Australians are using compounded and unapproved versions of the diabetes drug Ozempic amid a world-wide shortage.
The drug is now being used as an unofficial weight loss aid and to keep up with demand, pharmacies are producing replicas and shipping to customers across the country.
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Compounded semaglutide and tirzepatide are already being used by hundreds of Australians, and on Thursday, Eucalyptus – a Woolworths backed telehealth start up – said it would too start selling compounded semaglutide.
Under its plan, Eucalyptus would have registered nurses make the alternate drug which then could only be prescribed by Eucalyptus doctors and nurses.
An investigation by the ABC found at least seven compounding pharmacies and telehealth companies selling off-brands versions of the medications to customers.
But Australia’s medicine regulator, Therapeutic Goods Administration (TGA) said Novo Nordisk was the only authorised pharmaceutical company to supply medication containing semaglutide.
“Compounded therapeutic goods have not been evaluated by the TGA for safety, quality and efficacy,” the TGA said in a statement.
Compounding pharmacies are allowed to create versions of medications for patients with a prescription but are unable to secure the mass-produced option.
In these cases, the compounded medication is exempt from being tested by an independent body before being sold.
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Compounded medicines should only be made for individual patients – however pharmacies are selling them at an industrial sale which the TGA said “may expose pharmacists to liability if a patient has a negative outcome, particularly if a TGA approved product is available to treat the patient’s medical condition”.
“The compounding exemptions in the Therapeutic Goods Regulations 1990 [legislation] do not apply if a pharmacist … is compounding products for bulk supply in anticipation of patient’s needs,” a spokesperson said in a statement to the ABC.
“Compounding medicines on a commercial-like scale has the potential to adversely affect many patients, as they are not subject to rigorous testing for safety and quality.”