TGA publishes second Serious Shortage Medicine Substitution Notice

3 Sep 2020

The Therapeutic Goods Administration (TGA) has released its second set of Serious Shortage Medicine Substitution Notices (Notices) for Estradot (oestradiol) 100 and 25 transdermal patches. Estradot is used as hormone replacement therapy to relieve menopause symptoms.  

Notices were introduced under consultation with the TGA’s COVID-19 Medicine Shortages Working Group, in which the AMA is a member. The changes aim to “relieve pressure on doctors and allow patients to receive their medicines from their pharmacist without delay” during the COVID-19 pandemic. 

A Notice allows pharmacists to substitute a strength, dose form, or extended/sustained/immediate release form, of a medication without first contacting the prescriber. It is the pharmacist’s professional practice requirement to contact the prescriber as soon as practicable when a substitution has occurred.  

Substitution can only occur when the Notice has been published by the TGA. Pharmacists cannot substitute medications within the same therapeutic class containing a different active ingredient.  

The Notices for Estradot 100 and 25 outlines protocols the pharmacist must follow, including specific medications that are approved to be supplied as a substitute. Estraderm MX and Climara are identified as appropriate substitutions.  

More information is available on the TGA website, here.