A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review.

ABSTRACT:

Introduction and objective

The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serious and are prioritized for signal detection, irrespective of statistical criteria. We have analysed the results of our previously published scoping review to determine whether DME signals differ from those of other adverse events in terms of time to communication and characteristics of supporting reports of suspected adverse drug reactions.

Methods

For all signals, we obtained the launch year of medicinal products from textbooks or regulatory agencies, extracted the year of the first report in VigiBase and calculated the interval between the first report and communication (time to communication, TTC). We further retrieved the av

SUBMITTER: Sartori D 

PROVIDER: S-EPMC11018663 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature