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New Ways of Detecting ADRs in Neonates and Children
Ricardo Jimenez, Anne Smith, Bruce Carleton1
1Pharmaceutical Outcomes Programme, Child and Family Research Institute, Vancouver, Canada. bcarleton@popi.ubc.ca.
Insights
Severe adverse drug reactions (ADRs) are a significant concern in children, leading to hospitalizations and deaths. Improved pediatric drug safety evaluation is crucial for predicting harm and ensuring safe medication use.
Area of Science:
- Pharmacovigilance
- Pediatric Drug Safety
- Adverse Drug Reactions
Background:
- Severe adverse drug reactions (ADRs) contribute significantly to hospital admissions and mortality in the USA.
- Incidence of ADRs is notably higher in hospitalized children (11%) compared to outpatients (1%).
- Pediatric drug safety evaluation is complex due to limited clinical trials and off-label drug use in children.
Purpose of the Study:
- To highlight the challenges in detecting ADRs in neonates and children.
- To review existing strategies for identifying and evaluating pediatric ADRs.
- To emphasize the urgent need for enhanced pre- and post-market drug safety evaluation in pediatric populations.
Main Methods:
- Review of systematic reviews and existing methodologies for ADR detection.
- Discussion of various surveillance strategies including case reports, active surveillance, and pharmacoepidemiology.
- Examination of age-related physiological changes impacting drug metabolism and pharmacodynamics in children.
Main Results:
- ADRs are a major cause of hospital admissions and deaths, with a significant impact on pediatric patients.
- Diverse methods like anecdotal reporting, active surveillance, and pharmacoepidemiology are employed for ADR identification.
- Age-related physiological differences in children necessitate tailored approaches to drug safety monitoring.
Conclusions:
- A comprehensive, multi-method surveillance approach is essential for robust post-market drug safety monitoring in children.
- Improving pediatric drug safety evaluation is critical for preventing serious harm and ensuring safe medication practices.
- Enhanced evaluation in both pre- and post-market phases is needed to predict and mitigate risks in pediatric drug use.
Abstract:
Severe adverse drug reactions (ADRs) cause 5-7% of all hospital admissions, an estimated 2,000,000 severe reactions, and over 100,000 deaths each year in the USA. A recent systematic review indicated that the overall incidence of ADRs was 11% in hospitalized children and 1% in outpatients. Detecting ADRs in neonates and children is challenging, particularly because there are fewer clinical trials involving children than adults and drug use in children is common without a labeled indication. Ontogeny and significant physiological changes related to age have an impact on metabolic drug clearance and pharmacodynamics in children compared to adults, as well as on drug action. A variety of strategies have been developed for the identification and further evaluation of ADRs, starting from case reports and advancing into more structured methodologies, such as active surveillance, for accumulating the necessary information. While each approach has merit, a comprehensive surveillance approach with different methods is required to monitor drug safety in the post-market period. Among the methods that have shown value in neonates and children are anecdotal reporting, voluntary organized reporting, prescription event monitoring, pharmacoepidemiology using administrative databases, and active surveillance. There is an urgent need to improve the evaluation of paediatric drug safety in the pre- and post-market phases of drug evaluation in order to better predict in whom serious harm may occur and better ensure the safe use of drugs for neonates and children.
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