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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.

ABSTRACT: 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. [ABSTRACT FROM AUTHOR]

Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were "Certain" whereas Naranjo's algorithm categorized 96.74% of ADRs as "Probable". Cohen's kappa showed a "Minimal" agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments. [ABSTRACT FROM AUTHOR]