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事件回放2008年10月6日,国家食品药品监督管理局接到云南省食品药品监督管理局报告,云南省红河州6名患者,使用完达山制药厂(2008年1月更名为黑龙江省完达山药业股份有限公司)生产的两批剌五加注射液(批号:2007122721、2007121511,规格:100ml/瓶)出现严重不良反应,其中有3例死亡。无独有偶,20日,山西太行药业生产的茵栀黄注射液致四名新生儿发生不良反应,其中一名死亡,事件被媒体曝光。据相关媒体报道,完达山自8日开始主动停产,配合国家食品药品监督管理局调查组的调查,至今调查尚未完成。目前所有产品都受到严格监控,企业没有人可以接近生产车间及库房。有人在现场看到,完达山药业始终大门紧闭,除了药监部门工作人员和部分厂领导以外,任何人都不能进入厂区。10月14日,中国药品生物制品检定所检验初步结果显示,黑龙江省完达山制药厂生产的刺五加注射液部分批号的部分样品有被细菌污染的问题;2天后,卫生部责令完达山召回已上市的全部刺五加注射液。各地还要进一步落实药品不良反应报告责任,严密监测刺五加注射液不良反应报告;18日,该药厂生产的所有注射剂被暂停销售使用。黑龙江省完达山制药厂依据《药品品召回办理办法》有关规定,主动召回其所有规格和批号的注射剂产品。刺五加、茵栀黄,这些中药注射液药品再度把人们拉回到几年前的回忆中,曾经的齐二药事件、欣弗事、鱼腥草件……注射液药品安全问题再度接受拷问。
Replay of the incident On October 6, 2008, the State Food and Drug Administration received a report from the Yunnan Provincial Food and Drug Administration. Six patients in Honghe Prefecture of Yunnan Province used Wandasan Pharmaceutical Factory (renamed Heilongjiang Province in January 2008). Dashan Pharmaceutical Co., Ltd.) produced two batches of Indomethacin injections (batch number: 2007122721, 2007121511, specifications: 100 ml/bottle) with serious adverse reactions, including 3 deaths. Coincidentally, on the 20th, Shanxi Yintai Pharmaceutical produced Yinzhihuang injection caused adverse reactions in four newborns, including one death, the incident was exposed by the media. According to relevant media reports, Wandashan has stopped production since the 8th and cooperated with the investigation of the investigation team of the State Food and Drug Administration. The investigation has not yet been completed. At present, all products are strictly monitored and no one in the company can approach the production workshop and warehouse. Some people at the scene saw that Wanda Pharmaceutical has always closed its doors. No one except the staff of the drug administration department and some factory leaders can enter the factory. On October 14, the preliminary results of the inspection by the National Institute for the Control of Pharmaceutical and Biological Products showed that some samples of some batches of Acanthopanax Injection produced by the Wandashan Pharmaceutical Factory of Heilongjiang Province were contaminated with bacteria; 2 days later, the Ministry of Health ordered Wanda Shan recalled all Acanthopanax injections already on the market. All localities must further implement the reporting responsibility for adverse drug reactions and closely monitor the adverse reaction reports of Ciwujia Injection; on the 18th, all injections produced by the pharmaceutical company were suspended for sale. Wandashan Pharmaceutical Factory of Heilongjiang Province voluntarily recalled all injection products with its specifications and batch numbers in accordance with the relevant provisions of the “Measures for Drug Product Recall”. Acanthopanax and Yinzhihuang, these traditional Chinese medicine injection medicines once again pull people back into the memories of a few years ago, once the Qi 2nd medicine incident, Xinfu things, Houttuynia herbicide injection safety problems again accepted Torture.