How does an office order and prepare compounded medications like semaglutide (glucagon-like peptide-1 (GLP-1) receptor agonist) or tirzepatide?

Ordering and Preparing Compounded Medications in the Office Setting

Offices should NOT order or prepare compounded medications like semaglutide or tirzepatide themselves, as these medications require proper pharmaceutical compounding facilities and are available as FDA-approved commercial products through standard prescription channels.

Understanding GLP-1 Medications and Their Availability

GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists are available as FDA-approved medications that do not require compounding:

• Semaglutide (Ozempic®): Available as prefilled pens for subcutaneous injection at doses of 0.25 mg, 0.5 mg, 1 mg, or 2 mg weekly 1, 2
• Tirzepatide (Mounjaro®): Available as prefilled pens for subcutaneous injection at doses up to 15 mg weekly 2, 3

Commercial Availability and Costs

The 2024 Standards of Care in Diabetes provides clear pricing information for these medications:

• Semaglutide: Monthly cost approximately $1,123 (AWP) or $903 (NADAC) for the 1 mg pen 2
• Tirzepatide: Monthly cost approximately $1,228 (AWP) or $982 (NADAC) for the 15 mg pen 2

Proper Medication Acquisition Process

1. Prescribe through standard channels:

   • Write a prescription for the FDA-approved commercial product
   • Send to a licensed pharmacy for dispensing
   • Ensure proper insurance coverage/prior authorization if applicable

2. Avoid compounded versions:

   • Compounded medications lack the same quality control as FDA-approved products
   • May have inconsistent potency, sterility concerns, or contamination risks
   • FDA has issued warnings about compounded versions of these medications

Patient Education and Monitoring

When prescribing these medications:

1. Provide proper injection training:

   • Demonstrate correct subcutaneous injection technique
   • Review storage requirements (refrigeration)
   • Explain dose titration schedule

2. Monitor for adverse effects:

   • Common side effects include nausea (17-44%), diarrhea (13-32%), vomiting (6-25%), and constipation (3-23%) 2
   • Watch for hydration status, especially if patient is taking insulin or sulfonylureas 2

Special Considerations

• Renal function: No dose adjustment required for semaglutide in patients with reduced renal function 2
• Contraindications: Personal or family history of medullary thyroid carcinoma, MEN type 2, history of pancreatitis 2
• Clinical efficacy: Tirzepatide has shown superior glycemic control and weight reduction compared to semaglutide in head-to-head trials 4

Common Pitfalls to Avoid

• Attempting office-based compounding: This violates pharmacy regulations and poses safety risks
• Using non-FDA approved sources: Increases risk of counterfeit or substandard medications
• Improper storage: These medications require refrigeration until dispensed to patients
• Inadequate dose titration: Starting at full therapeutic dose increases gastrointestinal side effects

Remember that these medications are potent therapies with significant clinical benefits when used appropriately through legitimate pharmaceutical channels. The practice of compounding these medications outside of licensed compounding pharmacies is inappropriate and potentially dangerous.