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Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016.

Charlton, R; Damase-Michel, C; Hurault-Delarue, C; Gini, R; Loane, M; Pierini, A; Puccini, A; Neville, A; Snowball, J; Morris, JK; et al. Charlton, R; Damase-Michel, C; Hurault-Delarue, C; Gini, R; Loane, M; Pierini, A; Puccini, A; Neville, A; Snowball, J; Morris, JK; EUROmediSAFE consortium (2019) Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016. Pharmacoepidemiol Drug Saf, 28 (11). pp. 1519-1528. ISSN 1099-1557 https://doi.org/10.1002/pds.4881
SGUL Authors: Morris, Joan Katherine

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Abstract

OBJECTIVES: 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. DESIGN AND SETTING: 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). MAIN OUTCOME MEASURES: Anti-epileptic drug (AED) prescriptions. RESULTS: 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). CONCLUSIONS: 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.

Item Type: Article
Additional Information: This is the peer reviewed version of the following article: Charlton, R, Damase‐Michel, C, Hurault‐Delarue, C, et al. Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016. Pharmacoepidemiol Drug Saf. 2019; 28: 1519– 1528, which has been published in final form at https://doi.org/10.1002/pds.4881. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions.
Keywords: antiepileptic medications, epidemiology, health care databases, sodium valproate, EUROmediSAFE consortium, antiepileptic medications, epidemiology, health care databases, sodium valproate, 1115 Pharmacology And Pharmaceutical Sciences, 1117 Public Health And Health Services, Pharmacology & Pharmacy
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Pharmacoepidemiol Drug Saf
ISSN: 1099-1557
Language: eng
Dates:
DateEvent
8 November 2019Published
26 August 2019Published Online
22 July 2019Accepted
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
EMA/2015/25/PHEuropean Medicines AgencyUNSPECIFIED
PubMed ID: 31452307
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/111146
Publisher's version: https://doi.org/10.1002/pds.4881

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