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Conquer Your Weight
Episode #95: What's the Deal with Compounded GLP Medications?
Show Notes
October 16, 2024
In this week's episode, we'll talk about compounded GLP-1 medications. We'll talk about why they are being made, what to consider in terms of safety and efficacy, and why everyone has been talking about tirzepatide so much over the last two weeks.
To learn more and to work with Dr. Sarah Stombaugh, please visit www.sarahstombaughmd.com
Are you taking a GLP medication? We are thrilled to share we are offering an online course, The GLP Guide, to answer the most common questions people have while taking GLP medications.
To sign up, please visit: www.sarahstombaughmd.com/glp
Transcript
Dr. Sarah Stombaugh:
Before we get into the episode, I am thrilled to announce we are launching an online course, The GLP Guide. The GLP guide is a must have resource for patients who have been prescribed any of the GLP medications such as Wegovy, Ozempic, semaglutide, Zepbound, Mounjaro, tirzepatide, Saxenda, liraglutide. There are a lot of them and this course is available for anyone to purchase. We often hear from people who haven't been given much information about their GLP medications. No one has told them how to handle side effects, what nutrition recommendations they should follow, or what to expect in the longterm. And it can be really intimidating and simply frustrating to feel like you're alone in your weight loss journey. With the GLP guide, you'll get access to all of the answers to the most common questions for patients using GLP medications, not sure how to use your pen, struggling with nausea, wondering how to travel with your medications. We've got you covered for only $97 for one year access. This is an opportunity you do not want to miss. The course is launching on October 1st. For more information and sign up, please visit www.sarahstombaughmd.com/glp. You don't have to be on this journey alone. We are here to guide you.
And now for today's episode, this is Dr. Sarah Stombaugh and you are listening to the Conquer Your Weight podcast.
Announcer:
Welcome to the Conquer Your Weight podcast, where you will learn to understand your mind and body so you can achieve long-term weight loss. Here's your host, obesity medicine physician and life coach, Dr. Sarah Stombaugh.
Dr. Sarah Stombaugh:
Hello everyone and welcome to today's episode. We are talking about a very hot topic, which is compounded GLP medications. Now this is something that's been going on really over the last one to two years, but it really came to a head just last week when there was a announcement that tirzepatide was no longer on the FDA shortage list and things just totally blew up. So what I would like to do is take a moment, take it all the way back to talk about what are compounded medications, what is happening with these medications, specifically the compounded GLP medications, and then what is going on right now and why is everyone talking about, oh my gosh, maybe these medications will not be available any longer. So I will get you all of the information. My goal here is to really be factual, provide information about what is going on.
This is not any sort of endorsement for any specific medication, any specific pharmacy, any specific recommendation that you should take as medical advice. My recommendation is that you have questions for your own personal healthcare. You should talk with your own physician, with your own provider and make sure that you are getting answers for what will be best for you. But let me share a little bit so that you can understand a little bit more about this space because hear everything from, oh my gosh, compounded medicines are totally safe, they're totally effective, they're totally cheap. And then you will hear people like do not get those. You will definitely die. So there must be some sort of in-between and that is probably true. So let's talk about what are compounded medications in general. Now, compounding refers to a compound pharmacy making medications for patients in a way different than or in place of traditional medications.
So this can happen for a lot of different reasons. Most commonly, we're thinking about generic medications that have been on the market for a long time and that a patient might be looking for a more affordable option or maybe they're looking for it in a different form. So something that comes in a tablet, maybe they'd like it in a chewable version. Maybe someone has an allergy to a component of a medication and so therefore they need it formulated in a slightly different way. And things like this are very common and reasons that compounding even exists in the first place. So when you take a medication and make it compounded version of it, you are taking the active pharmaceutical ingredient, basically the active medication in its powder form and then converting that into the form that the patient needs. And so medications can be converted into liquids, into pills, into chewables, into suppositories, into injectables, into sublingual drops for example.
So lots of different ways, topicals, even lots of different ways that medications can be given and that may be appropriate for different things. So for some specific examples, I can think back to in practice I had a patient once who needed to take an antibiotic and it was one of those gigantic horse pills and he was not able to swallow that large pill and so we wanted him to be able to take a liquid version of the medication. But the pediatric dosing for example, would've had him taking huge, huge volumes of medication that wasn't feasible. And so we used a compounding medication in order to make that available in a liquid dose for him. Or I had a patient who was allergic to corn and there was corn starch. That was the ingredient of one of their medications. And so the pharmacy worked with a patient to make a version that would be safe for them to take.
So this happens in a lot of different capacities. Very safe thing to do, very commonly done and very appropriate in certain settings. Now when we think about compounding in general, we're generally talking about, as I mentioned before, generic medications. Medications that have been around for a long time or even if they're not generic medications because it's a very specific patient indication like an allergy for example, that it would require this patient to get an alternative form of the medication. Now what's interesting is that when we talk about new medications, we talk about medications like the GLP-1 receptor agonist. So these are the Wegovys, Ozempics, Zepbounds, Mounjaros, other medications as well. These medications that become just blockbusters totally popular, very effective medications. People are really interested in getting their hands on these medications and they'd like to get that in a safe, effective and affordable way.
And so compounding has filled that space. Now, generally when we're talking about new medications, new medications are under patent and when we think about patent, different aspects of the medication can be patented. So for example, the medication itself, like the active pharmaceutical ingredient, the molecular formula of the medication will be patented. The formula itself. So if something is an extended release versus a short acting, sometimes that formula itself can be patented. The device that it's given or delivered in may be formulated or patented rather. So a device like a inhaler or device like an injectable pen like we're seeing in the GLP medications, that part may be patented. And so a pharmaceutical company that makes a medication will patent these different parts of the medication. But each of those things are separately patented. And generally when we look at pharmacy patents, they take about a decade or so before they expire.
Now there's lots of weird things and we could get into other medications and stuff that's happened there, but what I will say is that in the GLP space, the medication itself, like the active pharmaceutical ingredient, the active molecule is patented. The formula, the injectable is patented and then the mechanism like those pens for example, are patented. So lots of different patents, maybe even more. I am certainly not a patent law expert, but these will protect these medications in the situation of other people. Then being able to make them, so when a pharmaceutical company makes these new medications, they have the sole rights to be able to make those medications and basically earn the profit off of a medication that they have developed. And that makes sense. They are doing the research, they're doing the development, they're doing the clinical trials and the FDA approval and the whole process to bring these medications to market.
And then they, by putting the patent on are saying, Hey, for a period of time we solely will benefit from this medication and from the profits of this medication. Now, in recent years, these medications have been so popular that they have gone onto the FDA drug shortage list and there is a loophole in the FDA that basically says when a medication is on the drug shortage list, that that medication can be legally made by a compounding pharmacy in order to meet the need of people who are not able to be met from the brand name medication. So when we look at medications like Ozempic and Wegovy, Zepbound, Mounjaro over the last couple of years, all of these medications have been on the shortage list. And so what that means is that there is this loophole that says, Hey, it is legal for these medications to be made in a compounding way.
And so that is what's been happening over the last couple of years is that these pharmacies have been able to make the medication legally and that is kosher and everything is okay assuming that these medications continue on the drug shortage list. Now what is interesting is there's other parts of this as well. Just because it's legal doesn't mean that it's safe doesn't mean that you're getting an effective medication. And so that's the part where people have really been cognizant of as a physician or another provider, making sure am I providing my patients with a safe option, with an effective option, with something that is going to be a good and reliable option for them. And so this is the piece that is a little bit more of a gray zone. And so when we look at what does it mean to be safe, what does it look to be effective from a safety standpoint, these are medications that you are injecting into your body.
And so they need to be safe. Our GI systems, if you swallow a pill for example, our bodies do a pretty amazing job at handling small amounts of toxin, but we inject them into us and things like bacteria for example can be deadly. And so there is no risk tolerance here for any sort of breaches. In sterility, you want to make sure that what you are getting is completely sterile, completely free of any sort of contaminant. You want to be getting a very safe medication. Now safe is important, but sterile saline salt water is safe. So you also want to make sure that you're getting something that is effective. When we think about effectiveness, the most effective option is going to be something that is an identical copy to the branded medications. So that will mean that if there is a chemical analysis done of the product that it shows, yes, side by side we do the brand name, we do our compounded version.
And yes, these are identical products. Now there are plenty of stories of places that are making versions that are not identical versions that are similar to but not the exact same as, and I will caution you that that is extremely, extremely sketchy. You want to be getting something, you only want to be getting something that is an identical copy to. When I think back to organic chemistry, for example, in undergraduate years of college, if you take a single atom and change that, if you take a single bond and change that, this makes a major difference. As a simple example, if you think about the difference between carbon dioxide and carbon monoxide, this carbon dioxide is normal. It's in our air, it's when we breathe in, we breathe in oxygen. When we breathe out, we breathe out carbon dioxide. It is a normal thing, certainly you can have too much of it, but it's common.
No one's thinking about that as a dangerous substance or a dangerous gas. When we look at carbon monoxide, which is only one oxygen different compared to carbon dioxide. Carbon monoxide is a dangerous poisonous gas that can quickly kill you if you are exposed to high amounts of it. And so you don't want to be off by just a tiny little bit here. You want to be getting an exact copy of the medication. So the safest options are those that are sterile, those that are an exact copy of the medication and companies that are demonstrating consistently batched by batch. Are they testing these for sterility? Are they testing these to make sure that these are identical copies, that they've not gotten a contaminated active pharmaceutical ingredient that when a patient gets this medication that they are actually getting what they say that they are getting. And so these are the things, is it safe?
Is it effective? Is it actually what it says that it is? Because you don't want to be getting 99% similar. You want to be getting the exact same thing. But when we're thinking about getting the exact same thing in a generic version made by these compounding pharmacies, this is a weird drama has really come up over the last couple of weeks here because the loophole that allows us is because of the FDA shortage list. So these medications, Ozempic, Wegovy, Zepbound, Mounjaro, over the last couple of years, these medications have been on the shortage list. And what that means is that Ozempic and Wegovy, those are the same product. Those are both semaglutide products. Ozempic being for the treatment of type two diabetes, Wegovy being for the treatment of obesity, both semaglutide. And then we've got Zepbound and Mounjaro. These are both tirzepatide products. So Zepbound being for the treatment of obesity, Mounjaro being for the treatment of type two diabetes, these are both tirzepatide products.
So because of shortages of these medications, it has been legal to compound these medications, the semaglutide and tirzepatide medications over the last couple of years here. Now that may not always be the case. These medications, they've been very popular, they've been on the shortage list. And Eli Lilly, the pharmaceutical company that owns the Zepbound and Mounjaro medications, Eli Lilly has been cracking down really hard about tirzepatide people who are making the compounded versions of it. And they have been sort of pressuring the FDA over the last couple of weeks here to say, okay, our medication is not under shortage anymore. So that medication was removed from the shortage list about a week and a half ago. It raised a lot of drama. The Outsourcing Facilities Association, basically a group that represents many large compounding pharmacies sued the FDA to say, are you sure that this shortage is actually over because we don't actually think that the shortage is over.
Have you thoroughly investigated this? We still hear a lot of reports of patients getting this medication or having trouble rather getting this medication. And by the way, you told us this super abruptly, this is a major interruption to patient care. And so the OFA sued the FDA saying all of these things, you really shut this down abruptly without really much evidence. I think you need to do a more thorough investigation. The FDA at the end of last week then came back and said, okay, you're right. We will do a more thorough investigation. We'll be doing that over the next month or so, and by November 21st we will come up with a formal report evaluating the shortage of their true appetite medication and then deciding moving forward what that looks like. And hey, between now and then it is legal to continue compounding these medications. So we'll see this is a evolving situation, but keeping in mind there's a lot of big players in this, both on the compounded medication side, both in the pharmaceutical side, we're going to see a lot play out legally and fighting over some of these patent laws and how these things are effective, how these things are safe and how these things are able to be accessed a lot, a lot, a lot is going down with that.
And so the things that I really want to point out are this, if you were getting a compound medication, it's really important that you know that you're getting a safe option. If the medication is doing nothing for you, you feel like you have no response to the medication. That is often concerning to me that someone may be getting a knockoff version that is really a knockoff. It's not an identical copy to the medication. It's not a generic version of it, it's really just something similar to but not exactly the same. You want to know that the compounding pharmacy that has been recommended to you, that your provider is ordering from that they are following safety regulations. There are 503B facilities, there are 503A facilities. There are non-registered facilities to basically there are facilities, everything from robotic state-of-the-art, the most impressive facility you can imagine similar to pharmaceutical companies.
And then there's Walter White mixing up something in his basement and that's an extreme, but then there's everything in between. And so you want to know, am I getting something that's coming from a state-of-the-art facility where it's safe, where they're testing for the sterility, where they're testing for the efficacy to make sure I'm getting what I say that I'm getting. So that piece is really, really important and understanding what is your provider's plan if these shortages go away, if these medications are no longer available. Now, I don't think this is going to be an abrupt thing that happens given the recent events here over the last week and a half or so. We've seen that there's a lot of people who have a lot of stakes in this field, but it's something that may not always be available. And we're talking about the next 10 years or so before some of these medications are off of patent and being able to be made just flat out legally, easily.
Now there's a bajillion loopholes. We start getting into legal stuff, and I've had all sorts of questions raised when I've talked about this on social media. What I will say is this, it is an option. It is an option that may be something to consider to talk to your provider about. There are people who are doing it safely, there are people who are doing it less safely. It may not always be available as an option. And so you need to know if that weren't available, are there other medications that I could switch to from a brand name perspective? What would be the plan? How would you support me with this? Because what we realized in the last week or so is that there were a lot of patients who felt like they were just left completely high and dry, felt like they had been completely blindsided by this decision.
And that is not a situation that we want anyone to be in. And so some considerations to take into mind. If you have questions, always feel free to reach out to me info@sarahstombaughmd.com. We would love to address those for you in our social media content on our online platform, The GLP Guide, that online course that we have created to be able to answer things. And so reach out, let us know. We would love to help address these. Clarify what are muddy waters right now. And as I said, this is an evolving situation. I will provide an update I think over the next month or two as we have a little bit more information about what this will look like moving forward. But right now my recommendation is know where you're getting your medication, know how it's available for you in terms of what are the loopholes that allow this to continue to be the case moving forward. If there are interruptions, how would your provider recommend handling that situation? And that's it. Lots of stuff that's changing here. So thank you so much for joining me on today's episode. We will see you all next week.
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