Current Prescribing Practices of Oral Anti-Reflux Medications in the Neonatal Population

This quality improvement project aimed to examine the current practices in the prescribing of oral histamine-2 receptor agonists (H2RA) and proton pump inhibitors (PPI) in a freestanding children's hospital level four newborn intensive care unit (NICU) in the year 2016. PPI and H2RA drugs are prescribed for ulcer diseases and disorders relating to gastroesophageal reflux. Use of these medications in preterm infants has been associated with adverse sequela including increased infections, candidemia and necrotizing enterocolitis. Guidelines have cautioned against the use of acid suppression medications in neonates. The current usage remains widespread and variable. In order to make improvements in this area, current usage needs to be examined. Project objectives: 1. Gain approval and support for the project; 2. Gather data to determine current prescription trends; 3. Analyze data, compare to current literature and derive clinical implications from results; 4. Disseminate results to a wider audience by informing acid suppression prescribers (NNPs, neonatologists, fellows, and my fellow NNP clinician colleagues) of the results, literature comparison and clinical implications to encourage the use of evidence-based data regarding appropriate clinical use and areas for future quality improvement. Acid-suppression medications are frequently used in the infant population even though these medications have clear risks and their usefulness in reducing symptoms is limited. Prescription rates have increased over time with no clear justification. Mayo Clinic (2005), found a 16-fold increase in the number of acid-suppressing prescriptions in infants between 1999 and 2004. Ward and Kearns (2013) found that PPI prescription had 7.5-fold increase from 1990 to 2004 in infants < 12-mo age. Adverse effects have been reported in 23% of infants treated with H2 blockers and 34% of those treated with PPI's. A prospective cohort study found 37.4% higher risk of sepsis, pneumonia & UTI infection in children with PPI use. The Plan Do Study Act (PDSA) cycle was used review the prescription of each oral acid-suppressing medication individually beginning with Omeprazole and Ranitidine, as they are the most commonly prescribed oral anti-reflux medications in the NICU. Due to time constraints, these were the only two drugs analyzed. A retrospective chart review was performed for each infant who received an acid suppressant. Frequency of oral H2RA/PPI treatment, duration of drug exposure, indication for drug initiation, total drug exposure (mg) and percentage of infants remaining on treatment at discharge was determined. The results from that data were compared to current evidence literature and most recent recommendations for drug use and prescription. Of the 222 infants evaluated, 33% (n=74) ever received an H2RA or PPI; 28% (n=62) received an oral PPI and 10% (n= 23) received an H2RA. Five percent (n=11) received dual therapy. Infants with gastroesophageal reflux disease (relative risk [RR] = 3.13) and those with ear, nose and throat diagnosis (airway anomalies [RR =2.34]) had the highest H2RA/PPI treatment probabilities followed by those with a congenital diaphragmatic hernia (RR = 2.34; P < .05). In treated infants, the average duration of drug exposure during admission was 20.1 days. The majority of treated infants (78% [n=58]) remained treated at discharge. The results were shared and discussed with providers in an NNP monthly staff meeting and presented in a peer reviewed poster presentation forum. A simplified education module was presented to nursing staff. The outcome of this project will be used as a foundation for further quality improvement projects examining acid suppression prescribing trends. Recommendations were made to improve current oral anti-reflux medication stewardship in the NICU. To avoid overtreatment in the neonatal population, pharmacological therapy should be limited to selected infants suffering from GER complications. To identify appropriate population, current use should be analyzed and compared to recent evidence based literature. Current prescription guidelines of anti-reflux medications should be created/modified.