title: [Pharmacovigilance in child and adolescent psychiatry].
abstract: 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).
authors.affiliation: 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>
authors.forename: Karin
authors.initials: K
authors.lastname: Egberts
authors.affiliation: Universitätsklinikum für Kinder- und Jugendpsychiatrie, <location>Wien</location>
authors.forename: Andreas
authors.initials: A
authors.lastname: Karwautz
authors.affiliation: Klinik für Kinder- und Jugendpsychiatrie und Psychotherapie, Universität Ulm.
authors.forename: Paul L
authors.initials: PL
authors.lastname: Plener
authors.affiliation: Klinik für Kinder- und Jugendpsychiatrie und Psychotherapie, Universität Ulm HEMERA Klinik, Privatklinik für Seelische Gesundheit, Jugendliche und junge Erwachsene, <location>Bad Kissingen</location>
authors.forename: Claudia
authors.initials: C
authors.lastname: Mehler-Wex
authors.affiliation: Arbeitsgemeinschaft «Kinder- und jugendpsychiatrische Pharmakologie» der AGNP, <location>Nürnberg</location> Klinik für Kinder- und Jugendpsychiatrie und Psychotherapie, Universität Ulm Vivantes Klinikum, Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik, <location>Berlin</location>
authors.forename: Michael
authors.initials: M
authors.lastname: Kölch
authors.affiliation: Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Würzburg.
authors.forename: Su-Yin
authors.initials: SY
authors.lastname: Dang
authors.affiliation: Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Würzburg.
authors.forename: Regina
authors.initials: R
authors.lastname: Taurines
authors.affiliation: Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Würzburg.
authors.forename: Marcel
authors.initials: M
authors.lastname: Romanos
authors.affiliation: 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>
authors.forename: Manfred
authors.initials: M
authors.lastname: Gerlach
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D016903:Drug Monitoring; D005858:Germany; D006801:Humans; D001523:Mental Disorders / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010818:Practice Patterns, Physicians'; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011785:Quality Assurance, Health Care; D016896:Treatment Outcome
chemical_list: D011619:Psychotropic Drugs
keywords: Entwicklungspsychopharmakologie; Kinder- und Jugendpsychiatrie; Pharmakovigilanz; Qualitätssicherung; Therapeutisches Drug Monitoring; child and adolescent psychiatry; developmental psychopharmacology; pharmacovigilance; quality assurance; therapeutic drug monitoring