Steroid Recall -- Meningitis

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At least the NYTimes article stated the location of the epidurals....kind of frightening that they were lumbars and not cervicals.
 
Looks like these cases were from compounding pharmacies. Link there?
Were these pharmacies accredited. I have reps flooding me lately with compounding topical creams. House wives , MDs etc all asking me to use their specific cream. Enough already..
Regards,
 
CDC Update:
http://www.usatoday.com/story/news/nation/2012/10/03/cdc-rare-meningitis/1611095/

26 cases in 5 states so far, 4 deaths.

"Eighteen of the cases are in Tennessee where a Nashville clinic received the largest shipment of the steroid suspected in the outbreak. The drug was made by a specialty pharmacy in Massachusetts that has since issued a recall.

Three cases have been reported in Virginia, two in Maryland, two in Florida and one in North Carolina. Two of the deaths were in Tennessee; Virginia and Maryland had one each, the Centers for Disease Control and Prevention said."

"The Food and Drug Administration identified the maker of the steroid as the New England Compounding Center, a specialty pharmacy in Framingham, Mass."
 
I've had multiple patients call and cancel their procedures this morning. Sounds like local morning talk shows are picking this story up.
 
i had one patient ask me about this. But she is smart and realized that it has to do with one speciality compounding pharmacy that was supplying these surgery centers. the news was not an indictment on all spine procedures
 
I have just issued a press release to my hospital and staff so we are all on the same page

So glad I followed logic and science and decided against compounded meds long ago
 
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30 phone calls from patients, one cancelled procedure due to fear.
I blame the CDC/FDA for forcing doctors to move to compounding centers.
 
i have gotten at least 10 calls. The surgery center has gotten at least 10-15 calls.
 
Hospital in Evansville, IN (St Mary's) is reporting 560 exposed.
 
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nd92 said:
Hospital in Evansville, IN (St Mary's) is reporting 560 exposed.
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wow that's horrible.

I always use hte brand name DepoMedrol. I think the push for PF methylpred was d/t PEG and subsequently embolization.....

You cant win in this!!! urgghhhhh. I feel bad for the patients. The MDs were just trying to help people, cant fault them
 
That is amazing about Evansville. I thought hospitals were extremely risk adverse and would never use compounding pharmacies. The hospitals I deal with use name brand only or the generic but never a compounded product.
 
This surgery center in Evansville is actually physically connected to an orthopedic practice building.
While it is technically still part of the hospitals surgery department, there are physician share holders in that facility.
It is run just like a free standing surgery center. (Very limited first hand information on my part).
 
hopefully this (bad) news sheds a little light on the potential dangers of injecting near the spine. Specifically with respect to CRNAs doing these type of procedures.

I am not advocating that CRNAs do not wash their hands as well as doctors. I am advocating that they do not have the training of a doctor, do not have the subspecialized expertise of a pain specialist to identify when bad things happen post procedure. They have zero training in post procedure management.
we are not technicians and these are not just flu shots. Hopefully the public, lawmakers, CMS paper pushers all realize this.

Who knows though,
Big Nursing will probably put out a statement saying that it was all evil profit driven doctors that caused these cases and the (rural area) patient caring CRNAs would never use contaminated roids.
 
myrandom2003 said:
This surgery center in Evansville is actually physically connected to an orthopedic practice building.
While it is technically still part of the hospitals surgery department, there are physician share holders in that facility.
It is run just like a free standing surgery center. (Very limited first hand information on my part).
Click to expand...

You are correct. I have been in the Evansville area for about a decade, and I didn't realize it was part of St Marys until very recently. I always assumed it was part of the orthopedic practice.
 
geauxg8rs said:
hopefully this (bad) news sheds a little light on the potential dangers of injecting near the spine. Specifically with respect to CRNAs doing these type of procedures.

I am not advocating that CRNAs do not wash their hands as well as doctors. I am advocating that they do not have the training of a doctor, do not have the subspecialized expertise of a pain specialist to identify when bad things happen post procedure. They have zero training in post procedure management.
we are not technicians and these are not just flu shots. Hopefully the public, lawmakers, CMS paper pushers all realize this.

Who knows though,
Big Nursing will probably put out a statement saying that it was all evil profit driven doctors that caused these cases and the (rural area) patient caring CRNAs would never use contaminated roids.
Click to expand...

I agree. This should be a lesson to patients and the public that Spine Procedures are serious business. Nurses doing interventional Pain Management is not appropriate. I hope our societies use this opportunity to educate the public and the regulators.
 
Oh, I don't think the CRNAs will be able to entirely weasel out of responsibility for their actions if they are shown to have created aspergillus meningitis. PainCare in NH employs CRNAs to do interventional pain procedures and was one of the clinics obtaining PF methylprednisolone from NECC. Interestingly the owner of PainCare that encouraged and permitted the non-sensical practice of having non-physicians doing surgical procedures and spinal pain injections, lost his license to practice medicine permanently in January.

Michael J. O’Connell, M.D. - License # 7690
1/5/12 - The New Hampshire Board of Medicine approved a Settlement Agreement for Michael J. O'Connell, M.D. Dr. O'Connell has agreed to a permanent voluntary surrender of his license to practice to avoid further delay and expense of proceedings arising out of the certain allegations regarding improper relationships with former patients.
 
geauxg8rs said:
hopefully this (bad) news sheds a little light on the potential dangers of injecting near the spine. Specifically with respect to CRNAs doing these type of procedures.

I am not advocating that CRNAs do not wash their hands as well as doctors. I am advocating that they do not have the training of a doctor, do not have the subspecialized expertise of a pain specialist to identify when bad things happen post procedure. They have zero training in post procedure management.
we are not technicians and these are not just flu shots. Hopefully the public, lawmakers, CMS paper pushers all realize this.

Who knows though,
Big Nursing will probably put out a statement saying that it was all evil profit driven doctors that caused these cases and the (rural area) patient caring CRNAs would never use contaminated roids.
Click to expand...

PinchandBurn said:
I agree. This should be a lesson to patients and the public that Spine Procedures are serious business. Nurses doing interventional Pain Management is not appropriate. I hope our societies use this opportunity to educate the public and the regulators.
Click to expand...

algosdoc said:
Oh, I don't think the CRNAs will be able to entirely weasel out of responsibility for their actions if they are shown to have created aspergillus meningitis. PainCare in NH employs CRNAs to do interventional pain procedures and was one of the clinics obtaining PF methylprednisolone from NECC. Interestingly the owner of PainCare that encouraged and permitted the non-sensical practice of having non-physicians doing surgical procedures and spinal pain injections, lost his license to practice medicine permanently in January.

Michael J. O’Connell, M.D. - License # 7690
1/5/12 - The New Hampshire Board of Medicine approved a Settlement Agreement for Michael J. O'Connell, M.D. Dr. O'Connell has agreed to a permanent voluntary surrender of his license to practice to avoid further delay and expense of proceedings arising out of the certain allegations regarding improper relationships with former patients.
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I understand the issue of whether CRNAs should be allowed to do interventional procedures. But how is that relevant to a tainted and recalled batch of steroids? In this case, it doesn't matter who did the injection.
 
algosdoc said:
shown to have created aspergillus meningitis.
Click to expand...

If those RN's are able to create an entire class of disease, they must be pretty talented. No wonder they are making so many inroads into medicine...
 
facetguy said:
I understand the issue of whether CRNAs should be allowed to do interventional procedures. But how is that relevant to a tainted and recalled batch of steroids? In this case, it doesn't matter who did the injection.
Click to expand...

The issue is that CRNAs aren't trained to recognized and treat potential complications from interventional pain procedures.

The recent cases are a reminder that interventional spine procedures carry real risks that nurses aren't trained to evaluate after the fact, and in particular they're not trained how to prevent them,....after a weekend course or two.

That's a major issue if CRNAs are allowed to perform pain procedures.

The other obvious issue is that you can't properly learn how to perform procedures after a weekend course on a cadaver. That just doesn't compared to the 1000-2000 proctored cases on live patients that physicians undergo over 12-18 months of fellowship/residency.
 
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bedrock said:
The issue is that CRNAs aren't trained to recognized and treat potential complications from interventional pain procedures.

The recent cases are a reminder that interventional spine procedures carry real risks that nurses aren't trained to evaluate after the fact, and in particular they're not trained how to prevent them,....after a weekend course or two.

That's a major issue if CRNAs are allowed to perform pain procedures.

The other obvious issue is that you can't properly learn how to perform procedures after a weekend course on a cadaver. That just doesn't compared to the 1000-2000 proctored cases on live patients that physicians undergo over 12-18 months of fellowship/residency.
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All true, but I'm still not seeing the relevancy vis a vis the recall. Someone who has performed a million of these procedures would still be injecting the tainted steroid.
 
facetguy said:
All true, but I'm still not seeing the relevancy vis a vis the recall. Someone who has performed a million of these procedures would still be injecting the tainted steroid.
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A nurse will not pick up the diagnosis of meningitis as quickly as a physician or will miss it completely.

Treatment of meningitis is time sensitive, more so with bacterial meningitis. If you properly diagnosis it quickly, the patient lives, if you don't diagnosis promptly, the patient dies. So if a nurse does an interventional procedure, but doesn't have a clue how to diagnose or treat a complication, the patient dies.

That is the relevance.
 
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bedrock said:
A nurse will not pick up the diagnosis of meningitis as quickly as a physician or will miss it completely.

Treatment of meningitis is time sensitive, more so with bacterial meningitis. If you properly diagnosis it quickly, the patient lives, if you don't diagnosis promptly, the patient dies. So if a nurse does an interventional procedure, but doesn't have a clue how to diagnose or treat a complication, the patient dies.

That is the relevance.
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I see what you're saying. But that also assumes, and it may well be true, that all of these patients returned to the doc who performed the procedure and were at that point diagnosed. It's conceivable, though, that the pain doc wasn't the one to eventually diagnose the patient (and by extension neither would the CRNA have been).

But I understand your position. I guess I was picturing these patients showing up at an ER somewhere, or perhaps their PCP's office, in which case it wouldn't matter who had performed the epidural.
 
bedrock said:
A nurse will not pick up the diagnosis of meningitis as quickly as a physician or will miss it completely.

Treatment of meningitis is time sensitive, more so with bacterial meningitis. If you properly diagnosis it quickly, the patient lives, if you don't diagnosis promptly, the patient dies. So if a nurse does an interventional procedure, but doesn't have a clue how to diagnose or treat a complication, the patient dies.

That is the relevance.
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Well played. Pain Management is a medical specialty and is not a job for technicians.
 
who still uses depo for spine procedures?
 
Apparently people across 20+ states still use depo according to the articles.
Is there any other steroid? I stopped changing my practice patterns when I stopped changing my hair patterns, 1992.
I always use the milky one for my needle pokes.
 
The affected lot numbers are:
Medication Lot Number Beyond-Use-Date
Methylprednisolone Acetate (PF) 80 mg/mL Injection 05212012@68
06292012@26
08102012@51 11/17/2012
12/26/2012
2/6/2013
 
Have any of you in practice or fellowship had a lot of patients cancel because of this? Worried if there will be any long term consequences to practices/businesses.
 
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bedrock said:
Tons of people. Over half of the anesthesia pain guys I know use depo for epidurals. I used kenalog until the damn FDA black box warning came out, but now I use depo for most ILESI.
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hey bedrock-

as you know my primary training was anesthesia. As you mentioned in most of my training, albeit one MD, everyone was using depomedrol for ILESI.

Is kenalog more pervasive in PMR circles?
 
PinchandBurn said:
hey bedrock-

as you know my primary training was anesthesia. As you mentioned in most of my training, albeit one MD, everyone was using depomedrol for ILESI.

Is kenalog more pervasive in PMR circles?
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Saw a definite trend that way.

Also Kenalog is much more common with ISIS council and ISIS presidents.

I think that kenalog is the best particulate steroid out there for duration and efficacy, with less side effects than depo.

Unfortunately, the FDA didn't listen to ISIS which argued against the FDA black box for kenalog and I'm not using kenalog for epidurals until we get real tort reform in this country.

I've seen website just full of ignorant patients who can't wait to sue their doctor because he used kenalog for their epidural, and they think kenalog is the sole reason their back hurts, not the 20 years they spent doing manual labor.
 
bedrock said:
Saw a definite trend that way.

Also Kenalog is much more common with ISIS council and ISIS presidents.

I think that kenalog is the best particulate steroid out there for duration and efficacy, with less side effects than depo.

Unfortunately, the FDA didn't listen to ISIS which argued against the FDA black box for kenalog and I'm not using kenalog for epidurals until we get real tort reform in this country.

I've seen website just full of ignorant patients who can't wait to sue their doctor because he used kenalog for their epidural, and they think kenalog is the sole reason their back hurts, not the 20 years they spent doing manual labor.
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wow...that's ridiculous!

I wonder how these docs can prove their innocence? Now that it's 'off label'. Totally ridiculous! perhaps I hsould write that in all my consents, all steroids are ''of label'.
 
Basic question (remember, I'm a chiropractor here): The recall is all about lumbar epidurals and not any other steroid-related injections.

So how does the steroid used for lumbar epidurals differ from that used for cervical epidurals (or peripheral joint injections, for that matter)?
 
facetguy said:
Basic question (remember, I'm a chiropractor here): The recall is all about lumbar epidurals and not any other steroid-related injections.

So how does the steroid used for lumbar epidurals differ from that used for cervical epidurals (or peripheral joint injections, for that matter)?
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It doesn't..... NYT article today states they are looking for everyone that had any injections with this batch of steroids
 
facetguy said:
Basic question (remember, I'm a chiropractor here): The recall is all about lumbar epidurals and not any other steroid-related injections.

So how does the steroid used for lumbar epidurals differ from that used for cervical epidurals (or peripheral joint injections, for that matter)?
Click to expand...

It has nothing to do with the procedure and everything to do with a particular batch from a certain pharmacy. The reason this is such a big story is that these procedures are SO safe to begin with when performed by properly trained physicians.
 
specepic said:
It has nothing to do with the procedure and everything to do with a particular batch from a certain pharmacy. The reason this is such a big story is that these procedures are SO safe to begin with when performed by properly trained physicians.
Click to expand...

The early reports mentioned lumbar epidurals, but apparently it's not just lumbars, which makes more sense. Thanks.
 
Where did that culpability thread go? :ninja: 😏
 
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the only way to prevent overuse of ESI for everyone is to allow CRNAs to do them.

But seriously, a month ago a patient was practically getting into my face wanting me to give him an ESI for 100% axial back pain. I told him I wanted to try something else first and that ESI, although given in the back, is not a good treatment for axial back pain. He was not happy with me and probably went to someone else who routinely gives ESI for any type of pain (DM neuropathy, knee OA, etc). 😱
 
fyi, some insurances only allow for facet/RFA for axial LBP only after an epidural has failed for 'treatable sources'. just got a letter today from a blue cross reviewer stating as such.
 
saw one of the patients in the hospital of an infected batch from another pain doc in Miami.....luckily his CSF was clear. But boy was he stressed out.
 
I had a patient yesterday refuse shoulder injection for severe OA, fearful of meningitis. Even my assurances our supply was safe did not sway him. The discussion on where the meninges are were lost on him.
 
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