Following the Medicines and Healthcare Products Regulatory Agency (MHRA) review of the impact of the 2023 risk minimisation measures for isotretinoin and the October 2025 survey of dermatology services, the Commission on Human Medicines (CHM), has recommended an updated approach to the prescribing requirements for isotretinoin. 

Advice for healthcare professionals

Healthcare professionals are asked to review these new measures and supporting materials and integrate them into their clinical practice:

Second prescriber requirement for under 18s no longer required

The second prescriber regulatory requirement for patients under 18 years of age has been replaced by alternative risk minimisation measures.  

Updated Risk Minimisation Measures

Alternative risk minimisation measures have been introduced to ensure isotretinoin continues to be prescribed and dispensed safely. These measures are:

• the MHRA Acknowledgement of Risk Form for all patients has been updated.
• a clinical audit of risk minimisation measures is to be developed and implemented by the British Association of Dermatologists (BAD).
• a patient information video has been produced by BAD with oversight from the MHRA and the CHM, to explain the risks associated with isotretinoin treatment in an accessible format.

Existing risk minimisation measures continue to remain in place

Including: 

• counselling the patient on mental health and sexual side effects throughout treatment
• patients of child-bearing potential should continue to be entered into the Pregnancy Prevention Programme (MHRA)
• healthcare professionals should continue to use the Patient Reminder Card (MHRA)
• healthcare professionals should continue to use the Pharmacist Checklist (MHRA) 

Refer to the MHRA Drug Safety Update (Jan 26) for full details and advice.

Clinicians are reminded that isotretinoin is included in the NCL Red-List (Oct 25). The NCL Red List contains medicines that are on hospital formularies but owing to their speciality, safety or monitoring requirements, prescribers should not be asked to continue in primary care. 

The NCL Acne vulgaris primary care clinical pathway includes isotretinoin prescribing as a treatment option for secondary use only.