New regulatory guidance for prescribing isotretinoin published on 31st Oct
November 1, 2023
The Commission on Human Medicines (CHM) Isotretinoin Implementation Advisory Expert Working Group (IIAEWG) report and MHRA Drug safety update for isotretinoin were published on 31st Oct 2023.
Changes to current practice are required for all healthcare professionals involved in isotretinoin prescribing, in order to meet the new regulatory guidance. There are particular implications for those prescribing for under 18s, including agreement by 2 healthcare professionals that it is the most appropriate treatment before it is prescribed.
The BSPAD are in agreement with the British Association of Dermatologists (BAD) that it may take a month to introduce the risk minimisation materials and that the requirement for a second approved named HCP for prescribing isotretinoin for patients under 18 years old may take longer to embed, up to 6 months.
We understand the changes will be challenging and the BAD and the BSPAD share your concerns. The BAD has created an isotretinoin clinical resources page on the BAD website here, which has all the new compulsory risk minimisation materials, patient information (including an isotretinoin guide for young people) and a number of implementation tools to support healthcare professionals to make the required changes. There are 5 training videos including one specifically about prescribing for under 18s. There is also a ‘Frequently Asked Questions’ page which we hope provides useful information. This will be monitored ongoing and feedback from members will be key to this process.