Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review
- PMID: 35185536
- PMCID: PMC8850382
- DOI: 10.3389/fphar.2021.777498
Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review
Abstract
Introduction: Adverse drug reactions (ADR) are an important cause of morbidity and mortality in pediatric patients. Due to the disease severity and chemotherapy safety profile, oncologic patients are at higher risk of ADR. However, there is little evidence on pharmacovigilance studies evaluating drug safety in this specific population. Methods: In order to assess the incidence and characteristics of ADR in pediatric patients with oncohematogical diseases and the methodology used in the studies, a systematic review was carried out using both free search and a combination of MeSH terms. Data extraction and critical appraisal were performed independently using a predefined form. Results: Fourteen studies were included, of which eight were prospective and half focused in inpatients. Sample size and study duration varied widely. Different methods of ADR identification were detected, used alone or combined. Causality and severity were assessed frequently, whereas preventability was lacking in most studies. ADR incidence varied between 14.4 and 67% in inpatients, and 19.6-68.1% in admissions, mainly in the form of hematological, gastrointestinal and skin toxicity. Between 11 and 16.4% ADR were considered severe, and preventability ranged from 0 to 74.5%. Conclusion: ADR in oncohematology pediatric patients are frequent. A high variability in study design and results has been found. The use of methodological standards and preventability assessment should be reinforced in order to allow results comparison between studies and centers, and to detected areas of improvement. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96513, identifier CRD42018096513.
Keywords: adverse drug reactions; hematology; neoplasms; oncology; pediatrics; pharmacovigilance; systematic review.
Copyright © 2022 Amaro-Hosey, Danés and Agustí.
Conflict of interest statement
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
References
-
- Bellis J. R., Kirkham J. J., Thiesen S., Conroy E. J., Bracken L. E., Mannix H. L., et al. (2013). Adverse Drug Reactions and Off-Label and Unlicensed Medicines in Children: a Nested Case-Control Study of Inpatients in a Pediatric Hospital. BMC Med. 11, 238. 10.1186/1741-7015-11-238 - DOI - PMC - PubMed
-
- Call R. J., Burlison J. D., Robertson J. J., Scott J. R., Baker D. K., Rossi M. G., et al. (2014). Adverse Drug Event Detection in Pediatric Oncology and Hematology Patients: Using Medication Triggers to Identify Patient Harm in a Specialized Pediatric Patient Population. J. Pediatr. 165, 447–e4. e4. 10.1016/j.jpeds.2014.03.033 - DOI - PMC - PubMed
Publication types
LinkOut - more resources
Full Text Sources
Research Materials