From association to alert—a revised approach to international signal analysis
✍ Scribed by Marie Lindquist; Ivor Ralph Edwards; Andrew Bate; Helena Fucik; Ana Maria Nunes; Malin Ståhl
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 161 KB
- Volume
- 8
- Category
- Article
- ISSN
- 1053-8569
No coin nor oath required. For personal study only.
✦ Synopsis
From the inception of the WHO international drug monitoring programme, the main aim has been to detect signals of adverse reaction problems as early as possible. The Uppsala Monitoring Centre (UMC), is now in a better position to ful®l this mission. Using the latest technology, new tools have been developed which allow for rapid, robust and comprehensive data mining of the WHO database. Based on retrospective time scans made during the pilot phase the current threshold used is the 97.5% con®dence level of dierence from 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 ®le of all drug±ADR associations. Already we produce some 50 signals per year, cisapride and tachycardia being an example of a controversial signal only recently accepted. With the addition of new tools for follow-up of important signals such as complex variable data mining techniques, and the combination of WHO ADR data with sales and prescription ®gures from the IMS, we will be able to provide more information that should bene®t regulators, producers, prescribers, and most importantly, the users of medicines.