Document Detail

Monitoring product safety in the postmarketing environment.
MedLine Citation:
PMID:  25114782     Owner:  NLM     Status:  PubMed-not-MEDLINE    
The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.
Robert G Sharrar; Gretchen S Dieck
Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Therapeutic advances in drug safety     Volume:  4     ISSN:  2042-0986     ISO Abbreviation:  Ther Adv Drug Saf     Publication Date:  2013 Oct 
Date Detail:
Created Date:  2014-08-12     Completed Date:  2014-08-12     Revised Date:  2014-08-15    
Medline Journal Info:
Nlm Unique ID:  101549074     Medline TA:  Ther Adv Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  211-9     Citation Subset:  -    
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