Prescription safeguards failing children
From Health cover exception, it is clearly unacceptable when it becomes the norm.’’
While she defends the right of doctors to prescribe off-label, and says restricting this right would impose too great a limit on clinical freedom, Gazarian thinks it is overused and should be limited to circumstances where it can be justified by pre-specified criteria, as this will reduce inappropriate use and exposure to unnecessary risk.
A separate paper, published in the Medical Journal of Australia last year, of which she was lead author, found the level of off-label prescribing was also common in adults — between 7.5 and 40 per cent of the total.
That paper proposed three scenarios where off-label use was appropriate: when such use was justified by high-quality research evidence, within the context of a formal trial or research project, and in exceptional circumstances, where such use was justified by individual clinical circumstances.
The Australian Health Ministers Advisory Council has already commissioned a working group to review the issue and consider how the safety of paediatric prescribing can be improved.
To close the evidence gaps, Gazarian argues for a ‘‘ co-ordinated and wellresourced national approach’’ — including the commitment of public funds — to conduct studies on children. She also says there should be a national evidence-based prescribing information resource, to give doctors, pharmacists, nurses and others the latest evidence on what drugs work best.
And she calls for US-style incentives for pharmaceutical companies to conduct studies, and for drug licences to be updated when new research data shows a particular use for a drug is safe and effective. At the moment, licence provisions are only extended if a manufacturer makes an application to the TGA — something they currently have little incentive to do.
A spokesman for the drug manufacturers’ umbrella body Medicines Australia said it ‘‘ acknowledges the need for ethically conducted, evidence-based research for the benefit of all children who may need medicines which haven’t been specifically designed for them.
‘‘ One of the questions that needs to be considered is how best to establish a regime which can provide appropriate incentives to encourage research that will provide children with licensed medicines,’’ he said.
A spokeswoman for the TGA said the regulator was ‘‘ very keen to progress better paediatric information about drugs’’ and the AHMAC initiative was key to achieving that.
‘‘ The TGA is very keen to see increased paediatric data, bearing in mind the ethical considerations, and to find solutions that would encourage companies to produce better paediatric evidence,’’ she said. Due to space constraints, Body Parts does not appear this week