Medicines Evaluation Board, Utrecht, the Netherlands; Erasmus University Medical Center, Rotterdam, the Netherlands.
Medicines Evaluation Board, Utrecht, the Netherlands.
Vaccine. 2018 Dec 18;36(52):7956-7964. doi: 10.1016/j.vaccine.2018.11.003. Epub 2018 Nov 8.
Among all post-marketing medication error reports submitted to EudraVigilance, vaccines are the most frequently reported medicinal products. This study aims to describe the characteristics of vaccination errors submitted to Eudravigilance between 2001 and 2016.
EudraVigilance is a spontaneous reporting database for adverse events maintained by the European Medicines Agency. We extracted Individual Case Safety Reports (ICSRs) submitted to EudraVigilance between 1 January 2001 and 31 December 2016. Reports were included for analysis if a vaccine was reported as interacting or suspect drug and at least one medication error term was listed as an adverse reaction. ICSRs were stratified by age and gender, by year of reporting, region of origin, reporter profession, seriousness of outcome, ATC, and type of error.
In total, 7097 ICSRs were included in the study. We observed a yearly increase in the reporting of vaccination errors, with the proportion to all vaccine ICSRs increasing from 0.4% to 4.0% between 2001 and 2016. The majority of reports was classified as serious (4248, 59.9%), but non-serious reports were increasingly reported since 2012. The mean age of patients was 24.1 years. The most frequently reported vaccines were influenza (13.5%), bacterial and viral combined (12.3%), and hepatitis vaccines (11.8%). A total of 8167 medication error terms were reported. The most frequently reported terms were "Inappropriate schedule of drug administration" (27.2%), "Incorrect route of drug administration" (12.5%) and "Drug administered to patient of inappropriate age" (10.0%). For infants and children, the error "Drug administered to patient of inappropriate age" was reported more often than for all other age categories.
Vaccination errors are increasingly submitted to EudraVigilance. Errors related to the schedule are the most common errors reported with vaccines. However, consequences of vaccination errors appear to be relatively mild.
在向 EudraVigilance 提交的所有上市后药物错误报告中，疫苗是报告最频繁的药品。本研究旨在描述 2001 年至 2016 年间向 Eudravigilance 报告的疫苗接种错误的特征。
EudraVigilance 是由欧洲药品管理局维护的不良事件自发报告数据库。我们从 2001 年 1 月 1 日至 2016 年 12 月 31 日期间向 EudraVigilance 提交的个别病例安全报告（ICSR）中提取数据。如果报告将疫苗列为相互作用或可疑药物，并且至少列出一种药物错误术语作为不良反应，则将报告纳入分析。ICSR 按年龄和性别、报告年份、原籍地区、报告人职业、结果严重程度、ATC 和错误类型分层。
共纳入 7097 份 ICSR。我们观察到疫苗接种错误报告逐年增加，2001 年至 2016 年期间，疫苗接种错误报告占所有疫苗 ICSR 的比例从 0.4%增加到 4.0%。大多数报告被归类为严重（4248 份，59.9%），但自 2012 年以来，非严重报告的报告比例逐渐增加。患者的平均年龄为 24.1 岁。报告最多的疫苗是流感（13.5%）、细菌和病毒联合疫苗（12.3%）和肝炎疫苗（11.8%）。共报告了 8167 种药物错误术语。报告最频繁的术语是“药物给药时间不当”（27.2%）、“药物给药途径不当”（12.5%）和“给不合适年龄的患者给药”（10.0%）。对于婴儿和儿童，与所有其他年龄组相比，报告的错误“给不合适年龄的患者给药”更为常见。
向 EudraVigilance 提交的疫苗接种错误报告越来越多。与疫苗接种相关的错误与计划有关，是报告最常见的错误。然而，疫苗接种错误的后果似乎相对较轻。
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