小儿消化科住院患儿超说明书用药分析

Off-label drug use in hospitalized children at Pediatric Digestive Department

目的了解小儿消化科住院患儿的超说明书用药情况，为制订超说明书用药管理措施提供参考。方法从2015年7月1日至2016年6月30日吉林大学第一医院小儿化科1560例住院患儿中随机抽取300例患儿的病历资料进行回顾性分析，总计医嘱总条数为11400条，涉及药品201种。依据《中国药典临床用药须知》《新编药物学》《国家处方集》《处方管理办法》及药品说明书的内容逐项点评用药情况，不符合相关规定内容的即为超说明书用药。结果300例患儿超说明书用药发生率为84．7％（254／300）。共发现超说明书用药医嘱条数2998条，占总医嘱条数的26．3％（2998／11400）。超说明书用药主要表现在所使用药品无儿童用药信息[75．2％（2277／3025）]、超适应证[7．1％（216／3025）]、超说明书给药剂量[6．4％（194／3025）]和超说明书给药频次[5．6％（170／3025）]等方面。使用频率居高的超说明书药物主要集中在抗菌药物、抗病毒药物、消化及呼吸系统用药方面。结论小儿消化科住院患儿超说明书用药发生率较高，部分用药可能存在一定安全风险，超说明书用药规范迫在眉睫。

Objective To investigate the current situation of off-label drug use in hospitalized children in Pediatric Digestive Department. Methods Clinical records of 300 children were randomly collected from 1 560 cases of gastrointestinal diseases in Pediatric Digestive Department of the First Hospital of Jilin University from July 1, 2015 to June 30, 2016; totally 11 400 medical orders involving 201 kinds of drugs were reviewed. Use of medicines in children was analyzed according to Notes on Clinical Medication of Chinese Pharmacopoeia, New Pharmacology, National Formulary, Prescription Management and drug instructions; medical orders that were inconsistent with the regulations were defined as off-label drug use. Results Incidence rate of off-label drug use was 84. 7% （254/300） ; off-label rate of medical orders was 26.3% （2 998/11 400）. Main causes of off-label drug use included lack of notes for children [ 75.2% （ 2 277/3 025 ） ], over-indication [ 7. 1% （ 216/3 025 ） ], off-label dosage [ 6. 4% （ 194/3 025 ） ] and off-label frequency of administration [ 5.6% （ 170/3 025 ） ]. Off-label medication mainly involved antibacterial, antiviral, digestive and respiratory drugs. Conclusion Off-label drug use is common in Pediatric Digestive Department that needs urgent management of medical regulations.