» Articles » PMID: 34881404

The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions

Overview
Journal Drug Saf
Specialties Pharmacology
Toxicology
Date 2021 Dec 9
PMID 34881404
Citations 8
Authors
Affiliations
Soon will be listed here.
Abstract

Introduction And Objective: European Union legislation has mandated the submission of European Economic Area non-serious reports to the EudraVigilance database since November 2017. As spontaneous reports of suspected adverse reactions to medicines represent a key source of safety signals, the European Medicines Agency has undertaken this work to assess the effects of this requirement on the characteristics of the reports submitted to EudraVigilance and on the detection of adverse drug reactions through routine analyses of the database.

Methods: Changes in the numbers of serious and non-serious reports transmitted to EudraVigilance were examined over the period during which the legislation was implemented. The numbers and nature of potential safety signals emerging from established statistical algorithms used at the European Medicines Agency applied either to only the serious reports or to all reports in EudraVigilance were compared.

Results: Up to November 2017, less than 25% of European Economic Area reports in EudraVigilance were classified as non-serious, since than this figure was slightly above 60%. This change accompanied an increase in the total number of reports received. Addition of non-serious reports to the signal detection process resulted in a small overall increase in signals of disproportionate reporting with some new signals of disproportionate reporting appearing and some existing signals of disproportionate reporting disappearing; the sensitivity of the signal detection system was slightly increased and the proportion of signals of disproportionate reporting that corresponded to known adverse drug reactions (a measure of efficiency) was unchanged.

Conclusions: The change in legislation has led to a small increase in sensitivity, without affecting the efficiency of the routine statistical measures used. The number of non-serious reports as a proportion of reports in EudraVigilance is likely to increase over time and further monitoring of the impact on signal detection is required. Further work is also required on the qualitative impact of non-serious reports on the nature of signals detected and on their evaluation.

Citing Articles

Improving adverse drug event reporting by healthcare professionals.

Shalviri G, Mohebbi N, Mirbaha F, Majdzadeh R, Yazdizadeh B, Gholami K Cochrane Database Syst Rev. 2024; 10:CD012594.

PMID: 39470185 PMC: 11520514. DOI: 10.1002/14651858.CD012594.pub2.


Safety Profiles Related to Dosing Errors of Rapid-Acting Insulin Analogs: A Comparative Analysis Using the EudraVigilance Database.

Ilie I, Vonica-Tincu A, Dobrea C, Butuca A, Frum A, Morgovan C Biomedicines. 2024; 12(10).

PMID: 39457586 PMC: 11504911. DOI: 10.3390/biomedicines12102273.


Overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: a scoping review using a systematic approach.

Wang R, Bonomo Y, Hallinan C BMJ Open. 2024; 14(7):e085166.

PMID: 39025811 PMC: 11733909. DOI: 10.1136/bmjopen-2024-085166.


The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.

Bahri P, Genov G, Arlett P, Sarinic V, Korakianiti E, Nolte A Drug Saf. 2024; 47(10):941-956.

PMID: 38987419 PMC: 11399220. DOI: 10.1007/s40264-024-01451-3.


Navigating duplication in pharmacovigilance databases: a scoping review.

Kiguba R, Isabirye G, Mayengo J, Owiny J, Tregunno P, Harrison K BMJ Open. 2024; 14(4):e081990.

PMID: 38684275 PMC: 11086478. DOI: 10.1136/bmjopen-2023-081990.


References
1.
Candore G, Juhlin K, Manlik K, Thakrar B, Quarcoo N, Seabroke S . Comparison of statistical signal detection methods within and across spontaneous reporting databases. Drug Saf. 2015; 38(6):577-87. DOI: 10.1007/s40264-015-0289-5. View

2.
Postigo R, Brosch S, Slattery J, van Haren A, Dogne J, Kurz X . EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. Drug Saf. 2018; 41(7):665-675. PMC: 5990579. DOI: 10.1007/s40264-018-0647-1. View

3.
Potts J, Genov G, Segec A, Raine J, Straus S, Arlett P . Improving the Safety of Medicines in the European Union: From Signals to Action. Clin Pharmacol Ther. 2019; 107(3):521-529. PMC: 7027976. DOI: 10.1002/cpt.1678. View

4.
Wisniewski A, Bate A, Bousquet C, Brueckner A, Candore G, Juhlin K . Good Signal Detection Practices: Evidence from IMI PROTECT. Drug Saf. 2016; 39(6):469-90. PMC: 4871909. DOI: 10.1007/s40264-016-0405-1. View

5.
Santoro A, Genov G, Spooner A, Raine J, Arlett P . Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works. Drug Saf. 2017; 40(10):855-869. PMC: 5606958. DOI: 10.1007/s40264-017-0572-8. View