Klin Farmakol Farm. 2010;24(4):208-213

Risk management systems and restricted drug distribution systems in the U. S. A.

Jozef Kolář
Ústav aplikované farmacie, Farmaceutická fakulta VFU Brno

Risk management systems – risk minimization action plans (RiskMAPs), risk evaluation and mitigation strategies (REMS), risk management

plans (RMPs) and restricted drug distribution systems (RDDSs) are discussed. The author describes several the most famous programs like

APPRISE (darbepoetin alfa, Aranesp®, epoetin alfa, Epogen®, Procrit®), ATAP (alglucosidase alfa), E.A.S.E.™ (alvimopan, Entereg®), FOCUS

(fentanyl, Onsolis™), LEAP (ambrisentan, Letairis®), Lumizyme ACE (alglucosidase alfa, Lumizyme™), MTAP (alglucosidase alfa, Myozyme®),

NEXUS (romiplostim, Nplate™), PLUS (abarelix, Plenaxis™), PROMACTA® CARES™ (eltrombopag, Promacta®), SHARE® (vigabatrin, Sabril®),

T.A.P.® (bosentan, Tracleer®).

restricted drug distribution systems.

Keywords: risk management systems, risk minimization action plans, risk evaluation and mitigation strategies, risk management plans,

Published: December 31, 2010  Show citation

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Kolář J. Risk management systems and restricted drug distribution systems in the U. S. A. Klin Farmakol Farm. 2010;24(4):208-213.
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