Medication-wide surveillance of pregnancy drug safety in large-scale real-world data: systematic generation of missing evidence to inform clinical decision-making

Most prescription drugs lack enough evidence on their safety for use during pregnancy.

Our overall aim is to systematically gather new evidence for the safety of a comprehensive range of prescription drugs during pregnancy, using national health registers.We will investigate the safety of every prescription drug class (i.e., “medication-wide”) in Swedish national register data 2006-2024, regarding important fetal/neonatal outcomes (e.g., congenital anomalies).

We will refine a hypothesis-generating statistical method (TreeScan, suitable for diagnostic outcomes) with multiple comparison adjustment and propensity score stratification.Results from hypothesis-generating methods need corroboration. Therefore, found signals will be investigated also with in-depth pharmacoepidemiological models.

Also, an interdisciplinary expert panel will qualitatively review results, considering, e.g., statistical robustness, consistency with prior evidence, and clinical and biological plausibility.The applicant will lead a team of a postdoc and statistician (medication-wide analysis, yrs 1-2, corroboration analyses, yrs 3-4) and lead the expert panel’s work (qualitative review, yrs 3-4).Missing drug safety evidence in pregnancy can cause both unsafe use and undertreatment of chronic and acute illness.

This project will yield new systematic evidence on drug safety to inform clinical decision-making. It will also provide a novel surveillance method for Swedish and international implementation.