Children overprescribed combination asthma medication: Study

New research has found the vast majority of Australian children with asthma are still being inappropriately prescribed fixed-dose combination (FDC) asthma medication, alarming experts.   
 
Almost 90% of children who received a FDC in a large new study did not have a preceding inhaled corticosteroid (ICS) prescription, indicating that an FDC had been prescribed as a first line controller therapy in conflict with the national guidelines.
 
The findings, published in the International Journal of Environmental Research and Public Health, were derived from Pharmaceutical Benefits Scheme (PBS) dispensing data that tracked nearly 36,000 children and adolescents aged 1–18 years who were dispensed at least one FDC between January 2013 and December 2018.
 
According to the Australian Asthma Handbook, FDC controller medicines for asthma in children and adolescents aged 6–18 years should only be prescribed after an initial ICS has proven ineffective in controlling symptoms.
 
They are not recommended at all for children aged five and under.
 
The findings are ‘concerning’ according to the lead author of the new study, Dr Nusrat Homaira, a respiratory epidemiologist and senior lecturer in paediatrics at UNSW Medicine.
 
‘Most alarmingly, in our study cohort – which looked at 10% of the Australian population – we found that around 3500 Australian children aged five or under are dispensed FDC inhalers annually,’ she said.
 
‘There is lack of evidence suggesting benefit of FDC in children, especially in preschoolers.
 
‘Some data suggests it may even increase [the] risk of asthma exacerbation and result in development of tolerance to asthma relievers in young children.’
 
The study is based on the first data analysis of national asthma dispensing patterns since 2014.
 
It comes two years after the Pharmaceutical Benefits Advisory Committee (PBAC) made recommendations that FDC dispensing patterns in children were ‘unacceptably high’ and needed to change.
 
So why is it still happening?
 
Dr Kerry Hancock, GP and Chair of the RACGP Specific Interests Respiratory Medicine network, was a member of the reference group for the post-market review of PBS medicines used to treat asthma in children.
 
She told newsGP that a major contributor for the overprescribing of FDCs has been clinicians using adult guidelines to treat children.
 
‘There’s no doubt that when combination therapies became available in the early 2000s, that really made a difference to managing adult asthma,’ she said.
 
‘Because that was so revolutionary and we all saw the impact that that had in adulthood asthma, I think it just then leapt over into managing paediatric asthma: “If it’s good enough for adults with asthma, then why can’t it be used in children?”
 
‘[This approach came at expense of] clinicians looking at the guidelines and understanding that the management of childhood asthma is so very different from managing adult asthma.’

Chair of the RACGP Specific Interests Respiratory Medicine network Dr Kerry Hancock.
 
‘Consumer pressure’ has also played a role, according to Dr Hancock.
 
‘There were submissions [to the post-market review] saying there were data that there was consumer pressure for these medications without the true understanding that there wasn’t good evidence about the role of those medications in children,’ she said.
 
‘Like an adult saying, “Well, my asthma has been so well controlled with this medication, why can’t I have it for my child?”.’
 
While FDC dispensing rates for children remain high, the study does show that patterns are improving.
 
The annual incidence of FDC dispensing declined from 14.7 to 7.2 per 1000 children over the five year period covered by the study.
 
In addition, the frequency of FDC dispensing per 1000 children without a preceding ICS declined from 2.1 to 0.5 in children aged 1–2 years, from 7.2 to 1.7 in 3–5 years, from 14.8 to 5.1 in 6–11 years, and from 18.6 to 11.9 in those aged 12 and over.
 
‘More work needs to be done, but we are moving in the right direction,’ Dr Homaira said.
 
Dr Hancock believes the declining numbers show the efficacy of efforts to increase education among clinicians, including changes to the PBS listings and software alerts when prescribing.
 
‘I feel this reflects [the] GP response to the initiatives,’ she said.
 
‘The study in question has only looked at data until 2018 and since then there have been even more interventions that I anticipate will lead to even more appropriate diagnosis and management of children with asthma.’
 
An estimated 20.8% of Australian children aged 0–15 years are diagnosed with asthma, making it the most common chronic childhood disease.
 
What is most challenging about childhood asthma, Dr Hancock says, is not the decision around treatment, but making the initial diagnosis.
 
‘Is this asthma that we are treating, or is it some wheeze with an upper respiratory tract infection? Once you make that diagnosis, it’s not hard to then make the decision about what the child needs to be treated with,’ she said.
 
‘If there is any uncertainty in the diagnosis, there’s step-wise management. GPs can do a trial of therapy of an inhaled steroid as long as they’re then reviewing the child to see if that is effective in controlling their symptoms.
 
‘In adult medicine you can usually be a little bit more confident about your diagnosis, and once you’ve got your diagnosis, they stay on their medication. But in children, we have always been recommended a trial on, then a trial off, especially in the sorts of children we’re seeing in general practice.
 
‘It’s different with other [children] who are … forever at the emergency department.’
 
As FDCs are one of the most expensive asthma controller medicines on the market, Dr Homaira says following the guidelines will also see the overall cost of treatment drop.
 
In the study, the overall cost of FDC prescriptions was $7.8 million, split between the Government ($4.5 million) and patients ($3.3 million).
 
‘It’s important that clinical practice guidelines, like the Australian Asthma Handbook, are properly adhered to by medical practitioners,’ Dr Homaira said.
 
‘Clinical guidelines standardise clinical care, reduce waste of health resources, and improve the value of healthcare.’
 
Dr Hancock agrees.
 
‘In March 2019, the paediatric section of the Australian guidelines had an overhaul to hopefully provide GPs and other clinicians confidence in the challenges we all have in managing especially the young child that presents with a wheeze and/or cough and/or breathlessness,’ she said.
 
‘And emphasising under what circumstances initiating preventer therapy is indicated and what that preventer therapy should be.’
 
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asthma Australian Asthma Handbook childhood asthma FDC ICS PBS Pharmaceutical Benefits Scheme