ORCID
- Rohit Shankar: 0000-0002-1183-6933
Abstract
Objectives: Annual completion of a Valproate Risk Acknowledgement Form (RAF) is mandated in the United Kingdom due to neurodevelopmental risks of in utero valproate exposure. The number of women of childbearing potential taking valproate, the uptake of the RAF within this population and their clinical outcomes is not known or monitored. This study surveyed responses of clinicians administering the RAF to women of childbearing potential taking valproate medications.
Materials and Methods: Study design—national online survey distributed to clinical specialists throughout the United Kingdom via their national organizations. Participants—clinicians qualified to counsel and administer the valproate RAF (as defined by the Medicines and Healthcare products Regulatory Agency). Main outcome measures—quantitative and qualitative responses regarding identification, uptake, effects and reactions to the RAF. Trial registration—registered at the Clinical Governance and Audit Committee at Royal Free London NHS Foundation Trust Hospital.
Results: 215 respondents covering more than 4775 patient encounters were captured. Most patients continued on valproate, 90% with epilepsy as the indication. Respondents reported that seizure control deteriorated when switched to levetiracetam (33%) and lamotrigine (43%), compared to 7% when continuing valproate (P <.001).
Conclusions: 33%-43% of clinicians reported seizure control deterioration in women changed to alternatives to valproate. Informed consent requires women considering a change are given this information. Systematic capture of data automated through online RAFs and linked to patient outcomes is needed. There remains little data on valproate given for indications other than epilepsy.
DOI
10.1111/ane.13231
Publication Date
2020-03-10
Publication Title
Acta Neurologica Scandinavica
Volume
141
Issue
6
ISSN
0001-6314
Embargo Period
2021-03-10
Keywords
congenital malformations, informed consent, medicines and healthcare products regulatory agency (MHRA), neurodevelopmental disability, risk acknowledgement form (RAF), teratogenicity, valproate
First Page
483
Last Page
490
Recommended Citation
Angus-Leppan, H., Moghim, M., Cock, H., Kinton, L., Synnott Wells, M., & Shankar, R. (2020) 'Valproate risk form—Surveying 215 clinicians involving 4775 encounters', Acta Neurologica Scandinavica, 141(6), pp. 483-490. Available at: https://doi.org/10.1111/ane.13231
