LONDON, Jan. 22 -- The government of the United Kingdom issued the following news:
Prescribingrequirements for isotretinoin, a treatment for severe acne, are being updated by the Medicines and Healthcare products Regulatory Agency tostrengthen its ability tomonitorsafe prescribing whilesupporting patient access to treatment. The updated approachfollows independent advice fromtheCommission of Human Medicines (CHM)whichcarried outa review of the impact of the existing safety measures for the prescribing of isotretinoin.
Isotretinoin isused primarily where there is a risk of permanent scarring and other treatments have not worked. Followingadvice fromthe 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 thatsafety measures are working well, with healthcare professionals now spending more time discussing the benefits and risks of isotretinoin with patients andmonitoringthem more closely for side effects. However, therequirement for treatmentofyoungpeople under 18 to be agreed bytwo-prescriberswas found to be causing potential delays in access to treatment for someunder-18s, with minimal evidence of disagreement between prescribers about treatment decisions.
Given this evidence, the CHM hasrecommendedthat healthcare professionals can prescribe isotretinoin to under-18s withoutseeking the agreement ofa second prescriber, ensuring young people with severe acne benefit from both safer and moretimelyaccessto 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 updatedAcknowledgement ofRiskFormto help healthcare professionals implement the current requirementsfor isotretinoinmore effectively.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Theupdated safety measureswillensure patients who needisotretinoin for the treatment of severe acne are able to access it when it is needed,whileensuring that robust oversightof patient safetyremainsin placethroughout treatmentand 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 treatmentoption.That'swhyit'simportant patientscanaccess this treatment both safely, and in a timely manner.
As part of its wider impact review, the CHMconsidered the results of an October 2025surveycompleted byboth private and NHS prescriberswhichprovided assurance that most services are following current prescribing requirements andevidence thatthe majority ofcurrent measures are beingadhered to.These responses provided reassurance that changes could be made.
Dermatology serviceshave also agreed to take part in future clinical audits run by the British Association of Dermatologists (BAD), and audit data will be regularlysubmittedto the MHRA, strengtheningitsability tomonitorthe safety of isotretinoin prescribing across the UK.This was a critical factorin theconsiderationsof the CHM.
All other existing safety measuresput in place in 2023will remain ineffect, including the need for patients and their healthcare professional to signanAcknowledgementof RiskForm before starting treatment and the requirement for healthcare professionals toadvisepatients on the risks of side effects.Additionally, a patient videohas beendeveloped bytheBAD to further inform patients of potential side effects and when isotretinoin should andshouldnotbe used.
The MHRA expects all prescribers, including those in the private sector,tocomply fully with risk minimisation measures.Dermatology serviceswill be subject to regular audits and further regulatory action will be considered if compliance is notmaintained.
The changestake effectimmediately. Healthcare professionals and patients can find more informationin theDrug Safety Update.
Anyone who suspects that they are experiencing a side effect from isotretinoin isadvised tospeakto a healthcare professional and report it directly to theMHRA Yellow Card scheme."
Notes to editors
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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating all medicines and medical devices in the UK by ensuring they work and areacceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy, and quality of medicinal products.
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Suspected side effects or adverse drug reactions to any medicines should be reported to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
