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 |