Compounded GLP1s

Shortages, access, and cost have led to compounding GLP1s, which has created confusion and misinformation for patients and healthcare providers. Join us as we discuss this practice and delve into what you need to know as a healthcare provider.

THE GAMECHANGER: The advent of GLP1s is a true GameChanger in the health of patients with diabetes, cardiovascular diseases, and obesity, and has led to access issues for manufactured products.

 

Guests
Tenille Davis, PharmD, RPh
Chief Advocacy Officer
Alliance for Pharmacy Compounding

Scott Brunner, CAE
CEO
Alliance for Pharmacy Compounding

Host
Geoff Wall, PharmD, BCPS, FCCP, BCGP
Professor of Pharmacy Practice, Drake University
Internal Medicine/Critical Care, UnityPoint Health
 
Reference
https://a4pc.org/advocacy/educating-prescribers/

https://a4pc.org/advocacy/statements-and-other-resources/

https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf

 
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CPE Information
 
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Review criteria for compounding drugs on the FDA drug shortage list.
2. Discuss the facts and misinformation surrounding compounded GLP1 medications.

0.05 CEU/0.5 Hr
UAN: 0107-0000-24-145-H01-P
Initial release date: 04/15/2024
Expiration date: 04/15/2025
Additional CPE details can be found here.

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Transcript

Speaker 1: 0:08

Hey, ce Plan members from CE Impact. This is Game Changers. I have a few people with me today to lean on for this conversation, because it is a big one, and one that we all need to understand is healthcare providers, because there's so much misinformation and we're trying to do a lot of good for patients, so sometimes it might feel like patients know more about this than we do, and so we want to ensure that that is not the case and provide you with adequate information. I think we're all on the same page in saying that the advent of GLP-1s is a true game changer. It has enabled people to not only lose weight effectively, but it has also improved the health of patients with diabetes and cardiovascular diseases that are tied to carrying excess weight. So I think the benefits of this are still even to come.

Speaker 1: 0:54

I feel like I keep seeing studies that are like it's good for this, it's good for this, and so that will continue. That said, you know we're still early on in this as well, so I know people are, you know, a little nervous about the risk and long-term. You know benefits and risk associated with it as well. But, as with any new medication, you know I also think we're all aware that there have been some exploitations and you know things that maybe aren't being done legally, and so our goal here today is to really talk about the benefit of these medications in therapy and also how to do it the right way. So I think shortages, the desire initially to have them off-label, when there wasn't an approved medication for weight loss but it was working have led the marketplace to compounding some of these products, and whenever we're dealing with compounds that are commercially available, you know there's always issues there. So here with us to talk about that are a few people. First, our regular conversationalist and contributor, jeff Wall. Hi, jeff.

Speaker 2: 1:57

Hello, how are you doing?

Speaker 1: 1:58

Great, and also two people from the Alliance for Pharmacy, compounding Scott Bruner and Tennille Davis. So thank you both and welcome.

Speaker 3: 2:08

Thank you, glad to be here.

Speaker 1: 2:10

So first I'd like to start. Scott and Tennille, can you each just take a minute to tell us about the Alliance for Pharmacy Compounding and its place in pharmacy, and then as well, a little bit about your role, you and your role with APC. Yeah, I'll be happy to start, and then as well, a little bit about your role, you and your role with APC.

Speaker 3: 2:26

Yeah, I'll be happy to start and then hand off to Neil. I am the CEO of the Alliance for Pharmacy Compounding. We are a trade association. We are the industry association for pharmacy compounding and our members are, of course, pharmacists and technicians, but also supply chain professionals and marketing professionals and educators and even some prescribers and a handful of patients. We represent around 500 compounding pharmacies or outsourcing facilities and that amounts to around 47, maybe just shy of 4,800 members just shy of 4,800 members and our job is to protect patient access to compounded medications. Compounded medications are an essential line of therapy in the American healthcare system. As I'm sure we'll discuss. Compounding is not always as well known to prescribers and patients and others, and I think the light that is being shown on compounding right now is an opportunity to talk about the benefits of those therapies.

Speaker 1: 3:33

Great Thanks, scott. Yeah, as we were talking about you know, we started pharmacy started by compounding, so that is our mainstay, and sometimes it does get a bad rap, so I think it'd be great to talk through that. Tenille, can you tell us a little bit about your role?

Speaker 4: 3:46

Sure, yeah, At its heart, APC is an advocacy organization and I'm lucky enough to have been brought in recently I just started with the organization in February as the chief advocacy officer. So we do a lot of work for our members to educate, you know, different regulators of pharmacy, as well as the media and the public, about what compounding is, what compounding is not, and help clarify any rules or laws that are being proposed that might, you know, limit or hinder patient access to compounded medications. Since I've been, you know, brought on, been after the GLP-1 phase started and we've done a lot of media interviews to try to help correct misinformation out there. My history I ran a sterile and non-sterile compounding pharmacy for 16 years in Arizona before I came on with APC. I also am a member of the Arizona State Board of Pharmacy, though I am speaking today on my personal capacity and not as a member of the board.

Speaker 1: 4:47

Yes, that's important. I didn't realize you had only been there since February. So, yeah, you've been thrown right in, but sounds like your background is great and you have a lot to bring to the table. So I'm so I'm so happy to have you on today. We are looking forward to this conversation, so let's get into it. First, I guess I'll tee it up and then maybe pass it off to Jeff but how did we get here? So maybe you know sort of I know that's, maybe we'll be here for an hour and a half just talking about that but how did we get to this space? I think with GLP-1s in particular and I know, scott, maybe you touched a little bit on just compounding in general, so maybe even talk about that a little bit.

Speaker 3: 5:30

Yeah, I think how we got here is the advent of a blockbuster drug that, frankly, nobody in defense of Novo Nordisk and Eli Lilly I don't think anybody could have predicted the splash that this drug has made. I hear pharmacists who've been around for 40 or 50 years doing compounding say they've never seen anything like it. It's bigger than the AIDS drugs. It may be equivalent to the advent of birth control in the 1950s and 1960s. And with the extraordinary demand for that drug and the inability of the drug manufacturers to keep up with that demand, so enters compounding into the equation. Fda guidance allows compounding pharmacies to prepare essentially a copy and that's the exact wording, essentially a copy of an FDA approved drug when that drug formally appears on the FDA drug shortage list. Simaglutide has been on the drug shortage list since March of 2022. Terzepatide not quite as long, but they both are on that list, and so compounders have been responding to prescribers who are directing their patients to compounded versions of these drugs.

Speaker 3: 6:47

I do want to make clear to your listeners nothing happens in traditional compounding until a doctor or other prescriber writes a prescription for a patient. Compounders don't just get to decide when they're going to dispense a compounded drug. The doctor has to specifically write the prescription for that patient for that drug. So it's not as if the doctor writes Wegovy on the script and the patient hops down to the pharmacy and the pharmacist says oh, I don't have any of that. Let me compound something for you.

Speaker 3: 7:18

The doctor must, or other prescriber must, write the script for semaglutide or terzapatide, and then it goes to a state licensed pharmacy that dispenses medications pursuant to a prescription for an individual patient, and I'm sure we'll talk shortly about how do you distinguish between what's legitimate and what's not. But that's the first question Do you have a prescription for it? And the second question would be has the physician sent you to a state licensed pharmacy to have that medication dispensed? If neither of those things are true, either of those things is not true, there's a good chance the activity might be illicit. So we can talk more about that, I suspect.

Speaker 1: 8:00

Yeah, and Scott, when you say formerly on the list, formally sorry.

Speaker 3: 8:03

Oh, formally. Okay, I thought you said formerly on the list Formally. Sorry, oh, formally.

Speaker 1: 8:06

Okay, I thought you said formerly that's my Alabama drawl. I'm like whoa, is that forever? Yeah, formally no, my.

Speaker 3: 8:10

Alabama drawl gets in the way sometimes.

Speaker 1: 8:14

Yeah, and how often is that list updated, danielle you?

Speaker 3: 8:17

want to talk about that. It's updated ongoing.

Speaker 4: 8:20

It is updated ongoing.

Speaker 3: 8:21

It's not perfect, but, yeah, go ahead.

Speaker 4: 8:37

It's not ongoing. It is updated documentation up to date. So I usually recommend, you know taking a screenshot of the drug shortage list on FDA's website at least once a week and storing that indefinitely to prove that if ever a regulator came in and said, was it on shortage when you were compounding it, you can pull up that week's data and say yes, it was.

Speaker 4: 8:58

Yeah, it's not updated as frequently as some other drug shortage lists, like the ASHP list, which is a little more rapidly adapting to what changes are happening in the marketplace. But it's not by any means like goes on the list and then the FDA forgets about it. Yeah, yeah, never.

Speaker 3: 9:16

Yeah, there are some certain tricky things with the FDA drug shortage list, though that folks should know. Again, the exact language in FDA guidance is the drug has to be listed as quote currently in shortage. If you go to the FDA drug shortage list and look around, you might find indications that certain dosage forms and dosage strengths of Wegovi and Ozempic and Munjaro are quote available. The FDA drug shortage list, the website, is very confusing in that regard. But just because it's listed as those certain dosage forms are listed as available, that's not what the guidance says. It is semaglutide or terzepatide injection that must be listed as currently in shortage and that's what.

Speaker 3: 10:01

I hadn't checked it today, but as of very recently. That's how those are listed there, and so someone might say well, if semaglutide injection is in shortage, how are compounders getting the API, the active pharmaceutical ingredient? And Tenille can talk a little bit more about this, but it's our well. First of all, the API is readily accessible from FDA registered facilities and compounders can only acquire API that readily accessible from FDA-registered facilities, and compounders can only acquire API that comes from an FDA-registered facility. It's actually, as we understand it, the pen to inject the drug that is creating the shortage right now and, tenille, you may want to elaborate a bit on that because it creates confusion. People are saying how can compounders get the API if the drug's in shortage? And again, it's not the API that's in shortage.

Speaker 4: 10:49

Yeah, the drug shortage list lists semaglutide or trisepatide injection as what is currently in shortage but, as you'll notice, ribelsis semaglutide tablets are not in shortage because there really isn't a shortage of the API itself. If you go on FDA's website, you can find all of the FDA registered manufacturers of semaglutide API on there. You know Novo Nordisk is listed, but a lot of other ones are as well. Compounding pharmacies are required to source any of their API that they use in a compounded product from FDA-registered wholesalers that are required to get their API from FDA-registered manufacturers, which must come with a valid certificate of analysis. You know licensure in the state, all of those kind of things.

Speaker 4: 11:36

So there's a lot of kind of hoopla in the media that says you know if they're, you know if Novo Nordisk can't supply Ozempic injections, where are the pharmacies getting this? What must it be? And a lot of you know speculation that is not necessarily warranted. Additionally, the manufacturers come out with statements saying that they don't sell the API to compounding pharmacies and you know our response to that has been well, of course they don't. You know, typically drug manufacturing companies use contract manufacturers to manufacture API for them. They might put that in the final dosage form in factories that they own, like you know, put the injection solution into a pen device. They also might use contract manufacturers to do that part, but of course they're not selling API to compounders, because that's not how this system works in general. It's a you know kind of a misleading statement, but it, you know, makes sense, coming from someone trying to protect their financial interests and you know, their product that they've done the R&D for.

Speaker 1: 12:39

Yeah, absolutely, jeff. I'm going to turn it over to you. I have lots of questions, but I know you have a lot of questions too, so I want there's a lot of confusion there.

Speaker 2: 13:23

I think you know you were. You know Scott had pointed out that he'd never seen anything like this, and I have to admit I'm a little more skeptical because I'm old enough that I did see this. I did see this with Fen-Phen and you know I. You know I remember when I came out of school the Fen-Phen craze had just started and it was pretty much the same thing. You couldn't keep it on the shelves. You know there were these weight loss clinics popping up all over the place and you know, basically they were a broom closet, a weight scale and a credit card machine, and that's pretty much all you needed.

Speaker 2: 13:47

Of course, in the 21st century we've moved on to telehealth and telemedicine, which is a good thing, but I think there is some concern that not all compounding pharmacies are operating at the level of rigor that I think probably members of your organization are, and so I think so. I think the first question is you know? You know it sounds to me like like the ability to purchase this medication. I think there's a lot of misconceptions out there saying that you know pharmacies, compounding pharmacies, are getting it from China or India and we're not really sure you know what's actually in it. There may not be anything in it. What you know, what do you guys think?

Speaker 4: 14:28

I think that that's a lot of misplaced hysteria, honestly. Sure, there are counterfeit drug manufacturers out there. That's not compounding. There are sellers of research-grade peptides on the internet. That's not compounding. A lot of those things are being conflated with legitimate compounding and it's not a fair comparison. But I understand that it's confusing. The regulatory framework that surrounds compounding is confusing and it's a lot easier for people to say you know, it's not FDA approved, so thus it must be unsafe, which is not a logical fallacy. But that is the jump that people are making, because it's an easier, one-size-fits-all solution for patients than trying to understand the nuance of legitimate compounding versus all of the other stuff that is in.

Speaker 4: 15:17

You know, the media Right, but if a doctor you know wanted to use a compounding pharmacy to help supply medicine to their patients that they weren't able to get otherwise, there's a lot of different steps that that provider or patient could take to make sure that they're dealing with a company that's legitimate.

Speaker 4: 15:34

You know, you can always look on a state board of pharmacy website to make sure that that pharmacy is actually a real pharmacy and that exists.

Speaker 4: 15:41

You can also call and talk to the pharmacist If you have questions about processes, where they get their API from. If you wanted to see a copy of a C of A, any reasonable, legitimate pharmacist that doesn't have anything to hide wouldn't have any reason with providing that to you. An average consumer probably can't read a C of A, but if you asked for one and the pharmacist was like no, no, no, that to me would seem like a red flag, because if there's nothing to hide, you know there is nothing to hide. So it's that lack of nuance in like the media and reporting that like hurting our consumers and also making them afraid to use compounded meds in general, like patients, that that is their only option. There isn't an FDA approved alternative that happens to be on shortage, like the. You know us vilifying an entire industry because counterfeit drugs exist isn't fair, but I understand that that's a lot easier for the public to understand than the very complicated framework that surrounds compounding pharmacies.

Speaker 1: 16:44

I was going to say. I think it's also like the other way around. I mean, I think there's so many people that I know going to med spas that are just, you know, they're very trusting, and so, like, what are some of the questions that should be asked in those spaces?

Speaker 3: 17:01

Well, we can both address that. But I do want to go back to something that was said earlier about the rigor of compounding pharmacies. I would be the first to acknowledge that any profession, any industry, has its bad actors. But the compounding pharmacies that are preparing injectable GLP-1s are sterile compounding labs. They automatically must adhere to a higher standard of care and compliance. Usp-797. That's the chapter of the chapter of the US Pharmacopeia that guides sterile compounding, as well as the Food and Drug Cosmetic Act, fda guidance, state law.

Speaker 3: 17:39

A compounding pharmacy is simply not going to stay in business very long if it doesn't adhere to those standards. The State Board of Pharmacy will come in and inspect them, the FDA will come in and inspect them, etc. And so, generally speaking, I would assert that the pharmacies that are preparing compounded GLP-1s are doing it, adherent to those standards. And so, when I said earlier, your prescriber writes a prescription for you and sends you to that state-licensed pharmacy, you can have some sense of confidence that that pharmacy is adhering to those standards, if indeed you've checked the Board of Pharmacy website and they haven't been written up for violations etc. The conflation the problem is with drug manufacturers and most recently bless his heart the FDA commissioner himself who conflated legitimate compounding with some of that illicit activity, and so I don't think you can refer to something you buy on the internet without a prescription as a compounded drug. It's not. It's an illicit substance.

Speaker 2: 18:45

And I think that's fair. But I think the question and to Jen's point is that I know myself in town here where we are and I'm sure this is happening all over the United States where people are going to these med spas and they show up and again it's like the old weight loss clinics of the fen fender. They walk in, they go on a scale, they say yep, you're a candidate, and they literally hand them three months of semi-glutide injectable. Where are they getting it from and how can the consumer and their overriding primary care physician go? Yes, just what you said.

Speaker 2: 19:20

This is a trusted source, you know, we know what's going on and I think that's the key is that, yeah, you're right, there's bad actors in all areas of pharmacy, no doubt, and bad apples, you know, kind of ruin those things. But because this is something that's outside of what most experienced providers are understanding you said yourself that they often don't understand what compounding is I think there is a legitimate concern among providers and pharmacists who are unaware of what's going on because they don't understand that. You know, like what you just said, that there is for legitimate compounding pharmacies this extremely regimented FDA you know FDA approved but process that allows you know appropriate drug to be sent, and so I think that's the key. Yeah, I certainly, you know, think that certain subspecialties of medicine dermatology, other types who are very used to seeing you know compounded medications right, because so often the medications they're using ophthalmology just literally don't exist right and they absolutely rely on compounded pharmacies.

Speaker 2: 20:26

I think this is a little bit different because I think there is the thought, for better or worse, that chicanery can occur, and I think that's the key is less. You know, here's a prescription for X patient for Y semiglutide, and they're going to go to a compounding pharmacy to get it filled. I don't think there's the problem. I think there's a lot of questions again about these kind of online or med spas that they're literally handing them month supplies of the drug. I think that's the question.

Speaker 2: 20:57

Yeah, well and again, let's talk about telehealth forms and about med spas.

Speaker 3: 21:01

I'm going to make some sweeping generalizations. So if you'll allow me to speculate, I would suspect that the majority of dispensing of compounded GLP-1s right now is between an individual doctor and a patient and the prescription is filled by a state-licensed compounding pharmacy. With the telehealth platforms there are also contract pharmacies that fulfill for the telehealth platforms and Tennille can address this more fully. The question there for the pharmacy that is doing that fulfillment is is there a legitimate patient prescriber relationship? And then you've got med spies and again sweeping generalization. But generally speaking those don't tend to be owned by pharmacies. They tend to be owned by physicians et cetera.

Speaker 3: 21:50

And it's our understanding that some of the compounding that goes on with those med spas is physician clinic compounding, which is honestly regulated differently than pharmacy is regulated Generally speaking. Oversight over that. Well, there's some question of who actually has authority. Pharmacy boards would tell you that if a physician is doing compounding themselves, the pharmacy board doesn't have much authority to regulate. And of course the medical board is looking at that and saying, oh, it's the board of pharmacy because it's compounding, but a physician is doing it. And so I don't have the same confidence, honestly, in some of the compounding that might be going on by a physician and his or her staff. That might be going on by a physician and his or her staff, as I do for the compounding that we go on with a state-licensed sterile compounding pharmacy.

Speaker 3: 22:39

Tenille, you want to add color there?

Speaker 4: 22:41

Sure. I would just like to point out that med spas are not pharmacies. That's not compounding. Med spas are entirely other businesses. There's two main types of categorization of compounding pharmacies 503A pharmacies and 503B pharmacies.

Speaker 4: 22:54

503a pharmacies must dispense patient-specific prescriptions written by an individual provider for an individual patient. If you can walk into a med spa and step on a stegale and get handed medication, there's a 0% chance that could be specific to you because there's not been enough time for a prescription to be sent and sent back. There are med spas that could be potentially sourcing office use compounded semaglutide from 503b outsourcing facilities. Those are bigger organizations that must follow CGMP guidelines so they're held to a higher standard than 503a pharmacies and they're allowed to compound in bulk for office use or office administration a patient. All they would need to do when they get receive that.

Speaker 4: 23:39

You know that prescription medication. It would legally have to have a label on it. You would be able to tell where it comes from. If it comes from joe's abc pharmacy, there'd be a very good chance that, like, how did that happen? Like you know, this is supposed to be a very good chance that, like, how did that happen?

Speaker 4: 23:52

Like you know, this is supposed to be a patient-specific prescription, but if it came with the name of one of these very big outsourcing facilities, I think that you might have a better sense of safety in the product because of the rigorous standards that those guys must follow. But it's kind of the same. It's like people see these advertisements for med, spas or telehealth companies and we keep having to correct yes, but that's not pharmacy. Those are separate companies. They have their own business models and we should ask them where they're getting their semaglutide, because it shouldn't, in the normal way of doing pharmacy, be from a 503 pharmacy, unless there is some time between the patient visit and either the patient being shipped or picked up the medication at that clinic at a later date.

Speaker 3: 24:42

But if it's instantaneous, that doesn't seem like it goes with the 503a model, right, yeah, so talk a bit about real quickly the, the, the process a pharmacist goes through to validate a prescription, and that, that relationship that I mentioned yeah, and yeah, I'm sure jeff is, you know, familiar with the triad, the, you know, pharmacist, physician, patient relationship.

Speaker 4: 25:03

pharmacist has a duty to you know, make sure that a prescription written for a patient is written under the, you know, typical prescriber, patientpatient relationship status, like they can't just fill things based on a patient filling out a questionnaire and we have, you know, that corresponding responsibility to ensure that the patient was seen in good faith. Telemedicine does make that a little more challenging because there can be asynchronous visits and things like that, but it is the pharmacist's duty to make sure that that prescription was written by an appropriate prescriber for an appropriate patient, for an appropriate indication.

Speaker 1: 25:41

If a patient is going to a med spa, is the suggestion to have the patient ask where they're getting that from and ensure that it's a 503b? What would be the recommendation? Because I think pharmacists get that question like how do I know? Um, you know, because they're just going in like just trusting the system that's what I would do if I was a patient.

Speaker 4: 26:05

Um, if you get a vial and it's not labeled, or any, you know, if you get pre-filled syringes without a label on it, like I, you know, you know I wouldn't that's a red flag, but I think patients don't know that.

Speaker 2: 26:15

You know what I mean.

Speaker 1: 26:16

Like I think they're so trusting, so that that would be like I think that's.

Speaker 2: 26:20

I guess that's my concern is that I don't think the average patient would even think to ask and I think, in all honesty, they probably don't want to know. You know, you know they, you know, I mean I'm seriously you know, they've heard this miracle drug. They can't get it from their doctor or they can't afford it because their insurance won't pay for it. And around here in, here in Des Moines, you can get three months of semi-glutide of these spas for 700 bucks. You know, cash money on the, on the barrel head, and I think that that that you know. Yeah, I mean you know, even if they wanted to ask, I suspect they're like, well, it's probably okay, you know, and so I mean I think I think the point is is that, yeah, I mean, I think in a perfect world we would have patients say, okay, where exactly are you getting this from? Or you know, I mean can, can you tell me, can you walk me through that I? And I also suspect that that if COVID taught me anything is that the effective health literacy of the average patient is zero. So you know, I think that that that I, I, I I see where you guys are coming from and I and I get that. You know it's kind of a different model.

Speaker 2: 27:21

But I think the question my physicians ask is well, how do I know when, when, my, when my patients come to me and say, hey, I was going to go to this med spa and you know I can get a, you know, a three month supply of this stuff from the nurse practitioner there for 700 bucks? Is that a good idea? And I think that that my physicians ask me all the time that question and, I suspect, ask you guys. You know the media probably asked you guys those questions and I hate to say don't trust med spas.

Speaker 2: 27:46

You know. I hate to say you know I don't want to make a sweeping generalization because I have no doubt that there are ethical places out there that are using 503A pharmacy, you know that are actually getting know. We can't do that. So I wish there was an easier way, you know, like I wish I could just say you know, you know if, if, if the spa or wherever they're using it has the Alliance for Pharmacy Compounding Approvals, you know, symbol on it, you can trust them sort of thing. Right, and if, and if there is a if there's a way short of calling them or doing that. I think that would really help my providers a lot.

Speaker 3: 28:33

Yeah well, we are not good housekeeping. I wish we were. We don't necessarily have a seal of approval, but I do think if the patient's going to a prescriber in the first place, the prescriber should at least consider whether or not he or she can write that script for that particular patient and send it to a state licensed pharmacy, rather than having the patient go to a med spa and again, I'm not anti-med spa, I'm sure there are some that are performing to the highest levels of rigor. But I also know to your point that it can be a sketchy enterprise as well and frankly, that splashes on legitimate compounding. Sketchy enterprise as well and, frankly, that splashes on legitimate compounding. And that's part of what this sort of conversation we hope to help clear that up.

Speaker 2: 29:17

The other question I sometimes guess and we kind of talked about this offline before you do occasionally see compounding orders that will have, you know, vitamins with the semi -glutide, you know, add a little B12 or a little B6. And I think, again, there's some confusion out there and, scott, I'm glad you kind of talked about this is that, well, we're kind of skirting the FDA rules because we're adding something to a compounded product that doesn't exist commercially, right? I think there's some confusion out there, that-.

Speaker 3: 29:48

Well, I would not call it skirting FDA rules. I think what the FDA rules say is if there's a clinical benefit in the judgment of the prescriber that adding that to an FDA approved drug will have that clinical benefit for the patient, then it's not skirting rules, it's well within the rules and it's serving that patient's needs. I think, as Tennille will tell you as the clinician. The question is what is?

Speaker 3: 30:18

clinical benefit. When is it a legitimate clinical benefit? The interesting thing right now is that what's being done by many, many compounding pharmacies these sterile compounding pharmacies is they are making an exact copy of the FDA approved version of the drug, and they're allowed to do that as long as the drug's on the shortage list. The drug's off the shortage list and then we enter into a world where compounders can't make a copy of the drug. But if the prescriber judges that a combination of semaglutide and something else would have a clinical difference for the patient, then they can prescribe that and the compounding pharmacy can prepare it. But again the question goes back to what is clinical difference and who gets to decide? Right?

Speaker 2: 30:58

right, right, danielle, you want to comment on that?

Speaker 4: 31:01

Yeah, I mean, some of these prescribers are asking for these kind of combinations. So you know, a lot of times the pharmacy hasn't just like decided that this is what they're going to make.

Speaker 2: 31:10

Oh, no, no, no, no.

Speaker 3: 31:11

Yeah, all right.

Speaker 4: 31:16

We all know we give pyridoxine injections to pregnant women that can't stop puking. We all know that vitamin B12 could be a problem for patients on a very low calorie diet, not eating enough fruits and vegetables. But I agree that these combinations right now aren't always necessary from a legal standpoint because pharmacies are allowed to compound an essential copy of an FDA-approved product. But when and if Ozempic and Ligovic come off the drug shortage list, there may be opportunities for patients that would benefit from these combination products and could still potentially continue to receive these kind of things that are not copies because they are novel combination products. But we don't know when that's going to happen.

Speaker 4: 31:57

Semaglutide is a patented medication but it is no longer covered under exclusivity, so it has a little bit more legal space for compounders to make alternate dosage forms or alternate combinations once it does come off the drug shortage list. Trizepatide is currently still a new chemical entity and covered under exclusivity, so that one is going to be have some different legal challenges. If you know, monjaro comes off the drug shortage list, or is that bound?

Speaker 2: 32:27

Right, I mean my, my guess is neither, and neither of those drugs will probably come off the shortage list anytime soon. I hear they're just like almost impossible to get, and I, I, I mean honestly, I think the only thing that's going to cause those drugs come off the shortage list is the triple G drug. That's probably going to get approved, you know, this year, early next, because you know it'll be one more drug in the marketplace and, frankly, the data blows even GOP one drugs out of the water, you know, as far as its ability to have people lose weight it's. It's actually, you know, at least as good, if not better, than than bariatric surgery, which is just absolutely gobsmacking, you know. So, uh, yeah, I, you know it's, I, you know. The joke is that eventually, like statins everybody will be on these drugs.

Speaker 2: 33:10

You know, I mean, you know sooner or later, everybody will be on these medications.

Speaker 3: 33:13

Well, and the indications for the drugs keep expanding. Exactly. Cardiohealth last week I saw that there were indications that it may help with Parkinson's patients. I joke, I'm waiting for them to determine that semaglutide would be great to cure male pattern baldness.

Speaker 2: 33:31

That would literally be the absolute holy grail. Absolutely yeah, if it caused your hair to go back and you lost weight. Yeah you would literally be the holy grail of drugs.

Speaker 3: 33:42

That's what I said from my lips to God's ear. I do want to say one other thing about combination drugs, because there is something going on out there that causes us concern, and it is combination drugs that are semaglutide plus substances that don't meet the criteria for compounding. They're not a component of an FDA approved drug, they don't have a USP or NF monograph and they're not on FDA's 503A bulks list. There are certain peptides where prescribers are continuing aggressively and avidly to write and send to pharmacies, and pharmacies should not be combining those impermissible substances. So they tend to be peptides BP-157, et cetera.

Speaker 3: 34:31

Fda has categorized those where they cannot be compounded. Now, the dirty little secret here and I mentioned BP-157 in particular there are others. You can walk down to your local health food store, you can go on Amazoncom and you can buy that supplement and take it to your heart's delight, but FDA has taken it, in effect taken it off the market for compounders and we are seeing some of that going on, and we would urge compounding pharmacies not to fill scripts for those banned substances and we would urge prescribers to understand that they are banned substances and you shouldn't be writing scripts for them.

Speaker 2: 35:08

Yeah, I totally agree. So last thing I wanted to touch on I don't want to take too much of your guys's time, jenna, you might have a question or two too is, uh, when we talked about this offline too, uh, not only is subcutaneous, uh, glp-1 drugs now being looked at. Uh, you know there are other dosage farming. Obviously there's an oral form of semiglutide. Doesn't seem to be quite as effective in weight loss. Probably bioavailability would be my guess is one of the big reasons but sublingual GOP1 drugs. So maybe Tenille, you could speak to you know what you know about that Cause. Again, I'm already getting questions from my docs about it.

Speaker 4: 35:43

Sure, and when providers first were asking me about sublingual forms for patients that are, you know, definitely afraid of injections or worried about refrigeration, I was like this molecule is way too big for sublingual absorption. This doesn't make any sense from a pharmacological, pharmacokinetic standpoint. However, one of the suppliers of API has come up with a novel base to put the API in that they've done in vitro studies showing that this special base will help transport the semaglutide molecule across models of the subcutaneous sublingual tissue in a patient's mouth and they're recommending that, instead of using API, that pharmacists are crushing ribelsis tablets. So they're trying to create a non-injectable, non-oral dosage form for patients that will meet the criteria for compounding after drug shortage problem is resolved. Because sublingual formulae don't exist in the marketplace and when a drug is not on the shortage list, technically you should be using the finished product for compounding. So this company is recommending crushing ribelsis tablets, putting it in this special base for sublingual absorption, and then the patient puts that solution in their cheek or under their tongue for a minute or so every day.

Speaker 4: 37:08

Supposedly it reduces GI side effects compared to oral dosage forms. I mean, we all know the injectable dosage forms have plenty of GI side effects without being swallowed. So but it's also an option to help it, you know, expand access. There's not as many sterile compounding pharmacies as there are other types of non you know compounding pharmacies in the country and non-sterile compounding is less complex, has less regulation. You know company pharmacies in the country and non-sterile compounding is less complex, has less regulation. You know it's just more accessible to patients. So it, you know, hopefully it will be a way to expand access to patients and, you know, not step on any patent toes, especially because pharmacies are supposed to be using the finished drug product to compound it, because the doses are so much smaller Sublingually they're like one milligram a day or so, compared to ribelsis, which is 14 milligrams a couple of times a day, something like that. Um, it still ends up being, you know, not cost prohibitive for the compounder to make.

Speaker 2: 38:05

Right, and as you point out, you know, yeah, I mean because it's it's not sterile you wouldn't need to put it in a 797 and all that other stuff. Again, you're, because, again, I've just barely started hearing of this. Are you hearing where the you know? Because that's the question I'm going to get asked is is it cheaper, will they probably get it for less money than, say, compounded subcutaneous GLP-1 drugs?

Speaker 4: 38:33

I haven't heard the price comparison compared to the compounded subcutaneous GLP-1 drugs. I haven't heard the price comparison compared to the compounded subcutaneous versions. You know, likely it will be less expensive than the brand name products and that's only a function of the less cost that's going to go into it from marketing and research and development, advertising, all of those kinds of things that the brand name companies have. You know, a little individual compounding pharmacy doesn't have those kinds of overhead costs to cover in pricing their medications. But I haven't heard. I would imagine if I had to guess it's probably going to be similar to the injectable product, but that is just my guess. I haven't. I haven't heard of any actual pricing, right Fair enough.

Speaker 2: 39:11

My last question you know I, I have no doubt that the, the manufacturers you know of, of the drugs are, are, you know, I'm sure they're not, you know, often thrilled about, about compounding pharmacies. You know, you know Nova, you know Nova Nordisk and Eli Lilly are probably not jumping up and down about the fact that that compounding pharmacies are doing this. You know, have trying to help patients. You know, in your opinion, what has been their message, which I'm sure has been absolutely don't do that. And you know, but you know how are, how are you, because I'm sure they're telling prescribers that you know. So what can, what can we tell prescribers to say, hey, look, you know, I get it, this is a business thing. They wanna maintain their profit margins and all that stuff, but this is an absolutely viable, ethical, legal way to deliver medications to patients who need them.

Speaker 3: 40:00

Yeah, the message to prescribers ought to be if you can acquire FDA approved Wigovia, zympic, manjaro, zetbound, et cetera, rhabelsis for a patient and that is the right prescription in your judgment for the patient, that's what you ought to prescribe. But we're in a world right now where those are hard to come by and it's not fair, it's not rational and it's not compassionate to say to a patient you're going to have to do without this life-changing medication until we can manage our supply chain better. And again, fda guidance allows it. Sterile compounding pharmacies adhere to the high and rigorous regulatory framework and I think patients can be confident that what they're getting from a state-licensed compounding pharmacy is legitimate and is going to do for them what it purports to do.

Speaker 3: 40:54

I do want to say one game that Novo and Lilly are playing is filing lawsuits against compounding pharmacies.

Speaker 3: 41:00

Now they filed lawsuits against the med spas as well, and the claims against the med spas are that the med spas are advertising generic Wegovi or compounded Ozempic and those are big no-nos under federal law, and compounding pharmacies know that you should not market using the brand name.

Speaker 3: 41:19

On the other hand, they filed six or eight both Lilly and Novo lawsuits against legitimate compounding pharmacies for following the FDA guidance about essentially a copy to the letter. They've also made statements that they have acquired injectable compounded semaglutide and found impurities that's the word they use or potency discrepancies. The problem has been that Novo and Lilly have gotten great headlines out of those claims, but nobody's asked them to show their work. Nobody has said, eli Lilly, how did a company get its hands on a prescription that was dispensed to an individual patient? And, beyond that, even if you did get your hands on it, how old was it? Had it been properly refrigerated? Because all of those matter in terms of the potency of the drug. And so, like I say, they've made great headlines, they've been two by half with it, but nobody is asking them to show their work.

Speaker 2: 42:16

Right, and that's good to hear and again, I think that's that's an important message that you know, you know, I think that it's an important message to hear from, you know, from compounding pharmacists and people who are versed in this sort of thing.

Speaker 1: 42:31

So, jen, did you have any other questions? Yeah, I just had one. That I think something you just said, scott, kind of leads into it, but we talked a little bit offline before we started that. You know. One of the issues is that you know compounding medications is complex and there are a lot of layers. I mean you referred to it. I mean I've even learned a lot of things. I'm like, okay, wait, like following through the chain, and you know what is legal, what isn't, and you know how do you talk about the different compounding pharmacies, that sort of thing.

Speaker 1: 42:56

So, scott, you know you talked about, one of the problems is physicians don't understand that at all. So if us as pharmacists are confused and this is our space and you know we only learn so much about it in pharmacy school Physicians aren't getting any of this. And so to Jeff's point and I think we've talked about it a little bit but how can we better educate physicians on this? And, as an organization, do you know of any education that we can point physicians to so that they do understand how this all works and can feel confident in prescribing what's needed for patients?

Speaker 3: 43:29

Yeah, yeah, again I want to reiterate, hopefully there will be no confusion FDA approved drugs which many of all prescribers, I guess, have some understanding of. They got it in medical school, first line of therapy. Anecdotally, I have a son who next month graduates from the University of Florida School of Medicine. He's doing internal medicine. He's headed off to Michigan for a residency. I work with medicine residents.

Speaker 2: 43:57

So good to hear. Good to hear. Good to hear he's being a primary care doc. We need primary care docs.

Speaker 3: 44:01

Yeah, we're headed to Ann Arbor next week to look for an apartment.

Speaker 3: 44:04

But at any rate he's gone through four years of medical school and has never heard about compounded drugs. So we have all these medical students coming out thinking, I mean, they've only got one arrow in their quiver and it's FDA approved drugs, and so that's part of the problem. There's not enough conversation about these therapies that are enshrined in legislation and regulation with a purpose to assure that patients can continue to get the care they need even when a drug is in shortage, and so we would urge prescribers who are interested in compounding in general compounded drugs in general, not just GLP-1s to talk with their local compounding pharmacy. I think they will find the pharmacist delighted to share what they do, and it is complex, by the way.

Speaker 3: 44:50

We work with a lot of reporters and there are no black and white answers. So if you ask me, can compounders create a copy of an FDA approved drug? The answer is no except, and almost everything in compounding is nuanced and has that except in there, and that that makes it. That makes it very difficult to understand. Tenille, you may want to talk a bit about how you have educated prescribers and maybe some suggestions for how they learn more about compounding.

Speaker 4: 45:19

Yeah, sure, I mean. I think that the you know the statement to call your local compounder is great. I think that physicians having a relationship with a compounding pharmacist, whether they prescribe compound GLP-1s, is really great. Compounding pharmacists can be a huge resource for prescribers that have patients that have difficult problems to solve. That's our entire job as compounders is thinking outside of the box, you know, looking at a patient's problem and figuring out ways to help the physician solve it, and that's what compounding pharmacists really do best.

Speaker 4: 45:51

Apc has on its website some resources for physicians talking about compounding regulatory framework. You know we have a, you know a statement for physicians on peptides. You know we can provide resources as well if physicians have questions. I think you know there's trainings that physicians can go to to learn more about compounded drugs, but that's typically in the integrative medication, integrative medicine space, you know. But I think that a continuing education topic, like like what you guys are doing, is a great first step in, you know, opening their eyes, because I think if I didn't know a lot about something either, my first instinct would be like no, thank you, because my, my, my duty is to protect my patients, and if I don't feel confident, then that would make me worry. I understand that.

Speaker 1: 46:44

Yeah, yeah, it's such a it's. It's like the, the ultimate, like clinical, ethical, legal. You know all the complexities all in this one issue. So it is. It is hard to understand and I think it is. It is their job as pharmacists to help educate physicians about that and help them feel confident in taking best care of the patient, to your point like that's the ultimate goal for all of us.

Speaker 4: 47:07

One thing I would like to point out is most physicians have no idea how many compounded drugs are being administered to their patients without their knowledge. You know there's a lot of shortages in the marketplace. A lot of 503B outsources are supplying things like lidocaine injections, bicarb, all sorts of stuff like that to hospitals that are being routinely administered to their patients as part of their therapy, and none of them are being like oh no about that kind of stuff. There's just kind of a lot of hysteria on this side because of the media coverage, but you know, if they really knew how many compounded drugs are being administered, they might have a little bit more ease of mind.

Speaker 1: 47:43

Yeah, I think that's also within the four walls of a hospital and when you talk about ambulatory and you know that gets a little scarier. So yeah, that's a great point.

Speaker 2: 47:52

But yeah, and I think I think that's the thing is that the again the general public doesn't realize that to your point, that lots of medications in a hospital setting are outsourced to 403Bs or are made by admixtures in our own hospitals. So last word, scott Tennille what's the message you want our listeners to walk away with?

Speaker 3: 48:13

Well, we appreciate this opportunity. As we said, compounding has been around literally for thousands of years. It's where pharmacy began. It's been a part of the American health care system for generations. It's just been sort of hidden from the sort of hospital compounding that we've just talked about to. We haven't even mentioned veterinary compounding, where compounding is almost the norm rather than the exception. I guarantee your listeners know somebody, or maybe themselves have taken a compounded medication, and I think the GOP1 craze phenomenon whatever you'd like to call it is now shining light on a practice, hopefully in a positive way. A lot of what we've seen is not very positive, and our job is to demonstrate that this is more than legitimate. It is life enhancing and that's what compounding pharmacies do, Right.

Speaker 4: 49:04

Danielle, I would just like to, I guess, kind of reiterate that a lot of the things being covered in the media are not compounding, but they're being confused with compounding. And if a patient does see a practitioner and get issued a prescription for a compounded medication, if they want to call and speak to the pharmacist, a pharmacist will have a duty to speak to that patient and answer questions. If you can't get that, you know those answers then you know it might be something that you might reconsider taking or injecting into your body. And I appreciate so much the chance to be able to talk to you guys and, you know, be able to hopefully reach your audience. And if anyone in your audience has questions or needs clarification or wants to know about testing processes or anything related to the compounding of GLP-1s, they're more than welcome to reach out to me and I am happy to have a phone call, send them an email, whatever they want, to walk them through the process, to help you know, further, educate your members on how this all works. Really appreciate that.

Speaker 2: 50:07

Yeah, and Jen, I'm sure we can put the website in the show notes, you know? Yes, absolutely, I was just going to say that too.

Speaker 1: 50:13

I think we'll put Tennille, if you're okay. Website and the show notes. You know, I was just going to say that too. I think we'll put um to Neil. If you're okay with that, we'll put your contact information, um, in the show notes and also the. The website is a four a and then the letter or the number for uh pcorg. So if anybody has more questions or wants to know more about your organization, um, this has been so helpful. I agree, and so I'm really just appreciative of both of you and your time. I know you're just coming off of a big conference, so I know how that goes and your time is is limited and especially with this topic, I'm sure you have lots to do. So I really appreciate you being on with us today and that's it for this week. So if you're a CE plan member, be sure to claim your CE for this episode by logging into CEimpactcom and, as always, have a great week and keep learning. We'll talk to you next week.