Prescribing requirements for isotretinoin, a treatment for
severe acne, are being updated by the Medicines and Healthcare
products Regulatory Agency to strengthen its ability
to monitor safe prescribing while supporting
patient access to treatment. The updated approach follows
independent advice from the Commission of Human
Medicines (CHM) which carried out a review of the
impact of the existing safety measures for the prescribing of
isotretinoin.
Isotretinoin is used primarily where there is a risk of
permanent scarring and other treatments have not worked.
Following advice from the CHM's Isotretinoin Expert
Working Group and the Isotretinoin Implementation Advisory Expert
Working Group, the MHRA introduced enhanced safety measures in
April 2023 and committed to reviewing their impact.
The review found that safety measures are working well, with
healthcare professionals now spending more time discussing the
benefits and risks of isotretinoin with patients
and monitoring them more closely for side effects.
However, the requirement for
treatment of young people under 18 to be agreed
by two-prescribers was found to be causing potential
delays in access to treatment for some under-18s, with
minimal evidence of disagreement between prescribers about
treatment decisions.
Given this evidence, the CHM has recommended that
healthcare professionals can prescribe isotretinoin to under-18s
without seeking the agreement of a second prescriber,
ensuring young people with severe acne benefit from both safer
and more timely access to treatment. This is
in line with the approach taken by other international regulatory
bodies.
Patients can still request a second opinion from another
prescriber if they want to be reassured that isotretinoin is the
best treatment for them.
The CHM also recently endorsed updated advice on face-to-face
follow-up consultations, pregnancy testing, and sexual health
discussions, alongside an updated Acknowledgement
of Risk Form to help healthcare professionals
implement the current requirements for
isotretinoin more effectively.
Dr Alison Cave, MHRA Chief Safety Officer,
said:
The updated safety measures will ensure patients
who need isotretinoin for the treatment of severe acne are
able to access it when it is needed, while ensuring
that robust oversight of patient safety remains in
place throughout treatment and that patients are well
informed of the risks before starting treatment.
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.
As part of its wider impact review, the CHM considered the
results of an October 2025 survey completed
by both private and NHS prescribers which provided
assurance that most services are following current prescribing
requirements and evidence that the majority
of current measures are being adhered to. These
responses provided reassurance that changes could be made.
Dermatology services have also agreed to take part in future
clinical audits run by the British Association of Dermatologists
(BAD), and audit data will be regularly submitted to
the MHRA, strengthening its ability
to monitor the safety of isotretinoin prescribing
across the UK. This was a critical factor in
the considerations of the CHM.
All other existing safety measures put in place in
2023 will remain in effect, including the need for
patients and their healthcare professional to
sign an Acknowledgement of Risk Form before
starting treatment and the requirement for healthcare
professionals to advise patients on the risks of side
effects. Additionally, a patient video has
been developed by the BAD to further inform
patients of potential side effects and when isotretinoin should
and should not be used.
The MHRA expects all prescribers, including those in the private
sector, to comply fully with risk minimisation
measures. Dermatology services will be subject to
regular audits and further regulatory action will be considered
if compliance is not maintained.
The changes take effect immediately. Healthcare
professionals and patients can find more information in
the Drug Safety
Update.
Anyone who suspects that they are experiencing a side effect from
isotretinoin is advised to speak to a healthcare
professional and report it directly to the MHRA Yellow Card
scheme.”
