Your Checkup

Compounding Pharmacies vs. FDA-Approved: The Weight Loss Drug Dilemma

Ed Delesky, MD and Nicole Aruffo, RN Season 1 Episode 55

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The meteoric rise in demand for weight loss drugs has created widespread shortages, leading to the emergence of compounding pharmacies as an alternative source for these medications.

• Compounding pharmacies create custom medications by combining, mixing, or altering ingredients to meet specific needs
• Unlike FDA-approved medications, compounded drugs don't undergo the same rigorous safety and effectiveness reviews
• Dosing errors with compounded weight loss medications have led to serious adverse events requiring hospitalization
• Confusion between units, milliliters, and milligrams contributes to potentially dangerous dosing mistakes
• Some compounding pharmacies add unproven ingredients like vitamins, L-carnitine, and NAD to their formulations
• The long half-life of these medications (about one week) means overdose symptoms can persist for extended periods
• Pharmaceutical companies have responded with direct-to-consumer models offering FDA-approved versions at reduced prices
• Eli Lilly now offers Zepbound in vial form for approximately $499/month versus $1000+ for pen versions
• Novo Nordisk's NovaCare pharmacy provides direct-to-patient delivery of Wegovy single-dose pens at similar price points

Please talk to your healthcare provider about what option might be right for you, as these medications require careful consideration and proper dosing is essential for safety.


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Production and Content: Edward Delesky, MD & Nicole Aruffo, RN
Artwork: Olivia Pawlowski

Ed Delesky, MD:

Hi, welcome to your checkup. We are the patient education podcast, where we bring conversations from the doctor's office to your ears. On this podcast, we try to bring medicine closer to its patients. I'm Ed Delesky, a family medicine resident in the Philadelphia area.

Nicole Aruffo, RN:

And I'm Nicole Aruffo. I'm a nurse.

Ed Delesky, MD:

And we are so excited you were able to join us here again today. So if you want to hear more about what's going on in our lives and a little ditty about fun, stick around for the next five minutes or so. But if you are interested in getting right to the topic, maybe you skip ahead. Find a chapter marker, or somewhere between five and ten minutes is when we'll start talking about the content of interest. But we do have to tell you about our beverages that we had yesterday and the experience that we had next to us. What beverages did we had yesterday?

Nicole Aruffo, RN:

and the experience that we had next to us. What beverages did we get? We got extra dirty Grey Goose dirty martinis with blue cheese olives and they were delicious. I took like two sips of mine. I'm doing this like I'm like a headache girly and I'm finding that there are a lot of things that trigger a headache. One of them is alcohol. And then I have a headache that lasts for like four to five days, which, like some might call a migraine, and some might call migraine yeah.

Nicole Aruffo, RN:

I've done everything except like go for my neurology followup. So, however, things seem to be better anyway. So I just needed to get a little taste of the good nectar. That was a really good dirty martini, but then you finished it and I eat the olives.

Ed Delesky, MD:

Yeah Well, and I use you as a reference because my palate is not so sophisticated that sometimes I can't tell what is good and what is not good, and knowing that that is right down the street, that is an excellent little tidbit to add to our neighborhood thing. Speaking of neighborhood, what about the people that were sitting next to us?

Nicole Aruffo, RN:

they had a wild dining experience yeah, that was so annoying. We were sitting next to these two girls who were there before we got there and they won like the one girl, not the one that was like next to you, the one, like next to that girl. Yeah, was so rude to the waitress, so like we were sitting at the bar and then, like there are like certain staff that are like serving the the bar, the bar, so like it wasn't like the.

Nicole Aruffo, RN:

we were at the bar but we were on like the oyster section. So like it wasn't like the we were at the bar but we were on like the oyster section.

Ed Delesky, MD:

so like it wasn't like a bartender was right there so yeah, with like larry the lobster staring at us while he's like grooving in the ice, yeah and the one girl was like, so rude.

Nicole Aruffo, RN:

It was the girl that, like, came to take our order was so rude to her yeah which, like I like right off the bat, that was like 30 seconds into us being there and I just personally think, if you are rude, to like wait staff you're just like the lowest form of a human and it's like yeah, what are you doing?

Nicole Aruffo, RN:

yeah, like why are you being like this? Um, like someone's, like bringing you your food and your drink and like accommodating you, just like be polite to them, like where's your mother, like where's the farm you were raised on, whatever lowest bar you can hit yeah.

Nicole Aruffo, RN:

And then she, um, oh so she ordered like oysters rockefeller. And then she's telling her friend she's like I think I'm gonna get like however many raw oysters. She's like okay. So then the waitress comes back. She's rude to her again because, like she just like wasn't articulating, like she was just like speaking things at her that like didn't make sense. So she's rude to her again because, like she just like wasn't articulating, like she was just like speaking things at her that like didn't make sense. So she was rude to her again. Whatever comes back.

Nicole Aruffo, RN:

And then I think, like the other, like her other co-workers were like okay, we'll like switch out, because I'm like another girl came and like another random guy came and whatever, and they were like switching out. And then so she gets her raw oysters and then she eats half of them and then she tells her friend, you know, I don't really want the rest of these. Like I'm going to send these back and get some more oysters Rockefeller. And I'm just sitting there I'm like that's not like how it works. Like obviously, this is obviously your first time like in a restaurant before, but OK. So then she asked, and they were also. Another thing she was doing was just like flagging down, like any staff member who, like clearly wasn't their waitress, or anyone who, like they had seen before, she just like someone could nonchalantly be passing yeah, or it was like one of like the like busboy people or like the barbacks, or like someone who like didn't have on the server uniform and like.

Nicole Aruffo, RN:

So she like flags down this like guy and asks can I send these back and get whatever? And he's like I like. He's like I don't know who you are like, also, this probably isn't my job. He's like uh, I guess I'll go ask. So then I guess it was like one of the managers, because he had like regular clothes on. She asked to I want to send these back because I want something else.

Nicole Aruffo, RN:

And he's like okay, like you can't do that, like you ate half of them like you, can't it's not like it came out and like something was wrong with it, or like we brought you the wrong thing and like that's different to like send something back, which I also feel is like whatever sure, like it kind of went over the threshold yeah, like you ate half of it yeah you kept eating it, so like you didn't not like it, whatever.

Nicole Aruffo, RN:

yeah, he's like I'm pretty sure she was trying to just like get away with like that part of the bill. But then the manager guy was like I mean, you can order more of something, but and like I'll take this from you, but this isn't like a send back, you can order something else in addition to like.

Ed Delesky, MD:

You're entitled to not like something, but like that doesn't't?

Nicole Aruffo, RN:

you don't like get to not pay for it, or like send it?

Ed Delesky, MD:

back like you made a mistake yeah, um, so that was that.

Ed Delesky, MD:

And then these two girls were like facetiming someone the entire time which was kind of distracting for our experience, which was like annoying also, like why didn't you just invite this person fair, you could have talked to invited them it was so annoying yeah, and you know, they lingered longer than we were there and as we transitioned our evening to home, came back, fed ollie, and then we started walking to there's a place where you can go and get beers bring them home a little more like niche environment. And we are walking down the street and all of of a sudden we hear this guy yelling help, help. And then we see this little puppy oh, he's so cute who is just zigzagging in out of the street, in around cars and the way that people came together to stop traffic. One woman got out there and she was like Moses and she just put her arm up and she was like she was like parting the Red Sea.

Nicole Aruffo, RN:

She was like stop and she like for some reason, like cause we like saw that, and he's like, oh my God, the puppy. And then I saw this little, like tiny little puppy, like clearly not like trained or like doesn't know, like any commands or anything, Like it was like a really young puppy got out, I guess, and this guy it was like I don't know what kind of puppy it was, I think it was like mini golden doodle or something like that. And I was telling Eddie, I was like I'm pretty sure this had to have been like his, like girlfriend's dog or something, Cause I'm like not to be that person but like no guy, like a guy like him is not going to have like this little tiny dog.

Nicole Aruffo, RN:

There wasn't like a female influence. Um, oh yeah. So then, like we saw it, I don't know, I just like blindly started walking in the middle of the street because for some reason, like this woman in the middle of like, I just felt safe with her. She meant business and I was like no one's gonna drive. I'm safe in the middle of the street yeah, so traffic was stopped.

Ed Delesky, MD:

You know, a gaggle of people came around and kind of cornered the puppy.

Nicole Aruffo, RN:

Everyone was circling the dog.

Ed Delesky, MD:

And then eventually the puppy darted back into the guy's arms and he just sat there and his underwear was not white anymore. There was so much secondhand stress. What a beautiful moment to know that that ended well. But that was a really intense thing to witness and it had a happy ending, which I was really happy about, because that would have been devastating to see it otherwise oh my god. Yeah, which we don't have to think about because it didn't happen. All right. So what are we going to talk about today, nick?

Nicole Aruffo, RN:

Well, today we're talking about more about weight loss drugs, but specifically about the compounding pharmacies and all that. Yeah Right, absolutely.

Ed Delesky, MD:

And a little bit about.

Nicole Aruffo, RN:

I didn't fully read the outline yet.

Ed Delesky, MD:

And a little bit about how, in response to shortages and the rise of compounding pharmacies which we will explain how the drug companies are responding in their own way, in a kind of interesting way that actually directly impacts patients.

Ed Delesky, MD:

Of course, we've talked in this show on prior episodes that there is an extremely high demand for these GLP-1 receptor agonists, weekly injectable medicines like FDA-approved drugs like Wagovi, which come in pre-filled pens for weekly dosing, or Ozempic, which has multi-dose pre-filled pens for dosing, or the oral cousin, ribelsis, which is the same medicine, semaglutide, in oral form. There's also Zepbound, which is a terzepatide-based component specifically put in the weight loss bucket that has two active ingredients, a GIP and GLP receptor agonist, and again, it's indicated for adults who have obesity or who are overweight and have at least one weight-related medical problem, and it's also FDA-approved for moderate to severe obstructive sleep apnea and people who have obesity. And so because they're so effective at what they do treating obesity there is an incredibly high demand. And I think everyone saw this come about is that, like everyone who was on these medicines was having a tough time getting these medicines, and so the impetus for this episode was to discuss the response to that demand, which was the rise of compounding pharmacies.

Nicole Aruffo, RN:

Tell us a little more about how we got here with needing to compound these medications.

Ed Delesky, MD:

Yeah, so, like we were talking about, because of this extremely high demand, there was a supply constraint placed on many of the FDA approved products, and so, to circumvent that, people started going to get the medicine other ways, in compounded versions, and so I think it's important that we define our terms. So drug compounding is the process of combining, mixing or altering ingredients to create a medication tailored to an individual person's needs. Now, this is not a new concept. This has been around. You have the most experience between the two of us with these meds yeah, compounding pharmacies are not like a new thing.

Nicole Aruffo, RN:

Since all of these weight loss meds I mean, it's probably a new thing that kind of like the general public is now more familiar with. But any med you know kind of variation can be compounded. It's just the way that the medication is made in the pharmacy more often, um, some of like the more specialty meds outside of like the weight loss meds, the more specialty meds that you can't get it just like a regular commercial retail pharmacy, or if they have to be made a certain way because like a walgreens can't compound a med and they can't, you know, they don't have the whatever you need sure the particulars to compound it.

Nicole Aruffo, RN:

Or if you need like a medication in a liquid form but maybe it doesn't come in a liquid form already, they can like do that at a compounding pharmacy and you know things like that gotcha.

Ed Delesky, MD:

Are there any meds that like? Are you are aware of that?

Nicole Aruffo, RN:

I mean all of like the weird meds. I know, like a meprazole is a big one in peds.

Ed Delesky, MD:

Okay.

Nicole Aruffo, RN:

Um, that doesn't like. Come in a liquid right off the bat.

Ed Delesky, MD:

Ah, yes.

Nicole Aruffo, RN:

Yeah, and it has to go to like a compounding pharmacy and like, specifically, if it's, you know, like a, you know, like a kid can't swallow a pill, or maybe they're older but they have like a feeding tube or something you know sure. It needs to be liquid. That's like the first one right off the top of my head.

Ed Delesky, MD:

And so we want to emphasize that, while really useful, and they certainly serve a purpose compounding pharmacies and compounded drugs, moreover, specifically don't undergo the FDA pre-market review for safety, quality or effectiveness in comparison to FDA-approved drugs. Truly, a compounded drug should ideally only be used when a patient's specific medical needs cannot be met by available FDA approved drugs. So, pretty reasonably, here you listed off a great example right there of an infant who can't swallow a pill and it's not readily available at a Walgreens. Boom, great reason to have a compounded version of that that's liquid.

Ed Delesky, MD:

So when there was this shortage of semaglutide and terzepatide based medications for weight loss, then people started to go to compounding pharmacies, which is more often what you're seeing on tv when you're being advertised by like direct to consumer marketing for these specific weight loss medicines. So something to note is that the fda is aware of compounded semaglutide because I'm not seeing anything active about compounded terzepatide at this point but they are aware of compounded semaglutide products that are being marketed for weight loss and for a period of time it was reasonable because they're like a reasonable avenue to go, because it wasn't FDA approved, because it wasn't available in the market. So we found that these medications have a certain place in peds adult care, specialty care but now for something so common such as obesity, a lot more people are looking for this medicine and have reached out to compounding pharmacies to satisfy that need. But this isn't perfect. There's actually some negative downside to this. So what are we seeing out there? That's a little troublesome.

Nicole Aruffo, RN:

We're seeing a lot of errors in dosing. It seems that people are giving themselves too much of the medication.

Ed Delesky, MD:

And so when someone gives themselves too much of the medication, there are adverse events that can happen, some requiring hospitalization, and so, like you said, some of these are coming from dosing errors. But I mean, this isn't the clearest thing in the world. It seems there's a lot of different experiences that a patient may have. There's confusion that can come up. A lot of these people are getting from online doctors as well. I'm not seeing a lot of people who are seeing patients face-to-face saying like, yes, go to this compounding pharmacy and get your medication, because something we're seeing is that people are getting advice to give themselves X amount of maybe a milliliter, or maybe a milligram or maybe a unit, and I would say that that's pretty confusing, especially for someone who hasn't done an injection before.

Nicole Aruffo, RN:

Yeah, but you should also be receiving the correct syringes, which can potentially also be another issue.

Ed Delesky, MD:

Totally Right.

Nicole Aruffo, RN:

Like one unit and one ml is a lot, would be another issue.

Ed Delesky, MD:

Totally Right, like one unit and one ml is a lot.

Ed Delesky, MD:

But is a unit, an ml? No, right, and not. Everything is like one milliliter is one milligram either, so that opens up like a whole world of confusion, and so when people are overdosing in this way, they are getting the nausea, vomiting, increased risk for pancreatitis, and something that's really disturbing is that the half-life of this medicine is one week, and that's why you dose the medicine every week. A half-life is how long it takes for a drug to leave the body, and so if you have too much, this will stick around, and so you may not be able to eat and not be able to drink and lingers as an issue.

Nicole Aruffo, RN:

I think it's important also to note that you should always, always, always, check what the label on whatever medication it is and for whatever the concentration is, because that might be something different than what your doctor is telling you, because, like, the pharmacy might just carry a different prescription of something, or it might be com, or a different prescription, a different concentration of something.

Ed Delesky, MD:

Right.

Nicole Aruffo, RN:

So your pharmacy might carry something that's like higher or lower concentration per you know, one pill or one ml or one unit of whatever you're getting yeah it's like your doctor might tell you take two milligrams of something, and then it might even say like I don't know if it's like a liquid or an injection, like two milligrams or one unit. But then if you get it from a compounding pharmacy, where that might be a little bit different, and then your bottle says you know, maybe it's two units or whatever, yeah.

Nicole Aruffo, RN:

It might just be different but like, always go by what the bottle says, not necessarily what the you know, your discharge paperwork or like whatever your doctor kind of mentioned to you.

Ed Delesky, MD:

Absolutely, and like this is something to slow down and pay attention to because, especially when it comes to liquids and concentrations, it's so easy to make a mistake. Yeah, especially when, like you mentioned syringes earlier like syringes come in all different shapes and sizes. Maybe not all shapes, but they come in different sizes, maybe different diameters, and requiring different amounts to be drawn up, like one milliliter in a really tiny syringe may look very different to like one milliliter, the whole thing, whereas in a five ml syringe it fills up 20 of it, which is totally different.

Ed Delesky, MD:

And then, like you were saying, like where your doctor may tell you take 10 milligrams, but the concentration of the liquid is five milligrams per milliliter yeah like you have to sit down and do that math and say like how much?

Nicole Aruffo, RN:

yeah, I mean you shouldn't have to do the math because it should be on the label, on the bottle, but I don't know it should, I don't know.

Ed Delesky, MD:

Well, I was even seeing a guy this last week. He was doing every two week injections of testosterone and he was having a tough time actually drawing up the very specific amount of liquid to get the exact dose that he needed. So that's a whole other community of people out there who this affects. So it's just something very much to be aware of that, like, milliliters are not necessarily milligrams and are certainly not necessarily units, and you have to take special attention to the size of the syringe and the concentration of the medicine that you're getting. So one other thing that I think we should bring up is that these pens that people are getting, like the once injectable, make it very, very simple pens from the Wagovi and the Terzepatide, the Zepbound Usually the compounding pharmacies aren't giving you a pen.

Nicole Aruffo, RN:

Yeah, no, because well, it's like the pen, that's the expensive part to make, not the actual drug.

Ed Delesky, MD:

Exactly.

Nicole Aruffo, RN:

Really annoying, actually it is.

Ed Delesky, MD:

No, really annoying, actually, it is no, it yeah, and then we're going to it's such a coincidence that all those drugs that come in a pen are expensive.

Ed Delesky, MD:

And we're going to dive into that in the back half of the episode where, like, how these drug companies are making it more affordable quote unquote, more affordable but you kind of have to learn how to do the injection yourself in a syringe and a needle, not with the pen. So that's a whole other skill that perhaps you weren't used to before. But, like, there's tons of videos out there about how to do the pen self-injection, but it's not as easy to do the needle injection with the syringe. So just a couple, um, a couple of stories that the FDA did put out, uh, about errors in dose management. Just to put this into perspective, um, most of the errors came up in people like mistakenly drawing up more than the prescribed dose of multiple dose vials.

Ed Delesky, MD:

So like you get something and you have to actually pull up the medicine no-transcript, a quick interaction and the prescriber was like, oh yeah, do this real quick. And then like there was an error there. So like it's not all on the patient, it might be from the provider as well, or maybe a decimal point isn't in the right spot. So instead of taking, you know, 0.25 milligrams, you're taking 25 units or something like that. So it can get very confusing. So, aside from any of the changes or difficulty in dosing, compounding pharmacies sometimes have different ingredients and different forms of the medication that are also not FDA approved are also not FDA approved. So some compounders actually have ingredients like vitamin B12, b6, l-carnitine and NAD to their semaglutide products.

Nicole Aruffo, RN:

People love NAD nowadays.

Ed Delesky, MD:

That's such a niche biochem thing of the electron transport chain, I guess. Sure A real nerd in me, that's what they say Wow, that was a deep cut right there. Are you hearing about this like people are like, searching, like nad. Oh yeah, people go places to like get these like infusions I was like, look, I was getting this and learning this from like making this episode.

Nicole Aruffo, RN:

But I did, yeah, but you're seeing that people are like oh yeah, it's like a thing I want my, my semaglutide with my b12 I know a lot of people get b12 with that. They'll like get both. Um, I haven't heard like the nad being mixed in with it. I just know that's like a separate thing. People like go for their nad infusions and like b12 shot. Right, right, right Apparently it's the fountain of youth.

Ed Delesky, MD:

So, while this, these aren't looked at for safety and effectiveness.

Nicole Aruffo, RN:

Yeah, so don't take my word for it, but that's just what the people are doing.

Ed Delesky, MD:

Right and so like this is something that's out there that people are doing and it's unestablished, and so that's one of the important things.

Ed Delesky, MD:

We are kind of bound by evidence-based medicine and so this isn't looked at and so we don't know, and one usually operates in the realm of like if we don't know, it's probably not safe. Or semaglutide acetate, and these are actually different than the active ingredients in the base form in the approved drugs and these don't necessarily fall under any sort of FDA conditions for compounding, and so it just adds to a lot of confusion in this market altogether. So really you just have to be careful, because if you inject the wrong amount of medicine, this can lead to some really bad side effects like nausea, vomiting, abdominal pain, headache, migraine, and some people have required hospitalization, and these symptoms or side effects don't go away immediately because the medication lasts for a long time and the FDA is looking out for stuff like this.

Ed Delesky, MD:

So, because of all of the hoopla with compounding pharmacies and how expensive these medicines are and you kind of teased at this earlier. Pharmaceutical companies have responded, specifically Eli Lilly and Novo Nordisk have responded and offered direct to consumer models for people to be able to access the FDA-approved versions of these medications.

Nicole Aruffo, RN:

All right, eddie, tell us about this direct-to-consumer model that's out there.

Ed Delesky, MD:

So if someone didn't know Eli Lilly, we'll talk about Zepbound first. Eli Lilly has a self-pay journey program, is what it's called. It's from the Lilly Direct Self-Pay Pharmacy Solutions, and for a while they were offering reduced prices of ZepBound for the 2.5 milligram and 5 milligram vials, so that's specifically different than the injector pen. And so they were able to bring down the cost of this of production, because now they're only producing the drug, not the drug and the auto self-injector pen which, like you said earlier, it turns out to be the really expensive thing. And so this model that they have aims to provide transparent pricing by removing third-party supply chain entities, and so now altogether third-party supply chain entities, and so now altogether, through their direct-to-consumer system that they have, they have vial options where you draw up the medicine and you give it to yourself. But it's an FDA-approved drug of 2.5, 5, 7.5, and 10 milligrams. The 7.5 and 10 milligram doses were just recently added, and while the two and a half and five milligram ones were there all the while since the initiation of the program. So understanding that you're only missing the 12 and a half and 15 milligram doses which people use, but they may not be as common. And so, for pricing wise. You can find this on their website and we're recording this episode, sunday, march 30th but as it's currently written, the Zepbound self-pay journey program offers seven and a half and 10 milligram vials for $4.99 a month for the first refills within 45 days or so, and so $4.99 a month is admittedly still a very high number, but to compare, that is against the over $1,000 per month that these medicines cost in the pen. The 2.5 and 5 milligrams are more affordable. The 2.5 and 5 milligrams are more affordable. The data from at least February 25th 2025 suggests that the 2.5 milligram dose is $3.49 per month and 5 milligrams is $4.99 per month, like the other ones.

Ed Delesky, MD:

I thought this was a pretty cool thing when I found this initially, because a lot of people may want this medication but their insurance companies may not pay for it, and that's been one of the most frustrating things. You got nothing, and so we talked about how Zepbound has this new program. Novo Nordisk just came out with their program for Wagovi through their NovaCare pharmacy, and they offer a direct-to-patient delivery option for actually all of the FDA-approved doses, from 0.25 all the way up to 2.4 milligrams. Their price is quote-unquote, reduced at $4.99 per month for cash-paying patients, and the key piece to this is that Novo Nordisk is offering this in the single dose pens, compared to Zepbound which is being offered in syringes, and so that might be their little niche of offering like a hey, we're doing this, but we're still doing this with the pens. We just wanted to relay all of that information to you, knowing that some of these are updates and a changing environment, that information to you, knowing that some of these are updates and a changing environment, fda approval is really important in this whole thing, and that knowing that Zepbound and Wagovi now may be available through these direct programs, albeit still very expensive, at least they've undergone rigorous review for safety, quality and effectiveness and really reflect about where you're getting your medicines, as we kind of think back to our conversation about compounding pharmacies and, at the end of the day, make sure you always talk to your healthcare provider for any further advice that's specific to you.

Ed Delesky, MD:

So thank you for coming back to another episode of your Checkup. Hopefully you were able to learn something for yourself, a loved one or a neighbor. Please check out our website, send us some fan mail, please rate and review the show. If you don't mind, perhaps leave a comment where you're listening. Any of that support would be greatly appreciated and until next time, stay healthy, my friends. I'm Ed Dolesky. I'm Nicole Rufo. Thank you and goodbye Bye. This information may provide a brief overview of diagnosis, treatment and medications. It's not exhaustive and is a tool to help you understand potential options about your health. It doesn't cover all details about conditions, treatments or medications for a specific person. This is not medical advice or an attempt to substitute medical advice. You should contact a healthcare provider for personalized guidance based on your unique circumstances. We explicitly disclaim any liability relating to the information given or its use. Thanks for listening.

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