Medication history-wide association studies for pharmacovigilance of pregnant patients.

ABSTRACT:

Background

Systematic exclusion of pregnant people from interventional clinical trials has created a public health emergency for millions of patients through a dearth of robust safety data for common drugs.

Methods

We harnessed an enterprise collection of 2.8 M electronic health records (EHRs) from routine care, leveraging data linkages between mothers and their babies to detect drug safety signals in this population at full scale. Our mixed-methods signal detection approach stimulates new hypotheses for post-marketing surveillance agnostically of both drugs and diseases-by identifying 1,054 drugs historically prescribed to pregnant patients; developing a quantitative, medication history-wide association study; and integrating a qualitative evidence synthesis platform using

SUBMITTER: Challa AP 

PROVIDER: S-EPMC9481638 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature