Assessment of Adverse Drug Reactions in Geriatric Patients Admitted to a Tertiary Care Teaching Hospital in South India
Keywords:
Adverse Drug Reactions in Geriatrics, Drug Safety, Drug Related Problems, Post Marketing Surveillance, Pharmacovigilance.
Abstract
Assessment of Adverse Drug Reactions (ADRs) in Geriatric patients was carried out in a south Indian tertiary care teaching hospital. Our study focused on the greater susceptibility of geriatric patients to ADRs, which are an important health issues and a leading cause of morbidity. A single-centre prospective observational study was conducted with a total of 227 patients to investigate the occurrence and characteristics of ADRs. Males (58.62%,) were affected more than females (41.38%,). Age, polypharmacy, and Co-morbid diseases were the primary risk factors, accounting for 100%, 100%, and 94.82% respectively. The most significant risk factors identified were hypertension (51.72%), and type II diabetes mellitus (44.82%). The prevalence of ADRs was determined as 25.5% (n=58) with an incidence rate of 6.82%, Odds ratio (0.34, p=0.059) and Relative risk (142.65, p=0.0005). Oral administration of drugs (72.41%) lead to the most ADRs. Antibiotics and Antiplatelets (20.69%) caused the most ADRs such as Constipation (20.68%) by Clopidogrel, Various Reactions from Antibiotics (>17%) followed by Oedema (13.8%) by Prednisolone. Skin and Appendages (32.76%) were implicated by the majority of reactions. Most of the reactions were possible (WHO-UMC Scale - 53.45%), Moderate (Hartwig and Siegel Scale – 31%) and possible (Liverpool Causality Assessment Tool – 60.34%). Clinical pharmacists reported the highest (82.76%) ADRs. Our study contributes to the pharmacovigilance programme of the nation. There is a pressing need of reporting the ADRs and to develop tools to empower healthcare professionals that would significantly decrease the time required for initial assessment of ADRs and related harm.
References
1. World Health Organization. International Drug Monitoring: The Role of National Centres, Technical Report Series No. 498. Geneva: World Health Organization; 1972.
2. Ismeet Kaur et al.: Pharmacovigilance Programme of India: System put in place to Report Adverse Drug Reactions. Indian Journal of Pharmaceutical Education and Research, Vol 50, Issue 1, Jan-Mar, 2016.
3. Marie N O’Connor, Paul Gallagher, Stephen Byrne and Denis O’Mahony, “Adverse Drug Reactions in Older Patients during Hospitalization: Are they Predictable?” Age Ageing, Volume 41, Issue 6, 771- 776, November 2012.
4. Emma L. M. Jennings, Kevin D. Murphy, Paul Gallagher and Denis O’Mahony, “In-Hospital Adverse Drug Reactions in Older Adults; Prevalence, Presentation and Associated Drugs- A Systematic Review and Meta- analysis”, Age and Ageing, Volume 49, Issue 6, 948- 958, November 2020.
5. Lee Bowman, Bruce C. Caristedt, Emily F. Hancock and Curtis D. Black, “Adverse Drug Reactions Occurrence and Evaluation in Elderly In patients”, Pharmacoepidemiology and Drug Safety, Volume 5, Issue 1, 9- 18, January, 1996.
6. S. Malhotra, R. Karan, P. Pandhi and S. Jain, “Drug Related Medical Emergencies in the Elderly: Role of Adverse Drug Reactions and Non- Compliance”, Postgraduate Medical Journal, Volume 77 (913), 703- 707, November 2001.
7. Tadele Mekuriya Yadesa, Freddy Eric Kitutu, Serawit Deyno, Patrick Engeu Ogwang, Robert Tamukong and Paul E. Alele, “Prevalence, Characteristics and predicting Risk Factors of Adverse Drug reactions Among Hospitalized older Adults: A Systematic Review and Meta-Analysis”, Sage Open Medicine, Volume 9, August 2021.
8. Rebecca J. Beyth and Ron 1. Shorr, “Epidemiology of Adverse Drug Reactions in the Elderly by Drug Class”, Drugs and Aging, Volume 14, Issue 3, 231- 239, 1999.
9. Essebag, V., Reynolds, M. R., Hadjis, T., Lemery, R., Olshansky, B., Buxton, A. E., et al. (2007). Sex differences in the relationship between amiodarone use and the need for permanent pacing in patients with atrial fibrillation. Arch. Intern Med. 167 (15), 1648–1653.
10. Mohsen, A., Tripathi, L. P., and Mizuguchi, K. (2021). Deep learning prediction of adverse drug reactions in drug discovery using open TG–GATEs and FAERS databases. Front. Drug Discov. 1, 768792.
11. Zhang, F., Sun, B., Diao, X., Zhao, W., and Shu, T. (2021). Prediction of adverse drug reactions based on knowledge graph embedding. BMC Med. Inf. Decis. Mak. 21 (1), 38.
12. Greenblatt, D. J., Harmatz, J. S., von Moltke, L. L., Wright, C. E., Durol, A. L., Harrel-Joseph, L. M., et al. (2022). Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: Evaluation of sex-dependent differences.
13. Rodenburg E.M, Stricker B.H, Visser L.E, Sex-related differences in hospital admissions attributed to adverse drug reactions in the Netherlands. Br J Clin Pharmacol. 2011; 71: 95-104.
14. Onder G, Pedone C, Landi F 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: 1962-1968.
15. Pirmohamed M, James S, Meakin S et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004; 329: 15-19.
16. Shan Y, Cheung L, Zhou Y, Huang Y and Huang RS (2023) A systematic review on sex differences in adverse drug reactions related to psychotropic, cardiovascular, and analgesic medications. Front. Pharmacol. 14:1096366.
17. Arnold, A. P. (2017). A general theory of sexual differentiation. J. Neurosci. Res. 95 (1–2), 291–300.
18. Weersma, R. K., Zhernakova, A., and Fu, J. (2020). Interaction between drugs and the gut microbiome. Gut 69 (8), 1510–1519.
19. Cheng, S., Flora, D. R., Rettie, A. E., Brundage, R. C., and Tracy, T. S. (2022). Pharmacokinetic modeling of warfarin І - model-based analysis of warfarin enantiomers with a target mediated drug disposition model reveals CYP2C9 genotype-dependent drug-drug interactions of S-warfarin. Drug Metab. Dispos. 50 (9), 1287–1301.
20. Huang, Y., Shan, Y., Zhang, W., Lee, A. M., Li, F., Stranger, B. E., et al. (2023). Deciphering genetic causes for sex differences in human health through drug metabolism and transporter genes. Nat. Commun. 14 (1), 175.
21. Dubrall, D., Just, K.S., Schmid, M. et al. Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices. BMC Pharmacol Toxicol 21, 25 (2020).
22. Aagaard L, Strandell J, Melskens L, Petersen PS, Holme HE. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™. Drug Saf. 2012;35(12):1171–82.
23. Davies EA, O’Mahony MS (2015) Adverse drug reactions in special populations—the elderly. Br J Clin Pharmacol 80(4):796–807.
24. Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions amongst resident doctors. J Pharm Sci Res. 2011;3:1064–9.
25. Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res. 2011;2:129–36.
26. Sneha SG, Simhadri K, Subeesh VK, et al. Predictors of adverse drug reactions in geriatric patients: an exploratory study among cancer patients. South Asian J Cancer 2019; 8(2): 130–133.
27. Conforti A, Costantini D, Zanetti F, et al. Adverse drug reactions in older patients: an Italian observational prospective hospital study. Drug Healthc Patient Saf 2012; 4: 75–80.
28. Dormann H, Krebs S, Muth-Selbach U, et al. Adverse drug reactions in patients with gastroenterological diseases: does age increase the risk? Aliment Pharmacol Ther 2001; 15(2): 171–180.
29. Alhawassi TM, Krass I, Pont LG. Prevalence and risk factors for adverse drug reactions in older adults in the acute care setting. Pharmacoepidemiol Drug Saf 2015; 24(suppl. 1): 91.
30. O’Connor MN, Gallagher P, Byrne S, et al. Adverse drug reactions in older patients during hospitalisation: are they predictable? Age Ageing 2012; 41(6): 771–776.
31. Hadia, Rajesh; Joshi, Dhaval; Bhil, Dipika; Maheshwari, Rajesh. Incidence of Adverse Drug Reactions Among Elderly Patients: A Systematic Review and Meta-Analysis. Journal of the Scientific Society 49(2):p 91-102, May–Aug 2022.
32. Scondotto, G., Pojero, F., Pollina Addario, S., Ferrante, M., Pastorello, M., Visconti, M., et al. (2018). The impact of polypharmacy and drug interactions among the elderly population in Western Sicily, Italy. Aging Clin. Exp. Res. 30 (1), 81–87.
33. Obreli-Neto, P. R., Nobili, A., de Oliveira Baldoni, A., Guidoni, C. M., de Lyra Junior, D. P., Pilger, D., et al. (2012a). Adverse drug reactions caused by drug-drug interactions in elderly outpatients: A prospective cohort study. Eur. J. Clin. Pharmacol. 68 (12), 1667–1676.
34. Onder G, Petrovic M, Tangiisuran B, et al.. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med 2010;170:1142–8.
35. Liao PJ, Mao CT, Chen TL, Deng ST, Hsu KH. Factors associated with adverse drug reaction occurrence and prognosis, and their economic impacts in older inpatients in Taiwan: a nested case-control study. BMJ Open. 2019 May 10;9(5):e026771.
36. Shah R, Gajjar B, Desai S. A profile of adverse drug reactions with risk factors among geriatric patients in a tertiary care teaching rural hospital in India. Natl J Physiol Pharm Pharmacol. 2012;2:113–22.
37. Amin S, Shah S, Desai M, Shah A, Maheriya KM. An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital. Perspect Clin Res. 2018 Apr-Jun;9(2):70-75.
38. Shah SP, Desai MK, Dikshit RK. Analysis of cutaneous adverse drug reaction sat tertiary care hospital - A prospective study. Trop J Pharm Res. 2011;10:517–22.
2. Ismeet Kaur et al.: Pharmacovigilance Programme of India: System put in place to Report Adverse Drug Reactions. Indian Journal of Pharmaceutical Education and Research, Vol 50, Issue 1, Jan-Mar, 2016.
3. Marie N O’Connor, Paul Gallagher, Stephen Byrne and Denis O’Mahony, “Adverse Drug Reactions in Older Patients during Hospitalization: Are they Predictable?” Age Ageing, Volume 41, Issue 6, 771- 776, November 2012.
4. Emma L. M. Jennings, Kevin D. Murphy, Paul Gallagher and Denis O’Mahony, “In-Hospital Adverse Drug Reactions in Older Adults; Prevalence, Presentation and Associated Drugs- A Systematic Review and Meta- analysis”, Age and Ageing, Volume 49, Issue 6, 948- 958, November 2020.
5. Lee Bowman, Bruce C. Caristedt, Emily F. Hancock and Curtis D. Black, “Adverse Drug Reactions Occurrence and Evaluation in Elderly In patients”, Pharmacoepidemiology and Drug Safety, Volume 5, Issue 1, 9- 18, January, 1996.
6. S. Malhotra, R. Karan, P. Pandhi and S. Jain, “Drug Related Medical Emergencies in the Elderly: Role of Adverse Drug Reactions and Non- Compliance”, Postgraduate Medical Journal, Volume 77 (913), 703- 707, November 2001.
7. Tadele Mekuriya Yadesa, Freddy Eric Kitutu, Serawit Deyno, Patrick Engeu Ogwang, Robert Tamukong and Paul E. Alele, “Prevalence, Characteristics and predicting Risk Factors of Adverse Drug reactions Among Hospitalized older Adults: A Systematic Review and Meta-Analysis”, Sage Open Medicine, Volume 9, August 2021.
8. Rebecca J. Beyth and Ron 1. Shorr, “Epidemiology of Adverse Drug Reactions in the Elderly by Drug Class”, Drugs and Aging, Volume 14, Issue 3, 231- 239, 1999.
9. Essebag, V., Reynolds, M. R., Hadjis, T., Lemery, R., Olshansky, B., Buxton, A. E., et al. (2007). Sex differences in the relationship between amiodarone use and the need for permanent pacing in patients with atrial fibrillation. Arch. Intern Med. 167 (15), 1648–1653.
10. Mohsen, A., Tripathi, L. P., and Mizuguchi, K. (2021). Deep learning prediction of adverse drug reactions in drug discovery using open TG–GATEs and FAERS databases. Front. Drug Discov. 1, 768792.
11. Zhang, F., Sun, B., Diao, X., Zhao, W., and Shu, T. (2021). Prediction of adverse drug reactions based on knowledge graph embedding. BMC Med. Inf. Decis. Mak. 21 (1), 38.
12. Greenblatt, D. J., Harmatz, J. S., von Moltke, L. L., Wright, C. E., Durol, A. L., Harrel-Joseph, L. M., et al. (2022). Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: Evaluation of sex-dependent differences.
13. Rodenburg E.M, Stricker B.H, Visser L.E, Sex-related differences in hospital admissions attributed to adverse drug reactions in the Netherlands. Br J Clin Pharmacol. 2011; 71: 95-104.
14. Onder G, Pedone C, Landi F 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: 1962-1968.
15. Pirmohamed M, James S, Meakin S et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004; 329: 15-19.
16. Shan Y, Cheung L, Zhou Y, Huang Y and Huang RS (2023) A systematic review on sex differences in adverse drug reactions related to psychotropic, cardiovascular, and analgesic medications. Front. Pharmacol. 14:1096366.
17. Arnold, A. P. (2017). A general theory of sexual differentiation. J. Neurosci. Res. 95 (1–2), 291–300.
18. Weersma, R. K., Zhernakova, A., and Fu, J. (2020). Interaction between drugs and the gut microbiome. Gut 69 (8), 1510–1519.
19. Cheng, S., Flora, D. R., Rettie, A. E., Brundage, R. C., and Tracy, T. S. (2022). Pharmacokinetic modeling of warfarin І - model-based analysis of warfarin enantiomers with a target mediated drug disposition model reveals CYP2C9 genotype-dependent drug-drug interactions of S-warfarin. Drug Metab. Dispos. 50 (9), 1287–1301.
20. Huang, Y., Shan, Y., Zhang, W., Lee, A. M., Li, F., Stranger, B. E., et al. (2023). Deciphering genetic causes for sex differences in human health through drug metabolism and transporter genes. Nat. Commun. 14 (1), 175.
21. Dubrall, D., Just, K.S., Schmid, M. et al. Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices. BMC Pharmacol Toxicol 21, 25 (2020).
22. Aagaard L, Strandell J, Melskens L, Petersen PS, Holme HE. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™. Drug Saf. 2012;35(12):1171–82.
23. Davies EA, O’Mahony MS (2015) Adverse drug reactions in special populations—the elderly. Br J Clin Pharmacol 80(4):796–807.
24. Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions amongst resident doctors. J Pharm Sci Res. 2011;3:1064–9.
25. Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res. 2011;2:129–36.
26. Sneha SG, Simhadri K, Subeesh VK, et al. Predictors of adverse drug reactions in geriatric patients: an exploratory study among cancer patients. South Asian J Cancer 2019; 8(2): 130–133.
27. Conforti A, Costantini D, Zanetti F, et al. Adverse drug reactions in older patients: an Italian observational prospective hospital study. Drug Healthc Patient Saf 2012; 4: 75–80.
28. Dormann H, Krebs S, Muth-Selbach U, et al. Adverse drug reactions in patients with gastroenterological diseases: does age increase the risk? Aliment Pharmacol Ther 2001; 15(2): 171–180.
29. Alhawassi TM, Krass I, Pont LG. Prevalence and risk factors for adverse drug reactions in older adults in the acute care setting. Pharmacoepidemiol Drug Saf 2015; 24(suppl. 1): 91.
30. O’Connor MN, Gallagher P, Byrne S, et al. Adverse drug reactions in older patients during hospitalisation: are they predictable? Age Ageing 2012; 41(6): 771–776.
31. Hadia, Rajesh; Joshi, Dhaval; Bhil, Dipika; Maheshwari, Rajesh. Incidence of Adverse Drug Reactions Among Elderly Patients: A Systematic Review and Meta-Analysis. Journal of the Scientific Society 49(2):p 91-102, May–Aug 2022.
32. Scondotto, G., Pojero, F., Pollina Addario, S., Ferrante, M., Pastorello, M., Visconti, M., et al. (2018). The impact of polypharmacy and drug interactions among the elderly population in Western Sicily, Italy. Aging Clin. Exp. Res. 30 (1), 81–87.
33. Obreli-Neto, P. R., Nobili, A., de Oliveira Baldoni, A., Guidoni, C. M., de Lyra Junior, D. P., Pilger, D., et al. (2012a). Adverse drug reactions caused by drug-drug interactions in elderly outpatients: A prospective cohort study. Eur. J. Clin. Pharmacol. 68 (12), 1667–1676.
34. Onder G, Petrovic M, Tangiisuran B, et al.. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med 2010;170:1142–8.
35. Liao PJ, Mao CT, Chen TL, Deng ST, Hsu KH. Factors associated with adverse drug reaction occurrence and prognosis, and their economic impacts in older inpatients in Taiwan: a nested case-control study. BMJ Open. 2019 May 10;9(5):e026771.
36. Shah R, Gajjar B, Desai S. A profile of adverse drug reactions with risk factors among geriatric patients in a tertiary care teaching rural hospital in India. Natl J Physiol Pharm Pharmacol. 2012;2:113–22.
37. Amin S, Shah S, Desai M, Shah A, Maheriya KM. An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital. Perspect Clin Res. 2018 Apr-Jun;9(2):70-75.
38. Shah SP, Desai MK, Dikshit RK. Analysis of cutaneous adverse drug reaction sat tertiary care hospital - A prospective study. Trop J Pharm Res. 2011;10:517–22.
Published
2024-09-13
How to Cite
Mallesh Mandha, Purushothama Reddy K, V J Dawn, P V Soumya, V R Irene, & K A Ameena Kadar. (2024). Assessment of Adverse Drug Reactions in Geriatric Patients Admitted to a Tertiary Care Teaching Hospital in South India. Revista Electronica De Veterinaria, 25(1S), 835-844. https://doi.org/10.69980/redvet.v25i1S.891
Section
Articles
