Adverse drug reactions monitoring among breast cancer patients in a tertiary care teaching hospital
Keywords:ADR, Pharmacovigilance, Breast cancer, Anticancer drugs
Background: Breast cancer is responsible for 13% of deaths among women globally. The present study aimed to assess adverse drug reactions (ADRs) in breast cancer patients receiving treatment in a tertiary care teaching hospital.
Methods: This retrospective and descriptive study was conducted in the oncology department at sree mookambika institute of medical sciences, Kulasekharam, covering six months from May 2022 to November 2022. The study includes patients of any age diagnosed with breast cancer, treated with chemotherapy, and who developed at least one ADR during or after treatment. Patients who developed ADRs due to fresh blood or blood product infusion and had a history of drug abuse or accidental poisoning were excluded from the study.
Results: Three hundred fifty-eight breast cancer patients were evaluated, of which 142 developed ADRs. The study revealed that breast cancer was most prevalent among women aged 41-50. Seven (4.92%) had a history of tobacco smoking, 129 (90.85%) patients were married, and only 13 (9.15%) were unmarried. The most commonly prescribed chemotherapeutic drug for breast cancer patients was docetaxel (19.01%), Cyclophosphamide (15.49%) and nab. paclitaxel (12.67%). The study found that the most frequent ADR observed among the patients was febrile neutropenia (18.30%), followed by nausea and vomiting 14.79%). Causality assessment reported that 61.27% (87) of the ADRs were probable, and 29.58% (42) were possible.
Conclusions: Spontaneous adverse drug reporting and structured management are essential for monitoring the safe use of drugs. The findings suggest the need for effective pharmacovigilance programs and improved patient care in administering chemotherapeutic agents.
Naito Y, Kai Y, Ishikawa T, Fujita T, Uehara K, Doihara H et al. Chemotherapy-induced nausea and vomiting in patients with breast cancer: a prospective cohort study. Breast Cancer. 2020; 27:122-8.
Assi S, Torrington E, Cheema E, Hamid AA. Adverse drug reactions associated with chemotherapeutic agents used in breast cancer: Analysis of patients' online forums. J Oncol Pharm Pract 2021; 27:108–18.
Koliyakodu PS, Sudhakar R, Kurian MM, Jishnu RK, Kumar R, Lalitha L et al. A prospective observational study on evaluation of chemotherapy-induced adverse drug reactions in cancer patients in a tertiary care hospital. Ind J Pharm Pr. 2021;14:2-8.
Surendiran A, Balamurugan N, Gunaseelan K, Akhtar S, Reddy KS, Adithan C. Adverse drug reaction profile of cisplatin-based chemotherapy regimen in a tertiary care hospital in India: An evaluative study. Indian J Pharmacol. 2010;42:40-3.
Behera SK, Kishtapati CR, Gunaseelan V, Dubashi B, Chandrasekaran A, Selvarajan S. Chemotherapy-induced adverse drug reactions in cancer patients in a tertiary care hospital in south India. J Young Pharm 2017;9:593-7.
Aghamohammadi H, Shrestha S, Kavousi S, Milton B. Assessment of prescribing pattern of chemotherapy drugs and monitoring of adverse drug reaction in cancer patients. Int J Pharm Sci Invent. 2019;8:42-51.
Chopra D, Rehan HS, Sharma V, Mishra R. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey. Indian J Med Paediatr Oncol. 2016;37:42-6.
Balkhi B, Alqahtani S, Altayyar W, Ghawaa Y, Alqahtani Z, Alsaleh K et al. Drug utilization and expenditure of anticancer drugs for breast cancer. Saudi Pharm J. 2020;28:669-74.
Li M, Han M, Chen Z, Tang Y, Ma J, Zhang Z et al. Does marital status correlate with the female breast cancer risk? A systematic review and meta-analysis of observational studies. PLoS One. 2020;15:e0229899.
Nath L, Choudhury U, Lahkar M. A Study about the pattern of adverse effects of various oncology drugs in a Tertiary Care Hospital of North East India. Res J Pharmacol Pharmacodyn. 2022;14:208-12.
Belachew SA, Erku DA, Mekuria AB, Gebresillassie BM. Pattern of chemotherapy-related adverse effects among adult cancer patients treated at Gondar University Referral Hospital, Ethiopia: a cross-sectional study. Drug Healthc Patient Saf. 2016;8:83-90.
Sharma A, Kumari KM, Manohar HD, Bairy KL, Thomas J. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India. Perspect Clin Res. 2015;6:109.
Wahlang JB, Laishram PD, Brahma DK, Sarkar C, Lahon J, Nongkynrih BS. Adverse drug reactions due to cancer chemotherapy in a tertiary care teaching hospital. Ther Adv Drug Saf. 2017;8:61-6.