Valproate is a licensed medicine prescribed within mental health settings for bipolar disorder. It is a known teratogen, affecting approximately 20,000 people and costing the NHS £181 billion. This was a multidisciplinary project involving Surrey Heartlands Medicines Safety Team and Surrey and Borders Partnership NHS Foundation Trust, who developed a solution to reduce human suffering and cost by adhering to the Medicines and Healthcare Products Regulatory Agency (MHRA) valproate regulations through a clinical and digital redesign. The aim was to identify females in primary and secondary care across Surrey who take valproate for mental illness and to implement a pregnancy prevention programme for them by July 2022, using a digital clinical pathway supporting clinicians in the implementation process.

The method used was a combination of the Model for Improvement, the sequence for improvement from East London NHS Foundation Trust, UX design, and Agile project management. A valproate working group was formed with professionals from multiple disciplines to identify, understand and solve the problem. The solution was designed through co-production and project management methods that ensured a patient-centric solution.

A digital registry of all females of childbearing potential who are prescribed valproate was created. A bespoke electronic GP referral form for valproate reviews was implemented. A one-stop valproate dashboard was developed to support documentation. A live digital visualisation feature was added within the secondary care electronic patient record to ensure compliance with MHRA guidelines. Easy-to-read materials for females with learning disabilities and sensitively worded appointment letters that inform patients of the risks and importance of attending annual reviews were created. In addition, collaboration with the National Valproate Patient Safety Officer allowed the implementation of Systematized Nomenclature of Medicine Clinical Terms (SNOMED) codes to simplify the exchange of clinical information between systems.

The project has the potential to reduce harm and improve the patient experience, serving as a template for other medications with strong regulatory controls. Collaboration between primary and secondary care, clinicians, pharmacists and digital colleagues, and co-design with people prescribed valproate were essential to the success of the project. Ongoing work is required to ensure valproate-related materials are available in an accessible format for every person prescribed valproate. Valproate has also been implicated in paternal adverse effects, and this project solution is future-proofed to identify men on valproate. Through this work, people will only be treated with valproate in a way that safeguards the health of unborn children.