From No to Maybe on Compounded Obesity Medicines
Never is a long time and repeatedly telling people NO can be a futile exercise. Thus, doctors are landing somewhere between no and maybe on the use of compounded obesity medicines. Some are seeing a rationale for for using them while others remain resolute in opposition to them.
Shauna Levy is an obesity medicine physician and medical director of the Tulane Bariatric Center. She told NBC News:
“Not only are physicians more OK with prescribing compounded GLP-1 medications, but they are also advocating for them.”
Evolving Acceptance
Duke Health operates a primary care center in Hillsborough, NC, where clinicians routinely prescribe these compounded medicines. Leanne Owens is a physician assistant in that clinic who had some initial concerns about this:
“Is this truly the medication? And is the recipe the same recipe that’s being used by the commercial drug manufacturers? Anything that is new that we are considering offering to a patient, we want to make sure that we have done our research.”
But when the state stopped covering the branded versions, she prescribed compounded medicines for ten of her patients. She has come to trust these medicines, which the Duke Compounding Facility provides with the assistance of vetted and state licensed pharmacies.
But Scott Isaacs, President-Elect of the American Association of Clinical Endocrinology, says he remains uncomfortable:
“In theory, if you can get everything right, it can be a reasonable product. But the problem is that there are so many things that could go wrong.”
Questions to Ask
Writing in Medscape, Beverly Tchang takes a pragmatic approach, offering questions that people should ask before accepting a compounded obesity medicine.
1. Check the record of the compounding pharmacy.
2. Ask for the pharmacy’s state board inspection report.
3. Is the pharmacy accredited by the PCAB?
4. Does the pharmacy follow CGMP standards?
5. Where does the pharmacy source its active pharmaceutical ingredient?
6. Is the supplier registered with FDA?
7. Does the pharmacy use semaglutide base (not the salt of it) as the active ingredient?
8. Can they provide a certificate of analysis for the active ingredient?
9. Do they have third-party confirmation of potency, stability, and sterility of the final product?
Yes, this is quite a list.
Unlikely to Go Away
ConscienHealth founder Ted Kyle told Yasmin Tayag for the Atlantic that compounded obesity medicines are unlikely to disappear from the market:
“I am skeptical that off-brand forms of these medicines will fade away anytime soon. Part of the reason that supply problems are easing is because these off-brand products are filling some of the gap.”
Novo Nordisk, which stands in opposition to these practices, nonetheless concedes that the gap between what patients need and what they can supply will persist for some time to come. The head of their U.S. obesity business, Sylvia Shubert, recently said:
“While we will do our best to support those who want to start taking Wegovy, it is important to recognize that overall demand will continue to exceed supply and some patients may still have difficulty filling Wegovy prescriptions.”
So as we have said before, we have a mess on our hands with compounded obesity medicines and it is not clearing up. Responsible people are finding ways to cope.
Click here for Tayag’s reporting on the situation, here for more from NBC News, and here for Tchang’s guidance.
Tusch [Fanfare], art installation by Nevin Aladağ, photographed by Kaethe17, licensed under CC BY-SA 4.0
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August 17, 2024
August 19, 2024 at 9:27 am, John DiTraglia said:
we have a “compounded” semaglutide clinic and the drug is working as advertised but we still haven’t been able to answer question 5. Where does the pharmacy source its active pharmaceutical ingredient?
I’m thinking China.