Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data.

Andrej Segec Jim Slattery Daniel R Morales Justina Januskiene Xavier Kurz Peter Arlett

Published in: Pharmacoepidemiology and drug safety (2020)

We identified limited evidence that reporting of ADRs increased modestly and gradually for some new products and not for products with PASS requirement.

Keyphrases

adverse drug
electronic health record
emergency department
drug induced
big data