New Prescribing Guidelines for Isotretinoin Aim to Enhance Patient Access and Safety
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced updates to the prescribing rules for isotretinoin, a medication commonly used to treat severe acne. These changes are intended to improve monitoring of safe prescribing while ensuring timely access for patients, particularly those under 18 who require this treatment.
Changes in Prescribing Protocols
Following a review by the Commission on Human Medicines (CHM), it was determined that current safety measures are functioning effectively. Healthcare professionals are now reportedly engaging more with patients about the potential benefits and risks associated with isotretinoin. Nonetheless, the CHM found that the requirement for two prescribers to approve treatment for patients under 18 was causing delays, despite minimal evidence of differences in clinical judgement.
Recommendations from the CHM
The CHM has suggested that healthcare providers be allowed to prescribe isotretinoin to individuals under 18 without needing a second prescriber’s agreement. This decision aligns with practices adopted by other global regulatory bodies, aimed at facilitating quicker access to the medicine for adolescents suffering from severe acne.
Patients will still retain the option to seek a second opinion if they wish to confirm that isotretinoin is the appropriate treatment for them.
Updated Safety Measures and Ongoing Monitoring
In addition to the new prescribing guidelines, the CHM has endorsed updated recommendations regarding face-to-face consultations, pregnancy testing procedures, and sexual health discussions. The introduction of an updated Acknowledgement of Risk Form is expected to assist healthcare professionals in complying with current isotretinoin requirements more effectively.
Insights from Dr Alison Cave
Dr Alison Cave, MHRA Chief Safety Officer, commented that these updated measures are designed to facilitate access to isotretinoin for patients while maintaining robust oversight for patient safety. Severe acne poses significant mental health challenges and the risk of permanent scarring, making timely access to effective treatment essential.
Commitment to Ongoing Audits and Compliance
As part of the review, results from a survey conducted in October 2025 revealed that most private and NHS prescribers are adhering to current prescribing protocols. Based on this encouraging feedback, the CHM has decided to implement these changes. Furthermore, dermatology services have consented to participate in periodic clinical audits overseen by the British Association of Dermatologists (BAD), ensuring continued evaluation of isotretinoin’s safety across the UK.
All existing safety protocols established in 2023 will remain in force. These include the necessity for both patients and healthcare professionals to sign the Acknowledgement of Risk Form before treatment initiation, as well as informing patients about potential side effects. A patient video produced by the BAD will serve to further educate individuals about when isotretinoin is appropriate and the risks involved.
Looking Ahead
The MHRA expects comprehensive compliance from all prescribers, including those operating in the private sector. Regular audits will be conducted, and any non-compliance may prompt further regulatory measures.
These updated guidelines are effective immediately, with additional information available through the MHRA’s Drug Safety Update.
For anyone experiencing side effects from isotretinoin, contacting a healthcare professional is advised, and adverse reactions can be reported via the MHRA Yellow Card scheme.
Source: official statements, news agencies, and public reports.
https://www.gov.uk/government/news/isotretinoin-prescribing-requirements-updated-with-revised-risk-minimisation-measures
