Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that Integrated Care Boards monitor implementation of MHRA safety alerts on Topical Steroid Withdrawal across GP practices and community pharmacies.

NHS England is not aware that the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a National Patient Safety Alert on topical steroid withdrawal (TSW). NHS England's Patient safety team issued this National Patient Safety Alert in 2020, and it is avaiable at the following link:

https://www.england.nhs.uk/2020/08/steroid-emergency-card-to-support-early-recognition-and-treatment-of-adrenal-crisis-in-adults/

The safety alert mentions topical steroids, although they are not the focus of the alert. These alerts are a contractual requirement as set out in clause 33.8 of the NHS Standard Contract and so integrated care boards are expected to include consideration of these as part of their wider commissioning responsibilities.

The Care Quality Commission Regulation 12: Safe care and treatment' in Guidance on 12(2)(b) states that “Providers must comply with relevant Patient Safety Alerts, recalls and rapid response reports issued from the Medicines and Healthcare products Regulatory Agency (MHRA) and through the Central Alerting System”. Further information is avaiable at the following link:

https://www.cqc.org.uk/guidance-regulation/providers/regulations-service-providers-and-managers/health-social-care-act/regulation-12#:~:text=Guidance%20on%2012(2)(b)

Additionally, general practitioners are included, with further information is avaiable at the following link:

https://www.cqc.org.uk/guidance-providers/gps/gp-mythbusters/gp-mythbuster-91-patient-safety-alerts

In 2021, the MHRA published a Public Assessment Report (PAR), reviewing the available evidence for TSW reactions. This PAR is avaiable at the following link:

https://www.gov.uk/government/publications/topical-steroid-withdrawal-reactions-a-review-of-the-evidence

The PAR resulted in two Drug Safety Updates in 2021 and 2024 which aimed to raise awareness on the risk of TSW reactions and introduce new labelling. Both updates are available, respectively, at the following two links:

https://www.gov.uk/drug-safety-update/topical-corticosteroids-information-on-the-risk-of-topical-steroid-withdrawal-reactions

https://www.gov.uk/drug-safety-update/topical-steroids-introduction-of-new-labelling-and-a-reminder-of-the-possibility-of-severe-side-effects-including-topical-steroid-withdrawal-reactions