations, then they will, also, kill off most State protections at the same time. And they will do this at the same time that more and more contaminated products are filling the market, sicking or killing people.
Let's lay the blame where it belongs folks, the United States Supreme Court, which in 2002, stripped the FDA of most of its power to regulate compounding pharmacies.As much as some would love to blame the Republicans. The last opportunity to regulate this business was in 2007 when Congress had a chance but blew it. With a 3 billion dollar business and 7,500 companies, lots of lobbyists on their side and states running the show, plus all those hired lawyers suing and dragging the FDA into court constantly. Despite inspections, refusals to comply and delay strategies, it does make it frustrating for one to do their job.
Perhaps now with public outcries, folks in Congress will step forward, work together and pass laws allowing the FDA to establish regulations for these businesses and give them some teeth with which to start forcing compounding companies to follow the same regulations that the drug manufacturing companies must follow.
It isn't one party stopping progress from being made. Haven't some folks learned yet when it comes to government and human problems, it's never black or white as they seemed to be. Although it makes us feel good to think it is.
It sounds like a corporate death panel to me. I have to wash my hands????? a sterile field???? costly gov regulations! Here I got a Teabag, it'll make you feel all better. We at corporate headquarters really care.
why do docs buy from compounding pharmacies? are they cheaper?
Ed, I think docs use compounding pharmacies for drugs that aren't manufactured in bulk, smaller volume specialty made drugs that aren't readily available thru manufacturing pharmacies.
Correct jawzee. Need a liquid antibiotic that a drug company doesn't make? A compounding pharmacy will crush up some pills and add a cherry flavoring. Shake well before administering. The drug companies can't plan for every medical dose required, it would require enormous production lines. And in some cases you might only need a handful of doses per year. The economy isn't there. That's why compounding pharmacies exist. They are supposed to make individual doses based on a doctor's prescription.
What the problem is now: Compounding pharmacies are making entire batches to be used in hundreds or thousands of patients. That makes them little drug companies. But because they are considered "pharmacies" they aren't regulated like drug companies. By the way, they aren't supposed to be doing that.
Remember when pharmacists worked to stop the spread of disease and infections instead of worrying about having to dispense the "morning after" pill against their religious beliefs?? Those were the days....
Pharmacists dispense whatever pills they can synthesize and legally distribute. I think you are confusing a pharmacy with a church.
You display an inability to understand the difference between retail pharmacies and compounding pharmacies, though the issue has been thoroughly explained during the ongoing coverage of this problem. Retail pharmacies distribute birth control, compounding pharmacies are not involved in that end. Your ignorance is illustrative of your inability to understand those issues of which you opine, a characteristic that seems common amongst your philisophical ilk.
The morning after pill isn't part of the problem. Wake up.
Now we are getting to the nitty-gritty of the issue. A member of the State Pharmacy Board was a manager at Ameridose - in other words, she was being paid by the negligent murderers who own NECC and Ameridose.
Amazing that she refuses to resign from the board - must be politically connected big-time. She, and the rest of the State Board, are now much better targets for liability suits. Sounds like the Governor needs to clean house at the State Board of Pharmacy - just remove them all and start fresh. The legislators need to make sure there is an enforceable ethics law to prohibit (and severely punish) any family,financial, or gift relationship between all state licensing/regulating board members and any businesses, persons, or agencies that they oversee. When there are incestuous relationships between regulators and regulatees, you get big trouble.
This is simple looting of Medicare by Corporate greed! Nothing more, it's the new Romney way, trust me.
I hope all the people affected by these company's drugs sue the heck out of everyone connected to these company's for everything they have put these people through not to even mention the deaths..
Greed it seems to make people forget all about the people they are dealing with that are depending on them to give them a drug they need to live. If this were a foreign company it might make a little better sense but its here the USA, Geez.
Everyone found responsible in all of this should spend many many years behind bars in a hell hole of a prison as I'm tired of these types of people who put money before a persons health and life.
[SOURCE: http://vitals.nbcnews.com/_news/2012/10/28/14762148-state-officials-close-another-pharmacy-since-fungal-meningitis-outbreak ]
[SOURCE: http://www.mass.gov/eohhs/provider/licensing/occupational/pharmacy/about/board-members.html ]
This is the modus operandi and status quo in the world of sneaky weaseling, where the sneaky weasels and their cohorts constantly devise schemes to ensure that they regulate themselves for their own benefit regardless of the consequences to the health, safety, and well-being of others, where what ethical people consider to be a conflict of interest is viewed by the sneaky weasels and their cohorts as an "opportunity" for self-enrichment and self-aggrandizement . . .
This ongoing patently evil practice needs to end real soon, and the best way to put an end to it is to bring criminal charges against the sneaky weasels and their cohorts for the betterment and enlightenment of others, which certainly needs to include ensuring that the sneaky weasels and their cohorts forfeit their professional licenses and other credentials, because once sneaky weasels and their cohorts demonstrate indisputably that they have no ethical, moral, or professional concerns about inflicting harm, injury, and death upon the unsuspecting public, there is no redemption in this life for them, for sure . . .
For sure! :-o
Two problems exists with companies such as this if the owners are not prosecuted. 1. They will fain bankruptcy. And 2. Will change their location and reopen under a new name. The Public be damn.
Baldenario and SCGuardian---both of you stated excellent reasons why I as a citizen, and consumer, have taken the saying "Let the buyer beware" seriously. It's really pathetic that we live in that kind of world today, but we do! We need to do all that we can to change that, such as strive to be sure that the government does it's rightful part in making sure that regulations are being followed. But at the same time--I'm not holding my breath, but rather being very cautious and NON trusting.
First, no one is ever going to jail for any of this because lawyers are involved. In our state, after a sheriff department spent two years building a wide and sweeping case of serious crimes against several lawyers and law firms, including forgery, perjury, suborning perjury, obstruction of justice, framing two men, completely innocent, to go to prison--the long, long charges taken to the DA were reject outright. In a written document shared by the sheriff the DA said "We are not prosecuting ANY lawyers . . ." No matter who or what the crimes, including links to murders, corrupted judges, and more. From the Arapahoe County, Colorado, District Attorney. When the sheriff officers pushed harder the senior federal judge went AFTER THE SHERIFF INVESTIGATOR with threats! How crazy is this? And now just in Colorado to be sure.
So, in cases like these deaths the lawyers and law firms are all interlinked to the regulatory boards, just like so many corrupted judges from the federal bench on down, there to protect their friends and golf partners. So, no one is going to be criminally charged.
The firms are right now finalizing preparing bankruptcy documents, which were preplanned in most cases anyway, and that will wipe out any civil claims from the families of the dead and the others harmed.
Might try the same line of reasoning to thousands and thousands of killings and suicides and deaths all linked to financial collapse that transferred hundreds of billions upward to corrupted lawyers, law firms, banking and more and took peoples lives, homes, jobs, health care and maybe worse-worse-any real hope that our society of people with huge money and power have any care at all, any, for justice and fairness. They don't. They take, they have off-shore bank accounts, they try to run our government and lives with ZERO transparency in their finances or taxes.
These compounding pharmacies are already opening new ones under new corporate structures with the same owners, officers--and corrupted and dirty lawyers and law firms. Just the way it is.
There is a petition to request greater regulation of drug compounding facilities on the We the People, a WhiteHouse.gov website. Compounding facilities need greater regulation to meet the medical standards that warrant American’s trust in healthcare. You can view the petition here (you may have to cut and paste in
your browser:
.
Yet another example of Republican delusional thought: "business will always do the right thing".
FOR ITSELF