Pharmacy linked to outbreak issues wide recall

[Omaha Steve]

Source: AP-Excite

By GREG SCHREIER

ATLANTA (AP) - The pharmacy that distributed a steroid linked to an outbreak of fungal meningitis has issued a voluntary recall of all of its products, calling the move a precautionary measure.

The New England Compounding Center announced the recall Saturday. The company said in a news release that the move was taken out of an abundance of caution because of the risk of contamination. It says there is no indication that any other products have been contaminated.

The Food and Drug Administration had previously told health professionals not to use any products distributed by the center.

The Centers for Disease Control and Prevention posted updated figures to its website Sunday showing there are 91 confirmed cases of the rare form of fungal meningitis. The outbreak spans nine states and has killed at least seven people.

FULL story at link.


Read more: http://apnews.excite.com/article/20121007/DA1OVAJO3.html

---

In this Thursday, Oct. 4, 2012, file photo, a sign requesting "No Soliciting" hangs on the door of the New England Compounding Center, the pharmacy that distributed a steroid linked to an outbreak of fungal meningitis, in Framingham, Mass. The New England Compounding Center announced Saturday, Oct. 6, 2012, in a news release a voluntary recall of all of its products. The company said in a news release that the move was taken out of an abundance of caution because of the risk of contamination. It says there is no indication that any other products have been contaminated. (AP Photo/Stephan Savoia, File)

[jsr]

1. The FDA has more regulatory authority over a drug factory in China:

http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html

October 6, 2012
Scant Oversight of Drug Maker in Fatal Meningitis Outbreak
By DENISE GRADY, ANDREW POLLACK and SABRINA TAVERNISE

...The answer, at least in part, is that some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University...

Some physicians who work in big hospitals may not even know whether the drug they use is from a compounder. ...

[OldDem2012]

2. And guess which party has been actively eroding the power of the FDA? nt.

[jsr]

3. Yep.

[benld74]

4. I read the article today, VERY sobering indeed,,

but more investigation is needed. I mean IF certain drugs are in short supply, HOW can these places get hold of them? That is how they came to be, or at least that is what I got out of the article. THink I;ll read it again,,,,

[tawadi]

5. An abundance of caution?

What a joke.

[global1]

6. 17,676 Vials Is A Manufactured Lot Not A Compounded Prescription....

It seems clear to me by reading a NYT article on this incident that this New England Compounding Center was a manufacturing operation and not a small compounding pharmacy. A compounding pharmacy serves the public by making a custom dose of a medication for a specific patient.

A compounding pharmacy serves the public by making custom doses where the patient for some reason can't take a commercial medicine (i.e., can't swallow a tablet or capsule so they make it into a liquid format; the commercial product is unavailable and that life saving product is necessary for the patient; etc). There are countless examples of situations and needs for drugs on a one on one basis that are necessary and vital for the health and welfare of a patient.

One patient, one doctor, one compounded prescription. Compounding pharmacies serve small communities and are a necessary entity to the health care system.

In this case it appears that this New England Compounding Center was making large batches of a drug product and selling these batches all over the country - just like a major pharmaceutical manufacturer would do. The difference is that the major manufacturer has to go through an FDA approval process for that drug they are making. In this case they didn't go through that process and were trying to use the guise of a compounding pharmacy to skirt that process. In essence they were weaseling around the regulations to make a buck. They were competing with these small compounding pharmacies in the communities - perhaps even putting some of them out of business - just to make a buck.

Well a large batch of product can hurt a lot of people and this is what happened here. The FDA regulates manufacturers to prevent that from happening. Large manufacturers have recalls all the time because of this regulation and surveillance by the FDA. Large manufacturers have caused major outbreaks like this in the past. But using the guise of a compounding pharmacy to avoid regulation and surveillance by the FDA is wrong.

Be careful not to damn all compounding pharmacies because of the greed of large operations such as this one trying to work in the creases of the laws. We have to be careful now that a necessary part of the health care system - the compounding pharmacy - doesn't get caught up in this situation and is put out of business. There is no substitute for a good compounding pharmacy. Major manufacturers would like to see these small pharmacies put out of business - but they offer no suitable solution to the millions of people that need the services that are provided by small compounding pharmacies.

What needs to happen is that these large so-called pharmacy operations - that use the guise of a compounding pharmacy to skirt the regulation by the FDA need to be put out of existence. These are the pharmacy operations that should be focused on going forward and care needs to be taken that we don't throw the baby out with the bathwater by clamping down on all compounding pharmacies.

I'm sure there are people here on DU that use the necessary services of their local compounding pharmacy to serve their individual needs or members of their family's individual needs where no suitable alternative is made available by the large manufacturers. If you use a compounding pharmacy - tell your story here.

Remember folks that in the beginning all pharmacy was compounding pharmacy because there were no large pharmaceutical manufacturers. It is only when patented medicine was being made in large quantities that the FDA came into existence to avoid situations such as this one to not happen. The FDA came into existence to regulate and scrutinize these large operations. A lot of us lose sight of that fact - because we're not old enough to remember the way this all came about.

Again - large operations that are skirting the laws to make a buck like this one in question need to be stopped. Don't be fooled into thinking that all compounding pharmacies are at fault.

This is not a Democrat or Republican issue. This is an issue that effects all of us equally and is important for the public health of this country. Please don't try to politicize a situation like this. That would be wrong.