Gerlach Manfred, Renner Tobias, Romanos Marcel
Klinik und für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie Zentrum für Psychische Gesundheit, Universitätsklinik Würzburg, Margarete-Höppel-Platz 1, 97080, Würzburg, Deutschland.
Arbeitsgruppe "Kinder- und jugendliche Psychopharmakologie der Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie" (AGNP) e. V., Homburg/Saar, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2023 Jul;66(7):761-766. doi: 10.1007/s00103-023-03718-z. Epub 2023 Jun 5.
The drug treatment of mental illness in childhood and adolescence poses a particular clinical and legal challenge. Reasons for this include the often necessary off-label use and existing knowledge gaps regarding the long-term effects of the neuro-/psychotropic drugs used. In this article, the prerequisites for therapy with neuro/psychotropic drugs, such as the need for age-appropriate inclusion of children and adolescents in the decision-making and education process, as well as the evaluation of medication, the consideration of biological age- and maturation-related factors, and the special measures for off-label use, are discussed. We further discuss general problems in the development and use of neuro-/psychotropic drugs, such as the difficulties in relation to proof of effectiveness, reimbursement and liability issues of off-label administration, and the problems of conducting clinical trials with children and adolescents.
儿童和青少年精神疾病的药物治疗带来了特殊的临床和法律挑战。造成这种情况的原因包括经常需要的超说明书用药以及关于所使用的神经/精神药物长期影响的现有知识空白。在本文中,讨论了使用神经/精神药物进行治疗的前提条件,例如在决策和教育过程中需要让儿童和青少年适当地参与,以及药物评估、对与生物年龄和成熟相关因素的考虑,还有超说明书用药的特殊措施。我们还讨论了神经/精神药物研发和使用中的一般问题,比如有效性证明方面的困难、超说明书用药的报销和责任问题,以及针对儿童和青少年进行临床试验的问题。