Risk of adverse drug events in neonates treated with opioids and the effect of a bar-code-assisted medication administration system

Abstract

Purpose: The risk of adverse drug events (ADEs) in neonates treated with opioids and the effect of a bar-code-assisted medication administration (BCMA) system were studied.

Methods: A prospective cohort study of neonates in a neonatal intensive care unit (NICU) was conducted. A BCMA system was operative for 50% of the study period. Structured medical record audits were conducted to identify medication errors and preventable ADEs. Stratified frequency distribution and Cox proportional hazards analyses were used.

Results: Of 618 patients, 78 (12.6%) received postoperative care, 280 (45.3%) required assisted ventilation, and 72 (11.7%) were treated with opioids during their hospitalization. A total of 32 first preventable ADEs occurred. Univariate analyses demonstrated that postoperative status, assisted ventilation, and opioid administration were each significantly associated with ADEs. However, stratified frequency distribution analyses indicated that opioid administration during hospitalization was associated with preventable ADEs, controlling for postoperative status (p = 0.0019) or assisted ventilation (p = 0.0007). The odds ratio for any preventable ADE occurrence in a patient treated with an opioid was 4.74 compared with an infant not treated with an opioid. Patients who were treated with an opioid in the absence of a BCMA system had a 10% probability of an ADE after hospitalization for six days.

Conclusion: Infants in a NICU who were treated with opioids were at greater risk of a preventable ADE than other patients, adjusted for two medical conditions, assisted ventilation and postoperative status. A BCMA system reduced the risk of harm from an opioid medication error.