The 2022/23 national clinical audit will focus on preventing harm from valproate prescribing in patients able to be pregnant, the Pharmaceutical Services Negotiating Committee (PSNC) and NHS England (NHSE) have agreed.

Contractors can choose a six week period before 31 March 2023 to complete the audit, during which they must identify patients who are prescribed valproate and find out whether they have access to safety information and appropriate pregnancy prevention plans in place. The pharmacy must also ensure that it has procedures in place to ensure the safety of patients taking valproate.

NHSE said that community pharmacy teams are in an ‘ideal position to carry out this audit and ensure people understand the risks’, as their accessibility means that they ‘have the potential to encounter patients who do not engage with other care services regularly’.

Undertaking the audit is a mandatory part of the pharmacy’s NHS contractual requirements.

Sodium valproate, which is prescribed as a treatment for epilepsy and bipolar disorder, can cause birth defects in around one in ten babies born to those taking it while pregnant, and developmental problems in 30-40% of children whose mothers took the medicine while pregnant.

In October, the General Pharmaceutical Council (GPhC) reminded pharmacists to ensure that women and girls prescribed sodium valproate are informed about the risks of taking it during pregnancy, after reports of the drug being dispensed without safety warnings.

NICE guidance states that the medication ‘must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place’.

A similar audit was carried out by some community pharmacies as part of the 2019/20 Pharmacy Quality Scheme (PQS). PSNC said that the 2022/23 national clinical audit will be based on the PQS audit and will allow contractors to close the audit cycle by re-auditing their practice.

PSNC also said that it expected that the workload associated with the audit would be ‘manageable for all contractors’ as it would only cover a small number of patients. In the 2019/20 PQS audit, an average of 1.2 patients per pharmacy agreed to take part in the audit over a three-month period.

If no suitable patients are found to participate in the audit during the six-week period, contractors can tick the ‘No eligible patients’ box within the Valproate Audit 2022/23 tab on the Manage Your Service portal and submit this information.

In the PQS 2019/20 valproate audit:

  • 675 (5.6%) of patients who took part said that they had not been provided with advice and information in line with the MHRA Drug Safety Update 2018 concerning the potential impact on an unborn child;
  • 10.6% did not have a copy of the Patient Guide;
  • 11.1% did not have a copy of the Patient Alert Card; and
  • 4,374 (36.2%) women advised they did not have highly effective contraception in line with the Pregnancy Prevention Programme and of these, 1,159 (26.5%) were referred/signposted back to their GP or specialist to discuss contraception.

Alastair Buxton, PSNC director of NHS Services, said that it had originally been agreed by NHSE and PSNC that the audit would be included within the 2022/23 PQS. However, the start of the PQS scheme was delayed by the late agreement of the Community Pharmacy Contractual Framework (CPCF) and its scope was reduced.

PSNC had suggested that the audit be repeated in 2023/24 and that it was ‘pleased that NHS England agreed to our suggestion’, he added. PSNC also said that it had asked for flexibility around when the audit could be completed.

He added that ‘pharmacy teams have a vital role to play in ensuring valproate is prescribed and dispensed safely’ and that the audit would be ‘building on the important work that pharmacy teams completed in the 2019/20 PQS and supporting further action to address this important patient safety issue.’