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Adverse drug reactions in children--a systematic review
Rebecca Mary Diane Smyth1, Elizabeth Gargon, Jamie Kirkham
1School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, England, United Kingdom. rebecca.smyth@manchester.ac.uk
Insights
Adverse drug reactions (ADRs) in children are common, with incidence rates up to 10.3% for hospital admissions. While causality and severity are often assessed, avoidability requires more research to prevent these reactions.
Area of Science:
- Pediatric Pharmacology
- Public Health
- Drug Safety
Background:
- Adverse drug reactions (ADRs) in children represent a significant public health concern.
- Observational studies in pediatric populations were systematically reviewed across three settings: hospital admission, inpatient care, and community.
- The review focused on improving the detection, assessment, and prevention of pediatric ADRs.
Purpose of the Study:
- To systematically review observational studies on adverse drug reactions in children.
- To understand the incidence, causality, severity, and avoidability of ADRs in pediatric populations.
- To identify therapeutic classes most frequently associated with ADRs in children.
Main Methods:
- A comprehensive search of nineteen electronic databases was conducted.
- 102 observational studies involving children were included in the review.
- Data collected included drug classification, clinical presentation, risk factors, and assessments of causality, severity, and avoidability.
Main Results:
- Incidence of ADRs causing hospital admission ranged from 0.4% to 10.3% (pooled estimate 2.9%).
- Anti-infectives and anti-epileptics were frequently associated with ADRs in hospitalized children.
- Avoidability assessments were reported in only 19% of studies, with 7%-98% of ADRs deemed potentially avoidable.
Conclusions:
- Extensive literature exists on pediatric ADRs, providing incidence estimates and identifying high-risk drug classes.
- Further research is necessary to develop effective strategies for preventing ADRs in children.
- Improving the assessment of ADR avoidability is crucial for enhancing child safety.
Background:
Adverse drug reactions in children are an important public health problem. We have undertaken a systematic review of observational studies in children in three settings: causing admission to hospital, occurring during hospital stay and occurring in the community. We were particularly interested in understanding how ADRs might be better detected, assessed and avoided.
Methods And Findings:
We searched nineteen electronic databases using a comprehensive search strategy. In total, 102 studies were included. The primary outcome was any clinical event described as an adverse drug reaction to one or more drugs. Additional information relating to the ADR was collected: associated drug classification; clinical presentation; associated risk factors; methods used for assessing causality, severity, and avoidability. Seventy one percent (72/102) of studies assessed causality, and thirty four percent (34/102) performed a severity assessment. Only nineteen studies (19%) assessed avoidability. Incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children (pooled estimate of 2.9% (2.6%, 3.1%)) and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. Anti-infectives and anti-epileptics were the most frequently reported therapeutic class associated with ADRs in children admitted to hospital (17 studies; 12 studies respectively) and children in hospital (24 studies; 14 studies respectively), while anti-infectives and non-steroidal anti-inflammatory drugs (NSAIDs) were frequently reported as associated with ADRs in outpatient children (13 studies; 6 studies respectively). Fourteen studies reported rates ranging from 7%-98% of ADRs being either definitely/possibly avoidable.
Conclusions:
There is extensive literature which investigates ADRs in children. Although these studies provide estimates of incidence in different settings and some indication of the therapeutic classes most frequently associated with ADRs, further work is needed to address how such ADRs may be prevented.
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