National patient safety alertMHRA
Valproate patient safety alert over inaccurate results
The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations.
What to do now
Valproate may give inaccurate test results.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (NatPSA/2023/013/MHRA). Quoted as issued.
Summary
The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations.
The risk
Date of Issue: 28 November 2023
Reference No: NatPSA/2023/013/MHRA
This alert is for action by: Integrated Care Boards (in England), Health Boards (in Scotland), Health Boards (in Wales), and Health and Social Care Trusts (in Northern Ireland).
This is a safety critical and complex National Patient Safety Alert. Implementation should 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.
Advice for healthcare professionals
When: To begin as soon as possible and be completed by 31 January 2024 .
1 . Designate a new or existing group to co-ordinate the implementation of the new regulatory measures in providers, with oversight from a senior quality group. This group should include (but is not restricted to):
a. An appointed chair with delegated responsibility for the actions in this alert.
b. Representation from clinical leads in all the specialities named above and any other relevant departments.
c. A mechanism by which the group can involve and be informed by patients with lived experience.
2 . The group should be tasked with, and document, progress towards:
a. Updating all local guidance and protocols relating to prescribing of valproate to reflect the new regulatory position, including definitions of the roles and responsibilities of clinicians and provider organisations, and the recording of compliance with the risk forms
b. Commissioning work if necessary to understand the needs of the affected population, including those people most at risk of health inequalities.
c. Reviewing the results of local audit(s) of compliance with the existing PPP measures for girls and women of childbearing potential prescribed valproate.
d. Commissioning/determining the local pathways of care for women of childbearing potential and girls in relation to the prescribing and review of valproate.
e. Planning for and identification of clinical resource to meet the identified needs of the population and implement the new regulatory measures.
Based upon the findings of the above, the group should produce an Action and Improvement Plan by the alert deadline that is communicated with all relevant staff to ensure smooth implementation of the new regulatory measures and to allow for continuous improvement in care of patients who are considering or being prescribed valproate, including ongoing improvement, monitoring and audit.
Open the MHRA notice
Questions
Why has Valproate been recalled?
Valproate may give inaccurate test results. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.