Doctors are being urged to consider ongoing HRT shortages when initiating new patients on HRT transdermal patches as disruptions to their supply are set to continue into the remainder of the year.
The shortages, caused by manufacturing issues and a surge in demand, are affecting multiple brands of estradiol and combination estradiol/norethisterone patches, the TGA advised this week [link here]. It said supply of some Australian-registered HRT patch products will remain ‘very limited’ in 2025
“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. We understand it can be frustrating when you are unable to get your preferred brand of a medicine, but using other brands, including overseas-registered products, may be unavoidable at times during these shortages,” the regulator said.
It advised that limiting initiations “will help preserve available supply for existing patients”.
According to the TGA, shortages are expected to persist for several widely used products, with some not anticipated to return to normal supply until December 2025.
These include:
• Estradot patches (25, 50, 75 and 100 mcg) – expected resolution by 31 December 2025
• Estraderm MX 75 – extended shortage until 10 October 2025
• Estalis Sequi 50/140 – shortage extended until 17 October 2025
Several other strengths, such as Estradot 37.5, Estraderm MX 25, 50 and 100, and Estalis Sequi 50/250, have recently returned to supply.
To reduce the impact, the TGA has approved the supply of overseas-registered alternatives for all strengths of Estradot patches under Section 19A of the Therapeutic Goods Act. These are subsidised on the PBS.
Pharmacists are also able to substitute products under a Serious Scarcity Substitution Instrument (SSSI), dispensing an alternative brand or multiple lower-strength patches to achieve the prescribed dose without requiring a new script.
However, the regulator has cautioned that not all substitutions are PBS-subsidised. For example, Estraderm MX 75 mcg patches are not PBS-listed, and overseas-registered Estramon patches contain different pack sizes, which can affect subsidy arrangements.
The TGA said prescribers may be contacted by patients and pharmacists to authorise alternative strengths or substitute products, and that extra support may be needed for patients navigating unfamiliar brands or patch regimens.
Patients are advised to consult their pharmacists about available substitutes and to speak with their doctor if their prescribed medicine is unavailable. Alternatives such as oral tablets, gels, and vaginal pessaries remain available
The regulator acknowledged the “concern and frustration” caused by the ongoing shortages and said it would continue to monitor supply and update its shortages database.
The Australasian Menopause Society has published a Guide to MHT Doses providing guidance on approximately equivalent doses of the different MHT/HRT products in Australia.
It noted that all doses of Climara have been deleted from the market and there will be a reduction in supply until supply is exhausted.
The AMS said pharmacists were being encouraged to contact suppliers Medsurge Healthcare Pty Ltd for orders of Estramon, and Sandoz for orders of Estradiol Transdermal System.