Strengthen the Monitoring and Reporting of Adverse Drug Reaction at a Tertiary Teaching Hospital

Adverse Drug Reaction (ADR) is under-reported in India despite being the top producer of generic drugs in the world due to limited knowledge of the importance of reporting and monitoring ADR among the people of India; including the healthcare professionals. This perspective and observational study were designed to strengthen ADR monitoring over a period of six months based on medical records data analysis and personal interviews of patients. Data from various parameters were included in the evaluation like patient demographic characteristics, drug profile, and drug reaction outcomes. The severity of drug reaction and predisposing factors were also assessed. The overall incidence rate of serious ADRs in the patient population as per reports was 0.24% and gender was not significant risk factor. The highest ADR rate was 59.61% in 19-64 years and the moderate ADR rate was 19.23% in the age group of 65 years and above in general medicine wards. The most common ADR was urticaria with rashes, with an antibiotic class of drugs (42.3%). The majority of ADR (Type A reaction) had moderate severity, thus most of them require intervention, out of which 48.07% of the patients received symptomatic treatment. The most common disposing factor was poly-pharmacy (82.69%). The results obtained will contribute to the design of a new program for the Pharmacovigilance services i.e., ADR monitoring and reporting in every hospital throughout the nation. The quality and quantity of ADR reporting by clinical pharmacists will be strengthened and improved, which ensure the safer use of drugs in hospitals.