T 49: Establishment of Foreign Adverse Event Reporting System in Korea (KAERS-foreign)

Poster Presenter

Hyun-Kyung An

Korea Institute of Drug Safety & Risk Management
Korea, Republic of

Objectives

The Korea Adverse Event Reporting System–foreign (KAERS-foreign) was established in August 2014 to collect foreign Adverse Events, especially Serious Adverse Drug Reactions (SADR) with revision of related rules. This study is aimed at introducing the Foreign Adverse Event Reporting System in Korea.

Method

Insert edits here From 21 August 2014, the KAERS-foreign has received Individual Case Safety Reports (ICSRs) based on ICH E2B(R2) guidelines defining data elements for transmission of ICSRs. For efficiently detecting and managing of Signals, an Oracle Health Sciences safety solution, Empirica SignalTM, was adopted.

Results

Insert edits here The total number of foreign ICSRs reported from 21 August 2014 to 31 December 2015 was approximately 1.29 million. Of those ICSRs, SADRs were 99.2%. We constructed a dataset for signal detection which was included usable ICSRs through Validation and Data cleansing process. Validation and Data cleansing process includes combining initial and follow-up reports into one final report, identifying drug names provided by WHO Drug dictionaries, and taking the MedDRA terms as standard events terms. Highlighting the limitations of traditional methods such as individual case review, today’s drug safety environment calls for strategies to proactively identify and expeditiously manage safety issues. For this reason, Korea Institute of Drug Safety & Risk Management (KIDS) adopted Empirica SignalTM that efficiently provides a pharmacovigilance and safety risk management environment. We are especially going to use data mining technology from Empirica SignalTM to detect Signals and a workflow for classifying and documenting the outputs of earlier reviews and Signal scores provided by TopicsTM.

Conclusion

Insert edits here With the establishment of the KAERS and KAERS-foreign for collecting ICSRs and introduction of Empirica SignalTM for analysis, KIDS established the post-marketing surveillance process periodically providing safety information to Ministry of Food and Drug Safety (MFDS) for supporting evidence-based decision of regulatory actions. Now, KIDS are making a plan to combine domestic and foreign data in one database. Expanding the availability ADR reports by using domestic and foreign ICSRs, production of more meaningful safety information will be possible. Following the global trend, the transition from ICH E2B(R2) to ICH E2B(R3), a revised Guideline released in May 2005, KIDS are also planning to establish a domestic and foreign combination system based on E2B(R3). To prepare for the development a new system, further understanding of the benefits and challenges of implementing E2B(R3) in KAERS is also needed.