Updated MHRA guidance for use of valproate containing medicines in pregnancy

Valproate medicines in females: the MHRA has produced updated clinical guidance and an annual risk assessment form to aid compliance with the Pregnancy Prevention Programme

The Medicines and Healthcare products Regulatory (MHRA) has published a drug safety update to help healthcare professionals, including pharmacists, to comply with the requirements of the valproate Pregnancy Prevention Programme (PPP), also known as “prevent”, when supplying valproate medicines to females of child-bearing age. A new Annual Risk Acknowledgement Form has been developed which must be completed by the specialist when initiating treatment and during all future reviews; once complete, it must be countersigned by the patient/carer. This is intended to reduce and eliminate valproate exposure in pregnancy in view of its teratogenic effect. The Annual Risk Acknowledgement Form should be completed even if there are compelling reasons to demonstrate that there is no risk of pregnancy.

Valproate is known to be highly teratogenic at all strengths. Exposure during pregnancy carries a 10 per cent risk of children being born with congenital malformations and 30 to 40 per cent risk of neurodevelopmental delays including lower intellectual ability, memory problems and delays in walking and talking. Prescribers must ensure females of child-bearing age satisfy the requirements of the PPP.

The MHRA has recommended a range of resources for healthcare professionals, including pharmacists:

• A guidance summary with safety advice – National Institute for Health and Care Excellence
• The ‘Pan-College’ clinical guidance covering  issues related to valproate supply encountered in practice
• Joint guidance on the prescribing of valproate in females under the age of 18 years – British Paediatric Neurology Association and the Royal College of Paediatrics and Child Health

The NPA Pharmacy Services team has also published the following resources to support pharmacy teams dispensing valproate medicines to females of childbearing age:

• A suite of patient safety resources, intended to raise the awareness of the risks of valproate and other medicines used during pregnancy amongst the pharmacy team and patients
• Valproate: patient safety alerts and risks of exposure in pregnancy
• Valproate and related medicines: in utero exposure risks for female patients

For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk. 

Produced by the NPA Pharmacy Services team April 2019.