Published: 2017-07-22

Pharmacovigilance in cancer chemotherapy in regional cancer center of Eastern India: prospective observational study

Anima Rout, Rajendra K. Panda, Vedvyas Mishra, Prasant Parida, Srikant Mohanty


Background: Globally cancer is the leading cause of morbidity and mortality with annual death rate of 12%. According Indian Council of Medical Research, more than 1300 Indians die every day due to cancer. Chemotherapy is one of the multimodal approaches for treatment of cancer and regimens are much complex and cancer patients are more susceptible to adverse drug reaction with little tolerance due to diminished immunity. The present study was done to evaluate the prevalence of various adverse drug reactions with different cancer chemotherapy regimens, their nature and severity as well as their causality assessment as per WHO scale.

Methods: This prospective observational study was conducted from July 2015 to June 2016. Patients receiving cancer chemotherapy from regional cancer centre, Cuttack were observed during the study period for the adverse drug reactions. Those ADRs were analysed for causality assessment, severity and preventability.

Results: It was observed that after the initiation of chemotherapy, ADRs were observed in 92 (88.46%) patients. Among these 329 observed ADRs, during the study period, female predominance was observed in the age group 51-60yrs. Most common ADRs observed were nausea and vomiting 57 (17.37%), alopecia 46 (13.98%) and neutropenia 38 (11.55%). ADRs were most commonly seen with the haematological systems (37.68%) followed by gastrointestinal system amounting 25.22% of the total ADRs. Platinum Compound (58.35%), followed by antibiotics, antimetabolites, were the most common group of drugs causing different adverse drug reactions. On causality assessment, as per WHO-UMC criteria 68.38% were probable and 31.62% ADRs were possible. Severity assessment showed majority of the ADRs were moderate 228 (69.31%) followed by mild 67 (20.36%) and severe 34 (10.33%). It was observed that majority 212 (64.45%) of the ADRs were not preventable, 72 (21.88%) were definitely preventable and 45 (13.67%) were probably preventable.

Conclusions: Cancer chemotherapy has definitely improved the quality of life, but associated ADRs need early diagnosis, prompt management and routine reporting. Thus, pharmacovigilance will definitely reduce morbidity and mortality, so also the financial burden for the patients and society.


Adverse drug reaction, Anticancerous drugs, Chemotherapy induced, Pharmacovigilance

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