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-   -   13,000 Got Suspect Steroid Shots; Risk Uncertain (https://www.neurotalk.org/spinal-disorders-and-back-pain/177674-13-000-suspect-steroid-shots-risk-uncertain.html)

Dr. Smith 10-08-2012 06:41 PM

13,000 Got Suspect Steroid Shots; Risk Uncertain
 
NEW YORK (AP) — As many as 13,000 people received steroid shots suspected in a national meningitis outbreak, health officials said Monday. But it's not clear how many are in danger.

Officials don't how many of the shots may have been contaminated with meningitis-causing fungus. And the figure includes not only those who got them in the back for pain — who are most at risk — but also those who got the shots in other places, like knees and shoulders.

Read rest of story...

Also, Google: Pharmacy linked to outbreak issues wide recall

I hope no-one here has been affected.

Doc

Gracemary 10-08-2012 10:29 PM

So..why are the clinics
 
still wanting to give injections? If u refuse.....they look at u...like you are a weirdo. I read so much on line. No needles in my neck. They will not help me. Any suggestions what I can tell these Pm Doctors that I do nt want them.

Dubious 10-08-2012 10:57 PM

Quote:

Originally Posted by Dr. Smith (Post 920946)
NEW YORK (AP) — As many as 13,000 people received steroid shots suspected in a national meningitis outbreak, health officials said Monday. But it's not clear how many are in danger.

Officials don't how many of the shots may have been contaminated with meningitis-causing fungus. And the figure includes not only those who got them in the back for pain — who are most at risk — but also those who got the shots in other places, like knees and shoulders.

Read rest of story...

Also, Google: Pharmacy linked to outbreak issues wide recall

I hope no-one here has been affected.

Doc


Truly a sad story. I've followed it as well and while I have no first hand knowlege that any doses were or were not used for multiple regions of the body, I've not seen anywhere in the press that any of those doses were used for anything but "low back" patients.

It is quite conceivable that this product could have been used across the board for neck, knees, shoulders, etc., but such has not been the stated case in the (objective?) press! Perhaps it is a different dose/product for those regions? It is not surprising unfortunately, with all of the recent attacks on health care and pressure on manufactures/providers to curtail costs. Right or wrong, it would not surprise me if money is also cut from QC as well!

I wish the best for all of the unfortunate victims!

Leesa 10-09-2012 07:11 AM

I'm really surprised that more of us haven't had trouble with steroid injections, as anything that is iinjected into the spinal canal can cause infections and big problems. That's one reason that I refused to have any more, besides the fact that they weren't workiing. The doc wanted to try more of them, but I said NO> He didn't particularly like that, but i didn't particularly care. :rolleyes:

From what I read, it could also cause arachnoiditis too, which is an incurable condition!!

I just hope everyone is ok. God bless & take care. Hugs, Lee

Dr. Smith 10-09-2012 11:21 AM

Quote:

Originally Posted by Dubious (Post 921002)
It is quite conceivable that this product could have been used across the board for neck, knees, shoulders, etc., but such has not been the stated case in the (objective?) press! Perhaps it is a different dose/product for those regions?

Well... it was just stated so in the NY Times, by AP, and many other credible outlets, as can be seen by googling the headline. All articles I've seen have said that all the contaminated injections came from the same compounding pharmacy in MA, and were distributed throughout the other states mentioned.

I didn't know that compounding pharmacies were in that kind of mass-production/distribution business.

Doc

mrsD 10-09-2012 11:29 AM

This is a generic product. The brand name is by Pfizer and called SoluMedrol. SoluMedrol comes in dry form, with a diluent to add on the spot...I would think this minimizes contamination. Their system is very complex, to reconstitute as well. This generic product is premixed...and that may be a problem.

Sometimes injectables are in short supply, and compounding pharmacies can take up that slack.
If you knew how fastidious it has to be to make infusions, and injectables, you'd understand the problem. The FDA has been after compounding pharmacies for a long time, and this time it looks like something will be done. There are many home infusion places that make chemo injectables, and other things as well.
With a product like this, it could be
1) contaminated raw product (the steroid powder).
2) contaminated ampoules used to put the drug into
3) poor hood maintenance and/or air flow and filter problems
4) sloppy technique, or not following protocols.
You can be sure all will be looked at minutely now.

With epidurals there is another problem. Sometimes the doctor can nick or penetrate the dura by accident. If you search "epidurals" you find the rate of these errors. With this type of contamination, a dura puncture is very serious.

Steroids suppress the immune system giving the fungus more opportunity to become more virulent.

It is a very terrible situation, with several levels of potential
error, and blame.

mrsD 10-09-2012 11:57 AM

This is a list of all the recalled products:

http://www.neccrx.com/List_of_all_pr...nuary_2012.pdf

Dubious 10-09-2012 04:31 PM

Quote:

Originally Posted by Dr. Smith (Post 921114)
Well... it was just stated so in the NY Times, by AP, and many other credible outlets, as can be seen by googling the headline. All articles I've seen have said that all the contaminated injections came from the same compounding pharmacy in MA, and were distributed throughout the other states mentioned.

I didn't know that compounding pharmacies were in that kind of mass-production/distribution business.

Doc

True doc, it would be interesting to know if the product was used for other regions of the body too! The whole thing is so sad.

mrsD 10-09-2012 04:49 PM

We'll find out eventually.... it will take some time.

Injecting into a joint space is also dangerous with less virulent
organisms like this fungus because there is little immune protection in the joint capsule interior, there too.

I hate to be a doomsday person, but I worked a short contract in home infusion, and I would never work full time in that capacity. I was very relieved to leave. :rolleyes:
All one needs is a couple of disgruntled employees and you would faint if you saw what I saw where I worked --and that was almost a decade ago!

NECC is listed on the net as having 60 employees! Very difficult to supervise that many IMO. Typically only a very small number are licensed pharmacists at home infusion or compounding pharmacies.
There are licensed infusion technicians.

It could very well be that things like this were going on for a while and just never caught. With all the many shortages going on now in the past 2-3 yrs on so many drugs, including injectables, compounding pharmacies are filling that niche more and more.

There are frequent procedures done to test the air quality and cleanliness. They even run cultures periodically. All one needs is some mess-up at this task, and mayhem can result.

I agree it is very sad and very scary too.

mrsD 10-11-2012 08:13 AM

More disturbing news of another incident:

http://news.yahoo.com/suit-firm-prov...225304842.html

Gracemary 10-11-2012 07:53 PM

So are they still giving the shots ?
 
Or are the Doctors still doing the same injections? I am so glad that I did not get the injections in my neck. Two Doctors wanted to give them to me. I refused. It was in July & August. I am thankful that I listen to that little voice in my head. :rolleyes:

mrsD 10-12-2012 05:53 AM

This article answers Dubious' question about other injection sites and risk:

http://news.yahoo.com/cdc-meningitis...201601881.html

Mentioned in this article is an ankle injection.

mrsalkire 10-12-2012 02:46 PM

So grateful it wasnt mine! Or in my state for that matter. Praying for those whose lives have been effected

ginnie 10-12-2012 06:27 PM

Hi Mrs.D
 
Thank you for the information about the injections. I have a friend in Chicago area, who had this shot in the time frame mentioned. Her family, and me,( a friend )are worried. she has no symptoms yet, or anything negative happening but she is also 83 years old and scared. The psychological worry this has caused is severe to many. Plenty of blame to go around, and I do hope this never happens again. ginnie

eva5667faliure 10-15-2012 03:56 PM

to all thank you for all the information
you all post so we can educate ourselves

i myself have had
2 steroid shots about 2 years
a disco gram
8 shots in total for that
then the myelogram 9-11-12
this is when 8cc of spinal fluid
was taken


someone who cares

mrsD 10-15-2012 07:25 PM

More bad news :

http://news.yahoo.com/fda-pharmacys-...190649992.html

As I feared, the facility had poor protocols, poor equipment, and
sloppy technique. With two more drugs now being considered tainted, it looks like a global problem there. Much of the time consumed in compounding injections is maintaining sterile technique. It is a huge job and full of responsibility, and cutting corners, or improperly trained employees just cannot be allowed!

mrsD 10-19-2012 01:34 AM

As I feared.... I am afraid this is only the tip of the iceberg and
previously those damaged were not caught or revealed soon enough:

http://news.yahoo.com/fungal-meningi...--finance.html
Quote:

There were hints of looming trouble before the meningitis outbreak. The Boston Globe cited several employees who expressed concern about pressure to work fast and disregard of safety in the push to profit. At least one of the Ameridose employees, Ronnie Leger, made official complaints last year with the FDA and Occupational Safety and Health Administration and says he got fired for doing so, according to the Globe.

An FDA inspection in 2008 detected deficiencies at Ameridose, including shipping drugs prior to ensuring their sterility.
When elderly patients have strokes, die unexpectedly, etc they usually are not researched. I have to wonder how long this was actually going on at this compounding center. Most of the deaths so far involve elderly patients who developed strokes as a result of this infection.

Gracemary 10-22-2012 01:54 AM

No injections
 
The Doctors are still giving injections. Why? People are scared to death. With worry that they are going to get sick. Since they had the injections. Do the Doctors really care or is it just the cash their getting. I just don't get it. I hope everyone that had a injection are okay. God bless

mrsD 10-22-2012 02:47 AM

This article explains the "safety issues" involved with epidurals.

There has always been a risk with this route of treatment near the spine (CNS). Should the needle be placed imperfectly by just a tiny amount...the drug would pierce the dura and enter the CNS. The preservatives in the brand name are not FDA approved for use inside the spinal cord because animal experiments have shown damage.

So the doctors order the preservative free compounded product instead.

http://www.usatoday.com/story/news/n...eroid/1616653/

The brand name product comes with a dry powder that is mixed with a sterile diluent liquid before use. This takes time and care and I can see the premixed type from a compounding pharmacy would be easier, and the dosage would be already figured out and less errors would be likely. But preservative free means that extreme care must be taken. Most sterile products have preservatives in them to keep down the growth of any accidental organisms present.

SoluMedrol, comes in a preservative free version and is a brand name, and as such is much more expensive than the compounded types.
At the bottom of this link is a diagram of how to reconstitute the product with the diluent:
http://dailymed.nlm.nih.gov/dailymed...o.cfm?id=58932
When looking at this link, it is very apparent how complex this treatment really is.

This article explains the complications possible with epidural steroids:
http://www.apsf.org/newsletters/html...8_epidural.htm

mrsD 10-23-2012 12:21 AM

a decade of problems!
 
http://www.detroitnews.com/article/2...436/1409/rss36

more and more disturbing facts coming to light. :(

Horrifying!

http://news.yahoo.com/u-meningitis-o...062256456.html

gatorhead 10-24-2012 03:32 PM

I shed some light on this in one of my other posts and I believe it to be true. I have no data to back it up but I can add 2+2 and as my son says it equals 5! The recent pill mill laws were a growing trend, hyped by an "epidemic". Treating physicians can no longer prescribe their known patients with narcotic pain medicines. Instead they have to seek out "PAIN Clinic's" some of which are pill mills, pay the cash get what you want, go to the next one. The one's that nee it cannot get it. The ones who want it get more than they need.

It never was about patient safety. In Florida at least our Governor opposed the pill mill law and was lobbied by those who operate them. Its big bucks. The DEA stepped in and questioned every single doctor about their prescriptions and why they prescribe this to said patient and then ask why that is a better alternative than say, yoga. Finally as of July 1 , 2012 you have to have a certification as a pain doctor to prescribe. You can see where this is a pain in the royal butt for doctors.

The answer to the problem started becoming popular about 8 years ago. Sure they gave them long before that but the epidural/nerve root blocks started becoming the norm and is the ONLY solution at many of the "legit" Pain clinics left here in Florida. Problem is they are cutting corners buying the cheapest drug from where ever they can. There are many cases where a dirty needle was stuck back into the vial to obtain more medicine!Just as there were always injections, there were always complications.

The injection trend is here to stay! There is far more money to be made with it than there ever was writing a script. Most places charge on average between $1500-$1800 per injection and do it up to 3 times in 6 months. They charge for office visits on top of that and have you come in for follow ups inbetween. They could only charge for the office visit prior to these and the whatever kickback they received from the pharmaceutical companies. In addition to this they are not bothered at all by the DEA! So for them it is a free for all, win situation no matter how you look at it.

Injections anyone?

ginnie 10-24-2012 03:38 PM

Hi Gator head
 
You are correct in everything you said. My doctor admitted to being harassed by the DEA on all scripts. Still she did prescribe for me. If you are in my area, she is a physiatrist/pain specialist, Name Dr. Emese Simon on Robinhood lane in Sarasota. Very compassionate doctor! No I don't want the shots, and she won't force them. Take care Gator head. You put the problem in plain english. I think there is going to be trouble over this whole issue. ginnie:hug:

Dubious 10-25-2012 09:20 PM

Quote:

Originally Posted by gatorhead (Post 925483)
I shed some light on this in one of my other posts and I believe it to be true. I have no data to back it up but I can add 2+2 and as my son says it equals 5! The recent pill mill laws were a growing trend, hyped by an "epidemic". Treating physicians can no longer prescribe their known patients with narcotic pain medicines. Instead they have to seek out "PAIN Clinic's" some of which are pill mills, pay the cash get what you want, go to the next one. The one's that nee it cannot get it. The ones who want it get more than they need.

It never was about patient safety. In Florida at least our Governor opposed the pill mill law and was lobbied by those who operate them. Its big bucks. The DEA stepped in and questioned every single doctor about their prescriptions and why they prescribe this to said patient and then ask why that is a better alternative than say, yoga. Finally as of July 1 , 2012 you have to have a certification as a pain doctor to prescribe. You can see where this is a pain in the royal butt for doctors.

The answer to the problem started becoming popular about 8 years ago. Sure they gave them long before that but the epidural/nerve root blocks started becoming the norm and is the ONLY solution at many of the "legit" Pain clinics left here in Florida. Problem is they are cutting corners buying the cheapest drug from where ever they can. There are many cases where a dirty needle was stuck back into the vial to obtain more medicine!Just as there were always injections, there were always complications.

The injection trend is here to stay! There is far more money to be made with it than there ever was writing a script. Most places charge on average between $1500-$1800 per injection and do it up to 3 times in 6 months. They charge for office visits on top of that and have you come in for follow ups inbetween. They could only charge for the office visit prior to these and the whatever kickback they received from the pharmaceutical companies. In addition to this they are not bothered at all by the DEA! So for them it is a free for all, win situation no matter how you look at it.

Injections anyone?

While I feel sad that all of this has led to such an awful outcome, one should not throw the baby out with the bath water!

In over 20 years of clinical practice, I oversaw and sent out numerous patients when indicated for various types of spinal ESI's. They were always done by very reputable PM docs in the area. There were and are a few unscrupulous ones who most referers were aware of, so we just stayed away from them.

In my experience, those whom I sent to one of the "good guys," at best were helped tremendously and at at worst, had no relief. A couple here and there (rare) had temporary complications of an "epidural headache" but they were carefully followed up and resolved within a week or two. On the other hand, the "bad boys" were known for various serious failures and complications. One of the worst ones was a patient who had too many discograms, one of which was septic and because it was work comp, went undiagnosed for 6 months. Not pretty.

So I guess my thought is that one should exhaust all conservative efforts to address their spinal pain issues before progressing to ESI or surgery with the understanding that if you go the latter two routes, you have made a thoughtful and educated decision so that if something goes wrong, while that would not be okay, at least you weighed the risks! ESI's DO help an awful lot of people....unfortunately some will get hurt in the process!

gatorhead 10-25-2012 11:15 PM

Quote:

Originally Posted by Dubious (Post 925974)
While I feel sad that all of this has led to such an awful outcome, one should not throw the baby out with the bath water!

In over 20 years of clinical practice, I oversaw and sent out numerous patients when indicated for various types of spinal ESI's. They were always done by very reputable PM docs in the area. There were and are a few unscrupulous ones who most referers were aware of, so we just stayed away from them.

In my experience, those whom I sent to one of the "good guys," at best were helped tremendously and at at worst, had no relief. A couple here and there (rare) had temporary complications of an "epidural headache" but they were carefully followed up and resolved within a week or two. On the other hand, the "bad boys" were known for various serious failures and complications. One of the worst ones was a patient who had too many discograms, one of which was septic and because it was work comp, went undiagnosed for 6 months. Not pretty.

So I guess my thought is that one should exhaust all conservative efforts to address their spinal pain issues before progressing to ESI or surgery with the understanding that if you go the latter two routes, you have made a thoughtful and educated decision so that if something goes wrong, while that would not be okay, at least you weighed the risks! ESI's DO help an awful lot of people....unfortunately some will get hurt in the process!

I truly do understand they have their place in medical treatment. Where I am now it is all the rage, and all they are looking to do and acting like it is a cure all. Then when you do subside and have them done and they DON'T work for you all the sudden you're the bad guy! The last clinic I was "supposed" to get an injection from told me they didn't have an issue with the batch they were using. 3 people have died this week from that clinic that I decided against the shot(s)

ginnie 10-26-2012 10:13 AM

To dubious
 
What irritates me is when PM says they won't help you anymore unless you DO the shots, and or the surgery. I have had two spinal fusions. Not doing that great below the fusion site. I don't want more surgery, and I don't want more shots. I have had enough. ginnie

mrsD 10-27-2012 07:47 AM

far far worse
 
This is far far worse than I ever expected, or anyone else for that matter!

http://news.yahoo.com/fda-pharmacy-t...--finance.html

Quote:

Staffers at a pharmacy linked to the deadly meningitis outbreak documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile, according to federal health inspectors.

In a preliminary report on conditions at the pharmacy, the Food and Drug Administration said Friday that even when the contamination at New England Compounding Center exceeded the company's own safety levels, there is no evidence that staffers investigated or corrected the problem. The FDA uncovered some four dozen reports of potential contamination in company records, stretching back to January this year.

ginnie 10-27-2012 08:17 AM

Yes MrsD
 
Yes, this health scare is one of the worst. and doctors down here want to use the needle because they arn't prescribling pain medcations much...Leaves patients in a terrible position, not to mention physical pain. How will trust ever be re-established? ginnie:hug:

Dr. Smith 10-27-2012 04:43 PM

Quote:

Originally Posted by mrsD (Post 926367)
This is far far worse than I ever expected, or anyone else for that matter!

http://vitals.nbcnews.com/_news/2012...ew-deaths?lite

http://abcnews.go.com/Health/Wellnes...ry?id=17570870

http://www.washingtonpost.com/fdas-a...bc7_video.html

Doc

mrsD 11-01-2012 12:15 AM

More news...

http://news.yahoo.com/mass-firm-tied...173229843.html

It is horrific.
Quote:

In a related story, The Boston Globe reported Wednesday that NECC sent customers a report card touting the cleanliness of its labs, even though internal tests showed widespread contamination.

The Quality Assurance Report Card claimed that during the first half of 2012, there were no instances of contamination exceeding accepted standards on surfaces in "clean rooms," where the company produced sterile injectable medications.

But company records indicate that during that same period, the company's own internal testing showed that 33 surface samples from the clean rooms contained bacteria or mold at levels requiring corrective action. Those results were disclosed in a report released Friday by FDA investigators.


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