Evaluating medicines:: let's use all the evidence

被引:29
作者
Kelman, Chris W. [1 ]
Pearson, Sallie-Anne
Day, Richard O.
D'Arcy, C.
Holman, J.
Kliewer, Erich V.
Henry, David A.
机构
[1] Australian Natl Univ, Natl Ctr Epidemiol & Populat Hlth, Canberra, ACT, Australia
[2] Australian Natl Univ, ANU Med Sch, Canberra, ACT, Australia
[3] Univ New S Wales, Inst Canc, Sydney, NSW, Australia
[4] Univ New S Wales, St Vincents Hosp, Sch Clin, Sydney, NSW, Australia
[5] Univ New S Wales, Sch Med Sci, Sydney, NSW, Australia
[6] Univ Western Australia, Ctr Hlth Serv Res, Perth, WA 6009, Australia
[7] Canc Care Manitoba, Epidemiol & Canc Registry, Winnipeg, MB, Canada
[8] Univ Manitoba, Dept Community Hlth Sci, Winnipeg, MB R3T 2N2, Canada
[9] Univ Newcastle, Sch Med & Publ Hlth, Newcastle, NSW 2308, Australia
关键词
D O I
10.5694/j.1326-5377.2007.tb00883.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The current drug regulatory system is outdated and relies primarily on a process of premarketing evaluation, followed by periodic reviews of reported adverse events. While long-term medicine use for chronic conditions is now commonplace, current drug evaluation systems do not incorporate the comprehensive evidence accruing over time in clinical practice. Good quality, routinely collected data on medicines use are now available in some countries. " Consistent with international opinion, we propose an expanded and integrated system of medicines regulation for Australia, based on a surveillance system that improves safety monitoring by complementing existing systems, making best use of routinely collected data, and leveraging the power of information technology. Australia is well placed to pilot such a model system.
引用
收藏
页码:249 / 252
页数:4
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