Australia’s regulatory authority for medicines issued safety warnings on less than 30 percent of the issues identified by regulators in Canada, the U.S. and U.K., according to a study by the University of Sydney’s Charles Perkins Centre and School of Pharmacy.

The study, which covered the years between 2007 and 2016 found Australia’s regulatory authority for medicines, indicated the Therapeutic Goods Administration (TGA) needs to improve evaluation of safety notifications to doctors and other prescribers.

The paper identified 1,441 advisories issued in the four countries over the 10-year period, covering 680 drug safety concerns, and overall the study found Australia’s regulators were only consistent in the decision to warn 10 percent of the time.

Around 250,000 hospital admissions each year in Australia are due to harm from medicine use, at an annual cost of $1.4 billion dollars, the study noted.

“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,” chief investigator Associate Professor Barbara Mintzes said in a statement.

Mintzes said the results indicated there is a need for better understanding of how decisions to issue safety warnings are made.

This would help ensure emerging risks of medicines are effectively communicated to doctors and other prescribers as well as the public.

“We would like to see much more attention paid to ensuring that doctors and patients are informed of new evidence of harmful side effects of medicines, and what to do to prevent them,” study co-author Joel Lexchin, a visiting professor at the Charles Perkins Centre, said in a statement. “For this to happen, more resources are needed both for safety communication and to evaluate what works best to get these messages across.”

The research also reflects the different ways each country approaches drug safety, with national medicines policies determining the behaviour of medicines regulators and the availability of information to healthcare professionals and the general public.

Before new medicines hit the market, each country’s regulatory agency must first approve them for use with decisions generally based on limited safety evidence collected during clinical development.

“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?” Mintzes continued.

The study also noted once a drug enters 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.



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