Utilisation of antiepileptic medicines in girls and women of childbearing potential - a study in three European countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26083
• EU PAS number:
  EUPAS19129
• Study ID:
  26083
• Official title and acronym:
  Utilisation of antiepileptic medicines in girls and women of childbearing potential - a study in three European countries
• DARWIN EU® study:
  No
• Study countries:
  France

  Italy

  United Kingdom
• Study description:
  The use of certain antiepileptic drugs (AEDs) is known to increase the risk of both physical and neurodevelopmental abnormalities in the foetus 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 study will use electronic healthcare data from databases in the United Kingdom, France and Italy (Tuscany and Emilia Romagna). The study will calculate the prevalence of AED prescribing in all females of childbearing age and in females during pregnancy, 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 new users stratified by calendar year, age at prescription and indication for prescribing and evaluate the extent to which women switch AED products, particularly in relation to pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacy & Pharmacology, University of Bath

United Kingdom

Pharmacy & Pharmacology, University of Bath

United Kingdom

Pharmacologie En Population cohorteS biobanqueS (PEPSS), Hopitaux de Toulouse

France

Centre for Environmental and Preventive Medicine, Queen Mary University of London United Kingdom, Drug Policy Service, Emilia Romagna Region Health Authority Italy

Study timelines

Date when funding contract was signed

Planned: 16/12/2016

Actual: 16/12/2016

Study start date

Planned: 09/05/2017

Actual: 24/05/2017

Data analysis start date

Planned: 09/09/2017

Actual: 09/09/2017

Date of interim report, if expected

Actual: 04/05/2018

Date of final study report

Planned: 09/05/2018

Actual: 07/06/2018

Sources of funding

EMA

Study protocol

Initial protocol

EMA EUROmediSAFE AED PROTOCOL_EU PAS Register

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable