FAERS Business Intelligence System (FBIS)

The FDA Adverse Event Reporting System (FAERS), which is a database that contains information on adverse event and medication error reports submitted to FDA which is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The health informatics structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonization (ICH E2B1).

Designed and developed the solution for Center for Drug Evaluation and Research’s (CDER) Office of Surveillance and Epidemiology (OSE) to detect, evaluate, and act upon adverse effects reported to FDA proactively and ability to analyze and perform data mining on various dimensions e.g. Designated Medical Events, Medication Error, Adverse Event, Drug and Active Ingredient to detect a pattern.

FBIS a fully-integrated suite of analytics tool launched since 2012 that provides charts, reports and ad-hoc query capability on over nine million reports of adverse events and reflects data from 1969 to the present. Some key features of FBIS below:

Designated Alert Screening Reports (DASR) and Medication Error Screening Reports (MESR) for detecting signals of serious risk which is critical for FDA’s safety evaluators to monitor and enforce post-market drug safety.

Critical alert reports delivered to safety evaluator’s on-time for mandatory evaluation as per regulations and helped improve critical drug safety for FDA.

Integrated adverse events and medication data to terms in the Medical Dictionary for Regulatory Activities (MedDRA) and provided capability for safety evaluators to slice and dice data using MEDRA hierarchy.

Quick Query to perform multi-dimensional analysis on fixed set of 50 dimensions e.g. products, active ingredients, drugs, lots etc. and drill down to reported adverse event and view the associate MedWatch reports.

Reporting by health care providers, consumers, patient outcome presented as scheduled reports, canned reports, personalized query and ad-query.

Data extracted from FAERS systems daily, transformed and aggregated for optimal performance.

Quick Facts:

Number of Users: 300+

Number of Adverse Events Stored: Over 9m

Deployed In: Enterprise wide in FDA

External Interfaces: FAER

Canned Reports: 200+ reports with role based data restrictions

Other Features: Ad-Hoc Query, Email Notification, personalized scheduling of reports

Technology: SAP Business Objects, Oracle Data Warehouse, Informatica