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Publication, Part of

[MI] Medicines and Pregnancy Registry - Antiepileptic use in females aged 0 to 54 in England: April 2018 to March 2021

Publication Date:
30 Sep 2021
Geographic Coverage:
England
Date Range:
01 Apr 2018 to 31 Mar 2021
Page contents

Summary

NHS Digital is working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop comprehensive national Medicines and Pregnancy Registries which can give a better understanding of the use, benefits, and risks of medicines taken in pregnancy.

This report is an analysis of existing administrative patient data as a proof of concept, to establish the use and value of these data sets in supporting robust and sustainable medicine registries. The data produced are designed to support the MHRA in monitoring the level of success of the valproate pregnancy prevention plan and to enable the wider health and care system to further understand outcomes for women prescribed valproate during pregnancy and their children and consequently to improve patient care.

Antiepileptics are important in controlling seizures and other epilepsy symptoms and untreated epilepsy in pregnancy can result in harm to the mother and child. However, use of some antiepileptic drugs during pregnancy has been associated with a range of harmful effects to the child. Valproate is a licensed treatment for epilepsy and bipolar disorder. It is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. In 2018, following further evidence on the nature and magnitude of risks to the unborn child the MHRA advised that valproate must not be used in any woman or girl able to have children unless she is supported by a Pregnancy Prevention Programme (PPP). This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

To monitor the implementation of and adherence to the valproate PPP, understand changes in the use of antiepileptics and the impact of these changes on women and their children, and to facilitate further research into outcomes following the use of antiepileptics in pregnancy, MHRA and NHS Digital are developing an antiepileptics registry.

Highlights

This report is to provide information on the prescribing of medicines in relation to pregnancies based upon data from the core register which has been developed to form the basis of the planned wider medicines registries and to identify limitations in the existing data sources.

The key findings are listed below. 

48,562 females (aged 0 - 54) were prescribed valproate on one or more occasion between April 2018 and March 2021

Of which, 21,438 females were prescribed valproate in March 2021.

Of the 21,438 females prescribed valproate in March 2021:

  • 1,824 (8.5%) were aged 0 to 11 years of age
  • 550 (2.6%) aged 12 to 15 years
  • 8,548 (39.9%) aged 16 to 44 years
  • and 10,516 (49.1%) aged 45 to 54 years.

This report finds a general decrease in prescribing prevalence throughout the reporting period

There was a reduction of 6,010 in the number of females aged 0 to 54 who were prescribed valproate in a month

from 27,448 in April 2018 to 21,438 in March 2021

Of the 21,438 females that were prescribed valproate in March 2021, 216 females were classed as 'new starters' of valproate.

A new starter of valproate is defined as an individual who has received a prescription of valproate within the current month, but has not received a prescription of valproate in the previous 12 months

There were fewer new starters of valproate in March 2021 (216) compared to March 2020 in which there were 282 new starters

Valproate prescribing and pregnancy

This includes conceptions identified since April 2018

  • Of the 48,562 females prescribed valproate, 690 females had a total of 757 conceptions
  • 222 of those females were prescribed valproate in a month in which they were pregnant
  • Of the 222 females, 28 were identified as new additions in the most recent 6 months, October 2020 to March 2021

 

Topiramate prescribing and pregnancy

This includes conceptions identified since April 2018

  • 92,482 females prescribed topiramate between April 2018 and March 2021
  • 4,840 females had a total of 5,305 conceptions
  • 1,185 females were prescribed topiramate in a month in which they were pregnant

Trends in valproate and topiramate prescribing

​​​​​​Between the first financial year of data (2018/19) and last financial year of data (2020/21)

  • The prescribing of valproate during pregnancy decreased by 51%
  • The prescribing of topiramate during pregnancy increased by 36%

Last edited: 29 September 2021 11:24 am