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Anatomisch-Therapeutisch- Chemische Klassifikation Mit Tagesdosen Für Den Deutschen Arzneimittelmarkt Gemäß § 73 Abs

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Anatomisch-Therapeutisch- Chemische Klassifikation Mit Tagesdosen Für Den Deutschen Arzneimittelmarkt Gemäß § 73 Abs Uwe Fricke · Anette Zawinell 27. November 2009 Anatomisch-therapeutisch- chemische Klassifikation mit Tagesdosen für den deutschen Arzneimittelmarkt gemäß § 73 Abs. 8 Satz 5 SGB V Beschlussfassung der Arbeitsgruppe ATC/DDD des Kuratoriums für Fragen der Klassifikation im Gesundheitswesen WIdO · GKV-Arzneimittelindex Die Publikation ist ein Beitrag des GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO) und wurde für die Geschäftsstelle der Arbeitsgruppe ATC/DDD des Kuratoriums für Fragen der Klassifikation im Gesundheitswesen erstellt. Anatomisch-therapeutisch-chemische Klassifikation mit Tagesdosen für den deutschen Arzneimittelmarkt gemäß § 73 Abs. 8 Satz 5 SGB V. Beschlussfassung der ATC-Arbeitsgruppe des Kuratoriums für Fragen der Klassifikation im Gesundheitswesen Stand: 27. November 2009 Berlin, im November 2009 Wissenschaftliches Institut der AOK (WIdO) im AOK-Bundesverband GbR Rosenthaler Str. 31, 10178 Berlin Geschäftsführender Vorstand: Dr. Herbert Reichelt (Vorsitzender), Jürgen Graalmann http://www.aok-bv.de/impressum/index.html Aufsichtsbehörde: Senatsverwaltung für Gesundheit, Umwelt und Verbrau- cherschutz Brückenstraße 6, 10179 Berlin Pharmazeutisch-technische Assistenz: Manuela Steden Titelfoto: Ulrich Birtel Nachdruck, Wiedergabe, Vervielfältigung und Verbreitung (gleich welcher Art), auch von Teilen des Werkes, bedürfen der ausdrücklichen Genehmigung. E-Mail: [email protected] Internet: http://www.wido.de Inhalt Hinweise .........................................................................................................................6 Wichtige Information ....................................................................................................6 Vorwort...........................................................................................................................7 1 Einleitung ........................................................................................................11 1.1 Der GKV-Arzneimittelindex............................................................................................ 11 1.2 Internationales ATC/DDD-System ................................................................................ 12 1.2.1 WHO Collaborating Centre for Drug Statistics Methodology.............................. 12 1.2.2 WHO International Working Group for Drug Statistics Methodology ...................................................................................................................... 13 1.3 Herbal ATC Classification ............................................................................................... 14 1.3.1 Struktur................................................................................................................................ 15 1.3.2 Nomenklatur....................................................................................................................... 15 1.3.3 Allgemeine Prinzipien...................................................................................................... 16 1.3.4 Änderungen der HATC-Klassifikation.......................................................................... 17 1.3.5 Definierte Tagesdosen (DDD)......................................................................................... 17 1.4 Deutsches ATC/DDD-System.......................................................................................... 18 1.4.1 Amtliche deutsche Fassung ........................................................................................... 19 2 Das anatomisch-therapeutisch-chemische (ATC) Klassifikationssystem......................................................................................21 2.1 Grundsätzliche Bemerkungen........................................................................................ 21 2.1.1 Struktur................................................................................................................................ 21 2.1.2 Nomenklatur....................................................................................................................... 22 2.2 Umfang des ATC-Klassifikationssystems.................................................................... 22 2.3 Grundregeln der Klassifikation...................................................................................... 23 2.3.1 Allgemeine Prinzipien...................................................................................................... 23 2.3.2 Klassifikation von Monopräparaten............................................................................ 25 2.3.3 Klassifikation von Kombinationspräparaten............................................................. 26 2.3.4 Klassifikation von Phytopharmaka, Homöopathika und Anthroposophika............................................................................................................... 28 2.4 Änderungen der ATC-Klassifikation............................................................................. 29 3 3 DDD ..................................................................................................................30 3.1 Definition............................................................................................................................. 30 3.2 Grundregeln für die DDD-Festlegung.......................................................................... 31 3.2.1 Monopräparate.................................................................................................................. 32 3.2.2 Pädiatrische DDD.............................................................................................................. 34 3.2.3 Kombinationspräparate................................................................................................... 35 3.2.4 Andere Faktoren................................................................................................................ 36 3.2.4.1 Gruppen mit Standarddosen.......................................................................................... 36 3.2.4.2 Depotzubereitungen......................................................................................................... 37 3.2.4.3 Intermittierende Dosierung............................................................................................ 37 3.2.4.4 Behandlungsdauer............................................................................................................ 37 3.2.5 Verwendete Einheiten...................................................................................................... 38 3.2.6 Priorisierung von Informationsquellen für die Ermittlung der DDD................... 39 3.2.6.1 WHO-Empfehlung aus Index und Guidelines ........................................................... 39 3.2.6.2 Literaturangaben............................................................................................................... 40 3.2.6.3 Durchschnittliche Hersteller-DDD................................................................................ 41 3.2.6.4 Individuelle Dosierungsempfehlung gemäß Zulassung.......................................... 41 3.2.7 Grundregeln bei der DDD-Festlegung gemäß einer individuellen Herstellerempfehlung – Ergänzungen zum Regelwerk der WHO ....................... 42 3.2.7.1 Allgemeine Grundregeln................................................................................................. 42 3.2.7.2 Angaben zur Anwendungshäufigkeit.......................................................................... 43 3.2.7.3 Angaben zur Dosierungseinheit.................................................................................... 44 3.2.7.4 DDD-Berechnung bei Kombinationspackungen....................................................... 48 4 Literatur ...........................................................................................................49 5 Zusammenfassung der Stellungnahmen........................................................50 6 Beschlussvorlagen neue Wirkstoffe des Jahres 2009 ..................................52 6.1 Empfehlung zu ATC-Codes neuer Wirkstoffe ........................................................... 52 6.1.1 Prasugrel.............................................................................................................................. 52 6.1.2 Dapoxetin............................................................................................................................ 53 6.1.3 Histrelin ............................................................................................................................... 55 6.2 Empfehlung zu DDD-Berechnungen neuer Wirkstoffe .......................................... 56 4 7 Beschlussvorlagen zu den Änderungsvorschlägen der Hersteller und Verbände .................................................................................69 7.1 Empfehlungen zu ATC-Änderungen oder DDD-Änderungen................................ 69 7.1.1 Tiopronin.............................................................................................................................. 69 7.1.2 Zinksulfat............................................................................................................................. 71 7.1.3 Thalidomid........................................................................................................................... 75 7.1.4 Polidocanol ......................................................................................................................... 77 7.1.5 Fusidinsäure.......................................................................................................................
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