A life-cycle approach to monitoring benefits and harms of medicines

Banks, Emily; Pearson, Sallie-Anne

doi:10.5694/mja12.11028

Topics

Collection of high-quality data and management of risk are ongoing needs

Regulatory agencies worldwide are giving greater recognition to postmarketing surveillance, as part of a life-cycle approach to maintaining safety of medicines.1,2 This approach involves monitoring the potential benefits and harms of each medicine, and managing risks, throughout development, preregistration testing, registration and postmarket use in the community.

1 National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT.
2 Faculty of Pharmacy, University of Sydney, Sydney, NSW.

Correspondence: emily.banks@anu.edu.au

Acknowledgements:

Emily Banks is supported by the National Health and Medical Research Council. Sallie-Anne Pearson is supported by the Cancer Institute NSW.

Competing interests:

No relevant disclosures.

1. Psaty BM, Meslin EM, Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA 2012; 307: 2491-2492.
2. Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Ethical and scientific issues in studying the safety of approved drugs. http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspx (accessed Jun 2012).
3. Therapeutic Goods Administration. Evaluation of a new medicine — the TGA’s lifecycle approach to regulation. http://www.tga.gov.au/newsroom/btn-pm-regulation.htm (accessed Jun 2012).
4. Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet 2005; 365: 82-93.
5. Avorn J. In defense of pharmacoepidemiology — embracing the yin and yang of drug research. N Engl J Med 2007; 357: 2219-2221.
6. Vandenbroucke JP, Psaty BM. Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA 2008; 300: 2417-2419.
7. Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet 2008; 372: 2152-2161.
8. Panel to Review the Transparency of the Therapeutic Goods Administration. Review to improve the transparency of the Therapeutic Goods Administration. http://www.tga.gov.au/pdf/consult/review-tga-transparency-1101-final-report.pdf (accessed Jun 2012).
9. Department of Health and Human Services, US Food and Drug Administration. The sentinel initiative — national strategy for monitoring medical product safety. http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf (accessed Jun 2012).

Online responses are no longer available. Please refer to our instructions for authors page for more information.