Original Research Article DOI: 10.18231/2393-9087.2018.0002 Indian Journal of Pharmacy and Pharmacology, January-March, 2018;5(1):4-6 4 Pattern of adverse drug reactions in rural tertiary care medical college and hospital of Himachal Pradesh: A retrospective observational study Himani Prajapati 1 , Dinesh Kansal 2,* , Usha K.Chaudhary 3 1 Patient Safety Associate, 2 Professor and HOD, Dept. of Pharmacology, 3 Associate Professor, Dept. of Anaesthesia, Dr. RPGMC Tanda, Kangra, Himachal Pradesh, India * Corresponding Author: E-mail: Dinesh.Kansal56@gmail.com Abstract Introduction: Adverse events can lead to admission in hospital, prolongation of hospitalization, increase in investigations as well as treatment costs, deformities, danger to life and even death. Objective: The aim of this study was to conduct adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital. Methods: A retrospective observational study was conducted on ADRs reported in adverse drug monitoring center of our hospital from April, 2016 to December, 2016. Data such as age, gender, diagnosis, drug intake, types of ADRs, treatment and outcome of the reactions were collected. Each reported patient was assessed individually. Causality assessment was done on Naranjo’s probability scale. Modified Hartwig’s criteria were used to assess the severity of ADRs. Results: A total of 173 reports were studied. 65 (38%) patients were males and 108 (62%) were females. The majority of ADRs were due to cancer chemotherapy agents in 87 (50%), followed by anti-tubercular drugs in 22(13%), antimicrobial agents in 22 (13%) and anti-retroviral drugs in 16(9%). Out of total 574 events, 192 (34%) complaints comprised of gastro-intestinal manifestations. On Naranjo’s probability scale, 111 (64%) reactions were probable, 54 (31%) as possible and 8 (5%) as certain. According to Modified Hartwig’s criteria 130 (75%) reactions were mild, 29 (17%) were moderate and 14(8%) were severe. Conclusion: Health-care providers will have to do vigilant monitoring and reporting of ADR´s. Keywords: Pharmacovigilance, Adverse drug reactions, Chemotherapy, Causality assessment, Tertiary care teaching hospital. Introduction Adverse events can lead to hospitalization, prolonged stay, increase in investigations and treatment cost, birth defects and even death. World Health Organization (WHO) defines ADR as “response to a drug, which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function. 1 Pharmacovigilance Programme of India (PvPI) 2014 states that 6.7% of patients have serious adverse events. Similar studies have documented that hospital admissions due to ADR were 3.4%, hospital readmissions were 3.7%, and mortality was 1.8%. 2 Materials and Methods This was a retrospective observational study conducted for a duration of 6 months, from April 2016 to December 2016 at Dr. Rajendra Prasad Government Medical College and Hospital Kangra at Tanda. ADR details were collected from the Adverse Drug Monitoring Center of the institution. Patient information such as age, gender, diagnosis, drugs prescribed, types of ADR, treatment and outcome of the reaction were collected. Each reported patient was assessed individually. Causality assessment was done based on Naranjo’s probability scale. The total score was calculated based on the scale and it was categorized as certain (score >9), probable (score 5-8), and possible (score1-4). 3 Results Total 173 case reports were studied. Of these males were 65 (38%) and females were 108 (62%). (Fig.1). Fig. 1: Gender distribution Age and Gender Distribution: Most of the patients were in age group of 19 to 80 years (95%). prevalence of ADR’s was more in female population. The mean age of males was 49.15 16.86 years and females was 47.58 15.69 years. Maximum 71(41%) patients were from the age group 41 – 60 years. (Table 1). Table 1: Age and gender distribution Age group Male Female Total (173) 1 - 18 Yrs 5 3 8 (4.62%) 19 - 40 Yrs 14 36 50 (28.90%) 41 – 60 Yrs 28 43 71 (41.04%)