Spontaneous adverse drug reaction monitoring in oncology: Our experience.

ABSTRACT

BACKGROUND: Adverse drug reaction (ADR) monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. MATERIALS AND METHODS: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted demographics, premedication (if any), diagnosis, chemotherapy (regimen, cycles), medication history, and alteration in the treatment or co morbidities, ADRs (severity and management). Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. RESULTS: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52%) followed by pyrimidine antagonists (19.88%). The most common malignancy reported in our hospital was Carcinoma breast (20%) followed by leukemia (12%) and Ca ovary (12%). Alopecia (27.76%) was the most common ADR followed by anemia (7.48%), thrombocytopenia (6.96%) and constipation (6.16%). CONCLUSION: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.