O03 Implications of the implementation of the new UK regulatory framework for the prescribing of isotretinoin: an assessment of the impact on outpatient capacity

Abstract Isotretinoin is a highly successful, established, oral treatment for acne vulgaris. In the UK isotretinoin is usually prescribed by, or under the supervision of, a consultant dermatologist. Concerns have been raised by patients about potential links between isotretinoin and both mental health (suicide and depression) and sexual side-effects (erectile dysfunction). In the UK, the Commission on Human Medicines (CHM) undertook a review process and decided that, in light of uncertainties about these claims, new regulatory measures were needed in the UK. These include a ‘cooling-off’ period prior to the initiation of therapy, a face-to-face consultation 4 weeks after the start of treatment, and a requirement for a second specified healthcare professional (HCP) to approve isotretinoin in those aged < 18 years. An Isotretinoin Implementation Advisory Expert Working Group published recommendations on how to meet the new regulations in 2023. The aim of this study was to assess the impact of the changes. Information about patients commenced on isotretinoin over 12 months was mapped to the new guidance and the additional HCP time required compared with current practice. The assumption in the analysis is that the patient will attend for three appointments in the first few weeks of treatment: initial consultation, consultation to start treatment and a follow-up 4 weeks later. Additional time was allowed for the need to discuss and document sexual side-effects. For those aged < 18 years an additional appointment with the second HCP was included. The study population was 750 000. During the 12-month period, 365 patients started isotretinoin, 163 male and 202 female, with 78 aged < 18 years. Overall, an additional 331 h of HCP time (mix of specialist nurses and doctors) was identified as necessary to deliver the recommendations. This equates to around 993 20-min appointments per year. If this is extrapolated for England it means about 75 000 additional appointments. This will have a significant impact on services, in particular on patients with other inflammatory skin conditions who are already disadvantaged by the prioritization of skin cancer targets. The approach of the CHM is not replicated anywhere in the world. There is an urgent need to review the interpretation of the scientific evidence underpinning the change in the regulatory framework; it is apparent that the views of expert, experienced, dermatologists were not appropriately heeded. It is also very important to work with the CHM to mitigate the very significant impacts of the changes on (i) people with acne, including the harm of withholding treatment or deterring patients from accepting treatment (e.g. scarring, depression and other adverse psychosocial outcomes) and (ii) people with other skin conditions.