Electronic Health Records (EHRs) in Signal Detection and Evaluation

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 24, 11:00AM - 12:30PM

Session Number:
118

Room Number:
157AB

Level:
Intermediate

Type:
Session

Title:
Electronic Health Records (EHRs) in Signal Detection and Evaluation

Chair(s):
Preciosa M. Coloma, MD,PhD,MSc,RPh
Researcher
Erasmus University Medical Center, Netherlands

Description:
Safety-related warnings and market withdrawals of prominent drugs in recent years have fueled efforts to explore other data sources and develop new methodologies in order to offset the limitations of existing safety signal detection systems. One of the important resources proposed as having enormous potential for proactive surveillance are electronic health records (EHRs). There are various initiatives that have been launched worldwide to investigate the secondary use of EHRs for this purpose. In this session, we will give an update on these ongoing initiatives.

Learning Objective(s):
Discuss initiatives using electronic health records for drug safety signal detection and evaluation;Discuss lessons learned from these initiatives and opportunities for implementation within existing pharmacovigilance systems.

Presentation(s) & Speaker(s):
Separating the Big Fish from the Small Fry: Strategies for Evaluation and Triage of Potential Signals Identified from EHR
Preciosa M. Coloma, MD,PhD,MSc,RPh
Researcher
Erasmus University Medical Center, Netherlands

Can Electronic Health Care Records be Exploited for Drug Safety Signal Detection? Lessons Learned From the EU-Adverse Drug Reactions (ADR) Project
Gianluca Trifiro, MD,PhD
Assistant Professor, Dept of Clinical and Experimental Medicine and Pharmacology
University of Messina , Italy