8752 The Ethical Concerns Of Improper Semaglutide Administration After Acquisition From A Compounded Pharmacy

Abstract

Disclosure: S. Haider: None. R.E. Thomas: None. E.D. Reed: None. S. Panja: None.

31-year-old F with PMH of obesity presented with intractable nausea and vomiting. Pt was initiated on semaglutide injections for weight loss by her PCP, however, given prohibitive costs and supply chain issues pt had not initiated her medication until a month later after purchasing from a compounding pharmacy. Her PCP sent instructions via text message after explaining in person at her initial evaluation.Pt was meant to initiate at 5 units (0.25mg/0.05ml) SQ, however mistakenly injected 50 units (2.5mg/0.5ml) after misreading the text message.Shortly thereafter pt began experiencing intense nausea followed by recurrent emesis. Vitals on admission significant for tachycardia. Labs showed gradually falling blood sugars (107, 91, 73). In the ED patient received IVF and a D5% NS drip was started to head off hypoglycemia. She was given Zofran and Reglan alongside meals in order to transition to, and sustain PO intake. On this regimen pt was able to tolerate a diet.Her blood sugars were monitored and improved as did her medical condition. Pt was discharged home and instructed to return should her symptoms recur. Pt opted to stop home semaglutide and follow up with PCP. She was prescribed PO Zofran and Reglan PRN with meals until PCP visit and telemetry verified QTc was not prolonged. This case report is to highlight the dangers of compounded semaglutide. Its ease of acquisition coupled with unregulated formulations, unknown effectiveness and unpredictable side effects are alarming. Ethical concerns arise as the overwhelming need for semaglutide’s compounded formulations may not be to lower morbidity and mortality, and shortages are occurring due to increased general population awareness of the weight loss benefits. Concerns include the possibility of incorrect formulations containing too little, too much or no active ingredient at all. These all lead to questions on effectiveness and long-term side effects. In addition to poor patient side effect and administration understanding, the potential for misuse and harm is increased multiple fold with unregulated compounding pharmacies advertising the medication.At present, all doses of Wegovy are in short supply with the exception of 2.4 mg/0.75 mL. This has spurred the FDA to authorize compounding pharmacies to produce and market additional doses. Wegovy is specifically approved for weight loss unlike Ozempic, another GLP-1 agonist, which is only approved for type 2 Diabetes. According to the FDA: Regarding compounded Semaglutide, the FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and acetate. The salt forms are different active ingredients than those used the approved drug, (which contain the base form of semaglutide). The FDA is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.

Presentation: 6/3/2024