HRT patch shortage extends to December

An ongoing shortage of hormone replacement therapy (HRT) patches is set to continue, with the Therapeutic Goods Administration (TGA) announcing some products will remain in shortage until December.
 
Updating its advice this month, the TGA says supplies of Estradot 37.5 and Estraderm MX 100 are expected to return to normal by next month, but shortages of Estradot 25, 50, 75 and 100 are predicted to last until 31 December 2026.
 
The Serious Scarcity Substitution Instrument for the products, first introduced by the TGA in November 2024 to manage the shortage of some estradiol products, has now been extended until 28 February 2027.
 
GP and women’s health expert Associate Professor Magdalena Simonis told newsGP the continued shortages are ‘very frustrating’ and place ‘an enormous onus’ back on GPs.
 
‘We’ve found ourselves in exactly the same situation we’ve been in before. Nothing has changed,’ she said.
 
‘It’s also disappointing because it means there’s quite a bit of neglect with respect to women’s health.’
 
Associate Professor Simonis said the supply issue has never fully recovered from disruptions during the COVID-19 pandemic, when increased production was also promised.
 
‘The shortage around the time did not seem to really trigger increased production, which is what we were told,’ she said.
 
‘We were promised it would take until the end of 2025 to properly restore itself, but it never really has.
 
‘These are unacceptable delays and interruptions to treatment. We know that substituting it with something different doesn’t necessarily mean that women are going to have the same response, even to the same dose of a different version of estrogen.’
 
The TGA says it was notified by pharmaceutical companies Sandoz and Juno Pharmaceuticals of ongoing shortages of their estradiol and combination estradiol/norethisterone (norethindrone) transdermal patch products due to ‘manufacturing issues and an unexpected increase in demand’.
 
‘Unfortunately, as the limited global supply continues to fluctuate, we cannot predict with certainty which Australian-registered HRT patch products might be available at any time,’ it says.

Associate Professor Simonis said production and demand has increased globally due to ‘increased menopause and perimenopause awareness’ among both health professionals and the community.
 
The TGA advises prescribers to take the shortages into account when initiating HRT treatment with new patients.
 
‘Limiting initiations in this shortage period will help preserve available supply for existing patients,’ it said.
 
But Associate Professor Simonis said the supply shortage remains ‘a gender equality issue’.
 
‘If men had the same issues accessing medication that levelled them out hormonally and helped them sleep better, reduced their hot flushes so they didn’t have embarrassing bouts of sweating and red flushing while at work, then you know that would be a completely different story,’ she said.
 
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hormone patches hormone replacement therapy HRT HRT shortage menopausal hormone therapy menopause MHT perimenopause TGA women’s health