Improving Recognition and Reporting of Adverse Drug Reactions in the NICU: A Quality Improvement Project

Adverse drug reactions (ADRs) are under-recognized and under-reported in the Neonatal Intensive Care Unit (NICU) population, with up to 95% of all ADRs not reported. Compared with non-elderly adults, pediatric patients are 3 times more likely to experience an ADR, with varying rates from 0.6% to 16.8%. The Children’s Mercy NICU has an ADR rate of 0.29% (2015). This high rate presents an opportunity to increase recognition and reporting, and improve characterization of ADRs in the NICU. METHODS: The primary aim of this quality improvement project was for 70% of patients who received specified medications (indomethacin, dexmedetomidine, fentanyl, lorazepam, dexamethasone, or hydrocortisone) in the first 3 months of age to be assessed daily for ADRs. We selected these medications due to the frequency of use and well-understood ADR associations. For each ADR recognized, the Naranjo score, was calculated and compared with the neonatal-specific Du score to assess the effectiveness of ADR characterization. RESULTS: Implementation occurred on May 15, 2017. We completed 3 PDSA cycles over 1 year. The bedside monitoring tool was utilized 83% of the time. Twenty-eight potential ADRs were identified, far exceeding the number reported before implementation. The Du score appeared to better characterize ADRs compared with the Naranjo score. CONCLUSIONS: Use of a bedside monitoring tool improves ADR detection. We experienced challenges with consistently identifying patients on target drugs and getting the tool to the bedside. Application of the Du score for ADR classification in neonates appears to be more appropriate than the use of the Naranjo.