Exclusive: Pharmacy teams are not to blame for the sodium valproate scandal, in which hundreds of pregnant women have taken a drug that is dangerous to unborn babies, a pharmacy industry leader has said.

The epilepsy medication sodium valproate has been given to women in the UK for years without proper warnings causing autism, learning difficulties and physical deformities in up to potentially 20,000 babies in Britain, The Sunday Times has reported.

The article, published on Saturday (17 April), claimed that some of the pregnant women who received valproate had been given the drug in plain boxes with the information leaflets missing. Others received boxes with pharmacy labels stuck over the pregnancy warnings, it claimed.

But Leyla Hannbeck, CEO of the Association of Independent Multiple pharmacies (AIMp), told The Pharmacist yesterday (19 April), that pharmacy teams should not be blamed.

‘The vast majority of pharmacists do ensure that their patients receive information regarding the risks that come with taking sodium valproate,’ she explained.

‘However, there is no excuse for pharmacists not including the leaflets in boxes,’ she added.

Under guidance issued by the Medicines Healthcare Regulatory Agency (MHRA) in 2018, pharmacy teams are required to discuss the risks of pregnancy with patients of childbearing age and issue a warning card each time they dispense sodium valproate.

According to a survey conducted by the General Pharmaceutical Council (GPhC), over 94% of women of childbearing age said they had been provided with advice and information from pharmacy teams in line with the MHRA’s 2018 Drug Safety Update.

Valproate manufacturers produce the epilepsy medicine in original packs of 30 or 100, which Ms Hannbeck said does not align with the prescribing patterns of GPs who prescribe sodium valproate in 28- or 56-day courses.

This means pharmacists are often forced to split packs and put the medicine in spare plain boxes so the correct amount is given to patients.

‘We have been calling for manufacturers to adhere to GP prescribing patterns for years,’ she said.

‘Not only would it free up pharmacists' time but it would be safer for patients to receive the medicine in its original packaging and avoid human error altogether,’ she explained.

In November 2021, the Department of Health and Social Care and the MHRA launched a consultation that proposed that sodium valproate always be supplied in its original packaging.

The MHRA could not tell The Pharmacist when the results of the consultation would be published.

Ms Hannbeck did not think pharmacy teams would receive any negative backlash from The Times’ story, but called on pharmacists to ensure they ‘prioritise’ the correct valproate dispensing going forward.

Duncan Rudkin, Chief Executive of the GPhC, told The Pharmacist that the regulatory body works ‘closely’ with partner organisations to 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. In June 2021, we wrote to all pharmacy professionals to emphasise this point and to outline how to supply sodium valproate safely,’ he explained.

‘Our inspectors check that pharmacies are providing sodium valproate safely and complying with the MHRA Pregnancy Prevention Programme at every inspection.

‘Our inspectors will also follow up directly with a pharmacy if we receive reports that a specific pharmacy has dispensed sodium valproate to a woman without the right label or information leaflet, so the pharmacy can take action to make sure sodium valproate is dispensed safely in the future,’ he added.

Figures published by NHS Digital this month (April) suggested that nearly 50 women in England were prescribed sodium valproate during pregnancy between October 2020 to September 2021.

This is despite the MHRA announcing a ban on the prescribing of valproate to women and girls of childbearing age unless they are on a pregnancy prevention programme.