本院儿科门诊超说明书用药情况调查与分析

Survey and analysis of pediatric outpatient off-label use in our hospital

目的了解本院儿科门诊超说明书用药情况并进行分析,为临床合理用药提供参考。方法随机抽取本院2013年1月至12月儿科门诊处方,根据药品说明书内容,对超说明书用药处方进行用药类型、年龄分段和药物种类统计分析。结果共抽取儿科门诊处方2 400张,含8 472条用药记录。按处方和用药记录统计,超说明书用药发生率分别为23.96%和10.10%。超说明书用药类型主要包括超年龄(37.5%)、超给药剂量(30.4%)、超适应证(14.7%)和超用药频率(11.9%)4种;超说明书用药发生年龄段居首位是婴幼儿期(11.43%),其次是青春期(10.5%)和学龄前期(10.43%);超说明书用药种类发生率居前三位依次是呼吸系统药物(12.00%)、中成药(10.74%)、抗生素(10.23%)。结论本院儿科门诊超说明书用药较常见,存在一定的医疗安全隐患。对于超说明书用药集中的年龄段及药物,临床药师应对其进行密切监测并适当干预。

AIM To analyze the situation of off-label use in pediatric outpatients for references of rational drug use in the clinic. METHODS The outpatient pediatric prescriptions from January to December 2013 were selected in our hospital, and compared with the drug instructions. The content including medication type, age and category of drugs were adopted to statistically analyze the situation of offlabel drug use. RESULTS A total of 2 400 prescriptions with 8 472 records were sampled, and the incidence rates of off-label drug use of prescriptions and records were 23.96% and 10.10%, respectively. The problems such as ultr-age （ 37.5% ） , high dosage （ 30.4% ）, super indication （ 14.7% ） and high - frequency of administration （ 11.9% ） were the top-four types of off-label use. The rate in different age groups ranked as the top-three were infants （11.43%）, followed by the adolescents （10.5%） and preschool （10.43%）. The top-three categories of medicines in off- label use were respiratory system drugs （12.00%）, Chinese medicine （10.74%） and antibiotics （10.23%）. CONCLUSION The off-label use is common in pediatric outpatients department, which causes security risks in the medical process. For the age and drugs with high frequency of off-label use, close monitoring and suitable intervention should be conducted by clinical pharmacists.