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A guide to understanding and implementing risk evaluation and mitigation strategies in organ transplantation.
MedLine Citation:
PMID:  23448822     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Objective-To review the components of the Congressional mandate for risk evaluation and mitigation strategies (REMS) managed by the Food and Drug Administration and assess their impact on health care providers practicing within the organ transplant arena.Data Sources and Extraction-A non-date-limited search of MEDLINE and EMBASE (January 2007-June 2012) was conducted by using the following search terms: risk evaluation and mitigation strategies, REMS, and organ transplant, including a query of the individual organs. Information from the Federal Register and the Food and Drug Administration was also evaluated.Data Synthesis-REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. Elements of REMS programs may consist of 3 levels: a medication guide, communication plan, and elements to assure safe use. A medication guide is used to help prevent serious adverse events, aid in patients' decision making, and enhance medication adherence. Communication plans help educate health care providers and encourage adherence with REMS. The elements to assure safe use is a restrictive process implemented when it is deemed necessary to ensure safe access for patients to products with known serious risks. In transplant medicine, REMS currently exist for belatacept (medication guide and communication plan) and the mycophenolic acid derivatives (medication guide and elements to assure safe use).Conclusion-REMS are another step in the evolution of the development and marketing of pharmaceutical agents. Use of REMS in solid-organ transplant is becoming common. Transplant clinicians must provide required patient education and become involved with other aspects of REMS implementation to reduce the serious risks of pharmaceuticals and to improve patients' outcomes.
Authors:
Steven Gabardi; Eric M Tichy
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Progress in transplantation (Aliso Viejo, Calif.)     Volume:  23     ISSN:  1526-9248     ISO Abbreviation:  Prog Transplant     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-03-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100909380     Medline TA:  Prog Transplant     Country:  United States    
Other Details:
Languages:  eng     Pagination:  58-63     Citation Subset:  N    
Affiliation:
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
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