{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T04:39:41Z","timestamp":1772771981495,"version":"3.50.1"},"reference-count":33,"publisher":"Hogrefe Publishing Group","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Zeitschrift f\u00fcr Kinder- und Jugendpsychiatrie und Psychotherapie"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:p> 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 f\u00fchrt h\u00e4ufig zu einem nicht altersspezifischen Gebrauch der Medikamente. Junge Patienten weisen jedoch besondere Stoffwechselbedingungen sowie eine h\u00f6here Vulnerabilit\u00e4t f\u00fcr unerw\u00fcnschte Arzneimittelwirkungen (UAW) auf. Es ist daher notwendig, eigene Daten zur Pharmakokinetik, Wirkung und Sicherheit von Psychopharmaka bei Minderj\u00e4hrigen zu generieren. Auch die Gesetzgebung hat diese Situation erkannt und auf nationaler sowie europ\u00e4ischer Ebene entsprechende Vorschriften sowie wissenschaftliche Programme eingef\u00fchrt. Ziel der unter dem Begriff der Pharmakovigilanz zusammengefassten Ma\u00dfnahmen ist es, das Nutzen-Risiko-Verh\u00e4ltnis eines Arzneimittels kontinuierlich zu evaluieren, UAWs so schnell wie m\u00f6glich zu entdecken und deren Risiken durch geeignete Ma\u00dfnahmen, z. B. konsequentes Therapeutisches Drug Monitoring (TDM), zu minimieren. Der folgende Artikel erl\u00e4utert die Notwendigkeit sowie Grundlagen der Pharmakovigilanz in der Kinder- und Jugendpsychiatrie und stellt ein vom Bundesministerium f\u00fcr Arzneimittel und Medizinprodukte (BfArM) gef\u00f6rdertes multizentrisches epidemiologisches Forschungsprojekt (\u00abTDM-VIGIL\u00bb) 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. <\/jats:p>","DOI":"10.1024\/1422-4917\/a000329","type":"journal-article","created":{"date-parts":[[2014,12,24]],"date-time":"2014-12-24T02:34:58Z","timestamp":1419388498000},"page":"21-28","source":"Crossref","is-referenced-by-count":21,"title":["Pharmakovigilanz in der Kinder- und Jugendpsychiatrie"],"prefix":"10.1024","volume":"43","author":[{"given":"Karin","family":"Egberts","sequence":"first","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universit\u00e4t W\u00fcrzburg"},{"name":"Arbeitsgruppe \u00abTherapeutisches Drug Monitoring\u00bb der Arbeitsgemeinschaft f\u00fcr Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP), N\u00fcrnberg"},{"name":"Arbeitsgemeinschaft \u00abKinder- und jugendpsychiatrische Pharmakologie\u00bb der AGNP, N\u00fcrnberg"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Karwautz","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum f\u00fcr Kinder- und Jugendpsychiatrie, Wien"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul L.","family":"Plener","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie und Psychotherapie, Universit\u00e4t Ulm"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Mehler-Wex","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie und Psychotherapie, Universit\u00e4t Ulm"},{"name":"HEMERA Klinik, Privatklinik f\u00fcr Seelische Gesundheit, Jugendliche und junge Erwachsene, Bad Kissingen"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"K\u00f6lch","sequence":"additional","affiliation":[{"name":"Arbeitsgemeinschaft \u00abKinder- und jugendpsychiatrische Pharmakologie\u00bb der AGNP, N\u00fcrnberg"},{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie und Psychotherapie, Universit\u00e4t Ulm"},{"name":"Vivantes Klinikum, Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik, Berlin"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Su-Yin","family":"Dang","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universit\u00e4t W\u00fcrzburg"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Regina","family":"Taurines","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universit\u00e4t W\u00fcrzburg"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcel","family":"Romanos","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universit\u00e4t W\u00fcrzburg"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manfred","family":"Gerlach","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universit\u00e4t W\u00fcrzburg"},{"name":"Arbeitsgruppe \u00abTherapeutisches Drug Monitoring\u00bb der Arbeitsgemeinschaft f\u00fcr Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP), N\u00fcrnberg"},{"name":"Arbeitsgemeinschaft \u00abKinder- und jugendpsychiatrische Pharmakologie\u00bb der AGNP, N\u00fcrnberg"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"101","reference":[{"key":"c1","volume-title":"Diagnostic and statistical manual of mental disorders. Text revision","author":"American Psychiatric Association","year":"2000","edition":"4"},{"key":"c2","unstructured":"Arzneimittelkommission der deutschen \u00c4rzteschaft. (Hrsg.). (2005). Sonderheft Pharmakovigilanz. AVP (Arzneiverordnung in der Praxis), Berlin 32, 1\u201330."},{"key":"c3","doi-asserted-by":"publisher","DOI":"10.1055\/s-2004-832687"},{"key":"c4","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2008.11.016"},{"key":"c5","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1997.03540280039031"},{"key":"c6","doi-asserted-by":"publisher","DOI":"10.1111\/j.1751-7893.2012.00374.x"},{"key":"c7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001407"},{"key":"c8","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.313.7056.530"},{"key":"c9","doi-asserted-by":"publisher","DOI":"10.1055\/s-0031-1286291"},{"key":"c10","unstructured":"EMA Paediatric Committee . (2012).\nEMA 428172\/2012: 5-year report to the European Commission. Prepared by the European Medicines Agency (eu.europa.eu\/health\/files\/paediatrics\/ 2012-09_pediatri_-report-annex-1-2_eu.pdf)."},{"key":"c11","first-page":"99","volume":"2","author":"Fegert J. M.","year":"2009","journal-title":"Forum f\u00fcr Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie"},{"key":"c12","doi-asserted-by":"publisher","DOI":"10.1055\/s-2007-972573"},{"issue":"6","key":"c13","first-page":"e002574","volume":"3","author":"Gyllensten H.","year":"2013","journal-title":"British Medical Journal Open, Jun 20"},{"key":"c14","doi-asserted-by":"publisher","DOI":"10.1016\/j.pedhc.2011.10.009"},{"key":"c15","unstructured":"Herxheimer, A. \nCrombag, M. R. \nAlves, T. L.  \n(2010).\nHealth Action International (HAI) Europe: Direct patient reporting of adverse drug reactions: A twelve-country survey & literature review. Retrieved from  www.haiweb.org\/14012010\/14Jan2010ReportDirectPatientReportingofADRsFINAL.pdf."},{"key":"c16","doi-asserted-by":"publisher","DOI":"10.1055\/s-0031-1286287"},{"key":"c17","doi-asserted-by":"publisher","DOI":"10.1007\/s608-011-274-x"},{"key":"c18","doi-asserted-by":"publisher","DOI":"10.1055\/s-0029-1239540"},{"key":"c19","first-page":"193","volume":"17","author":"Klampfl K.","year":"2010","journal-title":"Psychopharmakotherapie"},{"key":"c20","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2009.0018"},{"key":"c21","doi-asserted-by":"publisher","DOI":"10.1055\/s-0031-1291294"},{"key":"c22","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.17.2215"},{"key":"c23","first-page":"23","volume":"111","author":"Lehmkuhl G.","year":"2014","journal-title":"Deutsches \u00c4rzteblatt International"},{"key":"c24","volume-title":"Manual for the ECDEU Assessment Battery","author":"National Institute of Mental Health","year":"1970","edition":"2"},{"key":"c25","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-011-0997-4"},{"key":"c26","doi-asserted-by":"publisher","DOI":"10.2165\/00019053-200321090-00002"},{"key":"c27","doi-asserted-by":"publisher","DOI":"10.1111\/j.1651-2227.2008.00676.x"},{"key":"c28","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0b013e31827a1aad"},{"key":"c29","first-page":"A-2778","volume":"104","author":"Thomann K. D.","year":"2007","journal-title":"Deutsches \u00c4rzteblatt"},{"key":"c30","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.03982.x"},{"key":"c31","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2012.05.053"},{"key":"c32","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2011.0142"},{"key":"c33","doi-asserted-by":"publisher","DOI":"10.1186\/1753-2000-2-24"}],"container-title":["Zeitschrift f\u00fcr Kinder- und Jugendpsychiatrie und Psychotherapie"],"original-title":[],"language":"de","link":[{"URL":"https:\/\/econtent.hogrefe.com\/doi\/pdf\/10.1024\/1422-4917\/a000329","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,17]],"date-time":"2021-03-17T05:20:44Z","timestamp":1615958444000},"score":1,"resource":{"primary":{"URL":"https:\/\/econtent.hogrefe.com\/doi\/10.1024\/1422-4917\/a000329"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,1]]},"references-count":33,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2015,1]]}},"alternative-id":["10.1024\/1422-4917\/a000329"],"URL":"https:\/\/doi.org\/10.1024\/1422-4917\/a000329","relation":{},"ISSN":["1422-4917","1664-2880"],"issn-type":[{"value":"1422-4917","type":"print"},{"value":"1664-2880","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,1]]}}}