Introduction The lack of evidence for drug dosing in pregnancy represents a large unmet need for pregnant women and their unborn child. This study examines Dutch stakeholders’ perceptions of model-informed dosing in pregnancy as part of an effort to build a model-informed pregnancy formulary (MIPF).

Methods Online focus groups and individual interviews were conducted with health care practitioners (HCPs) from various specialties (gynecology, pharmacy, general medicine, midwifery and other medical specialties) and with currently or recently pregnant women. The perceived barriers and facilitators for implementing a MIPF were identified using a hybrid thematic analysis.

Results 30 HCPs and 10 pregnant women participated in nine focus groups and three interviews. The awareness of pharmacokinetic changes in pregnancy varied across focus group participants. While a majority of HCPs and pregnant women found a MIPF to be a relevant innovation, several participants across both groups indicated that the lack of information on fetal safety constituted another important gap to address. The information needs of HCPs in order to be willing to apply model-informed dosing recommendations varied. A majority of participants indicated that they preferred model predictions to be clinically verified for the concerned drug. HCPs expressed different preferences with regards to the most appropriate website for publishing model-informed dosing advice. Several pregnant women indicated that they wanted to be informed on the evidence behind model-informed dosing recommendations.

Conclusions Stakeholders’ views on the barriers and facilitators for relying on model-informed dosing in pregnancy will be further investigated through an online survey and will inform the design of a MIPF.