A prospective study of adverse drug reactions in a tertiary care teaching hospital

More Pankaj Daulat, Ambika Abhishake V. J., Prabhakar Singh, Bhupendra Raj


Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.

Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organization (CDSCO), New Delhi. ADRs were assessed for their causality, severity, and preventability as per the standard scales. Data was analysed using descriptive statistics and expresses in percentages.

Results: Overall occurrence of ADRs was slightly more in males (55%). Maximum (26%) suspected ADR reported during study period was skin rash. Skin (44%) was the most commonly affected organ system. Antimicrobials (68%) were the drug group most commonly involved in ADRs. Most of the suspected ADRs were probable in causality assessment, moderate in severity and probably preventable.

Conclusions: The study results revealed opportunities for interventions in ADR management to ensure safer drug use.


Causality, Pharmacovigilance, Preventability, Severity

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Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5.

Alomar MJ. Factors affecting the development of adverse drug reactions. Saudi Pharmaceut J. 2014 Apr 1;22(2):83-94.

Hakkarainen KM, Hedna K, Petzold M, Hägg S. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions–a meta-analysis. PloS One. 2012 Mar 15;7(3):e33236.

Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharmacists. JYP. 2010 Jul;2(3):315.

Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, Arnau JM. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol. 2005 Dec;60(6):653-8.

John LJ, Arifulla M, Cheriathu J, Sreedharan J. Reporting of adverse drug reactions: A study among Clinicians. J App Pharmaceut Sci. 2012 Jun 1;2(06):135-9.

Pharmacovigilance program of India. CDSCO. Ministry of Health and Family Welfare, Government of India. 2010. Available at: Accessed 9 November 2017.

World Health Organization. International drug monitoring: The role of the hospital. Geneva, Switzerland: World Health Organization. 1966.

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(2):239-45.

The Use of the WHO-UMC System for Standardised Case Causality Assessment. Available at: http://www.who-umc. org

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Sys Pharmacy. 1992 Sep 1;49(9):2229-32.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hospital Pharmacy. 1992 Jun;27(6):538.

Gupta R, Sheik A, Strachan D, Anderson HR. Increasing hospital admission for systemic allergies disorders in England: analysis of national admission data. Br Med J. 2003;327(7424):1142-3.

Chawla S, Kalra BS, Dharmshaktu P, Sahni P. Adverse drug reaction monitoring in a tertiary care teaching hospital. J Pharmacol Pharmacother. 2011;2(3):196-8.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2007;65(2):210-6.

Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hospital Pharmacy. 1993 Dec;28(12):1199-204.

Glassen DC, Pestotnik SL, Evans RS, Burke JP. Computerised surveillance of adverse drug events in hospital patients. JAMA. 1991;266:2847-51.

Prosser TR, Kamysz PL. Multidisciplinary adverse drug reaction surveillance programme. Am J Hosp Pharm. 1990;47:1334-39.

Wester K, Jonnson AK, Spigset O, Druid H, Hagg S. Incidence of fatal adverse drug reactions: a population based study. Br J Clin Pharmacol. 2007;65(4):573-9.

Gor AP, Desai SV. Adverse drug reactions (ADR) in the inpatients of medicine department of a rural tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR. Indian J Pharmacol. 2008;40(1):37-40.

Wester K, Trivedi HR, Shah BK, Tripathi CB. Adverse drug reaction in inpatient of internal medicine wards at a tertiary care hospital: a prospective cohort study. J Pharmacol Pharmacother. 2011;2(1):21-5.

Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA. The nature of adverse events in hospitalized patients: results of Harvard medical practice study II. N Engl J Med. 1991;324(6):377-84.

Acharya T, Mehta D, Shah H, Dave J. Pharmacovigilance study of adverse cutaneous drug reactions in a tertiary care hospital. Nat J Physiol. Pharm Pharmacol. 2013;3:75-81.

Jha N, Bajracharya O, Namgyal T. Prevalence of adverse drug reactions with commonly prescribed drugs in different hospitals of Kathmandu valley. Kathmandu Univ Med J. 2007;5(4):504-10.

Palanisamy S, Kumaran KSGA, Rajasekaran A. A study on assessment, monitoring, and reporting of adverse drug reactions in Indian hospital. Asian J Pharm and Clin Res. 2011;4(3):112-6.

Avery AJ, Anderson C, Bond CM, Gifford A, Hannarord PC. Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):49-72.