The prescribing requirements for isotretinoin have been updated by the Medicines and Healthcare products Regulatory Agency (MHRA) with the aim of strengthening patient safety while improving access to treatment.
The changes, outlined in an MHRA drug safety update, follow an impact review of enhanced safety measures introduced in April 2023, alongside independent advice from the Commission on Human Medicines (CHM).
Isotretinoin is typically prescribed where acne has been resistant to other treatments or where there is a risk of permanent scarring. The 2023 measures were designed to ensure patients were made aware of the drug’s benefits and risks and to monitor for potential side effects, including sexual health and severe mental health concerns.
Healthcare professionals reported that the measures were generally working well, with more thorough patient discussions and closer monitoring. However, the CHM identified that a specific element requiring two prescribers to agree on treatment for patients under the age of 18 had the unintended consequence of delaying access for some young people, without clear evidence of added safety benefit.
Second prescriber requirement removed
In response, the CHM recommended removing the requirement for agreement from a second prescriber for under-18s, which forms the basis of the MHRA’s updated prescribing requirements.
Under the updated approach, prescribers can initiate isotretinoin treatment for young people without seeking a second prescriber’s sign-off, bringing the UK in line with practices adopted by other regulatory bodies internationally.
New risk minimisation measures include a streamlined Acknowledgement of Risk Form for all patients, which asks patients to confirm their understanding of the indication for isotretinoin and gives prescribers the opportunity to confirm that no appropriate alternative treatments are available. This should be ‘used in clinical practice as soon as is feasible’, the drug safety update said.
Patients and their families still retain the option to request a second opinion on an isotretinoin prescription if they want further reassurance about treatment decisions, and this is outlined on the updated form.
Commenting on the announcement, 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.’
Isotretinoin prescribing changes in practice
The MHRA expects full compliance from prescribers across the NHS and private sector, and regular audits will strengthen oversight of safe prescribing practices across the UK.
These audits will be developed and carried out by the British Association of Dermatologists (BAD) and the information gathered will be submitted to the CHM for review.
‘If there is evidence that services are not following the risk minimisation measures in place for isotretinoin, further regulatory measures will need to be considered,’ the drug safety update said.
The BAD has also developed a patient information video to support patients’ understanding of the risks associated with isotretinoin. Healthcare professionals should advise patients to watch the video prior to starting treatment and may wish to send them a link to the video before their initial appointment.
The risk-minimisation measures introduced in 2023 and the updates and clarifications made in October 2025 to maintain safe isotretinoin prescribing and support clinical oversight must continue to be followed, the MHRA added.
This article was originally published by our sister publication Hospital Healthcare Europe.
