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Clinical audit to focus on valproate harm reduction during pregnancy


By Isabel Shaw

18 Nov 2021

Every community pharmacy in England will be required to complete a clinical audit this year that focuses on valproate, PSNC has said.

The aim of the 2021/22 clinical audit for pharmacies is to reduce the ‘potential harm caused by taking valproate during pregnancy’, the negotiator said in an announcement made on its website earlier this week (16 November).

The audit must be completed by all community pharmacy contractors as part of their NHS contractual requirements, the body added.

Valproate is used prescribed to treat epilepsy, bipolar disorder and to prevent migraine headaches.

The plan follows a recent presentation by NHS England and Improvement (NHSE&I) on the results of the Pharmacy Quality Scheme (PQS) 2019/20 valproate audit.

PSNC said the results of the Pharmacy Quality Scheme (PQS) 2019/20 valproate audit demonstrated 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 audit found that 5.6% of women had not been provided with advice and information concerning the potential impact of valproate on an unborn child.

It also discovered that 10.6% of women did not have a copy of the patient information and 36.2% did not have highly effective contraception in line with the guidance of the Valproate Pregnancy Prevention Programme.

‘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,’ PSNC explained.

PSNC said the paperwork for the audit is being finalised and that more information on the audit time and how the audit results are to be submitted will be ‘confirmed shortly’.

Alastair Buxton, PSNC director of NHS services 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.’

He added: ‘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.’

A Government consultation, launched by the Department of Health and Social Care earlier this month (1 November), proposed that sodium valproate should always be supplied in its original packaging.

‘By dispensing medicines in their original packs, it will be easier for pharmacies to ensure that patients will receive the patient information leaflet (PIL), which provides detailed information on the safe and effective use of the product,’ the consultation document explained.

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