Key Summary
- MHRA has refined isotretinoin prescribing to improve access while keeping safety tight.
- Doctors no longer need a second prescriber, reducing delays for young patients.
- All other safeguards, risk forms and monitoring remain in place.
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the prescribing rules for isotretinoin, used to treat severe acne, to strengthen its ability to monitor safe prescribing.
This is being done following a review of the existing safety measures, introduced by the MHRA in 2023, to prescribe isotretinoin by the Commission of Human Medicines (CHM).
The enhanced safety measures were introduced by MHRA following advice from the CHM’s Isotretinoin Expert Working Group and the Isotretinoin Implementation Advisory Expert Working Group.
The CHM review found that safety measures were working, but recommended that healthcare professionals be allowed to prescribe isotretinoin to under-18s, without seeking the agreement of a second prescriber.
The commission found that it was causing delays, though there was little evidence of disagreement between the two prescribers about treatment decisions.
Patients can still request a second opinion from another prescriber if they want to be reassured about isotretinoin’s efficacy.
All other existing safety measures will remain.
This includes the need for patients and healthcare professional to sign an Acknowledgement of Risk Form before starting treatment and for healthcare professionals to advise patients on the risks of side effects.
The British Association of Dermatologists (BAD) has developed a video informing patients of potential side effects of isotretinoin, and when it should and should not be used.
The MHRA expects all prescribers, including those in the private sector, to comply fully with risk minimisation measures, and regulatory action will be taken if compliance is not maintained.
MHRA Chief Safety Officer Dr Alison Cave said the updated safety measures will help patients access isotretinoin with a robust safety oversight in place.
“Severe acne can have a significant impact on a patient’s mental wellbeing and can lead to permanent scarring.
“For these individuals, isotretinoin may be the only effective treatment option. That’s why it’s important patients can access this treatment both safely, and in a timely manner.”
