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Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review
Kristopher Amaro-Hosey1,2,3, Immaculada Danés2,3,4, Antònia Agustí2,3,4
1Clinical Pharmacology Service, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Insights
Adverse drug reactions (ADRs) are common in pediatric cancer patients, with significant variability in study methods and findings. Improving standardized reporting and assessing preventability are crucial for better patient outcomes.
Area of Science:
- Pediatric Oncology
- Pharmacovigilance
- Drug Safety
Background:
- Adverse drug reactions (ADRs) significantly contribute to morbidity and mortality in pediatric patients.
- Oncologic patients face elevated ADR risks due to disease severity and chemotherapy.
- Limited pharmacovigilance data exists for drug safety in pediatric oncohematology.
Purpose of the Study:
- To assess the incidence and characteristics of ADRs in pediatric oncohematology patients.
- To evaluate the methodologies employed in existing pharmacovigilance studies.
- To identify areas for methodological improvement in ADR research.
Main Methods:
- Systematic review of fourteen studies (eight prospective, half inpatient-focused).
- Data extraction and critical appraisal using a predefined form.
- Free search and MeSH terms used for study identification.
Main Results:
- ADR incidence ranged from 14.4% to 67% (inpatients) and 19.6% to 68.1% (admissions).
- Common ADRs included hematological, gastrointestinal, and skin toxicities; 11-16.4% were severe.
- Causality and severity were frequently assessed, but preventability assessment was often lacking.
Conclusions:
- ADRs are frequent in pediatric oncohematology patients.
- Significant variability exists in study designs and reported results.
- Reinforcing methodological standards and preventability assessment is essential for comparative analysis and improvement.
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.
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