小儿复方氨基酸注射液安全风险管理

Safety Risk Management of Pediatric Compound Amino Acid Injection for Children

目的:药品安全不是“零风险”。受限于上市前临床试验的样本量不足、观察时间短、受试对象单一等缺点,人们对药品安全性的认识是有限的,很多潜在风险未被发现。该文通过对企业小儿复方氨基酸注射液的药物安全风险管理的初步探索,进一步完善和优化本品安全风险管理措施。方法:该文通过对企业2016~2019年小儿复方氨基酸注射液不良反应监测数据的汇总分析,其中包括用药人群、用药原因、用法用量和给药途径分析,发现、识别、评估产品存在的潜在安全性风险,制定本品种的风险安全管控措施并落实,将风险最小化,切实保障患者用药安全。结果:小儿复方氨基酸注射液的不良反应以新的类型为主,主要集中在皮肤及皮下组织类疾病和胃肠系统疾病。另外超说明书用药即滴注超速是小儿复方氨基酸注射液发生不良反应的一个重要原因且存在区域差异,主要原因是临床用药标准的缺乏、临床用药习惯、医院监测与管理不足和医护人员认知偏差。结论:企业更新产品说明书新增了皮肤及皮下组织类疾病和胃肠系统疾病的不良反应,指导临床用药,大大降低新的不良反应风险。通过采用业务推广人员培训、临床医药护人员风险沟通方式后,2020年滴速超速超说明书用药行为导致不良反应由2016~2019年的12.67%降低到6.47%,证明本品的药品安全风险管理方法与措施是有效的。

Objective:Drug safety is not “zero risk”. Awareness of drug safety is generally limited due to the shortage of sample size,shorter observation time and single subjects in premarket clinical trials,and many potential risks have not been discovered. To analyze drug safety risk management of Pediatric Compound Amino Acid Injection,further improve and optimize the safety risk management measures. Methods:This article summarized and analyzed the monitoring data of adverse reactions of Pediatric Compound Amino Acid Injection from 2016to 2019,including analysis of medication population,medication reasons,usage and dosage,route of administration and medication area. Identified and evaluated the potential safety risks of the products,implemented the safety control measures of the products,minimized the risks,and effectively guaranteed the medication safety of patients. Results:The adverse reactions of the product mainly focus on unexpected types,and their SOC are mainly focus on skin and subcutaneous tissue disorders and Gastrointestinal disorders. In addition,the fast drip was an important reason for the adverse reactions of Pediatric Compound Amino Acid Injection,and there is also obvious region difference. The major causes include the lack of clinical medication standards,clinical medication habits,inadequate hospital monitoring and management,and cognitive deviation of medical staff. Conclusion:The adverse reactions of skin and subcutaneous tissue disorders and Gastrointestinal disorders are added to product patient inserting,which can guide clinical medication and greatly reduce the risk of new adverse reactions. The analysis results showed that after the training of salesmen and the face to face communication of clinical medical and nursing personnel,the adverse reactions caused by fast drip decreased from 12.67%to 6.47%. The drug safety risk management methods and measures of this product are effective.