Isotretinoin – changes to prescribing guidance and additional risk minimisation measures

The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. 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The second prescriber regulatory requirement for patients under 18 years of age has been replaced by alternative risk minimisation measures. The product information for isotretinoin will be updated over the coming months to reflect this change. Services can implement this change immediately, although the CHM acknowledge that some transition time may be required.

New Risk Minimisation Measures

Alternative risk minimisation measures have been introduced to ensure isotretinoin continues to be prescribed and dispensed safely and all other existing risk minimisation measures continue to remain in place. The updated approach is designed to strengthen the Medicines and Healthcare products Regulatory Agency’s (MHRA) ability to monitor safe prescribing while supporting patient access to treatment. These measures are:

• The 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 CHM, to explain the risks associated with isotretinoin treatment in an accessible format.

Further information and advice can be found on the Drug Safety Update.