附带溶媒药品有效期的风险防控管理

Risk Prevention and Control Management Practice on the Validity Period of Drugs With Solvent

目的对中国医学科学院血液病医院附带溶媒药品的有效期风险管理环节进行调研并实施精细管控对策,以期为该类药品管理与临床用药风险防范提供参考。方法研究时间为2017年7月—2020年12月,调查中国医学科学院血液病医院注射剂中附带溶媒药品的品种、有效期、批号、溶媒成分等相关信息的标注情况和管理环节,找出附带溶媒药品的高危风险点,对风险点实施精细管控对策,制定相应管理规范,加强该类药品入库前监管流程和入库后管理,并持续追踪管理效果。结果调研阶段中国医学科学院血液病医院应用附带溶媒的16种药品中,存在药品内外包装有效期标识不统一、药品附带溶媒标注信息不全、外包装无法开盒查验、相关人员知晓情况不足等情况。实施精细化的管理对策后,调研中发现的风险点均已得到管控并合格,管控措施实施阶段新引进的附带溶媒药品均纳入有效期风险管理,临床中未发生关于附带溶媒药品效期管理相关的不良事件。结论附带溶媒药品的有效期及相关信息标注情况不统一,是该类药品管理的高危风险点,应引起高度重视。除了建议药品监督管理部门进一步完善相关管理规定外,从生产企业、医药公司配送,到医院验收入库、药房发放至临床应用需要加强全程化的风险管理,才能达到有效降低该类药品管理风险的目标,保证医疗质量和患者安全用药。

Objective To investigate the risk management link of the validity period of the accompanying solvent drugs in the Institute of Hematology and Blood Disease Hospital,Chinese Academy of Medical Sciences and implement fine control measures,in order to provide reference for the management of such drugs and the risk prevention of clinical drug use.Methods This study was conducted from July 2017 to December 2020,to investigate the labeling and management of related information such as the variety,expiry date,batch number,solvent composition and other related information of the drug with solvent in injections in Institute of Hematology and Blood Disease Hospital,Chinese Academy of Medical Sciences,and to find out the high-risk points of the drug with solvent,implement fine management and control measures for risk points,formulate corresponding management specifications,strengthen the supervision process before and after storage of such drugs,and continue to track the management effect.Results Among the 16 drugs with solvent used in Institute of Hematology and Blood Disease Hospital,Chinese Academy of Medical Sciences during the investigation stage,there were some situations such as inconsistent expiration date labels on the inner and outer packaging of drugs,incomplete labeling information on drugs attached with solvents,the outer packaging could not be opened for inspection,and the relevant personnel were not aware of the situation.After the implementation of refined management measures,the risk points found in the investigation had been controlled and qualified,and the newly introduced drugs with solvent in the implementation stage of the control measures were included in the risk management of validity period.There were no adverse events related to the management of the expiry date of the drug with a vehicle in the clinic.Conclusion The validity period of drugs with solvent and the labeling of related information are not uniform,which is a high-risk point in the management of such drugs,and should be paid great attention.In addition to suggesting that the drug supervision and management department further improve the relevant management regulations,it is necessary to strengthen the risk management of the whole process from the distribution of production enterprises and pharmaceutical companies,to the acceptance of the hospital,the distribution of pharmacies to the clinical application,in order to effectively reduce the management risks of such drugs.The goal is to ensure the quality of medical care and the safety of medication for patients.