我国不良反应通报药品的风险再评估与应对措施分析

The risk reassessment and countermeasures for the drugs reported in adverse drug reaction information bulletin of China

目的:再评估国家不良反应通报药品的风险水平,总结针对这些药品国家采取的相应控制措施。方法:选取2001-2016年间国家食品药品监督管理总局发布的《药品不良反应信息通报》中报道的药品,对通报的每个药品不良反应(ADR)的发生频率和严重程度进行赋值,分别计算药品相应的风险分值,并建立药品的风险矩阵。将ADR发生频率和严重程度均高于平均值的药品界定为高风险药品。结果:在117个通报药品中,有53个药品符合风险评估要求,其中,西药34个(64%),中药20个(38%),注射剂26个(49%)。处于高风险区域药品共计10个,分别是注射用头孢硫脒、盐酸氨溴索注射剂、维生素K1注射液、左氧氟沙星注射剂、胸腺肽注射剂、骨肽和复方骨肽注射剂、红花注射液、香丹注射液、细辛脑注射剂、脉络宁注射液。目前国家已对28个药品(53%)采取了风险控制措施。28个药品中撤市3个,暂停生产和销售1个,修改说明书的22个。结论:医院和医药专家应有药品风险的概念,建立药品的使用频次,不良反应发生率和严重性案例的收集、描述和汇总日常工作制度,明确药品的预警级别目录,对高风险药品实施重点监测管理,以最小化用药风险。

OBJECTIVE To reassess the risk levels of these drugs issued by annual adverse drug reaction（ADR）information bulletin of China Food and Drug Administration（CFDA）and summarize their control measures taken by CFDA.METHODSThese drugs reported in ADR Information Bulletin of CFDA during 2001 to 2016 were collected,and the risk score of each drug was calculated according to the different value of the frequency of ADR occurrence and the degree of severity of ADR,then the risk matrix was established.Drugs were defined as high risk if the ADR frequency and severity were higher than the average value.RESULTS Of the 117 drugs with ADR released by the CFDA,53 were eligible for data requirement of risk assessment tool.And 34 out of 53 drugs were western medicines（64%）versus 20 Chinese medicines（38%）,and 26 injections（49%）.There were 10 high risk drugs,including cefathiamidine injection,ambroxol hydrochloride injection,vitamin K1 injection,levofloxacin injection,thymosin injection,bone peptide and compound bone peptide injection,safflower injection,Xiang Dan injection,asarone injection,and Mailuoning injection.Twenty eight drugs（53%）were controlled by countermeasures on risk by the CFDA.Among the 28 drugs,3 drugs were withdrawn from the market,1 was suspended from sales and production,and 22 were required to revise drug instructions.CONCLUSION Hospitals and medical experts should have the concept of drug risk score and set up daily work system on the collection,description and summary of the frequency of drug use and the serious adverse reaction cases,and design the drug warning directory and key monitoring system for high risk drugs in order to minimize the harm.