Main Article Content

Abstract

Aims


To assess the pattern of adverse drug reactions in patients receiving cisplatin based cancer chemotherapy in tertiary care cancer institute.


Materials and Methods


A prospective, observational study was carried out from February 2014 to march 2015 after getting an approval from human ethical committee. Clinical and treat­ment data were collected from patients who underwent cisplatin based chemotherapy during the study period. Central Drugs Standard Control Organization (CDSCO) forms was used to record the adverse drug reactions (ADRs). The ADRs were assessed for causality, severity, preventability and predictability by suitable scales.


Result


During the study period, a total of 163 ADRs were reported from 54 patients received cisplatin based chemotherapy. Out of them 23(42.59%) were males and 31(57.41%) were females. Prevalence of oral cancer (44.4%) and cervical cancer (20.37%) were higher. Most of ADRs were associated with gastrointestinal system (57.83%).Vomiting 39(72.2%) was most frequent ADR reported. Other ADRs observed were nausea, alopecia, diarrhea, bone marrow depression, constipation, numbness, mucositis.


Conclusion


Cisplatin is one of the most widely used anticancer drug and has a high potential to cause various adverse effects in cancer patients. Gastrointestinal ADRs were much more frequent than others. Most of the reactions were probably preventable with use of premedication.

Keywords

Cisplatin Adverse drug reactions (ADRs) Central Drugs Standard Control Organization (CDSCO).

Article Details

How to Cite
BK Mangal, P Agrawal, V Kushwaha, S Singh, A Gupta, & A Singh. (2021). Pattern of adverse drug reactions of cisplatin based drug regimen in a tertiary care cancer institute. International Journal of Research in Pharmacology & Pharmacotherapeutics, 5(1), 1-7. https://doi.org/10.61096/ijrpp.v5.iss1.2016.1-7

References

  1. [1]. Smith DL .The effect of patient non- compliance on health care costs. Med Interface. 6, 1993, 74-84.
  2. [2]. WHO 1972, International drug monitoring. Role of national centres. WHO Technical report series no. 498. Geneva, Switzerland. [Accessed 2012 Sep 20]. Available from: http://who-umc.org/graphics/24756.pdf.
  3. [3]. World Health Organization Collaborating Center for International Drug Monitoring. The importance of Pharmacovigilance. Safety monitoring of medicinal products. Geneva: World Health Organization, 2002.
  4. [4]. World Health Organization. Safety monitoring of medicinal products. Guidelines for setting up and running a Pharmacovigilance centre. [Accessed on 2008 Dec 31].Available from: http://www.who-umc.org/graphics/4807.pdf.
  5. [5]. WHO. Safety of Medicines. A Guide to detecting and reporting adverse reactions. Why health professionals need to take action. WHO/ EDM/QSM/2002.2
  6. [6]. Adithan C. National pharmacovigilance programme. Indian J Pharmacol. 37, 2005, 347.
  7. [7]. Aggarwal SK. Calcium modulation of toxicities due to Cisplatin. Met Based Drugs. 5, 1998, 77–81.
  8. [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. 279, 1998, 1200–5.
  9. [9]. The use of the WHO–UMC system for standardized case causality assessment. [Accessed 2014 Aug 21]. Available at http://www.who-umc.org/graphics/4409.Pdf.
  10. [10]. Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 27, 1992, 538.
  11. [11]. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 49, 1992, 2229–32.
  12. [12]. 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. Ind J Pharmacol. 42(1), 2010, 40–43.
  13. [13]. Poddar S, Sultana R, Sultana R, Akbor MM, Azad MA, Hasnat A. Pattern of adverse drug reactions due to cancer chemotherapy in tertiary care teaching hospital in Bangladesh. Dhaka Univ J Pharm Sci. 8(1), 2009, 11–16.
  14. [14]. Sasmi MB. Adverse drug reaction profile of cisplatin-based chemotherapy regimen in a tertiary care hospital in India. Int J Basic Clin Pharmacol. 4(6), 2015, 1214-1219.
  15. [15]. Bahl A, Sharma DN, Julka PK, Rath GK. Chemotherapy related toxicity in locally advanced non-small cell lung cancer. J Cancer Res Ther. 2(1), 2006, 14-6.