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Current Drug Safety

Author(s): Ravi Thakur, Jagminder Kaur Bajaj, Archana Dutta and Shabir Sidhu*

DOI: 10.2174/1574886317666220216100515

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Retrospective Observational Study to Evaluate Causality, Preventability and Severity of Adverse Drug Reaction Associated with Anticancer Drugs in a Tertiary Care Hospital in Northern India

Page: [335 - 343] Pages: 9

  • * (Excluding Mailing and Handling)

Abstract

Background: Chemotherapy has high efficacy, but it is associated with several adverse drug reactions (ADRs).

Objectives: A retrospective observational study to explore the prevalence, causality, and preventability of ADRs of anticancer agents was conducted.

Methods: The study was carried out at Punjab Institute of Medical Sciences Jalandhar, Punjab after obtaining IEC approval. The data was collected from cancer patients undergoing treatment at the hospital. The causality assessment of the collected data was done by using WHO causality assessment criteria. The preventability and severity of the reported ADRs were also assessed.

Results: From 50 medical records, a total of 47 ADRs were recorded among 25 patients, out of which 16 were females and the rest were males. The cancer cases observed were breast carcinoma, leukaemia, lung, colon, and ovarian cancer. The highest number of ADRs were observed with alkylating agents, followed by taxanes, antimetabolites, kinase inhibitors, and monoclonal antibodies. The most affected organ systems were the gastrointestinal system, blood, and lymphatic system. According to the causality assessment, the majority of the ADRs were of the "possible" category. Preventability analysis showed that 85.11% of ADRs were unavoidable reactions, while 14.89% of ADRs were possibly avoidable. Severity analysis of ADRs showed that 87.23% of ADRs were mild and 12.77% were of moderate severity. The majority of the ADRs were unavoidable and mild to moderate in severity.

Conclusion: Since the majority of the ADRs were of the unavoidable category, it indicates that the treatment regimens are acceptable as per the current clinical management of cancer patients.

Keywords: Pharmacovigilance, causality assessment, adverse drug reactions, chemotherapy, preventability assessment, severity assessment.

Graphical Abstract

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