PHARMACOVIGILANCE STUDY OF ANTICANCER DRUGS IN A DISTRICT GOVERNMENT HOSPITAL OF CENTRAL INDIA: A PROSPECTIVE OBSERVATIONAL STUDY

ANERI PATEL; ANJALI KUSHWAH

doi:10.22159/ijcpr.2025v17i4.54590

Authors

ANERI PATEL Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore, Madhya Pradesh, India https://orcid.org/0009-0009-4084-747X
ANJALI KUSHWAH Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore, Madhya Pradesh, India

DOI:

https://doi.org/10.22159/ijcpr.2025v17i4.54590

Keywords:

Anticancer drugs, Pharmacovigilance, Adverse drug reactions, World Health Organization-Uppsala Monitoring Centre scale

Abstract

Objective: Anticancer drugs are responsible for most adverse drug reactions (ADRs) in cancer patients worldwide. ADR reporting of anticancer drugs is sporadic in India, especially in rural areas, due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India (PvPI). This study assessed the causality and severity pattern of ADRs with anticancer drugs in cancer patients.

Methods: An observational, prospective, and single-center study was conducted at the oncology unit of the District Government Hospital, Jhabua, of Madhya Pradesh. Patients of either sex, aged>18 y, reporting ADRs with anticancer drugs from April 1, 2024, to July 31, 2024, were included. The analysis focused on demographic data of the patients, suspected drugs, causality assessment using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, and severity assessment.

Results: The age group of 41-60 y (61%) and females (68%) reported the highest number of ADRs. The maximum number of ADRs was reported with the use of platinum compounds (cisplatin, carboplatin, and oxaliplatin) (34%), followed by taxanes (paclitaxel and docetaxel) (28%). The gastrointestinal system (39.38%) was the most commonly involved, and nausea (20.33%) was the most common ADR among all. The majority of ADRs were certain (76%) and mild (48.36%).

Conclusion: ADR reporting, monitoring, and timely management are important to increase the outcome of anticancer treatment. It’s important to increase awareness regarding PvPI among healthcare professionals and patients.

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References

1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-63. doi: 10.3322/caac.21834, PMID 38572751.

2. Jokhadze N, Das A, Dizon DS. Global cancer statistics: a healthy population relies on population health. CA Cancer J Clin. 2024 May-Jun;74(3):224-6. doi: 10.3322/caac.21838, PMID 38572764.

3. Sathishkumar K, Chaturvedi M, Das P, Stephen S, Mathur P. Cancer incidence estimates for 2022 and projection for 2025: result from national cancer registry programme India. Indian J Med Res. 2022 Oct-Nov;156(4&5):598-607. doi: 10.4103/ijmr.ijmr_1821_22, PMID 36510887, PMCID PMC10231735.

4. Geneva Switzerland world health organization meeting on international drug monitoring: the role of national centres; 1971 and world health organization. International drug monitoring: the role of national centres report of a WHO meeting. World Health Organization; 1972. Available from: https://iris.who.int/handle/10665/40968.

5. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 3;329(7456):15-9. doi: 10.1136/bmj.329.7456.15, PMID 15231615, PMCID PMC443443.

6. Shukla S, Sharma P, Gupta P, Pandey S, Agrawal R, Rathour D. Current scenario and future prospects of adverse drug reactions (ADRs) monitoring and reporting mechanisms in the rural areas of India. Curr Drug Saf. 2024;19(2):172-90. doi: 10.2174/1574886318666230428144120, PMID 37132145.

7. The use of the WHO-UMC system for standardised case causality assessment. Available from: https://www.who.int/docs/default-source/medicines/pharmacovigilance/whocausality-assessment.pdf. [Last accessed on 25 Apr 2025].

8. Kumar R SR, Jindal A SR, Garg P, Kaur A, Kumar S, Tilak Raj R. Pharmacovigilance study of anticancer drugs in a Tertiary Care Teaching Hospital in North India: a retrospective study. Cureus. 2023 Sep 10;15(9):e44984. doi: 10.7759/cureus.44984, PMID 37822427, PMCID PMC10562879.

9. Prasad A, Datta PP, 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 Pharmacovigilance. 2013 Feb 8;1(2):107.

10. Giri K, Palandurkar K, Giri R, Agrawal U. A retrospective pharmacovigilance analysis at tertiary care hospital: an observational study. Asian J Pharm Clin Res. 2022 Aug 7;15(8):51-6. doi: 10.22159/ajpcr.2022.v15i8.45019.

11. Soldin OP, Chung SH, Mattison DR. Sex differences in drug disposition. J Biomed Biotechnol. 2011 Feb 23;2011:187103. doi: 10.1155/2011/187103, PMID 21403873, PMCID PMC3051160.

12. Mandal A, Gangopadhyay T, Mandal S. Drug utilization study in a radiotherapy unit of a Tertiary Care Teaching Hospital in Rural West Bengal, India. Asian J Pharm Clin Res. 2022 Nov 7;15(11):126-30. doi: 10.22159/ajpcr.2022.v15i11.45709.

13. Mathur DR, Vohra DA, Jain DS, Malhotra DH. Assessment of pattern of adverse drug reactions from anti-cancer drugs in a Tertiary Care Hospital: a cross-sectional study. IJMSCRR. 2022 Aug 31;5(4):263-8.

14. 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. 2010 Jun 25;8(1):11-6. doi: 10.3329/dujps.v8i1.5330.

15. Datta S, Zosangpuii C, Ningthoujam G, Paonam SD, Leisangthem TD, Nameirakpam MD. A retrospective study on adverse drug reactions of anticancer drugs in a Tertiary Care Hospital in Northeast India. J Clin Diagn Res. 2021;15(11): FC01-FC05. doi: 10.7860/JCDR/2021/51095.15687.

16. Sunny S, Thampi A, JJ, Shetty N, Babasahib SK, Chacko C. Assessment of adverse effects of most commonly prescribed anticancer drugs in a Tertiary Care Teaching Hospital. IJOPP. 2018;10(4):270-5. doi: 10.5530/ijopp.10.4.55.

17. 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 Jan-Mar;37(1):42-6. doi: 10.4103/0971-5851.177015, PMID 27051157, PMCID PMC4795375.