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Valproate MHRA guidance: limitations and opportunities

Watkins, L; Cock, HR; Angus-Leppan, H; Morley, K; Wilcock, M; Shankar, R (2019) Valproate MHRA guidance: limitations and opportunities. Frontiers in Neurology, 10. p. 139. ISSN 1664-2295 https://doi.org/10.3389/fneur.2019.00139
SGUL Authors: Cock, Hannah Rutherford

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Abstract

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.

Item Type: Article
Additional Information: © 2019 Watkins, Cock, Angus-Leppan, Morley, Wilcock and Shankar. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Keywords: 1109 Neurosciences, 1103 Clinical Sciences, 1701 Psychology
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: Frontiers in Neurology
ISSN: 1664-2295
Dates:
DateEvent
20 February 2019Published
4 February 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
URI: http://openaccess.sgul.ac.uk/id/eprint/110596
Publisher's version: https://doi.org/10.3389/fneur.2019.00139

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