New medicines should be granted a provisional safety rating until their safety and effectiveness have been proven amongst the wider //population, experts have said in the latest Medical Journal of Australia.

Recent experience with Vioxx and some other prescription medicines, which were withdrawn on safety grounds after marketing, has shown that reliance on pre-marketing trials and voluntary adverse reaction reports from health professionals does not provide adequate protection, said population health expert Associate Professor Chris Kelman, of the National Centre for Epidemiology and Population Health in Canberra, and colleagues.

Trials usually last no more than 12 months, so do not evaluate the increasingly common longterm use of medicines by patients with chronic disorders, Assoc Prof Kelman said. Voluntary adverse reaction reports depend on a health professional making a link between the drug and an adverse event. This system fails when the adverse outcome is common and has other causes, as with heart attacks and Vioxx.

“The current system for evaluating drug safety is outdated,” Assoc Prof Kelman said.

“We propose an expanded and integrated system of medicines regulation for Australia, based on a surveillance system that improves safety monitoring by complementing existing systems, making best use of routinely collected health and pharmaceutical data, and leveraging the power of information technology to link and analyse these data.

“Other countries have established such systems successfully, and Australia has fallen behind the rest of the world, despite the availability of excellent data.”

Under the proposed system, new drugs would be given provisional approval with a ‘Caution – New Medicine’ rating, and be required to undergo strict periodic review using linked population health data-sets.

“Periodic review would be based on accumulated adverse drug reaction reports, recent dru
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