Federal regulators have detected contamination in two more drugs made by a Massachusetts pharmacy tied to a deadly meningitis outbreak, but neither medication made its way to Maine, except in a topical form still considered safe.
Regulators announced Thursday that they had found bacterial contamination in preservative-free betamethasone, an injectable steroid for treating joint pain, and cardioplegia solution, a medication used in heart surgeries, that were made by the New England Compounding Center.
Maine Coast Memorial Hospital in Ellsworth received multiple doses of betamethasone from the now-closed pharmacy, but in a topical gel form that has not been linked to contamination problems.
According to an Oct. 23 list released by the U.S. Food and Drug Administration, no Maine hospitals or doctors received the injectable form of betamethasone or cardioplegia solution from NECC.
Injectable betamethasone is different from another injectable steroid made by NECC that has been implicated in a fungal meningitis outbreak. A fungus detected in a steroid called methylprednisolone acetate manufactured by NECC is being blamed for the outbreak that has spread to 19 states, sickening 377 people, 28 of whom have died.
The tainted methylprednisolone acetate also was not received or used in Maine. The state has recorded no cases of fungal meningitis, though health officials are monitoring 74 Maine residents who were treated in New Hampshire with the contaminated steroid injections.
The Maine Board of Pharmacy voted Thursday to immediately suspend NECC’s license to operate in the state.
The outbreak prompted an Oct. 6 recall of all of NECC’s products. Maine Coast Memorial Hospital had already removed the topical betamethasone from its shelves, said Tim McCall, pharmacy director.
“We pulled and quarantined everything” from NECC, he said.
Most drugs made by the Framingham, Mass., pharmacy have not been linked to illnesses. But the FDA recommended that patients who received the products be notified about the potential risk of infection.
More than 30 health care organizations in Maine were customers of NECC. None purchased the tainted methylprednisolone acetate.
Federal regulators also are testing the injectable betamethasone and cardioplegia solution for fungus. Results are pending.
The FDA had said previously that it was investigating whether the cardioplegia solution and medications used in eye surgeries were connected to the outbreak.
The “clinical significance” of this week’s discovery of bacteria in the two new NECC products “is not known,” the FDA said in a statement.
Some of the types of bacteria identified in NECC’s injectable betamethasone and cardioplegia solution are rarely reported to cause disease in humans, the FDA said. As of Thursday, the U.S. Centers for Disease Control and Prevention had not received any reports of laboratory-confirmed cases of bacterial infections linked to the two drugs.
The findings “reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics and health care providers should not use any NECC-supplied products,’’ the statement said.
NECC has suspended operations and is being investigated for its role in the meningitis outbreak. Investigators there have found standing water from a leaking boiler, filthy floor mats and records indicating drugs were shipped before sterility tests were returned.
The outbreak has stirred calls for stricter regulation of compounding pharmacies, which step in to manufacture medicines when drugs from pharmaceutical companies become unavailable or when patients need custom-made formulations.
The industry is loosely regulated by the FDA and state pharmacy boards. Maine has no compounding facilities that operate on a large scale, but some individual pharmacies mix their own drug formulations as needed.
Scrutiny has also fallen on a sister company of NECC called Ameridose LLC. The Westborough, Mass., company was closed on Oct. 10 and issued a voluntary recall of all of its products this week after the FDA directed it to improve its sterility testing procedures.
Ameridose is a major supplier of common injectable drugs, such as morphine, lidocaine and the anticoagulant heparin. Maine hospitals are among some of its customers.
The company said Wednesday that it had not received any reports of adverse reactions to its recalled drugs. The FDA said it recommended the recall “out of an abundance of caution.”
The Maine Board of Pharmacy also took action Thursday on Ameridose, voting to ask the company to surrender its license to do business in Maine, according to Doug Dunbar, a spokesman for the Maine Department of Professional and Financial Regulation, which oversees the board.
Board members have offered NECC a consent agreement. If the pharmacy signs off on it, its license in Maine would be revoked.
The Associated Press and Reuters contributed to this report.
And this comes at a time when so many teaparty republicans want government out of their lives. If nothing else, the deaths that resulted from a lack of oversight should teach the latter the importance of regulations.
Lepage and his cronies, ever the proponents of big business at any cost, are proof that politics before people is not a prudent course.
Ya you have no idea as to what you are talking about..that lab..is in framingham .ma…what does lepage have to do with a thing here?ever been to framingham .ma? i suppose you would also like to blame him for all murders that happen in Maine
I think the point that mainegal was trying to make was that reducing regulations on things like food and drugs is going to put everyone in danger. There is a reason that the FDA regulations came into existence in the first place. People who want to get rid of government seem to forget the useful functions that government performs. You cannot trust companies to regulate themselves because greed will trump doing the right thing every time. That has been proven time and time again.
Government does nothing useful. It is merely a system to provide low-effort paychecks to the party faithful and other societal parasites. Take a good look at New York. No preparation for the storm because all the money was siphoned off by the party piglets for their no-show city jobs. Mayor Big Gulp is more interested in running a marathon for Kenyans than in getting utility power back on for taxpayers. He reconsidered only after he saw the lynch mobs gathering on Staten Island.
BDN-in the 1960s, there was a saying, “America. Love it or leave it.” Maybe it’s time for you to have a different experience, if you think our government does nothing useful.
Who would be left to support you party hacks?
When I read replies such as yours, it only reinforces the fact that there are some very reading-challenged commenters on here. Apparently, you think everyone else shares your inability to comprehend English.
I know that lab is in MA. Do YOU not know that many, many vials from that lab were distributed to facilities here in Maine? No, perhaps you don’t know…or perhaps your inability to retain news from three days or so ago reigns supreme. My comment meant that Mainers can be and have been affected by not only this lab, but as indicated in more news releases since,a few others.
What does Lepage have to do with it? Think, man, think! Like all “good” republicans,he wants to cut gov’t regulations anywhere he can. That helps businesses cut corners and save money, as this lab did. Cutting corners can result in death. Comprehend now?
I know there are some people who have serious reading comprehension problems and whose ability to see things clearly is blinded by the barrage of bull they are fed. When all else fails, go back to school and take some courses to see if you can improve those problems.
Mainegal wants to put Dale McCormick in charge of state drug safety. A loyal party member who wants to do for drug safety what she did for affordable housing.
Really dislike responding with facts but here I go. That lack of oversight occurred in Massachusetts. The governor of the Commonwealth is a buddy of Obama. The House has 128 Democrats to 32 Republicans and the Senate has 36 Democrats to 4 Republicans. Now for the analysis. Sounds like failed liberal democratic policies to me.
the lack of oversight goes straight back to Romney while he was governor. The company continually failed to meet standards, in 2004, they were reprimanded for it, and then Romney withdrew the reprimand. The Mass. department of health released records going back more than a decade that showed many citations at NECC. The company was allowed to regulate themselves.
Patrick has been governor now for 5 years. Is the Mass. crime lab scandal Romney’s fault as well? It is time for the Democrats to stop blaming everything past and present on former Republican administrations.
as long as republicans continue to support deregulation, yes. I’ll stick the blame where it belongs.
and I laugh when republicans complain that we’re always blaming past administrations when republicans in our own state continue to blame previous democratic administrations for the problems here in Maine.
Btw, go look up NECC’s political contributions.
Please help me to understand how contributing to Brown and Romney are responsible for this outbreak. The Dept. of Public Health was apparently the agency charged with oversight of this industry. This is more of a failure of the state agency to do fulfill their duties than any politician.
because the company supports being able to regulate themselves – which Romney and Brown support – and obviously with NECC’s history, they shouldn’t be.
Very few states actually regulate compounding pharmacies very well
You are absolutely right. It apparently is a very gray area as which agency or agencies, state or federal, should be regulating these compounding pharmacies. It appears that there is movement on involving the FDA to assist in regulating and monitoring this industry, which I think is a step in the right direction.
I completely agree – here’s pretty good article about that : http://www.boston.com/business/news/2012/10/29/compounding-pharmacies-have-long-evaded-the-tight-oversight-governing-established-drug-makers/KCnU0fS75nFlsJSUoDroyI/story.html
Former regulators and legal scholars say the Food and Drug Administration has lacked enough authority and resources to effectively monitor compounding pharmacies.For example, the type of FDA scrutiny used to approve and inspect new drugs — a tightly choreographed process involving multiple clinical trials and inspections of plants where medicines are made according to strict sterility standards — could not easily be replicated for compounding pharmacies. Such pharmacies custom-produce drugs not always available commercially, including treatments that are in short supply or have been pulled from the market because of a lack of demand.“To perfectly enforce the statutes, the FDA would need a much larger budget,” said I. Glenn Cohen, an assistant professor at Harvard Law School who codirects its Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. “But they’re doing the best they can, given their resources and the political constraints.”Congressman Edward J. Markey on Monday released a report outlining the roles of state and federal regulators and how the industry “has historically resisted a federal role” in its oversight. A review by his office of pharmacy board records, FDA compliance records, and news reports since 2001 found 23 deaths and 86 serious illnesses linked to products from compounding pharmacies, excluding the latest meningitis cases.********************now tell me which party doesn’t like the FDA and feels we need to let businesses regulate themselves?
Look, I agree that business should not regulate itself. I work for a very large corporation (inside the Fortune 50) and trust me regulation can be good and is necessary. That is not what this is about. This is not about philosophy or party affiliation. The burden of regulation fell to the state not because of lack of funding to the FDA but more to historical precedent of states regulating these businesses. Massachusetts very well could have given the Dept. of Public Health more resources under Governor Patrick but has elected not to do so. That has been their choice, apparently the Governor and legislature had other priorities they felt were more important.
In July, Brown was one of 10 senators to sign a letter to the Drug Enforcement Agency arguing that regulations on the compounding industry should be loosened.
and, another poster originally brought party affiliation into it, and then you blamed it on “failed liberal policies”
so which is it? are politics part of the problem or not?
Federal agencies – and the FDA in particular in this case – don’t regulate intrastate commerce. Pharmacies have always been a business which is licensed to conduct business in a single state.
Pharmaceutical companies, on the other hand, operate in interstate commerce, which subjects then to federal and not state regulation.
This is the historical background.
both the state board, and the FDA had done inspections on this particular company in 2004. They passed the inspections, but the FDA cited previous concerns and felt NECC should receive a formal reprimand.
FDA will only get involved if they are shipping across state lines, as I mentioned. They clearly were, which is why the FDA had any role at all. Otherwise, it’s left entirely to the state Pharm board.
You did not directly bring party affiliations into the discussion. I read into your comments that you certainly were not talking about Democrats based upon your wording and your past tag line of “Reclaim Maine Vote Democrat 2012”. Basically no I do not believe it is failed party politics. I believe it is a failure of government itself. People like you, or perhaps I should say my perception of people like you, liberal or conservative, who blame the other side for every problem that presents itself, are not helpful in solving the problems affecting us.
Tag line? you have me confused with another poster.
And you blamed “the other side” as well in your first comment.
I am sorry, you’re right. Lack of attention, I was thinking of another poster.
I did and was wrong in doing so. I was reacting to the following post which was *prior* to my first post. After going back and forth and reflecting on what has been said, I believe it is a breakdown of the system and not a political problem.
*mainegal17 ***1 day ago
· And this comes at a time when so many teaparty republicans want government out of their lives. If nothing else, the deaths that resulted from a lack of oversight should teach the latter the importance of regulations.
Lepage and his cronies, ever the proponents of big business at any cost, are proof that politics before people is not a prudent course.
Really dislike responding with facts but here I go. That lack of oversight occurred in Massachusetts. The governor of the Commonwealth is a buddy of Obama. The House has 128 Democrats to 32 Republicans and the Senate has 36 Democrats to 4 Republicans. Now for the analysis. Sounds like failed liberal Democratic policies to me.
Really dislike responding with facts but here I go. That lack of oversight occurred in Massachusetts. The governor of the Commonwealth is a buddy of Obama. The House has 128 Democrats to 32 Republicans and the Senate has 36 Democrats to 4 Republicans. Now for the analysis. Sounds like failed liberal Democratic policies to me.
East_mill, you really don’t need to keep repeating your message. I know there are some who can only grasp things if they learn by rote. Those are called animals and/or Tea Party types. I grasp things by reading…once. Sounds like you failed to get it, when those lousy liberal dem. teachers tried to educate you.
First off the system was down when I replied and I did not think my reply was accepted. My mistake for not being patient enough for the system to come back up (that is accepting responsibility for one’s actions). Second I did receive a great education both in secondary school and at a liberal Boston university. One thing I learned is to think for myself, not just spew regurgitated party agenda Democrat or Republican. I also do not assume what another is thinking. I do not believe my thoughts on education or teachers ever came up.
And if they aren’t safe, there’s two funeral parlors in town to cover up the physician’s mistakes.
This company should have been shut down a long time ago of not for greed.
http://bostonglobe.com/metro/2012/10/22/mass-compounding-pharmacy-has-long-list-violations-cleared-outside-monitor-now-jail/zusDQSurMqUXwuhavf5KEJ/story.html