Sumit Kumar, Badruddeen, S. P. Singh, Juber Akhtar, Mohammad Irfan Khan, Mohammad Ahmad, Usama Ahmad
Sumit Kumar1, Badruddeen2*, S. P. Singh1, Juber Akhtar2, Mohammad Irfan Khan2, Mohammad Ahmad2, Usama Ahmad2
1Department of Pharmacology and Therapeutics, GSVM Medical College, Kanpur (U.P.), India.
2Faculty of Pharmacy, Integral University, Lucknow (U.P.), India.
Volume - 13,
Issue - 10,
Year - 2020
The objective of the study was to ascertain the different type of adverse drug reactions associated with analgesics, used for treating pain associated with different ailments in a tertiary care hospital and determine their causal relationship with the offending drug. This observational, non-interventional study was conducted in a tertiary care hospital at GSVM medical college Kanpur (U.P), India. Adverse drug reactions were reported by the physicians of different department and ADRs were assessed for different parameters-causality assessments, outcome and seriousness of ADRs as per World health organization (WHO), Expanded Rawlins and Thompson’s classification scale was used for determining type of ADRs, Predictability using CIOMS guidelines, severity using modified Hartwig’s scale and preventability as per Schumock and Thornton criteria. A total of 192 adverse drug reactions were reported from analgesics during treatment in tertiary care hospital. The Burden of ADRs in each patient was 2.25. Most of the adverse drug reactions were observed in the age group of 40–60 year. Gastritis (22.4%) was commonly reported reaction. Among analgesics, Aceclofenac + Paracetamol leads to 10.94% ADRs followed by Piroxicam (10.43%). Most of the adverse drug reactions on causality assessment were of Probable (96.35%) and possible (3.65%) nature. Type -A ADRs account for more than 50% of the total reported ADRs, followed by Type-B, C and D. Severity of most ADRs was found to be mild (94.80%) followed by severe and moderate and serious ADRs account in 4.69% cases and among serious ADRs most common were hematemesis (33.33%) and rash (22.22%). Most of the ADRs were of not-predictable type (69.27%) and not preventable type (96.34%). Digestive system was the most common organ system associated with Analgesics –ADRs.
Cite this article:
Sumit Kumar, Badruddeen, S. P. Singh, Juber Akhtar, Mohammad Irfan Khan, Mohammad Ahmad, Usama Ahmad. Assessment of Analgesics Induced Adverse Drug reactions in a Tertiary Care Hospital. Research J. Pharm. and Tech. 2020; 13(10):4861-4864. doi: 10.5958/0974-360X.2020.00855.0
Sumit Kumar, Badruddeen, S. P. Singh, Juber Akhtar, Mohammad Irfan Khan, Mohammad Ahmad, Usama Ahmad. Assessment of Analgesics Induced Adverse Drug reactions in a Tertiary Care Hospital. Research J. Pharm. and Tech. 2020; 13(10):4861-4864. doi: 10.5958/0974-360X.2020.00855.0 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-10-58
1. Parthasarathi G, Karin N, Milap C N. A Textbook of Clinical Pharmacy Practice, Essential Concepts and skills, second edition, India; Universities Press Private Limited. 2012; 105.
2. Kumar S, Badruddeen, Singh S P, Juber A, Khan M I. Evaluation of dermatological adverse drug reactions in a tertiary care hospital of northern India. Research Jour Pharm and Tech. 2019; 12(7): 3517-3521.
3. Kumar S, Badruddeen, Singh S P, Khan M I.A prospective study of adverse drug reactions due to platinum analogs-chemotherapy in tertiary care hospital. Asian J Phar and Clinical Res. 2018; 11(6): 215-218.
4. Murphy B M, Frigo L C. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm. 1993; 28: 1199–204.
5. Choudary K D, Bezbaruah K B. Prescribing pattern of analgesics in orthopaedic in-patient department at tertiary care hospital in Guwahati, Assam, Northeast India. Indian J Pharmacol. 2016; 48(4): 377–381.
6. Zaki S A. Adverse drug reaction and causality assessment scales. Lun Ind. 2011; 28(2): 152–153.
7. Nebeker J R, Barach P, Samore M H. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. An Int Med 2004; 140: 795-801.
8. Rawlins M D, Thompson J W, Davies D M. Pathogenesis of adverse drug reactions. Textbook of adverse drug reactions. Oxford University Press 1977; 10.
9. Sharma H L and Sharma K K 2017. Pharmacodynamics: Principles of pharmacology 3rd edition Paras medical publisher, pg:72.
10. Schumock G T, Thornton J P. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992; 27: 538.
11. Council for International Organization for Medical Science (CIOMS) WGI, guidelines for preparing core clinical-safety information on drugs. Council for international organization for medical sciences, Geneva; 1994.
12. Gunaseelan V, Mandal S K , Prasad V N , Khumukcham R , Devi K P and Singh T T. Adverse drug reactions to cancer chemotherapy in a regional cancer center in northeast India. Indian Jour Pharma Sci and Res. 2014; 5(8): 3358-3363.
13. Hartwig S C, Siegel J, Schneider P J. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992; 49: 2229–32.
14. Rejimon G, Reghu R. Drug utilization pattern of non-steroidal anti-inflammatory drugs in patients attending orthopaedic department of a hospital in Kerala. Jour Pharm Sci and Res. 2018; 10(5): 1014-1016.