National Patient Safety Alert. Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

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.

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).

Content

Due to the known significant risk of serious harm to a baby after exposure to valproate in pregnancy, these measures aim to ensure valproate is only used if other treatments are ineffective or not tolerated, and that any use of valproate in women of childbearing potential who cannot be treated with other medicines is in accordance with the Pregnancy Prevention Programme (PPP). Given these and other risks of valproate, these measures also aim to reduce initiation of valproate to only in patients for whom no other therapeutic options are suitable.

• A. Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
• B. At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes

Advise leaders that current safety measures for valproate continue to apply, including the valproate PPP for any girls and women of childbearing potential. 

Advise leaders in general practice and pharmacy that teams should continue to prescribe and dispense valproate but also discuss the current warnings and upcoming measures relating to valproate with their patients and consider together how it affects the patient’s individual circumstances. New educational materials should be integrated into local guidance to ensure patients are able to make an informed choice.

Actions required

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.