Paediatric harmful adverse drug events (PHADE).

Background and Objectives: It is well established that adverse drug events are frequent in paediatric hospital practice. The objective of this study is to systematically quantify and report the incidence of harmful adverse drug events across our institution and to identify predominant medications and error types. Methods: We prospectively compiled a validated medication safety database for paediatric inpatients within our institution over a three-and-a-half-year period. All incidences of apparent patient harm relating to medication error were investigated and analyzed to determine veracity, severity of harm, phase of medication process, error type, causative medication, and contributory factors enabling each event. Results: We identified 59 harmful adverse drug events, with an overall rate of 15.5 per 10⁵ patient bed days. Most events occurred during administration (n = 27) and prescribing (n = 26) phases. Almost half of all harm (49%) was associated with opioids; a broad range of medication classes accounted for other harm. Harmful events occurred in 7.3 per 10⁵ administrations of morphine and 13.3 per 10⁵ administrations of hydromorphone. Wrong dose was the most frequently encountered error type. Conclusions: This is the first study to quantify harmful adverse drug events in paediatric hospital practice. Our prospective analysis and compilation of harmful medication errors in paediatric hospital practice, reported with denominators of opioid administrations, and patient bed days, is a new standard for comparison in the long-discussed problem of paediatric harmful adverse drug events. By focusing on identified problematic drugs, error types, and contributory factors, we identify opportunities for interventions, error prevention and harm reduction.