Schröder Carsten, Dörks Michael, Kollhorst Bianca, Blenk Tilo, Dittmann Ralf W, Garbe Edeltraut, Riedel Oliver
1 Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS , Bremen, Germany .
2 Department of Health Services Research, Carl von Ossietzky University Oldenburg , Oldenburg, Germany .
J Child Adolesc Psychopharmacol. 2017 Nov;27(9):806-813. doi: 10.1089/cap.2016.0202. Epub 2017 Jun 15.
Only little is known about antipsychotic (AP) off-label use (OLU) in pediatric populations. It was the aim of this study to examine the frequency as well as the risks of off-label AP use in underaged patients.
To calculate the frequency of off-label AP prescriptions for the years 2004-2011, we used claims data of more than two million minors aged 0-17 years. Off-label prescriptions were analyzed with regard to type of OLU, physician specialty, and underlying diagnoses. Incidence rates of selected adverse events were calculated for on-label as well as for OLU. The risk of poisoning associated with on- or OLU was assessed in a nested case-control study.
The annual share of pediatric AP users with off-label prescriptions varied between 52.3% and 71.1%. OLU by indication (42.8%-66.5%) was the most common type of OLU. Of the subjects with OLU by indication, 52.5% had a diagnosis of hyperkinetic disorder. Adverse events were scarce (incidence rates between 0.8 and 8.6 per 10,000 person-years), and no significant difference was observed between on- and OLU.
Because of their frequent use in hyperkinetic disorder patients, APs are commonly prescribed off-label for minors. Since OLU by contraindication was rare and the risk of the adverse events under study was similarly small for on- and OLU, this is not necessarily an indication for inappropriate treatment. It rather indicates that further randomized studies are needed to examine efficacy and safety of pediatric AP use in this indication.
关于抗精神病药物（AP）在儿科人群中的超说明书使用（OLU），人们了解甚少。本研究旨在调查未成年患者中超说明书使用AP的频率及风险。
为计算2004年至2011年超说明书使用AP处方的频率，我们使用了200多万名0至17岁未成年人的索赔数据。对超说明书处方进行了分析，涉及超说明书使用类型、医生专业及潜在诊断。计算了标签内及超说明书使用情况下选定不良事件的发生率。在一项巢式病例对照研究中评估了标签内或超说明书使用相关的中毒风险。
接受超说明书处方的儿科AP使用者的年比例在52.3%至71.1%之间变化。按适应证进行的超说明书使用（42.8% - 66.5%）是最常见的超说明书使用类型。在按适应证进行超说明书使用的受试者中，52.5%被诊断为多动障碍。不良事件较少（发生率为每10000人年0.8至8.6例），标签内及超说明书使用之间未观察到显著差异。
由于AP在多动障碍患者中频繁使用，所以常用于未成年人的超说明书处方。由于禁忌证导致的超说明书使用很少见，且所研究的不良事件在标签内及超说明书使用情况下风险同样较小，这不一定表明治疗不当。相反，这表明需要进一步进行随机研究，以检验儿科使用AP在该适应证下的疗效和安全性。
