It's a Fungus amongus.

[Sapphire Silk]

Some of you may have heard about the fungal meningitis cases going around. The cases are non-contagious, and caused by contaminated steriods. The fungus (Aspergillius, a common fungus found everywhere) somehow got into steriods made by a compounding pharmacy in Massachusetts.

We had two cases at the hospital where my students have clinic. One of my students had one of the patients (she was actually doing quite well at the time and has likely been discharged by now).

Apparently the CDC has been consulting with our infection control docs over this

It's nasty stuff.

[Andara Bledin]

Yeah, I'd heard about that.

Seems the powers that be are going to be working on forcing compounding pharmacies either stick to the legal requirement that they only compound on an as-prescribed basis, or they have to pass the same safety requirements as any other manufacturer of medicine.

The article I read was pretty scary; these aren't the first deaths due to this type of issue.

Here's an article at Reuters

Scary, scary stuff.

^-.-^

[Amina516]

I've been following the news on that. It sounds dreadful.

[mhkohne]

Ok, apparently I've been completely ignorant of the scale of compounding pharmacies - I had thought they were only local operations. That outfit is way bigger than I thought!

Those guys should surely be held to GMP just like any manufacturer is - if 130,000 people are potentially affected, you can't be doing half measures on your handling!

[Lachrymose]

The smallish company I work for is one that has treated patients with some of these injections.

I don't believe anyone treated by us has been infected, but the CDC and state health department are making us call all patients that could have possibly been infected.

Of course, it's really freaking the people out getting the call and the media is not helping matters either.

[LillFilly]

My Dad was lucky; he started getting sick after one of his shots, but that was a complete coincidence because he checked with his dr. and they use shots supplied by a different company; said they stopped using the one in the news a long time ago. Lucky for him!

[Sapphire Silk]

Ok, apparently I've been completely ignorant of the scale of compounding pharmacies - I had thought they were only local operations. That outfit is way bigger than I thought!

Those guys should surely be held to GMP just like any manufacturer is - if 130,000 people are potentially affected, you can't be doing half measures on your handling!

Yeah, that's a problem with these pharmacies; the FDA can only get involved after something happens, which makes no sense. But that's a discussion for Fratching.

I use a compounded cream for joint pain: it is a mixture of Valtoren jel (an NSAID cream), another pain cream, neurontin, and a couple of other things. It's expensive, but cheaper than buying the Valtoren cream on its own, and my insurance actually covers the cost more than Valtoren by itself. The stuff has been a godsend for me.

The pharmacy is located in Alabama. I live in North Carolina.

[telecom_goddess]

fungal meningitis? I have not heard of this. But then I don't take steroids for anything except an inhalor.

Wow.

[Sapphire Silk]

fungal meningitis? I have not heard of this. But then I don't take steroids for anything except an inhalor.

Wow.

It's not contagious, and the cause is contamination in the manufacturing process. I've been following the case with interest.

[Andara Bledin]

The Christian Science Monitor has an article with more information about the contaminated drugs from the New England Compounding Center.

The lack of sterility in the facility is deplorable, as were their practices.

It's pretty much a given at this point that the top pharmacists at the facility are going to be permanently stripped of their licenses.

The state governor is also going to ensure that there are regulations in place to prevent this particular situation from existing in the future.

^-.-^

[mhkohne]

The Christian Science Monitor has an article with more information about the contaminated drugs from the New England Compounding Center.

The lack of sterility in the facility is deplorable, as were their practices.

It's pretty much a given at this point that the top pharmacists at the facility are going to be permanently stripped of their licenses.

The state governor is also going to ensure that there are regulations in place to prevent this particular situation from existing in the future.

^-.-^

I generally hate to inflict to inflict more work on the FDA, or more regs on folks doing buisiness, but perhaps we need to put these kind of operations (at least when they do injectables) under full GMP compliance.

[Sapphire Silk]

I generally hate to inflict to inflict more work on the FDA, or more regs on folks doing buisiness, but perhaps we need to put these kind of operations (at least when they do injectables) under full GMP compliance.

We do. We really do. A lot of compounding pharmacies are in the mass manufacturing business. They fulfill a crucial need for certain drugs. The drug used in this case, methylprednisolone, or Solu Medrol, is a cheap, generic steriod that is in a shortage because big Pharma makes more money on "blockbuster" drugs like Lipitor.

We've had to scramble to figure out what drugs to use to replace the ones that are in short supply. We run into issues with allergies with the drugs that are available. It's really, really scary for me when we can't give the drug the doctor says is the best choice because it is in short supply.

We need to majorly reform our pharmaceutical industry.

We had a death from this last week, though, at the hospital where I do clinic. One of my students was involved in her very early care, before she went to ICU. I never expected a national situation to end up in my hospital like this. It's always somebody else. Not today

[Andara Bledin]

We need to majorly reform our pharmaceutical industry.

We need to majorly reform pretty much every one of those various systems that hinder creation and manufacturing.

But that's a discussion for Fratching.

^-.-^

[wolfie]

I read a news item about this, and before the contaminated steroid outbreak (24 dead, 300 sick), this fungus had caused (worldwide, cumulative) around 30 cases, virtually all in people with compromised immune systems.

[Andara Bledin]

And, in further news, Ameridose, the sister company to NECC, has voluntarily recalled all medications.

Brief at Reuters
More details at WSJ

The FDA had called for improvements to their manufacturing process, but they have chosen to recall all product produced since April that has not yet expired. They state they have chosen to be over-cautious in light of the issues faced by NECC.

In related news, a separate compounding pharmacy, Infusion Resource, has also surrendered its license and is recalling all products.

^-.-^