Prescribing\u00a0requirements for isotretinoin, a treatment for severe acne, are being updated by the Medicines and Healthcare products Regulatory Agency to\u00a0strengthen its ability to\u00a0monitor\u00a0safe prescribing while\u00a0supporting patient access to treatment. The updated approach\u00a0follows independent advice from\u00a0the\u00a0Commission of Human Medicines (CHM)\u00a0which\u00a0carried out\u00a0a review of the impact of the existing safety measures for the prescribing of isotretinoin.\u00a0\u00a0<\/p>\n
Isotretinoin is\u00a0used primarily where there is a risk of permanent scarring and other treatments have not worked. Following\u00a0advice from\u00a0the CHM\u2019s 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.\u00a0<\/p>\n
The review found that\u00a0safety measures are working well, with healthcare professionals now spending more time discussing the benefits and risks of isotretinoin with patients and\u00a0monitoring\u00a0them more closely for side effects. However, the\u00a0requirement for treatment\u00a0of\u00a0young\u00a0people under 18 to be agreed by\u00a0two-prescribers\u00a0was found to be causing potential delays in access to treatment for some\u00a0under-18s, with minimal evidence of disagreement between prescribers about treatment decisions.\u00a0<\/p>\n
Given this evidence, the CHM has\u00a0recommended\u00a0that healthcare professionals can prescribe isotretinoin to under-18s without\u00a0seeking the agreement of\u00a0a second prescriber, ensuring young people with severe acne benefit from both safer and more\u00a0timely\u00a0access\u00a0to treatment.\u00a0This is in line with the approach taken by other international regulatory bodies.\u00a0\u00a0<\/p>\n
Patients can still request a second opinion from another prescriber if they want to be reassured that isotretinoin is the best treatment for them.\u00a0<\/p>\n
The CHM also recently endorsed updated advice on face-to-face follow-up consultations, pregnancy testing, and sexual health discussions, alongside an updated\u00a0Acknowledgement of\u00a0Risk\u00a0Form\u00a0to help healthcare professionals implement the current requirements\u00a0for isotretinoin\u00a0more effectively.\u00a0<\/p>\n
Dr Alison Cave, MHRA Chief Safety Officer, said:\u00a0\u00a0<\/p>\n
The\u00a0updated safety measures\u00a0will\u00a0ensure patients who need\u00a0isotretinoin for the treatment of severe acne are able to access it when it is needed,\u00a0while\u00a0ensuring that robust oversight\u00a0of patient safety\u00a0remains\u00a0in place\u00a0throughout treatment\u00a0and that patients are well informed of the risks before starting treatment.\u00a0<\/p>\n
Severe acne can have a significant impact on a patient\u2019s mental wellbeing and can lead to permanent scarring. For these individuals, isotretinoin may be the only effective treatment\u00a0option.\u00a0That\u2019s\u00a0why\u00a0it\u2019s\u00a0important patients\u00a0can\u00a0access this treatment both safely, and in a timely manner.<\/p>\n
As part of its wider impact review, the CHM\u00a0considered the results of an October 2025\u00a0survey\u00a0completed by\u00a0both private and NHS prescribers\u00a0which\u00a0provided assurance that most services are following current prescribing requirements and\u00a0evidence that\u00a0the majority of\u00a0current measures are being\u00a0adhered to.\u00a0These responses provided reassurance that changes could be made.\u00a0<\/p>\n
Dermatology services\u00a0have also agreed to take part in future clinical audits run by the British Association of Dermatologists (BAD), and audit data will be regularly\u00a0submitted\u00a0to the MHRA, strengthening\u00a0its\u00a0ability to\u00a0monitor\u00a0the safety of isotretinoin prescribing across the UK.\u00a0This was a critical factor\u00a0in the\u00a0considerations\u00a0of the CHM.\u00a0<\/p>\n
All other existing safety measures\u00a0put in place in 2023<\/a>\u00a0will remain in\u00a0effect, including the need for patients and their healthcare professional to sign\u00a0an\u00a0Acknowledgement\u00a0of Risk\u00a0Form before starting treatment and the requirement for healthcare professionals to\u00a0advise\u00a0patients on the risks of side effects.\u00a0Additionally, a patient video\u00a0has been\u00a0developed by\u00a0the\u00a0BAD to further inform patients of potential side effects and when isotretinoin should and\u00a0should\u00a0not\u00a0be used.\u00a0<\/p>\n The MHRA expects all prescribers, including those in the private sector,\u00a0to\u00a0comply fully with risk minimisation measures.\u00a0Dermatology services\u00a0will be subject to regular audits and further regulatory action will be considered if compliance is not\u00a0maintained.\u00a0<\/p>\n The changes\u00a0take effect\u00a0immediately. Healthcare professionals and patients can find more information\u00a0in the\u00a0Drug Safety Update<\/a>.\u00a0<\/p>\n Anyone who suspects that they are experiencing a side effect from isotretinoin is\u00a0advised to\u00a0speak\u00a0to a healthcare professional and report it directly to the\u00a0MHRA Yellow Card scheme<\/a>.\u201d\u00a0<\/p>\n Notes to editors\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is responsible for\u00a0regulating all medicines and medical devices in the UK by ensuring they work and are\u00a0acceptably safe.\u202f All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.\u202f\u202f\u202f\u202f\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u202f\u202f\u202f\u00a0<\/p>\n The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy, and quality of medicinal products.\u00a0<\/p>\n