‘A big difference’: Poisons Standard change brings hope

GPs have welcomed reduced paracetamol pack sizes which came into effect this month, as a new report describes a health system that is ‘failing’ children on medicine safety.
 
The analysis, commissioned by the Pharmaceutical Society of Australia (PSA), indicates an average of 93 Australian children go to emergency departments each day due to medicine-related problems.
 
Researchers from the University of South Australia who compiled the ‘Medicine Safety: Child and Adolescent Care’ study suggest around half of those cases are preventable.
 
Much of the harm to children is caused by foreseeable medicine interactions, unsafe off-label use or poisoning from medicines such as paracetamol, they wrote, with PSA President Associate Professor Fei Sim describing the health system as ‘failing kids’.  
 
The PSA gave its strong support to Therapeutic Goods Administration (TGA) changes to the Poisons Standard that came into effect from 1 February.
 
Now, general sale packs of paracetamol are limited to 16 tablets (down from 20) with pharmacy packs limited to 50 unless issued under the supervision of pharmacist.
 
Paracetamol tablets and capsules also now need to be sold in blister packaging.
 
It is a move backed by many GPs, with the Chair of RACGP Specific Interests Child and Young Person’s Health Dr Tim Jones believing it will have an impact.
 
‘Paracetamol is by far and away the number one cause of overdose-related illness causing harm to our children, be it accidental or deliberate – so we really welcome the tightening of the restrictions around its supply,’ he told newsGP.
 
‘It’ll make a big difference.’
 
The RACGP has previously endorsed the TGA’s move towards greater restrictions for paracetamol, a change first flagged in September 2022.
 
According to the PSA report, adolescents aged 15–19 now account for a growing proportion of hospital poisoning admissions, increasing from 61% in 2013–14 to 68% in 2022–23. Of those cases, 85% are attributed to paracetamol.
 
The study also cited Canadian research showing drugs approved with paediatric indications mostly only include dosing information for adolescents.
 
It found many oral drugs with indications for younger children do not have paediatric formulations, which authors said ‘can lead to unsafe alterations of adult formulations’.
 
They also described clinical trials in young children as ‘often lacking’.
 
The report authors made several further recommendations, including a new reporting and learning system for medicine safety incidents, mandatory indication on prescriptions for children and adolescents, and manual dose checks when paediatric prescriptions are dispensed.
 
For Dr Jones, the key issue for general practice is the importance of adhering to good prescribing guidelines.
 
‘By far and away, the biggest thing I can see for us as GPs is with our principle of “first, do no harm”, and always considering the rationale for medications that are being prescribed to children,’ he said.
 
‘Outside of overdoses or accidental mis-dosings, the number one reason why a child’s going to end up in hospital would be due to medication-related side effects.
 
‘Even something as simple as considering the need for antibiotics in certain situations, we need to keep that front of mind.’
 
The PSA study also raises concerns about increasing off-label use of medicines such as melatonin.
 
‘This is of concern as the efficacy and safety of medicines used off-label may not be fully understood, and some studies have shown a higher risk of adverse events when medicines are used off-label in children,’ the authors wrote.
 
Dr Jones said he recognises the trend of off-label prescribing, which he also feels ‘contributes negatively to safety’ – and agrees with another of the study’s findings which points towards more children using medicines concurrently.
 
It cites an ABS National Health Survey from 2022 which found 3.4% of children aged 0–17 years had five or more different medicines dispensed within six months.
 
‘In my time as a GP, we are increasingly seeing polypharmacy in our young people,’ Dr Jones said.
 
‘Particularly with the complexity of adolescent and young people's mental health, we often see people on multiple medications or supplements.
 
‘We just need to acknowledge the risk of combining medications in young people, particularly if there is an overdose risk, or if the child or young person becomes unwell again.
 
‘It just brings us back to that rational prescribing argument – we really need to make sure that we’ve got good governance and good oversight and that any prescribing decisions are robust.’
 
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medicine safety paracetamol Poisons Standard TGA Therapeutic Goods Administration