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Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms

AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropr...

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Autores principales: Maharshi, Vikas, Nagar, Pravesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5830848/
https://www.ncbi.nlm.nih.gov/pubmed/29515278
http://dx.doi.org/10.4103/ijp.IJP_733_16
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author Maharshi, Vikas
Nagar, Pravesh
author_facet Maharshi, Vikas
Nagar, Pravesh
author_sort Maharshi, Vikas
collection PubMed
description AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropriate reporting of adverse drug reactions (ADRs). This study was aimed to compare three major online reporting systems (US, UK, and WHO) of the world and also to check their compatibility with the respective ADR reporting form. MATERIALS AND METHODS: A total of 89 data elements to provide relevant information were found out from above three online reporting systems. All three online systems were compared regarding magnitude of information captured by each of them and scoring was done by providing a score of “1” to each element. Compatibility of ADR reporting forms of India (Red form), US (Form 3500), and UK (Yellow card form) was assessed by comparing the information gathered by them with that can be entered into their respective online reporting systems, namely, “VigiFlow,” “US online reporting,” and “Yellow card online reporting.” Each unmatching item was given a score of “−1”. RESULTS: VigiFlow scored “74” points, whereas online reporting systems of the US and UK scored “56” and “49,” respectively, regarding magnitude of the information gathered by them. Compatibility score was found to be “0,” “−9,” and “−26” in case of ADR reporting systems of US, UK, and India, respectively. CONCLUSION: Our study reveals that “VigiFlow” is capable of capturing the maximum amount of information but “Form 3500” and “Online reporting system of US” are maximally compatible to each other among ADR reporting systems of all three countries.
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spelling pubmed-58308482018-03-07 Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms Maharshi, Vikas Nagar, Pravesh Indian J Pharmacol Research Article AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropriate reporting of adverse drug reactions (ADRs). This study was aimed to compare three major online reporting systems (US, UK, and WHO) of the world and also to check their compatibility with the respective ADR reporting form. MATERIALS AND METHODS: A total of 89 data elements to provide relevant information were found out from above three online reporting systems. All three online systems were compared regarding magnitude of information captured by each of them and scoring was done by providing a score of “1” to each element. Compatibility of ADR reporting forms of India (Red form), US (Form 3500), and UK (Yellow card form) was assessed by comparing the information gathered by them with that can be entered into their respective online reporting systems, namely, “VigiFlow,” “US online reporting,” and “Yellow card online reporting.” Each unmatching item was given a score of “−1”. RESULTS: VigiFlow scored “74” points, whereas online reporting systems of the US and UK scored “56” and “49,” respectively, regarding magnitude of the information gathered by them. Compatibility score was found to be “0,” “−9,” and “−26” in case of ADR reporting systems of US, UK, and India, respectively. CONCLUSION: Our study reveals that “VigiFlow” is capable of capturing the maximum amount of information but “Form 3500” and “Online reporting system of US” are maximally compatible to each other among ADR reporting systems of all three countries. Medknow Publications & Media Pvt Ltd 2017 /pmc/articles/PMC5830848/ /pubmed/29515278 http://dx.doi.org/10.4103/ijp.IJP_733_16 Text en Copyright: © 2018 Indian Journal of Pharmacology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Research Article
Maharshi, Vikas
Nagar, Pravesh
Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
title Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
title_full Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
title_fullStr Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
title_full_unstemmed Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
title_short Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
title_sort comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5830848/
https://www.ncbi.nlm.nih.gov/pubmed/29515278
http://dx.doi.org/10.4103/ijp.IJP_733_16
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