Postmarketing surveillance: strengths and limitations - The flucloxacillin-dicloxacillin story
Postmarketing surveillance: strengths and limitations - The flucloxacillin-dicloxacillin story
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DOI：
10.5694/j.1326-5377.1999.tb127751.x
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发表时间：
1999-03-15
影响因子：
11.4
通讯作者：
McDonald, MM
中科院分区：
文献类型：
--
作者：
McNeil, JJ;Grabsch, EA;McDonald, MM
药物不良反应的自发报告仍然是监测上市药品安全性的主要方法。尽管这些方案取得了许多成功，但它们只能可靠地检测到可能的药物相关事件范围中的一小部分，并且几乎没有提供有用的定量数据。最近证明了与氟氯西林有关的自发报告的一些局限性。澳大利亚的报告表明氟氯西林相关黄疸的风险可能不可接受，但新西兰和英国等使用该药物明显相似的国家的自发报告数据不足以证实或反驳这一主张。自发监测应辅之以对新药使用者群体的系统监测，使用记录链接来跟踪他们的后续情况 健康。尽管在澳大利亚引入此类计划存在一些障碍，但应考虑解决如何实施此类系统的问题。
Spontaneous reporting of adverse drug reactions continues to be the principal method used for monitoring the safety of marketed drugs. Despite the many successes attributed to these schemes, they can reliably detect only a small fraction of the range of possible drug-related events and provide virtually no useful quantitative data.Some of the limitations of spontaneous reporting were demonstrated recently in relation to flucloxacillin. Reports in Australia suggested the likelihood of an unacceptable risk of flucloxacillin-associated jaundice, but the data from spontaneous reporting in countries with apparently similar use of the drug, such as New Zealand and the UK, were insufficient to confirm or refute this proposition.Spontaneous monitoring should be supplemented by the systematic monitoring of cohorts of users of new drugs, using record-linkage to track their subsequent health. Although several impediments exist to the introduction of such a scheme in Australia, consideration should be given to addressing how such a system might be implemented.