Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016.
Adolescent
Adult
Anticonvulsants
/ administration & dosage
Bipolar Disorder
/ drug therapy
Child
Cohort Studies
Databases, Factual
Epilepsy
/ drug therapy
Female
France
Humans
Italy
Middle Aged
Practice Patterns, Physicians'
/ standards
Pregnancy
Pregnancy Complications
/ drug therapy
United Kingdom
Valproic Acid
/ administration & dosage
Young Adult
antiepileptic medications
epidemiology
health care databases
sodium valproate
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
17
10
2018
revised:
17
06
2019
accepted:
22
07
2019
pubmed:
28
8
2019
medline:
25
7
2020
entrez:
28
8
2019
Statut:
ppublish
Résumé
In November 2014, the CMDh (a regulatory body representing EU Member States) advised doctors not to prescribe sodium valproate for epilepsy or bipolar disorder in preg nant women, in women who can become pregnant, or in girls unless other treatments are ineffective or not tolerated. This study aimed to determine if this warning led to changes in prescription patterns. Cohort of 5.4 million women aged between 10 and 50 years identified in electronic health care data from United Kingdom, France, and Italy (2007-2016). Anti-epileptic drug (AED) prescriptions. The prevalence of women receiving AED prescriptions in 2016 varied from 12.2 per 1000 to 29 per 1000 in the four regions. The incidence of prescribing any AED (excluding clonazepam, gabapentin, and pregabalin) fell each year on average by 7.5% (95% CI, 7.0%-8.0%; Emilia Romagna), 9.6% (8.3%-11.0%; France), 7.1% (6.7%-7.6%; Tuscany), and 0.4% (0.2%-1.0%; United Kingdom). The relative odds of prescribing sodium valproate rather than any other AED decreased more after 2014 compared with before the end of 2014 in France (OR = 0.77; 95% CI, 0.60-0.98), Tuscany (0.81; 0.76-0.86), Emilia Romagna (0.83; 0.76-0.90), and the United Kingdom (0.92; 0.80-1.06; not statistically significant). There is evidence that the CMDh warning did lead to changes in prescription patterns of sodium valproate in women of childbearing age. There were considerable differences in prescribing practice amongst regions of Europe.
Substances chimiques
Anticonvulsants
0
Valproic Acid
614OI1Z5WI
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1519-1528Informations de copyright
© 2019 John Wiley & Sons, Ltd.
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