MHRA Pregnancy Prevention Programme for Topiramate
A new Pregnancy Prevention Programme has been introduced by the MHRA for Topiramate, which is a potently teratogenic drug. Every six months around 190 women are prescribed topiramate during pregnancy – usually for migraine and initiated in general practice. However, MHRA guidance states: ‘Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled’.
Prescribers must annually review women with childbearing potential, consider switching to an alternative if possible, ensure a highly effective method of contraception is in place and complete an Annual Risk Awareness Form. Epilepsy patients must be reviewed by specialists. Migraine patients may be managed in general practice.
Community Pharmacy can support relevant patients by:
- Signposting to GP for a discussion.
- Dispensing in original packs if possible.
- Giving the patient a warning card.
Practices and pharmacists with further queries should contact their ICB pharmacy team.
Ensure this is added to your risk register and that you have audits in place to ensure compliance.