PI-090 - PERCEIVED BARRIERS AND FACILITATORS FOR MODEL-INFORMED DOSING IN PREGNANCY AMONG HEALTHCARE PRACTITIONERS AND PREGNANT WOMEN: A QUALITATIVE STUDY.

C. Koldeweij¹, M. Kleuskens¹, B. Dean Franklin^2,3, C. Litjens⁴, L. Scheepers⁵, S. de Wildt^1,6; ¹Radboud University Medical Center, Nijmegen, The Netherlands, ²Imperial College Healthcare NHS Trust, London, England, United Kingdom, ³University College London, London, England, United Kingdom, ⁴Dutch Teratology Information Service's, Hertogenbosch, The Netherlands, ⁵Maastricht University Medical Centre, Maastricht, The Netherlands, ⁶Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.

Background: The lack of evidence for medication doses in pregnancy represents a large unmet need for pregnant women and their unborn child. This study examines the perceptions of stakeholders in the Netherlands regarding model-informed dosing in pregnancy as part of an effort to build a model-informed pregnancy formulary (MIPF) for clinical use.

Methods: Online focus groups and interviews were conducted with health care practitioners (HCPs) from various specialties (pharmacy, midwifery, general medicine, gynecology 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: 36 HCPs and 11 pregnant women participated in nine focus groups and five interviews. Barriers and facilitators identified by HCPs extended across four domains and 15 categories whereas pregnant women described barriers and facilitators across four domains and 12 categories. While most HCPs and pregnant women found a MIPF to be a relevant innovation, their level of awareness of altered pharmacokinetics that may justify dose adjustments in pregnancy varied. Several participants across both groups indicated that the lack of information on fetal safety constituted a crucial gap to address. HCPs’ information needs in order to be willing to follow model-informed dose recommendations varied. Most HCPs indicated that they preferred model predictions to be clinically verified. Several pregnant women expressed a wish to be informed on the evidence behind model-informed dose recommendations.

Conclusion: Despite the perceived novelty of model-informed dosing among stakeholders, a MIPF was seen as a promising means to enhance the quality of pharmacological care for pregnant women and their unborn child.

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