Weih M, Thürauf N, Bleich S, Kornhuber J
Psychiatrische und Psychotherapeutische Klinik, Universitätsklinikum Erlangen.
Fortschr Neurol Psychiatr. 2008 Jan;76(1):7-13. doi: 10.1055/s-2007-980126. Epub 2007 Sep 26.
In psychiatry, there is an increasing use of drugs Off-Label. Especially antidepressants and antipsychotic drugs are prescribed more often outside approved indications. Main problems with Off-Label Use are drug safety, lack of reimbursement by health care providers and insufficient coordination between clinics and primary care psychiatrists. Many, especially older psychotropic drugs are approved for psychopathologic phenomena rather than on ICD-10 categories. According to current judication of the German supreme court for social issues, specific criteria for Off-Label Use have been defined. Now, in social legislation, under particular circumstances Off-Label Use is feasible. Recommendations of expert groups for psychiatry are currently lacking, but are expected in next future for Methylphenidate in treatment of adult attention-deficit-hyperactive disorder (ADHS). Especially important for all psychiatrists is to receive informed consent of the patient before initiation of a drug therapy Off-Label.
在精神病学领域，药品的超说明书用药情况日益增多。特别是抗抑郁药和抗精神病药物，在获批适应症之外的处方开具更为频繁。超说明书用药的主要问题包括药物安全性、医疗保健提供者不予报销以及诊所与基层精神科医生之间缺乏充分协调。许多精神类药物，尤其是较老的药物，获批是针对精神病理现象，而非基于国际疾病分类第十版（ICD - 10）的类别。根据德国社会问题最高法院的现行判决，已确定了超说明书用药的具体标准。目前，在社会立法中，在特定情况下超说明书用药是可行的。目前缺乏针对精神病学的专家小组建议，但预计未来针对哌醋甲酯治疗成人注意力缺陷多动障碍（ADHD）会有相关建议。对所有精神科医生而言，尤为重要的是在开始超说明书药物治疗前获得患者的知情同意。
