Box 1.
The Pharmacovigilance Risk Assessment Committee (PRAC) announced a pregnancy prevention programme in 2018, with six main points.43
Assess patients for the potential of becoming pregnant, and involve the patient in evaluating her individual circumstances and supporting informed decision making.
> Pregnancy tests before starting and during treatment as needed.
Counsel patients about the risks of valproate treatment.
> Explain the need for effective contraception throughout treatment.
> Carrying out reviews of treatment by a specialist at least annually.
> Introduce a new risk acknowledgement form that patients and prescribers will go through