The Scottish medicines in pregnancy programme: supporting the surveillance of medicines use during pregnancy and assessment of associated clinical outcomes

Pharmacological treatment during pregnancy is often necessary but presents challenges due to limited availability of safety data. In response to a UK-wide review of medicine safety, the Scottish Government commissioned the development of a national surveillance infrastructure to monitor medicines use during pregnancy and associated clinical outcomes. Two real-world data assets were developed by integrating routinely collected primary and secondary care data: the Scottish Combined Medicines Dataset (SCoMeD) consolidates medicines data, while the Scottish Linked Pregnancy and Baby Dataset (SLiPBD) captures comprehensive data related to pregnancies. Two exemplar case studies were conducted to test the utility of these datasets. First, an audit of anti-seizure medicines (ASM) prescribing 04.2018–03.2025; and second, a retrospective cohort study of pregnancies conceived between 04.2010 and 06.2023, matching ASM exposed to ASM unexposed pregnancies to assess pregnancy, baby, and early childhood outcomes. Study periods were chosen based on data availability. The linkage of SCoMeD and SLiPBD enabled national-level surveillance of ASM prescribing trends and in-utero exposures. ASM prescribing surveillance showed an expected decrease in the use of valproate and topiramate among women of childbearing age, reflecting regulatory risk minimisation measures. Observational analyses confirmed valproate-associated teratogenic and developmental risks, whilst supporting the relative safety of lamotrigine and levetiracetam during pregnancy. This programme demonstrates the value of leveraging nation-wide, whole system data for the surveillance of medicines safety in pregnancy. The linkage of real-world data provides regulatory-relevant evidence to inform guidelines and risk minimisation strategies. Scotland’s integrated medicines infrastructure positions the country as a key contributor in the European pharmacovigilance landscape. • There is considerable uncertainty regarding the safety of medicines during pregnancy due to pregnant women being frequently excluded from clinical trials. • Two new substantive data resources have been developed in Scotland to enable the national surveillance of medicine use during pregnancy and support ongoing efforts to de-risk regulatory decision-making. • The Scottish Combined Medicines Dataset (SCoMeD) and the Scottish Linked Pregnancy and Baby Dataset (SLiPBD) provide consolidated patient-level medicines data from both primary and secondary care and detailed pregnancy information, respectively, and can be linked to other national datasets to facilitate population-based pregnancy pharmacoepidemiology research.