The Weight Loss Drug Revolution: Helping patients avoid phony medicine scams

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Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs have made headlines for helping patients with type 2 diabetes, obesity and potentially a host of other medical conditions.

It is clear the antiobesity medicines are working. Patients want them. And they are not always willing to wait for their physicians to prescribe the new remedies.

How likely are patients to skip their doctor’s orders and go shopping online for pharmaceuticals? In a fall 2024 survey by Medical Economics, 78% of respondents said they were concerned about their patients attempting to procure GLP-1 RAs from online sources without their knowledge.

But that leaves patients vulnerable to online rip-offs or worse –– getting drugs that are inappropriate or even harmful. With the U.S. Food and Drug Administration (FDA) pronouncing the drugs in shortage, compounding pharmacies have stepped in to fill the void, but that may cloud the situation, not clarify it.

“Patients are very confused about where they get the product. Where is it legal to buy it? How easy is it to get it? What’s a compounding pharmacy versus the product coming from the legitimate manufacturer, like Eli Lilly or Novo Nordisk?” said Tim K. Mackey, Ph.D., who has studied online fraud as a professor of anthropology at the University of California San Diego.

“I think it’s very challenging for the average consumer to navigate all of this and understand it,” he said.

Meet the market

Mackey is the corresponding author of the study “Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases,” published last year in JAMA Network Open, which analyzed the validity of online sales of semaglutide. Tenille Davis, Pharm.D., is a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding (APC). Rob Nichols, Pharm.D., BCPS, is director of clinical operations for the Greenwood Pharmacy and Compounding Center of Waterloo, Iowa. They spoke with Medical Economics about the state of the GLP-1 RA marketplace as of late 2024.

The drugs have a strong record for treating type 2 diabetes but are relatively new for weight loss, and people like novelty. Word has spread that celebrities are using the medicines to drop weight and keep it off, with great results.

There are regular reports in the popular and scientific media about successful studies and more discoveries of other health benefits. There are some instances of extreme side effects, but apart from gastrointestinal upset, the medicines generally are safe.

Demand is skyrocketing. But the drugs are expensive, so people are looking for cheaper sources.

The FDA says the drugs are in short supply, opening the door for compounding pharmacies to make substitutes.

Telehealth blossomed during the COVID-19 pandemic, so patients have been consulting with doctors electronically. Along with the GLP-1 RA news reports, smartphones are ubiquitous in a nation of consumers who are comfortable shopping online.

In this situation, it is not easy for doctors to counsel patients on obtaining GLP-1 RAs, the experts said.

“Public health surveillance shouldn’t necessarily be the responsibility of physicians. They’re there to care for their patients,” Mackey said. Most physicians and medical students are not trained in safety issues that intersect with technology, he noted.

“But at the same time, these consumers are really, really interested in these products, and if you just say, ‘Well, you don’t need it, so we’re not going to prescribe it to you,’ you may be missing an opportunity to educate a patient about the potential risk of them sourcing it from another place,” Mackey said.

Prescription needed –– and let the buyer beware

First and foremost, GLP-1 RA medications are prescription drugs. Remind patients that they need a prescription to obtain them. Patients who try to get around that could lose money or get a product that is inappropriate for them, worthless or, even worse, harmful.

In Mackey’s study, he and colleagues in the United States and Hungary bought nonprescription semaglutide from six sources online. Three sent Ozempic injections that likely did not meet legitimate product quality standards. As for the other three, “Not only did they send us nothing, they tried to scam us out of more money by saying that we had to pay customs fees associated with getting the product imported into one of our testing sites,” Mackey said.

Online scam sites can be fairly sophisticated in design. Yet they can be identified, and platforms that host them could take them down easily, “but they may need encouragement through some sort of direct regulation or incentive to do the right thing because it’s not always required based upon the policies we have today,” Mackey continued.

What about compounded drugs?

Confusion abounds in the market when news media conflate illegal online drug sellers and legitimate compounding pharmacies that are supplying GLP-1 RA drugs, Davis said.

The situation goes beyond mere name-calling, even beyond billions of dollars in pharmaceutical sales: Human lives may be at risk. In fall 2024, Novo Nordisk CEO Lars Fruergaard Jørgensen cited FDA records when he told CNN that compounded versions of semaglutide were associated with at least 100 hospitalizations and 10 patient deaths. APC countered with its own issue brief, “Compounded GLP-1 Drugs and Patient Adverse Events,” picking apart his claims and asserting the importance of legitimate pharmacies.

Pharmacists mixing drug formulas started long before pharmaceutical giants began mass producing big bottles of pills or injections, Davis said.

“Compounding pharmacists have been helping to create medications for patients that need them,” Davis said. “Everything was created from scratch, essentially. So it’s been around for hundreds and hundreds of years, the traditional practice of pharmacy, and we existed far before GLP-1 drugs.”

When an FDA-approved medication is on the FDA’s shortage list, compounding pharmacies are legally authorized to create essentially a copy of that medication, Davis said.

Drug shortages can last for years. By autumn 2024, that was the case with semaglutide – in shortage since March 2022 – and tirzepatide – in shortage since December 2022. The FDA rulings on availability created time for a huge telehealth industry to spring up around compounded GLP-1 RA drugs, she said.

Davis acknowledged that compounded drugs are not the first choice for doctors and patients. Price can’t be a reason to choose compounded drugs, which often are not covered by insurance, she said. “That being said, in general, compounded GLP-1s are typically much less expensive than the commercial GLP-1 drugs,” because the pharmacies don’t have the research or operating costs of Big Pharma, she added.

However, the ability to sell compounded GLP-1s will soon be limited. The FDA announced on Dec. 19 that these drug shortages have ended, and the agency has issued new guidelines. Under these new guidelines, state-licensed pharmacies must cease compounding, distributing or dispensing tirzepatide injections by Feb. 18. Outsourcing facilities must do the same by March 1.

Finding a trusted partner

Kristina Henderson Lewis, M.D., M.P.H., SM, an associate professor of epidemiology and prevention at Wake Forest University School of Medicine, Lou Haenel IV, D.O., a specialist in endocrinology and diabetes with Roper St. Francis Healthcare in South Carolina, and Robert Kushner, M.D., professor of medicine and medical education at Northwestern University Feinberg School of Medicine, all said they typically advise patients against seeking out compounded GLP-1 RAs.

“It is fair to say that it may not undergo the classic FDA scrutiny,” Haenel said. “It’s certainly not being made by and delivered in a formulation as part of the parent company.”

But some physicians do prescribe the compounded formulas. There are trustworthy compounding pharmacists in the market, and Davis and Nichols offered advice on how physicians can find them. Some of their guidance can help patients as well.

• Get a pharmacy partner.

Davis and Nichols agreed physicians should develop relationships with trusted compounding pharmacists, not just for GLP-1 RA drugs. Compounding can expand the availability of treatments for patients.

“If you don’t already have a relationship with a local compounding pharmacy, try to create one. Reach out to them, meet them, get to know them and understand what the scope of their offerings are,” Nichols said.

• Ask questions.

A short conversation can reveal a lot about an organization, according to Davis.

“Compounding pharmacists are helpful people; they’re problem solvers,” she said. “They’re happy to answer questions about their quality assurance procedures, testing procedures [and] where they source their active pharmaceutical ingredients. And if you’re talking to a pharmacy that’s hesitant to answer any questions like that, I’d find a different partner.”

• Tell patients to ask questions.

The same advice holds true for patients, Davis said. Tell them to ask questions and be wary if a pharmacist is not up front with information.

“You don’t have to be a scientist, but ask the pharmacist some simple questions about their quality assurance procedures or their tests that they perform on the final batches of product,” she said. “If a pharmacist is willing to talk to you about those kinds of things, that’s a really good sign. If they’re not, it’s probably not such a good sign.”

• Use state resources.

APC operates “Is It Legit?” (https://a4pc.org/isitlegit/), a website that links to each state’s board of pharmacy so users can search for licensure, Davis said.

Physicians or their staff should look for any negative actions regarding a pharmacy license and proceed with caution, Nichols said. It is also fair to ask a pharmacist about their licensing status and the accrediting bodies that oversee them, he said.

• Sterile or nonsterile?

Doctors should be aware of the distinction between sterile and nonsterile compounding entities, Nichols said. Nonsterile compounding pharmacies have clean environments to make medicines but typically will not make injectable medications, whereas sterile compounding pharmacies have more stringent guidelines for aseptic preparation settings.

• Ask about patient instruction.

Doctors prescribe medicines, and pharmacists dispense them. It’s up to patients to get the drugs into their body, and they need to know how. GLP-1 RA drugs are injected, so doctors should ask pharmacists what level of counseling and instruction they must provide on preparing and administering injections.

In Nichols’ state of Iowa, “we’re required to counsel with each new prescription and dose change of the medication, so we are providing that education. And yes, usually that entails sitting down with the patient, especially if it’s their first time on a certain medication or a certain administration style,” he said. He noted that different states have different requirements for counseling, but pharmacists should be willing to answer patients’ questions.

• Look for insurance assistance.

Pharmacists and their staff may know about discounts or savings programs that patients and physicians may not be aware of. Many develop expertise in navigating patient insurance plans and prior authorization requirements, Nichols said. Doctors and patients should enlist their aid, he added.

“We’re trying to be responsible financially and be responsible from a safety standpoint, and make sure that the things we’re working [on] with providers … are affordable and can be reasonably expected to be effective for that person,” he said.

• Stay local.

Nichols said organizations or companies from elsewhere have reached out to his company because they see “compounding pharmacy” in the name. Although resources may abound on the internet, he prefers to work with local providers, and physicians should consider doing the same when they can.

“They know that they can trust us, and we know that we can trust their intentions with prescribing these medications,” he said.