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GPhC: Dispensing sodium valproate without information leaflet 'unacceptable'

The General Pharmaceutical Council (GPhC) has admonished pharmacy teams after a Sunday Times report revealed that some patients are still receiving their sodium valproate prescription without a leaflet warning of the risks. 

The Sunday Times investigation, published last week (April 16), 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: CCA: How pharmacy teams can advise patients on valproate safety


The exposé prompted the GPhC to post a tweet earlier this week, deeming these deviations from the safe supply of sodium valproate “unacceptable”.

“Everyone in pharmacy has a part to play to ensure women receive the right information,” it stressed.


“Vital” that valproate dispensed safely


“It is vital that women and girls are dispensed valproate safely,” Duncan Rudkin, chief executive of the GPhC, told C+D yesterday (April 20).

“We work closely 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,” he added.

Pharmacists must ensure that “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, he stressed.


Read more: Pharmacies in England to focus on valproate in next clinical audit


The GPhC wrote to all pharmacy professionals in June last year “to emphasise this point and to outline how to supply sodium valproate safely”, Mr Rudkin added.

It also provided specific reference on how to monitor the safe supply of the medication in its guidance to pharmacies on how to provide pharmacy services at distance and over the internet, the GPhC added.


GPhC inspectors “follow up” on unsafe dispensing reports


The regulator’s inspectors continue to “check that pharmacies are providing sodium valproate safely and complying with the Medicines and Healthcare products Regulatory Agency pregnancy prevention programme (PPP) every inspection”, Mr Rudkin said.


Read more: Pharmacists may have to supply sodium valproate in original pack


They respond to reports of specific pharmacies dispensing the medication women without including the right label or information leaflet by “follow[ing] up” with the pharmacy in question “directly”, he added.

This ensures that “the pharmacy can take action to make sure sodium valproate is dispensed safely in the future”, he said.

A GPhC spokesperson provided C+D with further detail on how they assess whether the medication is dispensed correctly in pharmacies. 

“Our inspectors check the pharmacy team are following the requirements of the PPP for valproate when assessing if relevant standards have been met” while conducting inspections of pharmacies, they shared.

“No pharmacies were found to have an issue or shortfall in relation to valproate and the PPP  which directly contributed to a standard being classed as not met since in the last year,” they said. 

Comparatively, eight pharmacies failed to meet standards associated with dispensing sodium valproate in between 2018 and 2019, and another six between 2019 and 2020. 

Additionally, the GPhC pursued 11 fitness-to-practise cases linked to “registrant non-compliance with the PPP” between 2018 and 2021, the spokesperson shared.


Sodium valproate case needs “immediate fix”


A Pharmacy Quality Scheme audit conducted last year showed that, of the 12,068 girls or women of childbearing potential who were questioned, 675 (5.6%) said that they had not been provided with information on the potential impact of valproate on pregnancies, C+D reported.

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]”.

The Sunday Times report noted that “the government has yet to respond” to the consultation.

Former health secretary Jeremy Hunt compared the prescription of sodium valproate to pregnant women without warning to the scandal of the anti-morning-sickness drug thalidomide.

“It beggars belief that after so many warnings this still hasn’t been sorted: this is a major risk to patient safety and ministers must order an immediate fix to prevent any more avoidable harm,” he told the Sunday Times.

Community Pharmacy Patient Safety Group chair Victoria Steele said the organisation “would like to see [the] changes outlined in the recent consultation on original pack dispensing introduced without delay”. 

It is “extremely concerning that some patients are still receiving medication without appropriate safety warnings”, she said. 

“Everyone involved in a patient’s care has an important part to play to ensure women receive the right information and counselling at the right time.” 

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