Pet Health Pharmacy shipping Pergolide compounded 2 months ago #pergolidestrength


Claudia Goodman
 

Please advise... a few months ago, I changed over to Pet Health Pharmacy in Az. Earlier this week, I called in two Rxs (two mares) and these arrived today. I am astounded to see these dates on the vials' labels:

1st Rx - compound date: 2/27/17 for 30 capsules ("use by 8/26/17")

2nd Rxcompound date" 3/3/17 for 25 capsules ("use by 8/26/17")  plus a 2nd vial with compound date of 4/25/17 ("use by 10/22/17")

Understanding the instability of compounded pergolide, I find it hard to understand how they would send me capsules that have been sitting on the shelf for two months already. I expect them to ship much fresher pergolide.

I am close to running out of the few I have left from my last order. Please -- what are your thoughts on this? Any reason that I should not demand a fresher batch? 
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


LJ Friedman
 

Petshealth makes 100 capsules when a particular strength is ordered.. If you ordered 30, then the remaining 70 stay on their shelf until the pergolide expires. 
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LJ Friedman  Nov 2014  San Diego, CA

 

https://ecir.groups.io/g/CaseHistory/album?id=2117 

.https://ecir.groups.io/g/CaseHistory/files/LJ%20and%20Jesse


Claudia Goodman
 

Didn't know that - thanks for filling me in. But that would still mean we are using pergolide that was compounded over 3 months prior when we get to the end of the order. Is that really okay to use pergolide sitting around that long? (Even if stored carefully on the door of our refrigerators?)
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


Lorna Cane
 

Hi Claudia,


I can add this to the conversation,wrt the pharmacy I have used for over a decade.In our Files under Canadian Sources.

It is from 2010 (I had asked about it back then), but my understanding is that testing is done on a regular basis:

"In November, 2010, Island Pharmacy ( then known as Shawnigan Lake People's Pharmacy ), B.C., sent 15 capsules from 2 lots of Pergolide Mesylate powder, to the lab for analysis, covering the powder that had been used over the last 6 months. They also sent both new and old capsules (capsulated for 3 months) The lab results said they were stable and compounded 1mg Pergolide Mesylate capsules with a measured 0.949mg/cap which is where the USP guidelines says it should be for compounded medication. "



--

Lorna in Eastern Ontario, Canada
ECIR Moderator 2002




Eleanor Kellon, VMD
 

Lorna's information shows they *might* be OK but doesn't prove it. They are under no legal obligation to check but first step would be to ask if they have stability testing then request a copy of it.  Good to see they do follow the law and correctly date their containers.
--
Eleanor in PA

www.drkellon.com 

EC Owner 2001


Nancy C
 

I had a convo with them last summer asking about stability testing.  They said they indeed have it and would share with me if I needed it. This was via telephone so no copy of discussion.
--
Nancy C in NH
ECIR Moderator 2003

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Claudia Goodman
 

Thank you all for responding to my concern. I'm going to press them on showing me their studies. I found data that supports what we have been assuming: poor stability over 30 days for capsulated powder. (This data may already be on ECIR files - it looks familiar.)

Link to stability study: https://aaep.org/sites/default/files/issues/proceedings-10proceedings-z9100110000274.pdf

Summary table of stability testing at 8 and 25 degrees C - from 5 different pergolide compounders.


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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


Claudia Goodman
 

On Sat, Apr 29, 2017 at 07:09 am, Nancy C wrote:

I had a convo with them last summer asking about stability testing.  They said they indeed have it and would share with me if I needed it. This was via telephone so no copy of discussion.

Nancy,

I just had a chat with Laura, a pharmacist at PHP. I had already corresponded via email with another pharmacist (twice) requesting any data they had that demonstrated 6 months stability fro compounded pergolide capsules, but did not get a response that included data/studies. Today, Laura informed me that they had no study, but were working on it because they understand many of their customers share compounded pergolide stability concerns.

Laura informed me that the basis for their claim for 6 month stability is based wholly on a USP recommendation - not based on studies. (I don't get that, but apparently it can work that way.) So there is no study data available to back that up, according to what I was just told. Laura mentioned that they did intermittent checks on the capsules and are endeavoring to provide a study to share, but none yet exists. 

I appreciated Laura's time and patience with me as I went over my concerns and answered many questions. She even looked up the compounding date of the pergolide capsules that are available to ship now at my mare's dose, which are unfortunately the same as last order: 2/27/17. She suggested I might consider pergolide prepared in an oil suspension for which USP grants 9 month stability (again, no data to back that up) and is available in their inventory with a 4/14/17 compound date. They ship out whatever inventory they have that can be used within the 6 months from compounding. They only compound fresh capsules of a dose when ordered if they are out of that dose or it would  "expire" within use interval. Otherwise, she noted, the cost of the drug would be much higher. She told me there was no minimum order size for which they would make up a fresh batch.

One anecdotal factor here is that on a 9mg dose, my mare's ACTH went from 19pg/ml (on 1/27/17) to 26 (on 5/8/17), with the last test about one week into starting the two month old pergolide capsules. That is not determinative of loss of potency, but it's not reassuring either.

Up until they labelled their last order with the compound date, I naively assumed they made up a fresh batch with each order. I've got to say that this stability issue, so important to tightly controlling PPID, seems quite under supported in the compounding world. I think it would helpful, if with every order of pergolide, we all requested the compound date and discuss our concerns over lack of data that demonstrates claimed stability.

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Claudia & Silhouette
  02/2014

California Central Coast 

Silhouette Case History


ferne fedeli
 

I checked my latest Pergolide (4mg) from Pet Health and the Compound Date was 4/22/17.  I don't remember seeing a Compound Date before, but I may have just overlooked it.
--

Ferne Fedeli

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Claudia Goodman
 

Fern, Yes, PHP began adding the compounded date very recently, as my last order was the first to have it on the vial. I commend them for doing so. Your compounded date is relatively recent and, therefore, less concerning (compared to mine).
 
As I've mentioned, this compounded date is what raised a flag for me because I have not seen a study that demonstrates stability beyond 30 days beyond compounding. The only study of capsulated powder pergolide mesylate I’ve seen barely shows acceptable stability at 30 days. Without studies to show otherwise (which PHP does not yet have but is working on), this would seem to be an unresolved issue.

The only capsules available at the dose I need now are already 3 months old. I'm not comfortable with that. They do have an oil suspension of pergolide at the dose I need that is about 6 weeks old, which will be my preference for now. They told me in oil suspension, it has 9 months stability (although no data to demonstrate) - and advised me not to refrigerate it. 

Really looking forward to reviewing more stability studies that supports what PHP is claiming.
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History