ASSESSMENT OF CAUSALITY, SEVERITY AND PREVENTABILITY OF ADVERSE DRUG REACTIONS OF CANCER CHEMOTHERAPY IN A TERTIARY CARE TEACHING HOSPITAL, GUJARAT, INDIAAbstract
Background: To evaluate the various adverse drug reactions with different cancer chemotherapy regimens, severity, causality assessment and preventability. Methods: This cross-sectional, observational study was carried out in the oncology department at a tertiary care teaching hospital over a period of one year. Data on Adverse Drug Reactions (ADRs) of anticancer drugs were collected of cancer patients diagnosed by a concerned clinician from the oncology department. These ADRs were assessed for causality using Naranjo’s probability scale. The severity and preventability of the reported reactions were assessed using the modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. Data were analyzed using Descriptive Statistics and Microsoft Excel. Results: Out of 683 ADRs recorded from 198 patients, m/c ADRs were alopecia (21.08%), n/v (17.27%) & nail pigmentation (11.56%), etc. Taxanes, Platinum compounds, Nitrogen mustards, Antibiotics, and Antimetabolites were the most common group of drugs causing ADRs. On Causality Assessment showed highest ADRs were “possible” (49.34%), “probable” (47.58%) & few were “doubtful” (3.07%). Severity Assessment showed a majority of the ADRs belonged to “mild” grade (91.21%), then “moderate” (8.05%) & “severe” (0.73%). It was observed that most of the ADRs were “Not Preventable” (57.83%), “Probably Preventable” (24.3%) & lastly “Definitely Preventable” (17.86%). Conclusions: The study shows that most of ADRs due to anticancer drugs belonged to “possible” grade as per Causality assessment, “mild” as per Severity Assessment, and “Not Preventable” as per Preventability Assessment.