Isotretinoin Clinical Resources
On this page, you can find a range of resources that have been developed to help healthcare professionals, clinical leads and managers understand and implement the new safety measures for isotretinoin prescribing. In addition, there are a number of patient information resources which healthcare professionals should be aware of.
For queries and feedback relating to the principles of these regulatory changes, please email the MHRA directly (info@mhra.gov.uk). For queries and feedback relating to the documents and tools produced by the BAD to support members in implementing these regulatory changes please email the BAD’s Clinical Standards Unit (clinicalstandards@bad.org.uk).
CHM/MHRA Resources
Two reports were produced by the Commission of Human Medicines (CHM) and the Medicines Healthcare product Regulatory Agency (MHRA) which form the basis of the new regulatory position. The first outlines the evidence reviewed and the key recommendations regarding isotretinoin. The second reviewed how these recommendations could be implemented in practice. The MHRA has also published its Drugs Safety Update for isotretinoin.
Market Authorisation Holders Compulsory Risk Minimisation Materials
The MAHs, at the request of the MHRA have produced a range of materials that are required to implement the new safety measures, which are linked below.
BAD Clinical Resources
The BAD has produced a number of documents that can help healthcare professionals get to grips with the new safety measures. Some of these can be adapted for local use – click here for the Word version for all BAD clinical resources.
Other Resources
Patient Information
It is a requirement that patients are given age-appropriate information prior to the prescription of isotretinoin. Below you can find links to a range of patient information resources which patients may find useful, in addition to the patient information leaflet product insert.
Video Resources
To help you interpret the report, the BDNG, BAD, and PCDS have produced a series of five short training videos covering all aspects of isotretinoin prescribing under the new regulatory position.
Frequently Asked Questions
These frequently asked questions have been developed to support HCPs in implementing the new safety measures for isotretinoin.
