Product information past perfect

Dowden, John S

doi:10.5694/j.1326-5377.2007.tb00797.x

Topics

Does drug product information need a use-by date?

Do not rely on the Australian approved product information for up-to-date advice about drug therapy. This seems to be the main message of Stockigt’s review of entries for thyroid disease in prescribing references, which are based on the product information supplied for each drug. In some cases the information was so out of date, its recommendations were potentially harmful.1

Australian Prescriber, Canberra, ACT.

Correspondence: jdowden@nps.org.au

1. Stockigt JR. Barriers in the quest for quality drug information: salutary lessons from TGA-approved sources for thyroid-related medications. Med J Aust 2007; 186: 76-79. <eMJA full text>
2. Mashford ML. Product information: what does it define? Aust Prescr 1994; 17: 39-41.
3. Therapeutic Goods Administration. Australian regulatory guidelines for prescription medicines. Canberra: Department of Health and Ageing, 2004. http://www.tga.gov.au/pmeds/argpm.htm (accessed Dec 2006).
4. Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medicines. JAMA 2002; 287: 2215-2220.
5. Therapeutic Goods Administration. The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods. Version 1. Canberra: Department of Health and Ageing, 2004. http://tga.gov.au/about/tgariskmnt.pdf (accessed Dec 2006).
6. Therapeutic Goods Administration. Initial discussion paper: improving access to prescription medicines information. Canberra: TGA, 2005. http://www.tga.gov.au/consult/2005/accesspmi.pdf (accessed Dec 2006).

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