Methods for the detection of adverse drug reactions in hospitalized children: a systematic review

Ramos, Sheila Feitosa; Alvarez, Nathália Rodrigues; Alcântara, Thaciana dos Santos; Sanchez, Júlia Mirão; Lima, Elisângela da Costa; Júnior, Divaldo Pereira de Lyra

doi:10.1080/14740338.2021.1924668

Cited by 5 publications

(2 citation statements)

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“…These methodological differences have probably influenced on the clinical results found. A systematic review on ADR detection methods in hospitalized children was carried out (Ramos et al, 2021) and found that methods such as intensive monitoring chart review or trigger tools are more effective but time consuming, whereas spontaneous notification showed the lowest rate of detection. They concluded that most of the studies used a combination of methods, which might indicate a growing concern in ADR care in hospitalized children.…”

Section: Discussionmentioning

confidence: 99%

“…ADR are an important cause of morbidity and mortality in patients of all ages, including pediatric population, and are considered a public health problem worldwide (Impicciatore et al, 2001;Clavenna and Bonati, 2009;Thiesen et al, 2013;Durrieu et al, 2014;Ramos et al, 2021). Children are more susceptible to ADR owing to insufficient standardized information, unlicensed and off-label use, unavailability of pediatric formulations, and physiological peculiarities inherent to age (Ramos et al, 2021).…”

Section: Introductionmentioning

confidence: 99%

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Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review

2022

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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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Section: Discussionmentioning

confidence: 99%