European network for the case-population surveillance of rare diseases (Euronet). A prospective feasibility study

被引:16
作者
Capella, D
Laporte, JR
Vidal, X
Wiholm, BE
Begaud, B
Langman, MJS
Rawlins, M
机构
[1] Autonomous Univ Barcelona, Inst Catala Farmacol, E-08035 Barcelona, Spain
[2] Med Prod Agcy, Uppsala, Sweden
[3] Karolinska Inst, Dept Clin Pharmacol, S-10401 Stockholm, Sweden
[4] Hop Pellegrin, Ctr Pharmacovigilance Bordeaux Aquitaine, F-33076 Bordeaux, France
[5] Univ Birmingham, Dept Med, Birmingham B15 2TT, W Midlands, England
[6] Univ Newcastle, Wolfson Unit Clin Pharmacol, Newcastle Upon Tyne, Tyne & Wear, England
关键词
surveillance of rare disease; European network;
D O I
10.1007/s002280050382
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Objective: Euronet, a case-population surveillance scheme, aims to estimate the risk of certain rare conditions which are commonly iatrogenic, by comparing drug use amongst non-selective cases with overall drug use in the general population. Methods: The method is based on three provisos: (1) all incident cases (irrespective of suspected aetiology) should be ascertained and studied; (2) a full drug history should be obtained from cases by direct interview; and (3) drug-use data for the products of interest should be available for this population from which cases are chosen. The feasibility of this problem-oriented approach for the identification of new signals of adverse drug reactions and for risk estimation will be tested in relation to agranulocytosis, Stevens-Johnson syndrome and toxic epidermal necrolysis in four defined areas in Europe, totalling 19 x 10(6) inhabitants, with these latest two outcomes being studied in only three regions. The design, methods and main limitations of this case-population surveillance approach are described.
引用
收藏
页码:299 / 302
页数:4
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