To study the pattern of adverse drug reactions among patients hospitalized in the medical wards of a tertiary care hospital

Anup Kumar, Dinesh Kansal, Parveen Kumar Sharma, Amit Bhardwaj, Sushma Sawaraj


Background: ADRs have a major impact on public health, quality of life.  ADRs are a recognized hazard of drug therapy. Although some ADRs are minor and resolve without squeal, others can cause permanent disability or death. Despite the methodological rigor of clinical trials, it is generally not possible to identify all safety issues associated with drugs during the pre-marketing research phase.  The only way to find out such occurrences is to be on active-look out for adverse events over a long time horizon in large population and in different host conditions. The information may be useful in identifying and minimizing preventable ADRs, while generally enhancing the knowledge of the prescribers to deal with them more efficiently.

Methods: This retro-prospective study was conducted in a tertiary care hospital for one year.  Data of those patients who experienced ADRs was recorded in detail from internal Medicine ward. An assessment of causality was done. Data was evaluated to determine the class of drugs and the organ systems frequently associated with ADR within the settings of the institute.

Results: The total incidence of ADRs was 7.59% in hospitalized patients with male predominance. Most common system involved was GIT followed by CNS and CVS. Antibiotics were most common culprits for ADRs followed by NSAIDS and hypoglycemic agents. In causality assessment probable ADRs were much more than possible ADRs. Severity of reaction in most of the patients was moderate. Majority of ADRs were Type A and maximum were probably preventable.

Conclusions: There is need to explore the reasons for this relatively low incidence rate of ADR’s in the Indian population. Under­reporting is one of the major factors with a lack of proper pharmacovigilance system which is still in budding state in India.


Adverse drug reactions, Hospitalized patients, Retrospective, Prospective, Medical wards

Full Text:



Vora MB, Trivedi SR, Shah BK, Tripathi CB. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital. J Pharmacol Pharmacother. 2011;2:21–5.

Zolezzi M, Parsotam N. Adverse dug reaction reporting in New Zealand: implications for pharmacists. Ther Clin Risk Manag. 2005;1(3):181-8.

Daga S. Pharmacovigilance- a commitment of medical professional. J Indian Med Assoc. 2008;106:775.

Almenoff JS, Pattishall EN, Gibbs TG, DuMouchel W, Evans SJ, Yuen N. Novel stastical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther. 2007;82:157-66.

The use of the WHO–UMC system for standardized case causality assessment. Accessed from: Accessed on 12th May 2016.

Rawlins MD, Aronson JK. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug reactions. Oxford: Oxford University Press; 1977: 10.

Hartwig SC, Seigel J. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm. 1992;49:2229-32.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.

WHO Adverse Reaction Terminology. Available at : http:// www. umc-products. com_graphics_ 3036 Accessed on 2nd April 2016.

Hurwitz N. Admissions to hospital due to drugs. Brit Med J. 1969;1:539-40.

De Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester A. The incidence and nature of in-hospital adverseevents: a systematic review. Qual Saf Health Care. 2008;17:216-23.

Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol. 1998;45:301-8.

Goyal YN, Singh A, Bhansali NB, Jiyo C, Mistry RA, Joshi ND. Pattern of adverse drug reactions in a tertiary care hospital. J Pharmcovig Drug Safety. 2011;8(1):19-24.

Chen YC, Huanq HH, Fan JS, Chen MH, Hsu TF, Yen DH, et al. Comparing characteristics of adverse drug events between older and younger adults presenting to a Taiwan emergency department. Medicine (Baltimore). 2015;94(7):547.

Palanisamy S, Arul Kumaran KSG, Rajasekaran A. A study on assessment, monitoring, documentation and reporting of adverse drug reactions at a multispeciality tertiary care teaching hospital in South India. Int J Pharm Tech Research. 2009;1:1519-22.

Lobo MC, Pinheiro SM, Castro JG, Momente VG, Pranchevicus MC. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol and Toxicol. 2013;14:5.

Koh Y, Kutty FBM, Li SC. Drug-related problems in hospitalized patients on polypharmacy: the influence of age and gender. Ther Clin Risk Manag. 2005;1(1):39-48.

Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as a cause of admission to hospital: Prospective analysis of 18820 patients. Br Med J. 2004;329:15-9.

Patel KJ, Kedia MS, Bajpai D, Mehta SS, Kshirsagar NA, Gogtay NJ. Evaluation of the prevalence and economic burden of adverse drug reactions presenting to the medical emergency department of a tertiary referral centre: a prospective study. BMC Clinical Pharmacology. 2007;7:8.

Sriram S, Ghasemi A, Devi M, Balasubramaniam R, Ramasamy R, Ravi TK, et al. Prevalence of adverse drug reactions at a private tertiary care hospital in South India. J Res Med Sci. 2011;16:16–25.

Uchit GP, Shrivastava MP, Badar VA, Navale SB, Mayabhate MM. Adverse drug reactions to antimicrobial agents in a tertiary care hospital in Nagpur. J Indian Med Assoc. 2012;110:224-7.

Gor AP, Desai SV. Adverse drug reaction in the in-patients of medicine department of a rural tertiary care teaching hospital and influence of Pharmacovigilance in reporting adverse drug reactions. Indian J Pharmacol. 2008;40:210-6.

Karthikeyan M. A prospective observational study of medication errors in general medicine department in a tertiary care hospital. Drug Metabol Drug Interact. 2013;28(1):13-21.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2008;65(2):210-6.

Samoy LJ, Zed PJ, Wilbur K, Balen RM, Abu-Laban RB, Roberts M. Drug-related hospitalizations in a tertiary care internal medicine service of a Canadian Hospital. Pharmacotherapy. 2006;26:1578-86.

Wilson RM, Michel P, Olsen S, Gibberd RW, Vincent C, El-Assady R, et al. Patient safety in developing countries: retrospective estimation of scale and nature of harm to patients in hospital. BMJ. 2012;344:832.

Rao PG, Archana B, Jose J. Implementation and results of an adverse drug reaction reporting programme at an Indian teaching hospital. Indian J Pharmacol. 2006;38:293-4.