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Methods Inf Med 1974; 13(01): 01-10
DOI: 10.1055/s-0038-1636131
Original Article
Schattauer GmbH

stematic Signalling of Adverse Reactions to Drugs

Systematische Anzeige Yon Arzneimittel-Nebenwirkungen
D. J. Finney
*   Department of Statistics, University of Edinburgh, Scotland
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Publication History

Publication Date:
10 February 2018 (online)

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Many national centres now cooperate with the World Health Organization in a system for monitoring information on suspected adverse reactions to therapeutic drugs. Proposals are made here for various methods of systematically producing signals from the computer files, with the object of indicating disproportions in frequencies that may be due to adverse reactions. Signals are intended to arouse suspicions and to stimulate deeper investigation; they are not to be equated with warnings of danger. Emphasis is laid on the dissemination of signals to national centres and on the logic of interpretation. Particularly important is restriction of the number of non-urgent signals, so as to ensure a reasonable chance of thorough investigation nationally for each that is transmitted.

Viele nationale Zentren beteiligen sich jetzt an dem Arzneimittel-Überwachungssystem der WeltGesundheits-Organisation tuid liefern Informationen über suspekte Nebenwirkungen von Drogen. In der vorliegenden Arbeit werden verschiedene Methoden erörtert, welche systematisch Signale aufgrund der im Computer gespeicherten Daten erzeugen und deren Ziel es ist, auf Mißverhältnisse in der Vorkommenshäufigkeit hinzuweisen, die durch Nebenwirkungen hervorgerufen sein, könnten. Diese Signale sollen Verdacht erregen und genauere Untersuchungen anregen; sie sind nicht als Gefahrensignale anzusehen. Besonderer Wert wird auf die Weitergabe der Signale an die nationalen Zentren und auf ihre logische Interpretation gelegt. Besonders wichtig ist die Beschränkung der Anzahl der nicht-dringlichen Signale; dadurch soll erreicht werden, daß eine echte Chance für eine gründliche Untersuchung auf nationaler Basis für alle übermittelten Signale besteht.

Key-Words

Adverse Reactions - Drug Interactions - Drug Monitoring - Information Retrieval - New Drugs

Schlüssel- TVo1·te1·

Nebenwirkungen - Drogen-Wechselwirlnmgen - Drogenüberwachung - InformationsvViedergewillllung - neue Drogen
 

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