The Therapeutic Goods Administration (TGA) has been notified of a current shortage for all strengths of Estradot (estradiol) hormone replacement therapy (HRT) transdermal patches due to manufacturing issues. The shortage is expected to continue until July 2021.
Estradot HRT patches are used for short-term relief of symptoms associated with menopause.
In order to reduce the impact of this shortage on patients the TGA has authorised the supply of five overseas-registered products under Section 19A of the Therapeutic Goods Act 1989. These products are similar in strength to the Australian registered Estradot patches that are in shortage.
The TGA has since become aware of a delay in the availability of some strengths of the overseas-registered product. In response, we are issuing Serious Shortage Substitution Notices for Estradot 25 and Estradot 100 patches. The notices specify substitutions that pharmacists are able to make for patients with a prescription for Estradot 25 or Estradot 100 patches. The notices allow Estradot patches to be replaced with the same strength of either Estraderm MX or Climara patches.
The notices must be given effect under state or territory law before pharmacists can supply according to the specified substitution. The patient must consent to the substitution. The pharmacist does not require prior approval from the prescribing doctor. However, pharmacists should notify the prescriber of the substitution as soon as possible. The notices apply from 26 August 2020 until 31 December 2020. The TGA may lapse the notices prior to this date, if it becomes evident that either the registered or the Section 19A products become available to meet demand in Australia.