• GAYATRI SUJIVE Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.
  • BENSAM T MATHEW Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.
  • MAMATHA K Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.
  • ANURADHA HV Department of Pharmacology, M.S. Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.


Objective: The process of aging involves an individual’s structural and functional depravity of their organ systems often results in compromised pharmacological principles of the prescribed drugs. Multimorbidity and polypharmacy along with change in pharmacokinetic and pharmacodynamic responses of drugs predispose the elderly to adverse drug reactions (ADRs). The present study was aimed to identify and report the characteristics and incidence of ADRs among geriatrics in an outpatient clinic.

Methods: This was a 6-month prospective hospital-based observational study among patients of either sex aged 60 years and above visiting an outpatient clinic at the study site. The suspected ADRs were categorized according to the Will’s and Brown classification system. Causality of these ADRs was verified by applying the WHO-UMC criteria and the Naranjo’s scale. Severity and preventability of the ADRs were classified using the modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. Multivariate logistic regression was used to determine the risk factors for developing ADRs.

Results: Among the 365 patients monitored, 57 (15%) patients experienced 60 ADRs. Therapeutic classes of drugs frequently associated with ADRs were the drugs used in hypertension (27 [45%]). Patients presenting with amlodipine (9 [15%]) induced pedal edema were observed with the highest frequency of ADRs. Polypharmacy (OR: 1.619, 95% confidence interval: 0.957−2.741, p=0.021) was observed as the influential risk factor for ADRs.

Conclusion: Pharmacist’s services and involvement in geriatric patient’s centered care can be associated with their improved health, quality of life and economic outcomes, a reduction in medicine-related adverse events, and limiting the morbidity and mortality in this age band.

Keywords: Geriatrics, Outpatient, Adverse drug reactions


1. World Population Ageing. Available from: development/desa/population/publications/./WPA2015_Report.pdf. [Last cited on 2018 Apr 16].
2. Age Care Statistics. Available from: [Last cited on 2018 Apr 18].
3. Harugeri A, Parthasarathi G, Ramesh M, Guido S, Basavanagowdappa H. Frequency and nature of adverse drug reactions in elderly in-patients of two Indian medical college hospitals. J Postgrad Med 2011;57:189 95.
4. Davies EA, O’Mahony MS. Adverse drug reactions in special populations the elderly. Br J Clin Pharmacol 2015;80:796-807.
5. Field TS, Gurwitz JH, Avorn J, McCormick D, Jain S, Eckler M, et al. Risk factors for adverse drug events among nursing home residents. Arch Intern Med 2001;161:1629-34.
6. Mangoni AA, Jackson SH. Age-related changes in pharmacokinetics and pharmacodynamics: Basic principles and practical applications. Br J Clin Pharmacol 2004;57:6-14.
7. Loya AM, González-Stuart A, Rivera JO. Prevalence of polypharmacy, polyherbacy, nutritional supplement use and potential product interactions among older adults living on the United States-Mexico border: A descriptive, questionnaire-based study. Drugs Aging 2009;26:423-36.
8. Cabello AJ, Del Pozo Gavilán E, Jiménez FJ, Rodríguez CM, Luna Del Castillo Jde D, Cañas EP, et al. Drug-related mortality among inpatients: A retrospective observational study. Eur J Clin Pharmacol 2016;72:731-6.
9. Olivier P, Bertrand L, Tubery M, Lauque D, Montastruc JL, Lapeyre- Mestre M, et al. Hospitalizations because of adverse drug reactions in elderly patients admitted through the emergency department: A prospective survey. Drugs Aging 2009;26:475-82.
10. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies. Ann Pharmacother 2008;42:1017-25.
11. Alhawassi TM, Krass I, Bajorek BV, Pont LG. A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clin Interv Aging 2014;9:2079-86.
12. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279:1200-5.
13. Patel H, Bell D, Molokhia M, Srishanmuganathan J, Patel M, Car J, et al. Trends in hospital admissions for adverse drug reactions in England: Analysis of national hospital episode statistics 1998-2005. BMC Clin Pharmacol 2007;7:9.
14. Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. Adverse drug events prevention study group. JAMA 1997;277:307-11.
15. Hohl CM, Nosyk B, Kuramoto L, Zed PJ, Brubacher JR, Abu-Laban RB, et al. Outcomes of emergency department patients presenting with adverse drug events. Ann Emerg Med 2011;58:270-90000.
16. Bond CA, Raehl CL. Adverse drug reactions in United States hospitals. Pharmacotherapy 2006;26:601-8.
17. Mandavi SD, D’Cruz S, Sachdev A, Tiwari P. Adverse drug reactions and amp; their risk factors among Indian ambulatory elderly patients. Indian J Med Res 2012;136:404-10.
18. de Figueiredo TP, de Souza Groia RC, Barroso SC, do Nascimento MM, Reis AM. Factors associated with adverse drug reactions in older inpatients in teaching hospital. Int J Clin Pharm 2017;39:679-85.
19. Salive ME. Multimorbidity in older adults. Epidemiol Rev 2013;35:75 83.
20. El Mahalli AA. WHO/INRUD drug prescribing indicators at primary health care centres in Eastern province, Saudi Arabia. East Mediterr Health J 2012;18:1091-6.
21. Nandagopal A, Koneru A, Rahman A, Pasha MK, Ali MK. Assessment of rational drug prescribing pattern in geriatric patients in Hyderabad metropolitan. Indian J Pharm Pract 2017;10:174-8.
22. Nagaraju MK, Manasa S, Manjunath R. Pharmacovigilance study in geriatric population. Asian J Pharm Clin Res 2015;8:395-9.
23. Kumar VP, Dhanapal CK. Drug prescribing pattern in geriatric patients in a rural teaching hospital. Unique J Pharm Biol Sci 2013;1:16-8.
24. 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;329:15-9.
25. Atkin PA, Veitch PC, Veitch EM, Ogle SJ. The epidemiology of serious adverse drug reactions among the elderly. Drugs Aging 1999;14:141 52.
26. Beyth RJ, Shorr RI. Epidemiology of adverse drug reactions in the elderly by drug class. Drugs Aging 1999;14:231-9.
27. Cecile M, Seux V, Pauly V, Tassy S, Reynaud-Levy O, Dalco O, et al. Adverse drug events in hospitalized elderly patients in a geriatric medicine unit: Study of prevalence and risk factors. Rev Med Interne 2009;30:393-400.
28. Passarelli MC, Jacob-Filho W, Figueras A. Adverse drug reactions in an elderly hospitalised population: Inappropriate prescription is a leading cause. Drugs Aging 2005;22:767-77.
29. Nguyen JK, Fouts MM, Kotabe SE, Lo E. Polypharmacy as a risk factor for adverse drug reactions in geriatric nursing home residents. Am J Geriatr Pharmacother 2006;4:36-41.
30. Siddarama R, Bharath NJ, Joshisree KP, Sahithi LV. Polypharmacy induced drug interactions, adverse drug reactions (ADR) and medication errors in tertiary care South Indian hospital. Int J Pharm Pharm Sci 2019;2:88-93.
88 Views | 23 Downloads
How to Cite
Original Article(s)