门诊超说明书用药情况分析及管理对策

Analysis and Management Countermeasures of Off-label Drug Use in Outpatient Prescriptions

目的分析门诊超说明书用药情况,为规范化管理超说明书用药提供参考,促进临床合理用药。方法以药品说明书为依据,从适应证、适应人群、给药剂量、给药频次、溶媒、给药途径和禁忌证等方面对宁波市妇女儿童医院分院2014年8月门诊处方的超说明书用药情况进行统计与分析,并根据临床指南、专家共识、循证医学或文献等以判断其合理性,提出管理对策。结果有1 866张处方出现超说明书用药,占总处方的18.69%。超说明书用药记录共有3 972条,占总用药记录的15.52%,其中"未提及儿童用药信息"是最常见的超说明书用药类型,占53.00%,其他依次是给药频次(17.55%)、给药剂量(10.70%)和超年龄用药(9.09%)等。结论本院超说明书用药基本合理,但为了保障患者用药安全,应加强超说明书用药的规范化管理。

OBJECTIVE To investigate off-label drug use in outpatient, and provide references for the standardization management of off-label drug use to promote rational clinical use of drugs. METHODS According to drug instructions, off-label prescriptions collected from the outpatient department of the branch hospital in August 2014 were analyzed statistically in seven aspects such as indications, suitable groups, dosage, frequency, solvent, route of administration and contraindications. The rationality was evaluated according to clinical guidelines, expert consensus, evidence-based medicine or literature. The management couhtermeasures werd proposed. RESULTS In this investigation, 1 866 off-label prescriptions were found, accounting for 18.69% of all prescriptions, and there were 3 972 off-label medication records, accounting for 15.52% of the total records. ＂Not mentioned pediatric drug information＂ was the commonest type of the off-label drug use, accounting for 53%, followed by frequency（17.55%）, dosage（10.70%） and age（9.09%）, etc. CONCLUSION Off-label drug use is basically reasonable in our hospital. In order to guarantee the safety of patients in medication, the hospital should strengthen the standardized management of off-label drug use.