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Sharon John*

Department of Pharmacy Practice, Al-Ameen College of Pharmacy, Bangalore, Karnataka, INDIA.


Adverse drug reactions (ADRs) have proved a significant problem in healthcare for decades, with varying severity and outcomes. The present study aims to determine the prevalence, nature, probability, severity and preventability of ADRs in a hospital setting. This prospective, observational study, conducted over a period of 8 months, assessed all in-patients with symptoms of an ADR and hospital admissions due to an adverse drug event. Probability (Naranjo and WHO-UMC scales), severity (Hartwig scale) and preventability (Shumock and Thornton criteria) were assessed. A total of 110 ADRs were reported in 94 patients. ADRs were the sole cause of hospital admission in 37.27% of patients. Geriatric patients [21(19.09%)] were most affected by ADRs and female predominance [60 (54.55%)] was noted among the patients suffering from an ADR. The gastro-intestinal system (29.09%) was predominantly affected. The therapeutic classes of drugs frequently associated with ADRs were anti-microbials [21(19.09%)] and analgesics [11(10%)], whereas, the most common drugs involved were prednisolone and paracetamol. The most commonly reported ADR was urticaria [11(10%)]. Of the 110 ADRs, 64.54% was probable and 19.09% was possible, according to the Naranjo scale. As per the WHO scale, 19.09% of the ADRs were certain. Majority of the ADRs were of moderate severity [61(55.45%)] and 10.90% were definitely preventable. Majority of the ADRs (63.63%) were managed by withdrawing the suspected drug. A recovery rate of 89.09% was achieved. The importance of adverse drug reactions is often underestimated. A higher level of vigilance is required for the detection of ADRs and to prevent a serious outcome.

Keywords: Adverse drug reaction, monitoring, hospital, probability, severity, preventability.

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