Cargando…
Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data
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...
Autores principales: | , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10122720/ https://www.ncbi.nlm.nih.gov/pubmed/37087705 http://dx.doi.org/10.1007/s40264-023-01294-4 |
_version_ | 1785029547371003904 |
---|---|
author | Kralova, Katarina Wilson, Carol-Ann Richebourg, Nicolas D’souza, Joan |
author_facet | Kralova, Katarina Wilson, Carol-Ann Richebourg, Nicolas D’souza, Joan |
author_sort | Kralova, Katarina |
collection | PubMed |
description | 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(®)) 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. METHODS: 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. RESULTS: 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. 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(®) 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. |
format | Online Article Text |
id | pubmed-10122720 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-101227202023-04-24 Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data Kralova, Katarina Wilson, Carol-Ann Richebourg, Nicolas D’souza, Joan Drug Saf Original Research Article 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(®)) 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. METHODS: 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. RESULTS: 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. 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(®) 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. Springer International Publishing 2023-04-23 2023 /pmc/articles/PMC10122720/ /pubmed/37087705 http://dx.doi.org/10.1007/s40264-023-01294-4 Text en © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Original Research Article Kralova, Katarina Wilson, Carol-Ann Richebourg, Nicolas D’souza, Joan Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data |
title | Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data |
title_full | Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data |
title_fullStr | Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data |
title_full_unstemmed | Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data |
title_short | Quality of MedDRA(®) Coding in a Sample of COVID-19 Vaccine Medication Error Data |
title_sort | quality of meddra(®) coding in a sample of covid-19 vaccine medication error data |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10122720/ https://www.ncbi.nlm.nih.gov/pubmed/37087705 http://dx.doi.org/10.1007/s40264-023-01294-4 |
work_keys_str_mv | AT kralovakatarina qualityofmeddracodinginasampleofcovid19vaccinemedicationerrordata AT wilsoncarolann qualityofmeddracodinginasampleofcovid19vaccinemedicationerrordata AT richebourgnicolas qualityofmeddracodinginasampleofcovid19vaccinemedicationerrordata AT dsouzajoan qualityofmeddracodinginasampleofcovid19vaccinemedicationerrordata |