Pattern of ADRs associated with various chemotherapeutic regimens at Oncology Department of Tertiary Care Teaching Hospital
2nd International Conference and Exhibition on Pharmacovigilance & Clinical Trials
November 18-19, 2013 Hilton San Antonio Airport, TX, USA

Srinivas V. J. Chakradhar, Pavani V. Sudhakar. Y. and J. Venkateshwar Rao

Accepted Abstracts: J Pharmacovigilance

Abstract:

Adverse drug reactions (ADRs) are the undesirable effects of the drug /medicinal product beyond its intended therapeutic effect when used for clinical purpose. The prospective observational study was aimed to evaluate the pattern of ADRs in hospitalised cancer patients at Mahatma Gandhi Memorial hospital, Warangal. The patients were interviewed from March to August 2012 about symptoms related to drug therapy. Detected and suspected ADRs were analysed for causality, severity, preventability and predictability using appropriate validated scales and were reported. Total 116 patients associated with hospitalizations were interviewed. A total of 439 ADRs were detected, documented, assessed and reported during the study period, the incidence was found to be 88.79%. The prevalence of ADRs mostly occurred in the age group between 41-50 years (30.75%) & most of the ADRs were seen in females (67.42%). Gastrointestinal system was the most commonly affected (54.44%); multiple drug therapy was identified as the major predisposing factor (39.65%). The possible ADRs according to WHO scale were 57.4% and according to Naranjo were 50.34%. The ADRs that are 58.08% were mild, 87% were preventable and 91.57% were predictable. The study was its kind and provided a baseline data regarding the safety profile of chemotherapeutic drugs in India. So, similar studies from different regions are needed to validate the findings of this study