Quality of safety reports on oral anticoagulants in the Russian state pharmacovigilance database. A cross-sectional study for 2017-2022.

Background

Quality of individual cases of safety reports (ICSR) is a challenge for modern drug safety studies. Purpose and Research

Design

In this cross-sectional study of the safety database, we studied reports completeness for direct oral anticoagulants (DOAC) received in 2017-2022. Study sample: A total of 1428 ICSRs were selected for analysis.

Results

The largest number of reports was received for rivaroxaban (638), and the number of records for apixaban and dabigatran was 454 and 336, respectively. The number of reports in the reporting period increased for apixaban only. The number of empty fields per report was 47.5% (52.5% for apixaban, 47.5% for rivaroxaban, and 37.5% for dabigatran). The worst-filled field was the dose of the drug (8.96%). The VigiGrade (VG) score for all reports was 0.268 (rivaroxaban-0.268, apixaban-0.233, and dabigatran-0.353). The VG index was higher for reports received from healthcare professionals (0.441) and authorized authorities (0.397). The proportion of well-documented cases decreased between 2017 and 2022, accounting for 1.82% overall. The average median score (0.44) was achieved in 22.34% cases. Possible main reasons for the decline in quality include the COVID-19 pandemic and the coinciding transition to a new version of the database.

Conclusions

Solutions to the problem of low-quality reports may include increasing the staffing, trainings, and introducing electronic control systems.