Jennie Smith, a seamstress at a ballet school in Kent, Ohio, had been trying to lose weight and keep it off for years. After losing 60 pounds through dieting only to gain 30 of it back, she wanted to try the new weight-loss drugs like Wegovy.
But they cost more than $1,000 a month and she didn't think her insurance would cover it.
So Smith did some research and found a cheaper version on one of dozens of online pharmacies that tout their own copies of these weight-loss drugs.
She did a virtual appointment with a health care provider to figure out the right dose, and the pharmacy sent the drug to her a few weeks later on dry ice. The price: around $300 a month.
She鈥檚 lost 40 pounds since September.
鈥淚t was like a light switch,鈥� she says. 鈥淎s soon as I started taking it, I noticed not only was I not eating, but I wasn't thinking about food.鈥�
But it wasn鈥檛 exactly Wegovy. Smith got what鈥檚 called a compounded medicine. It鈥檚 made with the same basic ingredient as Wegovy 鈥� semaglutide 鈥� but by a specialized pharmacy, not a drug company.
With the growing demand for weight-loss drugs like Wegovy, new online companies seem to pop up every day, offering telehealth prescribing of cheaper, compounded versions of the medicines. And for some patients, they offer a reprieve from the high name-brand prices, insurance company coverage denials and drug shortages.
The convenience and cost can be appealing, but there are some risks. Here鈥檚 what to know and how to protect yourself.
1. What are compounding pharmacies and are they legit?
Compounding pharmacies exist to help patients whose needs aren鈥檛 met by existing approved drugs. The compounded drugs are not generics, nor do they go through the Food and Drug Administration鈥檚 approval process. Instead, compounding pharmacists tailor drugs for individual patients who need them and are mostly regulated on the state level by boards of pharmacy.
For instance, if a drug is only available as a pill but an elderly patient can鈥檛 swallow one, a doctor would write a prescription so that a compounding pharmacist could prepare it in liquid form.
Compounding pharmacists are not supposed to make what are 鈥渆ssentially鈥� copies of commercially available approved drugs, . But sometimes, compounding pharmacies can legally pitch in during a drug shortage.
That鈥檚 what鈥檚 happening now. Wegovy is in short supply because the manufacturer, Novo Nordisk, can鈥檛 keep up with demand, .
But semaglutide 鈥� the active pharmaceutical ingredient in Wegovy 鈥� is widely available, says .
Compounding pharmacies are required to source their ingredients from FDA-registered facilities, says Brunner. 鈥淎nd they use some of the same FDA-registered facilities that the drug manufacturers use,鈥� Brunner says.
2. If I buy semaglutide online, how do I know whether to trust the website I order from?
Many of the new websites offering to ship medicine to your door offer compounded versions of popular drugs made in-house or at compounding pharmacies they partner with.
Be aware that some companies selling compounded semaglutide may not be in compliance with state and federal standards.
Novo Nordisk has taken for selling compounded semaglutide that鈥檚 not up to snuff. It says it found impurities, the wrong concentration of the drug 鈥� even some products that contain no semaglutide at all.
there have been hundreds of problems reported to the FDA鈥檚 voluntary adverse event reporting system associated with compounded semaglutide. As of the end of March, there were 99 hospitalizations and seven deaths. (To be sure, the brand name drugs also have hospitalizations and deaths in this database.)
When it comes to online compounding pharmacies, the , which represents the state regulators, has found more than 40,000 online pharmacies operating illegally or in a way they don鈥檛 recommend.
鈥淭here are legitimate pharmacies that operate online and I would say probably 5% of all pharmacies that operate online are legitimate,鈥� says
Consumers can use to see whether an online pharmacy meets its 鈥減atient safety and pharmacy practice standards, or applicable laws.鈥�
Carter says his organization checks 200 new online pharmacies a week. But as soon as a bad online pharmacy gets taken down, another two pop up in its place. 鈥淪o we just continue to do our due diligence, but it's kind of like you're on a hamster wheel,鈥� he says.
3. How can I check if the pharmacy or manufacturer is above board?
Since websites often work with several compounding pharmacies, and NABP can鈥檛 check everything, you can do more due diligence on your own.
One thing consumers can do to protect themselves is check that their pharmacy is licensed in their state, says Brunner. The FDA has a .
You can also ask the compounding pharmacist where they get their semaglutide, and check this to see if that factory is registered with the FDA. Licenses and registrations like this mean the facilities can be inspected and need to comply with safety and quality standards.
鈥淲e hear from prescribers frequently that they are being bombarded with advertisements from these so-called pharmacies that, in fact, are not pharmacies at all,鈥� Brunner says. 鈥淪o we do believe there's counterfeit activity out there. You'd best be careful. But never, never, never inject something in your body that you did not get [with] a prescription from a licensed prescriber and a state licensed pharmacy.鈥�
If you see anyone advertising compounded 鈥淥zempic鈥� or 鈥淲egovy鈥� instead of compounded semaglutide, it鈥檚 a red flag, Brunner says. Compounders aren鈥檛 legally allowed to use the name brand in their marketing. So what else might they be doing wrong?
鈥淥ur members will never tell you that they're selling compounded Mounjaro or compounded Ozempic,鈥� Brunner says. 鈥淭hey will tell you that they dispense semaglutide.鈥�
4. Is there any risk to getting a Wegovy prescription from an online doctor instead of my regular one?
The FDA and medical experts caution it鈥檚 safest to get FDA-approved name-brand drugs through your regular doctor and in-person pharmacy. But some people may feel uncomfortable talking to their doctors because of stigma about weight.
When Jennie Smith told her primary care doctor about using compounded semaglutide purchased online, he scolded her that she should try to lose the weight on her own.
鈥淚 thought, well, dang it, why couldn't I do this through sheer willpower?鈥� she says. 鈥淎nd there's just no way. There's just no way that I could have done it.鈥�
She鈥檚 losing weight on the compounded drug and says she hasn鈥檛 had any complications so far.
Still, it is crucial for patients to keep their regular doctors in the loop, says Dr. Scott Isaacs, the president elect of the American Association of Clinical Endocrinology and a professor at Emory University Medical School.
Unlike online providers who don鈥檛 get to know you (and your medical records) in person, your primary care provider can monitor other health issues that might complicate things.
鈥淵ou don't want to hide this from your doctor. I mean, they need to know,鈥� he says. 鈥淚 can tell you an example of a patient I saw yesterday that had lost significant weight and they were taking other medications 鈥� And the dose had to be adjusted significantly because of their weight loss and they didn鈥檛 know that.鈥�
Patients on insulin, for instance, might need a lower dose as they shed pounds while using semaglutide. Too much insulin can be dangerous and lead to seizures or even death.
Isaacs also says it鈥檚 important to physically check a patient鈥檚 thyroid because the drug 鈥� brand name or compounded 鈥� has a rare side effect: thyroid cancer.
He says he鈥檇 prefer patients work with him to get a prescription and avoid online pharmacies altogether. But he knows that鈥檚 just not always realistic.
鈥淚f there is a will, there's a way,鈥� he says.
You can contact 91福利 pharmaceuticals correspondent Sydney Lupkin at slupkin@npr.org.
Copyright 2024 91福利