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Monday, 25 June 2018
Page: 6094

Health Care

"a very small percentage of adverse effects are actually reported (research suggest around 5%); it is impossible to judge how common an adverse effect might be because there is rarely any denominator data, such as the number of prescriptions written for a specific drug; the quality of information reported is not always good enough to make a scientific case for a causal link between medicine and effect." UMC, WHO Collaborating Centre for International Drug Monitoring. ".... there is low awareness of available reporting systems...Significant resources may be needed to support an enhanced consumer reporting scheme." 'Low awareness of adverse drug reaction reporting systems: a consumer survey' by Jane Robertson and David A Newby, Med J Aust 2013. "I was given no warning that Sertraline might make me suicidal. I now have a brain injury after a suicide attempt" by Mr BKS in Australia. Antidepressant labels are devoid of the FDA 'suicidality' warning.

We Request: TGA should mandate all pharmaceutical companies to put clear warnings on the outside of the boxes of all dangerous medications. TGA should access denominator data, improve the quality of information reported via spontaneous reporting systems. The necessary and sufficient information required from the reporter, to assess a causal link between medicine and effect, should be requested in the user instructions on the TGA Blue cards. Blue cards should be given (with directions to equivalent online reporting) to every consumer at the point of drug sale and regularly to every patient in Australia.

from 156 citizens (Petition No. EN0607)