药品说明书“修改日期”项评价药品性能的应用研究

发布时间：2018-05-04 04:23

本文选题：药品说明书 + 分析　；参考：《中国医院药学杂志》2015年14期

【摘要】：目的:通过对医疗机构选用、维护、筛选药物品种提出警示,为寻找药品说明书管理参考依据或技术指标提供思路。方法:对943份药品说明书"修改日期"项的总修改次数、近5年的修改次数及近3年的修改次数以及修改次数百分比用EXCEL进行统计、分析。结果:说明书"修改日期"项适用于医疗机构用于药品生产企业品质的比较、品质较低的药物品种的评定、较高风险的药物品种的锁定以及药物品种的筛选、维护。结论:药品说明书存在修改频繁、不同厂家同品种药品的药品说明书差异,对医疗机构构成风险,需要有效的管理对策。"修改日期"项可用于评定药品法律风险;"修改日期"项用于评定厂家品质及药物治疗风险,或许在逻辑上并不足够完满,但毕竟在相关技术上实现了从无到有的突破,并且无碍在相关工作上体现出来的参考价值。
[Abstract]:Objective: to provide advice on the selection, maintenance and screening of drug varieties in medical institutions, and to find the reference basis or technical index for the management of drug instructions. Methods: EXCEL was used to analyze the total number of revisions, the times of revision in the last 5 years, the times of revision in recent 3 years and the percentage of revision times in 943 copies of drug instructions. Results: the term "date of revision" of the instruction is suitable for the comparison of quality of pharmaceutical production enterprises, the evaluation of drug varieties with lower quality, the locking of drug varieties at higher risk, and the selection and maintenance of drug varieties in medical institutions. Conclusion: the drug instructions are frequently revised, and the drug specifications of the same drugs are different in different manufacturers, which poses a risk to the medical institutions and requires effective management countermeasures. " The "modified date" can be used to assess the legal risk of drugs; the "modified date" to assess the quality of the manufacturer and the risk of drug treatment may not be logical enough, but it has achieved a breakthrough in related technology from scratch. And does not hinder in the related work manifests the reference value.
【作者单位】：中山市中医院;中山市博爱医院;南方医药经济研究所;
【分类号】：R954

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