While the TGA has approved alternatives to some products, they are not subsidised by the PBS.
The shortages of all strengths of oestradiol (Estradot) transdermal patches have been extended, the TGA has announced.
Along with this there are also shortages reported for oestradiol plus norethisterone (Estalis) transdermal patches.
Both medicines are used in the management of perimenopause and menopause.
The TGA said in a statement last Friday that supplier Sandoz Pty Ltd has blamed the shortage extension on “manufacturing issues”.
“The current return-to-supply dates for the different products are published on the Medicine Shortage Reports Database,” said the TGA statement.
“We have approved the supply of overseas-registered alternatives to Estradot 37.5 mcg, 50 mcg, 75 mcg and 100 mcg under section 19A of the Therapeutic Goods Act 1989.
“Up-to-date information about these products and how to access them is available on the Section 19A approvals database.”
While these alternatives are available, they are not currently subsidised by the Pharmaceutical Benefits Scheme, the TGA noted.
Related
According to the updated list, Estradot 25, 37.5, 50 and 75 strengths are expected to return to normal supply by 15 June 2024. Estradot 100 will be in shortage until 17 July 2024. Estalis Sequi 50/140 is expected to return to normal supply on 19 April, with Estalis Sequi 50/250 by 1 June. Estalis Continuous 50/250 is expected to return to normal supply on 15 April according to the database.
The TGA said the situation had been exacerbated by the discontinuation of the Climara brand of MHT transdermal patches at the end of 2023. It advised prescribers to consider the shortages when initiating new patients on MHT transdermal patches.
“Limiting initiations in this shortage period will help preserve available supply for existing patients,” it said.
“Patients and pharmacists may contact you for advice about prescriptions for estradiol-containing transdermal patch products and to authorise alternative strengths or substitute medicines. We acknowledge the difficulties involved in supporting your patients, and the burden these shortages have caused.”
There are currently 432 medicines in shortage in Australia as of 18 March, according to the TGA’s Medicine shortage reports database, including 44 which are listed as critical shortages, and 13 discontinuations.
