Schröder Carsten, Dörks Michael, Kollhorst Bianca, Blenk Tilo, Dittmann Ralf W, Garbe Edeltraut, Riedel Oliver
Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
Department of Health Services Research, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.
Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1395-1402. doi: 10.1002/pds.4289. Epub 2017 Aug 24.
So far, only little is known about antidepressant off-label use in pediatric patients. This is the first study examining the prevalence and the risks of off-label antidepressant prescriptions in minors over time in Germany and analyzing patterns regarding age, sex, drug class, and type of off-label use.
We used claims data of about two million individuals (<18 y) to calculate the share of off-label antidepressant prescriptions for the years 2004 to 2011, stratified by age, sex, and drug class. Off-label prescriptions were analyzed regarding underlying diagnoses, the prescribing doctor's specialty, and the type of off-label use. Incidence rates of adverse events were calculated for off- and on-label use, and the risk of suicidal events associated with off- or on-label use was examined in a nested case-control study.
The prevalence of off-label prescriptions decreased from 58.0% to 40.9%. Selective serotonin reuptake inhibitors were more frequently prescribed off-label than tricyclic antidepressants (37.7% vs 17.5% in 2011). The most common type of off-label use was off-label use by age, followed by off-label use by indication, and off-label use by contraindication. Adverse events were rare with no significant differences between on- and off-label use.
Although off-label antidepressant use in minors decreased over time, it is still common. However, this rather indicates a lack of approved drugs for the treatment of depression in this population than inappropriate medical treatment. This is supported by the fact that off-label use was not associated with a higher risk of adverse events than on-label use.
到目前为止，关于儿科患者抗抑郁药的非标签使用，人们了解甚少。这是第一项研究德国未成年人非标签抗抑郁药处方的患病率和风险随时间变化情况，并分析年龄、性别、药物类别和非标签使用类型模式的研究。
我们使用了约200万18岁以下个体的理赔数据，以计算2004年至2011年非标签抗抑郁药处方的比例，并按年龄、性别和药物类别进行分层。对非标签处方的潜在诊断、开处方医生的专业以及非标签使用类型进行了分析。计算了非标签和标签内使用的不良事件发生率，并在一项巢式病例对照研究中检查了与非标签或标签内使用相关的自杀事件风险。
非标签处方的患病率从58.0%降至40.9%。与三环类抗抑郁药相比，选择性5-羟色胺再摄取抑制剂更常被用于非标签处方（2011年为37.7%对17.5%）。最常见的非标签使用类型是按年龄的非标签使用，其次是按适应症的非标签使用和按禁忌症的非标签使用。不良事件很少见，标签内和非标签使用之间无显著差异。
尽管未成年人非标签使用抗抑郁药的情况随时间有所减少，但仍然很常见。然而，这更多地表明该人群缺乏治疗抑郁症的获批药物，而非不当医疗。非标签使用与标签内使用相比，不良事件风险并未更高，这一事实支持了这一点。
