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Position Statement:

Prescribing information (PI) and Consumer Medicine Information (CMI)

ESA is adopting an advocacy role with various bodies involved with pharmaceutical regulation in order to improve the quality of PI and CMI documents related to drugs used in our specialty.

Glucocorticoids - inconsistent, incomplete and unsafe Consumer Medical Information (CMI) persists
A paper submitted to Australian Prescriber on the problems with the CMI for glucocorticoid replacement medication was later withdrawn after the journal adopted some unusual editorial strategies to avoid publication.
ESA shares the concerns expressed by the authors of this paper relating to the accuracy and safety of PI and CMI for corticosteroid preparations prescribed for patients with pituitary and adrenal insufficiency.
The paper is available below, as well as a summary of online CMI sources for glucocorticoids and a summary of the interactions with the editorial committee of Australian Prescriber leading up to the withdrawal of the paper in August 2008.

PDF file Consumer Medicine Information (CMI) for glucocorticoid replacement medications one year on: unsafe errors persist (37KB)
Stockigt JR, Torpy DJ, Fuller PJ, Colman PG, Topliss DJ.
17 September 2008

PDF file Summary of On-line CMI for the Glucocorticoid Replacement Medications, Cortate and Hysone (20KB)

PDF file Summary of interaction with Australian Prescriber (22KB)

For futher information contact:
Prof Jim Stockigt, Consultant Endocrinologist, Epworth and Alfred Hospitals, Melbourne.
Email: jrs@netspace.net.au

 

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Revised October 2008