{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T03:37:52Z","timestamp":1783741072701,"version":"3.55.0"},"reference-count":23,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T00:00:00Z","timestamp":1766448000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Risk &amp; Safety in Medicine"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:p>\n                    <jats:bold>Background:<\/jats:bold>\n                    Quality of individual cases of safety reports (ICSR) is a challenge for modern drug safety studies.\n                    <jats:bold>Purpose and Research Design:<\/jats:bold>\n                    In this cross-sectional study of the safety database, we studied reports completeness for direct oral anticoagulants (DOAC) received in 2017\u20132022.\n                    <jats:bold>Study sample:<\/jats:bold>\n                    A total of 1428 ICSRs were selected for analysis.\n                    <jats:bold>Results:<\/jats:bold>\n                    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\u20140.268, apixaban\u20140.233, and dabigatran\u20140.353). 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.\n                    <jats:bold>Conclusions:<\/jats:bold>\n                    Solutions to the problem of low-quality reports may include increasing the staffing, trainings, and introducing electronic control systems.\n                  <\/jats:p>","DOI":"10.1177\/09246479251410804","type":"journal-article","created":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T10:32:53Z","timestamp":1766485973000},"page":"275-283","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Quality of safety reports on oral anticoagulants in the Russian state pharmacovigilance database. A cross-sectional study for 2017\u20132022"],"prefix":"10.1177","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6636-3950","authenticated-orcid":false,"given":"Aleksandr V.","family":"Matveev","sequence":"first","affiliation":[{"name":"Russian Medical Academy of Continuing Professional Education"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergey V.","family":"Glagolev","sequence":"additional","affiliation":[{"name":"Russian Medical Academy of Continuing Professional Education"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena A.","family":"Kruglova","sequence":"additional","affiliation":[{"name":"Pirogov Russian National Research Medical University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitry A.","family":"Sychev","sequence":"additional","affiliation":[{"name":"Russian Medical Academy of Continuing Professional Education"},{"name":"Russian Academy of Science"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,12,23]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajem.2024.09.016"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.123.030380"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.otsr.2022.103364"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.122.026723"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.4059"},{"key":"e_1_3_3_7_2","first-page":"98","article-title":"Consumption of oral anticoagulants in hospitals of the Russian Federation: analysis of the dynamics of procurement data","volume":"30","author":"Matveev AV","year":"2023","unstructured":"Matveev AV, Glagolev SV, Sychev DA, Department of Clinical Pharmacology and Therapy n.a. Acad. B.E. Votchal, Russian Medical Academy of Continuous Professional Education, Moscow, Russia. Consumption of oral anticoagulants in hospitals of the Russian Federation: analysis of the dynamics of procurement data. Pharma 2023; 30: 98\u2013106, Available from. https:\/\/pharmateca.ru\/archive\/article\/44195 [cited 2025 Feb 4]. 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