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

Ankita Sunilrao Jire, Chaitali S. Bajait, Vijay K. Mahobia, Vijay M. Motghare


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.


Cancer cervix, Chemotherapy-prescription pattern, ADR

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Park K. Park’s Textbook of Preventive and Social Medicine. 23rd edition. Jabalpur: Banarasidas Bhanot; 2015:388.

Bergman U, Grimsson A, Wahba AHW, Westerholm B. Editors studies in drug utilization (methods and applications) Europian Series No. 8. WHO Regional Publications; 1979:1.

Srishyla MV, Krishnamurthy M, Nagarani MA, Andrade C, Venketaraman BV. Prescription audit in an Indian hospital setting using the DD concept. Indian J Pharmacol. 1994;26:23-8.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. J Am Med Assoc. 1998;279(15):1200-5.

Lee A, Thomas SHL. Adverse drug reactions. In: Roger Walker and Clive, Editors. Clinical Pharmacy and Therapeutics 3rd ed. Spain: Churchill Living; 2003:33-34.

Nerurkar RP, Nadkar MY, Bichile SK. Need for monitoring adverse drug reactions. J Assoc Physicians India. 1998;46:673-4.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239-45.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Jordan K, Sippel C, Schmoll HJ. Guidelines for antiemetic treatment of chemotherapy-induced nausea and vomiting: past, present, and future recommendations. Oncologist. 2007;12:1143-50.

Flake ZA, Scalley RD, Bailey AG. Practical selection of antiemetics. Am Fam Physician. 2004;69:1169-74.

Warr DG. Chemotherapy- and cancer-related nausea and vomiting. Curr Oncol. 2008;15:S4-9.

Yeager CE, Oslen EA. Treatment of chemotherapy induced alopecia. Dermatol Ther. 2011;24:432-42.

Pavey RA, Kambil SM, Bhat RM. Dermatological adverse reactions to cancer chemotherapy. Indian J Dermatol Venerol Leprol. 2015;81:434.

Yanez JA, Teng XW, Roupe KA, Fariss MW, Davies NM. Chemotherapy induced gastrointestinal toxicity in rats: Involvement of mitochondrial DNA, gastrointestinal permeability and cyclooxygenase -2. J Pharm Pharm Sci. 2003;6:308-14.