meningitis outbreak 2012

[Spexxvet]

Seven more people have been diagnosed with fungal meningitis linked to possibly tainted vials of a steroid medication, the U.S. Centers for Disease Control and Prevention said on Sunday, bringing the total number of cases to 205 in 14 states.

NECC engaged in a little-known practice called drug compounding that is not regulated by the Food and Drug Administration, which generally oversees drug makers.

http://www.reuters.com/article/2012/...8970TQ20121014

I'm disturbed that we can be injected with something that is basically unregulated and uninspected.

[Clodfobble]

Please don't let media scare tactics get to you. "Compounding" just means the pharmacist assembled the drug themselves from the base medicine(s). It used to be synonymous with being a pharmacist, before they started mass-producing pills in factories. To say it is "not regulated" only means that the FDA didn't stand over the guy's shoulder and watch it being put into pill/IV/whatever form. The source medications (prednisone) are regulated, the pharmacy itself is regulated, the licensed pharmacist is regulated. The same kind of accidental contamination happens in pill factories too--and many of those aren't even within this country. You can google the massive recalls of children's Tylenol products for just one recent example.

[orthodoc]

One of the differences, though, between a drug company and a compounding pharmacy is that the pharmacy is only licensed to compound drugs for individual prescriptions - for individual, named patients. So it's by definition very small-batch preparation. There aren't many true compounding pharmacies anymore and they provide a needed service. However - this company, and others, were violating their licenses by preparing drugs in quantity for providers, not as filled prescriptions. Mass preparation differs from small-batch, and quality control isn't going to be there if it isn't built in to the process.

Hence the problem. There have also been accounts, not yet completely verified, that the culture of the place was to push production at the expense of quality checks. For example, product was shipped before control checks had come back from labs. Some drugs were recalled due to concentration problems. This is more than scary - we're talking bags of fentanyl and other OR medications that were made up at erroneous concentrations. NOT okay.

The compounding pharmacies need to keep to their licenses, period.

[BigV]

Originally Posted by Clodfobble

Please don't let media scare tactics get to you. "Compounding" just means the pharmacist assembled the drug themselves from the base medicine(s). It used to be synonymous with being a pharmacist, before they started mass-producing pills in factories. To say it is "not regulated" only means that the FDA didn't stand over the guy's shoulder and watch it being put into pill/IV/whatever form. The source medications (prednisone) are regulated, the pharmacy itself is regulated, the licensed pharmacist is regulated. The same kind of accidental contamination happens in pill factories too--and many of those aren't even within this country. You can google the massive recalls of children's Tylenol products for just one recent example.

Not to mention all those "not regulated" commercial enterprises that also take separate ingredients and compound them into products that you put into your body--restaurants.

There are lots of ways to become sick. I agree that the expectation is 100% that what a doctor injects into me will make be better, or at least "do no harm"--certainly not make me sick and die. But I believe it's a testament to how safe we actually *are* that such an unavoidable risk though small has drawn such attention. We're used to being kept safe partly by the regulations of government and partly by the good practices of businesses like these.

[Clodfobble]

Originally Posted by orthodoc

There aren't many true compounding pharmacies anymore and they provide a needed service.

The practice is becoming more popular, though. Walgreens has actually begun offering compounding services in many of their pharmacies.

Originally Posted by orthodoc

However - this company, and others, were violating their licenses by preparing drugs in quantity for providers, not as filled prescriptions. Mass preparation differs from small-batch, and quality control isn't going to be there if it isn't built in to the process.

Hence the problem. There have also been accounts, not yet completely verified, that the culture of the place was to push production at the expense of quality checks. For example, product was shipped before control checks had come back from labs. Some drugs were recalled due to concentration problems.

Ah, I did not know this part of the story. Clearly this particular place should be shut down. Do you happen to know if the pharmacists involved can be held criminally liable, or are they just going to lose their licenses?

[orthodoc]

Sorry, my internet connection is completely unreliable ... can't get the urls I wanted because it keeps timing out. But there were articles in the NY Times either Oct 12 or 13, and a Reuters article Oct 13 that addressed the issue. I suspect management may come in for some criminal charges, as they dictated the entire setup.