Paediatric harmful adverse drug events (PHADE)

Area of Science:

• Pediatric Hospital Medicine
• Patient Safety Research
• Pharmacovigilance

Background:

• Adverse drug events (ADEs) are a significant concern in pediatric inpatient settings.
• Quantifying harmful ADEs is crucial for improving medication safety in children.

Purpose of the Study:

• To systematically quantify the incidence of harmful adverse drug events in pediatric hospital practice.
• To identify the predominant medications and error types associated with these events.

Main Methods:

• Prospective compilation of a validated medication safety database for pediatric inpatients over 3.5 years.
• Analysis of all incidences of patient harm related to medication errors, including severity, phase, error type, and contributing factors.

Main Results:

• Identified 59 harmful adverse drug events, with an overall rate of 15.5 per 10⁵ patient bed days.
• Opioids were associated with nearly half of all harm (49%).
• Wrong dose was the most common error type, with specific rates for morphine and hydromorphone.

Conclusions:

• This study provides the first quantification of harmful ADEs in pediatric hospital practice.
• Establishes a new standard for comparing pediatric harmful ADEs using opioid administrations and patient bed days.
• Identifies specific drugs, error types, and factors to inform interventions for error prevention and harm reduction.