Experts Weigh-In on Compounded GLP-1/Semaglutide Solution

There are risks associated with obtaining compounded medications from unregulated sources or through telehealth platforms that may not prioritize patient safety. The industry experts emphasized the importance of seeking out reputable compounding pharmacies and consulting with qualified healthcare providers to ensure the safety and efficacy of compounded medications. Additionally, they touched on the need for a stronger regulatory framework to oversee the compounding industry, ensuring consistency and quality standards across different states.

Peter Ax, Founder and CEO, UpScriptHealth on the safety of compounded medications:

“We're probably seeing about 10% of the [GLP-1] market going into various compounding forms. You're looking at what is perhaps as much as a billion dollar marketplace in compounded drugs right now…If you want to talk about the risks associated with that of purchasing drugs on a compounded basis, you really have to think about risks in two levels. One is, there's the risk of the physician interaction and how robust it is and how meaningful it is and how safe it is. And then the second one is, how safe are these compounded drugs? These are not the branded drugs being manufactured in FDA facilities. They're being manufactured in compounding pharmacies, which are licensed and are inspected, but there's certainly more of a risk when you purchase a drug that is compounded than it is manufactured in an FDA approved facility.

I think you have to think in terms of risks two levels. You need to deal with a reputable firm online that's providing a robust telehealth offering or a robust interaction with clinician that's going to ask about your medical history. That's going to learn about potential drug interactions. That's going to speak to you about how to effectively use these drugs and how to safely use these drugs. And then secondly, do a second level of assessment of, okay, what is this compounding pharmacy? Who are they that I'm purchasing these drugs from? Are they properly licensed? Have there been any regulatory issues against them? Have there been any lawsuits against them? Have there been a patient care problem, etc.?

If you're going to purchase drugs online, if you're going to have interactions with clinicians online, you really have to do your homework. You really have to be smart about this, because, let's face it, we are investing potentially, really meaningful drugs that interact with our systems, and we need to be really cautious about what we're buying.”¹

Scott Brunner, CEO, Alliance for Pharmacy Compounding on the safety of use and identifying compound pharmacies vs. illicit actors:

“Counterfeit and illicit substances are a scourge in our healthcare system, and with the growth of GLP-1s, this phenomenon that we're seeing more and more counterfeit activity is taking place. We are seeing, not only sellers of substances that purport to be GLP-1 drugs. We're seeing entities that purport to be pharmacies that are not. There was a study a few months ago that had indicated that as many as 40% of online pharmacies were fake, which means not registered with not licensed by the State Board of Pharmacy or any of that. And those websites, they pop up. Somebody takes them down, and they'll pop up in another iteration. Many of them are selling what purport to be prescription drugs without a prescription, and it's just remarkably dangerous.

One of our concerns is the way that drug makers and others have conflated legitimate compounding with the illicit actors out there. Those aren't comparable. Those are those are two different things. There was a letter just recently sent from the Republican leaders of the House Energy and Commerce Committee to FDA asking FDA for a thorough report on how the agency is confronting this, the counterfeit activity out there, because patients are absolutely being harmed by this.

Many patients will meet one on one in person with a prescriber. It might be a physician, but it could be a nurse practitioner or a PA the provider in that situation determines that a [GLP-1] drug, is appropriate for the patient. In this period of shortage, they are likely to determine the compounded version is appropriate for the patient, and that provider will write a script for a compounded drug. I want to make it clear; a patient is prescribed what the provider writes. A provider can't write Wegovy on a script and hand it to the patient, then the patient dashes down to the pharmacy, and the pharmacist looks at the script and says, ‘Oh, well, I don't have any of that. I'm going to compound it’—It doesn't work that way. If a prescriber wants a patient to have Wegovy, that's what the pharmacy must dispense if it has it.

On the other hand, if the prescriber writes compounded, semaglutide and some dosage strength. That's the script that goes to the pharmacy. In those instances, when the patient is actually interacting with their prescriber, they can have high confidence that the prescriber may recommend a pharmacy or may ask them which pharmacy that do they want to use. Not all pharmacies are equipped to prepare those drugs, so it may not always be the normal pharmacy for the patient. One of the things patients can do in that circumstance is say, ‘hey, Doc, have you have you used this pharmacy for long? What do you know about them?’ Prescribers are generally familiar with the pharmacies that they're sending scripts to, and so that's a reasonable question to ask.

We are in this era now, though of telehealth platforms and telehealth platforms have become quite active in dispensing compounded GLP-1 drugs. Well, a patient who is prescribed a drug via telehealth platform is not meeting in person with that prescriber. It could be via video. It may be synchronous or asynchronous, etc. One of the things that the patient can do in that circumstance, if they want to know that the pharmacy the telehealth platform is sending their prescription to, is to look up the pharmacy on the State Board of Pharmacy website. In order to be a legitimate pharmacy, you have to be licensed by the state in which you reside. The pharmacy resides and any state to which they ship drugs. So, a patient can very easily go to the Board of Pharmacy website, look at the name of the pharmacy. If it's not there, there's a good chance they're not licensed in that state, and they may well be an illicit actor.

We have created APC, the Alliance for pharmacy compounding, has created a tool on our website that we call is it legit? And it is a shortcut for patients to be able to go to the licensee lookup on their State Board of Pharmacy website and type in the name of the pharmacy to make sure that it is indeed a licensed pharmacy. Now, in other instances, patients may want to talk to the prescriber, to the to the pharmacist. Nothing wrong with that. And if you are using a local pharmacy and you want to have some confidence that that GLP-1 drug that has been compounded for you is what it says it is talk to the pharmacist. They're going to tell you about the API they use and how they acquire it, and the third party testing that they do, and a pharmacy that is not willing to have that conversation with a patient is not a pharmacy you want to use.

So as a patient, just asking some questions and maybe letting your fingers do a little bit of walking in in looking up the pharmacy on the board of pharmacy website, are easy ways that you can have confidence that you're dealing with a legitimate, state licensed pharmacy.”^2,3

Tenille Davis, Chief Advocacy Officer, Alliance for Pharmacy Compounding, on strengthening the regulatory framework for compounded medications:

“We're always in kind of this delicate dance to balance patient access with patient safety. If we make the rules too stringent, sure, it'll make things really, really, really safe, but it'll be too expensive or too onerous for pharmacies to comply where patients won't be able to afford the resultant, you know, medications that come out of that. That being said, there's been times in the past where there's been some bad players in in the space that have done real harm to the reputational image of compounding pharmacy. And in those instances, it was less that they were the rules needed to be strengthened. It was more that those pharmacies weren't following the rules that even existed in the first place.

So, I think that to strengthen what we need is regulatory certainty. We need the same rules to be enforced, and we need that those rules to be enforced fairly and uniformly across all states and have the same expectations, whether you're in one state or the other. So, the rules don't necessarily need to be strengthened. There was nothing you know really ever shown that was wrong with the rules as they are. It's just that they need to be enforced more you know, more fairly, more accurately, more evenly.”⁴

References

1. Counterfeit Weight Loss Drugs & Potential Health Risks
2. Advantages & Disadvantages of Using Compounded Medications
3. Identifying Illicit Actors vs Compound Pharmacies
4. Strengthening Regulatory Framework for Compounded Medications