DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20173292

Comparison of methods of submission of suspected adverse drug reactions to the ADR monitoring centers in India

Sachin Kumar Kuchya, Sarita Shrivastav

Abstract


Background: Traditionally, paper based suspected ADR forms were the only way of submitting suspected ADR (sADR) data. Recently the mobile android based ADR reporting app© (App©) has also been developed and a copyright was granted to the author. This study is done to assess the two, viz. paper based and App based, methods of submission of sADR data.

Methods: The sADR data submitted to the ADR Monitoring Centre (AMC), at Department of Pharmacology, NSCB MC Jabalpur. There is no such scale to assess the completeness of suspected ADR data received by individual AMCs. Therefore, appropriate algorithm and scale for Completeness scoring of filled sADR forms was designed, the basic tenets were adhered. A set of 10 sADR forms, submitted by either method, were subjected to Independent assessment by 3 assessors, who were not part of this study. The scores were then subjected to analysis, which revealed minimal variation across the assessment. Hence, the scale was adopted for the study.

Results: A total of 403 sADR’s submitted to our AMC, were screened and subjected to scoring for completeness. Upon screening, 96.2% (257/267) sADR submitted via paper based sADR form and 100% (136/136) of those submitted via App stood valid, and hence included in the study. All the suspected ADR (sADR) submitted via ADR Reporting app were, complete. The sADR data submitted via ADR reporting app, had an average completeness score of 34.7±2.4 while those submitted via paper based form had an average of 29.2±2.4. The difference is highly significant on Wilcoxon two sample test (p<0.001) and Kolmogorov-Smirnov test (p<0.001).

Conclusions: Compared to traditional paper based system, the ADR reporting app based sADR submission, is a better method.


Keywords


ADR reporting app, NCC-PvPI, Pharmacovigilance, SRS, sADR

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