Adverse drug events and medication errors in Japanese paediatric inpatients: a retrospective cohort study

Area of Science:

• Pharmacovigilance
• Patient Safety
• Pediatric Medicine

Background:

• Limited data exists on adverse drug events (ADEs) and medication errors in pediatric inpatients outside Western countries.
• Assessing local epidemiology is crucial for enhancing global pediatric patient safety.

Purpose of the Study:

• To determine the incidence and characteristics of ADEs and medication errors in Japanese pediatric inpatients.
• To identify key stages in medication management for safety improvements.

Main Methods:

• A cohort study design was employed in the Japan Adverse Drug Events (JADE) Study.
• Data was collected from pediatric inpatients at two tertiary care teaching hospitals in Japan.
• Medical charts, incident reports, and prescription queries were reviewed to identify ADEs and medication errors, with independent physician classification of severity and preventability.

Main Results:

• The study identified 480 ADEs and 826 medication errors across 12,691 patient-days.
• The incidence rates were 37.8 per 1000 patient-days for ADEs and 65.1 per 1000 patient-days for medication errors.
• Only 8% of ADEs were deemed preventable, but 81% of medication errors had the potential to cause harm. Preventable ADEs primarily occurred during monitoring (78%), while potential ADEs were most frequent during ordering (95%).

Conclusions:

• Adverse drug events and medication errors are prevalent in Japanese pediatric inpatient settings.
• The proportion of preventable ADEs was low, highlighting the need for targeted interventions.
• The ordering and monitoring phases of medication management are critical areas for improving patient safety.