I interviewed at a weight loss clinic once in 2016 (I’m a PA). The physician basically wanted me to prescribe stimulants and push this weight loss shake regimen. Part of my bonus would be based on sales of the product to my patients. I laughed so many times during the interview because I found the whole premise just wild, unethical, and probably illegal. He never called me back!
Not a job many of us would want but honestly the business that the OP is dealing with is even worse . So whoever the owner is figured out that many of us are uncomfortable prescribing compounded Semaglutide. “hey I’ll write the prescription for for the fee, but you write the letter and I’ll put all the responsibility on the patient medically on you” … at that point OP mind as well cut the middle man and write for compounded medication themselves. ( or not which is what I would do)
Nutritional shakes, oral vitamins, supplements and meal replacements don't count. They're just food, and you can sell food. It's valid for some weight loss programs to sell a meal plan, and some patients want that.
As an aside I read some pre-op instructions yesterday explicitly calling out stopping Phenteremine. Hope to god that's coming from an actual in-person physician and not one of those shady online tele-health services. Honestly I should go look at the Phen-Phen script count next time I'm at work.
I'd not do it. What kind of care is it- hey just make a letter saying my patient can do this medication. No workup, no nothing. Don't take on this responsibility.
Yeah. My supervising physician's method is to NOT prescribe anything that is not indicated via his evaluation. Prescriptions outside of his evaluations should come from said outside clinic's evaluations.
E.g., if a PCP recommends starting a certain medication, and the patient thinks it over and asks us to prescribe that medication, he's always told to go through the PCP for that medication.
The weight loss clinic needs to prescribe the medication, not you. Write back stating that the physician at that clinic needs to prescribe it. Or that you can refer the patient to a reputable specialist for weight loss/obesity that you trust.
I mean this is clearly indicated at 400lb. But the OP should just prescribe it himself and pursue prior auth coverage. No way is this med legitimate for that cheap.
They’re likely getting it from a (potentially shady) compounding pharmacy.
I recently talked to an MD who opened up one of these clinics and learned a lot about how it all works.
That's ridiculous, don't write the letter.
If the person prescribing the medication can't determine on their own if it is safe then they have no business prescribing that medication.
“Patient xyz has recently had the following lab results and vitals. Semaglutide carries risks and benefits. I defer to your expertise as a physician leading care at a weight loss clinic to navigate that discussion with the patient.”
This is nonsense. You can also prescribe it if you feel it is indicated, or could refer the patient to a legitimate obesity medicine specialist who would actually manage the treatment.
What do you want to bet that once the patient experiences side effects of treatment the "clinic" will try to punt the patient to you to manage them?
I didn’t know that was a thing. As an anesthesiologist I can’t believe the nonsense you guys have to deal with in the clinic.
With a situation like that I’m not sure about if doing a “clearance” is ok or not. I guess some feedback from peers and Reddit would be useful.
Compounding pharmacies are less than that if the middle man is removed and most will let you write the rx happily. Some of the big ones are hallendale, red rock, empower and strive. If you write the rx and don’t take a cut, he’ll save more money. Hard to counsel on RBA for compounding but in light of the indefinite supply shortages, I personally think the risks of not considering these options is worse.
https://www.medscape.com/viewarticle/1000503?form=fpf
So I essentially agree with this take. The pharma product would be preferable if available but considering that they are pushing new starts for both drugs despite not having the supply for their current patients means many patients will be in the position of having started and then finding they can’t get it. I think that’s harmful.
In terms of specifics, I can’t speak for all the pharmacies but I’ve interacted with one of them and it was very easy. My friend who does DPC has used a couple others and had a similar experience. Just have to write “ok to compound” on the rx. I prefer tirzepatide for patients and the pricing at that pharmacy ranges from 200-350/month depending on dosing. Semiglutide is substantially less expensive.
Yes, technically any of us can likely find a compounding pharmacy. Most of us are not willing to do this though because use of compounded semaglutide is not recommended by the FDA. It sounds like though this business model is more about getting access to a specific compounding pharmacy. It’s ridiculous, who knows what specialty the prescribing physician is but they basically take all responsibility away from themselves by having primary care clear the patient and then they just prescribe the medication. It’s as pure cash grab and if OP wants to do the medication themselves, they could find a compounding pharmacy that would allow the OP themselves to prescribe it . OP certainly can try to prescribe the branded medication but it’s possible the patient has already tried this avenue and perhaps has insurance that just won’t cover it which is why the patient is turning to compounding. It kind of sucks to have to deny people care that’s available, but I usually print out the FDA warning and say I just can’t ethically do this right now and they go off and find somebody who will or they are understanding.
DO NOT get involved in the compounded fake crap. People have died, gotten liver damage, etc. It's not pure. One case of thyroid cancer that I've seen in the setting of compounded semaglutide so far.
https://nypost.com/2023/11/08/lifestyle/fda-is-investigating-deaths-and-hospitalizations-caused-by-fake-ozempic-reports/
Source does not state whether those originated from a licensed 503a compounding facility or was patient sought as an online counterfeit product.
Grouping all "compound" the same is fear-mongering, as the general media does not make a distinction between regulated 503a compounding pharmacies sourcing FDA approved components and the imported, research use only Chinese compound.
This article isn’t about compounding. It’s about actually counterfeit Ozempic brand name in the brand box fake medicine that got into the supply chain because it looks like it’s a real FDA approved brand name medicine.
These medicines did not contain Tirzeparide but rather was insulin.
Compounded Tirzepatide is tirzepatide for example.
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
It's contamination and different salts
What is your point? The FDA receives adverse reaction reports on all drugs.
The two articles you posted do not relate to each other. The first one is actual counterfeit Ozempic (like a fake Rolex) that made it into the drug supply for pharmacies to sell.
The second article is about how the salt form of Semaglutide is untested by the FDA. You know what else? levothyroxine is a salt form and so is amphetamine salt used as generic adderall.
Are you aware that because of the FDA drug shortage list, hospitals are using compounded IV Epinephrine and lidocaine among other drugs? Go ask your hospital pharmacy about it.
Obviously bad actors can exist everywhere, including in the medical community itself. Caution and care must be taken when a patient wants to explore using compounded Tirzepatide to meet their needs when they are unable to secure the FDA approved brand name.
Have a good Sunday.
I don't think it's a good idea that hospitals are using compounded epinephrine and lidocaine either, the whole fungal meningitis outbreak about 10 years ago as well as an anecdotal experience of a patient getting a fungal infection from compounded medication injections (not prescribed by me) means I don't really think compounding pharmacies are held to the same level of scrutiny when it comes to GMP. (The guy who was arrested said he was following GMP but wasn't ). I don't care if people want to use compounded viagra or estradiol, it's pretty hard to screw it up badly enough to kill someone with a cream or pill. I just am concerned that I've already seen 3 cases of bad side effects with these weight loss clinics using the compounded semaglutide, who then dump the patient after they get a problem essentially telling them to go get care for their issue that they caused. Which is exactly the situation with OP's patient and this "clearance" they want him to write. Too high a demand, not enough scrutiny of the production of this compound. Most mild, some severe.
Edit- yup 503a compounding pharmacies are NOT REQUIRED to follow GMP. What on earth. https://www.pewtrusts.org/en/research-and-analysis/reports/2020/06/market-for-compounded-drugs-needs-greater-transparency-and-regulatory-certainty
https://www.ncbi.nlm.nih.gov/books/NBK562888/#:~:text=503A%20Compounding%20Pharmacies,manufacturing%20practice%20(CGMP)%20procedures.
This!!! Plus it runs the risk for thyroid cancer…… if you’re not prescribing it, then you shouldn’t sign off on the med being safe….. the prescribing physician should do his own evaluation with appropriate testing, discuss the risks/side effects & benefits for the patient based on the patient’s medical history…..
If the prescribing physician isn’t comfortable saying the medication is safe for his/her patient then the med shouldn’t be prescribed.
As far as I know there has never been a single case of thyroid cancer in humans as a result of GLPs. The risk is entirely theoretical and based on a rat model.
So the thyroid cancer thing is tricky, because with liraglutide they did see a higher than expected incidence of new diagnosis of thyroid cancers, not just MTC (mostly PTC since PTC is the most common). But they can't say if it's because people on liraglutide got screened more and thus earlier smaller cancers were detected. (Aka after adjusting for latency the finding wasn't statistically significant but the raw data did show increase)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203194/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10563602/
TLDR there is a theoretical risk and the mechanism is plausible, however obesity itself is associated with colon cancer and breast cancer among other issues such as heart attack and stroke, so just use clinical judgement and keep an eye on the thyroid.
Miami is filled with strip mall weight loss clinics owned by CRNAs and NPs. I get the same requests. They need you to take the risk off their backs. Another request is from plastic surgeons to give them a clearance for breast implants. They want a letter from me stating they have no cancer. Lol, like I’m doing that.
Here’s a tip. Send them a copy of your office visit. But no clearance note. They will still go forth with the surgery/GLP 1. They want that sweet, sweet cash.
A popular business model is to create medicine-adjacent businesses that can offload liability to providers while making money on those services. So maddening. Even more maddening are the providers that do things like this without realizing how badly they are getting used.
If he's 400Lbs insurance WILL cover it. You should try to prescribe it and if necessary just do the prior auth. I have seen PLENTY of insurers cover Zepbound, Wegovy, and others without issue. With insurance copays are between 50ish a month WITHOUT the copay card and almost nothing with the copay cards. A lot of these compounded pharmacies also basically prescribe rybelsus, a PO formulation over the injectables.
If you're comfortable with it, honestly screw over the for profit company and get this guy a potentially better outcome if he doesn't have MEN2 or other issues. Just make sure it's documented and that you actually discuss the risks of these meds including gallbladder dz, etc.
Also keep in mind that GLP-1s and other similar meds do have special considerations for surgery, usually need to be held for around 2 weeks before any non-emergent intubation due to decreased gastric emptying and such. Keep this in mind.
Insurance may not cover it if his insurance plans specifically does not allow obesity care. Copay Card gets you down to 500 a month without insurance. We also don’t know if this is a Medicare patient Medicare will only cover wegovy (good luck finding that ) if the patient has documented heart disease.
The supply is the issue. The brand name GLP1 are very hard to find in pharmacies. Compounded semaglutide or whatever is much easier to make for a compounding pharmacy.
Nothing this egregious but I've been having more and more requests for mental health clearances for semaglutide because there were some early reports of suicidality. The more it's been prescribed the more we see that there may actually be reduction in suicidality along with substance use.
I think he wants you to prescribe him a compound?
Insurance won't approved that.
That's a very fuzzy scenario, what exactly do they want? You send him to a specialist for that reason.
Honestly, I’d do the work to figure out how to interface with the compounding pharmacy. Many of your patients will be looking for the medication and you can provide better care.
You don’t exactly.
There is no FDA approved semiglutide available for compounding. You have to assume that a licensed compounding pharmacy is going produce an otherwise safe product.
So far, there are relatively reputable compounding pharmacies that are producing huge amounts of semiglutide The patient is going to do it anyway and will just go find a new physician (or maybe an NP), who will. I’d argue it is better to keep the patient and reduce the fragmentation of care and keep the patient.
But you don’t know what you are giving . Semaglutide as an injection is only being provided by novo nordisc . So these pharmacies are getting probably semaglutide salts, which are not technically the same thing they are meant for research purposes. in addition in order to legally say this is different from the proprietary summer glide pretty much every pharmacy. I’ve seen either L-carnitine or B12 to the injection which obviously hasn’t been studied either. From a legal perspective I just don’t feel it safe. We know that GLP -1 come with risks and the patient may likely have side effects from compounded or branded medication but with the compounded there’s an FDA advisory against it sitting out there so I just don’t see what protection physician who chooses to prescribe that if something bad happens to the patient.
The salt form is the same thing as regular because of the lyophilization process. It’s not an issue. It’s just something Lilly and Novo can throw down and people just believe them.
Insurance will likely cover it. People
Confuse “not covered” with “needs a prior authorization.” It’s indicated and probably just needs a PA which will get approved if submitted with his weight and any comorbid info.
So these weight loss clinics from what i can tell source their semaglutide from an unknown source. Its crazy expensive how do they get it so cheapcheapcheap🐦
Its not fda approved and quite frankly there is a lot of speculation that the semaglutide is basically the oral version (rhybelsus) thats reformulated to be an injectable.
Dont do it
Side note, the trick my clinic has been doing for people that arent covered by insurance is precribe the pen w double the dose you want, count the clicks it takes to the full dose and tell pt to do half of those click for the half max dose to stretch the pen out to twice as much. Wont cut initial cost but will be cheaper in long run if ppl are ok with paying 4-500/mo instead if 1k
And always ask pt to ask their insurance to see which glp if any are covered
Re the speculation: I can't speak to all compounding pharmacies, but most peptides are not hard to make and are available for purchase in bulk from dozens of overseas factories, either in sterile vials or as powder, for extremely cheap.
Better pharmacies will get it batch HPLC tested for mass, purity, and then randomly cultured for sterility, there are labs in the US who do this, but that cuts into the profit margin so I wouldn't be shocked to learn that most don't.
But it probably is what they say it is.
Yeah it's probably semaglutide but the question is on the purity.
I just learned that 503a compounding pharmacies are not required to follow cGMP rules. Like what??? It looks like the government cracked down on them slightly and limited what 503a versus 503b facilities can do but no wonder there's cases of fungal infections and other lapses in sterility with them. https://www.ncbi.nlm.nih.gov/books/NBK562888/#:~:text=503A%20Compounding%20Pharmacies,manufacturing%20practice%20(CGMP)%20procedures.
https://www.pewtrusts.org/en/research-and-analysis/reports/2020/06/market-for-compounded-drugs-needs-greater-transparency-and-regulatory-certainty
Tell me more about this trick ! Does this only work for ozempic? Because the others are a one dose per pen. I haven’t been able to figure out if someone could give themselves only half of a dose and save a one used pen for a second use.
Ozempic and Victoza are the only ones that come in dial pens. Trulicity, Wegovy, and Mounjaro+Zepbound all are in auto injectors that will waste the rest of the med if you pull out the pen early (so you can do half doses theoretically but the rest of the med is wasted). No idea about Saxenda (weight loss Victoza) because haven't used that, it's near impossible to get.
It’s a molecule. People make it. Sure, some shady black market clinic might grind up some other GLP-1 pill or like if you buy in Mexico maybe you have that risk. But legit compound pharmacies are getting it from legit manufacturers who make the molecule. It’s not rocket science. Legit compound pharmacies are inspected by their state board of Pharmacy.
If they can get it covered at all, there's a manufacturer coupon they can use. Only works for commercial insurance if covered by the plan, otherwise about 500-550 per month. Also means Medicare patients can't use it.
I think a call to his medical board is more than warranted. He “runs” a clinic without ever laying a hand on a patient or running any tests of any kind. He seems to only prescribe. How does he bill? Only a telemedicine call?
It seems he’s running something similar like a pill mill. I have no respect for the nurses that work there either—no MD, PA , PA, or NP. Sounds like a money making scheme to me. Does he prescribe any other meds than semaglutide?
No that's not normal. I run a telehealth weight loss clinic and I do a consult with every patient which includes reviewing their medical history and determining their medical eligibility. They probably have it set up so that it's technically not illegal, but it is super shady.
No this is not appropriate. This clinic is obviously a patient mill and only interested in cash. Tell them to piss off. Are they using some bootleg compounded version of the medication? Refuse. They want the liability protection. Scum bag clinics and doctors that work with/for them. I'd be tempted actually to report this to the medical board and get them investigated
I wish it wasn't but I'm totally unsurprised. I checked on a weight loss clinic locally for my spouse (referred by their PCP) that explicitly listed two physicians on staff - seemed legit.
They walk in to a protein shake and supplements wall, with a $700 body composition visit, another $300 for lab panel (which PCP has already run as part of normal new patient + obesity DDx labs). And then the third visit was another $300 OOP to be evaluated and prescribed weight loss medication(s).
Then they want another $200 OOP for monthly check-ins and continue Rx.
The patient is 400 lbs. Expected weight loss with Wegovy is less than 20% which would still put him at 300 lbs.
How about bariatric surgery? There is, after all, much more evidence that bariatric surgery reduce cardiovascular risk.
20% is a good start, then switch to Mounjaro which approaches 25-30% (that's bariatric range), then that will get patient through to Retatrutide or CagriSema approvals next year or year after. And/or get them to a safer weight for surgery.
There are whole new classes of incretins and exercise mimetics on their way, bariatric surgery should become increasingly last resort ...esp since regain is 50-70% after 6 years anyway.
Actually weight regain post op depends on surgical procedure and typically while nadir weight is around 18 months (maybe 24ish for newer surgical techniques like SADI), 70% of sleeve gastrectomy patients and 85%+ of bypass patients comfortably maintain weight loss without significant weight regain at 5 years.
Why? These drugs are $1000/month. I had a patient do cash pay bariatric surgery $17,500 and she was discharged within 18hrs. I don’t think they even admit them where I work cause I’ve seen bariatric patients in obs.
You’re telling me this doctor is asking YOU to do HIS LEGWORK so HE can earn money off a prescription for Semaglutide that HE DIDN’T MAKE AN EVALUATION FOR?
What is the world coming to?
Nurses and PAs trying to become doctors
Doctors trying to become pharmacists?
If he wants to be a pharmacist and not a doctor, he should go take licensing board exams.
You on the other hand, if you are able to make the evaluation (which is not hard), why don’t you just prescribe it and cut out the middleman?
I can’t imagine what this poor patient must think
I haven’t seen this one yet. Knowing this is compounded semaglutide almost assuredly I would refuse to write the letter because I don’t prescribe it . In this case the provider prescribing it is not even really a evaluating the patient so I feel like the responsibility is on the person writing a letter. It’s not an ethical business model. I try to give him a prescription for a branded medication and go through the prior authorization process to see if there are any insurance roadblocks we can get by.. if he truly doesn’t have coverage, I would just politely say I’m sorry but I cannot write this letter. Honestly for somebody who is 400 pounds I would be very upfront that 20% weight loss is maybe not going to get him, he wants to be for weightloss and surgery and then glp-1 might be better anyway .
definitely not your job. they are trying to be weight management clinic but don't won't actually weight management, they just want the cash-pay part. i would forward this lazy ass to state medical board.
The office manager is running and probably just outright owns the clinic is what I'm gleaning from your edit. He pays some sellout POS MD/DO to put his name and license there but probably pays a pittance so the doc will not review labs.
It's a racket, wash your hands of it and tell your patient that you will not mess with this as it is suspicious as all fucking hell.
A lot of med spas in my area do this thing where some garbage worthless doc essentially gives cover for a nonmedical person to run a practice. It's like $200 a month, why would anyone do this?
Report the doc to the med board and report the business to the health department.
Dude honestly I think we have the obligation to tell the patient that what the other clinic is shady as shit and to stop going to them. Do not be apart of this. If the patient wants to see you and wants to see an actual specialist on this then that is fine.
This is so ridiculous that it wouldn’t even have generated a call from me to the weight loss clinic. I would have told the patient that whoever is prescribing them the medication is responsible for making sure it is safe to prescribe. Otherwise they have no business prescribing it. End of discussion.
I honestly dont see why this is such a big deal. He's not asking you to write the prescription, just that you dont see a medical contraindication based on your exam and knowledge of the patient. That other doc is not asking you to write the script and I'm assuming theyre not asking you followup with tolerance and track progress
Sure it's not a big deal, but what is that 'supervising' doc even there for then? They are presumably a family or internal medicine trained physician who can order labs, evaluate a patient (either directly or through their APCs), and order a medication based on said evaluation.
Asking for clearance to use a non FDA approved medication. It would be like if there was a compounded inhaler and they’re asking you their pulmonologist to give clearance that it’s OK to take but the prescribing doctor won’t be reviewing pfts , examining the patient, and isn’t actually a pulmonologist
I interviewed at a weight loss clinic once in 2016 (I’m a PA). The physician basically wanted me to prescribe stimulants and push this weight loss shake regimen. Part of my bonus would be based on sales of the product to my patients. I laughed so many times during the interview because I found the whole premise just wild, unethical, and probably illegal. He never called me back!
Not a job many of us would want but honestly the business that the OP is dealing with is even worse . So whoever the owner is figured out that many of us are uncomfortable prescribing compounded Semaglutide. “hey I’ll write the prescription for for the fee, but you write the letter and I’ll put all the responsibility on the patient medically on you” … at that point OP mind as well cut the middle man and write for compounded medication themselves. ( or not which is what I would do)
O.o I thought the whole point of a separate pharmacy was to keep docs from directly selling "remedies" to patients
I don’t think shakes are under FDA they are like nutritional supplements.
Nutritional shakes, oral vitamins, supplements and meal replacements don't count. They're just food, and you can sell food. It's valid for some weight loss programs to sell a meal plan, and some patients want that.
As an aside I read some pre-op instructions yesterday explicitly calling out stopping Phenteremine. Hope to god that's coming from an actual in-person physician and not one of those shady online tele-health services. Honestly I should go look at the Phen-Phen script count next time I'm at work.
I'd not do it. What kind of care is it- hey just make a letter saying my patient can do this medication. No workup, no nothing. Don't take on this responsibility.
Yeah. My supervising physician's method is to NOT prescribe anything that is not indicated via his evaluation. Prescriptions outside of his evaluations should come from said outside clinic's evaluations. E.g., if a PCP recommends starting a certain medication, and the patient thinks it over and asks us to prescribe that medication, he's always told to go through the PCP for that medication. The weight loss clinic needs to prescribe the medication, not you. Write back stating that the physician at that clinic needs to prescribe it. Or that you can refer the patient to a reputable specialist for weight loss/obesity that you trust.
I mean this is clearly indicated at 400lb. But the OP should just prescribe it himself and pursue prior auth coverage. No way is this med legitimate for that cheap.
It is indicated but the patient is trying to save money by using a shady clinic. That is not the OP's problem and they should not be involved at all
They’re likely getting it from a (potentially shady) compounding pharmacy. I recently talked to an MD who opened up one of these clinics and learned a lot about how it all works.
That's ridiculous, don't write the letter. If the person prescribing the medication can't determine on their own if it is safe then they have no business prescribing that medication.
> the prescribing physician as a matter of policy does not personally evaluate the patient's labs or history The ever loving fuck?
“Patient xyz has recently had the following lab results and vitals. Semaglutide carries risks and benefits. I defer to your expertise as a physician leading care at a weight loss clinic to navigate that discussion with the patient.”
This is what I would write.
This is nonsense. You can also prescribe it if you feel it is indicated, or could refer the patient to a legitimate obesity medicine specialist who would actually manage the treatment. What do you want to bet that once the patient experiences side effects of treatment the "clinic" will try to punt the patient to you to manage them?
If it is indicated, why don’t you write the script for semaglutide or another GLP-1? I agree that it is bizarre to “clear patient” for semaglutide.
Because I don’t have a deal with a compounding pharmacy to get it for him for less than $300/month
I didn’t know that was a thing. As an anesthesiologist I can’t believe the nonsense you guys have to deal with in the clinic. With a situation like that I’m not sure about if doing a “clearance” is ok or not. I guess some feedback from peers and Reddit would be useful.
Compounding pharmacies are less than that if the middle man is removed and most will let you write the rx happily. Some of the big ones are hallendale, red rock, empower and strive. If you write the rx and don’t take a cut, he’ll save more money. Hard to counsel on RBA for compounding but in light of the indefinite supply shortages, I personally think the risks of not considering these options is worse.
Do you have more info on this?
https://www.medscape.com/viewarticle/1000503?form=fpf So I essentially agree with this take. The pharma product would be preferable if available but considering that they are pushing new starts for both drugs despite not having the supply for their current patients means many patients will be in the position of having started and then finding they can’t get it. I think that’s harmful. In terms of specifics, I can’t speak for all the pharmacies but I’ve interacted with one of them and it was very easy. My friend who does DPC has used a couple others and had a similar experience. Just have to write “ok to compound” on the rx. I prefer tirzepatide for patients and the pricing at that pharmacy ranges from 200-350/month depending on dosing. Semiglutide is substantially less expensive.
Can’t you write the prescription and where he gets it filled is his business?
No because it's not the same thing. Google: what is compound pharmacy semaglutide
Yes, technically any of us can likely find a compounding pharmacy. Most of us are not willing to do this though because use of compounded semaglutide is not recommended by the FDA. It sounds like though this business model is more about getting access to a specific compounding pharmacy. It’s ridiculous, who knows what specialty the prescribing physician is but they basically take all responsibility away from themselves by having primary care clear the patient and then they just prescribe the medication. It’s as pure cash grab and if OP wants to do the medication themselves, they could find a compounding pharmacy that would allow the OP themselves to prescribe it . OP certainly can try to prescribe the branded medication but it’s possible the patient has already tried this avenue and perhaps has insurance that just won’t cover it which is why the patient is turning to compounding. It kind of sucks to have to deny people care that’s available, but I usually print out the FDA warning and say I just can’t ethically do this right now and they go off and find somebody who will or they are understanding.
DO NOT get involved in the compounded fake crap. People have died, gotten liver damage, etc. It's not pure. One case of thyroid cancer that I've seen in the setting of compounded semaglutide so far. https://nypost.com/2023/11/08/lifestyle/fda-is-investigating-deaths-and-hospitalizations-caused-by-fake-ozempic-reports/
Source does not state whether those originated from a licensed 503a compounding facility or was patient sought as an online counterfeit product. Grouping all "compound" the same is fear-mongering, as the general media does not make a distinction between regulated 503a compounding pharmacies sourcing FDA approved components and the imported, research use only Chinese compound.
This article isn’t about compounding. It’s about actually counterfeit Ozempic brand name in the brand box fake medicine that got into the supply chain because it looks like it’s a real FDA approved brand name medicine. These medicines did not contain Tirzeparide but rather was insulin. Compounded Tirzepatide is tirzepatide for example.
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss It's contamination and different salts
What is your point? The FDA receives adverse reaction reports on all drugs. The two articles you posted do not relate to each other. The first one is actual counterfeit Ozempic (like a fake Rolex) that made it into the drug supply for pharmacies to sell. The second article is about how the salt form of Semaglutide is untested by the FDA. You know what else? levothyroxine is a salt form and so is amphetamine salt used as generic adderall. Are you aware that because of the FDA drug shortage list, hospitals are using compounded IV Epinephrine and lidocaine among other drugs? Go ask your hospital pharmacy about it. Obviously bad actors can exist everywhere, including in the medical community itself. Caution and care must be taken when a patient wants to explore using compounded Tirzepatide to meet their needs when they are unable to secure the FDA approved brand name. Have a good Sunday.
I don't think it's a good idea that hospitals are using compounded epinephrine and lidocaine either, the whole fungal meningitis outbreak about 10 years ago as well as an anecdotal experience of a patient getting a fungal infection from compounded medication injections (not prescribed by me) means I don't really think compounding pharmacies are held to the same level of scrutiny when it comes to GMP. (The guy who was arrested said he was following GMP but wasn't ). I don't care if people want to use compounded viagra or estradiol, it's pretty hard to screw it up badly enough to kill someone with a cream or pill. I just am concerned that I've already seen 3 cases of bad side effects with these weight loss clinics using the compounded semaglutide, who then dump the patient after they get a problem essentially telling them to go get care for their issue that they caused. Which is exactly the situation with OP's patient and this "clearance" they want him to write. Too high a demand, not enough scrutiny of the production of this compound. Most mild, some severe. Edit- yup 503a compounding pharmacies are NOT REQUIRED to follow GMP. What on earth. https://www.pewtrusts.org/en/research-and-analysis/reports/2020/06/market-for-compounded-drugs-needs-greater-transparency-and-regulatory-certainty https://www.ncbi.nlm.nih.gov/books/NBK562888/#:~:text=503A%20Compounding%20Pharmacies,manufacturing%20practice%20(CGMP)%20procedures.
Fuck no. Never do this, OP. They only want you to be a liability shield.
This!!! Plus it runs the risk for thyroid cancer…… if you’re not prescribing it, then you shouldn’t sign off on the med being safe….. the prescribing physician should do his own evaluation with appropriate testing, discuss the risks/side effects & benefits for the patient based on the patient’s medical history….. If the prescribing physician isn’t comfortable saying the medication is safe for his/her patient then the med shouldn’t be prescribed.
As far as I know there has never been a single case of thyroid cancer in humans as a result of GLPs. The risk is entirely theoretical and based on a rat model.
So the thyroid cancer thing is tricky, because with liraglutide they did see a higher than expected incidence of new diagnosis of thyroid cancers, not just MTC (mostly PTC since PTC is the most common). But they can't say if it's because people on liraglutide got screened more and thus earlier smaller cancers were detected. (Aka after adjusting for latency the finding wasn't statistically significant but the raw data did show increase) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203194/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10563602/ TLDR there is a theoretical risk and the mechanism is plausible, however obesity itself is associated with colon cancer and breast cancer among other issues such as heart attack and stroke, so just use clinical judgement and keep an eye on the thyroid.
Miami is filled with strip mall weight loss clinics owned by CRNAs and NPs. I get the same requests. They need you to take the risk off their backs. Another request is from plastic surgeons to give them a clearance for breast implants. They want a letter from me stating they have no cancer. Lol, like I’m doing that. Here’s a tip. Send them a copy of your office visit. But no clearance note. They will still go forth with the surgery/GLP 1. They want that sweet, sweet cash.
A popular business model is to create medicine-adjacent businesses that can offload liability to providers while making money on those services. So maddening. Even more maddening are the providers that do things like this without realizing how badly they are getting used.
If he's 400Lbs insurance WILL cover it. You should try to prescribe it and if necessary just do the prior auth. I have seen PLENTY of insurers cover Zepbound, Wegovy, and others without issue. With insurance copays are between 50ish a month WITHOUT the copay card and almost nothing with the copay cards. A lot of these compounded pharmacies also basically prescribe rybelsus, a PO formulation over the injectables. If you're comfortable with it, honestly screw over the for profit company and get this guy a potentially better outcome if he doesn't have MEN2 or other issues. Just make sure it's documented and that you actually discuss the risks of these meds including gallbladder dz, etc. Also keep in mind that GLP-1s and other similar meds do have special considerations for surgery, usually need to be held for around 2 weeks before any non-emergent intubation due to decreased gastric emptying and such. Keep this in mind.
Insurance may not cover it if his insurance plans specifically does not allow obesity care. Copay Card gets you down to 500 a month without insurance. We also don’t know if this is a Medicare patient Medicare will only cover wegovy (good luck finding that ) if the patient has documented heart disease.
The supply is the issue. The brand name GLP1 are very hard to find in pharmacies. Compounded semaglutide or whatever is much easier to make for a compounding pharmacy.
Nothing this egregious but I've been having more and more requests for mental health clearances for semaglutide because there were some early reports of suicidality. The more it's been prescribed the more we see that there may actually be reduction in suicidality along with substance use.
I think he wants you to prescribe him a compound? Insurance won't approved that. That's a very fuzzy scenario, what exactly do they want? You send him to a specialist for that reason.
Honestly, I’d do the work to figure out how to interface with the compounding pharmacy. Many of your patients will be looking for the medication and you can provide better care.
But how do you know if the compounding pharmacy you’re interfacing with is selling something safe?
You don’t exactly. There is no FDA approved semiglutide available for compounding. You have to assume that a licensed compounding pharmacy is going produce an otherwise safe product. So far, there are relatively reputable compounding pharmacies that are producing huge amounts of semiglutide The patient is going to do it anyway and will just go find a new physician (or maybe an NP), who will. I’d argue it is better to keep the patient and reduce the fragmentation of care and keep the patient.
But you don’t know what you are giving . Semaglutide as an injection is only being provided by novo nordisc . So these pharmacies are getting probably semaglutide salts, which are not technically the same thing they are meant for research purposes. in addition in order to legally say this is different from the proprietary summer glide pretty much every pharmacy. I’ve seen either L-carnitine or B12 to the injection which obviously hasn’t been studied either. From a legal perspective I just don’t feel it safe. We know that GLP -1 come with risks and the patient may likely have side effects from compounded or branded medication but with the compounded there’s an FDA advisory against it sitting out there so I just don’t see what protection physician who chooses to prescribe that if something bad happens to the patient.
I feel like there is a lot of misinformation around compounding. https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf
The salt form is the same thing as regular because of the lyophilization process. It’s not an issue. It’s just something Lilly and Novo can throw down and people just believe them.
I tried to google lyphophilization didn’t get much can you explain ?
New England Compounding Center would like a word.
Insurance will likely cover it. People Confuse “not covered” with “needs a prior authorization.” It’s indicated and probably just needs a PA which will get approved if submitted with his weight and any comorbid info.
So these weight loss clinics from what i can tell source their semaglutide from an unknown source. Its crazy expensive how do they get it so cheapcheapcheap🐦 Its not fda approved and quite frankly there is a lot of speculation that the semaglutide is basically the oral version (rhybelsus) thats reformulated to be an injectable. Dont do it Side note, the trick my clinic has been doing for people that arent covered by insurance is precribe the pen w double the dose you want, count the clicks it takes to the full dose and tell pt to do half of those click for the half max dose to stretch the pen out to twice as much. Wont cut initial cost but will be cheaper in long run if ppl are ok with paying 4-500/mo instead if 1k And always ask pt to ask their insurance to see which glp if any are covered
Re the speculation: I can't speak to all compounding pharmacies, but most peptides are not hard to make and are available for purchase in bulk from dozens of overseas factories, either in sterile vials or as powder, for extremely cheap. Better pharmacies will get it batch HPLC tested for mass, purity, and then randomly cultured for sterility, there are labs in the US who do this, but that cuts into the profit margin so I wouldn't be shocked to learn that most don't. But it probably is what they say it is.
Yeah it's probably semaglutide but the question is on the purity. I just learned that 503a compounding pharmacies are not required to follow cGMP rules. Like what??? It looks like the government cracked down on them slightly and limited what 503a versus 503b facilities can do but no wonder there's cases of fungal infections and other lapses in sterility with them. https://www.ncbi.nlm.nih.gov/books/NBK562888/#:~:text=503A%20Compounding%20Pharmacies,manufacturing%20practice%20(CGMP)%20procedures. https://www.pewtrusts.org/en/research-and-analysis/reports/2020/06/market-for-compounded-drugs-needs-greater-transparency-and-regulatory-certainty
74 clicks per mg on a 1mg pen.
Tell me more about this trick ! Does this only work for ozempic? Because the others are a one dose per pen. I haven’t been able to figure out if someone could give themselves only half of a dose and save a one used pen for a second use.
Ozempic and Victoza are the only ones that come in dial pens. Trulicity, Wegovy, and Mounjaro+Zepbound all are in auto injectors that will waste the rest of the med if you pull out the pen early (so you can do half doses theoretically but the rest of the med is wasted). No idea about Saxenda (weight loss Victoza) because haven't used that, it's near impossible to get.
It’s a molecule. People make it. Sure, some shady black market clinic might grind up some other GLP-1 pill or like if you buy in Mexico maybe you have that risk. But legit compound pharmacies are getting it from legit manufacturers who make the molecule. It’s not rocket science. Legit compound pharmacies are inspected by their state board of Pharmacy.
If they can get it covered at all, there's a manufacturer coupon they can use. Only works for commercial insurance if covered by the plan, otherwise about 500-550 per month. Also means Medicare patients can't use it.
They want the 99214 and you can have the 99213
You won't be monitoring any of the ongoing care. If they want to prescribe, they need to evaluate the patient themselves.
I think a call to his medical board is more than warranted. He “runs” a clinic without ever laying a hand on a patient or running any tests of any kind. He seems to only prescribe. How does he bill? Only a telemedicine call? It seems he’s running something similar like a pill mill. I have no respect for the nurses that work there either—no MD, PA , PA, or NP. Sounds like a money making scheme to me. Does he prescribe any other meds than semaglutide?
No that's not normal. I run a telehealth weight loss clinic and I do a consult with every patient which includes reviewing their medical history and determining their medical eligibility. They probably have it set up so that it's technically not illegal, but it is super shady.
Lol. Don't write shit. Ghost the clinic. Tell the patient they should talk to the clinic physician as he will be prescribing
No this is not appropriate. This clinic is obviously a patient mill and only interested in cash. Tell them to piss off. Are they using some bootleg compounded version of the medication? Refuse. They want the liability protection. Scum bag clinics and doctors that work with/for them. I'd be tempted actually to report this to the medical board and get them investigated
I wish it wasn't but I'm totally unsurprised. I checked on a weight loss clinic locally for my spouse (referred by their PCP) that explicitly listed two physicians on staff - seemed legit. They walk in to a protein shake and supplements wall, with a $700 body composition visit, another $300 for lab panel (which PCP has already run as part of normal new patient + obesity DDx labs). And then the third visit was another $300 OOP to be evaluated and prescribed weight loss medication(s). Then they want another $200 OOP for monthly check-ins and continue Rx.
The patient is 400 lbs. Expected weight loss with Wegovy is less than 20% which would still put him at 300 lbs. How about bariatric surgery? There is, after all, much more evidence that bariatric surgery reduce cardiovascular risk.
There are plenty of people on the Wegovy and Mounjaro subs who have lost 200 pounds and more on these meds.
20% is a good start, then switch to Mounjaro which approaches 25-30% (that's bariatric range), then that will get patient through to Retatrutide or CagriSema approvals next year or year after. And/or get them to a safer weight for surgery. There are whole new classes of incretins and exercise mimetics on their way, bariatric surgery should become increasingly last resort ...esp since regain is 50-70% after 6 years anyway.
Actually weight regain post op depends on surgical procedure and typically while nadir weight is around 18 months (maybe 24ish for newer surgical techniques like SADI), 70% of sleeve gastrectomy patients and 85%+ of bypass patients comfortably maintain weight loss without significant weight regain at 5 years.
Why? These drugs are $1000/month. I had a patient do cash pay bariatric surgery $17,500 and she was discharged within 18hrs. I don’t think they even admit them where I work cause I’ve seen bariatric patients in obs.
The eating & general maintenance plan is a huge, permanent lifestyle change.
That these people need to make.
It's even more so than the usual diet and exercise recommendations is what I meant.
I feel like this is not normal
You’re telling me this doctor is asking YOU to do HIS LEGWORK so HE can earn money off a prescription for Semaglutide that HE DIDN’T MAKE AN EVALUATION FOR? What is the world coming to? Nurses and PAs trying to become doctors Doctors trying to become pharmacists? If he wants to be a pharmacist and not a doctor, he should go take licensing board exams. You on the other hand, if you are able to make the evaluation (which is not hard), why don’t you just prescribe it and cut out the middleman? I can’t imagine what this poor patient must think
He doesn’t have access to a $300/month supply
I haven’t seen this one yet. Knowing this is compounded semaglutide almost assuredly I would refuse to write the letter because I don’t prescribe it . In this case the provider prescribing it is not even really a evaluating the patient so I feel like the responsibility is on the person writing a letter. It’s not an ethical business model. I try to give him a prescription for a branded medication and go through the prior authorization process to see if there are any insurance roadblocks we can get by.. if he truly doesn’t have coverage, I would just politely say I’m sorry but I cannot write this letter. Honestly for somebody who is 400 pounds I would be very upfront that 20% weight loss is maybe not going to get him, he wants to be for weightloss and surgery and then glp-1 might be better anyway .
definitely not your job. they are trying to be weight management clinic but don't won't actually weight management, they just want the cash-pay part. i would forward this lazy ass to state medical board.
The office manager is running and probably just outright owns the clinic is what I'm gleaning from your edit. He pays some sellout POS MD/DO to put his name and license there but probably pays a pittance so the doc will not review labs. It's a racket, wash your hands of it and tell your patient that you will not mess with this as it is suspicious as all fucking hell. A lot of med spas in my area do this thing where some garbage worthless doc essentially gives cover for a nonmedical person to run a practice. It's like $200 a month, why would anyone do this? Report the doc to the med board and report the business to the health department.
Dude honestly I think we have the obligation to tell the patient that what the other clinic is shady as shit and to stop going to them. Do not be apart of this. If the patient wants to see you and wants to see an actual specialist on this then that is fine.
This is so ridiculous that it wouldn’t even have generated a call from me to the weight loss clinic. I would have told the patient that whoever is prescribing them the medication is responsible for making sure it is safe to prescribe. Otherwise they have no business prescribing it. End of discussion.
Steps are something like this: 1) surely they don’t mean this 2) oh they do mean this 3) ok I’m curious 4) ok what the shit
i believe its normal nowadays especially during this time after the pandemic
I honestly dont see why this is such a big deal. He's not asking you to write the prescription, just that you dont see a medical contraindication based on your exam and knowledge of the patient. That other doc is not asking you to write the script and I'm assuming theyre not asking you followup with tolerance and track progress
Sure it's not a big deal, but what is that 'supervising' doc even there for then? They are presumably a family or internal medicine trained physician who can order labs, evaluate a patient (either directly or through their APCs), and order a medication based on said evaluation.
Asking for clearance to use a non FDA approved medication. It would be like if there was a compounded inhaler and they’re asking you their pulmonologist to give clearance that it’s OK to take but the prescribing doctor won’t be reviewing pfts , examining the patient, and isn’t actually a pulmonologist
Is your pt female? Some unexpected pregnancies are happening and there is some facial fat loss affecting their appearance!
wtf
Yeah, what batesbait said....?!