Causality, severity and avoidability of adverse drug reactions in children: An 11-year review
Duaa Gaafar1,2,3, Noel Cranswick1,2,3, Renee Dimond4
1Departments of General Medicine, Infectious Diseases, and Children's Cancer Centre, Royal Children's Hospital, Parkville, Victoria, Australia.
Insights
Approximately 15% of pediatric adverse drug reactions (ADRs) were potentially avoidable. This highlights the need for better ADR documentation, pharmacovigilance, and clinician education to improve patient safety.
Area of Science:
- Pediatric pharmacology
- Drug safety and pharmacovigilance
- Hospital medicine
Background:
- Adverse drug reactions (ADRs) are a significant cause of hospital admissions in children.
- These reactions contribute to increased healthcare utilization and costs.
- Understanding the characteristics of ADRs in pediatric populations is crucial for prevention.
Purpose of the Study:
- To evaluate the causality, severity, and avoidability of ADRs in hospitalized children.
- To identify common drug classes and reaction types associated with pediatric ADRs.
- To determine the proportion of ADRs that could have been prevented.
Main Methods:
- Retrospective cohort study of 599 children (0-18 years) over 11 years.
- Exclusion of intentional drug misuse or overdose cases.
- Assessment of causality (Naranjo criteria), severity (Hartwig scale), and avoidability (Modified Schumock and Thornton scale).
- Categorization of ADRs into Type A (dose-related) and Type B (idiosyncratic).
Main Results:
- Most ADRs (74%) were mild; 15% were potentially avoidable.
- Antimicrobials (46%) and analgesics (9%) were most frequently implicated.
- Type B (idiosyncratic) reactions (56%) were more common than Type A (dose-related) reactions (44%).
- Avoidable ADRs resulted from unconsidered allergies, incorrect dosing, drug interactions, or lack of preventative measures.
Conclusions:
- One in six pediatric ADRs were potentially avoidable, indicating significant room for improvement.
- Enhanced ADR documentation, robust pharmacovigilance systems, and targeted clinician education are essential.
- Implementing preventative strategies can reduce the burden of ADRs in hospitalized children.
Aims:
Adverse drug reactions (ADRs) are a frequent cause of hospital presentations and confer increased healthcare costs. This study aimed to assess the causality, severity and avoidability of ADRs in hospitalized children.
Methods:
This is an 11-year retrospective cohort study of children aged 0-18 years who were either admitted to a quaternary paediatric hospital due to an ADR or who experienced such a reaction during their hospital stay. Those who presented with intentional drug misuse or overdose were excluded. Causality, severity and avoidability were assessed using the Naranjo criteria, Hartwig scale and Modified Schumock and Thornton scale, respectively. ADRs were categorized as Type A (dose-related) or Type B (idiosyncratic).
Results:
Of 599 children with ADRs, the median age was 8.7 years (3 weeks to 18 years). Most ADRs (74%) were mild, with 25% moderate and 1% severe. The most commonly implicated drugs were antimicrobials (46%), analgesics (9%), antiepileptics (8%) and monoclonal antibodies (6%). Type A reactions comprised 44%, with neurological symptoms to metoclopramide (22%) being the most common. Type B reactions (56%) most commonly occurred with antimicrobials (63%). Overall, 15% of ADRs were potentially avoidable: 9% definitely and 6% probably avoidable. Most avoidable ADRs were due to failure to consider documented allergies, inappropriate dosing, drug interactions or not applying preventative measures (e.g., premedication).
Conclusion:
Our study shows that one in six paediatric ADRs were potentially avoidable, highlighting the need for improved ADR documentation, pharmacovigilance and clinician education.
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