Adverse drug events (ADEs) injure millions of patients and cost society billions of dollars each year. A strong culture of safety has been linked with quality outcomes across Intensive Care Unit environments. Infants in the neonatal intensive care unit (NICU) are at even higher risk of ADEs compared to adults. Multi-center research linking practices and outcomes in this environment is lacking. A large study is needed to clarify the associations between practices and outcomes in preparation for a prospective, multi-center medication safety practice implementation project. The central objective of this proposal is to link specific medication safety practices with short-term adverse events and long-term adverse clinical outcomes from a nationally representative electronic medical record (EMR). Dr. Smith will accomplish this objective by using an existing dataset from 25% of the infants admitted to a NICU in the United States. Through a partnership with the Pediatrix Medical Group, composed of 276 NICUs in the U.S. encompassing 900 neonatologists, he will use a comprehensive inventory tool to assess baseline medication safety practices, ADE reporting, ADE response strategies, and ADE outcomes across NICUs. He will then link these data with the broader Pediatrix EMR to evaluate associations between safety practices, short-term adverse event and long-term adverse clinical outcomes including mortality and length of stay. This proposal will: 1) provide the first comprehensive understanding of how U.S. NICUs vary in their ADE prevention and response practices and 2) define for the first time both positive and negative associations between medication safety practices, ADEs, and clinical outcomes at the multi-center level. If this proposal is successful, we will identify best-practices that can be broadly implemented to improve outcomes in this vulnerable population.

Public Health Relevance

Adverse drug events injure millions of patients and cost society billions of dollars each year, and infants are at higher risk of adverse drug events than adults. We will combine existing robust clinical data with a comprehensive inventory tool of safety practices across 276 neonatal intensive care units to assess baseline medication safety practices, adverse drug event reporting and response strategies. This will allow us to rapidly conduct research to provide evidence on how to optimize care in hospitalized infants at high risk of adverse drug events. If this proposal is successful, we will identify best-practices that can be broadly implemented to improve outcomes in this vulnerable population.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21HD080606-02
Application #
9115649
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
Raju, Tonse N
Project Start
2015-08-01
Project End
2017-07-31
Budget Start
2016-08-01
Budget End
2017-07-31
Support Year
2
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Duke University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Thompson, Elizabeth J; Greenberg, Rachel G; Kumar, Karan et al. (2018) Association between Furosemide Exposure and Patent Ductus Arteriosus in Hospitalized Infants of Very Low Birth Weight. J Pediatr 199:231-236
Rivera-Chaparro, Nazario D; Ericson, Jessica; Wu, Huali et al. (2018) Safety, Effectiveness, and Exposure-Response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records. Pediatr Infect Dis J :
Kumar, Karan R; Clark, David A; Kim, Evan M et al. (2018) Association of Atrial Septal Defects and Bronchopulmonary Dysplasia in Premature Infants. J Pediatr 202:56-62.e2
Hornik, Christoph P; Onufrak, Nikolas J; Smith, P Brian et al. (2018) Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants. Cardiol Young 28:85-92
Romaine, Andrew; Clark, Reese H; Davis, Briana R et al. (2018) Predictors of Prolonged Breast Milk Provision to Very Low Birth Weight Infants. J Pediatr 202:23-30.e1
Ericson, Jessica E; Gostelow, Martyn; Autmizguine, Julie et al. (2017) Safety of High-dose Acyclovir in Infants With Suspected and Confirmed Neonatal Herpes Simplex Virus Infections. Pediatr Infect Dis J 36:369-373
Hwang, Michael F; Beechinor, Ryan J; Wade, Kelly C et al. (2017) External Evaluation of Two Fluconazole Infant Population Pharmacokinetic Models. Antimicrob Agents Chemother 61:
Patel, Ravi M; Zimmerman, Kanecia; Carlton, David P et al. (2017) Early Caffeine Prophylaxis and Risk of Failure of Initial Continuous Positive Airway Pressure in Very Low Birth Weight Infants. J Pediatr 190:108-111.e1
Parente, V; Clark, R H; Ku, L et al. (2017) Risk factors for group B streptococcal disease in neonates of mothers with negative antenatal testing. J Perinatol 37:157-161
Salerno, Sara; Hornik, Christoph P; Cohen-Wolkowiez, Michael et al. (2017) Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants. Pediatr Infect Dis J 36:855-859

Showing the most recent 10 out of 21 publications