Valproate Safety Audit 2018/19

To comply with the NHS contractual requirements associated with the Clinical Governance Essential Service, pharmacy contractors must perform an annual practice based audit. Audit is an integral aspect of ongoing clinical effectiveness and provides data of how patients are supported by community pharmacy systems and procedures.

Please remember that a clinical audit is a quality improvement process and should be viewed as a mechanism for gradually improving patient care. Helpful information on a guide to clinical audit can be found on the PSNC website

The LPC is committed to supporting pharmacies and when audit results are collated and analysed, this will highlight opportunities for service developments locally and will provide robust evidence of community pharmacy teams’ contributions to supporting patients.

This year the LPC is supporting the new clinical audit created by the Company Chemists’ Association (CCA), host of the Community Pharmacy Patient Safety Group, to explore community pharmacy’s contribution in supporting girls and women of childbearing potential in taking Valproate medicines. When the data is collected this will help to inform the monitoring activities of the Valproate Stakeholder Network, convened by the Medicines & Healthcare products Regulatory Agency.

The audit paperwork can be downloaded from the CCA website. You are encouraged to print out and complete the audit by hand, before submission via the electronic survey.

The audit is split into four sections and should be completed in stages. You will need to complete the audit twice – once in July 2018 (Phase 1) and then again in November 2018 (Phase 2). If you have a patient safety champion in your pharmacy team, they may wish to take the lead on this audit. Remember, a copy of all completed audit paperwork must be kept in the pharmacy as these may be required during contract monitoring visits.


Instructions for completing the audit

The audit should be completed in stages, as certain sections of the audit should be completed by specific dates, as outlined below. Remember, a copy of all completed audit paperwork must be kept in the pharmacy as these may be required during contract monitoring visits.

When to complete each section

  Phase 1 Phase 2
Audit Section Deadlines  (starting 1 July 2018) Deadlines  (starting 1 November 2018)
Section 1 (pre-audit survey) 8 July 2018 11 November 2018
Section 2 (PMR analysis) 8 July 2018 11 November 2018
Section 3 (patient data collection) 31 July 2018 30 November 2018
Section 4 (post-audit reflections) 31 July 2018 – ongoing 30 November 2018 – ongoing
DATA SUBMISSION 31 August 2018 31 January 2019

How to complete each section

  • Section 1 (pre-audit survey) should be completed before you begin the other sections of the audit. It is important to answer all questions honestly.  This will help to understand how well messages about the risks involving valproate medicines have been communicated.
  • Section 2 (PMR analysis) should be completed once you have completed Section 1, in the first week of the audit month, by the deadline specified above.
  • Section 3 (quantitative patient data collection) includes Table 1 and Table 2. These two tables should be completed throughout the whole audit month. The tables should be filled out every time a prescription for valproate is presented for a female patient, aged 12-49. Where clinically appropriate and in line with usual checking procedures, the prescription should still be dispensed to the patient, even if they are not on a PPP.
  • Section 4 (post-audit reflections) should be used to document reflections on the audit as well as changes that you intend to make to the ways in which you support patients on valproate medicines.

Data submission

Once you have completed all four sections of the audit, collate and submit your data to inform a national analysis report via:

Phase 1  (live until 31 August 2018)

Phase 2  (live until 31 January 2019)


CCA member companies will be disseminating the audit resources directly to their pharmacy teams so that they can participate. We would request that individual community pharmacies located in Hertfordshire that are part of large companies also submit their information via the survey monkey links above although you should check with your head office/area manager that this is supported before doing so.