某院生殖中心门诊超说明书用药调查分析

Investigution and Analysis of Off-label Drug Use in Fertility Clinic of One Hospital

目的:分析某院生殖中心门诊超说明书用药情况,为临床合理用药提供科学依据,并进一步规范医师的超说明书用药行为。方法:抽取某院2016年1~12月生殖中心的门诊处方,根据药品说明书内容,对超说明书用药处方进行统计分析,并查询相关文献对超说明书药品进行合理性评价。结果:共收集到超说明书用药处方4 176张,超说明书用药类型包括超适应证用药、超剂量用药和超给药途径用药。超说明书用药比例排名前3位的药品是阿司匹林肠溶片(42.05%)、地屈孕酮片(27.37%)、左卡尼汀口服溶液(16.02%)。超说明书用药中多数有循证医学证据支持,但也存在不合理用药现象。结论:该院生殖中心超说明书用药现象普遍存在,医院应重视超说明书用药情况,并建立相关管理制度予以规范,从而降低超说明书用药的法律风险,促进医院合理用药水平。

Objective：To analyze the situation of off-label drug use in fertility clinic of one hospital to provide scientific evidence for clinical rational drug use and further standardize the behavior of off-label drug use in clinical physicians. Methods：The outpatient prescriptions in the reproductive center of the hospital during January and December in 2016 were randomly selected, the off-label drug use prescriptions were statistically analyzed according to the drug package inserts, and the rationality of the off-label drug use were e-valuated by searching the related literatures. Results：A total of 4176 off-label drug use prescriptions were collected, the primary types of off-label drug use were off-label indication, off-label dose and off-label administration. The top 3 drugs with off-label use were aspi-rin enteric-coated tablets （42. 05%）, dydrogesterone tablets （27. 37%） and levocarnitine oral solution （16. 02%）. The most of off-label use was supported by evidence-based medicines, while unreasonable use still existed. Conclusion： Off-label drug use is very common in the reproductive center of the hospital. The hospital should pay more attention to the phenomenon and establish relevant management system to standardize the behavior of off-label drug use in order to reduce the legal risk and promote clinical rational drug use.