Objective: To evaluate the pattern of adverse drug reactions (ADRs) reported in cancer patients receiving anticancer drugs in an adverse drug reaction monitoring centre (AMC). Methods: The anticancer drug related ADRs received in AMC through spontaneous reporting and active surveillance methods from January 2014 to June 2016 were analyzed for demographic profile, organ system and department wise distribution of ADRs, common ADRs encountered, drugs responsible for causing ADRs, ADRs reported by healthcare professionals, number of ADR/ ADRs developed per patient and causality assessment of reported ADRs. Descriptive statistics were used for analysis and the values were expressed in numbers and percentages. Results: 2209 ADRs were reported from 1869 patients comprising of 764 males (40.88%) and 1105 females (59.12%). In our study, the most common ADRs observed were anemia (12.68%), neuropathy (11.18%) and neutropenia (6.07%). Causality assessment of ADRs by WHO-UMC causality scale revealed that 90.9% of ADRs were possible followed by 4.48% probable and 2.39% possible. The most common organ system wise classified ADRs were blood (24.22%) related reactions followed by gastrointestinal system (14.17%) related adverse effects. The most common drugs associated with ADRs were imatinib (13.94%) followed by docetaxel (9.55%), gemcitabine (8.56%) and paclitaxel (7.38%). Amidst 1869 patients, 301(13.63%) patients had developed two ADRs while 39 (1.76%) patients experienced three ADRs. Conclusion: The average ADR encountered per patient due to anticancer drug was about 1.18 in this study. Anemia, neuropathy and neutropenia were the most common ADRs reported.

Key words: Anticancer drugs, Chemotherapy, Tertiary care hospital, ADR monitoring centre (AMC).

Sapan Kumar Behera

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