Medication history-wide association studies for pharmacovigilance of pregnant patients.
Anup P ChallaXinnan NiuEtoi A GarrisonSara L Van DriestLisa M BastaracheEthan S LippmannRobert R LavieriJeffery A GoldsteinDavid M AronoffPublished in: Communications medicine (2022)
Here, we present roots of an agile framework to guide enhanced medication regulations, as well as the ontological and analytical limitations that currently restrict the integration of real-world data into drug safety management during pregnancy. This research is not a replacement for inclusion of pregnant people in prospective clinical studies, but it presents a tractable team science approach to evaluating the utility of EHRs for new regulatory review programs-towards improving the delicate equipoise of accuracy and ethics in assessing drug safety in pregnancy.
Keyphrases
- adverse drug
- public health
- end stage renal disease
- healthcare
- pregnant women
- ejection fraction
- chronic kidney disease
- electronic health record
- newly diagnosed
- big data
- drug induced
- prognostic factors
- palliative care
- transcription factor
- mass spectrometry
- artificial intelligence
- deep learning
- data analysis
- case control
- global health