Analysis of individual case safety reports of spontaneous reporting in adverse drug reaction monitoring centre at a tertiary care hospital
Keywords:Individual case safety reports, Vigiflow, Adverse drug reactions, Pharmacovigilance
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.
Vogler M, Conesa H R, Ferreira K A, Cruz1 F M, Gasparotto FS, Fleck K, et al. Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil. Pharm Med. 2020;34:327-34.
Nirumalla M, Sanapala S, Bobbili SV, Unni VK, Prathyusha P. A prospective study of adverse drug reactions in a tertiary care hospital in patients. Pharm Innovation J. 2019;8(2):277-86.
Bhattacharjee P, Das L, Ghosh R, Lalromawii, Das UK. Pattern of adverse drug reactions reported at a tertiary health care teaching hospital of Tripura: a retrospective study. Int J Basic Clin Pharmacol. 2016;5(4):1293-9.
Uppsala Monitoring Centre. The WHO Programme for International Drug Monitoring. Available at: https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/member-countries/. Accessed on 14 July 2022.
Thomas F, Abiri OT, Komeh JP, Conteh TA, Bah AJ, Kanu JS, et al. Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting. Int J Environ Res Public Health. 2022;19:3264.
Bansod KA, Bashir MSM, Ingle SS. Adverse Drug Reaction Profile in Amravati Region of India: A Pharmacovigilance Study. J Pharm Bioallied Sci. 2020;12(2):155-62.
Sen M, Singh A, Misra M. Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital. Int J Basic Clin Pharmacol. 2018;7(2):303-8.
Singh P, Agrawal M, Hishikar R, Joshi U, Maheshwari B, Halwai A. Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year. Indian J Pharmacol. 2017;49(6):432-7.
Swamy S, Bhanuprakash, Nadig P, Muralimohan, Shetty M. Profile of Suspect Adverse Drug Reactions in a Teaching Tertiary Care Hospital. J Pharmacol Clin Toxicol. 2013;1(1):1005.
Ramakrishnaiah H, Krishnaiah V, Pundarikaksha H P, Ramakrishna V. A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital. Int J Basic Clin Pharmacol. 2015;4(3):515-21.