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The new age of pharmacovigilance

Kathlyn J Ronaldson
Med J Aust 2009; 191 (3): 132-134.
Published online: 3 August 2009

The Therapeutic Goods Administration is strengthening pharmacovigilance, but strategies to encourage the conduct of pharmacoepidemiological research in Australia are needed

For four decades, spontaneous reporting has been the main mechanism by which adverse drug reactions are identified after a medicine is released onto the market, and the Australian program has been exceptionally effective. However, spontaneous reporting programs are limited in their ability to identify an association between a drug and an outcome that is common among the users independent of drug use, and they are not sufficiently sensitive to detect a small increase in the risk of certain rare events. In particular, the increasing long-term use of medication for prevention and control of chronic disease in otherwise healthy individuals presents a challenge to which current postmarketing surveillance mechanisms cannot effectively respond. For example, spontaneous reporting cannot detect an increased rate of myocardial infarction associated with hormone replacement therapy, rosiglitazone or rofecoxib; demonstration of these associations requires large, long-term randomised controlled trials.

  • Kathlyn J Ronaldson

  • Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC.


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