Documentation of Compounded GLP-1 Receptor Agonists in a Large Primary Care Dataset.

Abstract

Purpose: Large telehealth companies and smaller aesthetic medicine providers used compounded semaglutide and tirzepatide to meet consumer demand for these drugs during their shortages. In this study, we estimate the documentation rate of compounded formulations of these drugs in the US primary care and characterize differences between users of compounded and brand-name formulations of these drugs.

Methods: We conducted a retrospective cohort study using data from the American Family Cohort, a nationwide US database of electronic health records from primary care practices, spanning January 1, 2021, to December 31, 2024. Patients with documented semaglutide and/or tirzepatide use were included. Brand-name drug prescriptions were identified from structured data; compounded formulation use was identified from clinical notes. Outcomes included the proportion of patients using compounded formulations and their characteristics.

Results: Among 153 044 included patients (64.0% female, mean age 55.0 years), 8.2% used compounded formulations, which made up an increasing share of semaglutide and tirzepatide use over time. Users of compounded formulations had longer mean therapy durations (compounded only: 10.0 months vs. brand-name only: 7.8 months) and were more likely to be female, non-Hispanic White, nondiabetic, and to live in areas of lower socioeconomic deprivation compared to patients who used only brand-name drugs.

Conclusions: Between January 2021 and December 2024, documentation of compounded semaglutide and tirzepatide use in US primary care settings appeared lower than surveys reporting that approximately 23% of patients using these medications received them from compounders. This suggests that many patients may access these medications outside of coordinated care.

Plain language summary: During drug shortages from 2022 to 2024, many patients turned to compounded formulations of popular weight-loss medications semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) made by specialty pharmacies. We analyzed medical records from over 153 000 patients across the United States who used these medications to understand how often primary care doctors knew their patients were using compounded formulations. We found that only 8.3% of patients had documented use of compounded formulations in their medical records, far lower than previous surveys suggesting 23% of users get these medications from nontraditional sources like telehealth companies or aesthetic clinics. Patients using compounded formulations were more likely to be white, female, nondiabetic, and live in wealthier areas compared to those using brand-name versions. They also used the medications for longer periods. This gap between documented use and actual use suggests many patients are getting these medications outside their regular healthcare system, which could create safety concerns since doctors may not know about all the medications their patients are taking or be able to monitor for side effects properly.