Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms
Vikas Maharshi1, Pravesh Nagar2
1 Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India
2 Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India
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.
Dr. Vikas Maharshi
Department of Pharmacology, All India Institute of Medical Sciences, New Delhi - 110 029
|How to cite this article:|
Maharshi V, Nagar P. Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms.Indian J Pharmacol 2017;49:374-382
|How to cite this URL:|
Maharshi V, Nagar P. Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms. Indian J Pharmacol [serial online] 2017 [cited 2020 Oct 28 ];49:374-382
Available from: https://www.ijp-online.com/article.asp?issn=0253-7613;year=2017;volume=49;issue=5;spage=374;epage=382;aulast=Maharshi;type=0