【摘要】 目的:介绍发达国家,特别是美国上市药品撤市状况及技术规程,为我国建立相关制度提供经验。方法:检索文献和国外药品管理部门网站(FDA网站,WHO网站等),从中获取信息,归纳药品撤市的原因、时间及相关程序。结果:以有效性和安全性为基础的效益风险比是决定药品撤市的唯一标准。诸多复杂的因素会影响药物效益-风险的评估,也会影响最终是否作出将药品撤出市场的决定。这些因素包括①出现罕见、不可预测的不良反应;②药品出现比预期更严重的不良反应;③临床用药有更安全的选择;④联合用药导致严重不良反应;⑤容易被误用;⑥其他可选的风险管理方案失败;⑦药品有效性缺失。结论:美国等发达国家实施药品撤市管理工作较早,其制度以及工作程序值得借鉴。更多还原

【Abstract】 Objective:To review the status and procedures to withdraw drugs from the market in developed countries, especially in USA.Method:Papers and webs of drug administrations abroad were searched(such as FDA,WHO), in order to get messages and reports about timeline,reasons and programs of drug withdrawal from the market.Result:The risk-to-benefit ratio was based on drug efficiency and safety.The balance of the ratio greatly contributed to the decision to withdraw a drug from the market.Many complex factors went into making judgments about benefits and risks of drugs and into ultimately deciding whether a drug should be taken off the market,such as rare and unpredictable adverse drug reaction; more serious adverse drug reactions than predicated,available safer options,dangerous combinations,improper use, the failure of other risk management options and the limit of drug efficiency.Conclusion:The procedure of the drug withdrawal from the market was conducted in developed countries,such as USA,for many years,whose experiences are worth studying.更多还原