RETROSPECTIVE ANALYSIS OF REPORTED ADVERSE DRUG REACTIONS

Pharmacovigilance also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug- related problems. The World Health Organization (WHO) defines an ADR as ‘a response to a drug that is noxious, unintended and occurs at doses normally used in man for the prophylaxis, diagnosis, therapy of disease, or for modification of physiological function’. The study conducted was a cross sectional retrospective study using modified ADR form from Central Drugs Standard Control Organization (CDSCO) and assessment was performed using different scales. This is a retrospective observational study, conducted on reported ADRs at a quaternary care hospital from 2009 ? 2014. The main aim of this study is to assess the incidence, pattern of ADRs, causality, offending drugs, and to prevent the occurrence. Each reported ADR was assessed for its causality by using Naranjo’s scale. The severity of each reported ADR was assessed using modified Hartwig & Siegel scale and preventability of ADRs by modified Schumock & Thornton scale. The adverse drug reactions which occur in this quaternary care hospital reaction had a large number of reactions but most of which were in mild to moderate range. The prescribing of large number of medications causing low intensity of ADRs indicates the use of cautious responsibility due to direct liability and awareness.