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Valproate chosen again as clinical audit focus for pharmacies in England

All pharmacies will have to complete a national clinical audit focusing on sodium valproate, the Pharmaceutical Services Negotiating Committee (PSNC) has announced.

NHS England (NHSE) and PSNC have decided that the current year’s clinical audit (2022/23), will aim at “reducing the potential harm caused by taking valproate during pregnancy”, the negotiator revealed in an update yesterday (November 15).

It comes as the requirement to complete a national audit in 2019/202020/2021 and 2021/2022 was waived in recognition of the pressures faced by contractors during the pandemic.

Some contractors will have also already conducted a “similar valproate audit” as part of the 2019/20 Pharmacy Quality Scheme (PQS), PSNC added.

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”, it said.


PSNC: “Still more work to be done”


According to the PQS audit results published last year by NHSE, of the 12,068 patients who agreed to take part in the audit, 675 (5.6%) said that they had not been provided with information on the potential impact of valproate on pregnancies.

Some 10.6% of patients did not have a copy of the Patient Guide, while 11.1% did not have a copy of the Patient Alert Card.

“The results therefore show that while 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 patients receive the correct information about valproate and the risk of birth defects,” PSNC said.

Read more: ‘Clinical negligence claims against pharmacists ignoring sodium valproate guidance cannot be ruled out’

PSNC director of NHS services Alastair Buxton revealed that it had been “originally” agreed “this audit would be included in the 2022/23 PQS”.

However, “due to the delayed start of the scheme, PSNC negotiated the removal of some of the scheme’s requirements”, he added.

The negotiator is “pleased” that NHSE agreed to its suggestion to repeat this same audit in the 2022/23 national clinical audit, he said.

“Pharmacy teams have a vital role to play in ensuring valproate is prescribed and dispensed safely,” Mr Buxton said.


Sodium valproate developments


An investigation published by The Sunday Times in April found that despite repeated warnings about the risks of providing sodium valproate to pregnant women, many patients continue to receive their prescriptions from pharmacies without information leaflets.

In other cases, patients took home “boxes with pharmacy labels stuck over the pregnancy warnings”, according to the Sunday Times report.

Read more: GPhC: Dispensing sodium valproate without information leaflet 'unacceptable'

Following the publication of this story, the General Pharmaceutical Council (GPhC) told C+D that “it is vital that women and girls are dispensed valproate safely”.

Pharmacists must ensure “the patient label is not placed over the warning labels or warning sticker on the box” and should provide “the appropriate information leaflet/card” in the box when dispensing the drug to women of childbearing age, the GPhC added at the time.

Last month, the GPhC sent an “important reminder” to all registered pharmacy professionals about dispensing valproate and further information about the actions the regulator is taking when valproate is not supplied safely.

Last year, the Department of Health and Social Care launched a consultation – which ran until December 13 – that proposed that the supply of sodium valproate “must always be in original packaging regardless of the conditions we set around [original pack dispensing]”.

However, the government has yet to publish the outcome of the consultation.

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