Scientific Analysis with a Retrospective Method on the Incidence and Severity of Adverse Drug Reactions in Hospitalized Cancer Patients

Authors

Diyah Wahyuni , Cinantya Meyta Sari , Budi Suprapti

DOI:

10.29303/jppipa.v10i9.8624

Published:

2024-09-25

Issue:

Vol. 10 No. 9 (2024): September : In Progress

Keywords:

ADRs, Adverse drug reaction, Antineoplastic drugs, Cancer, Pharmacovigilance

Research Articles

Downloads

How to Cite

Wahyuni, D., Sari, C. M., & Suprapti, B. (2024). Scientific Analysis with a Retrospective Method on the Incidence and Severity of Adverse Drug Reactions in Hospitalized Cancer Patients . Jurnal Penelitian Pendidikan IPA, 10(9), 6883–6892. https://doi.org/10.29303/jppipa.v10i9.8624
Crossref
Scopus
Google Scholar
Europe PMC

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Abstract

Adverse Drug Reactions (ADRs) often result from omissions or inadequate use of preventative measures, making them definitely or probably preventable. Discrepancies between clinical severity and patients' perceptions of ADRs' impact on their well-being highlight the need for targeted interventions. This study focused on the frequency, manifestations, and severity of ADRs from chemotherapeutic agents, utilizing a cross-sectional design with data from ADR reports spanning November 2021 to October 2023 at dr. Saiful Anwar General Hospital, Indonesia. A total of 177 ADRs were analyzed descriptively. Of these, 99 (55.93%) occurred in women, with the highest incidence in the 19–60-year age group (77.40%). The most common malignancies were Chronic Myeloid Leukemia (10.17%), Colorectal Malignancy, and Non-Hodgkin Lymphoma (9.60% each). ADRs related to chemotherapy constituted 41.80%, involving drugs such as cisplatin, oxaliplatin, afatinib, imatinib, and Doxorubicin. The severity distribution was 70.37% mild, 27.16% moderate, and 2.47% severe. Monitoring and reporting these ADRs are crucial for patient safety and preventing recurrence.

References

Athauda, A., Nankivell, M., Langley, R. E., Alderson, D., Allum, W., Grabsch, H. I., Starling, N., Chau, I., & Cunningham, D. (2020). Impact of sex and age on chemotherapy efficacy, toxicity and survival in localised oesophagogastric cancer: A pooled analysis of 3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03). European Journal of Cancer, 137, 45–56. https://doi.org/10.1016/j.ejca.2020.06.005

Califano, R., Tariq, N., Compton, S., Fitzgerald, D. A., Harwood, C. A., Lal, R., Lester, J., McPhelim, J., Mulatero, C., Subramanian, S., Thomas, A., Thatcher, N., & Nicolson, M. (2015). Expert Consensus on the Management of Adverse Events from EGFR Tyrosine Kinase Inhibitors in the UK. Drugs, 75(12), 1335–1348. https://doi.org/10.1007/s40265-015-0434-6

Charles, C., Bungener, C., Razavi, D., Mateus, C., Routier, E., Lanoy, E., Verschoore, M., Robert, C., & Dauchy, S. (2016). Impact of dermatologic adverse events induced by targeted therapies on quality of life. Critical Reviews in Oncology/Hematology, 101, 158–168. https://doi.org/10.1016/j.critrevonc.2016.03.003

Cheng, W. C., Lin, C. C., Liao, W. C., Lin, Y. C., Chen, C. H., Chen, H. J., Tu, C. Y., & Hsia, T. C. (2024). The difference between dacomitinib and afatinib in effectiveness and safety in first-line treatment of patients with advanced EGFR-mutant non-small cell lung cancer: a real-world observational study. BMC Cancer, 24(1), 1–11. https://doi.org/10.1186/s12885-024-11956-w

Choi, S.-E., & Kim, H.-S. (2012). Sodium Bicarbonate Solution versus Chlorhexidine Mouthwash in Oral Care of Acute Leukemia Patients Undergoing Induction Chemotherapy: A Randomized Controlled Trial. Asian Nursing Research, 6(2), 60–66. https://doi.org/10.1016/j.anr.2012.05.004

Cristina, V., Mahachie, J., Mauer, M., Buclin, T., Van Cutsem, E., Roth, A., & Wagner, A. D. (2018). Association of Patient Sex With Chemotherapy-Related Toxic Effects. JAMA Oncology, 4(7), 1003. https://doi.org/10.1001/jamaoncol.2018.1080

Datta, S., Zosangpuii, C., Ningthoujam, G., Paonam, S. D., Leisangthem, T. D., Nameirakpam, M. D., & Nameirakpam, S. S. (2021). A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India. Journal Of Clinical And Diagnostic Research. https://doi.org/10.7860/JCDR/2021/51095.15687

Davidson, M., Wagner, A. D., Kouvelakis, K., Nanji, H., Starling, N., Chau, I., Watkins, D., Rao, S., Peckitt, C., & Cunningham, D. (2019). Influence of sex on chemotherapy efficacy and toxicity in oesophagogastric cancer: A pooled analysis of four randomised trials. European Journal of Cancer, 121, 40–47. https://doi.org/10.1016/j.ejca.2019.08.010

Edwards, R., Andan, C., Lalla, R., Lacouture, M., O’Brien, D., & Sequist, L. (2018). Afatinib Therapy: Practical Management of Adverse Events With an Oral Agent for Non-Small Cell Lung Cancer Treatment. Clinical Journal of Oncology Nursing, 22(5), 542–548. https://doi.org/10.1188/18.CJON.542-548

Franconi, F., Campesi, I., Occhioni, S., Antonini, P., & Murphy, M. F. (2013). Sex and Gender in Adverse Drug Events, Addiction, and Placebo. In Handbook of Experimental Pharmacology (Vol. 214, Issue 214, pp. 107–126). https://doi.org/10.1007/978-3-642-30726-3_6

Freites-Martinez, A., Santana, N., Arias-Santiago, S., & Viera, A. (2021). CTCAE versión 5.0. Evaluación de la gravedad de los eventos adversos dermatológicos de las terapias antineoplásicas. Actas Dermo-Sifiliográficas, 112(1), 90–92. https://doi.org/10.1016/j.ad.2019.05.009

Gao, A., Zhang, L., & Zhong, D. (2023). Chemotherapy-induced thrombocytopenia: literature review. Discover Oncology, 14(1), 10. https://doi.org/10.1007/s12672-023-00616-3

Hirsh, V., Blais, N., Burkes, R., Verma, S., & Croitoru, K. (2014). Management of Diarrhea Induced by Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors. Current Oncology, 21(6), 329–336. https://doi.org/10.3747/co.21.2241

Korucu, F. C., Senyigit, E., Köstek, O., Demircan, N. C., Erdogan, B., Uzunoglu, S., & Cicin, I. (2018). A retrospective study on potential drug interactions: A single center experience. Journal of Oncological Sciences, 4(2), 80–84. https://doi.org/10.1016/j.jons.2018.06.001

Kumar, S., Badruddeen, B., S P, S., & Irfan Khan, M. (2018). A Prospective Study Of Adverse Drug Reactions Due To Platinum Analogs - Chemotherapy In A Tertiary Care Hospital. Asian Journal of Pharmaceutical and Clinical Research, 11(6), 215. https://doi.org/10.22159/ajpcr.2018.v11i6.24849

Kuter, D. J. (2022). Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies. Haematologica, 107(6), 1243–1263. https://doi.org/10.3324/haematol.2021.279512

Lavan, N., Burton, A. M., Scott, S. K., & McGettigan, C. (2019). Flexible voices: Identity perception from variable vocal signals. Psychonomic Bulletin & Review, 26(1), 90–102. https://doi.org/10.3758/s13423-018-1497-7

Maharani, L., & Yugatama, A. (2023). Prevalence of adverse drug reaction in Indonesia: A systematic review. Journal of Applied Pharmaceutical Science, 13(8), 55–67. https://doi.org/10.7324/JAPS.2023.91550

Monestime, S., Page, R., Jordan, W. M., & Aryal, S. (2021). Prevalence and predictors of patients reporting adverse drug reactions to health care providers during oral targeted cancer treatment. Journal of the American Pharmacists Association, 61(1), 53–59. https://doi.org/10.1016/j.japh.2020.09.001

Mugada, V., Ramineni, H., & Padala, D. (2017). 5-Fluorouracil induced severe febrile neutropenia and death. Journal of Young Pharmacists, 9(1), 133–134. https://doi.org/10.5530/jyp.2017.9.26

Öngören, Ş., Salihoğlu, A., Apaydın, T., Sadri, S., Eşkazan, A. E., Ar, M. C., Elverdi, T., Başlar, Z., Aydın, Y., & Soysal, T. (2018). Vincristine as an Adjunct to Therapeutic Plasma Exchange for Thrombotic Thrombocytopenic Purpura: A Single Institution Experience. Balkan Medical Journal, 35(6), 417–421. https://doi.org/10.4274/balkanmedj.2017.1215

Özdemir, B. C., Gerard, C. L., & Espinosa da Silva, C. (2022). Sex and Gender Differences in Anticancer Treatment Toxicity: A Call for Revisiting Drug Dosing in Oncology. Endocrinology, 163(6). https://doi.org/10.1210/endocr/bqac058

Patil, S., Rao, R. S., Majumdar, B., & Anil, S. (2015). Clinical Appearance of Oral Candida Infection and Therapeutic Strategies. Frontiers in Microbiology, 6(DEC). https://doi.org/10.3389/fmicb.2015.01391

Ruiz, J. N., Belum, V. R., Boers-Doets, C. B., Kamboj, M., Babady, N. E., Tang, Y.-W., Valdez, T. A., & Lacouture, M. E. (2015). Nasal vestibulitis due to targeted therapies in cancer patients. Supportive Care in Cancer, 23(8), 2391–2398. https://doi.org/10.1007/s00520-014-2580-x

Saber, M. M., Al-mahallawi, A. M., Nassar, N. N., Stork, B., & Shouman, S. A. (2018). Targeting colorectal cancer cell metabolism through development of cisplatin and metformin nano-cubosomes. BMC Cancer, 18(1), 1–11. https://doi.org/10.1186/s12885-018-4727-5

Sharma, P. K., Misra, A. K., Gupta, A., Singh, S., Dhamija, P., & Pareek, P. (2018). A retrospective analysis of reporting of adverse drug reactions to oncology drugs: An experience from a national center of clinical excellence. Indian Journal of Pharmacology, 50(5), 273–278. https://doi.org/10.4103/ijp.IJP-544-17

Soff, G. A., Ray-Coquard, I., Rivera, L. J. M., Fryzek, J., Mullins, M., Bylsma, L. C., & Park, J. K. (2022). Systematic literature review and meta-analysis on use of Thrombopoietic agents for chemotherapy-induced thrombocytopenia. PLOS ONE, 17(6), e0257673. https://doi.org/10.1371/journal.pone.0257673

Sunder, S. S., Sharma, U. C., & Pokharel, S. (2023). Adverse effects of tyrosine kinase inhibitors in cancer therapy: pathophysiology, mechanisms and clinical management. Signal Transduction and Targeted Therapy, 8(1). https://doi.org/10.1038/s41392-023-01469-6

Tian, F., Chen, Z., Zhou, D., & Mo, L. (2022). Prevalence of polypharmacy and potentially inappropriate medication use in older lung cancer patients: A systematic review and meta-analysis. Frontiers in Pharmacology, 13. https://doi.org/10.3389/fphar.2022.1044885

Wasano, K., Kawasaki, T., Hiraga, Y., Yamamoto, S., Tomisato, S., Hashimoto, Y., & Ogawa, K. (2017). Febrile Neutropenia in Patient with Head and Neck Cancer Treated with Docetaxel, Cisplatin and 5-fluorouracil (TPF Protocol). Practica Oto-Rhino-Laryngologica, 110(4), 287–293. https://doi.org/10.5631/jibirin.110.287

WHO. (2024). Global cancer burden growing, amidst mounting need for services. Retrieved from https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services

Yoon, S., Jeong, S., Jung, E., Kim, K. S., Jeon, I., Lee, Y., Cho, J.-Y., Oh, W.-Y., & Chung, J.-Y. (2021). Effect of CYP3A4 metabolism on sex differences in the pharmacokinetics and pharmacodynamics of zolpidem. Scientific Reports, 11(1), 19150. https://doi.org/10.1038/s41598-021-98689-z

Author Biographies

Diyah Wahyuni, Universitas Airlangga, Surabaya

Cinantya Meyta Sari, Universitas Airlangga, Surabaya

Budi Suprapti, Fakultas Farmasi, Universitas Airlangga, Surabaya

License

Copyright (c) 2024 Diyah Wahyuni, Cinantya Meyta Sari, Budi Suprapti

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Authors who publish with Jurnal Penelitian Pendidikan IPA, agree to the following terms:

  1. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution 4.0 International License (CC-BY License). This license allows authors to use all articles, data sets, graphics, and appendices in data mining applications, search engines, web sites, blogs, and other platforms by providing an appropriate reference. The journal allows the author(s) to hold the copyright without restrictions and will retain publishing rights without restrictions.
  2. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in Jurnal Penelitian Pendidikan IPA.
  3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).