Research: Report of the Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group

Report of the Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.

This file may not be suitable for users of assistive technology.

The Commission on Human Medicines (CHM) and its Isotretinoin Expert Working Group (IEWG) published their independent report in April 2023. A number of recommendations were made with the aim of improving the safety of isotretinoin for the treatment of acne.

The CHM recognised that implementation would require changes in organisational structures, regulatory advice, and clinical care and therefore set up a multi-disciplinary Isotretinoin Implementation Advisory Expert Working Group (IIAEWG), to advise on the best way to implement the recommendations. The IIAEWG was tasked with reporting to the CHM with their suggestions.

This report of the IIAEWG is aimed at all stakeholders involved in the use of isotretinoin, including patients, parents, healthcare professionals, healthcare organisations/providers and regulatory authorities.

For further information about the review and implementation of the recommendations, see the MHRA website.

The CHM has recommended an updated approach to the prescribing requirements for isotretinoin:

The second prescriber regulatory requirement for patients under 18 years of age has been replaced by alternative risk minimisation measures.  

The Acknowledgement of Risk Form for all patients has been updated. The revised Acknowledgement of Risk Form: 

a) Asks the patient to confirm that they understand the therapeutic indication of isotretinoin. The prescriber is also asked to confirm that isotretinoin is clinically indicated for the patient and that there is no other appropriate effective treatment. This provides additional safeguards on appropriate prescribing for all patients