177| International Journal of Pharmaceutical Research | July - Sept 2019 | Vol 11 | Issue 3 Research Article INCIDENCE AND ASSOCIATED FACTORS OF ADVERSE DRUG REACTIONS IN GENERAL MEDICINE DEPARTMENT OF A TERTIARY CARE TEACHING HOSPITAL RACHANA J 1 , C.S. SHASTRY 1* , UDAY VENKAT MATETI 1, 2 , RAGHAV SHARMA 3 , NANDAKUMAR UP 1 , SHARAD CHAND 1 1 Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru- 575 018, India 2 Department of Pharmacy Practice, G. Pulla Reddy College of Pharmacy, Hyderabad- 500028, India 3 Department of General Medicine, Justice K.S Hegde Charitable Hospital, Nitte (Deemed to be University), Deralakatte, Mangaluru- 575 018, India E-mail id: drcshastry@gmail.com Received: 22.05.19, Revised: 22.06.19, Accepted: 22.07.19 ABSTRACT Adverse drug reactions (ADRs) are one of the major causes of morbidity and mortality. To assess the incidence and cost involved in ADRs reported in the general medicine department. A prospective observational study was carried out for a period of 8 months from August 2016 to March 2017. Patients enrolled as per the study criteria then ADRs data was evaluated by assessment of causality, severity, and preventability. The cost incurred for the management of ADRs was calculated. From a total number of 240 patients, 127 (52.91%) were males and 113 (47.08%) were females. The causality assessment by Naranjo’s scale showed that the majority of the reactions was probable 32 (72.7%), followed by possible 12 (27.3%). Based on WHO-UMC Scale, 36 (81.8%) were probable, followed by 8(18.2%) possible reactions. Majority of the reactions, 29 (66%) were moderate in severity. About 42 (95.5%) reactions were probably preventable, and 2 (4.5%) were preventable. Total cost for the management of ADRs was INR 173673.00. The study concludes that regular monitoring of ADRs may be required to reduce the morbidity and to improve patient compliance, which in turn can produce a better therapeutic outcome. Key words: Adverse Drug Reaction, Causality Assessment, Incidence, General Medicine INTRODUCTION Drugs, the most common medical intervention, are used to improve the overall wellbeing by providing relief from sufferings and distress. Medications are considered as “double edged weapons” with appreciable potential to create harm (Fitzgerald, 2008). 1 It is estimated that about 5% of patients consuming a drug gets affected by its adverse effects (Martin et al., 1998). 2 The overall incidence of ADRs in Indian population ranges between 1.8 and 25.1%, of which the fatal ADRs accounts for about 1.8%. More than 50% of all approved drugs in the market are associated with some kind of adverse effects, which are not identified before their approval for clinical use (Sriram et al., 2011). 3 The World Health Organization (WHO) defines an ADR as “response to drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of a disease, or for the modification of physiological function” (WHO, 1972). 4 There are certain known risk factors of ADR – which can be distinguished into four as patient related, drug related, disease related and social. The major application of these risk factors is that they can be used to create ADR risk prediction models, which helps in identifying high risk patients for ADRs. The four distinct stages behind the creation of perfect risk prediction models are development and validation assessment in the first instance, followed by impact and implementation assessment (Tangiisuran, 2014). 5 The importance of monitoring of ADRs is well perceived from the 1960’s thalidomide to be the reason for phocomelia in newborns (Pradeep et al., 2015). 6 Timely detection and reporting of ADRs help in avoiding undesirable issues related to patient’s health as well as financial status (Wiffen et al., 2002). 7 In view of this a well-organized system was developed by the WHO in 1978 called as Pharmacovigilance.Pharmacovigilance is the process which involves identifying and evolving safety measures and signals throughout the marketing of the drug. The signals derived from both clinical trials and post marketing surveillance is advised to be detected in the early stages itself. This early detection of safety signals has been followed by leading pharmaceutical companies around the globe to identify and manage the risks by incorporating and implementing effective management plans throughout the product life cycle (WHO,