Update - Alphapharm, the makers of Hysone have accepted changes to the CMI recommended by the ESA and have submitted them to the TGA. We have just learned that the TGA have agreed to these changes with one small amendment. The makers of Cortate, Aspen Pharmacare although initially not willing to accept or submit many of the ESA recommendations, have told the ESA they would consider following suit once Alphapharm's submission was accepted without cost. We will keep you updated.
Recent media attention has covered attempts by a group of senior endocrinologists to lobby the Therapeutic Goods Administration (TGA) to review the Consumer Medicines Information(CMI) supplied with medications. The AADAI have given our support to these endocrinologists as we believe there is incorrect information as well as a lack of proper directions for patients with Addison's disease. We have written to the TGA and various interested parties to raise our concerns but so far they appear unwilling to accept there is a need for review.
- Submission to the Australian Prescriber by Dr Jim Stockigt and colleagues
- Response from TGA to Australian Prescriber (received 05 Aug, 2008)
- Response in the form of a letter to the editor by Dr Lynn Weekes of the National Prescribing Service (Aug 29, 2008)
- Following article by Adam Cresswell featuring AADAI member Kim Bradock (Aug 30, 2008)
- Letter to the TGA by the AADAI (19 Sep, 2008)
- Response by the TGA to the AADAI (1 Oct, 2008)
- Article in December AADAI Newsletter (Dec, 2009)
The Endocrine Society of Australia (ESA) also supports efforts to improve CMI for glucocorticoids and has published a position statement available at https://endocrinesociety.org.au/position-statements-posstat-mi.asp