Sonntag D, Trebst D, Kiess W, Kapellen T, Bertsche T, Kostev K
Department für Frauen- und Kindermedizin, Klinik für Kinder- und Jugendmedizin, Universität Leipzig.
Dtsch Med Wochenschr. 2013 Oct;138(44):2239-45. doi: 10.1055/s-0033-1349609. Epub 2013 Oct 22.
Due to lack of respective studies children often receive medication that is applied beyond the approved indication. The consequence of this off-label use is often an increased risk of unexpected and undesirable side effects. This study deals with the amount of off-label drug prescriptions among children and adolescents receiving outpatient treatment in Germany. The aim is to outline age-, gender-, region-, and insurance specific differences and to determine risk factors for an off-label prescription.
This is a retrospective study that has been conducted by means of the IMS Patient Database Disease Analyzer for the year 2010 considering three therapy classes (analgesics, antibiotics and antidepressants). The evaluation of the risk factors for an off-label prescription resulted from a multivariate logistic regression. Age- and dose-specific prescriptions were analyzed but not indication-specific prescriptions.
In total 189,285 children and adolescents with analgesics-, 147,089 with antibiotics-, and 15,405 with antidepressants prescriptions were identified. The percentage of patients with off-label prescriptions amounted to 0.9 % for analgesics, 2.5 % for antibiotics and 8.5 % for antidepressants. The off-label prescriptions made by general practitioners were significantly higher than those made by pediatricians and child psychiatrists. The number of off-label prescriptions in country sides was higher than in cities. In eastern states more off-label prescriptions were made than in western states of Germany.
The study shows that outpatient treatment of children and adolescents occurs widely with drugs corresponding to age and dosage. Off-label prescriptions not conform to indication were not determined. However, off-label drug use should be reduced further for outpatient treatment to ensure a safe and low-risk medical treatment for children and adolescents.
由于缺乏相关研究，儿童经常接受超出批准适应症范围使用的药物。这种超说明书用药的后果往往是意外和不良副作用风险增加。本研究涉及在德国接受门诊治疗的儿童和青少年中超说明书用药处方的数量。目的是概述年龄、性别、地区和保险方面的差异，并确定超说明书处方的风险因素。
这是一项回顾性研究，通过 IMS 患者数据库疾病分析仪对 2010 年的数据进行分析，涉及三类治疗药物（镇痛药、抗生素和抗抑郁药）。超说明书处方风险因素的评估来自多变量逻辑回归分析。分析了年龄和剂量特定的处方，但未分析适应症特定的处方。
共识别出 189285 名开具镇痛药处方的儿童和青少年、147089 名开具抗生素处方的儿童和青少年以及 15405 名开具抗抑郁药处方的儿童和青少年。超说明书处方患者的比例在镇痛药中为 0.9%，在抗生素中为 2.5%，在抗抑郁药中为 8.5%。全科医生开具的超说明书处方明显高于儿科医生和儿童精神科医生。农村地区的超说明书处方数量高于城市。德国东部各州的超说明书处方比西部各州更多。
该研究表明，儿童和青少年门诊治疗广泛使用符合年龄和剂量的药物。未确定不符合适应症的超说明书处方情况。然而，门诊治疗中超说明书用药应进一步减少，以确保为儿童和青少年提供安全、低风险的医疗服务。
