The Therapeutic Goods Administration is aware of current and anticipated shortages of all hydrocortisone tablet strengths due to manufacturing issues. We are working with the supplier Alphapharm Pty Ltd to manage the impact.
Hydrocortisone tablets are used to treat adrenal insufficiency conditions, including Addison’s Disease.
There are two brands of hydrocortisone tablets marketed in Australia: Hysone and Hydrocortisone Viatris. Alphapharm, a subsidiary of Viatris, is the ‘sponsor’ of both brands. Alphapharm can be contacted on 1800 274 276.
- Supply of the 20mg products is expected to resume on 30 June 2023.
- Supply of the 4mg products is expected to resume on 14 July 2023.
Anyone can go to the Medicine Shortage Reports Database (search for ‘hydrocortisone’) to check for updates to this information, as the anticipated supply return dates can change.
The TGA has taken action to reduce the impact of this shortage on patients by approving overseas-registered alternative hydrocortisone 20mg tablets under section 19A of the Therapeutic Goods Act 1989. The ‘section 19A’ product can be dispensed by pharmacists using the consumer’s regular valid prescription. There is no need to go back to the doctor to obtain a new prescription or additional approvals. Please visit the section 19A database for more information about this product.
Pharmacists can call Pro Pharmaceuticals Group on 1300 077 674 for more information and to order the overseas brand.
This overseas alternative is not subsidised under the Pharmaceutical Benefits Scheme (PBS). When the TGA authorises supply of an alternative product under section 19A, the company that supplies it can apply to have that brand subsidised through the PBS. However, the TGA cannot compel them to apply to list a product on the PBS.
The TGA is continuing to investigate the potential for supply of additional overseas-registered hydrocortisone medicines to further bolster supplies.
Alphapharm may also have emergency stock of hydrocortisone available. Pharmacists can call the company on 1800 274 276 to ask about emergency stock.
There are other corticosteroid tablets available in Australia.The TGA is closely monitoring the supply of these for any flow-on impact to their supply.
People unable to fill a prescription for hydrocortisone tablets should return to their doctor to discuss the potential need for a prescription for a different corticosteroid.
Supply of alternate hydrocortisone tablets is also available via prescribers using the Special Access Scheme (SAS):
- Call Pro Pharmaceuticals Group Australia on 1300 077 674 to access hydrocortisone 1mg tablets under the SAS.
- Call Link Medical Products on 1800 181 060 to access hydrocortisone 2mg tablets under the SAS.