Title: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
Volume: 17
Issue: 4
Author(s): Ravi Thakur, Jagminder Kaur Bajaj, Archana Dutta and Shabir Sidhu*
Affiliation:
- Department of Food Science and Technoloogy, Main Campus IK Gujral Punjab Technical University, Kapurthala, Punjab, India
Keywords:
Pharmacovigilance, causality assessment, adverse drug reactions, chemotherapy, preventability assessment, severity assessment.
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.
