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Valproate Prescribing Update: Specialist Review Requirements Adjusted for Male Patients

21 February, 2025

The MHRA has revised its guidelines concerning valproate prescriptions. Notably, male patients currently undergoing valproate treatment are no longer required to have their therapy reviewed by two specialists. This adjustment seeks to balance effective patient care with regulatory oversight.

Introduction:

Valproate is a widely used medication for managing epilepsy and bipolar disorder. Historically, stringent prescribing measures have been in place due to significant reproductive risks associated with its use, particularly concerning teratogenic effects when used during pregnancy. Recent evaluations by the Commission on Human Medicines (CHM) have led to updated guidance, specifically altering the specialist review requirements for male patients.

Updated Specialist Review Requirements:

  • Initiating Valproate in Patients Under 55 Years:
    • The requirement for a two-specialist review remains unchanged. New valproate prescriptions for individuals under 55 years should only proceed if two independent specialists determine and document that no alternative effective treatments are available, or if specific circumstances render reproductive risks irrelevant.
  • Male Patients Currently on Valproate:
    • The CHM has advised that male patients already receiving valproate therapy do not require a review by two specialists. This decision is based on recent assessments indicating that existing risk minimisation strategies are sufficient for this group.

Guidance for Healthcare Professionals:

  • For New Prescriptions:
    • Continue adhering to the two-specialist review protocol for patients under 55 years initiating valproate. Ensure thorough documentation of the decision-making process, highlighting the absence of viable alternative treatments or the inapplicability of reproductive risks.
  • For Existing Male Patients:
    • Routine specialist reviews are no longer mandated solely based on valproate therapy. However, maintain regular clinical evaluations to monitor treatment efficacy and patient well-being.
  • Educational Resources:
    • The MHRA has developed infographics to clarify scenarios requiring specialist reviews:
      • Female patients under 55 years
      • Male patients under 55 years
      • Patients 55 years and older
    • These resources are available on the MHRA website.
  • Reporting Adverse Reactions:
    • Healthcare professionals are encouraged to report any suspected adverse reactions associated with valproate use through the Yellow Card scheme.

Implications for Clinical Practice:

This updated guidance aims to reduce the administrative burden on healthcare providers while ensuring patient safety. By exempting male patients already on valproate from the two-specialist review requirement, resources can be allocated more effectively, focusing on patients with higher reproductive risk profiles.

Conclusion:

The MHRA’s revised guidelines reflect a nuanced approach to valproate prescribing, maintaining rigorous oversight where necessary and easing requirements where appropriate. Healthcare professionals should familiarise themselves with these changes to ensure compliance and optimal patient care.

Read more: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonellâ–Ľ): review by two specialists is required for initiating valproate but not for male patients already taking valproate

Citation:
Medicines and Healthcare products Regulatory Agency. “Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell): review by two specialists is required for initiating valproate but not for male patients already taking valproate.” Published 13 February 2025.

 

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