Hydrocortisone shortage
08 May 2023
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 is expected to resume for both brands in mid-April 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 an overseas-registered alternative hydrocortisone 20mg tablets under section 19A of the Therapeutic Goods Act 1989. These ‘section 19A’ products 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 these products.
Pharmacists can get more information and order the overseas brand from the approval holders:
- Medsurge Healthcare call 1300 788 261
- Pro Pharmaceuticals Group call 1300 077 674
These overseas alternatives are 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 contact them on 1800 274 276 to enquire about availability.
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.
The TGA is aware that supply of alternate hydrocortisone tablets is also available via prescribers utilising the Special Access Scheme (SAS)