Publication:

Study of prescription pattern and adverse drug reactions in patients with cervical cancer in tertiary care teaching institute

Background Cervical cancer is the second most common cancer in women especially in developing countries. In India, it is estimated that 1, 22, 644 new cases of cancer cervix occur every year. Incidence rate is 22 per lac population and mortality rate is 12.4 per lac population. The objective of this study was to study the prescription pattern and adverse drug reactions (ADRs) in patients with cervical cancer.

Methods Twenty five patients of cancer cervix Stage (IIa to IVb) receiving chemotherapy were enrolled in the study after written informed consent of patients. Approval was obtained from institutional ethics committee. It was cross sectional, observational study. Prescriptions were analysed for no. of drugs prescribed, time interval between two cycles, no. of cycles of chemotherapy. Any ADR observed by patient or treating physician was noted and causality was assessed by Naranjo’s algorithm. Preventability and severity of ADRs were assessed by modified Schumock and Thornton scale, modified Hartwig and Siegel scale respectively.

Results Twenty five patients were enrolled with mean age 52.24±8.66 years and mean weight 51.76±5.88 kg. 84% patients were on combination chemotherapy. Percentage of anticancer drugs prescribed were: cisplatin (72%); paclitaxel (40%); 5FU (36%); carboplatin (32%); gemcitabine (4%). Chemotherapeutic drugs were given at 3 weekly intervals for 6 cycles. ADR observed were nausea (76%), vomiting (40%), alopecia (32%), headache (12%), bodyache (12%), anorexia (12%), diarrhoea (8%) and malaise (4%). Causality assessment of ADR by Naranjo’s algorithm showed 89.8% probable and 10.2% possible reactions. According to modified Schumock and Thornton scale, 26.5% reactions are ‘not preventable’ however 73.5% are ‘definitely preventable’. According to modified Hartwig and Siegel scale, 75.5% were ‘mild level 1’severity however 24.5% were ‘moderate level 3’ severity.

Conclusions Among patients with CA cervix, cisplatin was most commonly prescribed drug. Nausea was most common ADR which is of ‘mild level 1’ severity.