STUDY OF ADVERSE DRUG REACTIONS PROFILE IN A TERTIARY CARE HOSPITAL: A RETROSPECTIVE OBSERVATIONAL STUDY

Sahana M. Mogali, Aruna Bhushan* and Md. Ajmat Khan

ABSTRACT

Objective: To study adverse drug reactions (ADRs) profile in a tertiary care hospital and to determine seriousness, predictability, causality, severity and outcome of ADRs. Method: A retrospective observational study was conducted in a tertiary care hospital over a period of five years. Recorded data was collected from various department regarding details of patients, drugs, ADRs and entered in a proforma. It was evaluated using appropriate scales. Simple descriptive statistics was used for analysis. Results: Total number of ADRs reported in five years were 410. As per criteria 330 ADRs were included and analyzed out of which female patients were 217 (65.76%) and males 113 (34.24%). Majority of patients were in age group of 21 to 50 years (69.7%). Among these reactions 29 (8.78%) were serious and 301 (91.21%) non-serious. Maximum ADRs reported from medicine department 188 (56.9%). Cutaneous ADRs were most frequent 134 (40.6%). Antiretroviral agents were most common drugs causing 80 (24.2%) ADRs. Overall predictability was 69.7%. When causality assessment was done 2 (0.6%) ADRs were certain, 121 (36.7%) probable and 207 (62.7%) possible. Severity assessment showed 129 (39.1%) reactions were mild, 201 (60.9%) moderate and none in severe grade. Outcome was 256 (77.6%) patients had recovered, 69 (21%) were recovering and 2 (0.6%) had not recovered from ADR. Conclusion: Most of ADRs in our study was due to polypharmacy. Due to these ADRs there is prolonged hospitalization and increase in economic burden. Hence there is always a need for prevention and periodical monitoring of ADRs.

Keywords: Adverse drug reactions, causality assessment, severity.