儿科病房中未获许可及超说明书用药情况：前瞻性研究
Unlicensed and off label drug use in paediatric wards: prospective study.
作者信息
Turner S, Longworth A, Nunn A J, Choonara I
机构信息
Department of Pharmacy, Alder Hey Children's Hospital, Liverpool.
出版信息
BMJ. 1998 Jan 31;316(7128):343-5. doi: 10.1136/bmj.316.7128.343.
OBJECTIVE
To determine the extent of use in children in hospital of drugs that are not specifically licensed for use in children (unlicensed) and of drugs that are used outside the terms of their product licence that apply to indication, age, dose, or route of administration (off label).
DESIGN
Prospective study of drugs administered on paediatric medical and surgical wards for 13 weeks.
SETTING
Regional children's hospital.
SUBJECTS
Paediatric inpatients in medical and surgical wards.
MAIN OUTCOME MEASURES
Comparison of the use of each drug with its product licence to determine whether the drug was used in an unlicensed or off label manner.
RESULTS
2013 courses of drugs were administered to 609 paediatric patients in 707 admissions. 506 (25%) of the drug courses (prescriptions) were either unlicensed (139) or off label (367) uses. In 256 (36%) of the 707 admissions patients received one or more courses of an unlicensed or off label treatment in hospital.
CONCLUSIONS
Use of drugs in an off label or unlicensed manner to treat children is widespread. Drugs are more likely to be used in an off label manner than in an unlicensed manner.
目的
确定医院中未获专门许可用于儿童的药物（未获许可药物）以及在产品许可条款规定的适应症、年龄、剂量或给药途径范围之外使用的药物（超说明书用药）在儿童中的使用程度。
设计
对儿科内科和外科病房给药情况进行为期13周的前瞻性研究。
地点
地区儿童医院。
研究对象
儿科内科和外科病房的住院患儿。
主要观察指标
将每种药物的使用情况与其产品许可进行比较，以确定药物是否以未获许可或超说明书的方式使用。
结果
在707例住院病例中，对609名儿科患者进行了2013个疗程的药物治疗。其中506个（25%）疗程（处方）属于未获许可（139个）或超说明书（367个）使用。在707例住院病例中，有256例（36%）患者在住院期间接受了一个或多个疗程的未获许可或超说明书治疗。
结论
以超说明书或未获许可的方式使用药物治疗儿童的情况很普遍。药物超说明书使用的可能性大于未获许可使用。
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