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目的:建立以药师为主导的药品上市后安全性监测工作模式。方法:医疗结构设立安全性监测工作的组织机构,制定工作流程、职责分工及完善质量控制。开展以药师为主体、药护结合的工作模式,采用综合诺式评估量表法进行不良反应评价。结果:通过实施以药师为主体、药护结合的工作模式,监测过程质量得到良好控制,经临床实践证实,监测结果真实,不良反应评价可靠。结论:此种药物安全性监测模式保证了临床监测数据的整体性、真实性及准确性。
OBJECTIVE: To establish a pharmacist-led drug safety monitoring post-marketing model. Methods: Establish the organizational structure of safety monitoring in the medical structure, set the work flow, divide the responsibilities and improve the quality control. To carry out pharmacists as the mainstay, combined with the mode of operation, the use of comprehensive assessment of non-performing scale Norovirus evaluation. Results: The quality of the monitoring process was well controlled through the combination of pharmacists and pharmacists. The clinical practice proved that the monitoring results were true and the adverse reaction evaluation was reliable. Conclusion: This drug safety monitoring mode ensures the integrity, authenticity and accuracy of clinical monitoring data.