title: [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.
authors.affiliation: Arzneimittelkommission der deutschen Ärzteschaft, Berlin.
authors.forename: Horst
authors.initials: H
authors.lastname: Möller
authors.forename: Amin-Farid
authors.initials: AF
authors.lastname: Aly
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D008508:Medication Errors / Q000331:legislation & jurisprudence* / Q000517:prevention & control*; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D060735:Pharmacovigilance; D017410:Practice Guidelines as Topic; D055553:Prescription Drugs / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D055553:Prescription Drugs