IX. Add I.3.1. Designated medical events

Some medical events are known to result on most occasions from exposure to medicines. Thus, when such events are reported, the prior probability of a causal relationship to one of the medicinal products listed in the ICSR is high. Hence the ICSRs will evoke concerns even before an SDR is observed. A list of these terms, complemented by important and serious events that should not be missed, should then be created and can serve as a safety net in signal detection. It is recommended that these designated medical events (DME) are drawn to the attention of signal detection assessors irrespective of any other statistical methods used and that they are prioritised for clinical review. Elements of the DME list are generally a relatively small subset of the IME list.

The list of DME should also be periodically reviewed based on experience gained and performance.