Drug/Patient Safety Audit

In 2017 the Patient Safety Agency published a Nationwide alert, warning clinicians about the dangers of using valproate in pregnancy.  This drug is teratogenic which may cause malformation of an embryo in the first and second trimester of pregnancy. 

From 2017 there was a clear mandate that it could not be used in women of child bearing age, unless they were on a Pregnancy Prevention Programme (PPP).  

Responsibility: The Trust use valproate for the treatment of bipolar disorder.  They needed to find all of patients taking valproate in order to inform them on the safety alert and if necessary, put in place a PPP 

Aim of the Study

To ensure that healthcare providers were responding to the alert and the supporting documents were in place and effective and minimise risk to the patient.


Health Care Organisations today have no quick and easy way to complete an assessment for such alerts due to the complexity of their systems. Medication and PPP information is usually hidden in clinical notes (unstructured text) making it very difficult to access the information quickly. 


Drug Audit. An audit was conducted to find girls and women who were prescribed valproate.  This was done to evaluate if clinicians had documented all these patients and had either: 

  • an MHRA* Risk Acknowledgement Form completed and started on contraception to prevent pregnancy (PPP) or  
  • Valproate stopped or discharged via GP. 

The platform

The platform makes it possible to analyse Electronic Patient Record (EPR) structured (specific content text fields) and unstructured (clinical notes) text instantly providing required information to identify all women who were prescribed valproate, details of any PPP and an audit of their notes to ensure the appropriate actions had taken place (e.g. Medicines and Healthcare products Regulatory Agency (MHRA) Risk Acknowledgement Form completed, started on contraception to prevent pregnancy, valproate had been stopped, discharged to GP). A year later, the audit was repeated to find all of those on valproate and ensure that they had a PPP in date. This is currently reviewed on an annual basis.   

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