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Are Australians kept in the dark about new risks of medicines?

30 April 2019
Australian regulator issued fewer warnings than other countries
Research shows communication about emerging safety risks of medicines is not consistent between countries. Experts call for better resourcing and evaluation of safety notifications to doctors and other prescribers.

A new study has analysed how often medicines regulators in four countries issued safety advisories about the same potential health risks, to identify differences in communication of important drug safety information.

“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 Evidence, Policy and Influence Collaborative at the University of Sydney’s Charles Perkins Centre and School of Pharmacy.

“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.”

Differences in regulatory decisions to warn

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. However 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.

Published in a research letter in JAMA Internal Medicine today, the paper identified 1441 advisories issued in the four countries over the 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.
Associate Professor Barbara Mintzes

“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?”

Call for better resourcing

The research likely reflected 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, said study co-author Joel Lexchin, a visiting professor at the Charles Perkins Centre and from York University in Canada.

“In Australia, around 250,000 hospital admissions each year are due to harm from medicine use, at an annual cost of $1.4 billion dollars,” said Professor Lexchin.

“Around half the time this harm is preventable. 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.

“For this to happen, more resources are needed both for safety communication and to evaluate what works best to get these messages across.”

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