186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss

In this episode, we discuss the efficacy and safety of semaglutide and tirzepatide for weight loss with a particular focus on the legal, regulatory, and safety aspects of these "compounded" GLP-1 receptor agonist medications. Key Concepts Semaglutide and tirzepatide have growing evidence that their clinical benefits extend beyond the treatment of diabetes. Evidence now shows benefit in a variety of obesity-related disease states regardless of a patient's diabetes status. Insurance coverage and drug cost is a major barrier to these medications, with cash prices exceeding $1000 per month in the US. There are many companies that are combining telemedicine visits with "compounded" GLP-1s to provide these medications at a reduced cost. The Food, Drug, and Cosmetic (FD&C) Act regulates compounded drugs. These regulations provide the legal context for pharmacies to compound GLP-1 medications. These regulations describe who can compound, what drugs can be compounded, and other unique circumstances (e.g. compounding in the context of a drug shortage). The FDA has released warnings regarding safety risks of compounded GLP-1s. The main safety concern is dosing errors; however, the warnings also include concerns of patients accessing drug products that are outside of the legal scope of the FD&C Act. The recent ADA statement recommends against the use of compounded GLP-1s due to these concerns. References Karagiannis T, Malandris K, Avgerinos I, et al. Subcutaneously administered tirzepatide vs semaglutide for adults with type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials. Diabetologia. 2024;67(7):1206-1222. doi:10.1007/s00125-024-06144-1 Müllertz ALO, Sandsdal RM, Jensen SBK, Torekov SS. Potent incretin-based therapy for obesity: A systematic review and meta-analysis of the efficacy of semaglutide and tirzepatide on body weight and waist circumference, and safety. Obes Rev. 2024;25(5):e13717. doi:10.1111/obr.13717 Jastreboff AM, Le Roux CW, Stefanski A, et al. Tirzepatide for Obesity Treatment and Diabetes Prevention. New England Journal of Medicine. 2024. Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (CMS-4208-P). Human Drug Compounding. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP 1 and dual GIP/GLP 1 receptor agonists: A statement from the American Diabetes Association. Diabetes Care. 2024 Dec 2:dci240091. doi: 10.2337/dci24-0091.

You can listen to 186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss online on Radio and Podcast. Open the player on this page to stream the available audio.

186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss is an episode from HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast by Sean P. Kane, PharmD, BCPS.

This episode is 01:20:40 long.

This episode was published on Dec 12, 2024.

Yes. Use the heart button on the episode page to add it to your favorite episodes list.

Yes. This page shows related episodes from HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast when more episodes are available from the podcast feed.