A STUDY ON DETECTING ADVERSE DRUG REACTIONS REPORTING IN A TERTIARY CARE TEACHING HOSPITAL

Background: An adverse drug reaction (ADR) is a reaction which is noxious and unintended and which occurs at dosages normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. It is important to identify the risks for ADRs, hence forth the common drugs causing ADRs, their therapeutic class, demographic data of patients suffered from ADRs & concomitant medications used should be known. Also ADR specific data such as type of reaction, system affected and probable causes will be of great help to minimize the ADRs. To detect the ADRs through spontaneous reporting system in our tertiary care teaching hospital and analyzing them by using World Health Organization (WHO) assessment scales. Method: An prospective observational study was conducted based on ADRs reporting between 1st June 2017 to 31st May 2018 to the ADR reporting unit of the our hospital i.e., Pharmacovigilance cell. The ADRs reported by spontaneous reporting system were from patients attending outpatient department (OPD), inpatient department (IPD) and casualty department. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics and outcome of the reactions. Assessment was also done for causality and severity. Result: Total 2639 ADRs were reported with in the period from 1st June 2017 to 31st May 2018. Antimicrobial agents (AMA) were the drug class most commonly involved and Non-Steroidal Anti-inflammatory Drugs (NSAIDs) were next to AMA. Cotrimoxazole a well-established agent was the individual drug most frequently reported in this study. Upon causality assessment, majority of the reports were rated as probable (55.89 %). Conclusion: The pattern of ADRs reported in our hospital is comparable with the results of other studies conducted in various hospital set up elsewhere. AMAs were causing maximum ADRs. This study provides a database of ADRs due to common drugs used in our hospital, which will help clinicians for optimum and safe use of these drugs. Hence strict vigilance is required for the use of these likely drugs and their safety assessment