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Tips for discussing patient safety and compounded GLP-1s
Healthcare providers need to use empathic patient-provider communication to address patient safety concerns around compounded GLP-1s.
Compounded GLP-1 receptor agonists are challenging the healthcare industry as medical professionals seek to determine the best patient-provider communication strategies for discussing the medications that providers fear imperil patient safety.
Indeed, compounded GLP-1 versions aren't FDA-approved, and many medical professionals consider that lack of approval as a point of caution. In January 2024, leading obesity groups including the Obesity Medicine Association, The Obesity Society and The Obesity Action Coalition released a joint statement warning patients against compounded GLP-1s.
Acknowledging the difficulty many patients face in obtaining GLP-1 medications -- cost, availability and insurance coverage chief among them -- the groups stressed that compounded medications aren't a great solution in terms of patient safety.
"We do not recommend the use of these alternatives," they wrote. "If you use these compounded alternatives, you may not be getting what you hoped for. You may also get something you did not want (other active substances have been found in some compounded versions). And, if there is a health concern that arises from the use of the alternative compound, pinpointing the cause could be difficult."
Similarly, the American Diabetes Association (ADA) issued a December 2024 statement also cautioning patients against compounded drugs. The ADA said it does not recommend use of compounded GLP-1 medications "due to uncertainty about their content and resulting concerns about safety, quality and effectiveness."
But the discourse around compounded GLP-1s doesn't need to be so black and white, according to Annie Lambert, PharmD, BCSCP, a clinical program manager for Compliance Solutions for Clinical Surveillance & Compliance at Wolters Kluwer Health. A compounding pharmacist herself, Lambert acknowledged that GLP-1s do add a new wrinkle to what has historically been a fairly safe and effective practice.
"That's the case right now because these GLP-1s are so popular, and there's so much demand," Lambert said in an interview. "However, there are plenty of other medications that we compound all the time, and they're safe, effective, tested and proven. It's just this little bubble of time that we're in right now that is shining a big spotlight on compounding."
The insurgence of potentially bad actors has made the compounding landscape murky, raising questions about patient safety and how clinicians can work with patients interested in these drugs.
"There are many ways to get safe compounded medications, absolutely," Lambert continued. "And then there are plenty of ways that are not safe."
To navigate the competing priorities of patient access to care and patient safety, Lambert said healthcare providers need to do their homework. By understanding the compounded GLP-1 landscape, healthcare professionals can guide their patients to the best medications that promote well-being and patient safety.
Docs must 'choose their hard' learning about drug compounds
Knowledge is power, especially when discussing drug compounds with patients. But according to Lambert, there's a lot that healthcare providers need to know about compounds, especially compounded GLP-1s. There's a lot of fear surrounding compounded GLP-1s fueled by data and anecdata indicating counterfeit compounds that can imperil patient safety.
"Whether it's providers or patients, there's still a lot of confusion about what it is," Lambert said of compounded GLP-1s. "What is a compounded medication? When would I prescribe one? When would I consider taking one?"
The fact of the matter is that many patients want to take a GLP-1, but due to high costs and drug shortages, they can't. Compounds pose a solution to this problem, Lambert said, but providers treating patients interested in these types of medications need to know their stuff.
"The first piece of advice I would give is to know your sources and do your homework," she stated. "Unfortunately, that does mean a little bit more work for the provider. Sometimes they just don't have that bandwidth, or they can't delegate that to someone else."
In those situations, healthcare providers might consider just solely discussing the reference products -- the FDA-approved versions of the drugs -- with their patients, Lambert advised.
"Those have limitations, too," she continued, citing a lack of insurance coverage, prior authorization requests, high costs and drug shortages. "[Providers] are going to have to do homework or work one way or the other. They have to choose their hard and consider which hard is going to most benefit patients."
Knowing that many patients will work outside their healthcare provider to obtain a compounded GLP-1 on their own, Lambert suggested it's worth learning a little bit about the compounding side of things. That way, the healthcare provider can guide their patients toward compounding pharmacies that will better promote patient safety.
There's a number of things healthcare providers should look into to determine whether a patient is accessing a safe compounded GLP-1. For example, Lambert said 503B outsourcing facilities have the highest level of rigor after the FDA-approved reference drug. Drugs manufactured in these facilities are most likely going to be safe, she said, and are listed on the FDA website.
Lambert said 503A pharmacies might obtain and sell compounded GLP-1s they receive from a 503B outsourcing facility or make them themselves. In those cases, healthcare providers need to do their research to ensure the 503A pharmacy is dispensing a safe medication.
Providers should ask whether this is a licensed pharmacy and seek answers about how they get the active pharmaceutical ingredients needed to compound the GLP-1 product. They might also ask when the 503A pharmacy's last board inspection occurred and how the pharmacy validates whether its compounds are, indeed, on the drug shortage list.
Unclear, inarticulate or wavering answers to those types of questions should be a red flag, Lambert advised. Likewise, healthcare providers should assess the quality of a pharmacy's website and dig deeply enough to determine whether it is a pharmacy posing as a medical spa.
"If it sounds too good to be true, it probably is," Lambert cautioned.
But despite extensive research, clinicians might still work with patients looking into compounded GLP-1 drugs from potentially unsafe sources. In these cases, it's important to lean on strong patient-provider communication skills to help guide patients toward a safer approach.
Using empathy to encourage holistic, provider-led care
People are clamoring for compounded GLP-1 drugs because they are highly desired medications that come with a litany of roadblocks barring patient access, Lambert indicated. The promise of weight loss is likely intriguing for the nearly 70 million adults in the U.S. with obesity, but as Lambert mentioned, GLP-1 medications aren't universally covered by insurance and come with prior authorization requirements.
Those financial limitations plus overall drug shortages are creating a sense of nationwide desperation. As a result, patients and providers alike might lose sight of long-term health and well-being goals.
"Think beyond that first dose," Lambert urged. "I know people really are desperate for these medications and providers are desperate to help their patients. But, slow down a bit to check the right things to make sure that it's safe."
Healthcare professionals need to lean on their empathic communication skills to make this happen, Lambert added. Patients won't wait for their providers to complete detailed checks on compounding pharmacies if they do not trust those providers.
Instead, providers should acknowledge their patient's desire to take a GLP-1 medication and their frustrations with the barriers to treatment they face. By being compassionate about the patient's struggles, providers can build trust and work alongside the patient to find the best and safest medication option available.
"That patient-provider relationship is built on trust," Lambert emphasized. "Clinicians should say, 'if you're going to do it, I want you to tell me, and I don't want you to be ashamed that you are looking for it. I don't want you to feel guilty. I would rather know so that I can keep you safe. Safety is number one; let's be safe.'"
Specifically, clinicians should outline a long-term vision for weight loss and GLP-1 care management. Regardless of whether a patient accesses a reference drug or a compounded GLP-1, patients need strong care management from a multidisciplinary care team to see the best results from these drugs.
But taking any compounded GLP-1 versions without the research and backing of one's provider could interfere with that longitudinal care plan.
"Getting one dose or getting started on a compounded GLP-1 medication may seem like a quick fix, but we're not going to get quick results here either," Lambert explained. "We have to think about this from a long-term perspective."
Again, that advice needs to be firmly grounded in empathy and compassion. After all, clear and open communication is itself a patient safety tool.
Without open communication about the medications a patient takes, healthcare providers can't tailor their care or help should an adverse drug occur. By stressing empathic communication, healthcare providers open opportunities to guide and monitor their patients taking compounded GLP-1 medications.
Sara Heath has reported news related to patient engagement and health equity since 2015.
