本院生殖医学中心超说明书处方调查与分析

Investigation and analysis of off- label use in reproductive medicine center of our hospital

目的调查分析本院生殖医学中心超说明书用药情况,探讨生殖医学中心超说明书用药管理模式,促进临床合理用药。方法随机抽取本院生殖医学中心2014年1月至12月处方,根据药品说明书相关内容,判断是否超说明书用药,并统计超说明书用药类型及相关药物。结合相关文献,根据超说明书用药循证级别及对患者影响程度的不同将超说明书用药分为A、B、C三个级别,统计各级别涉及的药品。结果共抽取2 400张处方,含用药记录8 648条。按处方和用药记录统计,超说明书用药发生率分别为21.96%(527/2 400)和7.15%(618/8 648)。超说明书用药类型主要包括超适应证(75.6%)、超剂量(11.0%)。涉及药品11种,A、B、C级构成比分别为35.1%、61.3%、3.6%,其中B级居多。结论本院生殖医学中心超药品说明书用药情况比较普遍,进行分级管理有利于减少超说明书用药带来的负面影响,促进临床合理用药。

AIM To investigate and analyze the situation of off-label use in reproductive medicine center of our hospital for exploring the management model of off-label use and promoting rational drug use in clinical. METHODS The prescriptions of reproductive medicine center of our hospital were randomly selected from January to December in 2014, and compared with the drug instructions. The type of off -label use and related drugs were analyzed. The off-label use was divided into A, B, C three levels according to related articles, evidence based level and different influence on the patients. RESULTS A total of 2 400 prescriptions with 8 648 medication administration records were selected. According to the prescriptions and medication administration records statistics, the occurrence rate of off-label use were 21.96% （527/2 400） and 7.15% （618/8 648）, respectively. The main types of off-label use were super indication （75.6%） and over dosage （11.0%）. The off-label use involved in 11 kinds of drugs, and the A, 13, C three levels were 35.1%, 61.3% and 3.6%, respectively. CONCLUSION The off-label use is common in reproductive medicine center of our hospital. The classification management of off-label use can reduce the negative impact of off-label use for patients and promote rational drug use in the clinic.