The Medicines and Healthcare Products Regulatory Agency (MHRA) has reviewed the impact of the implementation of the recommendations for isotretinoin advised by the Commission on Human Medicines (CHM) in 2023.

Changes to isotretinoin prescribing advice

• Follow-up consultations do not necessarily need to be in person (face-to-face) and could be remote if appropriate, however the first appointment should be in person (refer to the British Association of Dermatologists’ (BAD) remote follow-up guidance for further information).
• Medically supervised pregnancy testing may be performed remotely with appropriate oversight to ensure tests are performed correctly and safely (refer to the BAD remote pregnancy testing guidance for further information).
• Patients should be asked about sexual function at follow-up appointments, although by the third appointment, this may be brief (refer to the BAD Sexual function guidance for further information).

Clinicians are reminded that isotretinoin is NCL red-listed. 

The NCL Red List contains medicines that are on hospital formularies but owing to their specialty, safety or monitoring requirements, GPs should not be asked to continue the prescribing in primary care. The responsibility for prescribing these medicines should remain with the hospital specialist.

Regular review of the patient is essential to determine whether continued prescribing is safe and appropriate in primary care.

Prescribing by secondary care is approved as part of the NCL Primary Care Acne Vulgaris Pathway, applicable to trusts with relevant services or for continuation (JFC May 2023).

Important safety measures apply, including the Pregnancy Prevention Programme (PPP) for females of child-bearing potential. 

See the full MHRA Drug Safety Update for more information.