Original Article ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY GAJANAN P. KULKARNI, LOKESH V. PATIL * Department of Pharmacology, Bidar Institute of Medical Sciences (BRIMS), Bidar, Karnataka Email: drlokeshpatil@gmail.com Received: 20 Oct 2017, Revised and Accepted: 12 Dec 2017 ABSTRACT Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions. Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed. Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems. Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization Keywords: Adverse drug reaction, Pharmacovigilance, Causality assessment, Serious reactions © 2018 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open-access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijcpr.2018v10i1.24403 INTRODUCTION Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health care costs [1]. World Health Organization (WHO) defines an ADR as any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or cure of a disease [2]. ADRs are responsible for 5-11% of hospital admissions of which 60-70% are preventable [3, 4]. Spontaneous reporting has contributed significantly to successful pharma- covigilance [5]. The main objective of our study was to analyze the ADRs reported in our tertiary care hospital and assessment of severity of the reported ADRs to create a clinical database of commonly occurring ADRs resulting from the use of routine drugs in the hospital so as to prevent and reduce morbidity and bring about better patient care. MATERIALS AND METHODS Study design and site This was a prospective observational study conducted at ADR monitoring centre of Bidar Institute of Medical Sciences and Hospital, Bidar, Karnataka. The study was approved by the institutional ethics committee. Study duration The study was carried out over a period of 12 mo from July 2016 to July 2017. Sample size A total of 80 cases reported over a period of 12 mo were included in the study. Inclusion criteria 1. Patients of all age, both genders, seeking treatment at BRIMS Bidar and developed ADRs. 2. Patients willing to give written informed consent. 3. Suspected adverse drug reactions reported to the ADR monitoring centre Exclusion criteria Patients who were not willing to participate in the study Study procedure The suspected adverse drug reactions reported to the pharmacovigilance centre were filled into CDSCO spontaneous ADR reporting forms. A causal relationship was assessed and categorized by Naranjo’s algorithm and WHO–UMC causality scale [6]. The severity of each reported ADR was assessed using the criterion developed by modified Hartwig and Siegel scale [7]. All values were expressed in percentages and depicted using tables and charts. RESULTS ADRs were more in males 50 (62.5%) as compared to females 30 (37.5%) table 1. The major causative agents for ADRs were antitubercular drugs (50%) followed by other antimicrobial agents (25%) and intravenous fluid (15%), antihypertensives (2.5%), antiepileptic drugs (1.25%) and others 5(6%) (table 2). The most common organ system affected was a gastrointestinal system (45%) with symptoms of gastritis, nausea and vomiting followed by generalized features like chills, rigours and palpitations (26.5%). 20% of reactions affecting skin and appendages. The central nervous system along with hearing and the vestibular system was affected in 3.75% (3) each system (table 3). Assessment of the ADRs using Naranjo’s scale showed that 81.25% (65) of cases were classified as probable, 16.25% (13) were possible and 2.5% (2) of cases were in the doubtful category (table 4). On the assessment of ADRs by using WHO-UMC causality assessment scale the number of certain cases was 0% as no rechallenge was done, 74% were possible/likely, 25% were possible and 1% classified as unlikely (table 5). Severity Assessment by Modified Hartwig and Siegel Scale showed that 39(48.75%) ADRs were mild, 25 (31.25%) ADRs were mild and 16 (20%) ADRs were severe. No lethal effects were reported (table 6). International Journal of Current Pharmaceutical Research ISSN- 0975-7066 Vol 10, Issue 1, 2018