We call on the Therapeutic Goods Administration to formally recognise Australian general practitioners as well placed to prescribe isotretinoin safely, and to empower individual GPs to decide, based on their own competence, training and clinical experience, whether they are qualified to prescribe it for appropriate patients.
We write as Australian general practitioners in response to the TGA’s 2025 safety update on isotretinoin, including Roaccutane and its generic equivalents, which strengthens Product Information requirements around psychiatric and sexual disorders. We support these precautionary measures. We also ask the TGA to acknowledge what our day-to-day work already shows: general practice is built for the kind of careful, ongoing oversight isotretinoin requires.
We assess mental health, review family history, and monitor patients over time. We already use screening tools, prepare Mental Health Treatment Plans, and coordinate care with psychologists, psychiatrists and headspace services. We also understand that severe acne can bring depression, anxiety, low self-esteem and social withdrawal, and that safe treatment depends on knowing the difference between the burden of the condition and a possible adverse drug reaction.
We are also the main providers of reproductive and sexual healthcare across Australia. We counsel on contraception, prescribe hormonal and non-hormonal options, insert long-acting reversible contraception, order pregnancy tests, and provide confidential sexual health care for adolescents and young adults. These are exactly the skills needed for isotretinoin, a known teratogen that requires reliable contraception, regular pregnancy testing and ongoing counselling.
Specialist-only pathways create delays, cost, and unequal access, especially in regional, rural and remote communities. They also split care between providers. The new PI requirements will work best when one trusted clinician holds the full picture.
We ask the TGA to back safe, integrated care by trusting competent general practitioners to prescribe isotretinoin.
I work regionally and access to dermatologist is nearly impossible especially with costs of travel. I myself have used a Telehealth service with a dermatologist for acne and roacutane prescription and the care provided while safe would have been so much better in person where examinations could occur instead of sending pictures. Our accessibility and follow up with patients is the key reason why GP’s are placed so well to prescribe this medication.