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The government will crack down on replicas of Ozempic and other weight loss drugs, closing a loophole that allowed pharmacies to make and sell them to about 20,000 Australians.
Widespread and ongoing shortages of the brand-name drugs from pharmacies – especially for weight loss, as pharmacists prioritise stock for those with diabetes – have left patients turning to compounding pharmacies, which are making their own version of the drugs en masse.
The federal health minister, Mark Butler, said this increased the risk of safety issues and from October, compounding these similar weight-loss products – or compounded glucagon-like peptide-1 receptor agonists (GLP-1RA) – will be banned.
Butler said the majority of the 20,000 patients using the compounded GLP-1RA products are doing so for weight loss, so the move is not expected to severely affect diabetes patients.
“This action will protect Australians from harm and save lives,” Butler said.
There have been periodic global shortages of the prescription drugs Ozempic (semaglutide) and Mounjaro (tirzepatide), which are approved by the drugs regulator the Therapeutic Goods Administration (TGA) to treat type 2 diabetes.
The drugs, which are self-administered via an injection, are also prescribed to treat overweight people and obesity off-label, which means the TGA has not approved the drugs for those conditions. Doctors can still prescribe the drugs for weight loss if they believe the patient will benefit and it is is safe to do so.
Unlike usual pharmacies that sell manufactured medicines at pre-packaged strengths and quantities, compounding pharmacies often make up a prescription from scratch on site. This is an essential service for patients who may be allergic to an ingredient in a manufactured product, or who may require a unique dosage.
Children may also need a much smaller dose of an adult medicine, for example, or patients may need to continue on a medication no longer available on the Australian market while an alternative drug is found. Like a traditional pharmacy, a prescription from a doctor is required for compounded medicines.
Because compounded medicines are personalised for a specific clinical need and therefore usually made in small quantities, they are not subjected to the same safety regulations governing other medicine approvals.
However with shortages of Ozempic and Mounjaro, compounding pharmacies have been producing and providing commercial quantities of similar weight loss products, increasing the risk of safety issues, Butler said.
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These products are not identical to the brand name products.
In November Guardian Australia reported increasing numbers of patients were calling poisons information lines and presenting to emergency departments after taking weight loss drugs, whether the drugs were brand name drugs or products obtained online or through compounding pharmacists.
“I’m really concerned in the way in which this market has developed that compromises public safety,” Butler said.
The TGA’s chief medical advisor, Prof Robyn Langham, described it as “the right action to take”.
“The TGA will work with key medical, pharmacy and consumer stakeholders to support patients and their practitioners to navigate the change, and where appropriate help with guidance in finding alternative and safe medicines,” she said.
