ArticlePharmacoepidemiology and drug safety2021
Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe.
Article in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Mixed Impact of Direct Healthcare Professional Communications When Considering Proximal Outcomes and the Targeted Population: A Systematic Review.Pharmacoepidemiology and drug safety · 2025Pooled it
- Reducing Exposure Before Birth: An Interrupted Time Series Study of Prenatal Exposure to Fetotoxic Medications Under Risk Management Plans in Canada.Clinical pharmacology and therapeutics · 2026Article
- Secular Trends in the Use of Valproate-Containing Medicines in Women of Childbearing Age in Europe: A Multinational DARWIN EU Network Study.Pharmacoepidemiology and drug safety · 2025Article
- Trends in Prenatal Exposure to Antiseizure Medications Over the Past Decade: A Nationwide Study.Neurology · 2025Article
- How effective is the implementation of the valproate pregnancy prevention programme in Montenegro? - A 7-year national retrospective study.Therapeutic advances in drug safety · 2025Article
- Prenatal Exposure to Valproic Acid Across Various Indications for Use.JAMA network open · 2024Article
- Impact of Risk Minimisation Measures on Valproate Use among Women of Reproductive Age in Latvia Between 2013 and 2020: A 7-Year Nationwide Prescription Database Study.Drugs - real world outcomes · 2023Article
- Article
- Review
- Valproate utilisation trends among women of childbearing potential in Ireland between 2014 and 2019: A drug utilisation study using interrupted time series.Pharmacoepidemiology and drug safety · 2022Article
- Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe.Pharmacoepidemiology and drug safety · 2021Article
- Longitudinal Australian trends in the initiation of valproate medication among women of reproductive age and concurrent use of prescription contraceptives.Women's health (London, England)Article
Corrections and comments
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Authors and funding
6 authors at 6 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe purpose of this study was to evaluate the effectiveness of the risk minimisation measures (RMMs) implemented in Europe in 2014 for valproate-containing products to mitigate their risk during pregnancy and to characterise valproate prescribing patterns in women of childbearing potential (WCBP) before and after implementation of RMMs.
methodsA multinational cohort study based on existing data sources using a pre-/post- design was performed in five European countries (France, Germany, Spain, Sweden, UK) in an outpatient setting. Effectiveness of RMMs was assessed by comparing the proportion of valproate initiations as second (or subsequent) line therapy before and after implementation of RMMs (primary outcome) with an increase in this proportion indicating success of RMMs. Overall use of valproate and incidence of pregnancies in WCBP were also examined.
resultsThe proportion of valproate initiations as second line therapy increased after implementation of RMMs in incident female users in Sweden (from 81.1%, 95% CI 79.9%-82.3% to 84.5%, 95% CI 83.5%-85.5%) and the UK (from 66.4%, 95% CI 64.5%-68.3% to 72.4%, 95% CI 70.0%-74.9%), it remained the same in Germany and Spain and decreased in France from 48.7% (95% CI 45.6%-51.9%) to 40.6% (95% CI 37.6%-43.7%). In Sweden and the UK, the incidence of pregnancies exposed to valproate decreased in the post-implementation period: 8.0 vs 9.5 and 10.9 vs 16.9 per 1000 person-years, respectively.
conclusionThe results on primary outcome of this study suggest limited effectiveness of the RMMs. Additional RMMs were implemented in 2018.
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