Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

Manodeep Sen, Arpita Singh, Mukul Misra


Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.

Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.

Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.

Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.


Adverse drug reactions, AMC, Causality assessment, Pharmacovigilance

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Glossary of pharmacovigilance terms. Available at: Assessed 3 September 2017.

PvPI reaches out to rural masses. Available at: Assessed 3 September 2017.

ADR reporting form. Available at: Assessed 3 September 2017.

Rawlins MD, Thompson JW. Mechanisms of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug reactions. Oxford: Oxford University Press; 1991:18-45.

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

The use of the WHO-UMC system for standardized case causality assessment. Available at: Accessed 3 September 2017.

Lobo MG, Pinheiro SM, Castro JG, Momenté VG, Pranchevicius MC. Adverse drug reaction monitoring: Support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013;14:5.

Dutta SB, Beg MA, Bawa S, Anjoom M, Varma A, Singh NK. A retrospective analysis of adverse drug reactions in a tertiary care teaching hospital at Dehradun, Uttarakhand. Int J Basic Clin Pharmacol. 2015;4(1):121-4.

Subbanna PK, Chandy SJ. The role of active surveillance in improving the hospital adverse drug event reporting. Indian J Pharmacol. 2006;38:363-4.

Miller MA. Gender-based differences in the toxicity of pharmaceuticals - the food and drug Administration’s perspective. Int J Toxicol. 2001;20(3):149-52.

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital - their severity and cost involved. Pharmacoepidemiol Drug Saf. 2003;12(8):687-92.

Kharb P, Mittal N, Gupta MC. An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance programme of India in a tertiary care hospital of Haryana. Int J Basic Clin Pharmacol. 2015;4:556-60.

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 Clin Pharmacol. 2007;7:8.

Patidar D, Rajput MS, Nirmal NP, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdiscip Toxicol. 2013;6(1):41-6.

Jose J. Rao PG. Pattern of Adverse Drug Reactions Notified By Spontaneous Reporting In An Indian Tertiary Care Teaching Hospital. Pharmacol Res. 2006;54(3):226-33.

Caranasos GJ, Stewart RB, Cluff LE. Drug-induced illness leading to hospitalization. JAMA. 1974;228(6):713-7.

Shareef SM, Naidu CDM, Raikar SR, Rao YV, Devika U. Development, implementation and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana. Int J Basic Clin Pharmacol. 2015;4:757-60.

Vijayakumar TM, Dhanaraju MD. Description of adverse drug reactions in a multi-speciality teaching hospital. Int J Integr Med. 2013;1(26):1-6.

Suh DC, Woodall BS, Shin SK, Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother. 2000;34(12):1373-9.

Murphy BM, Frigo LC. Development, implementation and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm. 1993;28(12):1199-204,1240.