ADR that result in revision of patient information
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| The United Kingdom: Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health and sexual function issues.
In Apr 2023, the Commission on Human Medicines (CHM) published recommendations following its review of mental health and sexual side effects suspected to be associated with isotretinoin. The review considered all the available evidence, including information from patients and their families, and recommended new measures to strengthen the safety of isotretinoin treatment.
The product information for isotretinoin medicines has been updated following the review’s recommendations. This includes the addition of new warnings and precautions on potential mental health and sexual function side effects to the product information and the requirement for 2 healthcare professionals to agree that there is no other appropriate effective treatment in patients under 18 years of age.
Following its review, the CHM formed an Isotretinoin Implementation Advisory Expert Working Group, composed of experts and representatives of the healthcare organisations to advise on how best to implement the recommendations in clinical practice. The CHM endorsed the guidance from the Isotretinoin Implementation Advisory Expert Working Group.
The Isotretinoin Implementation Advisory Expert Working Group has worked with MHRA to develop guidance specifying which healthcare professionals have the appropriate expertise to be the Lead Prescriber (who makes the decision to initiate isotretinoin treatment); Second Approved Named Healthcare Professional (who agrees that isotretinoin is the most appropriate treatment option for adolescents under 18 years of age); and Follow-Up Prescriber (responsible for continuing and monitoring isotretinoin treatment). The Lead Prescriber must have expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. The Isotretinoin Implementation Advisory Expert Working Group also developed guidance on the assessment and monitoring of mental health and sexual function.
New compulsory regulatory risk minimisation materials have been developed for use with all patients consisting of an Acknowledgement of Risk Form, a Patient Reminder Card and a Pharmacist Checklist. These are available electronically and will be sent to relevant healthcare professionals by post.
The Acknowledgment of Risk Form must be completed with all patients initiating isotretinoin treatment. The new Acknowledgment of Risk Form has been developed to continue to record the patient’s acknowledgment of the known risk of harm to unborn babies during pregnancy; record acknowledgment of other risks including possible mental health and sexual function side effects; continue to record enrolment onto the revised Pregnancy Prevention Programme if the patient is of childbearing potential; and record the agreement of 2 independent healthcare professionals that there is no other appropriate effective treatment in patients under 18 years of age.
Advice for healthcare professionals:
- All patients must be counselled about the benefits and risks of treatment before isotretinoin is prescribed, including possible mental health and sexual function side effects; MHRA also asks the referrer (usually the general practitioner) to provide information about isotretinoin to the patient and provide counselling (where possible) regarding the benefits and risks of isotretinoin treatment.
- Isotretinoin is teratogenic; all patients of childbearing potential must be entered into the Pregnancy Prevention Programme.
- Prescribers should assess patients’ mental health before prescribing isotretinoin including the use of patient-reported outcome measures.
- Ask patients about any sexual function concerns before prescribing isotretinoin.
- Give the patient sufficient time to consider, reflect and ask questions before starting isotretinoin treatment.
- Use the new regulatory risk minimisation materials with all patients: Acknowledgement of Risk Form, Patient Reminder Card and Pharmacist Checklist.
- The Lead Prescriber, who initiates isotretinoin treatment, must have expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.
- Initiation of isotretinoin treatment in patients under 18 years of age now requires agreement by 2 independent healthcare professionals that there is no other appropriate effective treatment before it is prescribed. This means that isotretinoin should only be prescribed for severe acne that is resistant to adequate courses of standard therapy.
- Review patients approximately 1 month after initiation of treatment in a face-to-face (in-person) appointment.
- Monitor patients for side effects including mental health and sexual function side effects at each follow up appointment including objective mental health patient reported outcome measures.
- Any healthcare professional involved in the treatment of patients with acne, particularly prescribers of isotretinoin, should review the full details of the new requirements in the Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/isotretinoin-roaccutanev-introduction-of-new-safety-measures-including-additional-oversight-of-the-initiation-of-treatment-for-patients-under-18-years-of-age
In Hong Kong, there are 11 registered pharmaceutical products containing isotretinoin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction on isotretinoin, but these cases were not related to mental health or sexual function side effects.
Related news was previously issued by MHRA, and was posted on the Drug Office website since 27 Oct 2017, with the latest update posted on 27 Apr 2023. Letters to inform local healthcare professionals were issued by the DH on 27 Oct 2017 and 27 Apr 2023.
Currently, the sales pack or package insert of locally registered isotretinoin-containing products should include warnings on suicide, suicidal attempts and sexual dysfunction including erectile dysfunction and decreased libido.
As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Nov 1, 2023
Issued at HKT 14:00
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