title: Risk evaluation and mitigation strategy programs in solid organ transplantation: the promises of information technology.
abstract: 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 users who are unfamiliar with particular medication use provisions are at risk of unknowingly inappropriately fulfilling specific components. Institution-specific customization of vendor-provided CDS is useful to enhance provider awareness and ensure compliance with standards. Integration of health information technology systems to fulfill REMS requirements is novel and important to ensure consistency as healthcare standards evolve.
authors.affiliation: Department of Pharmacy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
authors.forename: Demetra S
authors.initials: DS
authors.lastname: Tsapepas
authors.affiliation: Department of Pharmacy, Hackensack University Medical Center, Hackensack, New Jersey, USA.
authors.forename: Jaclyn T
authors.initials: JT
authors.lastname: McKeen
authors.affiliation: Department of Pharmacy, Hartford Hospital, Hartford, Connecticut, USA.
authors.forename: Spencer T
authors.initials: ST
authors.lastname: Martin
authors.affiliation: Department of Pharmacy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Walker-McDermott
authors.affiliation: Department of Information Technology, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: Yang
authors.affiliation: Division of Nephrology, Department of Medicine, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
authors.forename: Jamie
authors.initials: J
authors.lastname: Hirsch
authors.affiliation: Division of Nephrology, Department of Medicine, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
authors.forename: Sumit
authors.initials: S
authors.lastname: Mohan
authors.affiliation: Department of Pharmacy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
authors.forename: Ruchi
authors.initials: R
authors.lastname: Tiwari
mesh_terms: D000069594:Abatacept; D033161:Government Regulation; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016377:Organ Transplantation; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D009173:Mycophenolic Acid
keywords: Immunosuppressants; Medication Safety; Risk Evaluation Mitigation Strategy; Transplantation