ABSTRACT
Title
The new Era of Signal Detection and Validation in Pharmacovigilance
Authors
G. Trifirò1, U. Moretti2, M. Lindquist3, S. Straus4 and A. Caputi1
1 Dept. Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy
2 Dept. of Public Health and Community Medicine, University of Verona, Verona, Italy
3 Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
4Pharmacovigilance, Medicines Evaluation Board (MEB), Den Haag, The Netherlands
1 Dept. Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy
2 Dept. of Public Health and Community Medicine, University of Verona, Verona, Italy
3 Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
4Pharmacovigilance, Medicines Evaluation Board (MEB), Den Haag, The Netherlands
Abstract
The tragedy of thalidomide was the trigger for the organization of the current pharmacovigilance system based on the collection and analysis of reports of suspected adverse drug reactions. Currently several national and international (e.g. World Health Organization (WHO) Vigibase and Food and Drug Administration AERS) spontaneous reporting system databases are available. Despite these data sources allow for the identification of some drug safety signals, overall they are far from optimal with respect to the timely signal detection and validation, as demonstrated by the cerivastatin and rofecoxib stories. In the last years longitudinal healthcare databases (i.e. general practice and claims databases) have been playing an emerging role for the studies of signal detection, in addition to signal validation studies. Preliminary studies have been conducted from the WHO Uppsala Monitoring Centre using single healthcare databases. Recently, several international initiatives have been set up both in USA (i.e. Sentinel, OMOP) and Europe (i.e. EU-ADR) to conduct signal detection through data mining of electronic medical records. Preliminary results of these ongoing projects showed the great potential of healthcare databases to complement spontaneous reporting system databases for both signal detection and validation. During this symposium international experts in pharmacovigilance and pharmacoepidemiology will present the most relevant national and international initiatives in the area of drug safety signal detection (i.e. experience from Italian spontaneous reporting databases and WHO Uppsala Monitoring Centre and EU-ADR project) and will discuss in depth about the limitations of traditional pharmacovigilance system and potential of healthcare databases for drug safety signal detection. As regard the need of new systems for timely signal detection, a perspective from the Dutch regulatory agency will be also provided.