Bid to overturn isotretinoin prescribing restrictions

A new move to allow GPs to prescribe oral isotretinoin is underway, following an RACGP application this month to the Therapeutic Goods Administration (TGA).
 
It seeks to lift restrictions limiting the acne medication’s prescription to dermatologists and is a significant step forward in the college’s campaign to expand prescribing to general practice.
 
The move has been a part of RACGP advocacy across several jurisdictions.
 
Listed as a Schedule 4 poison, isotretinoin can be a highly effective treatment against moderate-to-severe acne but can currently only be prescribed by specialist dermatologists.
 
In its application, the RACGP sets out its reasons for lifting the restrictions listed in the Poisons Standard’s Appendix D.
 
It said that while the restrictions are for potential teratogenicity and side effects, they act as a barrier to timely care, citing a shortage of dermatologists outside of metropolitan areas.
 
RACGP President Dr Michael Wright said, if approved, the change will be ‘in the best interest of our patients and our practices’.
 
‘It’s another example where the college is pushing to remove unnecessary regulation that stops GPs being able to provide the care patients need,’ he told newsGP.
 
‘It’s important that we safely expand the scope of what we do.’  
 
For Dr Tracey Purnell, RACGP Specific Interests Dermatology Chair, concerns surrounding the dermatology workforce are familiar at her clinic in regional New South Wales.
 
‘I work in Wagga Wagga and there is no dermatologist in Wagga who takes new patients,’ she told newsGP.
 
‘All of our patients have to travel outside of Wagga and be on long wait lists or they have to do telehealth. 
 
‘It’s not just a matter of time, it’s a matter of expense as well. I think the average out-of-pocket cost to see a dermatologist for a short appointment is a couple of hundred dollars.
 
‘You’re also often describing young people – it’s hard enough to get them in to see a GP and build a relationship with the GP.’
 
Dr Purnell referenced the work of her predecessor as RACGP Specific Interests Dermatology Chair Dr Jeremy Hudson to push the proposed change forward and said that for her, continuity of care is another key.
 
‘What we want to do is the best thing for our patients, and so being involved in the whole breadth of acne care and not just going to a point and then having to say “Oh, now I need to refer you to this other person and you might not actually be able to see them for six to 12 months”,’ she said.
 
‘It’s a commonsense thing really.’
 
Beyond the warning on birth defects, this year the TGA issued new advice to conduct a mental health assessment for all patients before starting isotretinoin, as well as new warnings on sexual health-related side effects.
 
However, for Dr Purnell prescribing isotretinoin would still be a logical expansion for GPs with the right education programs in place.
 
‘Prescribing isotretinoin is not only well within the scope of general practice, but it’s core to what we do all day, every day,’ she said.
 
‘The idea it might have mental health side effects, which isn’t proven, but again monitoring everyday mental health issues is what GPs do all day.
 
‘And then there’s monitoring of biochemical markers, in particular liver function tests and cholesterol – again, tests that GPs monitor all the time.’
 
If the proposed RACGP amendment comes into effect, it would not affect the medicine’s Schedule 4 classification but would change the current prescriber limitation in Appendix D to include GPs, allowing them to prescribe directly for moderate-to-severe acne and severe or treatment-resistant rosacea.
 
As previously reported in newsGP, other medications that can result in birth defects such as molnupiravir are not under the same restriction.
 
The RACGP application says the change will also reduce avoidable scarring, physical discomfort, and psychological morbidity.
 
There is also a notable precedent overseas, with GPs and nurse practitioners in New Zealand given the green light to prescribe isotretinoin in 2009.
 
Research into the impact of lifting restrictions in that country, published in 2017, noted that ‘pregnancy exposures to isotretinoin are similar when comparing GP and dermatologist prescriptions’.
 
It also concluded that the drug became ‘proportionally more accessible to Asian, Maori and Pacific people and people in lower socioeconomic groups than it was when funded only through dermatologists’.
 
The TGA is likely to discuss the RACGP amendment application in November this year.
 
It follows a successful campaign by the RACGP to allow GPs to prescribe ADHD medications in several jurisdictions across Australia.
 
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acne dermatology isotretinoin TGA