"Serious and Immediate Shortage of Hysone (Hydrocortisone) Tablets in Australia"

From: Ivone Johnson

To: Undisclosed-Recipient:;

Sent: Tuesday, November 06, 2007 9:36 AM

Subject: "Serious and immediate shortage of Hysone (hydrocortisone) tablets in Australia"  

HYSONE™ SUPPLY IN AUSTRALIA

 Alphapharm are the sole suppliers of hydrocortisone tablets in Australia. These tablets are sold as HYSONE 4mg or 20mg tablets.

 As you may be aware, many pharmacies are currently out of stock of HYSONE tablets. This problem has arisen due to the discontinuation of the low moisture starch sourced for use in the production of HYSONE.  As a result, many patients may not be unable to have their prescriptions dispensed over the coming weeks.

 We sincerely apologise for this unavoidable situation.

 Whilst our manufacturing team continues to analyse acceptable alternative formulations, we are not yet in a position to recommence commercial manufacture although we believe that we may be in a position to do so by mid-late November.

 In the meantime, we are pursuing the following strategies to ensure that patients who are short of HYSONE tablets can continue to receive essential supply:

 1.  We have a very small reserve stock of 20mg tablets, and a slightly larger reserve of 4mg tablets, which we are distributing on an individual patient basis following discussions with the prescriber. We would appreciate the assistance of members of the Endocrine Society in working with us to ensure that only patients genuinely short of tablets, and likely to run out before mid November, receive this reserve stock.

 2.  We are currently arranging for the importation of hydrocortisone 20mg tablets from the United Kingdom. Pending regulatory clearance we anticipate these tablets will be available for supply towards the middle of November.

 3. We have submitted a reformulated 4mg HYSONE tablet for registration by the TGA. We are hopeful of a positive response from the TGA evaluators shortly.

 We suggest that reserve stock is only supplied on the advise of either the endocrinologist or general practitioner managing the patient, after contacting Alphapharm Medical Affairs on 02 9298 3965.

 Yours sincerely,

Greg Pearce B.Pharm, Dip Hosp Pharm, PhD

Medical Advisor

Alphapharm Pty Ltd

 ESA Council provides the following advice to General Practitioners and other prescribers:
Although not precisely equivalent,  20 mg Hysone could reasonably be replaced by 25mg Cortisone Acetate or 5mg Prednisone or 5mg Prednisolone, until supplies of Hysone are restored.  4mg Hysone could be substituted with 5mg Cortisone acetate, 1mg prednisone or 1mg prednisolone.

 ESA
Ivone Johnson
145 Macquarie Street
Sydney.  NSW.  2000
Ph: 61 02 9256 5405
Fax: 61 02 9251 8174
Email: esa@racp.edu.au
Website: www.endocrinesociety.org

 ESA Seminar Meeting 9-11th  May 2008
Sydney Harbour Marriott
Website: www.esaseminar.org.au

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