GPhC condemns 'unacceptable' reports of valproate supply without warning leaflet

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GPhC condemns 'unacceptable' reports of valproate supply without warning leaflet

By Neil Trainis

The General Pharmaceutical Council has said it is “unacceptable” that women are continuing to be dispensed sodium valproate without an information leaflet and warned pharmacy teams they must ensure patients are aware of the risks posed by the medicine.

The regulator responded on Twitter to a Sunday Times report published at the weekend revealing that some prescribers continue to supply valproate to pregnant women without providing proper information about its effects on unborn babies.

As well as prescribers failing to make sure women had adequate information about the drug, the Times said it had heard from women who have recently received packs without the advice leaflet or with "pharmacy labels" placed over the pregnancy warning.

Medicines and Healthcare Regulatory products Agency guidelines say valproate medicines – which are predominantly used to treat epilepsy and go by the brand names Epilim, Episenta and Depakote – must not be used in women of childbearing potential unless the Pregnancy Prevention Programme (PPP) is in place.

Birth defects associated with the medicine can include limb defects, heart problems, cleft palate and learning difficulties. It is estimated that 27,000 women of childbearing age take sodium valproate in the UK.

GPhC examines eight cases in past 12 months

When asked by Independent Community Pharmacist how many pharmacists it has found dispensing sodium valproate without providing proper information in the last 12 months, what sanctions it has handed out and what intelligence it is using to uncover these incidents, the GPhC said it looked into eight cases raised by INFACT, a charity representing families affected by valproate.

Four of those cases, the regulator said, were closed because there were no patient details and not enough information for it to launch a full investigation.

In one case, the individual who raised the concern did not give the GPhC their consent to contact them, leaving it unable to verify the allegations. The case was closed.

The GPhC said it carried out investigations into the other three cases "which involved communicating with the patients and speaking with the registrants involved" and those were closed after "written advice" was given to the registrants.

GPhC chief executive Duncan Rudkin told ICP it is "vital that women and girls are dispensed valproate safely," explaining that the regulator works with partner organisations “to proactively highlight to pharmacy professionals and pharmacy teams what they must do when dispensing sodium valproate to women of childbearing age".

"This includes ensuring that the patient label is not placed over the warning labels or warning sticker on the box and providing the appropriate information leaflet/card."

He added that every GPhC inspection of a registered pharmacy involves checking that pharmacies provide the drug safely and comply with the PPP, explaining that any reports concerning the supply of sodium valproate without the necessary information are followed up directly with the pharmacy in question. 

The GPhC wrote to all pharmacy professionals in June last year advising them how to supply sodium valproate safely.

Estimated 20,000 people affected

Although the number of expectant mothers prescribed sodium valproate fell by 51 per cent between 2018-19 and 2020-21, 247 women were prescribed the drug while they were pregnant between April 2018 and September last year, according to the Medicines and Pregnancy Registry.

The 2020 Cumberlege Review estimated that 20,000 people in the UK had been affected by in-utero exposure to sodium valproate.

In that report, Baroness Cumberlege was scathingly critical of the NHS, private providers, regulators, professional bodies, pharmaceutical and device manufacturers and policymakers who she said had been “disjointed, siloed, unresponsive and defensive,” had failed to listen to patients’ concerns and moved too slowly to address the issue.

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