While many GPs would welcome the change, why do so many want to keep the restrictions?

Earlier this month the RACGP submitted an application to the TGA, arguing GPs should be able to prescribe oral isotretinoin (Roaccutane) for moderate to severe acne and severe or treatment-resistant rosacea – and 55% of just under 1000 GPs who responded to a new Healthed poll agree.

The retinoid is listed as a Schedule 4 poison, and can only be prescribed by specialist dermatologists. This is due to the risk of teratogenicity and other serious side effects – but the RACGP says that with shortages of dermatologists in rural and regional areas, the restrictions are creating a barrier to timely, effective treatment.

Many GPs in Healthed’s survey who support removing the restrictions cited the long wait times and cost to see dermatologists – and also noted that GPs could provide better monitoring and continuity of care – and often know the patient better.

Several suggested additional training to ensure GPs are up-to-date on current guidelines and protocols if the restrictions are lifted.

However, 45% of GPs in Healthed’s survey disagreed with the College’s position, saying existing restrictions are appropriate.

“Pregnancy catastrophes are more likely to occur as a result of unnecessary loosening of prescribing restrictions,” one GP said, adding that the risks associated with the drug outweigh any need to fast-track access to it.

Other GPs fear that pressure to prescribe the drug would increase if restrictions were lifted, while some said more prescribers would invariably lead to more adverse events, and some said they think dermatologists are better equipped to deal with the risks.

Risks of isotretinoin

Apart from the risk of birth defects, in April the TGA issued additional safety warnings regarding potential psychiatric and sexual disorders associated with the drug.

The TGA said it had identified 117 cases of serious psychiatric adverse events in its database, including depression (48 cases), suicidal ideation (28 cases), completed suicide (26 cases), attempted suicide (18 cases), psychotic disorder (15 cases) and anxiety (14 cases). There were also 24 reports of sexual dysfunction-related adverse events such as erectile dysfunction, hypoaesthesia, vulvovaginal dryness and decreased libido.

The Australasian College of Dermatologists (ACD) updated its position statement on isotretinoin for the treatment of acne last October, stating that “The current evidence does not point to a causal relationship between isotretinoin treatment and poor mental health,” and that there is “limited evidence to suggest an association between isotretinoin and sexual dysfunction.”

However, an investigation by the TGA concluded that “an association between isotretinoin and psychiatric/sexual disorders could not be ruled out.”

“Given the reported cases of severe and sometimes persisting adverse events and that isotretinoin is commonly used to treat severe cystic acne in adolescent populations, it was recommended the PI be updated as a precautionary measure and to align with international regulators,” the TGA said.

The ACD recommends psychological monitoring for patients prescribed the drug who have a history of prior mental illness. They say patients should be advised to report any mental health symptoms while on “any form of acne treatment,” noting a possible association between acne and mood disturbances.

The ACD position statement reinforced that the drug should not be prescribed in pregnancy, and that patients with the potential to become pregnant should use contraception while taking it. It also noted uncommon adverse effects including alopecia, headaches, myalgia, tiredness, and irritability.

The TGA is expected to discuss the RACGP’s submission at its meeting in November.

What your colleagues are saying

Comments from GPs who oppose lifting prescribing restrictions:

“I would not trust GPs to be as conscientious as specialist dermatologists. Pregnancy catastrophes are more likely to occur as a result of unnecessary loosening of prescribing restrictions. N.B. The prescribing of isotretinoin is never an emergency. Patients can wait for an appointment with the specialist. An unintended pregnancy in the context of isotretinoin is, however, a medical catastrophe. The latter must be avoided at all costs.”

“High risk of significant adverse reactions.”

“If we have higher numbers prescribing isotretinoin, then we will get higher associated suicide rates (causal or not, just based on numbers) and then the drug company might pull the drug off the market, which will be a disaster, because it’s such a great drug for many hard-to-treat acne cases.”

“Dermatologists are better qualified to deal with any possible side effects.”

“Often specialist involvement is valuable to the patient and reinforces the value of the treatment.”

“Patient pressure on GPs will increase if they are permitted to prescribe isotretinoin.”

“Leave to experts to handle – better compliance.”

“I think there are advantages of dermatologists managing isotretinoin, the only obvious limitation is the shortage of dermatologists and a tendency for them to focus on procedural medicine rather than non-malignant skin conditions where they are needed.”

Comments from GPs who support the RACGP’s submission to lift prescribing restrictions:

“A number of GPs have experience of isotretinoin prescribing, having worked outside of Australia. GPs provide contraception advice on a daily basis, required for isotretinoin in female patients, and prescribe a number of meds with potential for serious adverse effects, by taking necessary precautions. The aim is to prevent severe scarring in severe cases.”

“Frequently requested by patients. Long wait to see dermatologist. Expensive for young patients to see specialist. Monitoring as a GP is straight forward and we tend to have easier access to follow up.”

“GPs know patients better and will especially see patients more regularly to address developing depression. They also have a better relationship with patients to address contraception.”

“GPs already manage acne and are easier to access than dermatologists.”

“GPs are seeing their patients frequently and know them much better than dermatologists.”

“GPs with special interest should be able to prescribe isotretinoin. Personally, I do not want to prescribe this drug and would continue to refer to a specialist as I am not confident that I would prescribe and follow up correctly.”

“If the GP is confident with his knowledge and able to follow up with the patient as well as identify the risks and adverse events then they should be allowed to prescribe.”

“If the issue is toxicity in pregnancy, GPs are in as good a place to determine this as a dermatologist.”

“Isotretinoin is available to general practice in a large number of countries, the TGA needs to be pressured to remove this ridiculous restriction. There are far more dangerous drugs open to prescribe.”

“It is financially better to the patient and taxpayers. GPs will confidently and accurately follow the guidelines for indications and precautions needed as well as managing any side effects.”

“Many patients, especially in rural or underserved areas, face long waits to see dermatologists. Allowing trained GPs to prescribe isotretinoin could improve timely access to treatment. Continuity of care: GPs already manage long-term follow-up for other chronic conditions and could integrate acne care within the same framework. Early treatment of severe acne can reduce scarring, psychosocial impact, and long-term morbidity.”

“It’s a very common presentation in general practice, simple to diagnose and assess the patient. Currently patients are forced for referral and financial burden which not everyone can afford with the lack of outpatient clinics it seems unfair to our patients.”

“We are supposed to treat conditions like ADHD with no psychiatry background and are not allowed to prescribe the most effective treatment for acne…Please change it!”