Mandatory National Clinical Audit : Valproate audit

Each year community pharmacies are contractually required to participate in a single audit set by NHS England. For 2022/23, this audit will focus on preventing harm caused by valproate prescribing in patients of childbearing potential.

Community pharmacies will be required to conduct the audit over a six-week consecutive period, the workload is expected to be manageable as the number of patients covered by the audit is small. The six-week period can be chosen by each contractor as long as it is completed before 31st March 2023.

The 2022/23 national clinical audit is based on the audit conducted in the 2019/20 Pharmacy Quality Scheme (PQS) and will allow contractors to revisit the data and re-audit their practice to complete the audit cycle.

The PQS 2019/20 valproate audit can be accessed here

Pharmacy teams should familiarize themselves with, and adhere to the recommendations provided in the report. The results of the original audit showed that although a high number of patients were aware of the safety considerations associated with the use of valproate there is still more work to be done to ensure that all patients receive the correct information about valproate and the risk of birth defects.

The aim of the audit is:

  • To reduce the potential for harm from valproate prescribing in patients of childbearing age who are biologically able to be pregnant. 
  • To reinforce the actions that the MHRA has advised pharmacists need to undertake when dispensing valproate to patients of childbearing age who are biologically able to be pregnant.
  • To assess the extent to which the recommendations of the 2019/20 valproate audit have been embedded into practice.

To undertake the audit:

  • Choose a six-week consecutive period before 31st March 2023
  • Familiarize the pharmacy team with the MHRA Drug Safety Update 2018
  • Check that the pharmacy has supplies of the Patient Guides, Patient Cards and warning stickers to support and inform patients of the risks associated and the need to be enrolled in the Pregnancy Prevention Programme. These can be ordered from Sanofi’s medical information department on 0845 372 7101 or emailing
  • Collate data using the collection sheet which can be found in Appendix A of the NHS guidance document (see below)
  • Once the data collection is completed, enter the information on the Valproate Audit 2022/23 tab on the MYS portal. If there are no suitable patients found during the six-week period, tick the ‘No eligible patients’ box and submit this information
  • Retain the confirmation email received following the data submission as evidence

Following the audit, consider whether there are any changes that should be made to improve the compliance levels in line with GPhC and MRHA advice and record these changes using the template in Appendix B of the NHS guidance. This should be retained in the pharmacy as evidence of having completed the audit.

NHS Guidance Documents including data collection appendices