A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily

Abstract

Children represent one of the most susceptible groups to adverse drug reactions (ADRs), as a consequence of physiological growth and maturation of different organ systems. The aim of this study was to characterize the frequency, preventability and seriousness of ADRs recorded in the Pediatric Emergency Department (ED) of the University hospital of Messina, in Sicily. All the suspected adverse reactions to drugs and vaccines collected from 2012 to 2018 were selected and then analyzed. Only adverse drug reactions (ADRs) with a probable or possible causality assessment were included, according to the Naranjo Algorithm and the World Health Organization criteria; the preventability assessment using Schumock and Thornton criteria was also carried out. The Medical Dictionary for Regulatory Activities (MedDRA) was used to group ADRs. Of 75,935 admissions to the Pediatric ED, 120 were due to suspected ADRs. The rate of hospital admission due to ADRs (75.8%) was significantly greater than that of patients without ADRs (11.9%). Among pediatric patients with ADRs the median (Q1-Q3) age was 29.5 (12-73.25) months. Most of ADRs were observed in infants and children (43.3% and 41.7%, respectively vs adolescents, 15%). In addition, in children with ADRs, females [41 (14-105)] were older than males [23 (11-45)] (p=0.044). Most adverse reactions were serious (75.8%) and 20.8% were preventable or probably preventable; however, the majority of serious ADRs (93.4%) resulted without sequelae. The reactions were found to be as probable (54.2%) or possible (45.8%). Vaccines (n=63), antibacterials (n=31) and antiinflammatory medicines (n=14) were the most frequently drugs involved. Organ toxicity mapping due to vaccines was general disorders and administration site conditions (65.1%), nervous disorders (50.2%), cutaneous disorders (35%), followed by gastrointestinal disorders (20.6%). Cutaneous disorders (76%) gastrointestinal (20.7%),

Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital

“…In the current study, the Naranjo algorithm and WHO-UMC scales of causality assessment observed that most of the ADRs were probable/likely categories. Similar findings were also reported by Nasso et al, 2020 , Al-Damen and Basheti, 2019 , and Saqib et al, 2018 ). Because of their simplicity, the Naranjo algorithm and WHO-UMC scales are also used to evaluate the causality score in paediatric patients.…”

“…Moreover, the observed rate of ADR related to paediatric patients was 1.7 ADRs per 1,000 admissions. Nasso et al also reported similar findings (1.6 ADRs/1,000 admissions) in paediatric patients (Nasso et al, 2020). However, another study conducted by Lombardi et al, observed 2.2 ADRs per 1,000 paediatric admissions, which was higher as compared to our study (Lombardi et al, 2018).…”

“…Supported findings were also reported in the Jordan study and reported that 44.7% of ADRs were definitely and probably preventable ( Al-Damen and Basheti, 2019 ). Another study conducted among paediatric patients observed that 20% of ADRs were preventable or probably preventable ( Nasso et al, 2020 ). In the current study, most of the identified ADRs were found to be preventable.…”

“…The Naranjo algorithm (the total scores range from −4 to 13, the reaction is considered Definite if score >8, probable 5–8, possible 1–4 and doubtful = 0) and WHO-Uppsala Monitoring Centre (the suspected ADR is assessed as certain, probable, possible, unlikely and unclassified/unclassifiable) criteria were used to determine the causality of each suspected ADR ( Naranjo et al, 1981 ; World health organization and Uppsala Monitoring Centre WH/UMC, 2013 ). These validated tools have been used in several studies ( Dittrich et al, 2020 ; Nasso et al, 2020 ; Trubiano et al, 2016). Hartwig’s Severity Assessment Scale was used to evaluate the ADRs’ severity.…”

“…Children rarely articulate their personal medication therapy experiences; they are more susceptible to ADRs. As a result, inappropriate drugs usage in paediatric patients has a significant chance of causing a variety of ADRs ( Khan et al, 2020a ; Nasso et al, 2020 ). The paediatric patients are considered susceptible populations and are frequently underrepresented in randomized controlled trials (RCTs).…”