www.ijbcp.com International Journal of Basic & Clinical Pharmacology | September-October 2013 | Vol 2 | Issue 5 Page 548 IJBCP International Journal of Basic & Clinical Pharmacology Print ISSN: 2319-2003 | Online ISSN: 2279-0780 Research Article A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India Farhan Ahmad Khan 1 *, Sheikh Nizamuddin 2 , Najmul Huda 3 , Hitesh Mishra 1 INTRODUCTION Polypharmacy (prescribing more than five drugs concurrently) is more common in elderly patients because of existences of one or more diseases. But multiple medication increases the incidence of Adverse drug reactions (ADRs). ADRs as per the WHO definitions is “a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function”. 1 Moreover, other definition specifically excludes minor unwanted reactions (e.g., a slight dryness of the mouth): “A harmful or significantly unpleasant effect caused by a drug at doses intended for therapeutic effect (or prophylaxis or diagnosis) which warrants reduction of dose or withdrawal of the drug and/or foretells hazard from future administration.” However, these definitions (and others reviewed elsewhere) exclude error as a source of adverse effects. 2,3 ADRs have been found to enhance morbidity and mortality during hospitalizations. 4 ADRs have becomes an important challenge in today's modern medicine, ranked between the fourth and sixth leading causes of death in the USA. Very few studies on ADRs as the cause of hospital admissions were carried out in India. This compelled us to analyze the prevalence of ADRs as well as associated risk factors in elderly population of North India. Infections are one of the most important causes of patients visit in the hospital and Otolaryngology ABSTRACT Background: Polypharmacy, advancing age and longer duration of hospital stay are the factors responsible for adverse drug reactions (ADRs). This study has attempted to analyze the pattern of antimicrobial prescription in OPD & IPD of the Otolaryngology department and to detect, document, assess and report the suspected ADRs due to antibiotic use and preparation of guidelines to minimize the incidence of ADRs. Methods: A prospective study conducted at the TMMC&RC on patients aged >40 years, who visited the Otolaryngology department over a period of 5 months. Suspected ADRs were assessed for causality and severity using Naranjo’s probability scale and modified Hartwig’s criteria, respectively. Results: Out of 1200, 925 prescriptions were analyzed. Most patients were from 41-60 age (59.45%) followed by 61-80 age (37.29%) and least from >80 yr (3.24%). But the incidence of ADRs were found to be higher in patients of >80 yr age group n=8 (26.66%). The most commonly prescribed antibacterials were β-Lactams (64.61%). Out of 925 prescriptions studied, only 94 were found to have 154 ADRs. The most commonly identified ADRs were Gastrointestinal 47.40%, followed by Neurotoxicity 24.67%, cutaneous reactions 20.12%, Hepatic 4.54% and Kidney 3.24%. 74.67% of the ADRs were probable and 20.77% were possible type and only 4.54% were definite. 74.67% ADRs were found to be type A, and 25.32% type B. Conclusions: Our study showed that prevalence of ADRs was highest in elder age group and diarrhea was the most common ADR found. Therefore elderly patients should be given special attention when prescribing medications to avoid clinically significant harmful consequences. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients. Keywords: Antibacterial agents, Drug utilization, Adverse Drug reactions doi: 10.5455/2319-2003.ijbcp20131007 1 Department of Pharmacology, 2 Department of ENT, 3 Department of Orthopaedics, Teerthanker Mahaveer Medical College and Research Centre, TMU, Moradabad-244001, India Received: 23 June 2013 Accepted: 21 July 2013 *Correspondence to: Dr. Farhan Ahmad Khan, Email: dr.farhan.k@gmail.com © 2013 Khan FA et al. 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.