The current review of the Therapeutic Goods Administration is an opportunity to improve the system for updating product and consumer information on drugs
Pharmaceutical product information (PI) and consumer medicines information (CMI) are mandatory for prescription products in Australia, and government regulations specify that CMI must be consistent with PI.1 Health professionals and consumers should be able to assume that these sources are up-to-date and consistent with evidence-based best practice. However, this is not necessarily so, particularly for older medications.2,3 There is a wide discrepancy between the high-quality information available for new medications (eg, through series such as NPS RADAR [National Prescribing Service Rational Assessment of Drugs and Research]) and some existing texts2-4 that originate from pharmaceutical sponsors, who pay fees to the Therapeutic Goods Administration (TGA) for review and approval of their submitted material.
The full article is accessible to AMA members and paid subscribers. Login to read more or purchase a subscription now.
Please note: institutional and Research4Life access to the MJA is now provided through Wiley Online Library.
- 1 Epworth and Alfred Hospitals, Melbourne, VIC.
- 2 Monash University, Melbourne, VIC.
- 1. Australian Government Department of Health and Ageing, Therapeutic Goods Administration. Second discussion paper: improving access to consumer medicines information (CMI) and product information (PI). Canberra: Australian Government, 2007. http://www.tga.gov.au/meds/accesspmi2.htm (accessed Nov 2008).
- 2. 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. <MJA full text>
- 3. Endocrine Society of Australia. Position statement. Prescribing information (PI) and consumer medicine information (CMI). http://www.endocrinesociety.org.au/posstat_CMI.htm (accessed Nov 2008).
- 4. Stockigt JR, Torpy DJ, Fuller PJ, et al. Consumer medicine information (CMI) for glucocorticoid replacement medications one year on: unsafe errors persist. Melbourne: Endocrine Society of Australia, 2008. http://www.endocrinesociety.org.au/Glucocorticoids_unsafe_CMI_paper.pdf (accessed Nov 2008).
- 5. Stockigt JR. Summary of on-line consumer medicine information for the glucocorticoid replacement medications, Cortate and Hysone. Melbourne: Endocrine Society of Australia, 2008. http://www.endocrinesociety.org.au/Glucocorticoids_online_CMI_sources.pdf (accessed Nov 2008).
- 6. MIMS online. Product information for thyroxine, liothyronine, carbimazole and propylthiouracil. http://mims.hcn.net.au/ifmx-nsapi/mims-data/?MIval=2MIMS_ssearchMIMS (accessed Nov 2008).
- 7. Hammett R. Response from TGA to Australian Prescriber (received 05 Aug, 2008). Consumer Medicine Information for glucocorticoid replacement medications 1 year on – a reply to Professor Stockigt and others. Australian Addisons Disease Association, 2008. http://www.addisons.org.au/core.htm (Content, News and Media) (accessed Nov 2008).
- 8. Weekes L. Bid to clarify drug information. The Australian 2008; 30 Aug. http://www.theaustralian.news.com.au/story/0,,24257150-23289,00.html (accessed Nov 2008).
- 9. Donohoo EA. Misleading advertising of PI-based drug information [letter]. Med J Aust 2008; 188: 679-680. <MJA full text>
- 10. Dowden JS. Product information past perfect. Med J Aust 2007; 186: 51-52. <MJA full text>
- 11. Australian Government Department of Health and Ageing, Therapeutic Goods Administration. Regulatory reforms common to all product sectors. Consultation on regulatory reforms July/August 2008. http://www.tga.gov.au/regreform/common.htm (accessed Nov 2008).