Two-prescriber sign-off no longer required for isotretinoin

Healthcare professionals can now prescribe isotretinoin (Roaccutane; Cheplapharm or Reticutan; Ennogen Healthcare) to patients aged under 18 years without needing sign-off from a second prescriber, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

On 22 January 2026, the MHRA said that the removal of the two-prescriber requirement will help young people “benefit from both safer and more timely access to treatment”.

The requirement for a two-prescriber sign-off was implemented following a Commission on Human Medicines (CHM) review of isotretinoin in 2023, after patients had raised concerns about psychiatric and sexual sides effects of the medication.

“There should be greater oversight of isotretinoin treatment in those [aged] under 18 years, including agreement by two healthcare professionals that isotretinoin is the most appropriate treatment option before it is prescribed and that patients and their families have been adequately informed about the potential risks,” the review said.

However, following a CHM review of the new measures, also published on 22 January 2026, the MHRA said that while the measures had been working well, they had led to delays in treatment.

“The requirement for treatment of young people [aged] under 18 [years] 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,” it said.

The MHRA added that patients can still request a second opinion from another prescriber.

Isotretinoin is prescribed for severe acne, where there is a risk of permanent scarring and the patient has not responded to standard treatments, such as antibiotics and topical treatments.

The MHRA also said the acknowledgement of risk form for isotretinoin has been revised. Prescribers are now asked to confirm that isotretinoin is clinically indicated for the patient and that there is no other appropriate effective treatment.

Patients will also be asked to watch a patient information video, produced by the British Association of Dermatologists (BAD) with oversight from the MHRA and the CHM, which explains the risks associated with isotretinoin treatment.  

In addition, the BAD will develop and implement a clinical audit of risk minimisation measures.

Alison Cave, chief safety officer at the MHRA, commented: “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.”

A spokesperson for the BAD said: “The BAD worked closely with the CHM and MHRA over the past two years to provide evidence for their review on the impact of isotretinoin prescribing guidance published in 2023, particularly because it became clear that the two-prescriber requirement was causing delayed access for patients [aged] under 18 [years], and that agreement rates were really high from second prescribers.

“Importantly, patients still always have the right to a second opinion, and we are pleased that this is now explicit in the new acknowledgement of risk form.

“We have produced the patient information video as an accessible way for those being prescribed isotretinoin to understand their medication, particularly people who might have found other information resources less easy to understand,” they added.

In updated guidance, published in October 2025, the CHM’s Isotretinoin Implementation Advisory Expert Working Group said that patients should be asked about mental health and sexual dysfunction side effects at follow-up consultations, which could be held face-to-face or remotely.