TGA renews calls to limit new HRT patch prescriptions

An ongoing shortage of hormone replacement therapy (HRT) transdermal patches has triggered the Therapeutic Goods Association (TGA) to issue new advice to GPs to limit prescribing to new patients.
 
According to a new update from the TGA, the shortages are due to ‘manufacturing issues’ that are affecting multiple brands, with some products now not expected to return to normal supply until 31 December 2025.
 
The earliest some brand shortages are expected to ease is 30 June 2025.
 
GPs are being asked by the TGA to ‘please consider these shortages when initiating new patients on HRT transdermal patches’.
 
‘Limiting initiations in this shortage period will help preserve available supply for existing patients,’ it says.
 
‘We acknowledge the difficulties involved in supporting your patients, and the burden these shortages have caused.’
 
GP and women’s health expert Associate Professor Magdalena Simonis told newsGP these shortages continue to be ‘a really big issue’.
 
‘It’s affecting our prescribing practice, and you have to think about how can I help this woman?’ she said.
 
‘It’s been an issue from when we were going through COVID, and we assumed back then that it was due to COVID, but it has persisted ever since, and so it’s been really very tricky.
 
‘I’ve had patients [who] are actually halving their patches or extending the days between applying to savour them and make a one-month script last two months, so this is hard even for a short period of time, let alone for a protracted period.’
 
The TGA has confirmed they have approved ‘the supply of multiple overseas-registered estradiol-containing transdermal patch products’.
 
‘We have also approved the supply of overseas-registered products for both strengths of Estalis continuous transdermal patches,’ it said.
 
Australasian Menopause Society past President and GP Dr Karen Magraith said the ongoing shortages are causing ‘a lot of frustration’ and have significant impacts.
 
‘If patients can’t get hold of any hormone therapy, then go off it, this can cause them to have resurgent symptoms,’ she told newsGP.
 
‘It can also be important for women who are using hormone therapy for treatment of low bone density, so if there’s a significant gap in treatment, then this could have an impact on that.’
 
But it is important for GPs to know they still have options, Dr Magraith explained.
 
‘One obvious option is to use gel and there are two brands of gel available – one is on the Pharmaceutical Benefits Scheme and one is not,’ she said.
 
‘That would really be the direction to go for new patients who you want to prescribe transdermal estrogen, but there is a special case when it comes to the combined estrogen and progesterone patch as there’s no direct product that’s exactly the same.
 
‘Patients will need a consultation with their GP to discuss what the appropriate option might be there, and they’ll often need separate prescriptions.’
 
This is another thing that will add to the workload of GPs, Dr Magraith explained.
 
‘We often have phone calls and messages asking for alternative prescriptions, and so that adds to our workload and our cognitive load trying to work out what to do with these patients,’ she said.
 
Associate Professor Simonis said, during this period of shortage, it is important not to ‘minimise a woman’s symptoms’ as not all women ‘respond well’ to the gels.
 
‘We all have certain medications that work better for us than others, and not all women can take the gels as a substitute for the patches, so you need to also take that into consideration,’ she said.
 
‘It’s really important to be empathic, caring and to listen.’
 
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medication shortage menopausal hormone therapy menopause MHT perimenopause transdermal HRT patches women’s health