( g studies and commissioned Australian ...)Time to Overhaul Australia's Medicines Safety Surveillance System,Health

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 benchmark.”

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.”

Source-AMA
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