Australia’s medicines regulator lags well behind other countries when it comes to alerting the public about the emerging health risks of medicines and must improve its communication, new research has found.
A University of Sydney study analysed how often medicines regulators across four countries issued safety advice about the same potential health risks in a bid to identify differences in communication regarding important drug safety information.
The study identified 1,441 advisories issued in four countries over a 10-year span which covered 680 drug safety concerns.
Between 2007 and 2016, Australia’s Therapeutic Goods Administration (TGA) issued safety warnings on less than 30% of those identified by regulators in Canada, the United States and the United Kingdom.
“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,” University of Sydney Charles Perkins Centre’s chief investigator Associate Professor Barbara Mintzes said.
“Overall, we found that regulators were only consistent in the decision to warn 10% of the time,”
In Australia, it is estimated around 250,000 hospital admissions occur each year due to harm from medicine use, cost of $1.4 billion annually.
“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?,” Associate Professor Mintzes posed.
“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.”
The research was published in journal JAMA Internal Medicine
