pregnancy prevention programme (ppp)

Medicinal products that are known to potentially induce congenital abnormalities (teratogens), can have a pregnancy prevention programme (PPP). A PPP aims to prevent patients from becoming pregnant while using these medicinal products.

The programme assists the prescriber, the patient and the pharmacist in this regard prior,  during and after discontinuation of the treatment.

By means of additional counselling, the patient is informed of the risks associated with the particular medicinal product and the need for good contraception. The pharmacy can implement additional checks based on signals in the pharmacovigilance for delivering the medicinal product. Limitations to supplying the medicinal product can also be part of the pregnancy prevention programme.

Medicinal products authorised in the Netherlands with an approved  Pregnancy Prevention Programme are:

• Thalidomide, lenalidomide
• Isotretinoin, acitretin, alitretinoin
• Ambrisentan, bosentan

Medicinal products authorised in the Netherlands with an extra information brochure for the physician and/or patient – in addition to the SmPC and package leaflet – that is aimed at preventing pregnancy during drug use are:

• Eculizumab, eptotermin alfa, fingolimod, hydroxycarbamide, leflunomide, zoledronic acid

Further information
The elements of a PPP can vary per product. Additional information about the PPP as it pertains to the above products can be found on the website of the EMA (Annex IIB of the product information) and in the SPC. You can download this information by clicking on the products.

Additional information about the Referrals for isotretinoin can be found in the documents Annex I and Article 29.

Disclaimer
Information is provided here is about a limited number of products which have a specific pregnancy prevention programme. Not all products with potentially teratogenic properties have this kind of programme. Tuse of medicinal products during pregnancy should always be considered very carefully. Please consult the SmPC and the patient information for the complete product information.