Egberts Karin, Karwautz Andreas, Plener Paul L, Mehler-Wex Claudia, Kölch Michael, Dang Su-Yin, Taurines Regina, Romanos Marcel, Gerlach Manfred
Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Würzburg Arbeitsgruppe «Therapeutisches Drug Monitoring» der Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP), <location>Nürnberg</location> Arbeitsgemeinschaft «Kinder- und jugendpsychiatrische Pharmakologie» der AGNP, <location>Nürnberg</location>
Universitätsklinikum für Kinder- und Jugendpsychiatrie, <location>Wien</location>
Z Kinder Jugendpsychiatr Psychother. 2015 Jan;43(1):21-8. doi: 10.1024/1422-4917/a000329.
Rational pharmacotherapy is a challenging task in child and adolescent psychiatry. Increasing prescription numbers contrast with the uncertainties of safety and efficacy issues. The lack of clinical (authorization) trials often implies a non- age-specific use of drugs. However, young patients show particular metabolic conditions and a higher vulnerability for adverse drug reactions. Thus it seems mandatory to create age-specific pharmacological data about efficacy and safety of psychotropic drug use in minors. Legislation authorities became aware of this situation and introduced European and national scientific pharmacovigilance regulations and programmes accordingly in order to continuously evaluate the benefit-risk-ratio, detect, collect, minimize, and prevent adverse effects of drugs by appropriate measures, e.g., therapeutic drug monitoring. In this paper the principles and needs of pharmacovigilance in child and adolescent psychiatry are discussed. Furthermore a large multicenter clinical trial («TDM-VIGIL»), funded by the German Federal Institute for Drugs and Medical Devices, is presented, which appeals to collect epidemiological prescription and safety data of psychotropic drugs in children and adolescents using an internet-based data infrastructure (patient registry).
合理用药是儿童和青少年精神病学中一项具有挑战性的任务。不断增加的处方数量与安全性和有效性问题的不确定性形成对比。缺乏临床（批准）试验往往意味着药物的使用未针对特定年龄。然而，年轻患者具有特殊的代谢状况，且对药物不良反应的易感性更高。因此，有必要针对未成年人使用精神药物的有效性和安全性创建特定年龄的药理学数据。立法机构意识到了这种情况，并相应地出台了欧洲和国家的科学药物警戒法规及计划，以便持续评估效益风险比，通过适当措施（如治疗药物监测）检测、收集、最小化并预防药物的不良反应。本文讨论了儿童和青少年精神病学中药物警戒的原则和需求。此外，还介绍了一项由德国联邦药品和医疗器械研究所资助的大型多中心临床试验（“TDM-VIGIL”），该试验呼吁利用基于互联网的数据基础设施（患者登记系统）收集儿童和青少年精神药物的流行病学处方和安全性数据。
