Urgent GLP-1 Compounding Update with Pharmacist Vickie Paesano
On September 30, the FDA removed tirzepatide from the shortage list, creating confusion for patients and providers who rely on compounding pharmacies.
Vickie Paesano, third-generation owner of Preston’s Pharmacy, a trusted pharmacy serving 27 states,...
On September 30, the FDA removed tirzepatide from the shortage list, creating confusion for patients and providers who rely on compounding pharmacies.
Vickie Paesano, third-generation owner of Preston’s Pharmacy, a trusted pharmacy serving 27 states, shares insights as both a pharmacist and the owner of Core Aesthetic, her med spa.
Bill and Vickie discuss:
- What some pharma reps are doing on the ground to circumvent the provider relationship and block compounded versions of tirzepatide
- How the latest FDA regulations are impacting compounding pharmacies and aesthetic practices
- Vickie’s thoughts on navigating changing regulations from both sides of the industry
- Vickie’s predictions on how this tug-of-war over compounding will play out
Links
Read the FDA’s latest update to compounding pharmacies
Learn more about Core Aesthetic
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Bill Walker (00:04):
Hello everyone, and welcome back to Aesthetic Appeal, Aesthetic Brokers, leading edge information that comes to you from Southern California on what's going on in the medical aesthetic space with relationship to private equity and transactions with mergers and acquisitions that affect you as practice owners. Today, Aesthetic Brokers and Aesthetic Appeal is so excited to have the president and co-founder of Core Aesthetic, Vickie Paesano, a Pharm D by trade, incredibly unique experience and relevant information nationally for the aesthetic space. Vickie is out of Arlington, Virginia. She's a DC metro native. And Vickie, first off, thank you for coming on the show.
Vickie Paesano (00:59):
Thank you so much, Bill. Thanks for inviting me. This is great to see you again.
Bill Walker (01:03):
Yeah, it's wonderful to see you as well. Well, Vickie, why don't you introduce yourself and it'll be very apparent to our listeners what kind of perspective you're adding to this, because it's twofold.
Vickie Paesano (01:16):
Yeah, well, you did a pretty good job. So I am a pharmacist by trade, and specifically I do compounding. So the hot new thing, the last I would say year or two is the shortage of the weight loss medications, commonly known as Ozempic or Mounjaro. So our, I guess, shift in what we make the most of has been a lot of the semaglutide and tirzepatide. And to your point, we as the pharmacy supply all around the nation, so all the way out to your side. So as a pharmacy, from Preston's Pharmacy in Arlington, we supply all these medications to doctors and even patients if it's patient specific. So all over. So we're really seeing and hearing back from providers what they're struggling with. So are they able to prescribe medications, where can they get it, et cetera. And then along the way, my entrepreneurial self decided, why am I paying all these other people to make all this money? So I decided to open my own aesthetic practice and do the same thing, hiring in a couple of nurses and PAs that I like to call my best friends and let them do their thing, let them do what they do best, which is prescribe and take care of their patients.
Bill Walker (02:34):
That's amazing. I want to get into Core Aesthetics, but I think background wise it makes sense to talk about Preston's Pharmacy because I did live in the northern Virginia area in the DC Metro, and it is a very iconic, distinct practice. Can you just talk briefly about Preston's in Arlington?
Vickie Paesano (02:56):
Oh, that's really kind of you. That's really cool that we met on those terms. Then you know what this little shop is in the grand scope of things. So we got a tiny little shop, meaning let's call it five, 7,000 square feet in Arlington. It's been there since 1934. I am the third generation owner, and Bill happens to know that, that's crazy. All on the other side. And he was down the road about 20 minutes, and you know what this building looks like. So the only thing that's changed is the awning. It went to poop after all these years, and now it's black instead of green, still same brick.
Bill Walker (03:28):
And there's such a great breakfast diner that's just down the street from you guys. I used to frequent that a lot, but Preston's is more than just the neighborhood pharmacy for three generations. How many, educate us on what states you guys service and talk to us about that.
Vickie Paesano (03:50):
So that's a big list. So I can't list them all out for you currently, but let's just say that we have 27 states out of the whole entire 51 that we ship out to. So that's the short answer to that. And obviously we service the community, which is everyone that wants to come through since it's been there. So yeah, you're right, it is iconic. It is really cute there. And it's an open community pharmacy, but we also have these beautiful brand new labs that are made just for sale or compounding to make all these drugs, anything that's in the eye or in the vein to make it simple.
Bill Walker (04:25):
And so that's incredibly important is the pride. What I was impressed by when we spoke several months ago and met was the pride in the acumen with which you guys take the approach to in the compounding space is that zero room for sacrificing quality.
Vickie Paesano (04:49):
I don't want to mention any names, but we've got some athletes that come through that play a little ice and ball too. So it's got to be cute. We have to have murals, all the things.
Bill Walker (05:00):
Well, okay, so this is also a unique aspect. You're an avid fitness buff and you're a jock by trade as well.
Vickie Paesano (05:11):
It's all out there. Okay. Yeah,
Bill Walker (05:13):
Because that's important for our listeners. You kind of thread the needle on all three aspects.
Vickie Paesano (05:19):
Oh, I love that. So I basically take hobbies and for some would say I make them not fun and I make 'em work, but it's what I know. So yes. So I am avid CrossFitter. I turned to Olympic weightlifting. If you're from the DC area, then you'll know that I have something called Invictus, Washington, DC. And so it's a big name in CrossFit, if you will. They've been to the games every single year since 2011 when CrossFit was created. And this also is our little connection too, because you're out in Cali and CrossFit Invictus was originated in San Diego.
Bill Walker (05:56):
Invictus Plus, yeah.
Vickie Paesano (05:57):
Yeah. So it's very, very cool. It's all cool things that made us connect. Yeah,
Bill Walker (06:04):
Yeah. All of the guy population that revolves around Invictus and compounding pharmacy, advantages for wellness from my former marine buddies definitely ties into probably your client base for sure.
Vickie Paesano (06:22):
Oh yeah. Especially the base is right next to us. You know that right? Next to in DC and Navy Yard. Yep. Right there.
Bill Walker (06:29):
Vickie also is the president and co-founder of Core Aesthetics. Talk to us a little bit about how you came up with the idea for Core Aesthetic. What is the competitive advantage and how long have you guys been around and what have you seen in the space since you've become a part of the aesthetic world?
Vickie Paesano (06:49):
Okay, well, I love that. So this happened very organically and naturally right after Covid, because around Covid time, obviously the pharmacy was jam packed with covid testing and vaccinations. And then once the world opened up, if you will, all that business went away. So we went back to compounding and started trying to grow from infancy again. That led to, okay, let's see, what is the next big niche? Hence we found semaglutide, tirzepatide being a huge thing that people wanted and needed as well as. And then we realized, oh, there's so many providers that are trying to open more practices or add on a weight loss practice, but don't know how to write for it, don't know what to do. And so they're calling the pharmacy asking us to help them prescribe, what to do when this happens, how to convert doses, et cetera, things like that. So what I mean by organically is we kept getting these calls. There was a huge shortage. Everyone's asking us, how do you do this? How do you put this in our practice? We don't know how, you have ophthalmologists doing it, you have, everybody wants to grow their business by expanding into this field.
Bill Walker (08:06):
And it's much needed, to my understanding. I'm not a provider, I'm not a healthcare provider, but just from some readings that are open source, it's really concerning to me that we've seen this huge uptick from 30% in the early two thousands to some estimate even over 40% of Americans, 10 or 12 years later are now in the obese category. And can you define that from a, I've read some places where over a 30 BMI, but can you define some of the problems and the secondary health conditions that come about for obesity and why this is so important for Americans?
Vickie Paesano (08:46):
True. By textbook definition, you're absolutely right. Nailed it. 30 BMI or more, that means essentially you are hitting that cusp of, hey, cardiac and diabetes issues are going to skyrocket after that in your lifetime. However, if we back it up, in reality, once you get past that 27 mark, and you'll know these numbers from going your primary care and providers, they'll get you that, based on your body weight, bone density, mass and fat, right? So that's how you get that number. But more importantly, there's all these precursors that lead to it and insinuate that you're getting to this point of unhealthiness, right? That will lead to a shorter lifetime and expectancy, but they can be prevented. They can be certainly handled and controlled in a very successful way. It's like the first time a GLP has come out with such low side effects and proven to be so effective with just lowest side effects is the biggest thing. Because we've always had tablets and things like that with things that cause a lot of nausea. People would be, they would just no longer be compliant on their medications. So this is the first.
Bill Walker (09:54):
So that's interesting. So that is what is part of this phenomenon is the reduction that people have seen and the side effects from previous solutions that we were trying to figure out.
Vickie Paesano (10:07):
Correct. So let's put aside the science and how it works in the body. It's for the first time shown to work for people long-term successfully without having them rebound is the point. So this was a huge, huge thing for diabetes type 2, PCOS, patients who are the women that have that issue, they're born with it, and that ultimately will lead to infertility, but again, can be treated. So that became huge for that industry too. And then obviously you've got all the cardiac people that have family history that can be helped with when you have this drug.
Bill Walker (10:43):
Very interesting. If you would talk about how, again, refresh us on how you came to pass on creating Core Aesthetics and then if you would talk about some of the services that you've seen demand signals in and how does that shape your thought as a pharmacist, and how do you treat people, because you're such a fitness buff and you want people to
Vickie Paesano (11:05):
Tie it all together for you?
Bill Walker (11:06):
Yeah, tie it all together for me.
Vickie Paesano (11:09):
Okay. So, alright. Well the first thing is that I want providers prescribing something that they know what they're talking about, right? First and foremost. So I wanted to build a home that people, good people that know what they're talking about, that have had customer care, that have had patient care, can work at and know and you can trust them. So because I know I can control the drugs, I made that my formula, I made it especially proprietary with vitamin B6. As a matter of fact, that's safe in pregnant women, not that you're going to give this weight loss medication to them, but I know that this combination of the semaglutide plus that is proprietary to me. And then it also helps with the side effects of nausea. So cool. Someone can come see their provider, get the drugs that we know where it came from.
(11:59):
It came from an FDA regulated facility. I know how their protocol is. I know that there's a weight loss program that they're given with that to make sure that they follow it and they're given resources on where to go and what kind of fitness they're looking for. So we're able to combine all those resources and offer that in a membership program here at Core Aesthetics. Which is phenomenal I think. And because I have the medication, I'm able to cut the cost on that so I don't have to be unreasonable like so many places that are charging a thousand dollars a month for their medication.
Bill Walker (12:35):
I want to really dive into and get your thoughts on, and I'm going to reference open source from Reuters on the US FDA is to consider decision barring compounded versions of Lilly weight loss drug dated October 11th. Talk to us and catch us up to speed on what the Food and Drug Administration has been grappling with, what Lilly has been dealing with and how have you seen it impacting compounding pharmacies, and what does that decision mean for compounding pharmacies and for med spa aesthetic owners out there who have been prescribing semaglutide?
Vickie Paesano (13:17):
For a backstory for everyone. Compounding pharmacies are allowed to make medications that are on a shortlist made by the FDA. So if they deem that a medication is unavailable or not meeting the standards of the needs of the public, then it's on a shortage list. And then we are legally allowed to make it as a compounding pharmacy in the US that is So when they removed from the list.
Bill Walker (13:45):
So that I understand this because as a layman here in this space, I'm sitting here with pharmacist. So was the September 30th decision prior to this where the FDA removed, the active ingredient tirzepatide from the list of drugs experiencing on the shortage list? That was the precursor to this latest breaking news in the past couple of days, correct?
Vickie Paesano (14:14):
You are correct. Well done. Yes, yes, yes. You're doing a good job of that. Breaking, it down.
Bill Walker (14:19):
I'm holding on the tail of the plane here right now. And Vickie's a fighter pilot here. So we are basically in an area where there was a shortage, correct me on any of this if it's misspoken, Vickie. There was a shortage. We had compounding pharmacies that were there to help and fill up the space for the required prescriptions that were needed. And then we got to September 30th and they said it's no longer required. Lilly has it covered. And now in the most recent news that's hit the circuit is in the last couple of days they've said, hold on. Wait. It actually still is in the shortage.
Vickie Paesano (14:58):
That is all correct. That is very much correct. So during that short period of time, I know it only sounds very little, what a week or two, everyone was scrambling because that meant pharmacies had to stop immediately doing what they were doing. And all those patients that were currently on those now, they can no longer continue. So they have to get all new brand new prescriptions for the commercial product that you're referring to, the tirzepatide brand name, also known as Mounjaro.
Bill Walker (15:26):
Okay.
Vickie Paesano (15:29):
Unfortunately that Mounjaro wasn't available, truly though to everyone because they couldn't supply all these people that were bumped back hypothetically to the commercial product. They couldn't keep up with that. So they meaning Eli Lilly did try to open up a couple of satellite shops, if you will, but that still didn't cover it, is the point.
Bill Walker (15:51):
I see. Now, so because I'm not a provider, explain if you could just at a high level, what if any processes that need to change or concerns might a med spa owner have, if they've been prescribing these drugs to their patients and then they're told that they have to switch? Does that mess up their count of the number of injections that somebody has to take or do they need to come back in? How do you think of that from the med spa's perspective of communicating with their patients and ensuring that there's no mixups for anybody?
Vickie Paesano (16:40):
Well, that's exactly the problem. I'm glad you asked that.
Bill Walker (16:43):
Okay.
Vickie Paesano (16:44):
Here's my dirty little secret that I found out from talking to a provider in North Carolina. Okay? A good friend of mine has a very successful practice. Eli Lilly opened up a satellite shop in Ohio, sent their reps in brand new reps, this was literally last week, and went into their computers and was like, Hey, I'm going to make you a portal. Okay? So all you have to do is you can prescribe our brand name products directly to us and we'll ship it right to the patient. So what does that mean? Well, one that means the provider never spoke to the patient about how to use it, teach them on how to use it with the safety of it, what to do when something goes wrong and what are the directions. And then the other piece of that is they're obligated to pay for a single dose vial.
(17:30):
So they're copying, mimicking the compounding pharmacies concept. You get a vial, you get needles, and then now no one teaches you how to use it. Well, that's not great. But their plot or plan was that, if we're going to make it convenient for you, all you do is go into our portal, we'll just send it straight to their house. But you can see why that would be inconvenient. And here's an additional thing. Now the med spa doesn't get paid for their primary care time. They eliminated that, which is really not great for them, and they're charging the patient more because the patient's paying directly to Eli Lilly. And guess what? They're paying $499, which is actually more than the prices that the compounding pharmacies are charging per vile to the providers to make sure that they make money.
Bill Walker (18:18):
Interesting. So even with a compounding pharmacy that has a clean room, a sterile environment, let's say that meets all FDA requirements for compounding items that would be going into a human body on a variety of different things. It's more expensive to get it directly from the commercial brand manufacturer.
Vickie Paesano (18:39):
Right. And that was their way of trying to keep all their patients with the brand name product. Because I'm not sure if you're familiar, but the original products from prior to this whole conversation, they were auto injectables and so they didn't have vials. You would just literally click and there's no way of messing it up. There's only one dose that comes out. Boom, that's it.
Bill Walker (18:59):
I see.
Vickie Paesano (18:59):
So they couldn't supply those, and that's what was completely backwards. So now they're making these little vials that you have to pull out specific doses in.
Bill Walker (19:07):
So, that makes me ask the question then, Vickie, of talking about the touchpoint with providers at the practice. Without saying anything's right or wrong or a must or shall, what do you view as best practice with regards to patients and issuance of a prescription and then monitoring progress?
Vickie Paesano (19:37):
With the assumption that your provider is a solid person who knows what they're talking about? They know their product well, the minimum requirement for me would be that there is a CMB, so a baseline blood work. We want to make sure that your liver, kidneys are healthy enough for it. The medication is appropriate, basically. I'm making sure that there's no indicators that you are contraindicated, one. So I need that blood work seen by the provider, whether it's virtual or whatnot, but that needs to be collected. We need a medical history. So that should be discussed at least once over. And then after that, once we've established, Hey, this is what we/re going to go for, on average, one pound per week, here's a guideline, our weight loss program book, that's proven to be well, this shows you how much to eat, what to eat, make it real easy. Follow with this, check in with me once a month is what I would say.
Bill Walker (20:36):
Got it. So there's some sort of a touch point just to have periodic.
(20:41):
Oh yeah, for sure. It's like fitness, right? If someone's watching, you're going to work a little harder too. So it holds you accountable truthfully. Yeah,
(20:50):
I love it. Okay, that makes sense. That makes sense to me. Do you have any sense of when you think the industry as a whole will have this dilemma figured out? Do you think it's a six month thing? Do you think it's a year thing? What do you think about that? And then second part to that question is what types of generalized innovations do you see happening in the delivery vessel or the products themselves, and how do you think about that of what will continue to improve on as far as next iterations in this space?
Vickie Paesano (21:29):
So the FDA is going to, in my opinion, going to have to give up on fighting the tirzepatide. Semaglutide, let me start there. The patent on that active ingredient, it has been removed that will never go away. Compounding pharmacies will forever be able to make something of some sort with that medication.
Bill Walker (21:49):
Educate me on this. What are some of the subtleties between a semaglutide and a tirzepatide?
Vickie Paesano (21:57):
Okay, I appreciate that. So semaglutide was on the market first, and so that was originally for diabetes type two, and then they found that, hey, it does great on weight loss too. So then it was approved by the FDA for weight loss as well. Then a couple years later, let's call it fast forward, tirzepatide works on two different methods or mechanisms in the body to do a very similar thing, make you feel fuller. And so one injection per week just like semaglutide, and yet you just have that satiate feeling, which is great because the best way patients have said it to me is it quiets the hunger and the mind, so you can focus on everything else in life. You're not thinking about what's the next meal, what's the next snack, if you will.
Bill Walker (22:40):
Interesting.
Vickie Paesano (22:41):
Yeah. So that's how that kind of works for them. But that's the biggest difference. Now with Tirzepatide coming out later, all the more recent stuff is always going to have something a little bit cooler, a little better. It works in two mechanisms, so that means that not only it's going to be proven to better at weight loss, but then also less likely to cause you nausea, which is great.
Bill Walker (23:04):
Interesting.
Vickie Paesano (23:04):
Hence it tends to be a little bit more expensive too, to be honest. And a lot of insurances don't want to cover it.
Bill Walker (23:10):
A lot of people, it's so funny, for me personally, I can handle a lot of things that go with the medical industry or trauma, but a needle, you put a needle in front of me and I'm going to stare at you and pause and be like, okay, let's think about this if you're going to bring a needle near me. But if I'm somebody who's not a fan of needles, is there other forms? Is there anything that you can think of that this will come out down the road that would be a different form of the drugs?
Vickie Paesano (23:44):
So I don't know if that was a leading question then you know something or you didn't, but so compounding pharmacies do a sublingual drop of semaglutide currently.
Bill Walker (23:56):
What's a sublingual drop?
Vickie Paesano (23:58):
Oh I'm sorry. Okay, so have you seen CBD before where they just put little drops under their tongue? It's like an oil. You literally pull it out a bottle and you just drop and hold it under the tongue for CBD?
Bill Walker (24:08):
I'm like the wrong person for that, but I'm with you.
Vickie Paesano (24:10):
Oh yeah, you're right, government.
Bill Walker (24:11):
I'm with you. I'm listening.
Vickie Paesano (24:14):
California. You're in California though? Oh gosh.
Bill Walker (24:16):
I'm in California, so I am a student of the game for a portion of that, but okay, I'm with you.
Vickie Paesano (24:22):
Okay, so imagine essential oils. So you have a little bottle and you pull out one amount of it and you drop it right under the tongue and you just kind of hold it there, and then you eventually swallow. Imagine maybe already melted starburst, that's the texture it kind of is.
Bill Walker (24:39):
Okay.
Vickie Paesano (24:40):
So the whole point is, it adheres to the mucosal layer, so it absorbs better through that route.
Bill Walker (24:45):
What about a pill? Everybody loves a pill.
Vickie Paesano (24:49):
The pill has been available, it's called Rybelsus. It takes 70% the amount of extra drug, which is very expensive, obviously, just to get the same 10% absorption as a tiny little injection. So it's there.
Bill Walker (25:04):
Got it.
Vickie Paesano (25:04):
But it won't be as effective ever through the mouth. You know what I mean? And if you're going to go through all that, that's why some patients will come in and then they'll just have the provider take care of it for them. It's like they'll turn away like boom, done. Like a flu shot.
Bill Walker (25:20):
Okay, so now, okay, lemme ask this question. We're down the path with patients that you guys see at your med spa practice at Core Aesthetics. They lose weight that was unhealthy. It's effective. Now talk to me about the aesthetics aspect of this.
Vickie Paesano (25:39):
Oh, this is when it gets fun. So you're losing weight. You see 'em once per month, and it's cool because then you see all this loose skin, cuz that's when it's really worked, right? Unfortunately the skin doesn't tighten up as fast as the weight loss. So now what do we do? We got a bunch of little cool stuff that you don't have to go to plastic surgery for or tummy tuck for. We've got Morpheus radio frequency machines that you can do right there in office, and it will literally tighten the skin while still piercing deep enough into the tissue. I'm pointing here because that's where a lot of trouble spots are for a lot of people.
Bill Walker (26:20):
She's at the lower chin is what she's pointing to right now if you're not watching video of this.
Vickie Paesano (26:23):
Yeah, yeah, that's right here. And so it's amazing stuff that you can do right there in office. You use energy, radio frequency, all cool technology. I think that Bill was there to see some of that, if you went to the trade show at all. Actually really cool stuff because you leave the office in an hour and you actually see a difference and it continues to work. That's collagen to tighten over the month as well. So that's just one, and we're talking skin and fat still there. Then there's something called the Evolve Machine. They're electrode magnet pads that you can put all over the body, butt, side, et cetera. So it's noninvasive. You put some ultrasound jelly on there and it literally feels like you're doing 2000 crunches. That's what they promote per session of 15 minutes. And you can change the strength and frequency. Really cool to develop muscle tension again for a lot of people that are less mobile because a lot of these are obese patients, so it actually really, really helps them.
Bill Walker (27:24):
But I'll tell you, if I could get 2000 crunches done in 15 minutes, Vickie, I'm in. I don't know if I'll stand up and walk away from a gym session with you, but if I can get that done in 15 minutes, that's impressive.
Vickie Paesano (27:38):
Oh, it's the nastiest feeling, cuz if you've had to do max out crunches before then it's so wild. It feels like somebody's putting their little hands into your stomach and ripping you up on those last reps, like doing Murf or something like that, anyways.
Bill Walker (27:53):
Yeah,
Vickie Paesano (27:54):
Cool analogy. That was just for you.
Bill Walker (27:56):
Very cool. Well, I think you've touched on a lot of the topics that revolve around this, and I'm looking forward to seeing what kind of progress comes through the courts and ultimately how it impacts the med spa space. Vickie, any last minute thoughts or maybe pearls of wisdom that you would speak to with regards to compounding pharmacies? How you think about as a med spa owner yourself, the GLP-1s, the semaglutide, the tirzepatide phenomenon that's going on?
Vickie Paesano (28:38):
All in all, you should just really try to find a provider that is well-rounded and trusted because there's plenty of practices out there that are not exactly sure what they're trying to do, and they're just trying to grow for the purpose of expanding, just because people come in asking for the drug. But for it to be successful, you know this too, you have to follow and try to make a lifestyle change. And so they need to be an all-inclusive, almost like a primary care person. They have to see the global picture and be able to navigate with you on what to do. Hey, if you've got a lifestyle that you're always flying and you're busy, this and that, they need to be able to work with that. So that's what makes a provider really good. Or someone that's just like, here's the cookie cutter, here's just the drug.
(29:24):
Good luck. So finding a good provider that understands that, and obviously having the resources of quality drug is also huge too. Because they're also, just want everyone to know public service announcement, there's a lot of fake Chinese made imported stuff out there too. And we've tested them just to see for their purity and it's not so great. So there's a huge difference in importance in that in itself too. Don't get scammed. Okay, there's all these sponsored ads about get this for $2. You're like, wait, what is in that? I know it can't be that. Right? So for sure.
Bill Walker (30:02):
Awesome. So Vickie, thank you so much for joining everybody today.
Vickie Paesano (30:06):
Thank you for having me. Great questions, Bill.

Vickie Paesano
PharmaD, Co-Founder of Preston's Pharmacy & Core Aesthetic
Vickie, a PharmaD and co-founder of Arlington's Preston's Pharmacy and Invictus CrossFit in Washington, D.C., boasts over 13 years of experience leading healthcare teams and cultivating community wellness. Leveraging her deep understanding of pharmaceutical compounding, she co-founded Core Aesthetic to seamlessly integrate medical aesthetics with a holistic approach to healthcare, supporting individuals in achieving both health and beauty goals.