The RACGP hopes to cut long waits and high costs for severe acne and rosacea patients.
Hot on the heels of its successful campaign to expand GP prescribing rights for ADHD medications in several Australian states, the RACGP is moving into an area currently limited to dermatologists.
The college has lodged an application with the Therapeutic Goods Administration (TGA) to allow GPs to prescribe oral isotretinoin, in a move it says would improve timely access to care for patients with moderate-to-severe acne and severe or treatment-resistant rosacea.
Isotretinoin (Roaccutane) is indicated for severe cystic acne that is unresponsive to other therapies such as antibiotics and is strongly contraindicated in pregnancy for its teratogenic effects.
It has also long been linked with psychiatric side effects including depression, anxiety and suicidal ideation – which are also associated with having severe acne – and has carried an FDA black box warning since 2005 for suicide, depression, aggression and psychosis.
Currently listed as a Schedule 4 medicine, isotretinoin can only be prescribed by specialist dermatologists under Appendix D of the Poisons Standard, due to concerns over teratogenicity and other adverse effects.
RACGP Specific Interests Dermatology chair Dr Tracey Purnell, told Dermatology Republic that patients in her town often faced months-long waits, high out-of-pocket costs, or the need to travel for specialist care.
She said delays in treatment could result in higher risks of scarring and other complications, not to mention the damage to the patient’s mental health and self-esteem.
Dr Purnell said she believed that – adequately trained and educated – GPs were well-placed to prescribe isotretinoin and having that ability would be a “game-changer”.
“For me it’s always been about having continuity of care,” she said.
“There’s a lot of things to consider in the impacts of acne on people’s lives – to me it’s like a no-brainer [to allow GPs to prescribe].”
She said GPs were already managing many of the conditions that needed to be closely monitored in patients using isotretinoin, such as mental health, contraception and sexual health.
“It’s not just within our scope of practice, it’s core to what GPs do day in day out,” Dr Purnell told DR.
A spokesperson for the Australasian College of Dermatologists told The Medical Republic it planned to engage with the process “to ensure patient safety remails paramount”.
“Isotretinoin remains a complex drug, and we note the Royal Australian College of General Practitioners’ application for a review of the current scheduling,” the spokesperson said.
“As with all medicines, the Australasian College of Dermatologists … supports regular reviews of the Poisons Standard to ensure the scheduling reflects any new evidence on safety profile, risks and the level of clinical expertise and support required for safe and appropriate prescribing.”
Dr Purnell said she welcomed any opportunity for the colleges to work together to improve access to isotretinoin for patients.
She said the RACGP had been working on the submission for a long time, and they were looking forward to seeing the outcome when it comes up for discussion by the TGA in November.
But a TGA green light won’t mean automatic prescribing rights – negotiations will have to take place in individual states and territories in the same way it occurred for the expansion of ADHD medication prescribing.
However, Dr Purnell is hopeful that, if successful at the TGA, the move could be adopted in at least parts of Australia within six to 12 months.
“It would be good if it gets through,” she said.
“It’s been in the pipeline for a long time.”
The RACGP’s move comes just four months after the TGA released reinforced warnings about the risk of psychiatric side effects and potential sexual health side effects of isotretinoin.
In its new advice, published in April, the TGA said health professionals should be on the alert for psychiatric and sexual disorders in patients on isotretinoin, especially in adolescents.
Clinicians should “assess patients’ mental health and their family history of mental health conditions before starting isotretinoin”. They should “stop treatment immediately if mood-related changes occur and seek specialist advice if symptoms continue after stopping treatment”.
