News

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TGA criticised over lack of safety warnings

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The criticism stems from a comparative analysis of how often medicines regulators in four countries – Australia, Canada the US and the UK – issued safety advisories about the same potential health risks.
 
The study, which examined notifications issued between 2007 and 2016, revealed major discrepancies in the way potential safety warnings were disseminated in each country, with Australia seemingly lagging in many areas.
 
‘The Therapeutic Goods Administration [TGA] issued safety warnings on less than 30% of the issues identified by regulators in Canada, the US and the UK,’ chief investigator Associate Professor Barbara Mintzes said.
 
‘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.’
 
Overall, the paper identified 1441 advisories issued across the four countries, which covered 680 medication safety concerns. Regulators were only consistent in the decision to warn 10% of the time during this period.
 
‘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 Mintzes said.
 
‘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 Mark Morgan, Chair of the RACGP Expert Committee – Quality Care (REC–QC), told newsGP that while GPs access a variety of sources to try to garner new information, gaps exist in the way safety issues are communicated.
 
‘Post-marketing surveillance of medications that relies on manually created reports is a woefully inadequate system,’ he said.
 
‘If you look at the total number of reports received compared to the predicted number that you might expect, there is a huge gap.’
 
Associate Professor Morgan added there is scope for using longitudinal de-identified patient data to link prescriptions to the development of possible side effects, and regulators should look to the airline industry for methods on how to monitor and alert all users about potential issues across borders.

Aside from potential health implications, the researchers also found there is a fiscal incentive to improving the way drug-related safety information is communicated.


Associate Professor Mark Morgan said that while GPs can access a variety of sources to garner new information, gaps exist in the way safety issues are communicated.

Associate Professor Joel Lexchin, study co-author and emergency physician, said there are around 250,000 hospital admissions each year in Australia due to harm from medicine use, at an annual cost of $1.4 billion dollars. He believes approximately half of these presentations could be avoided, but more needs to be done.
 
‘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,’ he said.
 
‘For this to happen, more resources are needed both for safety communication and to evaluate what works best to get these messages across.’
 
The TGA responded to the criticism by stating it had a ‘robust framework’ for therapeutic product vigilance, with a spokesperson telling newsGP that the study was ‘limited’ in that it did not consider other risk management tools.
 
‘The TGA routinely collaborates with our international counterparts to understand and share emerging safety information about medicines,’ the spokesperson said.
 
‘However, each regulator may make different decisions in how they choose to communicate a safety issue based on a number of local factors, including the registration and funding status of the medicine, the real-world use of the product, including different patient populations, and the evidence base for the safety concern.
 
‘This explains the difference seen between all regulators in the study.’
 
While Associate Professor Lexchin conceded the study did not document the frequency of use of certain medications or whether they were approved for the same indications, he told newsGP many of the drugs have narrow enough indications that it is ‘very unlikely’ they would be used in different populations.
 
‘The TGA is correct that different regulators may analyse safety information differently. However, in order to know whether that might explain some differences it would be necessary for all of the regulators to explicitly say what evidence they used and how they analysed it,’ he said.
 
‘Regulators, including the TGA, frequently did not provide that information. More transparency is important.’
 
Associate Professor Lexchin added that the other measures the TGA mentioned are dependent on how well they are known and used.
 
According to Associate Professor Morgan, GPs receive medication safety information from a variety of sources, but the most accessible form of warnings – product information leaflets accessible in the desktop electronic medical record – also have issues.
 
‘There are in-built alerts about drug–drug and a limited number of drug–disease interactions, [but] these in-built alerts are seriously deficient,’ he said.
 
Associate Professor Dr Morgan said some of the problems include:

• meaningless alerts that cause ‘alert fatigue’
• failure to alert on re-prescribing
• failing to notice the impact of pathology results (such as deteriorating kidney function)
• failing to identify if necessary safety monitoring has occurred
• failing to suggest alternatives or provide contextual information about the seriousness of the alert
• failing to identify over-treatment and opportunities for de-prescribing. 

Future research will investigate why there is so little consistency between the regulators, the most effective communication method, and whether one culture is better than another at protecting patients’ health.

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medication safety warning TGA Therapeutic Goods Administration

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