New national shortage of PrEP part of ‘concerning’ trend

GPs are being warned to plan ahead with their patients, after an Australia-wide shortage of the life-saving HIV prevention antiretroviral drug, pre-exposure prophylaxis (PrEP), was declared.
 
On Wednesday, the Therapeutic Goods Administration (TGA) listed multiple brands of tenofovir/emtricitabine combination tablets as having ‘limited availability’ or being ‘unavailable’.
 
While the TGA said some shortages will be cleared by the end of this month, others are expected to last until March 2025.
 
It has cited manufacturing reasons for the shortages, saying ‘the sponsor is working to expedite the next shipment’.
 
RACGP President Dr Nicole Higgins says now is the time for GPs to talk to patients about options and supply.
 
‘We need to make sure that everyone who needs PrEP has access to it and has adequate supply,’ she told newsGP.
 
‘We also need to be able to council our patients on other ways to take PrEP and also on other HIV prevention methods.
 
‘In an absolute emergency, there is post-exposure prophylaxis available.’
 
The TGA website lists bottles of tenofovir-containing medication with supply impact dates that last until 11 October 2024 and 3 March 2025  while blister pack versions of the tablets have a supply impact date that lasts until 8 November 2024.
 
The shortages were announced on the same day as the Kirby Institute revealed that over the last decade, HIV diagnoses in Australia are trending downward.
 
It found overall HIV diagnoses have reduced by 33% in the last 10 years, with particularly significant reductions among Australian-born gay and bisexual men, where diagnoses reduced by 64%.
 
The Kirby Institute’s Professor Andrew Grulich said much of this reduction can be linked back to the introduction of treatments such as PrEP.
 
‘We’ve had tremendous success reducing HIV among gay and bisexual men in Australia, and in 2023, we saw record numbers of people prescribed PrEP for HIV prevention,’ he said.
 
‘We have the strategies and technologies to eliminate HIV transmission in Australia.
 
‘But we need to make sure PrEP and other prevention strategies are reaching the populations that most need them, including gay and bisexual men who were born overseas.’
 
Dr Higgins says this latest shortage is an addition to an increasingly worrying trend and has called on the Federal Government to investigate further.
 
‘Medication shortages, such as PrEP, are at best an inconvenience, but at worst can be life threatening,’ she said.
 
‘This is part of a global supply shortage, and Australia is a small market in the scheme of things.
 
‘But if this continues, the Australian Government needs to make a choice about ensuring that we have adequate stockpiles of essential medications on soil, or the capacity to be able to manufacture essential drugs.’
 
The TGA launched a medicine shortage investigation in February 2024, with the consultation process receiving 221 submissions.
 
It says the outcomes of these discussions, including recommendations on priority areas for potential reform, will be ‘provided to the Australian Government for consideration’.
 
In the meantime, Dr Higgins says GPs and patients will have to do the leg work to guarantee access. 
 
‘The medication shortages are not just an annoyance for GPs and patients, in some cases they can have significant impacts on cost and travel,’ she said.
 
‘It’s creating extra red tape and time for GPs and their patients to locate where medications are with pharmacies.’
 
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antiretrovirals HIV medication shortage PrEP sexual health