Pharmacist-made versions of the medication Ozempic could soon be banned in Australia by the Therapeutic Goods Administration (TGA).
Ozempic is used to treat type 2 diabetes. However, its recent popularity as a weight loss drug has led to a global supply shortage.
Some pharmacists have been creating their own versions of the drug for patients impacted by the shortage.
Now, the TGA is launching a crackdown that could restrict pharmacies from giving patients Ozempic substitutes.
TGA’s concerns over generic Ozempic
Under Australian law, individual pharmacists have been able to create their own version of Ozempic for patients affected by the shortage.
This meant a person could be prescribed Ozempic by their doctor, but receive a different version of a similar medication from their local chemist.
The TGA has now raised safety concerns over “high-risk active substances” in some of these medications, and over the possibility that telehealth providers are offering these medications to Australians.
Ingredients
GLP-1 RAs are a type of medication used to treat diabetes. They are present in drugs like Ozempic and Mounjaro.
GLP-1 RAs release insulin to help balance a person’s blood sugar levels.
The TGA said it now wants to restrict pharmacies from ‘compounding’ medications that contain GLP-1 RAs, such as generic Ozempic.
Compounding is when a pharmacy is licensed to mix and prepare medications specific to someone’s prescription or a doctor’s request.
Safety risks
Last year, the U.S. Food and Drug Administration reported an increase in adverse effects of compounded GLP-1 RAs and advised that people “should not use a compounded drug if an approved drug is available.”
The TGA said these pharmacy-developed medications are not evaluated for “safety and quality”, unlike other medications which are registered.
Next steps
The TGA has launched a consultation process to allow stakeholders, like compounding pharmacies, to discuss the proposed restrictions to GLP-1 RAs.
A similar process occurred in 2021 to restrict the compounding of medicinal cannabis due to associated risks.
A final decision on GLP-1 RAs is expected by June.
