Background: Children’s health is affected by several characteristics: developmental change over time; dependency on adults; and a distinct epidemiological profile of disease. These items, when combined with healthcare provider and system factors, create vulnerabilities for pediatric care that must be taken into account in pediatric patient safety (PPS) programs. The above-noted issues affect the risk of iatrogenic harm in many ways, of which the following are a few examples. 1) Children’s developmental processes affect their responses to medications, and medication dosages. However, there is a paucity of evidence that is directly relevant to children, and children of different ages, on the effectiveness and efficacy of drug interventions. The epidemiology of adverse events differs between adults and children. 2) Children’s dependency on adults can affect the risk of harm. For example, preverbal children cannot advocate for themselves. Moreover, family dynamics (e.g. multiple caregivers) can make it difficult to get a complete or accurate medical history. 3) In many countries, some health care is delivered in school and community settings, yet we know little about the potential for harm in these environments. More research is also needed on how delivery of care to children in lower-and-middle-income countries affects PPS. 4) Much health care for children is given by providers without specialized training in pediatrics (e.g. family physicians, staff in general emergency departments), who may not recognize differing trajectories of disease in children, which creates conditions for errors in diagnosis and treatment.

Conclusions: The dynamic nature of childhood influences the accuracy of diagnoses, effectiveness of treatments and risk of harm to children. Including more specific information that is relevant to these issues in systematic reviews will advance PPS endeavours. More research is needed on PPS in various settings of care and on global health issues in PPS.