European Good Pharmacovigilance Practices (GVP) on specific Risk Minimisation Measures of the pregnancy prevention program

This new guideline, currently under public consultation, defines the elements of the pregnancy prevention programme and specifies when such a programme or other risk minimisation measures are necessary to prevent the adverse consequences of taking medicines during pregnancy and to protect the health of the mother and the child.

Indeed, some medicines may have effects on the development of the embryo and foetus or on the unborn child.

The Pregnancy Prevention Programme (PPP) is a set of :

  • routine measures, and
  • additional Risk Minimisation Measures (RMM)

aimed to minimise exposure during pregnancy to a drug that may have a teratogenic effect or an adverse effect on the (neuro)development of the unborn child.

Although rarely necessary, a PPP may also be targeted at male patients where there is evidence that the use of a drug by the biological father may have a teratogenic effect via the sperm during conception.

The level of evidence of teratogenic risk determines the choice between a PPP or pregnancy-specific RMM.

Decision criteria* :

  1. Level of scientific evidence of the drug's teratogenic potential in humans, and
  2. Context of the likely use of the drug.

*To be regularly re-evaluated.

A PPP should, in principle, include the following additional Risk Minimisation Measures (RMM): 

  • Summary of Product Characteristics (SmPC) and package leaflet containing the following statements:

    - Contraindication in pregnancy

    - Contraindication in women of childbearing age not taking effective contraceptive measures

    - Information on the teratogenic risks of the medicinal product and corresponding recommendations in the Warnings section (section 4.4 of the SPC and section 2 of the package leaflet) and Pregnancy section (section 4.6 of the SPC and section 2 of the package leaflet).

  • Requirements for prescribing and dispensing (e.g. prescription by a specialist, presentation of negative pregnancy tests, etc.).
  • Educational material for health professionals
  • Educational material for patients

The above elements can be communicated for instance by means of guides, patient reminder cards or risk awareness forms.

The following RMM should be considered as part of the PPP: 

  • Secondary packaging labelling including an explicit statement in full text about the need to avoid pregnancy when using the medicinal product.
  • Direct healthcare professional communication (DHPC), if required.

The GVP Module XVI Addendum III on pregnancy prevention programme and other pregnancy-specific risk minimisation measures is out for public consultation until 31 May 2022.

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