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Pharmacoepidemiological safety studies in children: a systematic review
Osemeke U Osokogu1, Julijana Dukanovic1, Carmen Ferrajolo1
1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.
Pharmacoepidemiology and Drug Safety
|June 4, 2016
Summary
Pediatric pharmacoepidemiology studies face challenges including limited focus on neonates and rare drug use. Improving reporting and addressing small study sizes are crucial for advancing pediatric drug safety research.
Area of Science:
- Pharmacoepidemiology
- Pediatric Drug Safety
- Clinical Research Methodology
Background:
- Pediatric pharmacoepidemiology is crucial for ensuring medication safety in children.
- Existing studies often have limitations in scope and methodology.
Purpose of the Study:
- To identify and characterize challenges in published pediatric pharmacoepidemiological safety studies.
- To assess the current landscape of pediatric drug and vaccine safety research.
Main Methods:
- Systematic review of articles from Embase and Medline (inception to 2013).
- Sequential screening of titles, abstracts, and full texts with independent validation.
- Data collection on study characteristics, methods, and results.
Main Results:
- 268 studies were included, primarily focusing on drugs (54.9%) and children aged 2-11 years (75.4%).
- Most studies were retrospective cohort studies (64.9%) from North America (57.5%) and Europe (34.3%).
- Limited reporting on sample size/power calculations (10.1%) and underrepresentation of neonates and rarely used drugs were noted.
Conclusions:
- Pediatric pharmacoepidemiology research is developing but often excludes neonates, focuses on limited drug classes, and is concentrated in developed countries.
- Small study size presents a significant challenge in pediatric research.
- Enhancements in study reporting are necessary to improve the quality and impact of pediatric safety research.
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