UK Regulatory Agency Removes Two-Prescriber Requirement for Isotretinoin in Under-18 Patients
核心洞察
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has eliminated the requirement for two prescribers to agree before initiating isotretinoin therapy in patients under 18 years old, following a comprehensive review by the Commission on Human Medicines (搜索).
The change addresses treatment delays for young patients with severe acne (搜索) while maintaining safety through alternative risk minimization measures including enhanced acknowledgment forms, clinical audits, and patient education videos.
All other existing safety measures from 2023 remain in place, with dermatology services committing to regular clinical audits conducted by the British Association of Dermatologists (搜索) to ensure continued oversight of prescribing practices.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has removed the requirement for two independent prescribers to agree before initiating isotretinoin therapy in patients under 18 years old, following a comprehensive review that found the measure was causing treatment delays with minimal clinical benefit.
The decision, based on recommendations from the Commission on Human Medicines (搜索) (CHM), takes effect immediately and allows healthcare professionals to prescribe isotretinoin to under-18 patients without seeking agreement from a second prescriber. The change follows a review of safety measures implemented in April 2023 and data from an October 2025 survey of dermatology services.
Review Findings Drive Regulatory Changes
The CHM's review found that while safety measures introduced in 2023 were working well—with healthcare professionals spending more time discussing benefits and risks with patients—the two-prescriber requirement was creating potential delays in treatment access for young patients. The review revealed minimal evidence of disagreement between prescribers about treatment decisions, suggesting the requirement provided limited additional safety benefit.
"The updated safety measures will ensure patients who need isotretinoin for the treatment of severe acne (搜索) are able to access it when it is needed, while ensuring that robust oversight of patient safety remains in place throughout treatment," said Dr. Alison Cave, MHRA Chief Safety Officer.
The CHM considered that positive structural changes had been made to clinical pathways to improve patient counselling and monitoring. The commission also noted the limited treatment options for severe acne (搜索), which meant there was little disagreement between prescribers regarding isotretinoin treatment.
Enhanced Risk Minimization Measures Implemented
To replace the two-prescriber requirement, the MHRA has introduced several alternative risk minimization measures. These include an enhanced Acknowledgment of Risk Form, which is now available in digital format and should be used in clinical practice as soon as feasible. Hardcopies will be available from Marketing Authorisation Holders in the coming months.
A regular clinical audit of risk minimization measures will be developed and implemented by the British Association of Dermatologists (搜索) (BAD), with healthcare professionals expected to fully engage in the clinical audit process beginning in 2026. The October 2025 survey found that 97% of dermatology services agreed to participate in future clinical audits, providing the CHM with confidence to recommend removing the two-prescriber requirement.
The BAD has also produced a patient information video, with oversight from the MHRA and CHM, to explain the risks associated with isotretinoin treatment in an accessible format. Healthcare professionals should advise patients to watch the video prior to starting treatment, and patients must confirm their awareness of the video on the Acknowledgment of Risk Form.
Continued Safety Oversight and Monitoring
All other existing safety measures implemented in 2023 remain in effect, including the requirement for patients and healthcare professionals to sign an Acknowledgment of Risk Form before starting treatment. The MHRA expects all prescribers, including those in the private sector, to comply fully with risk minimization measures.
With each audit, information will be gathered by the BAD and submitted to the CHM for review. If evidence emerges that services are not following the risk minimization measures in place for isotretinoin, further regulatory measures will be considered.
The changes align with approaches taken by other international regulatory bodies and ensure that patients can still request a second opinion from another prescriber if they want reassurance that isotretinoin is the best treatment option for them.
Concerns about private practice adherence to regulations and limitations in available data from this sector were noted during the review. The October 2025 survey was conducted specifically to improve oversight of prescribing practices, including in the private sector.
Clinical Impact and Patient Access
Isotretinoin is used primarily for severe acne (搜索) where there is a risk of permanent scarring and other treatments have not worked. The medication can have a significant impact on patients' mental wellbeing and may be the only effective treatment option for individuals with severe acne.
The regulatory changes are designed to strengthen the MHRA's ability to monitor safe prescribing while supporting patient access to treatment. Healthcare professionals, patients, and caregivers are encouraged to continue reporting suspected adverse drug reactions through the Yellow Card scheme.