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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1403747

Willingness-to-use and preferences for model-informed antenatal doses: a cross-sectional study among European healthcare practitioners and pregnant women

Provisionally accepted
Charlotte Koldeweij Charlotte Koldeweij 1*Caroline Dibbets Caroline Dibbets 1,2Michael Ceulemans Michael Ceulemans 3,4,5Loes de Vries Loes de Vries 6Bryony D. Franklin Bryony D. Franklin 7,8Hubertina C. Scheepers Hubertina C. Scheepers 2,9Saskia N. De Wildt Saskia N. De Wildt 1,10
  • 1 Division of Pharmacology and Toxicology, Department of Pharmacy, Radboud University Medical Centre, Nijmegen, Netherlands
  • 2 Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, Limburg, Netherlands
  • 3 Department of Clinical Pharmacology and Pharmacotherapy, Faculty of Pharmaceutical Sciences, KU Leuven, Leuven, Belgium
  • 4 Department of IQ Healthcare, Radboud University Medical Centre, Nijmegen, Netherlands
  • 5 Child and Youth Institute, KU Leuven, Leuven, Belgium
  • 6 Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, s’Hertogenbosch, Netherlands
  • 7 Centre for Medication Safety and Service Quality,, Imperial College Healthcare NHS Trust, Faculty of Medicine, Imperial College London, London, England, United Kingdom
  • 8 Department of Practice and Policy, UCL School of Pharmacy, London, United Kingdom
  • 9 GROW School for Oncology & Reproduction, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands, Netherlands
  • 10 Department of Paediatric and Neonatal Intensive Care, Sophia Children's Hospital, Erasmus Medical Center, Rotterdam, Netherlands

The final, formatted version of the article will be published soon.

    Background: Physiological changes in pregnancy may affect drug safety and efficacy, sometimes requiring dose adjustments. Pregnancy-adjusted doses, however, are missing for most medications. Increasingly, pharmacokinetic models can be used for antenatal dose finding. Given the novelty of this technique and potential concerns about dose credibility, the acceptability of model-informed antenatal doses should be explored. Objective: We aimed to assess the willingness-to-use and preferred features for model-informed antenatal doses among healthcare practitioners (HCPs) and pregnant women in multiple European countries. Methods: A crosssectional, web-based study drawing on two open surveys was performed between 8 September and 30 November 2022. Each survey comprised statements drawn from prior focus groups, associated with Likert-scales. Themes included respondents' information needs, search behaviours along with their willingness-to-use and preferred features for model-informed antenatal doses. The surveys were disseminated through professional societies, pregnancy websites and social media. A descriptive analysis was performed. Results: In total, 608 HCPs from different specialties and 794 pregnant women across 15 countries participated, with 81% of respondents across both groups in the Netherlands or Belgium. Among pregnant women, 31% were medical professionals and 85% used medication during pregnancy. Eighty-three percent of HCPs found current antenatal pharmacotherapy suboptimal and 97% believed that modelinformed antenatal doses would enhance the quality of antenatal care. Most HCPs (93%) and pregnant women (75%) would be willing to follow model-informed antenatal doses. Most HCPs desired access to the evidence (88%), including from pharmacokinetic modelling (62%). Most pregnant women (96%) wanted to understand antenatal dosing rationales and to be involved in dosing decisions (97%). Conclusion: The willingness-to-use model-informed antenatal doses is high among HCPs and pregnant women provided that certain information needs are met.

    Keywords: Dose, Pregnancy, Pharmacokinetic models, Acceptability, implementation

    Received: 19 Mar 2024; Accepted: 29 Jul 2024.

    Copyright: © 2024 Koldeweij, Dibbets, Ceulemans, de Vries, Franklin, Scheepers and De Wildt. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Charlotte Koldeweij, Division of Pharmacology and Toxicology, Department of Pharmacy, Radboud University Medical Centre, Nijmegen, Netherlands

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.