基于风险矩阵法对某院中药注射剂不良反应的风险再评价

Risk reassessment of adverse reactions of traditional Chinese medicine injections in a hospital based on risk matrix method

目的:利用风险矩阵法评价某院中药注射剂药物不良反应(ADR)的风险水平,筛选该院高风险等级药品,并提出预警方案。方法:选取该院2015-2017年已上报国家药物不良反应监测网中的中药注射剂,计算每个药品的ADR发生频率,并对每种药品的严重程度进行赋值。将ADR发生率分别与ADR严重程度、药品的日均费用、限定日剂量和药物利用指数建立风险矩阵,把高于平均值的区域界定为高风险区域,区域中的药品界定为高风险药品,将同时存在于四个风险矩阵中高风险区域的药品界定为重点监控药品。结果:在12个中药注射剂中,血必净注射液为重点监控药品,其ADR主要发生于青中年男性和老年女性患者,多为速发型,累及器官以全身性损害、心血管系统损害、皮肤及附件损害为主。结论:利用多个维度建立风险矩阵法明确该院发生中药注射剂ADR的高风险药品。临床药师可通过回顾性分析和总结重点监控药品ADR的特点,拟定相关预警方案,开展事前干预,进一步减少重点监控中药注射剂发生ADR的风险。

OBJECTIVE To evaluate the risk level of adverse drug reactions(ADRs)of traditional Chinese medicine injection in a hospital by using risk matrix method.METHODS ADRs of traditional Chinese medicine injection reported to the national monitoring network for adverse drug reactions from 2015 to 2017 were searched to calculate the occurrence frequency of each ADR,and to assign a value to the severity of each drug.The risk matrix was established with ADR incidences and ADR severity,daily expenses,drug utilization index and limit daily dose,and those above average area were defined as high-risk areas,in the areas of drug defined as high-risk drugs,simultaneously present in four high-risk areas in drug risk matrix defined as monitored drugs.RESULTS Among the 12 traditional Chinese medicine injections,Xuebijing injection was the key monitoring drug,and its ADRs mainly occurred in young and middle-aged male and elderly female patients,mostly in quick hairstyle,involving systemic damage,cardiovascular system damage,skin and accessory damage.CONCLUSION The risk matrix method can identify the high-risk drugs of ADRs in the hospital from multiple dimensions.By retrospectively analyzing and summarizing the characteristics of the key monitoring drug ADRs,the clinical pharmacist can draw up relevant early warning plans,carry out pre-intervention,and further reduce the risk of the key monitoring drug ADRs.