Safe use of Valproate
Valproates (as sodium valproate or valproic acid) is a treatment for epilepsy and bipolar disorders, and other indications. Evidence from the National guidance on valproate-use-by-women-and-girls has shown that, if valproate is taken in pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects. There is also limited evidence of risks to men, and studies on this are ongoing.
MHRA Updates
Regulatory measures for Valproate prescribing:
Organisations to prepare for new regulatory measures for oversight of prescribing to all new patients and existing female patients
The MHRA has issued a critical NPSA alert of actions to ensure all prescribers are prepared for new regulatory measures for prescribing valproate to all new patients and existing female patients. An action plan for this implementation is due 31 January 2024.
The 2 new regulatory measures are:
- All initiations, in women and men, under 55 years must be agreed by two independent specialists with documented evidence that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
- At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Annual Risk Acknowledgement Form (ARAF), to include a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.
Legislative change for Valproate dispensing:
From October 2023, legislation changes have been made to ensure all patients (male and female) receive their valproate-containing medicines in the manufacturers original full pack that includes specific warnings with pictograms, a patient information leaflet and card. These documents alert patients to the risks to unborn babies if valproate is used in pregnancy.
There are exceptional cases where the manufacturer’s original full pack does not have to be supplied where:
(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied valproate-containing medicines in different packaging from its manufacturer’s original full outer packaging (for example, in a monitored dosage system) and
(ii) there are processes in place to make sure that the patient receives the Patient Information Leaflet.
NEL ICB is co-ordinating the implementation of the new regulatory measures in providers (primary and secondary care). A system group has been convened and further updates will be made available from the group.
Action for practices:
- Continue to prescribe valproates for existing patients and provide advice and reassurance when needed unless you are asked to stop prescribing by a specialist.
- Make every contact count (MECC)
- Use the opportunity to provide patients of childbearing potential with information
- Ensure existing patients of childbearing potential continue to use a highly effective form of contraception. General patient-friendly information on contraception methods can be found on page 6 of the bipolar-disorder. decision tool and NICE has also produced professional guidance on highly effective contraception https://bnf.nice.org.uk/treatment-summaries/contraceptives-hormonal/
- Prescribe appropriate quantities so that pharmacists can dispense a manufacturer’s original full pack which will include all the necessary safety information for the patient
- Where it is not in a patient’s best interests to prescribe a full original pack, please document the reason in the patient record
- A process for identifying patients in primary care without an Annual Risk Assessment Form (ARAF), followed by referral into specialist care is being developed and will be shared once completed