中国药物警戒 ›› 2020, Vol. 17 ›› Issue (4): 231-234.
DOI: 10.19803/j.1672-8629.2020.04.08

• 安全与合理用药 • 上一篇    下一篇

某院精神科门诊氯硝西泮超说明书用药现状分析

朱利芳1, 王来海1, 陈永新1, 王传升2, 张瑞岭2*   

  1. 1 新乡医学院第二附属医院药学部;
    2 新乡医学院第二附属医院精神科,河南 新乡 453002
  • 收稿日期:2019-05-06 修回日期:2020-06-28 出版日期:2020-04-15 发布日期:2020-04-10
  • 通讯作者: *张瑞岭,男,博士,主任医师,教授·博导,精神病学。E-mail: zhangruilingxx@163.com
  • 作者简介:朱利芳,女,硕士,药师,医院药学。
  • 基金资助:
    河南省高校科技创新团队支持计划(17IRTSTHN023); 河南省卫生计生科技创新型人才“51282”工程

Current Off-label Use of Clonazepam in Department of Psychiatry

ZHU Lifang1, WANG Laihai1, CHEN Yongxin1, WANG Chuansheng2, ZHANG Ruiling2*   

  1. 1 Department of Pharmacy, the Second Affiliated Hospital of Xinxiang Medical University;
    2 Department of Psychiatry, the Second Affiliated Hospital of Xinxiang Medical University, Xinxiang Henan 453002, China
  • Received:2019-05-06 Revised:2020-06-28 Online:2020-04-15 Published:2020-04-10

摘要: 目的 了解某院氯硝西泮超说明书用药现状,为制定精神科药物超说明书用药使用规范提供科学依据。方法 对2017年6月至2018年6月院内氯硝西泮门诊处方进行回顾性分析,以药品说明书为依据,结合文献调研分析氯硝西泮超说明书用药情况。结果 共抽取第二类精神药品处方7 200张,其中使用氯硝西泮的处方为1 080张,超说明书用药处方为972张,超说明书使用率高达90.00%,超适应证用药占95.06%,超剂量用药占4.94%;氯硝西泮超适应证用药的前四种疾病为焦虑、睡眠障碍、失眠症、抑郁症。各级医师所开具的超说明书用药处方率基本相当,差异无统计学意义(χ2=0.77,3.24,1.33,均P>0.05)。结论 该院氯硝西泮超说明书用药现象较为普遍,在临床治疗中存在一定合理性和必要性,亟待制定相关的超说明书用药专家共识规范,以保护医生用药行为、保障患者用药权益。同时,仍需要加强临床合理用药管理和教育,减少不合理用药现象,降低用药风险。

关键词: 氯硝西泮, 超说明书用药, 合理用药

Abstract: Objective To find out about the current off-label use of clonazepam and provide data for formulating related specifications in a psychiatry department. Methods The off-label use of clonazepam was analyzed based on drug instructions, literature research as well as retrospective analysis of the outpatient prescriptions of clonazepam in our hospital from June 2017 to June 2018. Results A total of 7 200 prescriptions related to psychotropic drugs of category were retrieved, 1080 of which involved clonazepam, and in 972 of the 1 080 prescriptions off-label use of clonazepam was found. The rate of off-label usage was as high as 90.00%. Among the cases of off-label use, 95.06% were related to indications and 4.94% to the dose. The top four diseases involving off-label use of clonazepam were anxiety, sleep disorder, insomnia and depression. The rates of off-label prescriptions by doctors at all levels were basically the same, with no significant difference (χ2=0.77, 3.24, 1.33, P>0.05). Conclusion The off-label use of clonazepam in the outpatient pharmacy is relatively common in our hospital, which is sometimes acceptable and necessary clinically. Guidelines for off-label drug use are urgently needed to supervise and protect physicians and ensure patients' safety. Meanwhile, irrational use should be contained to lower drug-induced risks.

Key words: clonazepam, off-label drug use, rational drug use

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