THE Therapeutic Goods Administration (TGA) has announced that a global shortage of type-2 diabetes medication, Trulicity (dulaglutide).
The regulator reported that Eli Lilly flagged concerns about shortages of the drug in Jun, "due to an unexpected increase in demand", as a result of patients being moved to the medication as an alternative to Ozempic (semaglutide), which has been prescribed off-label as a weight-loss treatment.
The TGA said that Trulicity is expected to be "temporarily out of stock at wholesalers across Australia until late Oct".
"From Nov, Eli Lilly is expecting limited supplies until at least early 2023, and can't guarantee that pharmacies will receive enough stock from wholesalers to fill your script for Trulicity when you need it," the regulator said.
"We recommend that patients with type-2 diabetes who are unable to fill their script for Trulicity should contact their doctor immediately to have their treatment reassessed."
The regulator has also approved an overseas-registered dulaglutide product temporarily under section 19A of the Therapeutic Goods Act 1989 for use in Australia.
"This is the same as the Australian-registered Trulicity, however it comes from a supplier in another country and may be considerably more expensive," the TGA said.
"Also, while the Australian-registered Trulicity is subsidised on the Pharmaceutical Benefits Scheme (PBS), the overseas-registered product currently is not.
"Even though the supplier of this overseas brand that has been approved under section 19A can apply to have it subsidised under the PBS, the TGA can't force them to do so."
Speaking with ABC News, Pharmacy Guild of Australia Victorian Branch President, Anthony Tassone, said the Trulicity supply shortages were causing significant shortages for patients, prescribers and pharmacists.
"We don't have the answers patients deserve, there are waiting lists for any stock that is delivered," he said.
Tassone added that measures need to be implemented to provide greater protection of supply for PBS-listed medications.
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