Risk evaluation and mitigation strategy programs in solid organ transplantation: the promises of information technology.
Risk evaluation and mitigation strategies (REMS) required by the Food and Drug Administration are implemented to manage known or potential risks associated with medications and to ensure ongoing safe use throughout the life of a pharmaceutical agent. Healthcare organizations have begun to adopt information technologies with clinical decision support (CDS) to ensure safe use of medications. Systems have been expanded and customized to also ensure compliance with regulatory standards. End [...]
Author(s): Tsapepas, Demetra S, McKeen, Jaclyn T, Martin, Spencer T, Walker-McDermott, Jennifer K, Yang, Alex, Hirsch, Jamie, Mohan, Sumit, Tiwari, Ruchi
DOI: 10.1136/amiajnl-2013-002446