Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of Yellow Card reporting for capturing cases of Topical Steroid Withdrawal.

Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.

In 2021, the MHRA published a Public Assessment Report (PAR), reviewing the available evidence for topical steroid withdrawal (TSW) reactions, which can be found at the following link:

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

To inform this report, a comprehensive review of the available evidence was undertaken. This included an assessment of data from Yellow Card reports to identify suspected spontaneous cases of TSW reactions associated with topical corticosteroids on the Yellow Card database, as well as information from the published literature and other medicines regulators. The review considered whether regulatory action was required to minimise the risk of these events.

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

The MHRA uses the Medical Dictionary for Regulatory Activities (MedDRA) to code suspected adverse drug reactions reported by patients and healthcare professionals via the Yellow Card scheme. MedDRA is an international, clinically validated medical terminology used by regulatory authorities and the biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing safety monitoring. MedDRA is updated twice annually, and new terms can be proposed by any MedDRA users. Following the publication of the PAR, the term “Topical steroid withdrawal reaction” was added to MedDRA as a lower level term in version 24.1 and made available to users of the Yellow Card website in February 2022 as part of routine updates. This helps to ensure that more reports pertaining to TSW reactions are appropriately captured. The MHRA continues to closely monitor Yellow Card reports submitted for suspected TSW reactions.

The MHRA continues to engage with the British Association of Dermatologist who have also released a statement, which is available at the following link:

https://cdn.bad.org.uk/uploads/2024/02/22095550/Topical-Steroid-Withdrawal-Joint-Statement.pdf

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the upcoming integration of NHS England into the Department will affect the operation of Directed Enhanced Services or Structured Medication Reviews in relation to long-term topical steroid use.

Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)

Work is progressing at pace to develop the design and operating model for the new integrated organisation, and to plan for the smooth transfer of people, functions, and responsibilities.

It is only right that with such significant reform, we commit to carefully assessing and understanding the potential impacts, as is due process. These ongoing assessments will inform our programme as appropriate.

At this stage, we do not anticipate any impacts on Structured Medication Reviews relating to long-term topical steroid use, nor on the operation of Directed Enhanced Services.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department plans to mandate (a) training and (b) continuing professional development for prescribers and pharmacists on recognising and managing Topical Steroid Withdrawal.

Answered by Karin Smyth - Minister of State (Department of Health and Social Care)

Regulated healthcare professionals need to meet the standards of proficiency, conduct, and performance set by the relevant professional regulator, which are independent of the Government. It is the responsibility of individual employers to ensure their staff have appropriate access to ongoing training and professional development to provide safe and effective care.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will publish guidance clarifying which organisation is responsible for ensuring that prescribers act on updated patient-safety information on topical corticosteroids.

Answered by Karin Smyth - Minister of State (Department of Health and Social Care)

The health and care professional regulators are responsible for the regulation of health and care professionals across the United Kingdom.

Regulators require all registrants to work within their scope of practice by only practising in areas where they have appropriate knowledge, skills, and experience. This also applies to prescribing.

The General Medical Council, the Nursing and Midwifery Council, the Health and Care Professions Council, and the General Pharmaceutical Council each publish guidance on prescribing for their registrants, which includes signposting to the Medicines and Healthcare products Regulatory Agency which monitors the safety of medicines.

Regulators can take action through fitness to practise processes where professionals on the register fail to uphold professional standards or practise outside of relevant guidance, posing a risk to patient safety.

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.

Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)

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

Found: Abrahams (Chair); Rushanara Ali; Lee Barron; Johanna Baxter; Mr Peter Bedford; Steve Darling; Damien Egan

Found: Abrahams (Chair); Rushanara Ali; Lee Barron; Johanna Baxter; Mr Peter Bedford; Steve Darling; Damien Egan

Found: Abrahams (Chair); Rushanara Ali; Lee Barron; Johanna Baxter; Mr Peter Bedford; Steve Darling; Damien Egan

Found: South) Mr Peter Bedford (Conservative; Mid Leicestershire) Steve Darling (Liberal Democrat; Torbay) Damien Egan

Members of the Education and Work and Pensions Select Committees have decided to undertake an inquiry that will consider how the Government can ensure it will deliver a successful Child Poverty Strategy.