Abstract
BackgroundValproate is a teratogenic drug that should be avoided during the preconception period and pregnancy. The aim was to explore general practitioners’ (GPs) prescription patterns over time, describe trends, and explore inter-practice variation within primary care.MethodsWe identified women of childbearing age (12–46 years old) in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network. We performed repeated cross-sectional analyses from 2004 to 2018 to determine rates of prescription and a retrospective cohort estimated the prevalence of use of valproate during pregnancy.ResultsIn 2004, 0.31% (95% Confidence Interval (95%CI):0.18 to 0.44%) women were prescribed valproate, decreasing to 0.16% (95%CI:0.07 to 0.24%) by 2018. Among women with epilepsy, the rate fell from 15.2% (95%CI:14.4 to 16.0%) to 8.8% (95% CI:8.2 to 9.7%) over the same period. In 2018, almost two thirds (62.2%) of women who were prescribed valproate had epilepsy only, whereas bipolar disorder and migraine accounted for 15.8% and 7.4% respectively. Contraceptive prescriptions did not increase over time, and only in 2018 was there greater odds of being prescribed contraception (OR 1.41, 95%CI:1.08 to 1.45). Just under a fifth (19.7%) of women were prescribed valproate during their pregnancy; two out of three of these pregnancies were preceded by folic acid prescription (5 mg). While some practices reduced their rate of valproate prescription, others did not.ConclusionsRegulatory guidelines have changed GPs' prescription patterns in women of childbearing potential for valproate but not for contraception. Further research is needed to identify the barriers of GPs and women of childbearing potential to undertaking contraception.
Highlights
Valproate is a teratogenic drug that should be avoided during the preconception period and pregnancy
Retrospective cohort design to report the use of folic acid and the outcomes of pregnancy for women exposed to valproate during the preconception period
All Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) data are pseudonymised at the point of data extraction and no personally identifiable data are available to researchers
Summary
Valproate is a teratogenic drug that should be avoided during the preconception period and pregnancy. The Medicines and Healthcare products Regulatory Agency (MHRA) released a “toolkit” for patient use to raise the awareness of potential effects of valproate in pregnancy. This advised health care professionals (HCPs) to discuss the need for contraception with patients and to provide a detailed description of the risk of congenital malformations in case of pregnancy [1]. Completion of an annual risk acknowledgment form is requested from the valproate user or their caregiver/guardian and from the prescribing general practitioner (GP) This is to confirm women’s understanding of the associated risks and the consequent measures which must be taken if they become pregnant while taking the drug
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