Antibiotics, type 2 diabetes and ADHD drugs in short supply
The new year is not expected to bring much relief for Australia’s serious shortages of antibiotics and drugs used to treat ADHD and type-2 diabetes.
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The arrival of 2024 is not expected to bring much relief for Australia’s serious shortages of antibiotics, self-injectables approved for type 2 diabetes but widely used off-label for weight loss, and popular drugs used to treat ADHD.
In fact, the Therapeutic Goods Administration (TGA) has warned self-injectables Ozempic (semaglutide), Trulicity (dulaglutide) and Mounjaro (tirzepatide) will be in limited supply until the end of 2024.
Ozempic, in particular, has gained rock star popularity in Australia through social media channels in the past two years. Some videos have attracted tens of millions of views.
In a statement, the TGA said Novo Nordisk, the pharmaceutical company that supplies Ozempic, had advised the TGA and the Medicine Shortage Action Group (MSAG) that supply throughout the rest of 2023 and 2024 would be limited.
According to the TGA’s Medicines Shortage Database (accessed December 6), both the 0.25/0.5mg and 1mg pre-filled Ozempic injection pens would be in “limited availability” until December 31, 2024.
“This additional demand is caused mainly by a rapid increase in prescribing for ‘off-label’ use (prescriptions to treat conditions other than those approved by the TGA),” the TGA said.
The TGA and MSAG have advised prescribers not to initiate any new patients on Ozempic, consider changing patients already on it to other treatments, and conserve stocks for patients already stabilised on the drug with no other treatment options.
The TGA said it was unable to stop off-label prescribing as it did not have “the power to regulate the clinical decisions of health professionals”.
The TGA has set up a dedicated web page on its website to help patients and prescribers with the Ozempic shortage.
The pharmaceutical company that makes type 2 diabetes drug Trulicty (dulaglutide), Eli Lilly, has also advised the TGA that availability of all strengths of Mounjaro (tirzepatide) will be limited until August 31, 2024, “due to unexpected high demand”.
“Availability of the 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg doses of Mounjaro is expected to vary over this time,” it said.
“As for similar medicines, including Ozempic, Mounjaro is indicated for the treatment of type 2 diabetes but is being prescribed off label at high levels to manage weight loss.”
Antibiotic shortages continue to be a problem in Australia, with more than 50 antibiotics and antivirals listed on the TGA’s drug shortage database as of December 26.
However, a Department of Health and Aged Care spokesman said the supply of oral antibiotics had improved, with shortages of many other products now resolved.
“The TGA continues to monitor supply of these products and will take regulatory actions if required,” he said.
One shortage of particular concern is a global shortage of benzathine benzylpenicillin that is expected to continue through 2024.
Benzathine benzylpenicillin is a specialised injectable antibiotic which is used in the treatment of bacterial infections including rheumatic fever, syphilis and group A streptococcal infections of the throat and skin.
It is also used to prevent serious conditions that follow these infections such as rheumatic heart disease, congenital syphilis and post-streptococcal glomerulonephritis (APSGN). Benzathine benzylpenicillin plays a significant role in rural and remote community health care.
“There will be very limited stock of Bicillin L-A in the lower strength available throughout the shortage period, with the availability of the 1.2-million-unit product to improve in early 2024. Pfizer Australia are closely controlling stock to ensure equitable supply,” the TGA said.
To help meet demand, the TGA has approved the importation and supply of an overseas-registered benzathine benzylpenicillin 1.2-million-unit vial (Brancaster Pharma, UK) under section 19A of the Therapeutic Goods Act 1989.
Meanwhile, patients using a number of strengths of the medication Vyvanse (lisdexamfetamine dimesilate) to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED) are expected to be waiting until March-April 2024 before supplies stabilise.
Takeda Pharmaceuticals Australia, which produces the drug, has notified the TGA that shortages of Vyvanse 30mg, 50mg and 60mg are affected by the worldwide shortage which has occurred because of “manufacturing issues”, the TGA said in a statement.
There are currently 441 medicines listed as in shortage on the TGA’s database, with another 58 anticipated (as of December 26).
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