(101) Drug utilisation studies in pregnant women for newly licensed medicinal products: reflections from IMI-ConcePTION

Publication Number: 1096

Background: Studies focusing on safety outcomes typically require large populations to comprehensively characterise the patient groups exposed to the medicines under investigation. However, there is often less information for sub-populations, such as pregnant or breastfeeding women, particularly when new medicines are considered. It is important to understand what information can be obtained from drug utilisation studies (DUS) involving pregnant women in the early years post-marketing to provide supportive information for safety studies.

Objectives: 1) to identify and review DUS for new medicines in pregnancy and breastfeeding; 2) to list and summarise key information items to be reported in a DUS for new medicines in pregnancy.

Methods: To identify post-marketing DUS of new prescription medicines or enantiomers in pregnancy, literature searches were undertaken in PubMed and Embase between January 2015 and June 2022, and in the ENCePP EU PAS Register to June 2022

Results: We identified 11 published DUS on new medicines in pregnancy from the ENCePP EU PAS Register, and none from other sources. Based on these studies, we created a detailed list of items that can be taken into account when undertaking a DUS in pregnant women for new drugs, within the first 3 to 5 years after marketing approval. Progress was reported annually in seven studies. Eight DUS included prescribing / dispensing data at individual patient level only for ambulatory care; specialist outpatient prescribing was included in three of these. All studies had as the main objective to report the number of pregnant women prescribed the medicine(s) of interest.

Conclusions: This review offers guidance on parameters to consider when undertaking a DUS for newly marketed medicines. The results of a DUS can confirm, at an early stage, whether there are sufficient exposed pregnancies available in the selected data sources to ensure that safety studies will be powered to detect any differences in the prevalence of adverse pregnancy or infant outcomes, and if there is a need for additional data from other databases. Databases with data on breastfeeding and hospital prescribing information are currently too scarce.