Published: 2022-10-27

Analysis of individual case safety reports of spontaneous reporting in adverse drug reaction monitoring centre at a tertiary care hospital

Gomathi S., Siddiraju Devipriya, Sudha K. M., Ramachandra Bhat C.


Background: In developing countries like India, the increased economic burden in healthcare system is due to adverse drug reactions (ADRs) related hospitalizations which in turn are related to polypharmacy associated with increased potential of ADRs. World Health Organization (WHO) started the program for international drug monitoring (WHO PIDM) in the year 1968. India is one of the member countries under WHO PIDM using the Vigibase for analysis of individual case safety reports (ICSRs). Aim of the study was to analyse the ICSRs by spontaneous reporting at ADR monitoring centre.

Methods: The present study was focused on analyzing the ICSRs of spontaneous reporting using Vigiflow data from the ADR monitoring centre (AMC), Madras Medical College, Chennai.

Results: A total of 541 ICSRs from the period between July 2017 and June 2018 were analysed. Among 541 ICSRs, 814 ADRs were analysed and found that the majority of the ADRs belonged to SOC of gastrointestinal disorders and the most of the ADRs were implicated by antimicrobial agents followed by non-steroidal anti-inflammatory drugs (NSAIDs). Among all the ICSRs, majority of the ADRs occurred in males (n=292) and the maximum number of ADRs were in the age group of 45-60 years (n=197). Of the 541 ICSRs, 313 were found to be of “serious” category and majority of the ICSRs outcome was found to be “recovered” (n=262). The causality assessment of the ICSRs were anlysed and found that the maximum number of ICSRs were under “probable” category as per WHO-UMC scale.

Conclusions: Robust pharmacovigilance activities plays important role in minimizing the ADRs for better patient safety.


Individual case safety reports, Vigiflow, Adverse drug reactions, Pharmacovigilance

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