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DOI: 10.1055/s-2003-40443
Generika in der rheumatologischen Pharmakotherapie
Generics in Rheumatological PharmacotherapyPublication History
Publication Date:
07 July 2003 (online)
![](https://www.thieme-connect.de/media/rheuma/200303/lookinside/thumbnails/10.1055-s-2003-40443-1.jpg)
Zusammenfassung
Therapeutische Äquivalenz zwei wirkstoffgleicher Medikamente wird angenommen, sobald Bioäquivalenz, d. h. vor allem eine vergleichbare Bioverfügbarkeit, belegt ist. Unter dieser Regelung sind relevante Diskrepanzen selten geworden, jedoch nicht gänzlich verschwunden. Dies weist auf immer noch bestehende Schwachpunkte des geltenden Zulassungsverfahrens hin, die im Einzelnen diskutiert werden. Der Therapeut muss Situationen unterscheiden, in denen eine unzureichende Behandlung ohne schwerwiegende Folgen bleibt - etwa beim Gebrauch analgetischer Wirkstoffe -, und solchen, bei denen die Bioverfügbarkeit kritische Bedeutung besitzt. Hierzu zählt insbesondere die Anwendung von Wirkstoffen geringer therapeutischer Breite und solcher Wirkstoffe, deren Wirksamkeit essenziell, aber nur schwer nachprüfbar ist, in der Rheumatologie etwa bei prophylaktischer oder krankheitsmodifizierender Medikation. Ciclosporin kann in beiden Kategorien als Beispiel dienen. Im Bereich der rheumatologischen Pharmakotherapie finden sich Hinweise darauf, dass wirkstoffgleiche Präparate im Fall der NSAR/ASS sowie bei Ciclosporin und Omeprazol nicht in jedem Fall austauschbar sind. Keine negativen, teils auch positive Berichte liegen für D-Penicillamin, Glukokortikoide, Goldsalze, Hydroxychloroquin, Methotrexat, Minocyclin und Sulfasalazin vor. Bei der Entscheidung zwischen wirkstoffgleichen Präparaten sollte der Therapeut die Art der Indikation und des betreffenden Pharmakons berücksichtigen. Er sollte offen für die Möglichkeit präparatbedingter Therapieprobleme bleiben und entsprechende Mitteilungen von Patienten ernst nehmen. Letztlich muss auch hier die eigene Erfahrung aktiv entwickelt werden. Ist die Entscheidung einmal getroffen, sollte das Präparat - Original oder Nachahmer - nicht mehr unnötigerweise gewechselt werden. Dies allerdings ist im Rahmen der Aut-idem-Regelung eine nur schwer zu verwirklichende Forderung.
Abstract
Therapeutic equivalence of two drugs with the same active ingredient is assumed if bioequivalence (first of all, a comparable bioavailability) has been demonstrated. With this ruling in place, relevant discrepancies have become rare although not a matter of the past. This points to persisting flaws in the current set of rules regulating approval of generic drugs (details will be discussed). In practical therapy, it is important to discriminate between situations in which insufficient treatment will remain without serious consequences (for example in the use of analgesics) and settings in which bioavailability is of crucial importance. The latter is especially true of drugs with narrow therapeutic index and agents whose actions are vital but difficult to control such as preventive/disease modifying drugs in rheumatological pharmacotherapy. In both categories, cyclosporine can serve as an example. Focusing on rheumatology, there is evidence that preparations containing NSAIDs, aspirin, cyclosporine or omeprazole are not freely interchangeable in each case. No negative, in some cases positive reports are available on d-penicillamine, corticosteroids, gold salts used in chrysotherapy (aurotherapy), hydroxychloroquine, methotrexate, minocycline, and sulfasalazine. When choosing from various drugs with the same active ingredient, the physician should consider the indication and the properties of that agent. He should remain open-minded for possible preparation-related problems and take pertinent patient reports serious. Last but not least, the physician must actively develop his experience with individual preparations. Once a decision on a preparation has been made, no unnecessary changes should be allowed. Unfortunately, the last recommendation is hard to follow in countries such as Germany which have adopted the “aut idem” rule (latin for: “or the same”) which makes it mandatory for the pharmacist to dispense a lower-priced “aut idem” preparation unless ruled out by the physician.
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Prof. Dr. med. Karl-Uwe Petersen
Pharmakologe und Toxikologe
Oberdorfstraße 22
52072 Aachen
Email: KarlUwe.Petersen@post.rwth-aachen.de