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

A. Segec (Lead / Corresponding author), J. Slattery, D. R. Morales, J. Januskiene, X. Kurz, P. Arlett

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Abstract

Purpose: To evaluate the impact of including a medicine in the list of medicinal products subject to additional monitoring (AM) on the reporting of adverse drug reactions (ADRs) in the european economic area (EEA). Methods: Interrupted time series using the monthly number of EEA ADR reports in EudraVigilance during 12 months before and after the addition to AM list. The main outcome was the change (%) in reporting of ADRs with step change as the a priori impact model. Further time series analysis was performed using Joinpoint Regression. Results: The analysis included 11 active substances. No significant immediate (step change) increase of reporting was identified for any product at time of addition to AM list. We identified a significant gradual increase of ADR reporting after addition to AM list (slope change) for two out of five new products—boceprevir (10% per month, 95% confidence interval (CI) 3%–18%) and denosumab-Xgeva (13% per month, 95% CI 4%–22%). No change was identified for Prolia, another denosumab-containing product not subject to AM. No significant increase was identified for any product included in the AM list due to the requirement to conduct a PASS. Conversely, a gradual decrease in reporting was identified for natalizumab (−5% per month; 95% CI −10% to −1%), rivaroxaban (−5%; −8 to −3%), and varenicline (−16%; −21 to −10%). The results were corroborated by the Joinpoint analyses, which yielded similar results. Conclusions: We identified limited evidence that reporting of ADRs increased modestly and gradually for some new products and not for products with PASS requirement.

Original languageEnglish
Pages (from-to)350-359
Number of pages10
JournalPharmacoepidemiology and Drug Safety
Volume30
Issue number3
Early online date16 Nov 2020
DOIs
Publication statusE-pub ahead of print - 16 Nov 2020

Keywords

  • additional monitoring
  • adverse drug reactions
  • impact
  • pharmacovigilance

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