The General Pharmaceutical Council (GPhC) has been asking pharmacists to ensure women and and girls are dispensed valproate safely.

“The GPhC is reminding all pharmacy professionals of what they must do to ensure women and girls receive the right information about valproate and the risk of birth defects,” the GPhC noted in an update to community pharmacists.

This reminder coincides with a letter being sent by NHS England to all women and girls aged 12-55 who are currently prescribed valproate which includes important reminders of safety considerations, including around contraception, pregnancy and regular prescribing reviews.

The GPhC have shared this letter with pharmacy professionals so they aware and are prepared to support patients taking valproate who may have questions.

The regulator has reminded the pharmacists that valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.

For women and girls, when they are dispensed valproate, they should expect:

  • to be provided with a Patient Card every time valproate is dispensed
  • for valproate to be dispensed with a copy of the patient information leaflet, and if repackaged, with a warning on the container supplied
  • to be reminded of the risks in pregnancy and the need for highly effective contraception, and a reminder of the need for annual specialist review, and
  • to be asked if they have received the Patient Guide

“You must make sure that the patient label is not placed over the warning labels or warning sticker on the box. Women taking valproate have shared with us examples of where this has happened,” the GPhC said.

“When patients are visiting pharmacies for pregnancy tests or emergency hormonal contraception remember to ask them about any medications they are taking so you can provide further advice if their medicines are teratogenic,” it said.

Meanwhile, the data collected by the NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) in England between April 2018 and September 2020 shows:

  • 47,532 females (ages 0-54) were prescribed one or more prescriptions for valproate in one or more months within the reporting period
  • 180 females were prescribed valproate while pregnant, and
  • 238 females stopped receiving prescriptions of valproate prior to their pregnancy.

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