国家重点监控药品超说明书临床合理应用专家共识

National Key Monitoring Drugs(the Second Batch)Expert Consensus on Rational Clinical Application for Off-label Drug Uses

目的旨在为医疗机构提供重点监控药品的超说明书合理使用建议,引导医务人员进一步规范应用国家重点监控药品。方法采用世界卫生组织(WHO)指南制定手册进行国家重点监控药品超说明书临床合理应用专家共识的研究设计。通过系统检索,广泛收集各省份存在的国家第二批重点监控药品的常见超说明书用药问题,采用德尔菲法调研专家并确定重点监控药品常见超说明书用药条目,采用文献调研、专家经验法整理形成相关证据体后,按照GRADE方法进行质量评价,并再次通过德尔菲法对推荐意见及证据级别达成共识,最终形成《国家重点监控药品超说明书临床合理应用专家共识》。结果通过对60位专家进行网络调查问卷调研,采用德尔菲法对超说明书用药条目达成共识,包括质子泵抑制剂、抗菌药物、糖皮质激素等药物品种,最终确定了37个临床问题,共形成38条推荐意见。结论该共识为医疗机构制订国家重点监控药品临床应用规范和处方(医嘱)审核点评规则提供参考与补充,确保重点监控药品使用的有效性和安全性,进一步提高医疗服务质量,降低重点监控药品不良事件的风险,促进合理用药。

Objective To provide medical institutions with expert recommendations for the rational off-label use of key monitored drugs and to guide healthcare professionals in further standardizing the application of national monitored drugs.Methods The research design for reaching expert consensus on the rational clinical use of national monitored drugs beyond their approved indications followed the guidelines of the World Health Organization(WHO).A systematic search was conducted to extensively collect common issues related to the off-label use of the second batch of national monitored drugs in various provinces.The Delphi method was used to survey experts and identify common off-label use items for the key monitored drugs.Literature research and expert experience were utilized to collate and form relevant body of evidence,and quality evaluation was carried out in accordance with the GRADE approach.Consensus was reached again through the Delphi method regarding the recommended advice and evidence level,which ultimately led to the formation of the“Expert Consensus on the Rational Clinical Use of Nationally Monitored Drugs Beyond Their Approved Indications.”Results A survey questionnaire was conducted among 60 experts through an online survey,and a consensus on off-label use items was reached using the Delphi method,covering drug categories such as proton pump inhibitors,antibiotics,glucocorticoids,and other medications.A total of 37 clinical issues were identified,resulting in a total of 38 recommended pieces of advice.Conclusion This consensus provides a reference and supplement for medical institutions to develop clinical application norms and prescription(medical order)review rules for national monitored drugs,to ensure the effectiveness and safety of their use.It further improves the quality of medical services,reduces the risk of adverse events related to national monitored drugs,promotes rational drug use.