On 24th April 2018, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced a change to the license for valproate medicines (Epilim, Depakote and generic brands). Valproate must no longer be prescribed to women or girls of childbearing potential, unless they are on the pregnancy prevention programme (PPP).

Utilised as a treatment for epilepsy and bipolar disorder, children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.

All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice. These regulatory changes have been further supported by:

  • smaller pack sizes to encourage monthly prescribing
  • a pictogram/warning image on valproate labelling

A letter was also sent to all relevant healthcare professionals outlining the new requirements. Additionally, updated educational materials were made available from the MHRA.

In June 2018, the Pharmacy Forum NI announced the publication, of a joint resource to support pharmacy teams in helping women and girls who have been prescribed valproate medicines.

The resource includes a decision pathway and key points for consideration to prompt conversations between the pharmacy team and their patients. It was developed in partnership, by the pharmacy organisations represented on the MHRA’s Valpraote Stakeholder Network, including the Pharmacy Forum NI, Community Pharmacy Northern Ireland, Community Pharmacy Scotland, Community Pharmacy Wales, Community Pharmacy Patient Safety Group, the Royal Pharmaceutical Society and the Pharmaceutical Services Negotiating Committee. You can download the resource here…

Valporate Guidance

Coupled with measures including GP system computer alerts, Valproate Action Plans and amended NICE Guidelines, it was hoped this approach would help to reduce the number of pregnancies exposed to valproate medicines to an absolute minimum and would make sure all women and girls of childbearing potential are aware of the risks. However, although use in female patients in the UK, continues to slowly decline, data shows a wide geographical variation in the prescribing of valproate medicines. Women have continued to report instances when pharmacists have not provided information leaflets or a Patient Card, when dispensing valproate. It is essential that healthcare professionals ensure that they are acting in full compliance with the new strengthened measures for pregnancy prevention. Follow the link for more information on the Drug Safety Update and advice on compliance…

Government Drug Saety Update