2021/22 National pharmacy clinical audit agreed

2021/22 National pharmacy clinical audit agreed

November 16, 2021

PSNC and NHS England and NHS Improvement (NHSE&I) have agreed that the 2021/22 national clinical audit will focus on valproate, with the aim of reducing the potential harm caused by taking valproate during pregnancy. The audit must be completed by all community pharmacy contractors as this is part of their NHS contractual requirements.

Community pharmacy contractors who participated in the 2019/20 Pharmacy Quality Scheme (PQS) may have completed a similar valproate audit as this was a quality criterion within this Scheme. The 2021/22 national clinical audit will be based on the PQS audit and will allow contractors to close the audit cycle by re-auditing their practice.

NHSE&I recently shared the results of the PQS 2019/20 valproate audit in a presentation at the Pharmacy Show. Of the 12,068 girls or women of childbearing potential (or their representative, where appropriate) who agreed to participate in the audit:

  •  675 (5.6%) 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.

The results therefore show that while a high number of patients were aware of the safety considerations, there is still more work to be done to ensure women and girls receive the correct information about valproate and the risk of birth defects.

The paperwork for the audit is being finalised and further information on the audit time period and how the audit results are to be submitted will be confirmed shortly; PSNC will alert contractors through our normal communication channels when this is available.

Commenting on the announcement, PSNC Director of NHS Services, Alastair Buxton said:

“PSNC is pleased that NHS England and NHS Improvement agreed to our suggestion of re-auditing this group of patients for the national clinical audit. Pharmacy teams have a vital role to play in ensuring valproate is prescribed and dispensed safely to women and girls.

Many contractors have told us they want to see the results of previous audits shared and the audit cycle being completed; this audit will achieve that aim, 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.”



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