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Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies
R L Bromley1,2, M Bickle Graz3, M Bluett-Duncan1
1Division of Neuroscience, Faculty of Medicine, School of Biological Sciences, Biology and Health, University of Manchester, Manchester, United Kingdom.
Frontiers in Pharmacology
|June 19, 2023
Summary
This study establishes essential recommendations for improving pregnancy pharmacovigilance by focusing on neurodevelopmental outcomes in medication-exposed pregnancies. The findings guide future research to better understand and mitigate potential developmental risks.
Area of Science:
- Pharmacovigilance
- Neurodevelopmental Science
- Pregnancy Studies
Background:
- Prenatal medication exposure can negatively impact fetal brain development, leading to neurodevelopmental issues.
- Existing pregnancy pharmacovigilance lacks sufficient neurodevelopmental outcome investigations.
- An international expert group convened to address this gap.
Purpose of the Study:
- To achieve consensus on core neurodevelopmental outcomes for pregnancy pharmacovigilance.
- To optimize methodological approaches for these studies.
- To identify barriers in conducting pregnancy pharmacovigilance with neurodevelopmental outcomes.
Main Methods:
- A modified Delphi study involving stakeholders and experts.
- Stakeholders defined key topics for medication-exposed pregnancies.
- Experts with relevant experience participated in two questionnaire rounds and a virtual meeting.
Main Results:
- 25 experts from 13 countries developed 11 recommendations.
- Emphasized neurodevelopment as a core pharmacovigilance feature, recommending study initiation in infancy through adolescence.
- Provided guidance on outcome measurement, comparator groups, confounding variables, and funding.
Conclusions:
- Enhanced focus on neurodevelopmental outcomes is crucial in pregnancy pharmacovigilance.
- Expert recommendations should guide complementary studies for comprehensive evidence.
- This will improve understanding of in utero medication effects on child development.
Keywords:
in utero exposuremedicinesneurobehaviorneurodevelopmentpharmacovigilancepregnancyteratogensMore Related Videos
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