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True or false? Compounding pharmacies can only use Prascend, not bulk pergolide

Barbara Rosensteel
 

The reason I'm posting is that a friend of mine has a gelding that she and her vet think, based on symptoms, has PPID.  The veterinarian has no experience with PPID.   The vet suggested a dexamethasone test, but they didn't do it.  They also did not pull blood for an eACTH test.  They are basing the diagnosis on visible symptoms (muscle wasting, weight loss, loss of topline, sheath swelling).   The owner started her horse on 1/mg prascend per day about 2-3 weeks ago. She is waiting for 8 weeks after starting Prascend (1 mg/day) to test ACTH to get an idea if the 1 mg Prascend is working (without a baseline I think it will be hard to know if it is or isn't, but I could not prevail on her with my recommendation to get an initial, pre-Prascend eACTH).  

I told her that many people get the pergolide in capsule form from compounding pharmacies, and if her horse has to go on a higher dose, it would be something to consider.  She then went on an internet search for information about compounded pergolide, and found this research paper, and two Horse.com articles.  This paper and articles are causing her to have strong doubts about the legality, efficacy, and quality of compounded pergolide. 


This 2012 Horse.com article presents the argument for not using compounded pergolide, under the headline "FDA No Longer Supports Compounded Pergolide Production".  http://www.thehorse.com/articles/28896/fda-no-longer-supports-compounded-pergolide-production

The next Horse.com article, written by a veterinarian in the May 2014 edition, talks about compounding pharmacies and compounded drugs, http://www.thehorse.com/articles/33541/careful-compounding  and includes the statement:

Compounded drugs may not be made in bulk, says Stanley, and if there is already an FDA-approved product on the market, pharmacies compounding any form of that drug must make it from the FDA-labeled product rather than from raw materials. For example, let’s say your horse with Cushing’s disease doesn’t care for his Prascend. Your veterinarian might write a prescription to a compounding pharmacy to have the medication made into a different flavor or form for your horse; however, the pharmacist must make the drug using Prascend rather than bulk pergolide.

According to this, the FDA prohibits compounding using the raw material of bulk pergolide, and that to compound using anything but Prascend is a violation of FDA rules. 

Related to this are the findings of a 2014 paper by Dr. Scott D. Stanley and H. D. Knych (UC Davis).  I only have this as a PDFThe purpose of the study was to assess the potency, and stability over time, of different formulations of pergolide mesylate obtained from various veterinary compounding pharmacies.

https://aaep.org/sites/default/files/issues/proceedings-10proceedings-z9100110000274.pdf

  One of their findings was that the initial concentrations of pergolide in all formulations (liquid, powder, capsules) were highly variable between products, with many having concentrations well below the label claim.  In addition, they found a high degree of variation in pergolide concentrations between two containers of the same product ordered from the same pharmacy on the same date.   Final assessment on product stability was difficult to determine, because 16 of 28 of tested products did not meet the FDA requirement for potency at the onset of the study.  (They did not name the compounding pharmacies in the paper.)

This is alarming if still true.   How can anyone know that the concentration of pergolide in the capsules they receive is the concentration they ordered?   The paper does close with the words:  "To ensure effective therapeutics, veterinarians should be vigilant and thorough when selecting a compounder.  Compounded medications should be prepared in a state-licensed facility, with strict quality control measures, byan experienced pharmacist who adheres to USP guidelines for good compounding practices." 

Unfortunately, they neglected to mention if the compounding pharmacies that produced the errant formulations met All, Some, of None of these criteria.  Or if the compounding pharmacies that did NOT have errant formulations DID meet all of these criteria.  That would have been a valuable piece of information.


I would very much like to get Dr. Kellon's, and others who are "in-the-know" on this subject, to comment on this. What do compounding pharmacies use to make the pergolide capsules and powder that so many on this list buy?  Can the compounding pharmacies so many on this list use be trusted to produce quality products that contain the concentration of pergolide that was ordered?  Under what circumstances can compounding pharmacies compound pergolide products that are essentially the same, except perhaps for dose, as Prascend (especially if they are made from Prascend)? 


Thanks,

Barbara Rosensteel

Baxter, Tennessee

September 2007 (?)


Eleanor Kellon, VMD
 

Barbara,

We are familiar with all of that information and if you search past messages you will find many discussions. Briefly though:

Prior to September 2011 there was no FDA approved pergolide for horses.  Between March 2007 and September 2011 there were no FDA approved pergolide drugs at all, for any species. Prior to 2007 there was a human version, Permax. Up until the approval of Prascend, the vast majority of horses were being treated with pergolide compounded from bulk drug. Liquid versions were most popular many years ago  but stability information now has most people using the capsules. I have no idea how many horses are currently on compounded vs Prascend but we have many here on compounded and they are doing just fine. We have members who have gone from compounded to Prascend and vice versa and there are certainly no obvious improvements in symptoms or lab work with Prascend on an equivalent dosage; nor is it true that if you use Prascend you can use a lower dose.

We do have members who have checked potency of the products they are using and have a list of pharmacies that members use but do not endorse any pharmacies. Are there bad pharmacies out there?  Of course there are. That's the value of feedback from a group this large.  Licensing, etc. is easy to check online.

As for legality, the FDA's position is laid out in those links you provided. However, the last two times it was challenged two different federal district courts have ruled against the FDA and upheld compounding from bulk drugs.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

celestinefarm
 

Dr. Kellon,

I believe Barbara's question is whether compounding pharmacies simply purchase pergolide from BI and convert it into a different form as their compound or if they are required by the FDA to obtain raw pergolide directly from BI. I've been asked this question by vets and others also and to tell you the truth, I'm not sure. I am confused personally as to whether compounding pharmacies can order bulk produced pergolide from whatever manufacturer to then compound and make capsules, liquid, etc. or if they must buy bulk pergolide from BI. If you search the internet, there are veterinary sites that say both.
--
Dawn Wagstaff and Tipperary   

Saline, MI  2003

Tipperary Case History

celestinefarm
 

Let me try this again. Can a compounding pharmacy purchase bulk pergolide from any source of their choosing, or do they have to buy it from Boehringer Ingleheim?
--
Dawn Wagstaff and Tipperary   

Saline, MI  2003

Tipperary Case History

Eleanor Kellon, VMD
 

The FDA would want compounded products made from Prascend tablets only.  BI likely gets their bulk pergolide from the same sources as these compounders, off shore drug manufacturers.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

LeeAnne
 

What?  Am I understanding this correctly?  Pharmacies are to buy Prascend tablets at (what price?) crush them up and make capsules out of them? The FDA is going to be forcing businesses to buy a drug from a certain company?  Seriously? How on earth are the pharmacies going to make the capsules small enough for 10mg and higher dosages???

I must be misunderstanding what you said?
--


LeeAnne,
Newmarket, Ontario. 

ECIR Archivist March, 2004
​ 

Barbara Rosensteel
 

Eleanor,

Thanks for your reply. 

If I'm understanding correctly: 

- The FDA has ruled that compounded pergolide must be made using BI's prascend.  But, in two federal court districts, the FDA has been ruled against which means that compounding pharmacies in those districts can compound from bulk pergolide.  Unless I am wrong, district court decisions apply only to the districts in which they are made, and some pharmacies might make the decision to use prascend regardless of the court ruling,  so the only way to know for sure is to ask the pharmacy if they use bulk pergolide or prascend.

- Bad pharmacies, for sure, but 16 out of 28 (58%) tested is a rather high percentage.   I'll check the files and messages to try to find the members who have checked the potency of the products they were using and which pharmacies they were using.   I suspect having the potency analyzed is expensive.

I'll pass your message onto my friend.

Thanks,

Barbara Rosensteel

Baxter, Tennessee

September 2007


Barbara Rosensteel
 

It is still unclear to me.    Question for clarification: Despite the FDA wanting compounded products to be made from Prascend tablets only, the compounding pharmacies do not have to comply with that rule and can make compounded products from bulk pergolide? (which they probably purchase from off shore drug manufacturers just like BI does).  It that true nationwide, or only in those federal court districts that ruled against the FDA in this matter?

Barbara

(Sorry, I have to re-create an auto-signature.  It seems to have been lost)

Eleanor Kellon, VMD
 

On Fri, Mar 24, 2017 at 07:50 am, Barbara Rosensteel wrote:
- The FDA has ruled that compounded pergolide must be made using BI's prascend.  But, in two federal court districts, the FDA has been ruled against which means that compounding pharmacies in those districts can compound from bulk pergolide.  Unless I am wrong, district court decisions apply only to the districts in which they are made, and some pharmacies might make the decision to use prascend regardless of the court ruling,  so the only way to know for sure is to ask the pharmacy if they use bulk pergolide or prascend.

 That is all correct.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

Eleanor Kellon, VMD
 

On Fri, Mar 24, 2017 at 05:04 am, LeeAnne Bloye wrote:
What?  Am I understanding this correctly?  Pharmacies are to buy Prascend tablets at (what price?) crush them up and make capsules out of them? The FDA is going to be forcing businesses to buy a drug from a certain company? 

 This is nothing new. When an FDA approved drug exists, compounding is only supposed to be done for unique situations (e.g. needs a liquid) and only when the FDA approved drug is used in the compounding.  The reasoning behind this is that when you use the FDA approved product as the base there is a set and known concentration of the active drug.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

ferne fedeli
 

I guess I didn't quite "get" this before either.  I thought if we were using a higher dosage than Prascend (1mg) that compounding was ok.  I certainly didn't realize that they were supposed to use the Prascend tablets to create my capsules...  Mercy!  I do see the reasoning (I guess), but it seems like they could buy the Pergolide from the same manufacturer as BI and accomplish the same thing at much less cost.

Where were the District Courts that ruled in favor of using the bulk Pergolide?

--

Ferne Fedeli

No. California

Regional Members Database Coordinator

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Maxine McArthur
 

But BI state clearly that the Prascend tablets are not to be crushed. If the compounding pharmacies crush and re-package the prascend as capsules, would this not alter the potency???
--
Maxine and Indy

Canberra, Australia 2010

https://ecir.groups.io/g/CaseHistory/files/Maxine%20and%20Indy

https://ecir.groups.io/g/CaseHistory/album?id=933


Casey76
 

Maxine,

Yes, it could effect the bioavailability, distribution, metabolism, and even excretion.  I have no experience with Prascend, but if the tablets are coated in any way, this is usually to ensure that they are metabolized at the right speed in the right place.  E.g. For some drugs it is important that they are metabolized via the stomach, others they need to reach the hind gut.


(I have a degree in Pharmacology , and I've worked in pharmacovigilance (drug safety) for 17 years)

--
Katrina

Mar 2017, Alsace, France

Tartine Case History: https://ecir.groups.io/g/CaseHistory/files/Katrina%20and%20Tartine

Tartine Photos: https://ecir.groups.io/g/CaseHistory/album?id=4725

Eleanor Kellon, VMD
 

On Fri, Mar 24, 2017 at 11:30 am, Maxine McArthur wrote:
But BI state clearly that the Prascend tablets are not to be crushed. If the compounding pharmacies crush and re-package the prascend as capsules, would this not alter the potency???

 That recommendation is an over abundance of caution because of the known potential toxicity of pergolide in humans. They are not timed release or gastric protected so it won't change anything in the short term but the additional processing does shorten "shelf life" so if you did have capsules made from crushed Prascend should only count on potency for 30 days.

It's highly unlikely anyone has capsules made from Prascend. If you did, they would probably have to cost more than Prascend does to keep the pharmacy from losing money.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

Eleanor Kellon, VMD
 

On Fri, Mar 24, 2017 at 10:10 am, ferne fedeli wrote:
Where were the District Courts that ruled in favor of using the bulk Pergolide?

 The rulings did not involve pergolide per se. They were related to compounding from bulk drug for animals.  One was in Texas.  I *think* the other was Florida.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

LeeAnne
 

I'm still confused. 

Barabara said:

The FDA has ruled that compounded pergolide must be made using BI's prascend.  

As I understood how it works currently: Compounding pharmacies purchase bulk pergolide from offshore producers the same as BI. The pharmacies legally can  make capsules (or pills or whatever) that has any dosage except 1mg of pergolide.  Only BI can sell pergolide in a 1mg dosage.   

Now some new(?) ruling has changed that so that compounding pharmacies must buy Prascend tablets from BI for making capsules?  Or must they only purchase bulk pergolide from BI?  

Talk about a sweet deal for BI as they would then be the sole middleman/supplier of pergolide to the US and not have the expense of making pills.  

Clearly there is a flaw in my interpretation of what is being said here. 




--


LeeAnne,
Newmarket, Ontario. 

ECIR Archivist March, 2004
​ 

Eleanor Kellon, VMD
 

On Sun, Mar 26, 2017 at 09:04 am, LeeAnne Bloye wrote:

As I understood how it works currently: Compounding pharmacies purchase bulk pergolide from offshore producers the same as BI. The pharmacies legally can  make capsules (or pills or whatever) that has any dosage except 1mg of pergolide.  Only BI can sell pergolide in a 1mg dosage.   

Now some new(?) ruling has changed that so that compounding pharmacies must buy Prascend tablets from BI for making capsules?  Or must they only purchase bulk pergolide from BI?  

 Dosage has nothing to do with it.  It has never been legal to compound from bulk drug when there is an FDA approved drug available. We had to get a special exemption, which was actually a statement the FDA would look the other way, when pergolide was pulled off the market for humans and there was no veterinary FDA approved drug. Now that Prascend is available, they are supposed to be compounding using that.  Before Prascend and the human pergolide ban they were supposed to be compounding using Permax - but weren't.  This is why the compounded drug is less expensive.

The legality is complicated. The FDA has no power to rule on anything. They can propose that certain things be made law but only Congress can make them a law.  The FDA also issues "position statements" which basically state how they interpret the law and how they will enforce it. However, position statements have no legal standing. There are existing laws against compounding from bulk drugs. However, two federal district courts have ruled that either that does not apply to animal drugs and/or the FDA is infringing on the rights of the states to oversee pharmacies.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001

Barbara Rosensteel
 

Thank you, Dr. Kellon, for the information and clarification, and to everyone who commented and asked questions on this topic.     I now understand.  :-)
--
Barbara Rosensteel

Sept 2007, Cookeville TN

ferne fedeli
 

I want to thank you also, Dr. Kellon, for clarifying this confusing issue for us all.
--

Ferne Fedeli

No. California

Regional Members Database Coordinator

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Ernie <kbarranch@...>
 

Hi y'all

Prascend is another EpiPen scam perpetrated on the American people by the FDA and our congressmen in Washington.
--
Ernie 7-2016

Brazoria County, Texas

Cheyenne

https://ecir.groups.io/g/CaseHistory/files/Ernie%20and%20Cheyenne 

https://ecir.groups.io/g/CaseHistory/album?id=1709