stematic Signalling of Adverse Reactions to Drugs

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

• References

• 1 Anonymous: International Drug Monitoring – The Role of the Hospital. WHO Technical Report Series No. 425. Geneva: 1969
• 2 Abmitage P. Tests for linear trends in proportions and frequencies. Biometrics. 11 1955; 375-386.
• 3 Cochran W. G. The planning of observational studies of human populations. J. roy. Statist. Soo. A 12S 1965; 234-265.
• 4 Cochran W. G. The effectiveness of adjustment by subclassification in removing bias in observational studies. Biometrics 24 1968; 295-313.
• 5 Cochran W. G. The use of covariance in observational studies. J. roy. Statist. Soc. C IS 1969; 270-275.
• 6 Finney D. J. The design and logic of a monitor of drug use. J. chron. Dis IS 1965; 77-98.
• 7 Finney D. J. Statistical aspects of monitoring for dangers in drug therapy. Meth. Inform. Med 10 1971; 1-8.
• 8 Finney D. J. Statistical logic in the monitoring of reactions to therapeutic drugs. Meth. Inform. Med 10 1971; 237-245.
• 9 Finney D. J. Problems, data, and inference. J. roy. Statist. Soc. (In Press)
• 10 Inman W HW. The reporting of adverse reactions to drugs – The British System. Proceed. European Soc. Stud. Drug Toxic 07 1966; 191-197.
• 11 Inman W HW. Role of drug-reaction monitoring in the investigation of thrombosis and the »pill«. Brit. med. Bull 26 1970; 248-256.
• 12 Inman W. H. W, Adelstein A. M. Rise and fall of asthma mortality in England and Wales in relation to use of pressurised aerosols. Lancet 1969; II, 279-285.
• 13 Inman W. H. W, Vessey M. P, Westerholm B, Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives. Brit. med. J 1970; II, 203-209.
• 14 Napke E. Drug adverse reaction alerting program. Canad. Pharm. J 20 1968; 251-254.
• 15 Patwaey K. W. Report on Statistical Aspects of the Pilot Research Project for International Drug Monitoring. Confidential Report prepared for World Health Organization. Geneva: 1969
• 16 Royall B. W. International aspects of the study of adverse reactions to drugs. Biometrics 27 1971; 689-698.
• 17 RoYALii B. W, Ventjlet J. Methodology for international drug monitoring. Meth. Inform. Med 11 1972; 75-86.
• 18 Wold H. O. Causal inference from observational data. J. roy. Statist. Soc. A 119 1956; 28-61.