PROFILE OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL: A CROSS-SECTIONAL STUDY
DOI:
https://doi.org/10.22159/ajpcr.2024v17i6.52049Keywords:
Adverse drug reaction, Naranjo scale, Modified Hartwig scale, PharmacovigilanceAbstract
Objective: The objective of this study was to analyze incidence, presentation, severity of adverse drug reaction, and identification of offending drug in a tertiary care hospital setting.
Methods: This was a cross-sectional study conducted in the department of pharmacology of a tertiary care medical institute for assessing the clinical spectrum and pattern of adverse drug reactions (ADRs). Total 50 patients with ADRs were included in this study on the basis of a predefined inclusion and exclusion criteria. Demographic details and history were noted in all cases. The Naranjo scale was used to determine the causality and categorize it into definite, probable, possible, or doubtful causation. Severity of the ADR was assessed using the modified Hartwig scale. The Statistical Package for the Social Sciences 23.0 version was used for statistical analysis. For statistical purposes, p<0.05 was considered as significant.
Results: In this study, out of 50 patients, there were 36 (72%) males and 14 females (28%). There was a male preponderance with M: F ratio being 1:0.388. The most common ADR symptoms were itching (76%) and skin rashes (26%). Antimicrobials were the leading cause of ADRs (14%), followed by antiretroviral agents (10%) and non-steroidal anti-inflammatory drugs (6%). The Naranjo scale classified 14% of ADRs as definite, 44% as probable, and 42% as possible. Severity assessment revealed 54% mild, 40% moderate, and 6% severe ADRs. The most affected age group among males was 41–50 years (20%), while among females, it was 31–40 years (10%).
Conclusion: Prompt recognition and management of ADRs are crucial for minimizing their adverse effects on patient health and for guiding safer prescribing practices in clinical settings.
Downloads
References
Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ. 2004;329(7456):15-19.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: Ameta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.
Aung AK, Walker S, Khu YL, Tang MJ, Lee JI, Graudins LV. Adverse drug reaction management in hospital settings: Review on practice variations, quality indicators and education focus. Eur J Clin Pharmacol. 2022;78(5):781-91. doi:10.1007/s00228-022-03287-1
Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: A prospective analysis of 3695 patient-episodes. PLoS One. 2009;4(2):e4439. doi: 10.1371/journal.pone.0004439
Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital--their severity and cost involved. Pharmacoepidemiol Drug Saf. 2003;12(8):687-92. doi: 10.1002/pds.871
Coleman JJ, Pontefract SK. Adverse drug reactions. Clin Med (Lond). 2016;16(5):481-5. doi: 10.7861/clinmedicine.16-5-481
Härmark L, Van Grootheest AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64(8):743-52. doi: 10.1007/s00228-008-0475-9
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45. doi: 10.1038/clpt.1981.154
Seselja Perisin A, Bukic J, Rusic D, Leskur D, Bozic J, Mihanovic A, et al. Teaching pharmacovigilance to healthcare students: Identifying gaps and opportunities for improvement. Pharmacy (Basel). 2021 Aug 26;9(3):147. doi: 10.3390/pharmacy9030147
Shamna M, Dilip C, Ajmal M, Linu Mohan P, Shinu C, Jafer CP, et al. Aprospective study on adverse drug reactions of antibiotics in a tertiary care hospital. Saudi Pharm J. 2014 Sep;22(4):303-8. doi: 10.1016/j. jsps.2013.06.004
Murali M, Suppes SL, Feldman K, Goldman JL. Utilization of the Naranjo scale to evaluate adverse drug reactions at a free-standing children’s hospital. PLoS One. 2021 Jan 13;16(1):e0245368. doi: 10.1371/journal.pone.0245368
Drici MD, Clément N. Is gender a risk factor for adverse drug reactions? The example of drug-induced long QT syndrome. Drug Saf. 2001;24(8):575-85. doi: 10.2165/00002018-200124080-00002
Martin RM, Biswas PN, Freemantle SN, Pearce GL, Mann RD. Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England: Analysis of 48 cohort studies. Br J Clin Pharmacol. 1998;46(5):505-11. doi: 10.1046/j.1365- 2125.1998.00817.x
Yadesa TM, Kitutu FE, Deyno S, Ogwang PE, Tamukong R, Alele PE. Prevalence, characteristics and predicting risk factors of adverse drug reactions among hospitalized older adults: A systematic review and meta-analysis. SAGE Open Med. 2021 Aug 18;9:20503121211039099. doi: 10.1177/20503121211039099
Onder G, Pedone C, Landi F, Cesari M, Della Vedova C, Bernabei R, et al. Adverse drug reactions as cause of hospital admissions: Results from the Italian Group of Pharmacoepidemiology in the Elderly (GIFA). J Am Geriatr Soc. 2002;50(12):1962-8. doi: 10.1046/j.1532- 5415.2002.50607.x
Gaur S, Paramjeet S, Srivastava B, Bhardwaj R, Ahuja S, Gunjita B. Evaluation of adverse drug reactions in teaching hospital in Kumoun Region. J Med Sci Clin Res. 2016 Aug;4(8):12139-45. doi: 10.18535/ jmscr/v4i8.76
Gonzalez EL, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2009;32(1):19-31.
Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions amongst resident doctors. J Pharm Sci Res. 2011;3(2):1064-9.
Malathi M, Shanthi M, Nambi T. Adverse drug reactions at a tertiary care hospital in South India-a prospective analysis. J Med Sci Clin Res. 2017 Sep;5(9):27451-6. doi: 10.18535/jmscr/v5i9.16
Published
How to Cite
Issue
Section
Copyright (c) 2024 SUSHMA NAIDU V, VIBHA RANI
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
