Some medicines carry a high risk of causing serious harm if taken during pregnancy. These risks may include congenital malformations, neurodevelopmental disorders, foetal growth restriction, miscarriage or other serious harm to the unborn child.
Pregnancy Prevention Programmes, often shortened to PPPs, are regulatory risk minimisation measures designed to reduce the chance of pregnancy before, during and shortly after treatment with these medicines. They are particularly important for medicines known or suspected to be teratogenic, including oral retinoids, valproate, topiramate, thalidomide, lenalidomide and pomalidomide.
For pharmacy teams, the important legal and practical point is this: a PPP is not usually a standalone piece of legislation called a “pregnancy prevention law”. Instead, the requirement normally arises from the medicine’s marketing authorisation, Summary of Product Characteristics, Patient Information Leaflet and MHRA-approved risk minimisation materials. The MHRA describes Pregnancy Prevention Programmes as measures that may be put in place where a medicine has a known or potential teratogenic effect: https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines