Authors : Mrunal G. Vekhande; Sushant Sawant; Dr. Deepanjana Dass; Dr. Savitri Mandavi; Dr. Prakash Khandelwal

Volume/Issue : Volume 9 - 2024, Issue 7 - July

Google Scholar : https://tinyurl.com/crm9be5e

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DOI : https://doi.org/10.38124/ijisrt/IJISRT24JUL727

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Abstract : Introduction: The incidence of adverse drug reactions (ADRs) has significant implications for patient safety and public health. In 1937, the introduction of sulphanilamide for streptococcal infections marked a pivotal moment in drug safety. Present study assessed the pattern, causality and severity of the ADRs reported from a tertiary referral centre.  Materials and Methods: Study conducted at the Mahatma Gandhi Mission Medical College and Hospital Kamothe Navi Mumbai recorded the pattern of ADRs between January 2021 and December 2022. The data was collected from the ADR Monitoring Center using the suspected ADR reporting form, version 1.4 of IPC, Ghaziabad, India. The suspected ADR forms were assessed to understand the pattern of ADRs regarding the completeness score of the ADR form.  Findings and Discussion: A total of 111 ADRs were recorded, with 43.24% of cases falling within the age range of 21 to 40. Antimicrobial medications were the main culprits behind the majority of ADRs reported by the departments of dermatology and general medicine. Rashes, edema, and urticaria are among the skin-related symptoms among the most frequently reported adverse drug reactions (ADRs). 72.9% of instances were classified as mild, according to severity assessment, whereas 57.65% of ADRs were found to be likely.  Conclusions: Because ADRs represent a serious threat to public health, our study highlights the significance of pharmacovigilance in tracking and preventing them. Databases on a national and international level are enhanced by systematic, regular reporting and monitoring of ADRs. In order to raise awareness of ADRs among patients and healthcare professionals, spontaneous reporting is still essential.

Keywords : Adverse Drug Reactions, Pharmacovigilance, Causality Assessment, Severity Assessment, Completeness Score.

References :

1. Chauhan S. Pharmacovigilance-A drug safety monitoring tool. J Pharmacovigil Drug Res. 2021;2:14-19.
2. Singh KN, Kanase HR. Pharmacovigilance programme of India: The beginning, current status and recent progress. Adv Pharmacoepidemiol Drug Saf. 2017;6:219.
3. Pharmacovigilance Programme of India [Internet]. [cited 2023 Aug 29]. Available from: https://ipc.gov.in/PvPI/pv_home.html
4. Gupta AK. A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital. J Med Acad 2020;3(2):54–58.
5. Gadhade JB, Hiray RS, Aherkar RY, Shah KU. Pharmacovigilance programme of India: revival of the renaissance. Int J Basic Clin Pharmcol. 2018;7:2281-2285.
6. Kuchya SK, Shrivastava S. Comparison of methods of submission of suspected adverse drug reactions to the ADR monitoring centers in India. Int J Basic Clin Pharmacol. 2017;6:2032-2037.
7. Thakare VS, Kavitha VD, Langade D. Prospective observational study to evaluate adverse drug reactions pattern in a tertiary level teaching hospital. Nat J Physiol Pharm Pharmacol. 2019;9(5):434-437.
8. Raina RS, Kaushal SB. Retrospective analysis on adverse drug reactions prevalence in the female population of Tertiary Care Hospital. Indian J Pharm Pharmacol. 2018;5:40-43.
9. Ankitha L, Ramesh H. A retrospective study of adverse drug reactions in a tertiary care center. Int J Basic Clin Pharmacol. 2020;9: 611-615.
10. Adhikari A, Bhattacharjee N, Bhattacharya S, Indu R, Ray M. Evaluation of adverse drug reactions in tertiary care hospital of Kolkata, West Bengal, India. J Young Pharm. 2017;9:311-314.
11. Prashanthi B, Modi H, Kalagara D. Adverse drug reactions (ADR’S) monitoring at tertiary care Hospital. J Drug Deliv Ther. 2019;9:195-198.
12. 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 Innov. 2019;8:277-286.