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处方前置审核对门急诊合理用药及超说明书用药管理的影响
高 志 ,韩璐璐,刘 芳,焦 蕊,张 伟,张 轶(中国医学科学院整形外科医院药剂科,北京 100144)
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中图分类号 R952 文献标志码 A 文章编号 1001-0408(2025)13-1666-05
DOI 10.6039/j.issn.1001-0408.2025.13.19
摘 要 目的 探讨处方前置审核系统对门急诊合理用药水平及超说明书用药管理的影响。方法 回顾性分析我院处方前置审核
系统上线后在2023年1-5月(静默审查阶段,对照组)、2023年6-10月(系统自动审核阶段,干预组1)、2023年11月-2024年3
月(系统自动审核+药师向医师集中反馈不合理处方阶段,干预组2)3个阶段的门急诊处方数据,对系统警示率、处方不合理率、已
备案超说明书用药率和假阳性不合理处方率进行比较分析,同时分析不合理处方的构成情况,并对医师提交的新增备案的超说明
书用药情况进行循证评价。结果 与对照组比较,经弹窗提示后,干预组1的系统警示率及处方不合理率均显著降低(P<0.05);经
系统提示和药师反馈后,干预组2的系统警示率及处方不合理率进一步降低(P<0.05),但与干预组1比较的差异无统计学意义
(P>0.05)。不合理用药类型以给药途径不合理为主,干预组1与对照组比较、干预组2与干预组1比较,给药途径不合理率均显著
降低(P<0.05)。与对照组比较,干预组1和干预组2的已备案超说明书用药率的差异无统计学意义(P>0.05),但前置审核软件
的实时提示以及药师的定期汇总反馈提高了医师对超说明书用药备案的意识。2023年6月至2024年3月,医师共提交超说明书
用药备案13项,均被不同级别证据支持,其中3项被美国FDA说明书批准,4项被Micromedex数据库收录,其余6项均被系统评价
或随机对照试验文献证据支持。结论 处方前置审核系统可显著提高门急诊合理用药水平,助力规范超说明书用药的管理。
关键词 处方前置审核系统;超说明书用药;循证评价;合理用药
Effects of prescription pre-review system on rational drug use and off-label drug use management in
outpatient and emergency department
GAO Zhi,HAN Lulu,LIU Fang,JIAO Rui,ZHANG Wei,ZHANG Yi(Dept. of Pharmacy, Plastic Surgery
Hospital, Chinese Academy of Medical Sciences, Beijing 100144, China)
ABSTRACT OBJECTIVE To explore the effects of prescription pre-review system on rational drug use and off-label drug use
management in outpatient and emergency department. METHODS A retrospective analysis was conducted on outpatient and
emergency department prescription data from three phases in our hospital: January to May 2023 (silent review phase, control
group), June to October 2023 (systematic automatic review phase, intervention group 1), and November 2023 to March 2024
(phase combining systematic automatic review with centralized feedback from pharmacists to physicians regarding irrational
prescriptions, intervention group 2). These phases followed the implementation of our hospital’s pre-prescription review software.
Statistical analysis of the prompt rate of alert, rate of irrational prescriptions, registered the off-label drug use rate and false positive
irrationality prescription rate were conducted. Meanwhile, the composition of irrational prescriptions was analyzed, and evidence-
based evaluation of the off-label drug use proposed by clinicians was also conducted. RESULTS Compared with control group, the
prompt rate of alert and the rate of irrational prescriptions in intervention group 1 were all decreased significantly after receiving
pop-up notification, with statistically significant differences (P<0.05). With the help of system warning and the pharmacists
feedback, the prompt rate of alert and the rate of irrational prescriptions declined further in the intervention group 2, but there was
no statistically significant difference when compared with intervention group 1 (P>0.05). The main type of irrational drug use was
improper administration routes. When comparing intervention group 1 with the control group, as well as intervention group 2 with
intervention group 1, a significant decrease in the rate of improper administration routes was observed, with statistically significant
differences (P<0.05). Compared with control group, there was no significant difference in the registered off-label drug use rate of
intervention group 1 and intervention group 2 (P>0.05). The doctor’s awareness of off-label drug use registration increased due to
the real-time alerts from the pre-prescription review software, along with the pharmacists’ regular summarization and feedback.
Total 13 items registrations of off-label drug use were proposed by clinicians from June 2023 to March 2024, all of which were
supported by evidence of varying levels; among them, 3 items received FDA approval, 4 items were included in the Micromedex
database, and the remaining 6 items were supported by evidence from system reviews or randomized controlled trials.
CONCLUSIONS Prescription pre-review system can improve
the level of rational drug use and assist in the standardized
*第一作者 主管药师,硕士。研究方向:临床药学。E-mail:gao-
zhi0000@163.com management of off-label drug use.
# 通信作者 副主任药师。研究方向:医院药事管理、临床药学。 KEYWORDS prescription pre-review system; off-label drug
E-mail:zyzxyj@yeah.net use; evidence-based evaluation; rational drug use
· 1666 · China Pharmacy 2025 Vol. 36 No. 13 中国药房 2025年第36卷第13期