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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)
                *
                                                       #
          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
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