Teratogenic Risk Impact Mitigation (TRIM) – An Evidence-Based Decision Framework

Funded by the Food and Drug Administration, HHS75F40121C00188

CoDES Members

Department: Pharmaceutical Outcomes & Policy

Almut G Winterstein RPh, PhD, FISPE

Distinguished Professor, Director For CoDES, Director For Consortium For Medical Marijuana Clinical Outcomes Research

Department: Pharmaceutical Outcomes & Policy

Nicole E Smolinski Pharm.D., Ph.D.

Research Assistant Professor

Principal Investigator

Almut G Winterstein, RPh, PhD, FISPE

Co-Investigators & Collaborators

Academic Collaborators: Sonja Rasmussen, Judy Maro, Thuy Thai, Nicole Smolinski
FDA Collaborators: Gita A. Toyserkani, Cynthia LaCivita, Leila Lackey, Sara Eggers, Esther Zhou
Trainees: Celeste Ewig, Yanning Wang

Objectives

This study aims to provide comprehensive evidence on the fetal exposure to teratogenic drugs, to develop an evidence-based Teratogenic Risk Impact and Mitigation (TRIM) Decision Support Tool to prioritize drugs for regulatory risk mitigation (REMS programs), and, harnessing data from billing and vital records to generate new evidence, to employ TRIM to prioritize drugs for risk mitigation.

TRIM is using the entire universe of MarketScan and Medicaid data to facilitate national estimates of teratogenic medication use and support safety studies on teratogenic risk. This includes a number of validated algorithms that the Winterstein research team has developed to support pharmacoepidemiologic pregnancy research, including algorithms to establish mother-baby linkages, establish pregnancy episodes and estimate gestational age, and ascertain adverse pregnancy outcomes, and that are available to all CoDES members.