Sanofi Global Pharmacovigilance, Paris, France.
, Berlin, Germany.
Drug Saf. 2023 May;46(5):501-507. doi: 10.1007/s40264-023-01294-4. Epub 2023 Apr 23.
In recent years, there has been increasing interest from regulatory agencies and scientific organisations into the recording, coding and reporting of medication errors. Accuracy and consistency in the handling of medication error reports ensure the safety and effectiveness of medicines and provide reliable information to both healthcare professionals and patients.
The authors have examined a sample of Medical Dictionary for Regulatory Activities (MedDRA) coded reports that describe medication errors to assess the accuracy and consistency of MedDRA coding, and to identify the main types of coding errors for the newly introduced COVID-19 vaccines.
The sample of coded terms was assessed by two MedDRA experts applying the Four Eyes Principle. It included 1500 reported terms drawn from the Uppsala Monitoring Centre database reported up to 25 August, 2021, describing medication errors for COVID-19 vaccines with their assigned MedDRA terms.
One third of the records could not be assessed because of incomplete or unclear verbatims. In one third, MedDRA term assignments were correct, but another third of the sample was not adequately coded. The most frequent coding errors corresponded to vague MedDRA Preferred Term assignments despite more detailed information being available in the verbatim for a more precise coding. This observation is similar to findings in the EudraVigilance database, where some of the most frequently assigned MedDRA terms for medication errors also represent vague concepts.
The findings indicate that understanding of medication error documentation and of the importance of accurate extraction of information from case narratives, as well as knowledge of MedDRA content and coding guidelines need to be reinforced. The authors provide useful references to training opportunities and to the applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Endorsed Guides for MedDRA users.
近年来，监管机构和科学组织对药物错误的记录、编码和报告越来越感兴趣。药物错误报告的准确性和一致性确保了药物的安全性和有效性，并为医疗保健专业人员和患者提供了可靠的信息。
作者检查了一组描述药物错误的医疗字典监管活动（MedDRA）编码报告，以评估 MedDRA 编码的准确性和一致性，并确定新引入的 COVID-19 疫苗的主要编码错误类型。
采用“四眼原则”，由两名 MedDRA 专家评估编码术语样本。它包括从 Uppsala 监测中心数据库中抽取的 1500 个报告术语，这些术语描述了截至 2021 年 8 月 25 日 COVID-19 疫苗的药物错误及其分配的 MedDRA 术语。
由于记录不完整或不明确，三分之一的记录无法评估。三分之一的记录中 MedDRA 术语的分配是正确的，但三分之一的样本没有得到充分编码。最常见的编码错误对应于模糊的 MedDRA 首选术语分配，尽管在详细信息在记录中可用，但更准确的编码需要更详细的信息。这一观察结果与 EudraVigilance 数据库中的发现相似，在该数据库中，一些最常分配给药物错误的 MedDRA 术语也代表模糊的概念。
这些发现表明，需要加强对药物错误文档的理解，以及从案例叙述中准确提取信息的重要性，以及对 MedDRA 内容和编码指南的了解。作者提供了有关 MedDRA 用户培训机会和适用的国际人用药品注册技术协调会认可指南的有用参考。
