| アブストラクト | INTRODUCTION: 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. OBJECTIVE: The authors have examined a sample of Medical Dictionary for Regulatory Activities (MedDRA((R))) coded reports that describe medication errors to assess the accuracy and consistency of MedDRA((R)) coding, and to identify the main types of coding errors for the newly introduced COVID-19 vaccines. METHODS: The sample of coded terms was assessed by two MedDRA((R)) 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((R)) terms. RESULTS: One third of the records could not be assessed because of incomplete or unclear verbatims. In one third, MedDRA((R)) term assignments were correct, but another third of the sample was not adequately coded. The most frequent coding errors corresponded to vague MedDRA((R)) 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((R)) terms for medication errors also represent vague concepts. CONCLUSIONS: 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((R)) 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((R)) users. |
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| ジャーナル名 | Drug safety |
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| 投稿日 | 2023/4/23 |
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| 投稿者 | Kralova, Katarina; Wilson, Carol-Ann; Richebourg, Nicolas; D'souza, Joan |
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| 組織名 | Sanofi Global Pharmacovigilance, Paris, France. katarina.kralova@sanofi.com.;, Berlin, Germany.;Sanofi Global Pharmacovigilance, Paris, France.;, Zurich, Switzerland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37087705/ |
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