The General Pharmaceutical Council (GPhC) has reminded pharmacists to ensure that women and girls prescribed sodium valproate are informed about the risks of taking it during pregnancy.

The GPhC said that it was ‘very concerned’ to hear from patient groups that women and girls prescribed sodium valproate were not always given the right information and advice about the drug by pharmacies supplying it, including important safety information relating to use in pregnancy.

It said that it has recently investigated instances of sodium valproate being dispensed by pharmacies in a white box with no safety warnings or Patient Information Leaflet.

Sodium valproate, which is prescribed as a treatment for epilepsy and bipolar disorder, can cause birth defects in around one in ten babies born to those taking it while pregnant, and developmental problems in 30-40% of children whose mothers took the medicine while pregnant.

NICE guidance states that the medication ‘must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place’

Between April 2018 and September 2020, 180 females were prescribed valproate while pregnant, while 47,532 females (ages 0-54) overall were given one or more prescription for the drug over the reporting period and 238 females stopped receiving prescriptions of valproate prior to their pregnancy.

In an email sent to pharmacists last week, the GPhC said that pharmacy professionals have a key role in supplying valproate safely, and that they should:

  • Provide female patients with a patient card every time valproate is dispensed
  • Dispensed valproate with a copy of the patient information leaflet or a warning on the container
  • Reminded patients of the risks in pregnancy, the need for highly effective contraception, and the need for annual specialist review
  • Ask patients if they have received the Patient Guide.

The GPhC said that patients had shared examples of the patient sticker being placed over the warning on the medicines packaging, even though the label should not be placed over it.

Some manufacturers such as Epilim now have a perforated warning card which can be flipped up or removed to reveal a space for the patient label. The card should always be kept with the box and both given to the patient, the GPhC added.

It also said that when patients visit pharmacies for pregnancy tests or emergency hormonal contraception, the pharmacist should ask them about any medications they are taking in order to be able to provide advice if the medicines are teratogenic.

The GPhC said that pharmacies should now:

  • ensure a system is in place to flag people who are at risk to make sure they are provided with the right information
  • make sure people at risk have a Pregnancy Prevention Programme in place and understand the risks, and refer to local contraceptive services if appropriate
  • refer people who have not had a review within the last 12 months to their GP or specialist and know who to contact if their circumstances change
  • record referrals and information provided on the patient medication record

In April, Leyla Hannbeck, CEO of the Association of Independent Multiple pharmacies (AIMp), told The Pharmacist that pharmacy teams should not be blamed for the scandal, in which hundreds of pregnant women took the drug despite it being dangerous to unborn babies.

While she said that there was ‘no excuse for pharmacists not including the leaflets in boxes’, she added that ‘the vast majority of pharmacists do ensure that their patients receive information regarding the risks that come with taking sodium valproate’,

The problem lay with the manufacturers who produced valproate in original packs of 30 or 100, forcing pharmacists to split packs into spare plain boxes to align with GP prescriptions of 28 or 56 day courses, she argued.

‘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.