Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme (PPP) is in place. The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a drug safety update on 24 April 2018 outlining this change. Pharmacists are advised to familiarise themselves with this update, which includes actions for pharmacists, as well as information on the conditions and guidance for the PPP.
The MHRA published a further drug safety update on 24 May 2018 which includes new materials to support the pregnancy prevention programme. These include:
- Patient Card – to be given by pharmacists to all female patients who are dispensed valproate medicines to inform them of the risks
- Patient Guide – to be provided to girls (of any age) and women of childbearing potential (or their parent/caregiver/responsible person) taking any medicine containing valproate
- Guide for Healthcare Professionals – for all prescribers, pharmacists, and other healthcare providers involved in the care of women and girls of childbearing potential using valproate medicines
- Annual Risk Acknowledgement Form – (revised version dated March 2019) for the specialist and patient (or their parent/caregiver/responsible person) to sign at initiation and at treatment reviews at least every year. The patient should receive a copy of the form; one copy should be filed in the specialist notes, and one copy sent to the patient’s GP
A joint resource has been developed to support pharmacy teams in helping women and girls who have been prescribed valproate medicines. It has been developed in partnership by the pharmacy organisations represented on the MHRA’s Valproate Stakeholder Network, including the Community Pharmacy Patient Safety Group, Community Pharmacy Northern Ireland, Community Pharmacy Scotland, Community Pharmacy Wales, the Royal Pharmaceutical Society, the Pharmacy Forum of Northern Ireland and the Pharmaceutical Services Negotiating Committee.
The resource builds on the MHRA’s national toolkit for all healthcare professionals and enables pharmacists to understand where they can advise and help patients. It also aligns closely with a clinical audit on valproate safety that the Company Chemists’ Association launched in June 2018. View Safe Supply of Valproate Medication here.
A pan-college guidance has been developed by Medical Royal Colleges on Valproate Use in Women and Girls of Childbearing Years. The RPS has endorsed this guidance.