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Valproate MHRA Guidance: Limitations and Opportunities
Lance Watkins1, Hannah Cock2,3, Heather Angus-Leppan4,5,6
1Mental Health and Learning Disability Delivery Unit, Llwyneryr Unit, Neath Port Talbot CLDT, Abertawe Bro Morgannwyg University Health Board, Swansea, United Kingdom.
Frontiers in Neurology
|March 8, 2019
Summary
New UK regulations for valproate medicines require careful consideration for women with intellectual disability (ID). Individualized care is crucial to balance safety with the epilepsy treatment needs of this vulnerable population.
Area of Science:
- Neurology
- Public Health
- Pharmacovigilance
Background:
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated regulations for valproate medicines, emphasizing teratogenic risks for women of childbearing age.
- The directive encourages withdrawal of valproate from women of childbearing age with epilepsy.
- These updated regulations may not adequately consider the unique needs of women with intellectual disability (ID).
Purpose of the Study:
- To examine the challenges in applying the new MHRA valproate directive to women with moderate to profound ID.
- To propose a pathway for informed consent regarding valproate use in women with ID, considering their cognitive abilities.
- To advocate for individualized, person-centered care in managing epilepsy in this vulnerable population.
Main Methods:
- Review of MHRA directives on valproate.
- Analysis of the challenges in obtaining informed consent for women with moderate to profound ID.
- Proposal of a case-by-case approach based on individual cognitive capacity.
Main Results:
- Women with moderate to profound ID may face risks to epilepsy control due to the directive.
- Many individuals with ID have seizures, with a significant portion being treatment-resistant.
- Current directives may not account for the inability of some individuals with ID to provide informed consent.
Conclusions:
- A nuanced, individualized approach is essential when implementing valproate safety directives for women with ID.
- Cognitive ability assessments are crucial for facilitating informed consent and decision-making.
- Collaborative, person-centered care is paramount to ensure the well-being and appropriate treatment of women with ID.
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