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Hassan Abdelwahab, Vithya T.*, Dr. Shankar Prasad, Vidya Shree M.


OBJECTIVES: To determine the prevalence, nature, probability, severity and preventability of ADRs in a hospital settings. METHODOLOGY: A prospective, observational study was conducted in the Medicine and Pediatrics wards, between December 2013 and August 2014. All in-patients who experienced an ADR and admissions due to an adverse drug event were included in the study. Probability (Narinjo and WHO-UMC scales), severity (Hartwig et al scale) and preventability (Shumock and Thornton preventability scale) were assessed. RESULTS: Over the study period of 9 months, a total of 153 ADRs were reported in 94 patients in which [7(4.57%)] were ADRs induced hospital admission. ADRs were higher in patient in the age group of 61-70 years [34(22.22%)], female predominance of gastro – intestinal reactions [72(47.05%)] was observed. Therapeutic classes of drugs frequently associated with ADRs were anti-microbial agents [57(37.25%)] followed by antihypertensive agents [11(7.18%)]. The most common drugs involved in causing ADRs were ceftriaxone and tramadol. The most commonly reported ADR was vomiting [23(15.03%)]. Of the 153 ADRs, [132(86.27%)] was probable and [11(7.18%)] was possible, [15(9.8%)] of the ADRs were possible and [10(6.53%)] were certain. Majority of the ADRs were of moderate severity [145(94.77%)]. Of the 153 ADRs, [17(11.11%)] were preventable and [35(22.87%)] of the ADRs were not preventable. Majority of the ADRs [117(76.47%)] were managed without withdrawing the suspected drug. A recovery rate of (95.43%) was achieved. Conclusion: The importance of adverse reactions is often underestimated. They are common and can be life threatening and unnecessarily expensive. Vigilance by clinicians in detecting, diagnosing and reporting adverse reactions is important for continued drug safety monitoring.

Keywords: Adverse drug reaction, Monitoring, Hospital.

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