Signalling Increases in Reporting in International Monitoring of Adverse Reactions to Therapeutic Drugs

The present »state of the art« of monitoring events based on spontaneous, voluntary, haphazard reporting is reviewed. Particular reference is made to the problem of signalling increases in reporting in the international monitoring of adverse reactions to therapeutic drugs. It is shown how a number of different avenues of research could be usefully pursued to provide signals for increases in reporting which are more specific and more sensitive than those which are currently available. In particular, the so-called »Centre-Batch« matrix is introduced, and it is shown that the information contained in it can be used with advantage to provide signals which are more informative than those which are obtained from data aggregated over several reporting centres. Other approaches introduced include methods for the detection of patterns of adverse events, the idea of using system measures for monitoring the performance of the monitoring system itself and the potentialities of signals based on quantitative data.