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Aim The November 2023, Medicines and Healthcare products Regulatory Agency (MHRA) via an National Patient Safety Alert (NatPSA) introduced updated regulatory measures for sodium valproate prescribing due to its teratogenicity. 1 Despite stringent measures introduced in 2018, including its contraindication in women of childbearing potential unless enrolled in the Pregnancy Prevention Programme (PPP), data from the Medicines and Pregnancy Registry show pregnancies in England continue to be exposed to valproate.From January 2024, stricter requirements were implemented, including prohibiting initiation in patients under 55 years unless no other therapeutic options are suitable. All newly initiated patients must have a Risk Acknowledgement Form (RAF) completed and signed by two independent specialists, while existing female patients require a second specialist signature on their revised RAF at their next annual review,2 with all previous measures (e.g. PPP) remaining in place. This audit aimed to evaluate compliance with these updated measures at a specialist paediatric centre over a three-month period (July–September 2024).Method Prescribing prompt questions/fields to determine valproate safety compliance were integrated and mandated on all on all valproate prescriptions throughout the trust.A retrospective audit was then conducted using data from the electronic patient record system (called EPIC). Two datasets were extracted, using a custom electronic reporting tool for both valproate dispensing records and inpatient administrations.The report was filtered to show date of valproate initiation, gender, and were classified as either newly initiated or on existing therapy. For each patient, the following data were collected though looking on patient medication records:Whether a completed RAF was uploaded to EPIC.Completion of the EPIC prescribing prompt asking, ‘Has a Risk Acknowledgement Form been completed and signed by two specialists?’Results A total of 72 patients received sodium valproate during assessed period, including 2 newly initiated patients and the remaining 70 patients were on established therapy. Of the newly initiated patients, 1 patient was fully compliant with MHRA guidance, including a RAF signed by two specialists and uploaded to EPIC. The second patient was at end of life therefore receiving palliative care, so a RAF form had not been uploaded.Among the existing patients, 28 were female and subject to the EPIC prompt introduced in January 2024. Of these, 68% had the prompt completed; however, no patients had a completed RAF uploaded to EPIC as these were completed locally. The remaining 41 male patients were not subject to the prompt, consistent with MHRA guidance.Conclusion This audit provides early insight into sodium valproate prescribing compliance under the updated MHRA alert. While findings suggest alignment with regulatory requirements, operational challenges were identified, particularly around verifying prescribers’ responses in the EPIC prompt regarding RAF completion. Subsequently, a system-level improvement was recommended to add a field within EPIC to record the date of RAF completion. This would enhance documentation, assist prescribers in identifying when annual reviews are due, and support safe prescribing practices. A follow-up audit over 12 months using an enhanced data report would provide a more representative assessment of long-term compliance.References Medicines and Healthcare products Regulatory Agency (MHRA). Valproate, organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients. [Internet]. www.gov.uk. 2023. Available from NatPSA-2023-013-MHRA.pdf (Accessed 1 June 2025).Medicines and Healthcare products Regulatory Agency (MHRA). Valproate – reproductive risks. [Internet]. www.gov.uk. 2025. Available from https://www.gov.uk/guidance/valproate-reproductive-risks (Accessed 1 June 2025).