Acne vulgaris is a common, chronic inflammatory skin disease of the pilosebaceous unit. Acne affects 12 per cent of all adult women and 85 per cent of teenagers, of whom 20 per cent experience severe acne. Acne imposes multiple burdens on patients, notably adverse psychosocial and emotional functioning, social isolation, anxiety, depression and suicidal ideation. Acne scarring affects almost half of patients: acne scarring relates to acne severity and delay in initiating effective therapy. The widespread and prolonged use of topical and oral antibiotics in acne raises strategic antimicrobial stewardship concerns.
Patients’ acne treatment escalation pathway commonly includes topical benzoyl peroxide and retinoids, topical and systemic antibiotics, combined oral contraceptives and spironolactone. This article focuses on the safe management of oral isotretinoin.
Oral isotretinoin was first licenced by the FDA in 1982 and is currently recommended as first-line therapy for people with severe acne. Oral isotretinoin effectively targets the key pathophysiological steps in acne. The current American Academy of Dermatology (AAD) clinical guideline states: “Oral isotretinoin is strongly recommended for severe acne, acne causing psychosocial burden or scarring, or acne failing standard treatment with oral or topical therapy”.
GPs in Ireland, the Netherlands, New Zealand, Canada and Norway are supported by clinical guidelines to safely and independently prescribe isotretinoin. The prescription of isotretinoin in the UK and Australia is currently restricted to dermatologists and clinicians under their governance. The Royal Australian College of GPs recently initiated a regulatory appeal to enable GPs in Australia to independently prescribe isotretinoin.
There is evidence of delayed and inequitable access to isotretinoin, adversely impacting women, ethnic minorities and lower social groups.
Clinical practice guidelines inform, support and lead high-quality patient care. The four strategic clinical competencies for doctors to safely prescribe isotretinoin were identified in a recent scoping review: dermatology, mental health assessment, laboratory monitoring and robust pregnancy prevention.
1. Dermatology: Acne is a common, chronic inflammatory skin disease of the pilosebaceous unit, usually presenting with comedones, papules, and pustules on the face and/or trunk. The diagnosis of acne is usually straightforward.
2. Mental health assessment: Acne imposes a significant psychological, emotional and mental health burden on many patients. A recent systematic review and meta-analysis concluded that there is no compelling evidence that at population level, isotretinoin increases the suicide rate and concluded: “Because of an increased risk for depression and anxiety, clinicians should pursue aggressive treatment of acne.” There are case reports and concerns that isotretinoin may adversely impact the mental health of some patients and clinical guidelines recommend that doctors prescribing isotretinoin, “should monitor for depression, anxiety, suicidal ideation/suicidality . . . and individualise theraputic decisions” in people taking isotretinoin.
Mental health assessment and regular monitoring are important components of safe isotretinoin prescribing. Many GPs have mental health training during GP training. Mental health issues are commonly present in everyday general practice. GPs are trained, experienced and well-placed to perform regular mental health assessments of patients taking isotretinoin.
3. Laboratory monitoring: Monitoring related to isotretinoin should include liver function tests, fasting lipid (triglyceride) panel and urine pregnancy testing. Taking a full blood count is unnecessary and not recommended. The current AAD guidelines acknowledge that, in otherwise healthy young adults, there is “little evidence to support the benefit of laboratory monitoring to detect adverse events”, and recommend testing “LFT and Lipids” before initiation and at peak isotretinoin dose: two blood tests only. The HPRA SmPC recommends testing baseline fasting lipids and LFTs, one month after initiation of isotretinoin and every three months thereafter. Clinicians, when reviewing patients and initiating isotretinoin therapy, take all these considerations into account when deciding on the frequency of blood monitoring required in healthy young adults.
4. Pregnancy prevention: Isotretinoin is a potent teratogen, causing severe foetal abnormalities in 15 – 30 per cent of live births. Doctors and pharmacists managing patients taking isotretinoin should comply with all the clinical, regulatory and ethical guidance to prevent foetal isotretinoin exposure. Pregnancy prevention is a shared responsibility for the (female) patient, pharmacist and the prescribing doctor.
Robust and verifiable pregnancy prevention: Given its teratogenic potential, prevention of foetal exposure to isotretinoin in pregnancy is the aim of the isotretinoin pregnancy prevention programme. It is essential to ensure patients taking isotretinoin are fully aware of the risks and the need to avoid becoming pregnant while taking it. Hence, safe management of isotretinoin requires a robust, verifiable pregnancy prevention programme. Being fully clear on the contraceptive options available to support patients in an appropriate and personalised way involves a discussion on contraceptive requirements. The full suite of contraceptive options incorporates contraception, emergency contraception and termination of pregnancy. It is vital that the prescribing clinician is trained and competent to accurately verify that a woman is not pregnant when commencing or taking isotretinoin. GPs are trained, competent and experienced in taking a detailed sexual and menstrual history, performing urine pregnancy tests in line with the pregnancy prevention programme, and prescribing the full suite of contraceptive options.
Consistent communication between prescriber and pharmacist is key, coupled with a shared understanding with the patient to ensure that a robust and verifiable pregnancy prevention is in place for female patients.
Women who are sexually active: Current clinical guidelines recommend dual contraception, one of which should be hormonal, for all sexually active women taking isotretinoin. LARC provides highly effective contraception with a small failure rate: hence the enduring requirement for dual contraception. The clinical, regulatory and ethical guidance aligns when managing these patients.
Women who are not sexually active: GPs and pharmacists get many requests for isotretinoin from young adolescent girls who are not sexually active. The SmPC for isotretinoin states that regarding pregnancy prevention programmes, “These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy”. The AAD guidelines clearly state: “For persons of childbearing potential, pregnancy prevention is mandatory with isotretinoin treatment
The robust, verifiable pregnancy prevention programme is built upon a solid foundation of fundamental clinical principles: Informed consent and shared decision making.
Informed consent: “Patients should be able to participate in decisions about their medical care, weighing the risks, benefits, and alternatives of a proposed intervention to ensure that the care they receive reflects their goals, preferences, and values”
Prevention of foetal isotretinoin exposure is our shared strategic objective. Clinicians supporting the safe use of isotretinoin embrace informed consent. Informed consent is a patient-centred process. Consent is not “a laundry list of potential risks recited to a patient” with a signature on a piece of paper. Shared decision making naturally flows from the informed consent process. Shared decision making supports our patient to make an informed decision, personalised to their specific wishes and unique situation.
This aligns with the SmPC, which states that “Individual circumstances should be evaluated in each case, when choosing the contraception method, involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.”
As part of patient consultations, GPs discuss the need for a robust verifiable pregnancy prevention programme with patients as part of their shared decision-making, informed consent and patient-centred care.
In Ireland, the clinical guidance for doctors may appear to vary from the HPRA SmPC guidance to which pharmacists refer and must adhere. isotretinoin to prevent foetal isotretinoin exposure.
The HPRA guidance mandates “compulsory hormonal contraception for all women of childbearing potential.” This regulatory mandate may appear to diverge from current clinical practice guidelines. However, the HPRA identifies and categorically excludes mandatory hormonal contraception for women in whom there are “compelling reasons” to believe that pregnancy cannot occur. These “compelling reasons” are not explicitly identified in the SmPC. The clinical guidance for doctors states “must adhere to complete abstinence.”
Hormonal contraception, while very safe, carries a well-documented risk profile. There are profound clinical, ethical and professional challenges, with medicolegal implications, for clinicians compelling women who are not sexually active, often young adolescent girls, to take hormonal contraception.
As outlined in this article, GPs possess the four key clinical competencies to safely and independently manage patients with acne using isotretinoin. There is also a clearly defined isotretinoin treatment pathway for our patients with severe acne. This pathway covers informed consent in which the need, requirements and choice of a suitable, robust, verifiable pregnancy prevention programme is discussed and agreed with the patient.
Pharmacists are highly trained professionals with extensive knowledge of medicines, providing holistic, patient-centred care. Pharmacists have a legal requirement and duty of care to counsel the patient on their isotretinoin therapy and ensure isotretinoin is prescribed appropriately.
The patient should be advised to attend the pharmacist with their prescription and understand that the pharmacist may ask the same questions: this is part of the pharmacist’s duty of care and an important safety net for all.
To support patient access whilst ensuring the safe prescribing and effective use of isotretinoin, doctors and pharmacists should collaborate to improve interdisciplinary communication. This is in the interests of patient safety to confirm there is a clear understanding and agreement in regard to a suitable, robust verifiable pregnancy prevention programme.
The Irish College of GPs recently hosted a comprehensive blended learning isotretinoin module to support safe, timely and equitable access to isotretinoin in primary care. This module is a shared education international collaboration between international acne experts, the Department of General Practice and the School of Pharmacy in UCC. This education module will be delivered again in Q4 2026, and pharmacists are again welcome to attend: the IPU will keep you updated.
Acne is a common and chronic disorder: GPs manage most common, chronic diseases. We have a clearly defined isotretinoin treatment pathway for our patients with severe acne. Together, we have trained almost 500 GPs to safely prescribe isotretinoin: an invaluable collaboration between HSE, GPs, dermatologists, pharmacists and medical indemnity organisations. GPs possess the four key clinical competencies to safely and independently manage patients with acne using isotretinoin. Pharmacists play a critical role in ensuring patients use isotretinoin safely and effectively, providing expert guidance, monitoring and support throughout treatment. GPs, pharmacists and our patients stand together on the cusp of a paradigm shift which will deliver safe, timely and equitable patient access to isotretinoin across Ireland.
References available on request.
Dr Diarmuid Quinlan, Medical Director, ICGP and
Dr Edel Burton MPSI PhD, School of Pharmacy, UCC
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