Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland: a population-based cohort study

Author:

McTaggart StuartORCID,MacColl GavinORCID,Gronkowski Karen,Wood RachaelORCID,Leach John PaulORCID,Bennie MarionORCID

Abstract

ObjectiveTo examine the impact of Medicines and Healthcare products Regulatory Agency (MHRA) safety alerts on valproate prescribing among women aged 14–45 years in Scotland and examine trends in pregnancies exposed to valproate.DesignPopulation-based cohort study.Participants21 983 women of all ages who received valproate between January 2011 and December 2019.MethodsAll valproate prescriptions issued to women in Scotland between January 2011 and December 2019 were identified and prevalence/incidence rates per 10 000 population derived. The impact of regulatory safety alerts on prescribing was analysed using Joinpoint models. Linked pregnancy records for January 2011 to September 2019 were identified and annual rates of pregnancy per 1000 valproate-treated women aged 14–45 years were calculated for each pregnancy outcome: live birth, stillbirth, miscarriage and termination.ResultsAnnual prevalent and incident rates of valproate prescribing declined in women aged 14–45 years between 2011 and 2019 from 40.5 to 18.3 per 10 000 population (54.8% reduction) and 7.9 to 1.3 per 10 000 population (83.5% reduction), respectively. Statistically significant changes occurred around the times of the MHRA safety alerts. The number of valproate-exposed pregnancies conceived each year fell from 70 in 2011 to 20 in 2018, a 71.4% reduction, and the number of live births fell from 52 to 14, a 73.0% reduction. Expressed as a rate this was a 46.4% decrease from 15.3 to 8.2 per 1000 valproate-treated women aged 14–45 years in 2011 and 2018, respectively. Live birth was the most common pregnancy outcome.ConclusionThis study demonstrates, for the first time, the capabilities of national data sets to identify drug exposure and derive pregnancy outcome at scale across Scotland. Building on this as part of an evolving national/UK surveillance capability will continue efforts to minimise in-utero exposure to valproate; enabling ongoing surveillance to understand better long-term outcomes, and to inform better provision of health and wider support services.

Funder

Medicines and Healthcare products Regulatory Agency

Scottish Government

Publisher

BMJ

Subject

General Medicine

Reference35 articles.

1. Joint Formulary Committee . British National Formulary. 77th ed. London: BMJ Group and Pharmaceutical Press; March 2019.

2. World Health Organisation . Who model list of essential medicines. 20 edn, 2017.

3. Comparative safety of anti-epileptic drugs during pregnancy: a systematic review and network meta-analysis of congenital malformations and prenatal outcomes

4. Comparative safety of antiepileptic drugs for neurological development in children exposed during pregnancy and breast feeding: a systematic review and network meta-analysis

5. Medicines and healthcare products regulatory Agency . Drug safety update: sodium valproate: risk of neurodevelopmental delay in children following maternal use, 2014. Available: https://www.gov.uk/drug-safety-update/sodium-valproate-risk-of-neurodevelopmental-delay-in-children-following-maternal-use

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3