[Adverse events related to substitution of generic products in Norway 2005].

Background: The Norwegian Medicines Agency has since 2003 encouraged health professionals to report adverse events (AEs) related to generic substitution through the spontaneous reporting system. Goals of this study were to evaluate the quality of these reported AEs and to assess whether there were signals of altered efficacy or AEs related to substitution of such products.

Material And Methods: The World Health Organisation's (WHO) tool for documentation grading was used to evaluate the AE reports.