Incidence of Adverse Drug Reactions in Patients on Cancer Chemotherapy in a Tertiary Care Teaching Hospital

ABSTRACT To assess the incidence of ADRs and their causal relationship to chemotherapeutic agents and to evaluate the severity and preventability of the ADRs. Patients above 18 years of age, on cancer chemotherapy were included. ADRs experienced by patients were identified and categorized using National Cancer Institute Common Terminology Criteria version 3.0 Questionnaire. The causality assessment of suspected ADRs was done using WHO and Naranjo's scales, severity assessment of ADRs using Hartwig and Siegel scale and preventability of ADRs using Schumock and Thornton scale. Results: The study was conducted in 109 patients (46 males, 63 females; mean age 53.75±12.75 years). Majority of the patients had breast cancer. Dry mouth and taste disturbances, were major ADRs found in 82.50% patients, dermatological ADRs alopecia, eczema and acne in 68.80%, hematological ADRs in 52.20%, and the least were the constitutional symptoms and renal ADRs (9.10% each). Causality assessment of ADRs using WHO scale identified 70.50% ADRs as Possible, 25.9% as Probable and only 1 ADR had a "Certain" causal link with the drug. Naranjo scale identified 61.4% ADRs as Probable, 36.6% as Possible and only one ADR had a "Definite" causal link with the drug. Severity assessment showed 65.90% as mild, 34.86% as moderate and none as severe ADRs. Nausea, vomiting, anorexia, fever, decrease in hemoglobin and neutrophil count were definitely preventable, diarrhea and constipation were probably preventable and the rest were not preventable. By implementing the ADR monitoring and reporting system, safe use of medications can be achieved

Assessment of quality of life of cancer patients in a tertiary care hospital of South India

Background: Quality of Life (QOL) measures have now become a vital part of health outcome appraisal and an effective way of capturing the personal and social context of patients. Aim: To assess the QOL of cancer patients by using a validated questionnaire. Settings and Design: A prospective study in the medical oncology clinic of a tertiary care hospital of South India. Materials and Methods: Patients receiving chemotherapy for different types of cancer were subjected to a validated questionnaire and their responses to the factors of the questionnaire were scored and analyzed. A Chi-square test was performed to assess the effect of age and type of cancer on the QOL of patients. Pearson′s correlation was done to assess the factors that had greater influence on the QOL. Results: A total of 32 (15 males; 17 females) patients were included and majority were in the age range of 61-80 years. Eleven types of cancer were identified. About 56% of the patients were assessed to have average QOL and 28% had below average QOL, 9% had above average, and 2 (6.25%) had significantly high QOL. The overall mean QOL score of the study population was 122.38 ± 13.86. Factors 1 (psychological well-being), 2 (self-adequacy), 3 (physical wellbeing), 4 (confidence in self-ability), 6 (pain), 7 (mobility), and 8 (optimism and belief) had significant influence on the QOL, while factors 5 (external support), 9 (interpersonal relationship), and 10 (self-sufficiency and independence) did not have a significant effect on QOL. Age (P=0.396) and type of cancer (P=0.371) did not have a significant effect on the QOL. Conclusion: The study showed that 80% of the total study population reported to have average and below average QOL, suggesting that an increasing importance is given to the incorporation of Quality of Life as an outcome, in addition to other clinical endpoints