Amid healthcare's GLP-1 gold rush, clinicians find themselves confronting a new challenge to patient-provider communication: managing patients taking unapproved GLP-1s.
Indeed, GLP-1 medications have taken the healthcare industry by storm, with the FDA approving them to treat diabetes and heart disease, as well as to support weight loss treatment. That's not to mention early but promising data indicating GLP-1s could one day treat diseases like addiction and dementia.
Those promising indications have made the drugs popular among healthcare consumers. According to May 2024 data from KFF, 6% of U.S. adults are currently taking a GLP-1 and 12% have taken one before. That includes 43% of adults who said they've been told they have diabetes, 26% with a heart disease diagnosis and 22% with obesity or overweight.
With CMS recently proposing coverage for the medications under Medicare and Medicaid, some experts predict use could become more widespread.
But as prescriptions for GLP-1s have increased, another concerning trend rises: patients accessing unapproved GLP-1s.
What are unapproved GLP-1 drugs?
The FDA considers unapproved GLP-1s to be any version of the medication that has not undergone the agency's approval process. Importantly, this includes compounded GLP-1s.
Compounded medications are essentially custom-made medications hand-mixed by pharmacists. Patients might receive a compounded medication because they are allergic to a certain dye used in the manufactured version of the drug or if they cannot swallow a tablet and need the medication in liquid form.
Compounding is also allowed when there are significant drug shortages, as was the case with GLP-1 medications.
However, the FDA is clear that compounded drugs are not FDA-approved. Although they can help meet some medical needs, there are risks associated with taking a compounded medication.
"Unnecessary use of compounded drugs may expose patients to potentially serious health risks," according to the FDA. "For example, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little active ingredient."
In particular, the FDA has detected some problems with compounded GLP-1s, including dosing concerns with compounded semaglutide and tirzepatide and some adverse events linked to compounded versions of those medications.
Unapproved GLP-1 drugs also include illegally marketed versions of these drugs. For example, the agency has flagged counterfeit versions of Ozempic and versions of semaglutide, tirzepatide or retatrutide that are falsely labeled "for research purposes" or "not for human consumption," the agency says. These medications are often sold directly to patients online.
Data shows that patients are using these types of medicines, at least at a modest rate.
Patients need to be comfortable and open with their doctor about anything they're taking because while a medicine can be safe, it is not necessarily safe for everybody.
Brent Smith, M.D.Board member of the American Academy of Family Physicians
A separate KFF poll showed that 10% of adults who have taken a GLP-1 got it from a medical spa. Another 11% got it from an online provider or website, although KFF did not distinguish between compounded drugs from telehealth providers and illegally marketed drugs.
Although it's promising that 79% of those taking a GLP-1 got a prescription from their primary care provider or another specialist, the nearly one-fifth of GLP-1 users who don't get their medicines from their doctor pose a challenge. After all, these patients need the strong, wraparound care management GLP-1s require, too.
But how do clinicians find out if their patient is taking an unapproved GLP-1?
Regardless of where a patient gets a GLP-1, it is essential that their primary care or family medicine provider knows about it, according to Brent Smith, M.D., a board member of the American Academy of Family Physicians (AAFP).
It simply comes down to patient safety, he said during a recent interview.
"Patients need to be comfortable and open with their doctor about anything they're taking because while a medicine can be safe, it is not necessarily safe for everybody," Smith explained. "And while a medicine may be doing great things, it may not be doing great things for everybody."
For example, a patient with diabetes or prediabetes might be taking other medications that affect their blood sugar. Although GLP-1s alone do not typically cause hypoglycemia or low blood sugars, the combination with other medications could lead to those issues. Primary care providers take into account all of the medications a patient takes and adjust dosages to prevent adverse drug events.
Normally, primary care providers do know the different medications their patients take. Although health IT interoperability can create some hiccups, medication lists are typically part of the medical record, and when necessary, patients are usually able to fill in the gaps.
But as noted above, around a fifth of patients are getting their GLP-1s from a source outside the traditional medical system, so it's incumbent upon them to share with their primary care providers about the drugs.
And if patients are getting unapproved GLP-1s, especially from unfamiliar online pharmacies, they might be reticent to share. After all, it's not uncommon for patients to report feelings of judgment from their healthcare providers. In fact, anywhere from 40 to 80% of patients with obesity said they've felt weight stigma from their providers before, one 2024 study found.
Patients might not share that they've gotten an unapproved GLP-1 for fear of judgment from their healthcare providers.
According to Smith, such a dynamic would be indicative of an unhealthy patient-provider relationship.
"If I have a patient who genuinely feels like they can't tell me they're doing something, we've got a problem," he asserted. "I've got to create a situation where they feel comfortable, and they've got to be open and honest with me about that. That's a mutual thing. I've got to create that situation, and then they've got to take advantage of it."
Indeed, healthcare providers won't love or even like every lifestyle decision their patients make. However, clinicians can use certain patient-provider communication strategies, including empathic communication, to maintain a positive and respectful relationship with that patient.
This ensures the clinician remains someone the patient wants to confide in.
Smith likened it to smoking cessation counseling.
But in the end, this is an important concept of medical ethics, which is autonomy. The patient gets to choose what they do with their body.
Brent Smith, M.D.Board member of the American Academy of Family Physicians
Practicing in the Mississippi Delta area, Smith treats some people who smoke. If he sees the pack of cigarettes or the smokeless tobacco during the clinical encounter, Smith will say something, but he knows not the berate his patients. He wants to counsel his patients toward well-being, and he can't do that if his patients don't trust him.
Clinicians need to ensure a similar situation doesn't happen if their patient is taking an unapproved GLP-1.
Smith advised clinicians to keep conversations about unapproved GLP-1s fact-based, not emotional or judgmental.
"You may say, 'I don't like that you're doing that for these reasons,'" he recommended.
The provider could be worried about the safety of the medication the patient is obtaining, especially if it sounds like the patient's accessing a drug that's counterfeit or not mixed correctly. Providers might also outline the reasons a patient is not a good candidate to take a GLP-1.
"But in the end, this is an important concept of medical ethics, which is autonomy," Smith said. "The patient gets to choose what they do with their body. That doesn't mean that we have to love you for doing that, and we don't have to like it. But we have to be able to communicate and treat you and still bear a relationship with mutual trust and respect."
Ensuring patient safety with unapproved GLP-1s
With a healthy patient-provider relationship, healthcare providers should be able to cultivate open communication with their patients and, ultimately, determine whether the patient is taking an unapproved GLP-1.
Getting to the heart of that information will help the clinician craft a better care plan moving forward. In addition to the patient safety and drug interaction considerations noted above, Smith said this knowledge helps support better patient engagement.
For example, providers treating patients accessing compounded GLP-1s can advise patients on the best compounding pharmacies in town.
Primary care and family medicine providers can also add to the wraparound care that helps patients succeed in their GLP-1 treatment course. Clinicians should still counsel patients on the many side effects of taking GLP-1s and provide support for lifestyle care management where applicable.
It's very rare for a provider to feel their professional boundaries pushed by a patient's medication choices. But with a background in sports medicine, Smith said he knows it can happen. He's been challenged by a patient's choices with pain management or performance-enhancing medications, he mentioned.
When a provider fears a patient's medication choices pose a danger to their medical ethics or license, he advised that they help the patient transition to a different provider. Clinicians should give patients other options for providers and continue to counsel the patient for an industry standard of 30 days as they transition to another person.
But those cases should be rare if the provider can continue cultivating a good relationship with patients.
"From a physician standpoint, patient's autonomy is still a deciding factor here," Smith concluded. "They're going to do what they want to do, but just having the ability to create a relationship or an environment where they trust you to tell you everything is going to be better for their health."
Sara Heath has covered news related to patient engagement and health equity since 2015.
