2026/2083

This is a request for information under the Freedom of Information Act 2000. It concerns your organisation’s response to, and implementation of, the regulatory measures introduced in January 2024 for the prescribing and monitoring of valproate (sodium valproate, valproic acid and valproate semisodium).

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a National Patient Safety Alert on valproate on 28 November 2023 (NatPSA/2023/013/MHRA; ‘the Alert’): https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-valproate-organisations-to-prepare-for-new-regulatory-measures-for-oversight-of-prescribing-to-new-patients-and-existing-female-patients-natpsa-slash-2023-slash-013-slash-mhra

The Alert set out required actions and asked that its implementation be ‘coordinated by an executive lead for quality (or equivalent) in Integrated Care Boards in England, Health Boards in Scotland, Health Boards in Wales, and Health and Social Care Trusts in Northern Ireland, alongside the Chief Pharmacist (or equivalent) and supported by the Medical Directors of organisations involved in the prescribing of valproate and clinical leads in neurology, psychiatry, paediatrics, learning disability and/or autism, contraception and sexual health, and general practice, with others included to meet local needs and clinical situations’.

Unless otherwise stated, each question below relates to the period from 28 November 2023 to the date of this request. Where I ask whether you ‘have’ a group, plan, policy or guidance, I am asking whether recorded information of that description is held by you (or on your behalf) and, where it is, for a copy of the current version or a link to it. Where a question concerns an ‘equivalent’ arrangement, I mean one which performs the same function under a different title.

1. Do you have a Valproate Safety Implementation Group (VSIG), or an equivalent group responsible for implementing the Alert? If the group has a different title, please state it.
2. Was the group in place before the Alert was issued, or was it established in response to the Alert? If the latter, please state the date of its first meeting.
3. What is the job title of the chair of the VSIG, and which organisation employs them? (I do not require the individual’s name.); and which organisations, services and professional groups are represented on the VSIG? If the group has terms of reference, please provide a copy (the names of individual members may be redacted).
4. Do you have an action or improvement plan (however titled) in response to the Alert? Please provide a copy of the most recent version held, including any recorded assessment of progress against it.
5. Did you commission or undertake any assessment of the number and needs of patients in your area affected by the new measures (for example, a baseline audit, health needs assessment or equality impact assessment, and how many have intellectual disability and whether these are in care)? If so, please provide a copy of, or link to, the resulting document or documents.
6. If you hold this information, how many patients in your area were prescribed valproate (a) in the twelve months to 30 November 2023 and (b) in the most recent twelve-month period for which you hold figures, broken down by biological sex? If you hold a figure for how many of these patients were recorded on a learning disability register, please provide it. I recognise that you may hold prescribing data only in aggregated form (for example, as items dispensed rather than patients treated) or without these breakdowns; if so, please provide what you do hold and indicate its source.
7. Please provide a copy of, or link to, your current local guidance, protocols or shared-care arrangements for the prescribing of valproate that reflect the regulatory measures introduced in January 2024.
8. Do you have specific guidance for biologically female patients of childbearing potential who are prescribed valproate and who decline to participate in the Pregnancy Prevention Programme (PPP)? Please provide a copy or link to the guidance.
9. Do you have specific guidance for patients with a learning disability (intellectual disability) who are prescribed valproate, including the assessment of their capacity to understand the teratogenic risk of valproate, to participate in the PPP and to complete the Annual Risk Acknowledgement Form (ARAF)? Please provide a copy or link to the guidance.
10. Do you hold any policy or guidance concerning patients who were previously prescribed valproate and no longer are (for example, on follow-up after discontinuation or switching, or on the identification and support of children exposed to valproate in utero)? If so, please provide a copy or link.
11. Do you hold any policy or guidance specific to the prescribing of valproate to biologically male patients, including the requirement for two specialists to approve initiation in new patients under 55 and the MHRA’s advice on paternal exposure? If so, please provide a copy or link.

1)    Yes, Valproate: National Patient Safety Alert (NatPSA) Greater Manchester ICP Implementation Group

2)    The group was established in response to the alert and the first meeting took place on 5^th February 2024

3)     Chair: Assistant Director of Medicines & Pharmacy – Safety, Stewardship & Governance, Greater Manchester Medicines Optimisation Team, NHS Greater Manchester

The group includes representation from the below organisations and services. Professional groups include medical, nursing, pharmacists and pharmacy technicians 

• Manchester University NHS Foundation Trust
• Salford Care Organisation Northern Care Alliance NHS Foundation Trust
• Neurology Service Bolton NHS Foundation
• Wrightington, Wigan and Leigh NHS Foundation Trust
• Greater Manchester Mental Health Trust
• Paediatrician with epilepsy interest
• Pennine Care NHS Foundation Trust
• Community Pharmacy Greater Manchester
• Manchester Local Care Organisation
• NHS Greater Manchester
• West Pennine LMC, AMD gtd Healthcare
• Tameside CMHT

Terms of Reference: 

4)    Yes we hold an action and improvement plan which records assessment of progress against it.

Disclosure of the Action and Improvement Plan, in scope of the request would, or would be likely to:

• inhibit the free and frank provision of advice, and
• inhibit the free and frank exchange of views for the purposes of deliberation.

The document contains sensitive information including patient specific cases related to pregnancy, capacity across the system, workforce, and any risks related to these. To share this information would be likely to negatively impact stakeholder engagement and cause a “chilling effect” relating to very important issues and concerns that would be likely to impact quality of patient care.

5)     In January 2024, Greater Manchester ICB undertook a review of the most recent Valproate Pregnancy Prevention Programme compliance audits completed across both primary care and secondary care in Greater Manchester between 2022 and 2023. A summary of the findings from the audit review:

We have completed an equality impact assessment, the final version of which is currently awaiting Greater Manchester rigour panel review. As this document is still under review we are unable to share it.

6)     

1. We do not hold this data for the twelve months to 30 November 2023
2. Total number of patients prescribed valproate in Greater Manchester in the most recent 12 month period is as follows:

Biological sex male: 5,451 patients

Biological sex female: 2,842 patients

Data taken from the NHS GM Valproate dashboard

7)    https://gmmmg.nhs.uk/guidance/clinical-guidance-and-pathways/valproate-guide/

8)     Guidance is included within the overarching Valproate Guide https://gmmmg.nhs.uk/guidance/clinical-guidance-and-pathways/valproate-guide/

9)    Guidance is included within the overarching Valproate Guide https://gmmmg.nhs.uk/guidance/clinical-guidance-and-pathways/valproate-guide/

https://gmmmg.nhs.uk/guidance/information-leaflets-for-primary-care/easy-read-valproate-version-6/

10) No

Do you hold any policy or guidance specific to the prescribing of valproate to biologically male patients, including the requirement for two specialists to approve initiation in new patients under 55 and the MHRA’s advice on paternal exposure? If so, please provide a copy or link.

Guidance is included within the overarching Valproate Guide https://gmmmg.nhs.uk/guidance/clinical-guidance-and-pathways/valproate-guide/a