Review Of Reports

All events are assessed by a physician using the same process as for reviewing ADR reports in the spontaneous reporting programme. A "relationship'' is established between the drug and the event following the protocol for causality assessment recommended by the World Health Organisation Collaborating Centre for International Drug Monitoring (WHO) (Meyboom and Royer, 1992). The events are classified according to system-organ class using the IMMP events dictionary which is a hierarchical terminology based on the WHO adverse reactions terminology (WHOART). The hierarchy has five levels and events can be sorted at each level into their clinically related groupings or individually. There are approximately 2600 event terms in the dictionary.

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