New vets questions regarding stability studies
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celestinefarm
I am moving my two remaining broodmares to a different veterinary practice as my long time vet has had health problems and is not consistently available. New vet practice requires me to be established client in order to see emergencies. Large practice with numerous vets and I have been happy with care. Yesterday I had one of their younger vets out to pull ACTH ( insulin and glucose , but she was delayed and we decided to skip due to mares having been fed beet pulp and supplements). We had a detailed discussion about the current PPID status of both mares, their current dosages of 1.5mgs and 2mgs.respectively of Prascend and my philosophy of dosing enough pergolide to keep ACTH numbers controlled. She was familiar with the Equine Endocrinology group, but had never heard of ECIR or Dr.Kellon( this blows my mind, we are located 25 miles from Uckele and she has her own horses). She put the ECIR website address into her phone so she could read it later. We had a long careful conversation about both of our experiences and attitudes toward compounded pergolide. She said she has had several horses that she pulled off of compounded and placed on Prascend who then responded well and ACTH went down. She also said that she does not normally Rx compounded anything for horses that is available in an FDA approved form because " the liability for the performance of that drug now falls completely on her and it's her license on the line. However, because of my experience and respect for her opinion on this, should I need to significantly increase pergolide, she would be willing to Rx as long as I would sign a release." We talked about the stability issues with compounded and I told her that the ECIR group members had contacted the pharmacies we use and asked for stability studies and had gotten at least one report. ( I was thinking Aviro had sent a member a report). She asked if she could get a link to that or copies and I told her I would send what was available. Saline, MI 2003 Tipperary Case History |
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Dawn,
Your best bet is to have her speak directly to the head pharmacist. All pergolide compounding pharmacies are aware of this group’s requests for stability studies. I doubt any will publicly release potency or stability testing results, but I’d love to be proven wrong! I’ve been told of potency testing results by pharmacists but have never seen their actual testing certificates. -- Cass, Sonoma Co., CA 2012 ECIR Group Moderator Cayuse and Diamond Case History Folder Cayuse Photos Diamond Photos |
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Hi Dawn. Here is the link to the discussion which prompted Dr. K's call for members to request stability study from their pharmacy #283688
I had several lengthy phone discussions and correspondence with Keith Barron, the head of pharmacy ops at Avrio. He was super generous with his time and I believe sincere about learning about our group's needs and trying to help.He helped me better understand the compounding process and the varying levels of rigor required to achieve certain certifications (which not all pharmacies hold). I told him that my vet is "compounding hesitant" and that I was preparing to have a discussion with her about increasing Andante's dosage, and coincidentally there was an active discussion going on in the group about stability and potency (which were my vet's concerns). He did share with me a certificate of analysis for a batch of pergolide manufactured in Europe on 6/01/2021 that was analyzed by CED Analytical in the U.S. in 12/2021 and showed a loss of purity after 6 months at a 2%. However, I don't think this is the same thing as potency. He said I could share the COA with my vet but asked that I not publish it, and I want to respect that request. Feeling a bit over my head in interpreting the data, I suggested making an introduction to Dr. K and that it might be of great value to our group if he was willing to participate in some sort of discussion forum facilitated by ECIRG to educate members on the compounding process (including QA). Before I had a chance to follow-up, a message was posted to the group asking people to forward any conversations/contacts with pharmacies they had to ECIR management team for further action. I provided Keith's contact info along with a summary of our discussion and some ideas for sharing the info he provided with the rest of the group. I am not sure where that process stands now, but I am sure we will hear about it eventually. I think there is a lot the pharmacies can learn about ECIR mission, goals and methods that could dispel any fears they may have about sharing information. I also think it would be very valuable for pharmacies to engage with us as a group to educate us about the production, QA and certification process for compounding so that we can be better equipped to have conversations with our vets about the use of compounded pergolide. Although I haven't always been happy with Avrio's business processes (reordering and shipping in particular) and customer service, I did come away from the conversation feeling very good about their QA processes. If your vet reached out to Keith, I believe she would find the conversation useful and reassuring. -- Alisa and Andante
San Diego County, CA 1/2014
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On Sat, Dec 17, 2022 at 07:31 AM, Alisa Martin wrote:
He did share with me a certificate of analysis for a batch of pergolide manufactured in Europe on 6/01/2021 that was analyzed by CED Analytical in the U.S. in 12/2021 and showed a loss of purity after 6 months at a 2%.Alisa, is the certificate of analysis dated December 2022, not 2021? Are you sure it describes loss of purity? -- Cass, Sonoma Co., CA 2012 ECIR Group Moderator Cayuse and Diamond Case History Folder Cayuse Photos Diamond Photos |
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Purity isn't a term that would be used in drug stability studies. Loss of potency is more like it.
-- Eleanor in PA www.drkellon.com |
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Cass, the COA was published in Dec. 2021, six months after manufacture. The data point refers to "chromatographic purity." As Keith explained it, it's not a stability or a potency study (as described by CED Analytical), but it does refer to the product being essentially the same in terms of quantity and purity as when originally manufactured (e.g. contains the same amount of pergolide and no other stuff added). Dr. K, are you interested in chatting with him? He was eager to connect with you. I know my way around data, but this COA is way too specialized for me to interpret. Moreover, I think it could be a fruitful conversation for both. Of all the contacts made by members, my impression is that Avrio was most willing to engage.
-- Alisa and Andante
San Diego County, CA 1/2014
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celestinefarm
Alisa, thank you so much for the detailed responses to my original question. All of this is helpful in my discussions with the vet and I will let her know that she needs to contact labs directly for any information regarding stability etc
-- Dawn Wagstaff and Tipperary Saline, MI 2003 Tipperary Case History |
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