Pharmacy - Preservative Free Depomedrol or Celestone?

[CaliDr]

Hey all!

I'm sure all of you are getting tons of phone calls like we are at the office. Our office staff has had considerable difficulty in locating a pharmacy that has preservative free depomed and/or celestone....can anyone recommend a reliable source for these? I'm having to possibly cancel all my procedures next week until we find somewhere to source these. Any help would be greatly appreciated...and I'm others reading this as well would be interested.

Feel free to DM me if you'd prefer to keep a reco off the post. Thanks all!

calidr.

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[bedrock]

The answer and lesson here is----stop using compounded preservative-free steroids. The increased risk of meningitis isn't worth the decreased risk of arachnoiditis. Only one of those will kill you.....

 

[Aether2000]

I don't understand why you would want to intentionally disable the safeguards built into the FDA approved product. Doing so by making it preservative free could lead to a repeat of the meningitis fiasco occurring in 11 states today.

 

[CaliDr]

thanks for the responses...maybe i left some details put. Im trying to find an FDA approved noncompounded preservative free option. Does this even exist? From the responses it appears the only options are to risk arach with fda approved preservative option vs. risk worse problems with a non fda approved pres free option. Just a lesser of two evils...

Ive asked around with other colleauges and everyone is doing something different. I hope this helps generate some good discussion given the recent issues as noted by argos. Thanks again

 

[Aether2000]

I don't think such exists.

 

[Ducttape]

"preservative free" dexamethasone maybe... but the days of getting "mass produced" preservative free depomedrol are gone.

 

[Aether2000]

I have not found any commercially produced dexamethasone that is preservative free. All of it, including single dose vials, contains benzyl alcohol 10mg added as a preservative, to prevent fungal and bacterial growth. Certainly from a compounding pharmacy it is obtainable preservative free, but clearly compounding pharmacies are operating illegally mass producing the product, then waiting for the physicians orders rather than making the drug after the order is received. This manufacturing in advance can lead to a repeat of a steroid injection induced meningitis or joint infection in a large number of people.

 

[emd123]

Of all the guys using commercially available (non-compounded) DepoMedrol, celestone, dexamethasone, kenalog and other steroids with benzyl alcohol or other minimal preservatives, how many cases of arachnoiditis from ESIs are you seeing?

Recently I decided to stay with the good old-fashion commercially available stuff, albeit maybe with some minimal preservatives, and boy am I glad I did.

By the way, where is the quality evidence to show that using special order preservative-free steroids to avoid arachnoiditis risk, is worth risking fatal meningitis outbreaks like the one we're having, in the first place?


Personally, if the needle is going in my back, I'll take my chances on a remote risk of arachnoiditis over fungal meningitis which could maim or kill me.

 

[specepic]

Yea, is anyone here aware of a real journal article that documents arachnoiditis in the context of:

-properly placed injection (not intrathecal)
-with modern steroid forumlations (i.e. an artcile in the last 10 years or so)

Where did the arachnoiditis hysteria come from??

I use standard name brand Depo for ILESI, Dex for TFESI, and Kenalog for repeat customers that had it in the past and did well. I will also offer Kenalog to Depo fails. I have a special part of my consent template regarding off label, but accepted use.

This system has been working well

 

[101N]

Where did the arachnoiditis hysteria come from??

I read and attend the national meetings and I don't sense that there is an 'arachnoiditis hysteria' resurgence. I don't think that arachnoiditis fears alone are what drive compounding.
Price may be a factor as well.

 

[Aether2000]

Agree with 101

 

[NEPain]

I agree with all the above.

My question is about fda approval. Is it true that compounded preservative free steroids are not "fda approved"?

Does that mean that we can use non "fda approved" treatments on our patients at will?


Do you understand what the loophole is that allows compounding pharmacies to legally make drugs to be used on humans that are not fda approved (assuming that statement is true)?

Does anyone have any idea what the price difference is between a compounded 10cc vial containing 400 mg of triamcinolone and 10 single dose vials of 40 mg (or some comparable comparison)?

 

[emd123]

I agree with all the above.

My question is about fda approval. Is it true that compounded preservative free steroids are not "fda approved"?

Does that mean that we can use non "fda approved" treatments on our patients at will?


Do you understand what the loophole is that allows compounding pharmacies to legally make drugs to be used on humans that are not fda approved (assuming that statement is true)?

Does anyone have any idea what the price difference is between a compounded 10cc vial containing 400 mg of triamcinolone and 10 single dose vials of 40 mg (or some comparable comparison)?

There is no FDA approval required for any treatment a physician prescribes.

The FDA approval is required for a drug company to advertise a drug or treatment as for a specific indication, but it is not required for a physician to use a drug or perform a procedure.

There's a huge amount of non-FDA approved treatments that are commonly used and never have been FDA approved. The bar is set so high for FDA approval and the costs to the drug companies so significant, that for a huge number of drugs and treatments it is just not economically feasable for a company to spend the money so that they can the FDA stamp of approval.

 

[specepic]

I read and attend the national meetings and I don't sense that there is an 'arachnoiditis hysteria' resurgence. I don't think that arachnoiditis fears alone are what drive compounding.
Price may be a factor as well.

Hmm, not my take at all

Why O why in the heck would you use a PF product if you wern't worried about negative effects of the preservatives (I for one do not think preservatives pose danger at all)?

My take from my hosp pharm was that NECC was more expensive than Kenalog, Depo, etc.

Enlighten me please

 

[Ducttape]

I agree with all the above.

My question is about fda approval. Is it true that compounded preservative free steroids are not "fda approved"?

Does that mean that we can use non "fda approved" treatments on our patients at will?


Do you understand what the loophole is that allows compounding pharmacies to legally make drugs to be used on humans that are not fda approved (assuming that statement is true)?

Does anyone have any idea what the price difference is between a compounded 10cc vial containing 400 mg of triamcinolone and 10 single dose vials of 40 mg (or some comparable comparison)?

no steroids are "fda approved" for epidural injection.

the compounding pharmacy is legally allowed to mix drugs for specific patients, but they are not legally allowed to mass produce the medications for sale...

and btw, to one of the above posters - there is a preservative free manufactured version of dexamethasone, from APP Pharmaceuticals.

 

[bedrock]

and btw, to one of the above posters - there is a preservative free manufactured version of dexamethasone, from APP Pharmaceuticals.

I just looked that up today. I think it is hysteria on the part of some to be shouting around that PF medications are evil.

I do think its reasonable to want your medications produced in a sterile fashion by a major manufacturer, not a mom and pop pharmacy.

The PF dex is the same stuff I've seen used as an IV medication in multiple hospitals. If they're injected that stuff directly into the bloodstream, I think we're ok to use it for TF epidurals.

I still think PF steroids are advantageous if they are manufactured sterile by a major company, not compounded by local pharmacy.

PF dex is the only one that is made that way, so I'll use it for TFESI, etc.

Otherwise will stick with commercially made depo-medrol with preservative for the other injections.

 

[Aether2000]

There is no commercially available pf dex. The APP pf dex contains sodium citrate which is a preservative commonly used in foods and medicine.

 

[Ducttape]

There is no commercially available pf dex. The APP pf dex contains sodium citrate which is a preservative commonly used in foods and medicine.

im guessing that, since citric acid is "natural" and present normally in the human body, it is not considered a preservative per se by the FDA. maybe more an "additive"?

so APP can market one of their versions of dexamethasone as preservative free.

(the preservative form also contains citric acid, just a lower concentration, along with benyl alcohol.)

 

[Aether2000]

It contains both sodium citrate (a preservative) and citric acid (ph adjustment). I think you are correct...they are attempting to market this as preservative free when it really isn't. The semantics over what constitutes a preservative probably come into play.

 

[bedrock]

It contains both sodium citrate (a preservative) and citric acid (ph adjustment). I think you are correct...they are attempting to market this as preservative free when it really isn't. The semantics over what constitutes a preservative probably come into play.

With your background I appreciate the thoughts on what is and isn't a preservative. It does appear there is a little false labeling on the part of the company regarding the PF and "preservative-containing" versions of dexamethasone.

Anybody know of any studies, even in vitro studies comparing the relative neurotoxicity of benzyl alcohol and sodium citrate?

I would think that at high concentrations benzyl alcohol would clearly be more neurotoxic, at the small doses in epidurals or peripheral nerve blocks, who knows, or neither matters....?

I've heard of anesthesiologists specifically choosing the PF version of dexamethasone to prolong their surgical blocks. As a PMR doc, I don't know if using PF steroid is taught in anesthesia residencies.

 

[Ducttape]

citrate and citric acid are part of the (i know this is reaching really far back) citric acid cycle.

benzyl alcohol is not part of any natural body chemistry that i know of...


well, it may be in some of those chronic alcoholics that i used to see every friday, saturday and cold nights in the ED...

 

[Aether2000]

MGPC is highly neurotoxic even in small doses. Benzyl alcohol is less so, or at least this is implied by Nik in clinically relevant doses. Sodium citrate is ?? With regard to antimicrobial activity, there are several studies using the substance as an inhibitor of strep species and at high concentrations, the chemical inhibits the growth of most bacteria.

 

[bedrock]

MGPC is highly neurotoxic even in small doses. Benzyl alcohol is less so, or at least this is implied by Nik in clinically relevant doses. Sodium citrate is ?? With regard to antimicrobial activity, there are several studies using the substance as an inhibitor of strep species and at high concentrations, the chemical inhibits the growth of most bacteria.

What's MGPC?

 

[Aether2000]

The preservative in single dose Depomedrol

 

[loveoforganic2]

It contains both sodium citrate (a preservative) and citric acid (ph adjustment). I think you are correct...they are attempting to market this as preservative free when it really isn't. The semantics over what constitutes a preservative probably come into play.

If you're putting either sodium citrate or citric acid into a buffer (e.g. plasma), there should be essentially no difference in effect between the two - they're a conjugate weak acid/base pair

 

[bedrock]

MGPC is highly neurotoxic even in small doses. The preservative in single dose Depomedrol.

Ok, that description reminds me of why I wasn't excited about using regular depo for epidurals.
Highly neurotoxic in small doses doesn't sound like the best thing to be injected along nerves......

 

[emd123]

Well, then. According to more than one study as noted in ASIPP's recent guidelines you don't need any steroids in epidurals for them to work. They say local anesthetics alone are just as effective. If the efficacy is from simply washing away inflammatory mediators and/or "breaking the cycle of pain" with the nerve block, why are we using steroids at all?

Is anyone doing this and seeing decent results?

 

[Aether2000]

It is a conundrum. MGPC has been used at least as far back as 1945 an a germicide and does have in rat studies neurotoxicity. However it has not been shown to cause neurotoxicity in humans as long as it is injected in the epidural space where the nerves are protected by myelin and dura. On the other hand, it has been the clinical experience that removal of the preservatives from these medications causes meningitis in more than one outbreak, well documented in the literature, dating as far back as 2001.

Perhaps the reason only around 1.5% of those exposed to the fungus laced medication is that the tip of the needle was subdural or subarachnoid. This is statistically what is reported in the literature.

 

[mg1193]

Solu-Medrol is available in preservative free 40mg doses, made by Pfizer. Labeling is for IV or IM use. Can this be used for epidurals safely?

 

[Ducttape]

Well, then. According to more than one study as noted in ASIPP's recent guidelines you don't need any steroids in epidurals for them to work. They say local anesthetics alone are just as effective. If the efficacy is from simply washing away inflammatory mediators and/or "breaking the cycle of pain" with the nerve block, why are we using steroids at all?

Is anyone doing this and seeing decent results?

i would love to try, but it seems the "standard of care" is to use steroids. hence no response to your query.