DOES PROOF OF CAUSALITY EVER EXIST IN PHARMACOVIGILANCE

被引：18

作者：

AURICHE, M ^{[1
]}

LOUPI, E ^{[1
]}

机构：

[1] PASTEUR MERIEUX SERUMS & VACCINES,DEPT POSTMKT SURVEILLANCE,DEPT PHARMACOVIGILANCE,F-69007 LYON,FRANCE

来源：

DRUG SAFETY | 1993年 / 9卷 / 03期

关键词：

D O I：

10.2165/00002018-199309030-00008

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof of a causal relationship between a drug and a specific event is quite exceptional. In most cases, this relationship remains subjective and is no more than inner conviction. Several means are at our disposal to achieve causal assessment: spontaneous reporting, clinical trials, cohorts with and without controls, and case-control studies, with each having advantages and limitations. The search for causality in pharmacovigilance is a necessary scientific goal, but a high degree of suspicion may be all that is necessary to withdraw a drug from the market if it is suspected of causing serious adverse effects.

引用

页码：230 / 235

页数：6

共 29 条

[1] Arme P., Analyse d’incidence en pharmacovigilance: application à la notification spontanée, (1991)
[2] Auriche M., Approche bayésienne de l’imputabilité des phénomènes indésirables aux médicaments, Thérapie, 40, pp. 301-306, (1985)
[3] Begaud B., Evreux J.C.L., Jouglard J.C., Lagier G., Imputabilité des effets inattendus ou toxiques des médicaments: actualisation de la méthode utilisée en France, Thérapie, 40, pp. 111-114, (1985)
[4] Bottiger L.E., Westerholm B., Drug-induced blood dyscrasias in Sweden, British Medical Journal, 3, (1973)
[5] Bryant C.D., Norman G.R., Expressions of probability: words and numbers, New England Journal of Medicine, 302, (1980)
[6] WHO co-operative trial on primary prevention of ischaemic heart-disease using clofibrate to lower serum cholesterol: mortality follow-up, Lancet, 2, pp. 279-385, (1980)
[7] Feinstein AR.I., Clinical epidemiology, (1985)
[8] Hutchinson T.A., Leventhal J.M., Kramer M.S., Kirch F.E., Lipman A.G., Et al., An algorithm for the operational assessment of adverse drug reactions: II. Demonstration of reproducibility and validity, Journal of the American Medical Association, 242, pp. 633-638, (1979)
[9] Karen F.E., Lasagna L., Towards the operational identification of adverse drug reactions, Clinical Pharmacology and Therapeutics, 21, pp. 247-254, (1977)
[10] Kenney R.M., Between never and always, New England Journal of Medicine, 305, pp. 1097-1098, (1981)

← 1 2 3 →