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Wirksamkeit und Nebenwirkungen von Arzneimitteln: Kommentar zur Rechtsprechung

Wirksamkeit und Nebenwirkungen von Arzneimitteln: Kommentar zur Rechtsprechung

          
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About the Book

Wirksamkeit und Nebenwirkungen sind die zentralen Kriterien für die medizinische Beurteilung des therapeutischen Nutzens von Arzneimitteln. Diese Beurteilung richtet sich nach den Regeln der evidenzbasierten Medizin und kann in der Praxis erhebliche methodische Schwierigkeiten bereiten. Da die beiden Kriterien gegensätzlich sind, erfordert die Endbeurteilung eines Arzneimittels ein "Abwägen" zwischen den beiden Kriterien, deren methodische Regeln bis heute wenig untersucht sind. Entsprechend schwierig ist die rechtliche Beurteilung von Arzneimitteln durch Gerichte und Verwaltungsbehörden: Sie geht zwar von der evidenzbasierten medizinischen Beurteilung aus, muss aber eigene Standards und Grenzwerte entwickeln und bei der Entscheidung im Einzelfall umsetzen. Damit ist das Spannungsfeld zwischen der medizinischer Beurteilung durch fallbezogene medizinische Gutachten und anhand wissenschaftlicher Publikationen einerseits und der rechtlichen Beurteilung von Arzneimitteln andererseits eröffnet. Muss sich die rechtliche Beurteilung auf eine summarische Plausibilitätskontrolle der medizinischen Beurteilung beschränken oder darf sie selbständige Überlegungen anstellen und allenfalls von medizinischen Gutachten abweichen? Vom Standpunkt der Rechtssicherheit wäre zu wünschen, dass die rechtliche Beurteilung der beiden zentralen Kriterien Wirksamkeit und Nebenwirkungen in den drei im Buch untersuchten Anwendungsgebieten der Zulassung, Pharmakovigilanz und Kostenerstattung GKV methodisch und beim Festlegen der Standards übereinstimmt. Die vorliegende Darstellung untersucht, inwieweit dieser Wunsch bisher in der Rechtsprechung verwirklicht worden ist. Aufgrund dieser Problemstellung setzt die Kommentierung einen Schwerpunkt bei den methodischen Fragen, welche sich bei der Anwendung von Rechtsnormen auf medizinische Fakten ergeben. Dabei wird angestrebt, den Leser näher an die evidenzbasierten medizinischen Grundlagen der einzelnen Fälle heranzuführen, als dies üblicherweise in p


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Product Details
  • ISBN-13: 9783754366592
  • Publisher: Books on Demand Gmbh
  • Publisher Imprint: Books on Demand
  • Height: 246 mm
  • No of Pages: 368
  • Spine Width: 19 mm
  • Weight: 657 gr
  • ISBN-10: 3754366599
  • Publisher Date: 24 Oct 2022
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Sub Title: Kommentar zur Rechtsprechung
  • Width: 189 mm


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