Valproate prescribing practices for women with intellectual disability across Europe.
intellectual disability
pregnancy
regulatory guidance
teratogenicity
valproate
Journal
Acta neurologica Scandinavica
ISSN: 1600-0404
Titre abrégé: Acta Neurol Scand
Pays: Denmark
ID NLM: 0370336
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
15
06
2020
revised:
21
07
2020
accepted:
16
08
2020
pubmed:
20
8
2020
medline:
20
4
2021
entrez:
20
8
2020
Statut:
ppublish
Résumé
Valproate (VPA) is a known teratogen associated with greater risk of major congenital malformations and other neurodevelopmental sequelae than all other licensed antiepileptic medicines. To reduce the potential for VPA-related teratogenicity, the European Medicines Agency issued recommendations in 2018. Over two-thirds of women/girls with intellectual disability (ID) may have treatment-resistant epilepsy that could benefit from VPA treatment. This investigation compared VPA prescribing practice for women/girls with ID between European countries, specifically evaluating the practice in the UK with that in other countries. An expert working group with representation from key stake-holding organizations developed a survey for dissemination to relevant professionals across Europe. Seventy one responses were received (27 UK, 44 Europe). Clinicians in the UK were more likely to report that they are working to mandatory regulations compared with European respondents (P = .015). European respondents were less likely to be aware of user-independent contraception options (P = .06). In The UK, VPA regulations were more likely to be applied to women with ID than in Europe (P = .024). There is heterogeneity in the application of VPA regulations across Europe for women/girls with ID. In both the UK and Europe, the regulations lack suitable adjustments for specific ID-related factors.
Sections du résumé
BACKGROUND
BACKGROUND
Valproate (VPA) is a known teratogen associated with greater risk of major congenital malformations and other neurodevelopmental sequelae than all other licensed antiepileptic medicines. To reduce the potential for VPA-related teratogenicity, the European Medicines Agency issued recommendations in 2018. Over two-thirds of women/girls with intellectual disability (ID) may have treatment-resistant epilepsy that could benefit from VPA treatment.
AIMS
OBJECTIVE
This investigation compared VPA prescribing practice for women/girls with ID between European countries, specifically evaluating the practice in the UK with that in other countries.
METHODS
METHODS
An expert working group with representation from key stake-holding organizations developed a survey for dissemination to relevant professionals across Europe.
RESULTS
RESULTS
Seventy one responses were received (27 UK, 44 Europe). Clinicians in the UK were more likely to report that they are working to mandatory regulations compared with European respondents (P = .015). European respondents were less likely to be aware of user-independent contraception options (P = .06). In The UK, VPA regulations were more likely to be applied to women with ID than in Europe (P = .024).
CONCLUSION
CONCLUSIONS
There is heterogeneity in the application of VPA regulations across Europe for women/girls with ID. In both the UK and Europe, the regulations lack suitable adjustments for specific ID-related factors.
Substances chimiques
Anticonvulsants
0
Valproic Acid
614OI1Z5WI
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
56-61Informations de copyright
© 2020 The Authors. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd.
Références
Weston J, Bromley R, Jackson CF, et al. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev. 2016;11;CD010224.
Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurol. 2013;12(3):244-252.
Tomson T, Battino D, Bonizzoni E, et al. Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. Lancet Neurol. 2018;17(6):530-538.
Ornoy A. Valproic acid in pregnancy: how much are we endangering the embryo and fetus? Reprod Toxicol. 2009;28(1):1-10.
Bromley RL, Baker GA, Clayton-Smith J, Wood AG. Intellectual functioning in clinically confirmed fetal valproate syndrome. Neurotoxicol Teratol. 2019;1(71):16-21.
European Medicines Agency. Valproate and related substances. EMA/145600/2018.2018. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f. Accessed 06 October 2020.
Medicines and Healthcare Products Regulatory Agency. New Measures to avoid valproate exposure in pregnancy. 2018https://www.gov.uk/guidance/valproate-use-by-women-and-girls. Accessed 06 October 2020.
Royal College of Psychiatrists. Prescribing anti-epileptic drugs for people with epilepsy and intellectual disability. Available at https://www.rcpsych.ac.uk/docs/default-source/improving-care/better-mh-policy/college-reports/college-report-cr206.pdf?sfvrsn=4db7a660. Accessed 06 October 2020.
Marson AG, Burnside G, Appleton R, et al. The SANAD II study of effectiveness of valproate or levetiracetam in generalised and unclassifiable epilepsy: an un-blinded randomised controlled trial [abstract]. 33rd International Epilepsy Congress, June 22 to 26, 2019 Bangkok. 2019;1027.
Doran Z, Shankar R, Keezer MR, et al. Managing anti-epileptic drug treatment in adult patients with intellectual disability: a serious conundrum. Eur J Neurol. 2016;23:1152-1157.
Angus-Leppan H, Moghim MM, Cock H, Kinton L, Synnott Wells M, Shankar R. Valproate risk form- surveying 215 clinicians involving 4775 encounters. Acta Neurol Scand. 2020;141(6):483-490.
Turky A, Felce D, Jones G, Kerr M. A prospective case control study of psychiatric disorders in adults with epilepsy and intellectual disability. Epilepsia. 2011;52(7):1223-1230.
Davies P, Reuber M, Grunewald R, et al. The impact and challenges of the 2018 MHRA statement on the use of sodium valproate in women of childbearing age during the first year of implementation, in a UK epilepsy centre. Seizure. 2020;79:8-13.
Angus-Leppan H, Shankar R, Cock H. Valproate, women, and exceptional circumstances. BMJ. 2018;28(362):k3625.
Watkins L, Cock H, Angus-Leppan H, Morley K, Wilcock M, Shankar R. Valproate MHRA guidance: limitations and opportunities. Front Neurol. 2019;10:139.