UK Regulatory Agency Places New Restrictions on Isotretinoin Prescribing

Oct 31, 2023 | Blog, Uncategorized

Most teens in the UK will need sign-off from two healthcare professionals before they can receive isotretinoin for severe acne, according to new regulations enacted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). Other safety measures introduced October 31 include updated patient information on potential risks of isotretinoin therapy and mandatory in-person assessments of patients’ mental and sexual health prior to initiation of therapy.

MHRA says that The Commission on Human Medicine’s Isotretinoin Implementation Expert Advisory Working Group, comprised of experts from fields including dermatology, general practice, and psychiatry, advised the Agency on the new measures. The British Association of Dermatologists, the British Dermatological Nursing Group, and other stakeholders have produced supplementary documents to assist clinicians in adhering to the new guidelines.

Under new measures, individuals 12 years of age up to age 18 will be assessed by a second healthcare professional in addition to the Lead Prescriber—a dermatologist. This second healthcare professional will independently assess the patient and determine whether isotretinoin is the only appropriate effective treatment. Roles and responsibilities of the two prescribers are fully described in a final report.

MHRA, an executive agency of the UK’s Department of Health and Social Care, is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

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