ADVERSE DRUG REACTIONS IN HIGH RISK PATIENTS- A PROSPECTIVE OBSERVATIONAL STUDY IN THE DEPARTMENT OF MEDICAL ONCOLOGY

Author(s)

Simhadri K1, George SS1, K Viswam S2, Koonisetty KS1
1M S Ramaiah University of Applied Sciences, Bengalore, India, 2M.S. Ramaiah University of Applied Sciences, Bangalore, India

OBJECTIVES: To detect, report, assess and document the ADRs associated with chemotherapy in geriatric patients.

METHODS: A hospital based prospective observational study was carried out among 153 inpatients in the department of medical oncology for a period of 6 months. Patients above 60 years of age with confirmed history of malignancy were included in the study. The potential risk factors for ADR were defined in relation to patient and chemotherapeutic regimen. The relationship between those risk factors and ADRs was assessed by univariate and multi variate logistic-regression analysis.

RESULTS: A total of 136 ADRs were observed in 94 patients, the mean age of the study population was 64.75±4.97 years among which females accounted for majority of the ADRs (60.64%). The organ systems mostly affected were found to be Gastrointestinal system (44.85%) (OR=1.358; 95% CI 0.69-2.64 p<0.001) followed by dermatologicals (30.15%) (OR=1.50; 95% CI 0.63-3.56 p<0.001) and immune system (17.65%) (OR=2.27; 95% CI 0.9-5.7 p<0.001). The most commonly reported ADR was found to be alopecia (30.15%) followed by diarrhoea (28.68%), vomiting (14.8%), neutropenia (7.35%), myelosupression (3.68%) and nephrotoxicity (2.94%). Cyclophosphamide (OR= 2.98 95%CI 1.26-7.07 p<0.001), Carboplatin (OR=13.359; 95%CI 3.056-58.406 p<0.001) 5 Fluoro Uracil (OR= 1.938 95%CI 1.266-2.935 p< 0.001) and Adriamycin (OR=16.45; 95% CI 2.41-112.22 p<0.001) were found to be the most significant drugs causing ADRs. Assessment of causality by WHO causality assessment scale indicated that 97% of the reactions were 'probable' and 1% was 'possible'. In one patient with cisplatin induced hypersensitivity reaction, rechallenge was attempted and the causality was made as ‘certain’.

CONCLUSIONS: Individualizing drug therapy, implementation of preventive measures will lead to reduction in the severity of ADRs and thereby reduce the economic burden to the patient and helps to improve the treatment outcome. Knowing the commonly occurring ADRs will aid the practitioner in early detection of ADRs.

Conference/Value in Health Info

2018-09, ISPOR Asia Pacific 2018, Tokyo, Japan

Value in Health, Vol. 21, S2 (September 2018)

Code

PCN3

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Oncology

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×