[Definitions related to pharmacovigilance and drug safety]

Abstract

Terms and definitions for drug safety management have changed and are not used uniformly. Due to the different use of definitions many studies cannot be compared directly. After the amendment of the EU Directive on pharmacovigilance in 2012 a proposal for using these terms und definitions now exists. However, some definitions and terms are imprecise. Furthermore, the authors make suggestions regarding a more detailed version of the terms in pharmacovigilance in order to have a better differentiation for types of medication errors.