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A Prospective, Observational Study on Adverse Drug Reactions in Hospitalized Pediatric Cancer Patients in a Tertiary
Nancy Khajuria1, Nikhil Menia2, Seema Gupta1
1Department of Pharmacology and Therapeutics, Government Medical College, Jammu, Jammu and Kashmir, India.
Insights
Adverse drug reactions (ADRs) are common in children undergoing chemotherapy, affecting 44.44% of patients. Fever and vomiting were most frequent, highlighting the need for enhanced drug safety measures in paediatric oncology.
Area of Science:
- Pediatric Oncology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Adverse drug reactions (ADRs) are a significant global health concern, particularly in pediatric oncology due to the common use of unlicensed or off-label medications.
- These reactions critically impact treatment quality and patient safety in vulnerable pediatric populations.
Purpose of the Study:
- To investigate the incidence and characteristics of chemotherapy-related adverse drug reactions in pediatric cancer patients.
- To assess the severity and causality of these ADRs using validated scales like the NARANJO probability scale.
Main Methods:
- An observational, prospective study was conducted over three months at SMGS Jammu, in collaboration with GMC Jammu's Pharmacology Department.
- Forty-five children undergoing chemotherapy were monitored using spontaneous and intensive reporting systems for ADRs.
- Statistical analysis included Chi-Square and Fisher Exact tests.
Main Results:
- Twenty out of 45 pediatric patients (44.44%) experienced adverse drug reactions, with a higher incidence in females (55%).
- Fever and vomiting were the most frequently observed ADRs, predominantly of moderate severity.
- Methotrexate, Vincristine, L-asparaginase, and Cytarabine were commonly associated medications; no significant link was found between anticancer drug categories and ADRs.
Conclusions:
- The study underscores the prevalence of ADRs in pediatric cancer patients, especially those with acute lymphoblastic leukemia.
- Findings emphasize the substantial impact of ADRs and the critical need for vigilant monitoring and improved drug safety protocols in pediatric oncology.
Background:
Adverse drug reactions (ADRs) pose a major health concern worldwide, especially in paediatric oncology where unlicensed or off-label drugs are commonly used. These reactions can have a significant impact on the quality of treatment and the safety of patients, particularly in vulnerable paediatric populations.
Aims And Objectives:
The purpose of this study is to examine the occurrence and characteristics of chemotherapy-related adverse drug reactions in children with cancer at a teaching hospital specialising in advanced medical care. Furthermore, it aims to evaluate the intensity and cause of these reactions by utilising the NARANJO probability scale and other assessment instruments.
Materials And Methods:
During a three-month period, we conducted a study at SMGS Jammu, in collaboration with GMC Jammu's Pharmacology Department. The study was observational in nature and followed a prospective approach. The study included 45 children undergoing chemotherapy, utilising both spontaneous and intensive monitoring systems to report and analyse adverse drug reactions. We conducted statistical analysis using Chi-Square and Fisher Exact tests.
Results:
Among the 45 patients included in the study, 20 individuals (44.44%) experienced adverse drug reactions (ADRs), with a higher prevalence observed among female patients (55%). Fever and vomiting were the most common adverse drug reactions observed, with most of them being classified as moderate in severity based on the Modified Hartwig and Siegel Scale. Commonly linked medications to adverse drug reactions include Methotrexate, Vincristine, L-asparaginase, and Cytarabine. There was no significant statistical link discovered between different categories of anticancer drugs and adverse drug reactions.
Conclusion:
this study highlights the prevalence of adverse drug reactions (ADRs) in children undergoing chemotherapy, particularly in those receiving treatment for acute lymphoblastic leukaemia. The findings emphasise the significant impact of ADRs on these patients. It is of utmost importance to closely monitor and manage adverse drug reactions (ADRs) in paediatric oncology, emphasising the importance of implementing improved drug safety measures.
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