PMID: 6402143Feb 12, 1983Paper

Identification of adverse reactions to new drugs. IV--Verification of suspected adverse reactions

British Medical Journal
G R Venning

Abstract

The verification processes were assessed for 18 important adverse drug reactions. Verification when achieved by formal studies was not obtained through cohort studies such as postmarketing surveillance or other follow up of drug users but through case-control studies or a similar disease orientated approach. When not achieved in this way the most useful aspects of uncontrolled studies were rechallenge and dose-response data. Analysis of the data and of the characteristics of different methods of verification suggested that there were four approaches to earlier discovery. (1) The best system seemed to be some form of record linkage, capable of providing at the same time data on incidence of adverse reactions and on prevalence of drug usage in patients with disease suspected of being drug induced. Until such a system can be established the relative efficacy of alternative approaches appears to be (2) review of all published first alerts, with prompt initiation of case-control or disease orientated studies for verification, (3) postmarketing surveillance of cohorts of drug users, and (4) voluntary reporting systems.

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Citations

Oct 20, 1989·Pharmaceutisch Weekblad. Scientific Edition·U Bergman
Apr 3, 1993·Lancet·H O LobelC C Campbell
Jan 1, 1984·Social Science & Medicine·A Melville
Jun 15, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hélène ThéophileBernard Bégaud
Nov 1, 1987·Medical Toxicology and Adverse Drug Experience·J McEwen
Jul 1, 1987·Medical Toxicology and Adverse Drug Experience·G R Venning
May 16, 2006·Pharmacoepidemiology and Drug Safety·Pascale Olivier, Jean-Louis Montastruc
Mar 1, 1992·Journal of Clinical Epidemiology·U Bergman
Jul 1, 1988·British Journal of Clinical Pharmacology·M D Rawlins
Nov 29, 2005·Journal of the American Academy of Dermatology·R Sonia BatraKenneth A Arndt
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Jul 3, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Toine C G Egberts
Oct 5, 1992·The Journal of Pharmacy Technology : JPT : Official Publication of the Association of Pharmacy Technicians·M C Allan
Oct 18, 2002·CNS Drugs·Staffan Hägg, Olav Spigset
Dec 1, 1994·Pharmazie in unserer Zeit·P Schädlich, F M Niemann
Mar 7, 1988·The Medical Journal of Australia·P M Brooks

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