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CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2016; 37(01): 42-46
DOI: 10.4103/0971-5851.177015
ORIGINAL ARTICLE

Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

Deepti Chopra
Department of Pharmacology, Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, New Delhi, India
,
Harmeet Rehan
Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India
,
Vibha Sharma
Department of Pharmaceutical Chemistry, Fixed Dose Division, CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi, India
,
Ritu Mishra
Department of PMSO, Cognizant Technology Solutions Pvt Ltd., Mindspace, Airoli, Mumbai, Maharashtra, India
› Institutsangaben Financial support and sponsorship Nil.
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Abstract

Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs). The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013) were studied. These reports were analyzed for various carcinomas under treatment, medications used, types of ADRs, organ system involvement, severity, causality assessment, and preventability. Results: Over a period of 2 years, a total 591 cases were received with an incidence of 58.6%. The prevalence of ADRs was more in female patients (73.6%) as compared to men. ADRs mostly occurred in the age group of 41-50 years (27.4%). Patients treated for breast carcinoma (39.1%) reported the highest incidence of ADRs. Cisplatin (19.6%) was found to be the most common offending drug. The most common ADR reported was nausea and vomiting (23%). Gastroenterology (40.1%) was the most affected system. About 50.2% of the ADRs required treatment and 12.9% ADRs were considered serious. Causality assessment revealed that 80% of the ADRs were possible. About 86.97% cases were found to be mild, and 51% were not preventable. Conclusion: The success of chemotherapy comes with the word of caution regarding toxicities of antineoplastic drugs. Pharmacovigilance of these drugs needs to be explored, and use of preventative measures needs to be enhanced in order to reduce the incidence and severity of ADRs.

Keywords

Adverse drug reaction - antineoplastic drugs - chemotherapy - oncology - pharmacovigilance


Publikationsverlauf

Artikel online veröffentlicht:
12. Juli 2021

© 2016. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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  • References

  • 1 Chabner BA, Amrein PC, Druker BJ. Antineoplastic agents. In: Bruntan LL, Lazo JS, Parker KL, editors. Goodman and Gilman′s The Pharmacological Basis of Therapeutics. 11 th ed. USA: MaGraw-Hill Companies, Inc.; 2006. p. 1315.
  • 2 Müller T. Typical medication errors in oncology: Analysis and prevention strategies. Onkologie 2003;26:539-44.
  • 3 Lau PM, Stewart K, Dooley M. The ten most common adverse drug reactions (ADRs) in oncology patients: Do they matter to you? Support Care Cancer 2004;12:626-33.
  • 4 Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The quality in Australian health care study. Med J Aust 1995;163:458-71.
  • 5 Mrugank BP and Hareesha RP: Prospective Observational, Non-Randomized, Parallel Sequence study for assessment of Adverse Drug Reactions due to Chemotherapeutic treatment in different types of Cancer patients. Int J Pharm Sci Res 2013;4;386-91.
  • 6 Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res 2006;54:226-33.
  • 7 Aagaard L, Strandell J, Melskens L, Petersen PS, Holme Hansen E. Global patterns of adverse drug reactions over a decade: Analyses of spontaneous reports to VigiBase™. Drug Saf 2012;35:1171-82.
  • 8 Couffignal AL, Lapeyre-Mestre M, Bonhomme C, Bugat R, Montastruc JL. Adverse effects of anticancer drugs: Apropos of a pharmacovigilance study at a specialized oncology institution. Therapie 2000;55:635-41.
  • 9 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.
  • 10 Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32.
  • 11 Safety of Medicines. Available from: http://www.whqlibdoc.who.int/hq/2002/.WHO_EDM_QSM_2002.2.pdf. [Last accessed on 2015 Jan 02].
  • 12 Poddar S, Sultana R. Pattern of adverse drug reactions due to cancer chemotherapy in tertiary care teaching hospital in Bangladesh. Dhaka Univ J Pharm Sci 2009;8:11-6.
  • 13 Kirthi C, Afzal A, Reddy M, Ali SA, Yerramilli A, Sharma S. A study on the adverse effects of anticancer drugs in an oncology center of a tertiary care hospital. Int J Pharm Pharm Sci 2014;6:580-3.
  • 14 Miller MA. Gender-based differences in the toxicity of pharmaceuticals - The food and drug administration′s perspective. Int J Toxicol 2001;20:149-52.
  • 15 Mallik S, Palaian S, Ojha P, Mishra P. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care teaching hospital in Nepal. Pak J Pharm Sci 2007;20:214-8.
  • 16 Prasad A, Pratim PD, Bhattacharya J, Pattanayak C, Chauhan AS, Panda P. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care teaching hospital in Eastern India. J Pharmacovigil 2013;1:107.
  • 17 A De. Monitoring of suspected adverse drug reactions in oncology unit of an urban multispeciality teaching hospital. Int J Res Pharm Biomed Sci (online) 2010;1:1-32.