基于失效模式和效应分析的静脉用茶碱类药物管理策略研究

Study on management strategy of intravenous theophyllines based on failure mode and effect analysis

目的用失效模式和效应分析（FMEA）法探讨静脉用茶碱类药物管理过程发生用药错误的风险点，改进管理措施，提高用药安全性。方法应用FMEA法对解放军总医院第一附属医院和哈尔滨医科大学附属第一医院静脉用茶碱类药品流通全环节可能存在的安全隐患进行分析，计算风险优先级数（RPN），以RPN〉216分的风险点为静脉用茶碱类药物管理过程中的关键风险点，针对这些风险点制定管理和技术策略，比较管理措施改进前后的防范效果。结果经综合评价，梳理出药品说明书信息缺失、给药剂量错误、患者评估失当、医嘱审核未有效拦截、血药浓度监测缺失、用药交代不完善等关键风险点，并针对这些风险点制定了管理及技术策略。实施管理策略及技术策略后，上述风险点的RPN评分从（269±41）分下降至（53±27）分，实施前后比较差异有统计学意义（t=9.454, P〈0.001）。结论利用FMEA法可将药物安全管理过程中失效模式的重要程度加以量化，明确高警示药品管理改善的优先顺序，可有效规避用药风险，提高用药安全性。

ObjectiveTo explore the risk points of medication errors in the management process of intravenous theophyllines by failure mode and effect analysis （FMEA） and improve the management measures to enhance the medication safety. MethodsThe potential safety risks in each link during intravenous theophyllines circulation in First Affiliated Hospital of PLA General Hospital and the First Affiliated Hospital of Harbin Medical University were analyzed using FMEA method and the risk priority number （RPN） was calculated. The risk points, whose RPN scores were 〉216, were taken as the key ones during the management of intravenous theophyllines. Management and technical strategies were drawn up for the key risk points and preventive effects before and after the improvement measures were compared.ResultsAfter comprehensive evaluation, the key risk points such as missing information of drug instructions, wrong dosage, inappropriate assessment for patients, omission of prescription checking, absence of blood concentration monitoring, and imperfection of doctor′s advice to patient and etc. were sorted out, and management and technical strategies were drawn up. The RPN scores of above risk points decreased from （269±41） to （53±27） before and after the implementation of preventive strategies and the difference was statistically significant （t=9.454, P〈0.001）.ConclusionThe importance of failure modes in safety management of drugs is quantified by FMEA method, priority sequence of improvement for high-alert medication management is pointed out, and medication safety is improved.