Pharmakovigilanz in der Kinder- und Jugendpsychiatrie
Abstract
Die rationale Therapie mit Arzneimitteln stellt eine Herausforderung in der Kinder- und Jugendpsychiatrie dar. Steigende Verordnungszahlen stehen im Kontrast zu erheblichen Unsicherheiten in Bezug auf die Arzneimittelsicherheit und Wirksamkeit. Der Mangel an (Zulassungs-)Studien führt häufig zu einem nicht altersspezifischen Gebrauch der Medikamente. Junge Patienten weisen jedoch besondere Stoffwechselbedingungen sowie eine höhere Vulnerabilität für unerwünschte Arzneimittelwirkungen (UAW) auf. Es ist daher notwendig, eigene Daten zur Pharmakokinetik, Wirkung und Sicherheit von Psychopharmaka bei Minderjährigen zu generieren. Auch die Gesetzgebung hat diese Situation erkannt und auf nationaler sowie europäischer Ebene entsprechende Vorschriften sowie wissenschaftliche Programme eingeführt. Ziel der unter dem Begriff der Pharmakovigilanz zusammengefassten Maßnahmen ist es, das Nutzen-Risiko-Verhältnis eines Arzneimittels kontinuierlich zu evaluieren, UAWs so schnell wie möglich zu entdecken und deren Risiken durch geeignete Maßnahmen, z. B. konsequentes Therapeutisches Drug Monitoring (TDM), zu minimieren. Der folgende Artikel erläutert die Notwendigkeit sowie Grundlagen der Pharmakovigilanz in der Kinder- und Jugendpsychiatrie und stellt ein vom Bundesministerium für Arzneimittel und Medizinprodukte (BfArM) gefördertes multizentrisches epidemiologisches Forschungsprojekt («TDM-VIGIL») vor, an dem zahlreiche kinder- und jugendpsychiatrische Zentren sowie Facharztpraxen aus dem deutschsprachigen Raum beteiligt sind. Ziel ist die systematischen Erfassung von Informationen zum Verordnungsverhalten und der Sicherheit von Psychopharmaka im Kindes- und Jugendalter mittels eines internetbasierten Patientenregisters.
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).
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