Print ISSN 2319-2003 | Online ISSN 2279-0780 doi: 10.5455/2319-2003.ijbcp20141228 IJBCP International Journal of Basic & Clinical Pharmacology www.ijbcp.com International Journal of Basic & Clinical Pharmacology | November-December 2014 | Vol 3 | Issue 6 Page 1078 Research Article Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases Prakash H. Bhabhor 1 , Tejas Kamleshbahi Patel 1 *, Roshni Vahora 2 , Parvati B. Patel 1 , Nimisha Desai 3 ABSTRACT Background: Epidemiological data are limited regarding clinical characteristic of adverse drug reactions (ADRs) in India. Aim: The aim was to assess ADRs with reference to the causative drugs, seriousness and their other clinical characteristics in Indian tertiary care teaching hospital. Methods: A spontaneous reporting based ADR monitoring study was conducted over a period of 2 years. The World Health Organization (WHO) deinition of an ADR and its seriousness was adopted. The organ system involvement was labeled by WHO-ADR terminology. ADRs were analyzed for causality by Naranjo’s algorithm, preventability by modiied Schumock and Thornton’s criteria and types of reactions by Rawlins and Thompson classiication. Subgroup analysis was performed between serious and non-serious reactions. Results: Of the total of 135 reactions reported 111 reactions from 97 patients were included for analysis. The incidences of overall and serious ADRs were 0.25 and 0.06 per 1000 patients, respectively. The most commonly implicated organ systems were skin and appendages (52.25%). The major causative drug classes were antimicrobials (40.28%), central nervous system (23.61%) and autacoids (15.97%). About two- thirds of the reactions (65.77%) were classiied as probable and one-tenth (8.10%) as preventable. The factors signiicantly associated with serious reactions were age group 40-60 years (odds ratio [OR]: 5.51), parenteral drugs (OR: 2.96), central and peripheral nervous system disorders (OR: 5.06), body as a whole - general disorders (OR: 9.05) and acute onset reactions (OR: 52.62). Conclusion: Antimicrobials are common causative agents. Cohort study is recommended to conirm the risk factors of serious ADRs in Indian population. Keywords: Pharmacovigilance, Adverse drug reaction monitoring, Serious reactions, Causative drugs, Antimicrobials 1 Department of Pharmacology, Gujarat Medical Education and Research Society Medical College, Vadodara, Gujarat, India, 2 Department of Skin & VD, Gujarat Medical Education and Research Society Medical College, Vadodara, Gujarat, India, 3 Department of Psychiatry, Gujarat Medical Education and Research Society Medical College, Vadodara, Gujarat, India Received: 13 October 2014 Accepted: 07 November 2014 *Correspondence to: Dr. Tejas Kamleshbahi Patel, Email: dr.tkp2006@yahoo. co.in Copyright: © the author(s), publisher and licensee Medip Academy. This is an open- access article distributed under the terms of the Creative Commons Attribution Non- Commercial License, which permits unrestricted non- commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. INTRODUCTION Adverse drug reactions (ADRs) hold special importance in healthcare as they account for hospitalization, the economic burden, and mortality. 1,2 The female gender, elderly age group, multiple medications and the recent introduction of new drugs are important risk factors for ADRs. 3 Other important factors for their occurrence are race, pregnancy, breastfeeding, alcohol intake, and state of liver and kidney functions. 4 Antimicrobial drugs and analgesics are most frequently responsible for ADRs. However, their patterns and causative drugs can vary due to different prescribing habits, use of newer drugs and referral bias. 5,6 Many of these ADRs are preventable. Identiication of it helps in achieving a substantial reduction in health care cost. 7 India is a part of World Health Organization (WHO) program for the global monitoring of ADRs that depends on spontaneous reporting. It operates for all drugs throughout their life span. It is the most affordable system, which can identify serious reactions, rare ADRs as well as generate