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The first publication includes data on valproate use by females aged 0 to 54 years, in England, from April 2018 to September 2020.
Valproate is a treatment for epilepsy and bipolar disorder which is known to cause harm to unborn children. The report provides information on prescribing in relation to pregnancies recorded in the registry. It does not provide a comprehensive review of the number of females affected.
NHS Digital is working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop Medicines in Pregnancy Registries in response to the Cumberlege Review1.
The registries will provide the health and care system with the insights needed to track outcomes and make informed clinical decisions around the prescribing of medicines during pregnancy. They will also enable medicines regulators to monitor prescribing practices and adherence to pregnancy prevention programmes.
This report uses data from existing patient level administrative datasets specifically Medicines dispensed in Primary Care2 linked to the Maternity Services Data Set (MSDS) and Hospital Episode Statistics (HES) data.
This report is not an investigation but is an analysis of existing administrative patient data to enable the health system to understand the care and outcomes for these patients and consequently to improve patient care. Any gaps identified in the data will help inform the future development of clinical registry functions for medicine registries.
The core register for the valproate registry, which is the subject of this report, will be extended to all antiepileptics and provide a basis to develop medicines in pregnancy registries in other clinical areas.
Notes for editors
- The Cumberlege report can be found here: the Independent Medicines and Medical Devices safety Review - Oral hearings (immdsreview.org.uk)
- The Medicines dispensed in Primary Care data is a monthly collection of patient level data about medicines dispensed and claimed for in community settings (primarily community pharmacy) from the NHS Business Services Authority (NHSBSA): Medicines dispensed in Primary Care NHS Business Services Authority data - NHS Digital