A Gap That Really Needs to be Filled (and Can Be Easily) here in Australia.

The following appeared a few days ago.

Drug safety watchdog to be replaced with new body

Julie-Anne Davies | December 06, 2008

Article from: The Australian

THE drug safety watchdog is to be abolished and a new committee with broader powers established in its place, under reforms planned by the Rudd Government.

The Weekend Australian has learned the Adverse Drug Reactions Advisory Committee will be replaced by a Medicines Safety Committee as part of an overhaul of the nation's drug safety system.

It is understood the Rudd Government will introduce a more vigilant drug safety regime that will include rigorous surveillance of prescription drugs after they have received approval to be sold in Australia.

A spokeswoman for the Therapeutic Goods Administration, which oversees drug safety in Australia, confirmed there were a "number of enhancements proposed to the pharmacovigilance framework for prescription medicines".

These will include the introduction of drug audits and the appointment of a drug monitor to oversee the safety of specific drugs.

The new drug safety committee will be given extra powers to oversee, assess and review risk-management plans of drug companies for approved medicines.

A more flexible protocol that will allow drugs to be suspended rather than withdrawn or recalled when safety issues arise is also expected to be in the legislative reform package slated to be introduced into federal parliament early next year.

The Weekend Australian earlier this year revealed chronic under-reporting by doctors and hospitals of serious adverse reactions to drugs could be creating a false picture of which medications pose a health threat.

Of the estimated 500,000 cases a year nationally of people becoming sick because of a drug they are taking, GPs report less than 2 per cent to the TGA.

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All I can say is amen to that and to point out that if ever there was an area where e-Health and Data Mining can help this is it.

Medicare has access to huge amounts of medicines and clinical outcome information that could be mined – with the right controls – to make a huge difference. I hope discussion of doing something like this is on the top of the agenda of the new National E-Health Management body.



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