Valproate MHRA Guidance: Limitations and Opportunities

Frontiers in Neurology

Rohit Shankar¹  Heather Angus-Leppan³  Kim Morley⁵  Hannah Cock⁷  Lance Watkins⁸  Mike Wilcock⁹ 

[1] 0Exeter Medical School, Knowledge Spa, Royal Cornwall Hospital, Truro, United Kingdom;Atkinson Morley Regional Neuroscience Centre, St George's University Hospitals NHS Trust, London, United Kingdom;Centre for Research in Public Health and Community Care, University of Hertfordshire, London, United Kingdom;Cornwall Partnership NHS Foundation Trust, Threemilestone Industrial Estate, Truro, United Kingdom;Department of Obstetrics and Gynaecology, Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust, Winchester, United Kingdom;Epilepsy Initiative Group, Royal Free London, London, United Kingdom;Institute of Medical and Biomedical Education, St George's University of London, London, United Kingdom;Mental Health and Learning Disability Delivery Unit, Llwyneryr Unit, Neath Port Talbot CLDT, Abertawe Bro Morgannwyg University Health Board, Swansea, United Kingdom;Royal Cornwall Hospitals Trust, Truro, United Kingdom;University College, London, United Kingdom;

关键词: valproate;    pregnancy;    communication;    risk assessment;    intellectual disability;   

DOI  :  10.3389/fneur.2019.00139

来源: DOAJ

【 摘 要 】

Recent publication of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has strengthened the regulatory measures for valproate medicines. It highlights the importance of making women of childbearing age with epilepsy aware of the teratogenic risks of valproate and encourages the withdrawal of it from those currently prescribed. While a significant directive, it raises concerns of not having considered the impact on special populations such as women with Intellectual Disability (ID). While it is important that women with ID are not excluded from such safety initiatives, due caution needs to be taken on a case by case basis preferably, to ensure their best interests are central to the decision making. Many women with moderate to profound ID cannot have informed consented sexual relationships not to mention cognitive incapability to make informed choices on medication suitability. These women are at potential risk of having their epilepsy control undermined due to the MHRA directives. Around 30% of people with moderate to profound ID have seizures of which 60% are considered treatment resistant. In this vulnerable population changes to medication without clear clinical and social insights could lead to increased harm levels. This paper enumerates the challenges of application of the new directive to these special populations and proposes a pathway based on individual cognitive ability to provide informed consent to facilitate the continuation or removal of valproate. It is important not to lose sight of individual circumstances and the importance of working collaboratively toward providing person center care.

【 授权许可】

Unknown