Pharmacovigilance Center, Information and Methodological Center for Expert Evaluation, Record and Analysis of Circulation of Medical Products under the Federal Service for Surveillance in Healthcare, 4-1 Slavyanskaya Square, Moscow, Russian Federation, 109074.
Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia (RUDN University), 6 Miklukho-Maklaya Street, Moscow, Russian Federation, 117198.
BMC Pharmacol Toxicol. 2021 Jan 8;22(1):5. doi: 10.1186/s40360-020-00470-x.
Comprehensive analysis of all available data in spontaneous reports (SRs) can reveal previously unidentified medication errors (MEs).
To detect MEs, we performed a retrospective analysis of SRs submitted to the Russian pharmacovigilance database in the period from January 01, 2012, to August 01, 2014. This study evaluated SRs of cases where beta-lactam antibiotics were the suspected drug.
A total of 3608 SRs were analyzed. MEswere detected in 1043 reports (28.9% of all cases). The total number of detected errors was 1214. Reporters themselves indicated MEs in 29 SRs. A term denoting an ME was selected in the "Adverse Reactions" section in 18 of these SRs, whereas in the other 11 reports information on the ME was found only in the "Case narrative" section. MEs were associated with wrong indications in 32.5% of the cases; 61.0% of these cases were viral infections. Various dosing regimen violations constituted 29.7% of MEs. A contraindicated drug was administered in 17.3% of all detected MEs, most commonly to a patient with a history of allergy to the suspected drug or severe hypersensitivity reactions to other drugs of the same group.
Automatic identification of MEs in the pharmacovigilance database is sometimes precluded by the absence of a code for the respective episode in the "Adverse Reactions" section, even when the error was detected by the reporter. The most frequent types of MEs associated with the use of beta-lactams in Russia are the leading risk factors of growing bacterial resistance.
综合分析自发报告（SRs）中所有可用数据，可以揭示以前未识别的药物错误（MEs）。
为了检测 ME，我们对 2012 年 1 月 1 日至 2014 年 8 月 1 日期间向俄罗斯药物警戒数据库提交的 SR 进行了回顾性分析。本研究评估了β-内酰胺类抗生素被怀疑为药物的 SR。
共分析了 3608 份 SR。在 1043 份报告（所有病例的 28.9%）中发现了 ME。共发现 1214 个错误。报告人自己在 29 份 SR 中指出了 ME。在这些 SR 中的 18 份中，在“不良反应”部分选择了表示 ME 的术语，而在其他 11 份报告中，仅在“病例叙述”部分发现了有关 ME 的信息。在 32.5%的病例中，ME 与错误的适应症有关；其中 61.0%的病例为病毒感染。各种剂量方案违规构成 29.7%的 ME。在所有检测到的 ME 中，有 17.3%的病例使用了禁忌药物，最常见的是对可疑药物过敏或对同一组其他药物有严重过敏反应的患者。
在药物警戒数据库中自动识别 ME 有时会受到“不良反应”部分中没有相应事件代码的限制，即使错误是由报告人检测到的。与俄罗斯使用β-内酰胺类药物相关的最常见 ME 类型是导致细菌耐药性不断增长的主要危险因素。
