Local drug alerts fall short
Experts suggest Australians are being kept in the dark about new risks of medicines.
A new study looked at how often medicine regulators in four countries issue safety advisories about the same potential health risks.
“Between 2007 and 2016, Australia’s regulatory authority for medicines – the Therapeutic Goods Administration or TGA – issued safety warnings on less than 30 percent of the issues identified by regulators in Canada, the US and UK,” said chief investigator Associate Professor Barbara Mintzes, from the University of Sydney.
“These findings reveal Australia’s regulator is falling well below the other countries in terms of how often emerging health risks of medicines are communicated, and that there is low consistency between countries.”
Regulatory agencies approve new drugs for use based on limited safety evidence collected during clinical development.
Once new drugs enter general use, other safety issues can become apparent including rarer or longer-term effects – prompting regulators to issue safety advisories on how to avoid or manage these risks.
The research went back over 1,441 advisories issued in four countries over a 10-year period, covering 680 drug safety concerns.
“Overall, we found that regulators were only consistent in the decision to warn 10 percent of the time,” said Associate Professor Mintzes.
“We really need better understanding of how decisions to issue safety warnings are made, to ensure emerging risks of medicines are effectively communicated to doctors and other prescribers as well as the public.
“Just how much does the seriousness of the risk or strength of the evidence come into play, and more importantly what are the public health implications of such decisions – especially for patients?”