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Departmental Publication (Guidance and Regulation)
Department for Education

Mar. 27 2024

Source Page: Make a claim through the risk protection arrangement (RPA)
Document: Academy trusts: RPA membership rules (PDF)

Found: Act 1974 ii) The Management of Health and Safety at Work Regulations iii) Workplace (Health, Safety


Departmental Publication (Guidance and Regulation)
Department for Education

Mar. 27 2024

Source Page: Make a claim through the risk protection arrangement (RPA)
Document: Church academies: RPA membership rules (PDF)

Found: Act 1974 ii) The Management of Health and Safety at Work Regulations iii) Workplace (Health, Safety


Departmental Publication (Guidance and Regulation)
Department for Education

Mar. 27 2024

Source Page: Make a claim through the risk protection arrangement (RPA)
Document: Local authority maintained community schools: RPA membership rules (PDF)

Found: independent review panels Source: Source of data 6 Summary of Cover provided by RPA The table


Departmental Publication (Guidance and Regulation)
Department for Education

Mar. 27 2024

Source Page: Make a claim through the risk protection arrangement (RPA)
Document: Voluntary controlled schools: RPA membership rules (PDF)

Found: independent review panels 5 Summary of Cover provided by RPA The table below sets out a high level


Departmental Publication (Guidance and Regulation)
Department for Education

Mar. 27 2024

Source Page: Make a claim through the risk protection arrangement (RPA)
Document: Voluntary aided, foundation and foundation special schools: RPA membership rules (PDF)

Found: independent review panels 5 Summary of Cover provided by RPA The table below sets out a high


Scottish Parliament Written Question
S6W-26096
Tuesday 26th March 2024

Asked by: Baillie, Jackie (Scottish Labour - Dumbarton)

Question

To ask the Scottish Government how many children have been affected as a consequence of their mothers being prescribed sodium valproate during pregnancy.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

We do not know the numbers of children affected because the information has not been collected historically.

In response to the Independent Medicines and Medical Devices Safety Review (IMMDSR), the Scottish Government commissioned Public Health Scotland (PHS) to establish a medicines in pregnancy surveillance asset. This resource will support monitoring and reporting to progress improvements in the safe use of valproate and other teratogenic medicines in Scotland. Its first output is due to be published by PHS in April 2024 and will include prescribing data and trends for valproate and other anti-seizure medicines.


Written Question
Mirtazapine
Tuesday 26th March 2024

Asked by: Lord Alton of Liverpool (Crossbench - Life peer)

Question to the Department of Health and Social Care:

To ask His Majesty's Government how many prescriptions for mirtazapine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for mirtazapine in each year since 2014; and what consideration NHS England has given to adding sexual dysfunction as a side effect on the patient information leaflets for mirtazapine.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The following table shows the total number of items issued for mirtazapine, each year since 2014 to 2023:

Time Period

Total items issued

2014

6,056,918

2015

6,783,906

2016

7,526,200

2017

8,198,345

2018

8,938,362

2019

9,702,599

2020

10,532,577

2021

11,249,963

2022

11,776,025

2023

12,401,593

Source: Data was provided by the NHS Business Services Authority, using the British National Formulary chemical substance mirtazapine

Note: Items have been dispensed, but not necessarily prescribed, in England.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.

The MHRA has received a total of 46 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with mirtazapine, four of which include information that suggest the suspected adverse reactions persisted after mirtazapine was withdrawn. The following table shows the number of Yellow Card reports of suspected mirtazapine related sexual dysfunction, and reports of sexual dysfunction that persisted after the drug was withdrawn, each year from 2014 to 2024:

Year

Reports of sexual dysfunction

Reports of sexual dysfunction that continued after mirtazapine was withdrawn

2014

3

0

2015

1

0

2016

2

0

2017

3

0

2018

1

0

2019

5

1

2020

3

0

2021

5

1

2022

10

1

2023

9

0

2024

4

1

Source: data provided by the MHRA.

It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known.

The MHRA continuously monitors the safety of medicines on the United Kingdom’s market, including mirtazapine. Reports of suspected adverse reactions are reviewed weekly by a multidisciplinary team as part of the MHRA’s signal detection process. The term signal is used to define any suspected adverse reaction or potential safety concern that requires further evaluation.

Responsibility for adding a side effect to the product information leaflet sits with the MHRA. The product information for mirtazapine reflects the data currently available, and does not include sexual dysfunction as a possible side effect. However, data from Yellow Card reports and other sources such as published studies and periodic safety assessments are kept under continuous review by the MHRA. The marketing authorisation holder has recently submitted the latest periodic safety update report to the MHRA, and this will be carefully assessed. If there is sufficient evidence and associated data about the potential to experience sexual dysfunction as a side effect, the patient information for mirtazapine can be updated.


Written Question
Yellow Card Scheme: Medical Records
Friday 22nd March 2024

Asked by: Christopher Chope (Conservative - Christchurch)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, on what date work on digitally linking Medicines and Healthcare products Regulatory Authority Yellow Card information to NHS clinical records (a) began and (b) is expected to be completed.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The Medicines and Healthcare products Regulatory Agency (MHRA) has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and to potentially enable faster access to information, where considered necessary for an assessment. Any such approach would be subject to strict information governance controls and prior consultation with stakeholder groups.

In 2020, the MHRA began delivery of a substantially enhanced Yellow Card platform under the SafetyConnect programme, aligned to the recommendations in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The new infrastructure is designed with the intent of enabling connectivity to other systems, to facilitate the exchange of information. During that time the MHRA has engaged with the NHS around the evolving technical options for robust and secure connectivity and enhanced user journeys. The first step in these enhancements is use of the common NHS login capability within Yellow Card, which is expected to go live in 2024.

Deeper connectivity between systems will be subject to internal and external stakeholder engagement and substantial information governance controls, with elements completed over a phased and multi-year work plan.


Departmental Publication (Statistics)
Department for Work and Pensions

Mar. 21 2024

Source Page: Review of the UK Material Deprivation Measures
Document: Review of the UK Material Deprivation Measures (PDF)

Found: Review of the UK Material Deprivation Measures


Departmental Publication (Policy and Engagement)
Department of Health and Social Care

Mar. 20 2024

Source Page: Tobacco and Vapes Bill: impact assessment
Document: Tobacco and Vapes Bill: impact assessment (PDF)

Found: Tobacco and Vapes Bill: impact assessment