蔡建韩辉王莉(.上海市奉贤区海湾旅游区社区卫生服务中心 上海 0400；.上海市奉贤区金汇镇社区卫生服务中心齐贤分中心上海 0400；3.广州珠江医院药剂科 广州 5080）

社区卫生服务中心儿科门诊超说明书用药调查

蔡建1韩辉2王莉3*
(1.上海市奉贤区海湾旅游区社区卫生服务中心 上海 201400；2.上海市奉贤区金汇镇社区卫生服务中心齐贤分中心上海 201400；3.广州珠江医院药剂科 广州 510280）

摘 要目的：了解基层社区卫生服务中心儿科门诊超说明书用药情况，为儿童合理用药提供依据。方法：抽取1家社区卫生服务中心儿科门诊2个月的用药处方，根据药品说明书判断是否存在超说明书用药，对超说明书用药进行统计分析。结果：共抽取处方678张，超说明书用药218张，发生率为32.15%。在218张超说明书用药处方中，共有超说明书用药283例，其中超剂量、超疗程为最常见的类型，构成比接近90.00%；超适应证用药、超适应人群用药和超给药途径用药构成比为11.66%。结论：社区卫生服务中心儿科门诊用药存在超说明书用药现象，应对儿童用药进行密切监测。

关键词儿科 门诊 超说明书用药

Survey of the off-label drug use in the outpatient pediatric department of the community health service center

CAI Jian1, HAN Hui2, WANG Li3
(Haiwan Community Health Service Center of Fengxian District, Shanghai 201400, China; 2. Qixian Branch of Jinhui Community Health Service Center of Fengxian District, Shanghai 201400, China; 3. Pharmacy Department of Zhujiang Hospital, Guangzhou 510280, China)

ABSTRACTObjective: To investigate the situation of the off-label drug use in the outpatient pediatric department of the community health service center so as to provide a reference for the rational drug use of children. Methods: The prescriptions of the outpatient pediatric department of one community health service center in 2 months were collected. Whether the offlabel drug use existed was evaluated according to the drug package inserts and statistically analyzed thereafter. Results: In 678 prescriptions totally selected, 218 were judged as the off-label drug use and its occurrence rate was 32.15%. In 218 prescriptions of off-label drug use, 283 cases were involved and among them the over dosage, and over course of treatment were the most common types, whose constituent ratio was close to 90%. The over indication of off-label drug use, over the target population and over administration route of the off-label drug use accounted for 11.66%. Conclusion: The phenomenon of the off-label drug use exists in the outpatient pediatric department in the community health service center and the medication for children should be closely monitored.

KEY WORDSpediatric department; out-patient; off-label drug use

药品是特殊商品，其使用直接关系到患者的生命健康。药品一经批准注册，说明书就赋予其保证药品质量、提供全面药物信息、保护患者用药安全的法律使命。但是在临床用药过程中，药品使用的适应证、剂量、患者群体和给药途径与药品说明书不符的情况普遍存在，这些不在药监部门批准的说明书范围之内，均属于“超说明书用药”。……