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Review
. 2022 Feb 3:12:777498.
doi: 10.3389/fphar.2021.777498. eCollection 2021.

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review

Kristopher Amaro-Hosey  1   2   3 , Immaculada Danés  2   3   4 , Antònia Agustí  2   3   4
Affiliations
Review

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review

Kristopher Amaro-Hosey et al. Front Pharmacol. .

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.

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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.

Figures

FIGURE 1
FIGURE 1
Study flow chart.
See this image and copyright information in PMC

References

    1. Amaro-Hosey K., Danés I., Vendrell L., Alonso L., Renedo B., Gros L., et al. (2021). Adverse Reactions to Drugs of Special Interest in a Pediatric Oncohematology Service. Front. Pharmacol. 12, 670945. 10.3389/fphar.2021.670945 - DOI - PMC - PubMed
    1. Barrett J. S., Patel D., Dombrowsky E., Bajaj G., Skolnik J. M. (2013). Risk Assessment of Drug Interaction Potential and Concomitant Dosing Pattern on Targeted Toxicities in Pediatric Cancer Patients. AAPS J. 15, 775–786. 10.1208/s12248-013-9489-z - DOI - PMC - PubMed
    1. 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
    1. Bouvy J. C., De Bruin M. L., Koopmanschap M. A. (2015). Epidemiology of Adverse Drug Reactions in Europe: a Review of Recent Observational Studies. Drug Saf. 38, 437–453. 10.1007/s40264-015-0281-0 - DOI - PMC - PubMed
    1. 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