Research and analysis

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

Report of 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.

• From: Commission on Human Medicines and Medicines and Healthcare products Regulatory Agency
• Published: 31 October 2023
• Last updated: 8 February 2024 — See all updates

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

PDF, 625 KB, 38 pages

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Details

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 - 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.

Published 31 October 2023
Last updated 8 February 2024 + show all updates

1. 8 February 2024

   Addendum (February 2024) section has been added to the main page

2. 31 October 2023

   First published.