Pregnancy for women with long-term medical conditions requires careful planning for the health of both mother and baby. The use of certain antiepileptic drugs (AEDs) is known to increase the risk of birth defects and neurodevelopmental disorders (e.g. autism and learning difficulties) in the fetus and child. The European Medicines Agency recently reviewed the evidence relating to the use of the AED sodium valproate during pregnancy and the risk of a woman having a child with a neurodevelopmental abnormality. Following this review the guidelines for prescribing valproate to women who could become pregnant were changed. This study aims to look at patterns of prescribing of AEDs to women aged 10-50 years, including those receiving their first ever AED prescription. The study will look at the percentage of women prescribed each AED, the age at which they are prescribed it, the medical condition they are prescribed it for (e.g. epilepsy, bipolar disorder), the number of women prescribed an AED during pregnancy and whether women switch between different AEDs before or during their pregnancy. The data from this study will inform work to manage and reduce the risk of sodium valproate and other antiepileptic drug exposures in women who could become pregnant.
The use of certain antiepileptic drugs (AEDs) is known to increase the risk of both physical and neurodevelopmental abnormalities in the fetus and child. The European Medicines Agency recently carried out a review of the evidence relating to the use of the AED sodium valproate during pregnancy. Following this review, the guidelines for prescribing sodium valproate to women of childbearing age were changed in January 2015. This drug utilisation study will calculate the prevalence of AED prescribing in all females of childbearing age and in females during pregnancy, between 2007 and 2016, stratified by calendar year, age at prescription and indication for prescribing. It will also look at the incidence of prescribing of each of the different AEDs among 'first-ever users' stratified by calendar year, age at first prescription and indication for prescribing. Finally the study will evaluate the extent to which women switch AED products, including which AEDs they switch to and from, particularly in relation to pregnancy. The data from this study will help inform risk minimisation measures in relation to sodium valproate and other AED exposures in women of childbearing potential.
This is a drug utilisation study, there are no health outcomes of interest. Pregnancy outcomes are included purely as a descriptive variable and no comments or conclusions will be made in relation to potential associations between drug therapies and pregnancy outcomes.
Rachel Charlton - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Julia Snowball - Collaborator - University of Bath