Published: 2016-12-30

An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital

Nishita H. Darji, Shilpa Jadav, Chintan Doshi, Rutvij Hedamba, Rusva Mistry, Hiren Trivedi


Background: Use of drugs itself may result into illness and death due to their adverse effects. In India 10-20% of inpatients developed adverse drug reactions. Most of these problems can be overcome by undertaking hospital based intensive monitoring. Objective of this study was to estimate the incidence and document the spectrum of ADRs in studied patients in terms of causality, severity, frequency, type and preventability. A prospective, observational, single centre study conducted among the indoor patients of the department of general medicine, Guru Gobind singh government hospital, Jamnagar over a period of 12 months.

Methods: Admitted patients who either had developed a clinically suspected ADR after admission (group A) or were admitted primarily because of an ADR (group B) were included. In all ADR related patients the necessary data was recorded on a pre-designed case record form, NCC-PvPI form and analysis was done.

Results: Total 3566 patients were screened. 87 patients had 101 ADRs, among them 62 from group A and 25 from group B with 2.44% incidence. In causality, by WHO-UMC and by naranjo scale most common ‘probable’ category in group A (54.7%) and group B (50%) and 89.9% group A and 84.6% in group B respectively.95.05% ADRs were ‘Not preventable’. Hartwig seigle’s scale maximum ADRs 65.4% ADRs in group A and 73.1% in group B were ‘moderate’ in severity.

Conclusions: Intercurrent illness, longer hospital stay and poly pharmacy was playing a major role in occurrence of multiple ADRs with 2.44% incidence in our setup.


ADR, Intensive monitoring, Indoor patients.

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Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ. 1998;316:1295-8.

Dikshit RK, Desai CK, Desai MK. Pleasures and pains of running a pharmacovigilance center. Indian J Pharmacol. 2008;40(1):31-3.

Mann RD, Andrews EB. Pharmacovigilance. Second Edition. John Willey and Sons, Ltd.: England; 2007:7.

Doshi MS, Patel PP, Shah SP, Dikshit RK. Intensive Monitoring of adverse drug reaction in hospitalised patients of two medical units at tertiary care hospital. Journal of Pharmacology Pharmacotherapeutics. 2012;3(4):308-313.

The use of the WHO-UMC system for standardized case causality assessment. Available at http://www.who Assessed 2012.

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.

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

Hartwig S, Seigel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Guidelines for the ATC classification and DDD assignment, 2013, 16th edition;. Available at Assessed 26 August 2013.

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

Tumwikirize WA, Ogwal-Okeng JW, Vernby A, Anokbonggo WW, Gustafsson LL, Lundborg SC. Adverse drug reactions in patient admitted on internal medicine wards in district and regional hospital in Uganda. African health sciences. 2011;11(1)72-8.

Lobo MG, Pinheiro SMB, Castro JGD, Gomes V, Cristina SM. Pranchevicius. Adverse drug reaction monitoring, support for pharmacovigilance at tertiary care hospital in Northen Brazil. 2013;14:5.

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.

Hurwitz N, Wade OL. Intensive hospital monitoring of adverse reactions to drugs. BMJ. 1969;1:531-6.

Javedh S, Midhun V, Shastry CS. A Prospective study on adverse drug reaction in medicine department. American journal of pharmatech research. 2013;3(6):507-17.

Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an indian tertiary care teaching hospital. Pharmacol. Res. 2006;54:226-33.

Wasserfallen J, Livio F, Buclin T, Tillet L, Yersin B, Biollaz J. Type, and cost of adverse drug reactions in emergency admissions. European Journal of Internal Medicine. 2001;12(5):442-7.

Capuano A, Motola G, Russo F, Avolio A, Filippelli A, Rossi F, et al. Adverse drug events in two emergency departments in Naples, Italy: an observational study. Pharmacological Research. 2004;50:631-636.

Gor AP, Desai SV. Adverse drug reactins (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.