From association to alert - A revised approach to international signal analysis

From the inception of the WHO international drug monitoring programme, the main aim has been to detect signals of adverse reaction problems as early a s possible. The Uppsala Monitoring Centre (UMC), is now in a better positio n to fulfil this mission. Using the latest technology, new tools have been developed which allow for rapid, robust and comprehensive data mining of th e WHO database. Based on retrospective time scans made during the pilot pha se the current threshold used is the 97.5% confidence level of difference f rom the generality of the database. To maximize the capacity for picking up signals, we intend to extend today's panel of expert consultants, as well as doing our own review. The new system includes an enhanced follow-up list of signals, a 're-signalling' procedure and a cumulative historical file o f all drug-ADR associations. Already we produce some 50 signals per year, c isapride and tachycardia being an example of a controversial signal only re cently accepted. With the addition of new tools for follow-up of important signals such as complex variable data mining techniques, and the combinatio n of WHO ADR data with sales acid prescription figures from the IMS, we wil l be able to provide more information that should benefit regulators, produ cers, prescribers, and most importantly, the users of medicines. Copyright (C) 1999 John Wiley & Sons, Ltd.