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From the World of Pharmacovigilance: Strengthening of risk minimisation measures for isotretinoin

Treatment with isotretinoin for patients under 18 must be approved by two prescribers

The UK medicines regulator, the MHRA, has recently announced a tightening of requirements for the use of the acne medication, isotretinoin, in order to ensure the safety of the medicine.1 In this blog we explain the background to this decision and consider it in the context of pharmacovigilance requirements.

Isotretinoin is licensed in the EU and UK for the treatment of acne that is severe or has a risk of permanent scarring and in cases where standard treatment is not adequate. Although isotretinoin is an effective treatment for acne in these circumstances, it is a retinoid and in common with all retinoids, it is a teratogenic substance. Consequently, the drug is contraindicated for use during pregnancy and is subject to robust pregnancy prevention measures. The MHRA’s announcement on 31st October 2023 proposed three additional safety measures in response to concerns raised by patients and the public about potential psychiatric and sexual side effects of isotretinoin:

  • Additional oversight for patients under 18

Prescribing of isotretinoin to patients under 18 must be undertaken by a specialist dermatologist and agreed by a second healthcare professional (HCP). Both HCPs should independently evaluate whether the patient satisfies the criteria to receive the drug, that is, having severe acne or risk of permanent scarring where standard treatment is not effective.

  • Better information on potential risks

Product information will be updated with further detail about the risks of isotretinoin, including the need for HCPs to explain the potential psychiatric and sexual side effects to patients.

  • Improved monitoring and assessment of mental health and sexual wellbeing

Patients’ mental and sexual wellbeing must be assessed in person before isotretinoin can be prescribed. Patients who receive isotretinoin will be monitored for side effects during subsequent appointments.

Additional Risk minimisation Measures

Risk minimisation measures (RMMs) proposed in the Risk Management Plan (RMP) can be divided into routine RMMs and additional RMMs.  Additional RMMs for isotretinoin include a pregnancy prevention plan and the use of a Dear Healthcare Professional Communication to request that prescribers put in place monitoring of patients for signs of depression. Once implemented, the effectiveness of additional RMMs are monitored, both in terms of process and outcomes. If existing RMMs are found to be ineffective for controlling a risk, they may be improved in a number of ways. The MHRA’s recent announcement is an example of strengthening of RMMs where current RMMs are not reducing the identified risk to an acceptable extent.

Liz Lynn and Saad Shakir

Reference

  1. Press Release: Treatment with isotretinoin for patients under 18 must be approved by two prescribers, under new MHRA rules. MHRA, 31st October 2023 https://www.gov.uk/government/news/treatment-with-isotretinoin-for-patients-under-18-must-be-approved-by-two-prescribers-under-new-mhra-rules. Accessed 7th December 2023