Medication Safety in Pregnancy

1.

This study will seek to determine the drug utilisation/prescription patterns of antiepileptic medicines in girls and women of childbearing potential and will give specific focus to:

• Antiepileptic medicines prescribed in first-ever users, by indication and age
• Time trends in prescribing over the last 10 years from 2007-2016, and in particular before and after the date of the EMA valproate referral in 2014 and the introduction of recommendations on the restrictions on valproate prescribing
• Switching between antiepileptic drugs, especially in relation to pregnancy

2.

Inventory of available data sources in all 28 EU Member States for potential use when evaluating the long-term risks for children associated with in-utero exposure (now available October 2018)

To evaluate the long-term risks for children associated with specific in-utero exposures, for example sodium valproate, a sufficiently large number of affected pregnancies need to be identified.  This can be done either through the use of a pregnancy exposure registry (if one is available), an established cohort study or else through the access to information on in-utero exposures in an extremely large number of pregnancies (to ensure a sufficient number of exposed pregnancies are included in the data).  Information on the health outcomes of the children can then be obtained by following up the children on a case-by-case basis or by linking the identified children to information on their health, education and developmental outcomes.  In addition, social media may in the future become a potential source of information.

3.

Study protocol to estimate the association between exposure to antiepileptic medicines in-utero and neurodevelopmental disorders in the offspring

Using information collected as part of the inventory, a detailed study protocol will be written that aims to estimate the association between exposure to antiepileptic medicines in-utero and neurodevelopmental disorders in the offspring.