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

Daniele Sartori (), Jeffrey K. Aronson, Nils Erlanson, G. Niklas Norén and Igho J. Onakpoya
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Daniele Sartori: Uppsala Monitoring Centre
Jeffrey K. Aronson: University of Oxford
Nils Erlanson: Uppsala Monitoring Centre
G. Niklas Norén: Uppsala Monitoring Centre
Igho J. Onakpoya: University of Oxford

Drug Safety, 2024, vol. 47, issue 5, No 6, 475-485

Abstract: 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 average completeness (via vigiGrade) of the reports in each case series in the years before the communication. We categorised as DME signals those concerning an event in the EMA’s list. We described the two groups of signals using medians and interquartile ranges (IQR) and compared them using the Brunner–Munzel test, calculating 95% confidence intervals (95% CI) and P values. Results Of 4520 signals, 919 concerned DMEs and 3601 concerned non-DMEs. Signals of DMEs were supported by a median of 15 reports (IQR 6–38 reports) with a completeness score of 0.52 (IQR 0.43–0.62) and signals of non-DMEs by 20 reports (IQR 6–84 reports) with a completeness score of 0.46 (IQR 0.38–0.56). The probability that a random DME signal was supported by fewer reports than non-DME signals was 0.56 (95% CI 0.54–0.58, P 0.80. Conclusions Signals of designated medical events were supported by fewer reports and higher completeness scores than signals of other adverse events. Although statistically significant, the differences in effect sizes between the two groups were small. This suggests that listing certain adverse events as DMEs is not having the expected effect of encouraging a focus on reports of the types of suspected adverse reactions that deserve special attention. Further enhancing the completeness of the reports of suspected adverse drug reactions supporting signals of designated medical events might shorten their time to communication and reduce the number of reports required to support them.

Date: 2024
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DOI: 10.1007/s40264-024-01403-x

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