Evaluation of suspected adverse drug reactions of Anti-Diabetic Drugs in a Tertiary Care Hospital for Type II Diabetes Mellitus
DOI:
https://doi.org/10.22270/ajprd.v13i4.1614Abstract
Background and Objective: The objective of the study was to evaluate and analyze ADRs in type II diabetic patients and to determine the causality, severity and preventability of reactions.
Methods: 150 diabetic patients on anti-diabetic drugs were evaluated prospectively over a period of three months. All patients were observed for ADRs which were then evaluated for its incidence, frequency, severity and causality. Causality was categorized according to the scores obtained from WHO-UMC scale and Naranjo scale.
Results and Discussion: A total of 22 ADRs were reported from 150 patients during the study period with female predominance over male. The biguanides class of drugs was responsible for causing the majority of ADRs while the GI system was the most affected organ system. Among the outcomes of 22 ADRs 17 were recovered 5 reactions still continued and there were no fatal evidence. The suspected ADRs were assessed for their causality, it was revealed that 19 were probable and 3 were possible and as per Naranjo scale 20 were probable and 2 possible.
Conclusion: These study results provide insight to the healthcare providers on the importance of monitoring and reporting ADR associated with the drug.
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References
Harrison T, Kasper D. Harrison’s principles of internal medicine.18thed.NewYork: McGraw-Hill Medical Publ. Division. 2012; 2968-3002.
Rajendra P, V is wanathan M. Epidemiology of type2 diabetes in India. Indian J Ophthalmol. 2021; 69(11):2932-2938.
Jiji K. Evaluation of Suspected Adverse Drug Reactions of Oral Anti-diabetic Drugs in a Tertiary Care Hospital for Type II Diabetes Mellitus. IJPP. 2019; 12(2).
Ebnezer AN,Terri WJ. Management of type 2diabetes; evolving strategies for the treatment of patients with type 2 diabetes. J. Metabol. 2011; 60(1): 1-23.
Parthasarathi G, Nyfort-Hansen K,Milap CN.A text book of clinical pharmacy practice. 2nd ed. Universities Press Private Limited, India. 2012; 104-10.
Raschetti R, Morgutti M, Menniti-Ippolito F, Belisari A, Rossignoli A, Longhini P,etal. Suspected adverse drug events requiring emergency department visits or hospital admissions. European Journal of Clinical Pharmacology. 1999; 54(12):959-63.
Sowmya MA, Sreelekshmi BS, Smitha S, Jiji KN, Arun SM, Uma D.Drug utilization pattern of anti-diabetic drugs among diabetic patients in a tertiary care hospital. Asian Journal of Pharmaceutical and Clinical Research. 2015; 8(2):144-6.
Aseefa MB, Teferi GF, Moneeza KS, Adem YD.The Genetics of Adverse Drug Outcomes in Type 2 Diabetes: A Systematic Review. Front. Genet. 2021; 12.
IDFDiabetesAtlas.Idf.org.2013.[cited31January].Available from:https://idf.org/e-library/epidemiology-research/diabetes-atlas/atlas-6th edition.html
Ramachandran A, Snehalatha C. Currents cenario of diabetes in India. J Diabetes. 2009;1(1):18-28.
Jamie JC, Sarah K P. Adverse drug reactions. Clin Med. 2016; 16(5):481-485.
Chi-Shiang W, Pei-Ju L, Ching-Lan C, Shu-Hua T, Yea-Huei K Y, Jung-Hse in C. Detecting Potential Adverse Drug Reactions Usinga Deep Neural Network Model.J Med Internet Res. 2019;21(2).
Patidar D, Rajput M, Nirmal N, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdisciplinary Toxicology. 2013; 6(1):41-6.
Marcia G A, Sandra M B P, Jose G D, Valeria G M, Maria-Cristina S P. Adverse drug reaction monitoring : support for pharmacovigilance a tatertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013; 14(5).
King H, Aubert R, Herman W. Global Burden of Diabetes,1995-2025:Prevalence, numerical estimates and projections. Diabetes Care. 1998; 21(9):1414-31.
World Health Organisation. WHO-UMC causality assessment system. Available from: http://www.who-umc.org/pdfs/causality.pdf.
Hane feld M.A carbose reduces the risk of myocardial infarction in type 2 diabetic patients; meta-analysis of seven long-term studies. European Heart Journal. 2004; 25(1); 10-6.
Arun C, Chitharanjan D, Vijaya SRD, Shashank K, Aditya C, Rahul R, et al. Clinical Review of Antidiabetic Drugs: Implications forType2 Diabetes Mellitus Management. Frontiers in Endocrinology. 2017; 8:6.
Singh H, Dulhani N, Kumar BN, Singh P, Tewari P, Nayal K. A Pharmacovigilance Study in Medicine Department of Tertiary Care Hospitalin Chattisgarh, India. J Young Pharm. 2010;2(1):95-100.
Tirthankar D, Abhik C, Abhishek G.Adverse drug reactions in type 2 diabetes mellitus patients on oral antidiabetic drugs in a diabetes outpatient department of atertiary care teaching hospital in the Eastern India. International Journal of Medical Science and Public Health.2016; 6(3):554-7.
Allu H, Prasanna kumar N, Hemanth kumar MC. Adverse Drug Reaction Monitoring and Reporting at H.S.K Hospital and Research Centre-Bagalkot. Journal of Hospital and Clinical Pharmacy. 2016; 2(2):54-62.
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