Pattern, severity, and outcome of adverse drug reactions in a tertiary care hospital: an evidence from a cross-sectional study
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Manik Chhabra
,
Manjeet Singh Jangra
,
Puneet Sharma
Abstract
Objectives
Study aim to describe the spontaneous reporting of the adverse drug reactions (ADRs) among the patients admitted to medicine department of a tertiary care hospital.
Methods
A prospective observational study was conducted over a period of four months at the medicine department. On the daily basis, all the patients aged >18 years admitted to the internal medicine department were followed and analyzed for occurrence of ADRs. Naranjo scale was used to determine causal relationship between the ADRs and suspected drugs. The nature of ADRs and its severity was assessed using the Hartwig scale.
Results
A total of 4,530 patients were screened for the ADRs, out of which 90 ADRs were developed in the 89 patients. The overall incidence of ADRs was found to be 1.96% in the studied population. The most common ADRs encountered during the study period were type A (augmented). The least number of ADRs were observed in the age group of 31–40 years. Furthermore, the more significant number of male patients suffered from a severe type of ADRs as compared to females. Sixteen ADRs were of the mucocutaneous type of reaction followed by dizziness in 12 cases. The higher number of patients recovering from the ADRs was in the age group 41–60 years. The outcomes of ADRs were not found to be statistically significant with gender and age groups.
Conclusions
There is a strong need to extend the monitoring and reporting of the ADRs to ensure the patient safety. However, the overall incidence of ADRs appeared to be less in our study, highlighting the need for strengthening reporting system of ADRs. The results indicate that elderly patients are at significant risk of developing ADRs.
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Research funding: This research did not receive any specific grant or fund from any funding agencies in the public, commercial, or not-for-profit sectors.
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Author contributions: All authors agreed for their contribution and agreed on the submission of this paper to this journal for the publication.
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Competing interests: Authors report no conflicts of interest to declare. The listed authors are solely responsible for the originality and content of the manuscript. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. It includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
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Informed consent: A signed informed consent form was taken from all the participants before data collection, and patients were given the freedom to deny the enrollment into the study. All participants agreed for the release of this paper by protecting their confidentiality in the published material.
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Ethical approval: This observational study was conducted at a North Indian tertiary care hospital after obtaining ethical approval from the Institutional Ethics Committee.
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Availability of data and material: The data associated with the article will be made available from the corresponding author upon the appropriate request.
References
1. Seenivasan, P, Anandan, S, Vivek, PI, Rajanandh, MG, Adikrishnan, S. Pattern of adverse drug reactions in a regional pharmacovigilance center of a tertiary care teaching hospital. Drugs Ther Perspect 2018;34:138–41. https://doi.org/10.1007/s40267-017-0474-y.Search in Google Scholar
2. Coleman, JJ, Pontefract, SK. Adverse drug reactions. Clin Med 2016;16:481–5. https://doi.org/10.7861/clinmedicine.16-5-481.Search in Google Scholar PubMed PubMed Central
3. Jangra, MS, Chhabra, M. Cycloserine induced suicidal tendencies and kanamycin induced ototoxicity in Indian MDR-TB patient: a case report. Curr Drug Saf 2018;13:211–3. https://doi.org/10.2174/1574886313666180605095842.Search in Google Scholar PubMed
4. Rashid, M, Rajan, AK, Chhabra, M, Kashyap, A. Levetiracetam and cutaneous adverse reactions: a systematic review of descriptive studies. Seizure 2020;75:101–9. https://doi.org/10.1016/j.seizure.2020.01.002.Search in Google Scholar PubMed
5. Gill, GK, Chhabra, M, Chawla, SPS. Levofloxacin-induced desquamation: a possible and rare case report. Curr Drug Saf 2020;15:61–4. https://doi.org/10.2174/1574886314666190708152223.Search in Google Scholar PubMed
6. Alsbou, M, Alzubiedi, S, Alzobi, H, Samhadanah, NA, Alsaraireh, Y, Alrawashdeh, O. Adverse drug reactions experience in a teaching hospital in Jordan. Int J Clin Pharm 2015;37:1188–93. https://doi.org/10.1007/s11096-015-0185-1.Search in Google Scholar PubMed
7. Wahlang, JB, Laishram, PD, Brahma, DK, Sarkar, C, Lahon, J, Nongkynrih, BS. Adverse drug reactions due to cancer chemotherapy in a tertiary care teaching hospital. Ther Adv Drug Saf 2017;8:61–6. https://doi.org/10.1177/2042098616672572.Search in Google Scholar PubMed PubMed Central
8. Raj, N, Fernandes, S, Charyulu, NR, Dubey, A, GS, R, Hebbar, S. Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Ther Adv Drug Saf 2019;10:2042098619865413. https://doi.org/10.1177/2042098619865413.Search in Google Scholar PubMed PubMed Central
9. Kalaiselvan, V, Srivastava, S, Singh, A, Gupta, SK. Pharmacovigilance in India: present scenario and future challenges. Drug Saf 2019;42:339–46. https://doi.org/10.1007/s40264-018-0730-7.Search in Google Scholar PubMed
10. Sharrar, RG, Dieck, GS. Monitoring product safety in the postmarketing environment. Ther Adv Drug Saf 2013;4:211–9. https://doi.org/10.1177/2042098613490780.Search in Google Scholar PubMed PubMed Central
11. Bavdekar, SB, Karande, S. National pharmacovigilance program. Indian Pediatr 2006;43:27–32.Search in Google Scholar
12. Duarte, M, Ferreira, P, Soares, M, Cavaco, A, Martins, AP. Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study. Drugs Ther Perspect 2015;31:316–22. https://doi.org/10.1007/s40267-015-0227-8.Search in Google Scholar
13. Smeaton, T, McElwaine, P, Cullen, J, Santos-Martinez, MJ, Deasy, E, Widdowson, M, et al.. A prospective observational pilot study of adverse drug reactions contributing to hospitalization in a cohort of middle-aged adults aged 45–64 years. Drugs Ther Perspect 2020;36:1–8.10.1007/s40267-019-00700-1Search in Google Scholar
14. Sundaran, S, Udayan, A, Hareendranath, K, Eliyas, B, Ganesan, B, Hassan, A, et al.. Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients. Pharmacy 2018;6:108. https://doi.org/10.3390/pharmacy6040108.Search in Google Scholar PubMed PubMed Central
15. Deb, T, Chakrabarty, A, Ghosh, A. Adverse drug reactions in Type 2 diabetes mellitus patients on oral antidiabetic drugs in a diabetes outpatient department of a tertiary care teaching hospital in the Eastern India. Int J Med Sci Publ Health 2017;6:554–8. https://doi.org/10.5455/ijmsph.2017.0423203102016.Search in Google Scholar
16. Kulkarni, V, Bora, SS, Sirisha, S, Saji, M, Sundaran, S. A study on drug-drug interactions through prescription analysis in a South Indian teaching hospital. Ther Adv Drug Saf 2013;4:141–6. https://doi.org/10.1177/2042098613490009.Search in Google Scholar PubMed PubMed Central
17. Rashid, M, Kashyap, A, Undela, K. Valproic acid and Stevens-Johnson syndrome: a systematic review of descriptive studies. Int J Dermatol 2019;58:1014–22. https://doi.org/10.1111/ijd.14411.Search in Google Scholar PubMed
18. Hemanthkumar, MC. Adverse drug reaction monitoring and reporting at HSK hospital and research center-Bagalkot. Indian J Pharm Pract 2016;9:49.10.5530/ijopp.9.1.10Search in Google Scholar
19. Sharma, R, Chhabra, M, Vidyasagar, K, Rashid, M, Fialova, D, Bhagavathula, AS. Potentially inappropriate medication use in older hospitalized patients with type 2 diabetes. A cross-sectional study. Pharmacy 2020;8:219. https://doi.org/10.3390/pharmacy8040219.Search in Google Scholar PubMed PubMed Central
20. 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;30:239–45. https://doi.org/10.1038/clpt.1981.154.Search in Google Scholar PubMed
21. Jose, J, Rao, PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res 2006;54:226–33. https://doi.org/10.1016/j.phrs.2006.05.003.Search in Google Scholar PubMed
22. Rajan, AK, Kashyap, A, Chhabra, M, Rashid, M. Linezolid induced skin reactions in a multi drug resistant infective endocarditis patient: a rare case. Curr Drug Saf 2020;15:222–6. https://doi.org/10.2174/1574886315666200516175053.Search in Google Scholar PubMed
23. Umar, BU, Sultana, S, Umar, BU, Ferdous, AH, Uddin, MK, Islam, SH. Study of adverse drug reactions in out-patient departments of a teaching hospital. Bangladesh J Pharmacol 2012;7:104–7.10.3329/bjp.v7i2.10760Search in Google Scholar
24. Hartwig, SC, Siegel, J, Schneider, PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229–32. https://doi.org/10.1093/ajhp/49.9.2229.Search in Google Scholar
25. Davies, EA, O’Mahony, MS. Adverse drug reactions in special populations - the elderly. Br J Clin Pharmacol 2015;80:796–807. https://doi.org/10.1111/bcp.12596.Search in Google Scholar PubMed PubMed Central
26. Lavan, AH, Gallagher, P. Predicting risk of adverse drug reactions in older adults. Ther Adv Drug Saf 2016;7:11–22. https://doi.org/10.1177/2042098615615472.Search in Google Scholar PubMed PubMed Central
27. Jetha, S. Polypharmacy, the elderly, and deprescribing. Consult Pharm 2015;30:527–32. https://doi.org/10.4140/tcp.n.2015.527.Search in Google Scholar
28. Yıldırım, AB, Kılınç, AY. Polypharmacy and drug interactions in elderly patients. Turk Kardiyol Dernegi Arsivi 2017;45(5 Suppl):17–21.10.5543/tkda.2017.92770Search in Google Scholar PubMed
29. Geer, MI, Sultana, S, Umar, BU, Ferdous, AH, Uddin, MK, Islam, SH. Frequency, types, severity, preventability and costs of Adverse Drug Reactions at a tertiary care hospital. J Pharmacol Toxicol Methods 2016;81:323–34. https://doi.org/10.1016/j.vascn.2016.04.011.Search in Google Scholar PubMed
30. Chen, EY, Diug, B, Bell, JS, Mc Namara, KP, Dooley, MJ, Kirkpatrick, CM, et al.. Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. Ther Adv Drug Saf 2016;7:4–10. https://doi.org/10.1177/2042098615618171.Search in Google Scholar PubMed PubMed Central
31. Elajez, R, Ezzeldin, A, Gaber, H. Safety evaluation of intravenous immunoglobulin in pediatric patients: a retrospective, 1-year observational study. Ther Adv Drug Saf 2019;10:2042098619876736. https://doi.org/10.1177/2042098619876736.Search in Google Scholar PubMed PubMed Central
32. Ali, S, Egunsola, O, Al-Dossari, DS, Al-Zaagi, IA. Adverse drug reaction reporting in a large tertiary hospital in Saudi Arabia: results of an incentive strategy. Ther Adv Drug Saf 2018;9:585–90. https://doi.org/10.1177/2042098618790209.Search in Google Scholar PubMed PubMed Central
33. Oshikoya, KA, Ogunyinka, IA, Ogar, CK, Abiola, A, Ibrahim, A, Oreagba, IA. Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017. Ther Adv Drug Saf 2020;11:2042098620905998. https://doi.org/10.1177/2042098620905998.Search in Google Scholar PubMed PubMed Central
34. Venkataraman, R, Rashid, M, Shrestha, H. Inappropriate medication use and cost comparison analysis of proton pump inhibitors: evidence from an Indian tertiary care facility. Curr Drug Saf 2020;15:147–55. https://doi.org/10.2174/1574886315666200311120151.Search in Google Scholar PubMed
35. Abeyaratne, C, Lalic, S, Bell, JS, Ilomäki, J. Spontaneously reported adverse drug events related to tapentadol and oxycodone/naloxone in Australia. Ther Adv Drug Saf 2018;9:197–205. https://doi.org/10.1177/2042098618760939.Search in Google Scholar PubMed PubMed Central
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Articles in the same Issue
- Frontmatter
- Minireview
- The effect of endurance, resistance training, and supplements on mitochondria and bioenergetics of muscle cells
- Reviews
- Cellular cross talk between epicardial fat and cardiovascular risk
- The physiological insight of Coenzyme-Q10 administration in preventing the incidence of reperfusion arrhythmia among patients undergoing coronary artery bypass grafting surgery
- Is it possible to treat nonalcoholic liver disease using a flavanol-based nutraceutical approach? Basic and clinical data
- An overview of post COVID sequelae
- Clinical implications of anti-idiotype antibodies in COVID-19
- Original Articles
- Monocyte chemoattractant protein-1 levels are associated with major depressive disorder
- Detection of soluble suppression of tumorigenicity 2 and N-terminal B-type natriuretic peptide in a rat model of aortic regurgitation: differential responses to omecamtiv mecarbil
- Preoperative monocyte-to-lymphocyte ratio as a potential predictor of bladder cancer
- AICAR promotes endothelium-independent vasorelaxation by activating AMP-activated protein kinase via increased ZMP and decreased ATP/ADP ratio in aortic smooth muscle
- Moderate-intensity exercise decreases the circulating level of betatrophin and its correlation among markers of obesity in women
- Impact of muscle mass on blood glucose level
- Behavioral alterations, brain oxidative stress, and elevated levels of corticosterone associated with a pressure injury model in male mice
- Patterns of drug therapy, glycemic control, and predictors of escalation – non-escalation of treatment among diabetes outpatients at a tertiary care center
- Pattern, severity, and outcome of adverse drug reactions in a tertiary care hospital: an evidence from a cross-sectional study
