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

S. P. H. Mandel; A. Levine; G. E. Beleno

doi:10.1055/s-0038-1635720

Methods of Information in Medicine, Table of Contents

Methods Inf Med 1976; 15(01): 1-10
DOI: 10.1055/s-0038-1635720

Original Article

Schattauer GmbH

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

Die Anzeige Vermehrter Meldungen an Ein Internationales Warnsystem Über Arzneimittelnebenwirkungen

Authors

S. P. H. Mandel

¹Biometrics Unit, Dept. of Mathematics, University of Otago, Dunedin, New Zealand; the Dept. of Mathematics, Tulane University, New Orleans, USA; the World Health Organization, Geneva, Switzerland
A. Levine

¹Biometrics Unit, Dept. of Mathematics, University of Otago, Dunedin, New Zealand; the Dept. of Mathematics, Tulane University, New Orleans, USA; the World Health Organization, Geneva, Switzerland
G. E. Beleno

¹Biometrics Unit, Dept. of Mathematics, University of Otago, Dunedin, New Zealand; the Dept. of Mathematics, Tulane University, New Orleans, USA; the World Health Organization, Geneva, Switzerland

Abstract

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.

Die Autoren geben eine Übersicht über den »State of the art« der auf spontaner, freiwilliger und zufälliger Meldung beruhenden Warnsysteme. Dabei wird insbesondere auf das Problem der Anzeige vermehrter Meldungen an das internationale Warnsystem über Arzneimittelnebenwirkungen eingegangen. Es wird dargelegt, wie eine Anzahl verschiedener Wege der Forschung nutzbringend verfolgt werden können, tun spezifischere und empfindlichere Hinweise als die derzeit verfügbaren auf vermehrte Meldungen zu bekommen. Im besonderen wird die sogenannte »Centre-Batch« Matrix vorgestellt und dabei gezeigt, daß die darin enthaltene Information nutzbringend verwandt werden kann, um Hinweise zu geben, die informativer sind als solche, die aus von mehreren Meldezentren gesammelten Daten gewonnen werden. Unter anderem werden Methoden für die Entdeckung von Nebenwirkungskonstellationen vorgestellt, die Idee geäußert, Überwachungsmaßzahlen für die Güte des Überwachungssystems selbst zu benutzen, und die Möglichkeiten von auf quantitativen Daten basierenden Signalen diskutiert.

Key-Words

Drug Monitoring - Adverse Reactions - Signals - Centre-Batch Matrix

Schlüssel-Wörter

Arzneimittel-Warnsystem - Nebenwirkungen - Signale - »Centre-Batch Matrix«

Full Text

References

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