The updated safety measures will strengthen the MHRA's ability to monitor safe prescribing while supporting patient access to treatment across all age groups.
Prescribing requirements for isotretinoin, a treatment for severe acne, are being updated by the Medicines and Healthcare products Regulatory Agency to strengthen its ability to monitor safe prescribing while supporting patient access to treatment. The updated approach follows independent advice from the Commission of Human Medicines (CHM) which carried out a review of the impact of the existing safety measures for the prescribing of isotretinoin.
Isotretinoin is used primarily where there is a risk of permanent scarring and other treatments have not worked. Following advice from the CHM's Isotretinoin Expert Working Group and the Isotretinoin Implementation Advisory Expert Working Group, the MHRA introduced enhanced safety measures in April 2023 and committed to reviewing their impact.
The review found that safety measures are working well, with healthcare professionals now spending more time discussing the benefits and risks of isotretinoin with patients and monitoring them more closely for side effects. However, the requirement for treatment of young people under 18 to be agreed by two-prescribers was found to be causing potential delays in access to treatment for some under-18s, with minimal evidence of disagreement between prescribers about treatment decisions.
Given this evidence, the CHM has recommended that healthcare professionals can prescribe isotretinoin to under-18s without seeking the agreement of a second prescriber, ensuring young people with severe acne benefit from both safer and more timely access to treatment. This is in line with the approach taken by other international regulatory bodies.
Patients can still request a second opinion from another prescriber if they want to be reassured that isotretinoin is the best treatment for them.
The CHM also recently endorsed updated advice on face-to-face follow-up consultations, pregnancy testing, and sexual health discussions, alongside an updated Acknowledgement of Risk Form to help healthcare professionals implement the current requirements for isotretinoin more effectively.
Dr Alison Cave, MHRA Chief Safety Officer, said:
The updated safety measures will ensure patients who need isotretinoin for the treatment of severe acne are able to access it when it is needed, while ensuring that robust oversight of patient safety remains in place throughout treatment and that patients are well informed of the risks before starting treatment.
Severe acne can have a significant impact on a patient's mental wellbeing and can lead to permanent scarring. For these individuals, isotretinoin may be the only effective treatment option. That's why it's important patients can access this treatment both safely, and in a timely manner.
As part of its wider impact review, the CHM considered the results of an October 2025 survey completed by both private and NHS prescribers which provided assurance that most services are following current prescribing requirements and evidence that the majority of current measures are being adhered to. These responses provided reassurance that changes could be made.
Dermatology services have also agreed to take part in future clinical audits run by the British Association of Dermatologists (BAD), and audit data will be regularly submitted to the MHRA, strengthening its ability to monitor the safety of isotretinoin prescribing across the UK. This was a critical factor in the considerations of the CHM.
All other existing safety measures put in place in 2023 will remain in effect, including the need for patients and their healthcare professional to sign an Acknowledgement of Risk Form before starting treatment and the requirement for healthcare professionals to advise patients on the risks of side effects. Additionally, a patient video has been developed by the BAD to further inform patients of potential side effects and when isotretinoin should and should not be used.
The MHRA expects all prescribers, including those in the private sector, to comply fully with risk minimisation measures. Dermatology services will be subject to regular audits and further regulatory action will be considered if compliance is not maintained.
The changes take effect immediately. Healthcare professionals and patients can find more information in the Drug Safety Update .
Anyone who suspects that they are experiencing a side effect from isotretinoin is advised to speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme ."
Notes
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy, and quality of medicinal products.
Suspected side effects or adverse drug reactions to any medicines should be reported to the MHRA Yellow Card scheme, either through the website ( https://yellowcard.mhra.gov.uk ) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
