A retrospective study of serious adverse drug reactions and associated risk factors in a tertiary care hospital
Keywords:Cancer, Hematological, Causality, Predictability
Background: Serious adverse drug reactions (ADRs) cause physical, psychological and economic harm to patients and society. This study was undertaken to understand serious ADRs in a tertiary care hospital and risk factors associated with it.
Methods: The serious adverse reactions that occurred over a one-year period were assessed. The serious adverse drug reactions, action taken, outcome, predictability, suspect drug, causality, patient demographics and risk factors for the reaction was collected. Chi-square test was applied for observing relationships of predisposing factors for serious ADRs.
Results: Out of a total of 984 reported adverse drug reactions, 94 (9.55%) were serious. Hematological disorders (41.05%) were the common serious ADRs followed by electrolyte disturbances (18.94%). Anticancer agents were the suspect drugs for majority of serious ADRs. Serious ADRs contributed to 39 (0.05%) admissions in the hospital. Recovery occurred in 97.87% of the patients. The causality was possible in 91.48% (n=86) and probable in 8.51% (n=8) of the serious adverse drug reactions. Males, patients even with a single concomitant disease and those with more than 2 concomitant medications were at increased risk (p<0.05) for developing serious ADRs.
Conclusions: Serious ADRs are a significant problem in health care. Measures should be taken to detect and treat them at the earliest to reduce suffering of the patient.
Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet. 2000;356:1255-9.
Lazarou J, Pomeranz BH, Corey PN. Incidence of ADRs in Hospitalized Patients -a metaanalysis of prospective studies JAMA. 1998;279(15):1200-5.
Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006;296(15):1858-66.
Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2008;65:210-6.
WHO Collaborating Centre for Drug Statistics Methodology and Norwegian Institute of Public Health. Guidelines for ATC classification and DDD assignment 2013. Available at: https://www. whocc.no/filearchive/publications/1_2013guidelines.pdf. Accessed on 14 September 2014.
The use of the WHO-UMC system for standardised case causality assessment. Available at: http://www.WHOUMC.org/graphics/4409.pdf. Accessed on 10 August 2014.
Rawlins MD. Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug reactions. Oxford: Oxford University Press; 1977: 10.
Vora MB, Trivedi HR, Shah BK, Tripathi CB. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital: A prospective cohort study. J Pharmacol Pharmacother. 2011;2(1):21-5.
Sharma H, Aqil M, Imam F, Alam MS, Kapur P, Pillai KK. A pharmacovigilance study in the department of medicine of a university teaching hospital. Pharm Pract (Granada). 2007;5(1):46-9.
Jamunarani R, Priya M. Analysis of adverse drug reaction related hospital admissions and common challenges encountered in ADR reporting in a tertiary care teaching hospital. Asian J Pharm Clin Res. 2014;7:141-3.
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.
Camargo AL, Cardoso Ferreira MB, Heineck I. Adverse drug reactions: a cohort study in internal medicine units at a university hospital. Eur J Clin Pharmacol. 2006;62:143-9.
Raut AL, Patel P, Patel C, Pawa A. Preventability, Predictability and Seriousness of Adverse Drug Reactions Amongst Medicine Inpatients in a Teaching Hospital: A Prospective Observational Study. Int J Pharm Chem Sc. 2012;1(3):1293-9.
Prasad A, Datta PP, Bhattacharya J, Pattanayak C, Chauhan AS, et al. Pattern of Adverse Drug Reactions Due to Cancer Chemotherapy in a Tertiary Care Teaching Hospital in Eastern India. J Pharmacovigilance. 2013;1:107.
Shamna M, Dilip C, Ajmal M, Linu Mohan P, Shinu C, Jafer CP, et al. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharm J. 2014;22:303-8.
Domenic AS. Diuretic-Related Side Effects: Development and Treatment. The J Clin Hypertension. 2004;6(9):532-40.
Muaed JA. Factors affecting the development of adverse drug reactions. Saudi Pharma J. 2014;22(2):83-94.
Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348:1556-64.
Zhang M, Holman CDJ, Price SD, Sanfilippo FM, Preen DB, Bulsara MK. Comorbidity and repeat admission to hospital for adverse drug reactions in older adults: retrospective cohort study. BMJ. 2008;337:2752.
Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol. 2006;2:349-51.
Schlienger RG, Oh PI, Knowles SR, Shear NH. Quantifying the costs of serious adverse drug reactions to antiepileptic drugs. Epilepsia. 1998;39(7):27-32.