ASSESSMENT OF ADVERSE DRUG REACTIONS OCCURRING AT DEPARTMENT OF NEUROLOGY OF A TERTIARY CARE HOSPITAL IN INDIA
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i10.27737Keywords:
Adverse drug reactions, Neurology, Causality, Severity, Predictability, Preventability, PolypharmacyAbstract
Objective: The purpose of this study was to assess the incidence and pattern of adverse drug reactions (ADRs) reported from the department of neurology of a tertiary care hospital in Karnataka, India.
Methods: It is a hospital-based prospective, observational study, conducted among the inpatients of all age groups of either sex for a period of 6 months. ADRs were reported by the clinical pharmacists and physicians of this hospital. ADRs obtained were categorized based on its causality, severity, preventability, predictability, and outcomes. Binary logistic regression was carried out to identify the predictors of ADR and Kaplan–Meier analysis was performed for survival analysis.
Results: A total of 250 patients were enrolled for the study in which 108 (43%) patients were presented with at least one ADR and a total of 212 ADRs were observed. The highest rate of ADRs was observed with antiepileptics 61 (29.5%). The most commonly reported that ADRs were skin reactions 23 (10.8%). Causality was assessed using three different scales which showed that most of the ADRs were probable. Severity, preventability, and predictability were assessed, of which 125 (59%) ADRs were moderate, 192 (90.6%) ADRs were probably preventable, and 156 (73.6%) ADRs were predictable, respectively. The outcomes showed that 150 (70.1%) patients recovered from the reactions. Predictors such as polypharmacy and duration of stay were found to be significant.
Conclusion: The study concluded that the prevalence of ADRs in the department of neurology is high. Thus, early detection and management of ADRs are essential to avoid further complications of the reaction.
Downloads
References
Rohilla A, Singh N, Kumar V, Kumar M, Sharma AD, Kushnoor A. Pharmacovigilance: Needs and objectives. J Adv Pharm Edu Res 2012;2:201-5.
Parthasarathi G, Olsson S. Adverse drug reactions. In: Parthasarathi G, Nyfort-Hansen K, Nahata MC, editors. A Textbook of Clinical Pharmacy Practice: Essential Concepts and Skills. 1st ed. Chennai: Orient Longman PVT Ltd; 2004. p. 84-102.
Alam K, Shakya R, Ojha P. Reporting adverse drug reactions among hospitalized medical patients: A prospective study from tertiary care hospital in Western Nepal. Nepal J Epidemiol 2014;4:330-6.
Law R, Bozzo P, Koren G, Einarson A. FDA pregnancy risk categories and the CPS: Do they help or are they a hindrance? Can Fam Physician 2010;56:239-41.
Nirojini PS, Yemineni R, Nadenla RR. Monitoring and reporting of adverse drug reactions in a South Indian tertiary care hospital. Int J Pharm Sci Rev Res 2014;24:259-62.
Vijayakumar TM, Dhanaraju MD. Description of adverse drug reactions in a multi-speciality teaching hospital. Int J Integr Med 2013;1:1-6.
Ramakrishna P. Collection, detection, assessment, monitoring and prevention of adverse drug reactions of antiepileptic drugs. Int Res J Pharm 2014;5:653-7.
Singh G. Do no harm-but first we need to know more: The case of adverse drug reactions with antiepileptic drugs. Neurol India 2011;59:53-8.
Patel NH, Padhiyar J, Shah YB, Dixit RK. Study of causality, preventability and severity of cutaneous adverse drug reactions in a tertiary care institute. GCSMC J Med Sci 2015;4:24-7.
Palanisamy S, Kumaran KS, Rajasekaran A. A study on assessment monitoring and reporting of adverse drug reactions in Indian hospital. Asian J Pharm Clin Res 2011;4:112-6.
Ahmed B, Nanji K, Mujeeb R, Patel MJ. Effects of polypharmacy on adverse drug reactions among geriatric outpatients at a tertiary care hospital in Karachi: A prospective cohort study. PLoS One 2014;9:e112133.
Lucca JM, Ramesh M, Ram D, Kishor M. Incidence and predictors of adverse drug reactions caused by drug-drug interactions in psychiatric patients: An empirical study. Trop J Med Res 2016;19:29.
Thuermann PA, Windecker R, Steffen J, Schaefer M, Tenter U, Reese E, et al. Detection of adverse drug reactions in a neurological department: Comparison between intensified surveillance and a computer-assisted approach. Drug Saf 2002;25:713-24.
Pal AB, Prusty SK, Sahu PK, Swain T. Drug utilization pattern of antiepileptic drugs: A pharmacoepidemiologic and pharmacovigilance study in a tertiary teaching hospital in India. Asian J Pharm Clin Res 2011;4:96-9.
Kumar BN, Nayak K, Singh H, Dulhani N, Singh P, Tewari P. A pharmacovigilance study in medicine department of tertiary care hospital in Chattisgarh (Jagdalpur), India. J Young Pharm 2010;2:95-100.
Raut AL, Patel P, Patel C, Pawar A. Preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital: A prospective observational study. Int J Pharm Chem Sci 2012;1:1293-8.
Antony A, Joel JJ, Shetty J, Umar NF. Identification and analysis of adverse drug reactions associated with cancer chemotherapy in hospitalized patients. Headache. Int J Pharm Pharm Sci 2016;6:3-7.
Kumar L. Pharmacovigilance/reporting adverse drug reactions: An approach to enhance health surveillance and extending market share by minimizing the chances of drug withdrawals. Int J Pharm Pharm Sci 2015;7:1-7.
Kulkarni GP, Patil LV. Analysis of adverse drug reactions spontaneously reported to adverse drug monitoring centre of a tertiary care hospital– prospective study. Int J Curr Pharm Res 2018;10:23-5.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
