{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss","description":"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 \u201ccompounded\u201d 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\u2019s 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 \u201ccompounded\u201d 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 M\u00fcllertz 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. https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2410819 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). https:\/\/www.cms.gov\/newsroom\/fact-sheets\/contract-year-2026-policy-and-technical-changes-medicare-advantage-program-medicare-prescription Human Drug Compounding. https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/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. https:\/\/www.fda.gov\/media\/98973\/download FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. https:\/\/www.fda.gov\/drugs\/human-drug-compounding\/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded FDA\u2019s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. https:\/\/www.regulations.gov\/document\/FDA-2017-N-2562-0029 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. ","author_name":"HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast","author_url":"http:\/\/helixtalk.com","html":"