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Recent experience with Vioxx and some other prescription medicines, which were withdrawn on safety grounds after marketing, has shown that reliance on pre-marketing trials and voluntary adverse reaction reports from health professionals does not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“The current system for evaluating drug safety is outdated,” Assoc Prof Kelman said.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
g studies, and commissioned Australian controlled analytical studies using the linked databases,” Assoc Prof Kelman said.
“Provisional approval could be upgraded once significant market experience is gained; for example, a medicine could be given a ‘gold’ safety rating after achieving an agreed
Prominent child health advocate Professor Fiona Stanley, of the Telethon Institute for Child Health Research in Western Australia, agreed that as medical care becomes more complex, it is paramount that Australia modernises its ‘archaic’ system of postmarketing surveillance for new drugs.
“The system proposed by Prof Kelman and colleagues has several advantages,” Prof Stanley said in an editorial written with Dr Eric Meslin, of Indiana University, USA, in the same issue of the MJA.
“However, there are also potential disadvantages associated with such a data linkage system.
“We must be able to demonstrate to the community that linking data for the sake of the public good does not invade their privacy.”
The National Health and Medical Research Council and the Australian Law Reform Commission are both reviewing alternative systems. Prof Stanley said she hopes these reviews will clarify and support the impetus to change.
“We strongly believe that Australia has an opportunity to establish a cutting-edge capacity to monitor its health care system, to avoid a repeat of the type of situation we saw with Vioxx,” she said.
“If society has the capability to better monitor the safety of new drugs, it may be unethical not to do so.
“We think the time has come to expect more … to actively seek to maximise the wellbeing of all citizens. Improved pharmacovigilance is one important step towards this goal.”
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