Abstract: The characteristics of cluster adverse drug events are shown as multiple adverse drug events with similar clinical manifestations centrally occuring in the same drug of the same or adjacent batch number manufactured by the same manufacturer within a short-term period. By analysis and evaluation on cluster adverse drug events, it is determined whether cluster adverse drug event is constituted. The early warning system on the cluster adverse drug events, which has been built by the National Center for ADR Monitoring, China, has an important role to monitor, feedback rapidly and control the suspicious product quality events. However, the warning information, based on the national database of the ADR individual case reports, could not present on the provincial work interface simultaneously. So the events settlement between national center and provincial centers did not keep consistency and continuity. In order to deal with the problem, the early warning system sharing platform was designed and practiced in the national database of the ADR individual case reports.

Key words: cluster adverse drug events, early warning system, sharing platform