Topics

getting vet to prescribe pergolide #legalityofpergolide

regina bruno
 

hope this is okay to put up here.  my recently graduated vet is not easily swayed.  thought some of this might be useful for folks.

COMPOUNDING TYPICALLY PERMISSIBLE WHEN:
a. A valid vet/client/patient relationship exists (VCPR Rule)
b. Use is limited to unique need in a specific patient or group of patients
c. No other method or type of drug delivery is practical, AND
d. No equivalent FDA approved product is on the market. •

COMPOUNDING TYPICALLY NOT PERMISSIBLE WHEN:
a. Exceeds VCPR rule (i.e., mass manufacture, advertising and distribution except in limited circumstances)
b. Mass advertised for large population of end users without justification (i.e. lack of other products to treat condition in that species)
 d. (sic)Compounded product mimics equivalent FDA approved product available on market

http://www.natrc.org/pdf/2015_Handout_Issues_in_Equine_Law.pdf

Definitions:
Equivalent:     -equal in value, amount, or value
                       -corresponding or virtually identical especially in effect or function

https://www.merriam-webster.com/dictionary/equivalent

Mimic:            -imitate closely

https://www.merriam-webster.com/dictionary/mimic#h3

Prascend:
"...PRASCEND Tablets should not be crushed due to the potential for increased human exposure and care should be taken to minimize exposure when splitting tablets..'.

DOSING TABLE

 

BODY WEIGHT 2 MCG/KG DOSAGE 4 MCG/KG DOSAGE
136 - 340 kg
(300 - 749 lb)
0.5 tablet 1 tablet
341 - 568 kg
(750 - 1,249 lb)
1 tablet 2 tablets
569 - 795 kg
(1,250 - 1,749 lb)
1.5 tablets 3 tablets
796 - 1,022 kg
(1,750 - 2,249 lb)
2 tablets 4 tablets


"Made in Japan and packaged in Germany...."

https://www.prascend.com/prescribe.html

--
Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .

Carol Grubb <headmare0@...>
 

I'm glad this warning about exposure to Prascend was put in this email as I had a bad experience.  As I was increasing my two PPID/IR mares dosage I was opening .25 mg capsules which meant I opened 8-10 caps until we found the right dosage for them.  One night I noticed I was feeling quite "unusual" with balance and coordination problems, dizziness and just not feeling "right", actually downright icky.  .  I called the Pet Health Compounding  Pharmacist the next day who confirmed that if I was going to be handling this med that i should be wearing gloves.  That helped immensely !  so please be careful when splitting tabs or opening capsules to adjust dosages.  
--
Carol
Tucson
2005?

Lorna in Ontario
 

Hi Carol,

Just to say it *could* have been something else.
I have halved capsules for years,depending on the ponies' requirements. I've never had that experience. I don't wear gloves.
Just wanted to offer another side.

--

Lorna in Eastern Ontario, Canada
ECIR Moderator 2002

 

 

Carol Grubb <headmare0@...>
 

Glad you didn't have any reaction.  I am extremely medication sensitive which I am sure is part of it.  
--
Carol
Tucson
2005?

regina bruno
 

i think this issue could be potentially relevant when trying to get a very resistant vet to prescribe a compounded product.

Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .

Lorna in Ontario
 
Edited

Sorry,  Regina, which issue?

--

Lorna in Eastern Ontario, Canada
ECIR Moderator 2002

 

 

regina bruno
 

"Sorry,  Regina, which issue?"


sorry Lorna.  you're gonna teach me this system one way or the other....


"...PRASCEND Tablets should not be crushed due to the potential for increased human exposure and care should be taken to minimize exposure when splitting tablets..'.

i think this issue could be potentially relevant when trying to get a very resistant vet to prescribe a compounded product.  my vet is not very experienced and some of these more technical issues, such as having to handle a medication that is "potentially" dangerous to get the horse to take it, might help her to feel better about writing a script for "pergolide" vs "Prascend".  she wants back up, science, law, and proof there of.





Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .

Lorna in Ontario
 

Aha! Good point.
Thanks.
--

Lorna in Eastern Ontario, Canada
ECIR Moderator 2002

 

 

celestinefarm
 

Regina, compounded pergolide comes in capsules with granular medications inside or liquid for syringing.  There is less exposure to pergolide via capsules than tablets, and even with liquid, one only needs to wear gloves. Most medications administered to horses warn of exposure because it's not typically FDA approved for humans and some do have side effects detrimental to humans.  You should always wash your hands immediately after administration of drugs. That includes wormers sold at every farm store and tack shop in the country. And banamine and bute paste. 

For example here is the warning for Bimeda's Equell Ivermectin Paste.                                              
WARNINGS Do not use in horses intended for human consumption. Not for use in humans. Keep this and all drugs out of reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Bimeda, Inc. at 1-888-524-

Regumate which is progesterone used to regulate cycles in mares and sometimes to support early pregnancies, can be absorbed through the skin and should be admistered with gloves. 

Chloramphenicol , of which I've had to use on two different occasions , can cause anaplastic anemia in humans , which can only be treated with a bone marrow transplant. I had to give a foal twice daily oral syringes to prevent joint sepsis after he was born as a "dummy" foal and was saved at MSU. Nothing like squirting a thick pasty syringe of dangerous antibiotic into a squirming foal , but he ended up with no sepsis. Wore goggles, masks, full raincoats and chemistry gloves to elbow for that one as did whoever I forced into holding the foal for me.

Your inexperienced vet will learn that she has to use what works and her clients are not always dummies about treating their horses. A little education goes a long way.
--
Dawn Wagstaff and Tipperary   

Saline, MI  2003

Tipperary Case History

regina bruno
 

"I had to give a foal twice daily oral syringes to prevent joint sepsis after he was born as a "dummy" foal and was saved at MSU. Nothing like squirting a thick pasty syringe of dangerous antibiotic into a squirming foal , but he ended up with no sepsis. Wore goggles, masks, full raincoats and chemistry gloves to elbow for that one as did whoever I forced into holding the foal for me.

Dawn, when I die, I want to come back as your horse.
--
Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .

celestinefarm
 

On Sun, Sep 24, 2017 at 04:09 pm, regina bruno wrote:
Dawn, when I die, I want to come back as your horse.
--
Regina and Smokey
June 26, 2017
Laurelville,  Ohio
LOL, You are not the first person that has said that. By the way, the chloramphenicol was a twice daily fun event for three weeks. And it was July , with temps in the 80s and 90s.



 
--
Dawn Wagstaff and Tipperary   

Saline, MI  2003

Tipperary Case History

Helen Temps
 

On Sat, Sep 23, 2017 at 02:57 pm, regina bruno wrote:
COMPOUNDING TYPICALLY NOT PERMISSIBLE WHEN:
a. Exceeds VCPR rule (i.e., mass manufacture, advertising and distribution except in limited circumstances)
b. Mass advertised for large population of end users without justification (i.e. lack of other products to treat condition in that species)
 d. (sic)Compounded product mimics equivalent FDA approved product available on market
• Use of the compounded product in lieu of FDA approved, for cost savings only, is legally prohibited and thus not an “insured occurrence”.
Regina,   I interpret that to mean that compounded Pergolide is no legal?  Not sure how this will convince my Vet (who says she could lose her license prescribing it) to prescribe!   Am I missing something?  Does this vary State to State in the US?  I am now confused more than ever. 
 
--

Helen Temps and Chloe  June 2017
Placerville, CA
https://ecir.groups.io/g/CaseHistory/files/Helen%20and%20Chloe.
https://ecir.groups.io/g/CaseHistory/album?id=6929

Nancy C
 

You cannot use "it's cheaper" as an argument for going to compound.

It is not illegal to prescribe pergolide.

Please have a look at the hashtags under this thread, ie #legalityofpergoldie, here

https://ecir.groups.io/g/main/search?q=%23legalityofpergolide&ct=1

For All you can find hashtags of commonly asked questions by looking for HASHTAGS button when on the groups.io web page.  Where on the page it is will depend on what device you are using.
--
Nancy C in NH
ECIR Moderator 2003

 

Save the date! The ECIR Group Inc. NO Laminitis! Conference, October 27-29, Tucson, AZ

Learn the facts about IR, PPID, equine nutrition, exercise and the foot
ECIRhorse.org
Check out the FACTS on Facebook
https://www.facebook.com/ECIRGroup
Support the ECIR Group Inc., the nonprofit arm of the ECIR Group
ecirhorse.org


Helen Temps
 

That is where I found the information, through the hashtags. I thought it rather confusing to use as a quote to get my vet on board. My Vet is saying she could lose her license so I thought I could find something for her.  I DID find Dr. Kellon's message also, so sent that on to her instead.  Hoping she will be OK with it now.  If not, guess I'll be looking for a vet who will prescribe.  As the dosage goes up, so does the cost!
--

Helen Temps and Chloe  June 2017
Placerville, CA
https://ecir.groups.io/g/CaseHistory/files/Helen%20and%20Chloe.
https://ecir.groups.io/g/CaseHistory/album?id=6929

Nancy C
 
Edited

Though it is a common reason used, I would disagree with her assessment about her license, but that is just me.  As outlined in the other posts, this falls on the pharmacy.

https://ecir.groups.io/g/main/topic/more_posts_on_legality_of/6059689

Again, the legality has nothing to do with writing a prescription for a compounded drug. Prescriptions don't have to specify the source of the drug. That's on the compounder. A veterinarian selling a compounded drug is another story but if all they do is write a prescription for pergolide they are not involved in any legal issues - although I'd bet the BI reps visiting practices tell them something different.
Eleanor in PA
********************

I would submit you and your vet are not exceeding the VCPR - the veterinarian-client-patient-relationship.

You and/or your vet are not mass marketing this.

This one is more complicated --  "Compounded product mimics equivalent FDA approved product available on market" 

From message  206354  (emphasis mine)

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 that 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 


from

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


I've found over the years that, sometimes, offering to sign a waiver of liability for your vet, absolving them of harm  for a protocol you wish to follow, gives them a little more courage.  I've never had to actually sign anything, but usually have been able to move them to try new things out.

Hope this helps.
--
Nancy C in NH
ECIR Moderator 2003

 

Save the date! The ECIR Group Inc. NO Laminitis! Conference, October 27-29, Tucson, AZ

Learn the facts about IR, PPID, equine nutrition, exercise and the foot
ECIRhorse.org
Check out the FACTS on Facebook
https://www.facebook.com/ECIRGroup
Support the ECIR Group Inc., the nonprofit arm of the ECIR Group
ecirhorse.org


LeeAnne Bloye <ecir.archives@...>
 

Helen, did you read the document in the files:
Getting Higher Pergolide Dosages.pdf 
--

- ​LeeAnne

ECIR Archivist, Newmarket, Ontario March 2004

Email Me - if link fails use ECIR.Archives at gmail dot com

Is your equine in the Pergolide Dosage Database? View the Pergolide Statistics

  Dawn's 10 Year Case History
     Taken For Granite Art

Quote of the moment: The human spirit must prevail over technology. - Albert Einstein
 

Helen Temps
 

Nancy, Excellent idea about the waiver!  Thank you also for putting all this in one post, much easier to digest this way.
--

Helen Temps and Chloe  June 2017
Placerville, CA
https://ecir.groups.io/g/CaseHistory/files/Helen%20and%20Chloe.
https://ecir.groups.io/g/CaseHistory/album?id=6929

Nancy C
 

Cookies help too.
--
Nancy C in NH
ECIR Moderator 2003

 

Save the date! The ECIR Group Inc. NO Laminitis! Conference, October 27-29, Tucson, AZ

Learn the facts about IR, PPID, equine nutrition, exercise and the foot
ECIRhorse.org
Check out the FACTS on Facebook
https://www.facebook.com/ECIRGroup
Support the ECIR Group Inc., the nonprofit arm of the ECIR Group
ecirhorse.org


Helen Temps
 

LeeAnne,   How do I get to the messages in the links from the PDF??  If I click on the link I get "This site can't be reached"; If I go to the Main Group page>Search> Message> enter # I get info that has nothing to do with this topic; If I go to CH group and search, I get "A new file has been uploaded" !!  
--

Helen Temps and Chloe  June 2017
Placerville, CA
https://ecir.groups.io/g/CaseHistory/files/Helen%20and%20Chloe.
https://ecir.groups.io/g/CaseHistory/album?id=6929

regina bruno
 

On Tue, Oct 10, 2017 at 01:22 pm, LeeAnne Bloye wrote:Helen, did you read the document in the files:
Getting Higher Pergolide Dosages.pdf 
--

- ​LeeAnne

ECIR Archivist, Newmarket, Ontario March 2004

Email Me - if link fails use ECIR.Archives at gmail dot com

Is your equine in the Pergolide Dosage Database? View the Pergolide Statistics

  Dawn's 10 Year Case History
     Taken For Granite Art

Quote of the moment: The human spirit must prevail over technology. - Albert Einstein


 
 
I have a question:  do vets ever use prescription pads or is it always this thing where someone calls a pharmacy?
 
--
Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .