Abstract
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.
| Language | English |
|---|---|
| Pages | 1519-1528 |
| Number of pages | 10 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 28 |
| Issue number | 11 |
| Early online date | 26 Aug 2019 |
| DOIs | |
| Publication status | Published - 1 Nov 2019 |
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Keywords
- antiepileptic medications
- sodium valproate
- health care databases
- epidemiology
Cite this
}
Did advice on the prescription of Sodium Valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016. / Charlton, Rachel; Damase-Michel, Christine; Hurault-Delarue, Caroline; Gini, Rosa; Loane, Maria; Pierini, Anna ; Puccini, Aurora; Neville, Amanda; Snowball, Julia; Morris, Joan K.
In: Pharmacoepidemiology and Drug Safety, Vol. 28, No. 11, 01.11.2019, p. 1519-1528.Research output: Contribution to journal › Article
TY - JOUR
T1 - Did advice on the prescription of Sodium Valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016
AU - Charlton, Rachel
AU - Damase-Michel, Christine
AU - Hurault-Delarue, Caroline
AU - Gini, Rosa
AU - Loane, Maria
AU - Pierini, Anna
AU - Puccini, Aurora
AU - Neville, Amanda
AU - Snowball, Julia
AU - Morris, Joan K.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - ObjectivesIn 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 settingCohort 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 measuresAnti‐epileptic drug (AED) prescriptions.ResultsThe 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).ConclusionsThere 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.
AB - ObjectivesIn 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 settingCohort 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 measuresAnti‐epileptic drug (AED) prescriptions.ResultsThe 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).ConclusionsThere 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.
KW - antiepileptic medications
KW - sodium valproate
KW - health care databases
KW - epidemiology
UR - http://www.scopus.com/inward/record.url?scp=85071622970&partnerID=8YFLogxK
U2 - 10.1002/pds.4881
DO - 10.1002/pds.4881
M3 - Article
VL - 28
SP - 1519
EP - 1528
JO - Pharmacoepidemiology and Drug Safety
T2 - Pharmacoepidemiology and Drug Safety
JF - Pharmacoepidemiology and Drug Safety
SN - 1053-8569
IS - 11
ER -