A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example

A European legislation was put in place for the reporting of medication errors, and guidelines were drafted to help stakeholders in the reporting, evaluation, and, ultimately, minimization of these errors. As part of pharmacovigilance reporting, a proper classification of medication errors is needed...

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Main Authors: Christophe Dessart, Fernanda Tavares-Da-Silva, Lionel Van Holle, Olivia Mahaux, Jens-Ulrich Stegmann
Format: Article
Language:English
Published: Wiley 2024-01-01
Series:Advances in Pharmacological and Pharmaceutical Sciences
Online Access:http://dx.doi.org/10.1155/2024/6435993
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author Christophe Dessart
Fernanda Tavares-Da-Silva
Lionel Van Holle
Olivia Mahaux
Jens-Ulrich Stegmann
author_facet Christophe Dessart
Fernanda Tavares-Da-Silva
Lionel Van Holle
Olivia Mahaux
Jens-Ulrich Stegmann
author_sort Christophe Dessart
collection DOAJ
description A European legislation was put in place for the reporting of medication errors, and guidelines were drafted to help stakeholders in the reporting, evaluation, and, ultimately, minimization of these errors. As part of pharmacovigilance reporting, a proper classification of medication errors is needed. However, this process can be tedious, time-consuming, and resource-intensive. To fulfill this obligation regarding medication errors, we developed an algorithm that classifies the reported errors in an automated way into four categories: potential medication errors, intercepted medication errors, medication errors without harm (i.e., not associated with adverse reaction(s)), and medication errors with harm (i.e., associated with adverse reaction(s)). A fifth category (“conflicting category”) was created for reported cases that could not be unambiguously classified as either potential or intercepted medication errors. Our algorithm defines medication error categories based on internationally accepted terminology using the Medical Dictionary for Regulatory Activities (MedDRA®) preferred terms. We present the algorithm and the strengths of this automated way of reporting medication errors. We also give examples of visualizations using spontaneously reported vaccination error data associated with the adjuvanted recombinant zoster vaccine. For this purpose, we used a customized web-based platform that uses visualizations to support safety signal detection. The use of the algorithm facilitates and ensures a consistent way of categorizing medication errors with MedDRA® terms, thereby saving time and resources and avoiding the risk of potential mistakes versus manual classification. This allows further assessment and potential prevention of medication errors. In addition, the algorithm is easy to implement and can be used to categorize medication errors from different databases.
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spelling doaj-art-dd3d1bb4a4a8453695cc30c9673b4e792025-08-20T03:24:26ZengWileyAdvances in Pharmacological and Pharmaceutical Sciences2633-46902024-01-01202410.1155/2024/6435993A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an ExampleChristophe Dessart0Fernanda Tavares-Da-Silva1Lionel Van Holle2Olivia Mahaux3Jens-Ulrich Stegmann4Global SafetyGlobal SafetyOpenSourcePVGlobal SafetyGlobal SafetyA European legislation was put in place for the reporting of medication errors, and guidelines were drafted to help stakeholders in the reporting, evaluation, and, ultimately, minimization of these errors. As part of pharmacovigilance reporting, a proper classification of medication errors is needed. However, this process can be tedious, time-consuming, and resource-intensive. To fulfill this obligation regarding medication errors, we developed an algorithm that classifies the reported errors in an automated way into four categories: potential medication errors, intercepted medication errors, medication errors without harm (i.e., not associated with adverse reaction(s)), and medication errors with harm (i.e., associated with adverse reaction(s)). A fifth category (“conflicting category”) was created for reported cases that could not be unambiguously classified as either potential or intercepted medication errors. Our algorithm defines medication error categories based on internationally accepted terminology using the Medical Dictionary for Regulatory Activities (MedDRA®) preferred terms. We present the algorithm and the strengths of this automated way of reporting medication errors. We also give examples of visualizations using spontaneously reported vaccination error data associated with the adjuvanted recombinant zoster vaccine. For this purpose, we used a customized web-based platform that uses visualizations to support safety signal detection. The use of the algorithm facilitates and ensures a consistent way of categorizing medication errors with MedDRA® terms, thereby saving time and resources and avoiding the risk of potential mistakes versus manual classification. This allows further assessment and potential prevention of medication errors. In addition, the algorithm is easy to implement and can be used to categorize medication errors from different databases.http://dx.doi.org/10.1155/2024/6435993
spellingShingle Christophe Dessart
Fernanda Tavares-Da-Silva
Lionel Van Holle
Olivia Mahaux
Jens-Ulrich Stegmann
A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example
Advances in Pharmacological and Pharmaceutical Sciences
title A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example
title_full A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example
title_fullStr A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example
title_full_unstemmed A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example
title_short A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example
title_sort model for monitoring spontaneously reported medication errors using the adjuvanted recombinant zoster vaccine as an example
url http://dx.doi.org/10.1155/2024/6435993
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