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

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.

Addendum - 22 January 2026

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• The second prescriber regulatory requirement for patients under 18 years of age has been replaced by alternative risk minimisation measures.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

b) Asks the patient to confirm that they understand they can seek a second opinion about their treatment

c) Has been streamlined to fit two pages

• 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 the BAD with oversight from the MHRA and CHM, to explain the risks associated with isotretinoin treatment in an accessible format. Healthcare professionals should advise patients to watch the video prior to starting treatment. Patients will need to confirm they are aware of the video on the Acknowledgement of Risk Form

All existing measures detailed in the report and the addendums below should continue to be in place.

For further information, please refer to our Drug Safety Update

Addendum - 27 October 2025

The CHM endorsed updated guidance on recommendations of the Commission on Human Medicines (CHM) Implementation Advisory Expert Working Group (IIAEWG):

Follow-up consultation guidance

The Commission on Human Medicines (CHM) endorsed changes to the IIAEWG recommendations that follow-up consultations do not necessarily need to be in person (face to face) and could be remote if appropriate. It was emphasised that this should be discussed and agreed with the patient and should take into account the clinical assessment, the patient's needs and preferences and safeguarding considerations. Prescribers should be mindful of professional standards and best practice (e.g. GMC guidance, guidance from professional bodies, and other relevant guidelines and local polices). The initial consultation should continue to be in person.

Updated BAD guidance for follow-up appointments during isotretinoin treatment (October 2025)

Remote pregnancy testing

The CHM advised that remote pregnancy testing may be regarded as a medically supervised test with appropriate guidance and oversight, to ensure tests are performed correctly and safely. The CHM advised that this recommendation was conditional on regular national clinical audits led by the British Association of Dermatologists (BAD) to monitor compliance to the SmPC and for BAD to develop clinical guidance on remote pregnancy testing.

Updated BAD guidance for remote pregnancy testing during isotretinoin treatment (October 2025)

Monitoring of sexual dysfunction

The CHM advised that patients should continue to be asked about sexual function at follow up appointments, although by the third appointment this may be brief. The CHM noted this monitoring was particularly important as the timeframe of onset of sexual function side effects is not known and has been reported to persist after treatment has completed.

Updated BAD guidance for monitoring sexual function during isotretinoin treatment (October 2025)

Addendum - February 2024

The Commission on Human Medicines (CHM) has advised that Band 7 Dermatology Clinical Nurse Specialists can be included as suitable Lead Prescribers in order to support trusts implementing the new regulatory requirements for isotretinoin. A Lead Prescriber is the healthcare professional who makes the decision to initiate isotretinoin treatment. (See section 2.1.1. Lead Prescriber, Report of Isotretinoin Implementation Advisory Expert Working Group, pages 12-13).

The Band 7 Dermatology Clinical Nurse Specialist must be an independent non-medical prescriber, with evidence of competency in isotretinoin initiation, working under the supervision of one of the clinicians listed below:

1. Consultant Dermatologist
2. Associate Specialist Dermatologist
3. Nationally accredited General Practitioner with an Extended Role (GPwER) working within a Consultant Dermatologist agreed pathway
4. Dermatology Nurse Consultant working within a Consultant Dermatologist agreed and supervised pathway.

The supervising clinician has the overall clinical responsibility for patients. The supervising clinician must be available to advise and assist the Band 7 nurse as appropriate. This is similar to consultant supervision of junior doctors. It is the responsibility of the supervising clinician to ensure that the Band 7 nurse works within their competence, for example only seeing patients with a confirmed diagnosis (please refer to British Dermatological Nursing Group Clinical Dermatology Nursing Role Descriptors). Work-place based assessments should be used to evidence competency in isotretinoin initiation including structured observation of practice and case-based discussions.