Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study.

INTRODUCTION: Infants in the neonatal intensive care unit (NICU) are among the most vulnerable patient populations and medication errors are a significant source of risk and harm to neonates. Smart infusion pumps have been implemented to support the safe medication administration process; however, the effect of using smart infusion pumps on medication safety in the NICU is still unclear. METHODS: We conducted an observational study with a prospective point-prevalence approach to investigate intravenous (IV) medication administration errors in the NICU at one academic medical center in the USA. Observations were conducted in 48 days in a 3-month data collection period in 2019. RESULTS: We observed a total of 441 patients with 905 IV medication administrations during the data collection period. The total number of errors was 130 (14.4 per 100 administrations). Of these, the most frequent errors were selecting the wrong drug library entry (5.3 per 100 administrations), unauthorized medication (0.7 per 100 administrations), and wrong dose (0.6 per 100 administrations). Sixty-eight errors (7.5 per 100 administrations) were unlikely to cause harm despite reaching the patient (category C errors), while the rest did not reach the patient. CONCLUSION: We identified the medication errors, which was unique to NICU populations, but no harm to the patients were identified. Most errors occurred due to a lack of compliance of using smart pump technology; therefore, potential exists to maximize safety related to medication administration practices in the NICU through hospital policy change and increasing adherence to appropriate use of smart pump technology.

A quality improvement initiative to reduce acid-suppressing medication exposure in the NICU.

BACKGROUND: Acid-suppressing medications (ASMs) are commonly prescribed in the neonatal intensive care unit (NICU), in particular among preterm infants, despite well-established adverse effects and little evidence to support efficacy. LOCAL PROBLEM: We sought to develop an initiative to reduce ASM exposure in our predominantly inborn level III NICU. Our specific aim was to reduce the number of nonindicated ASM prescriptions by 50% within a 12-month period. METHODS: Our multidisciplinary team developed an evidence-based guideline defining indications for ASM prescription in a level III NICU. Plan-do-study-act cycles included staff education, formal clinical practice guideline implementation, and implementation of standardized documentation tools in the electronic health record (EHR). Outcome measures were the number of nonindicated and total inpatient prescriptions started per month, duration of ASM prescription, and number of prescriptions continued after NICU discharge. Balancing measures were the number of patients started on thickened feeds and number of patients discharged home on nasogastric tube feeds. We used statistical process control and Pareto charts to assess these measures over a 12-month baseline period, 9-month implementation period, and 19-month post-implementation period spanning September 2017-December 2020. RESULTS: Nonindicated ASM prescriptions decreased from median 3 to 0 per month from the baseline to post-implementation period. Simultaneously, the median number of ASM prescriptions at discharge declined from 2 to 0 per month. The median duration of inpatient prescriptions declined from 23 to 7 days. Rates of patients started on thickened feeds and patients discharged home on nasogastric tube feeds remained stable throughout the study. CONCLUSION: Enactment of an evidence-based guideline was associated with a substantial decline in nonindicated ASM use in our NICU and a decline in duration of exposure to ASM's when prescribed. Our interventions proved effective in altering clinical practice and could be applied to other NICUs with similar patient populations aiming to reduce ASM use.

Elevated Intestinal Inflammation in Preterm Infants With Signs and Symptoms of Gastroesophageal Reflux Disease.

OBJECTIVES: Reflux is common in infancy; however, persistent signs and symptoms of gastrointestinal distress are often attributed to gastroesophageal reflux disease (GERD). In this pilot study, we aimed to characterize associations between signs and symptoms of suspected GERD and noninvasive markers of intestinal inflammation in preterm infants. METHODS: We reviewed Electronic Medical Record (EMR) data to identify clinical signs and symptoms among case patients (n = 16). Controls (n = 16) were matched on gestational age. Univariate and multivariate regression analyses were used to compare fecal calprotectin and urinary intestinal fatty acid binding protein (I-FABP) levels between cases and controls. RESULTS: We found no differences in baseline characteristics between cases and controls. In the multivariate regression analysis controlling for the proportion of mother's milk, cases had higher fecal calprotectin levels than controls, with no differences in I-FABP levels between cases and controls. CONCLUSION: Our findings suggest that preterm infants with signs and symptoms of GERD have higher levels of intestinal inflammation as indicated by fecal calprotectin compared to their controls. Further studies are needed to evaluate the role of intestinal inflammation in signs and symptoms of gastrointestinal distress and whether fecal calprotectin might have predictive value in diagnosing GERD.

Caffeine Therapy in Preterm Infants: The Dose (and Timing) Make the Medicine.

Caffeine is one of the most commonly utilized medications in the NICU. In preterm infants, short-term and long-term pulmonary and neurodevelopmental benefits of therapy are well documented in the literature. While robust evidence supports the use of standard doses of caffeine for apnea of prematurity or to facilitate successful extubation, much remains unknown regarding the boundaries of efficacy and safety for this common therapeutic agent. Escalating dosing regimens seem to provide additional benefit in select infants, but grave toxicity has also been documented with early utilization of high-dose caffeine. Conflicting data exist surrounding the ideal timing of initiation of therapy. Even the widely adhered to discontinuation point has been challenged by data supporting continued use. Until robust data definitively support change, practice should align with current evidence defining clear, safe, and efficacious dosing and timing of caffeine therapy.

Intravenous Lipid Emulsions in Infants: Is Balanced Better?

Parenteral nutrition (PN) is frequently required by extremely preterm infants due to gastrointestinal immaturity and complications of prematurity. Parenteral nutrition-associated cholestasis (PNAC) and intestinal failure-associated liver disease (IFALD) are common complications of prolonged PN. Plant-based intravenous lipid emulsions, containing proinflammatory omega-6 fatty acids and phytosterols, may contribute to these conditions as well as other comorbidities such as bronchopulmonary dysplasia and retinopathy of prematurity. Intravenous lipid emulsions containing animal-based fats, such as fish oil, contain fewer proinflammatory omega-6 fatty acids and more anti-inflammatory omega-3 fatty acids and antioxidants. SMOFlipid, recently Food and Drug Administration (FDA)-approved for adult use, is a blend of plant- and animal-based lipid emulsions with a favorable omega-6:omega-3 ratio that may prevent the development and progression of PNAC/IFALD in infants. Careful review of data supporting this alternative intravenous lipid emulsion is required prior to widespread use in neonatal intensive care.

Acid Suppression for Gastroesophageal Reflux Disease in Infants.

Gastroesophageal reflux is a normal physiologic occurrence that is common throughout infancy and usually resolves on its own. Infrequently, reflux causes complications and turns into gastroesophageal reflux disease (GERD), which may warrant intervention. Available interventions vary in invasiveness and supporting data may be lacking for efficacy and safety. Nonpharmacologic interventions are first-line therapy for GERD in infants, whereas pharmacologic and surgical approaches are controversial. Efficacy data are limited for pharmacologic strategies for infantile GERD and safety data have demonstrated serious risks, especially in younger infants. Utilization of these medications should be approached cautiously in this population, if appropriate diagnostic techniques determine acid suppression could be beneficial. A robust monitoring plan with frequent reassessment of need for therapy may optimize benefit and minimize risk.

Pharmacist-driven respiratory syncytial virus prophylaxis stewardship service in a neonatal intensive care unit.

PURPOSE: The development and implementation of a pharmacist-driven respiratory syncytial virus (RSV) prophylaxis stewardship program in a neonatal intensive care unit (NICU) are described. SUMMARY: An RSV prophylaxis stewardship service was created in the NICU at Brigham and Women's Hospital to align with the newly updated 2014 American Academy of Pediatrics (AAP) recommendations for palivizumab. The service comprised two NICU clinical pharmacists with oversight from the NICU medical director and the chair of the NICU infection control committee. Supervising physicians provided oversight for the identification of qualified patients on a weekly basis and assisted in the evaluation of controversial cases. The goals of the RSV prophylaxis stewardship service were to identify qualifying infants, improve adherence to the current AAP recommendations, educate staff and families on the recently updated AAP recommendations, streamline communication between providers regarding qualifying infants, and prepare and deliver palivizumab for administration in an organized and cost-effective manner. Twice-weekly "RSV prophylaxis days" were designated, with a set administration time on each day. Workflow was successfully streamlined between members of the healthcare team, including NICU pharmacists, prescribers, off-shift pharmacists, and nurses. CONCLUSION: Pharmacists involved in a multidisciplinary RSV prophylaxis stewardship service successfully identified qualifying patients for RSV prophylaxis while adhering to the latest AAP recommendations, educated staff and families regarding RSV, streamlined communication among healthcare providers, and ensured preparation of palivizumab in an organized and cost-effective manner.

Systemic Corticosteroids for the Prevention of Bronchopulmonary Dysplasia: Picking the Right Drug for the Right Baby.

Bronchopulmonary dysplasia is a morbidity of prematurity with implications into adulthood on respiratory and neurologic health. Multiple risk factors contribute to the development of bronchopulmonary dysplasia leading to examination of various strategies of prevention. Systemic corticosteroids are one prevention strategy with a large body of data, creating an ongoing controversy regarding the risks and benefits of therapy. Careful consideration of the available data along with the clinical characteristics of the individual infant is required before using this powerful therapy.

Pharmacotherapy for Patent Ductus Arteriosus: Current Options and Outstanding Questions.

Management of the patent ductus arteriosus (PDA) represents an ongoing challenge in the care of extremely premature neonates. Determining the optimal treatment strategy requires careful consideration of the potential risks and benefits of available therapies. Surgical ligation results in reliable ductal closure, but may result in numerous short-term complications and have a negative impact on long-term outcome. Intravenous indomethacin was the first pharmacologic agent widely utilized for PDA closure. Intravenous indomethacin effectively closes the ductus arteriosus and prevents pulmonary hemorrhage and severe intraventricular hemorrhage, but fails to mitigate short-term morbidities and improve long-term outcomes. Intravenous ibuprofen represents an alternative therapy with fewer renal adverse effects. However, intravenous ibuprofen does not prevent severe intraventricular hemorrhage and also has concerning adverse effects, including bilirubin displacement and the potential to increase the risk of chronic lung disease. Enteral ibuprofen has also been investigated, although gastrointestinal adverse effects limit widespread utilization. Acetaminophen (paracetamol) represents an enticing novel therapy due to wide availability, low cost, and an appealing safety profile. Ongoing investigation is required to determine the role of this agent in PDA treatment algorithms. Pending these results, clinicians must weigh the potential risks and benefits of each therapy for individual neonates considering all available evidence.

Utility of in-house fluconazole disk diffusion susceptibility testing in the treatment of candidemia.

Among 302 first candidemia episodes, 210 (69.6%) were initially treated with an echinocandin or polyene (E/P) antifungal drug. In 137 (72.5%) patients with fluconazole-susceptible isolates, treatment was changed to fluconazole based on disk diffusion susceptibility testing. Clinical outcomes were not compromised in patients receiving E/P who were de-escalated to fluconazole for treatment of candidemia based on disk diffusion results.

Intrapleural Antimicrobial Irrigation for Postpneumonectomy Empyema in Patients With Lung Cancer.

PURPOSE: Postpneumonectomy empyema (PPE) is a possible complication after a pneumonectomy in patients with lung cancer. The use of intrapleural (IP) antibiotic irrigation to treat infections in the pleural space may be indicated after systemic antimicrobial therapy, and drainage of the pleural space has been insufficient. METHODS: Adult patients ≥18 years old who received IP antibiotic irrigation between 2006 and 2011 were included. Demographic data, past medical history, surgical procedure, systemic antibiotics, and culture data were collected. Additionally, the IP antibiotic administered, the dose, and how it was prepared and administered were collected. RESULTS: A total of 18 patients were evaluated in this retrospective descriptive analysis. The majority of patients underwent an extrapleural pneumonectomy (EPP; 72%). Most patients received systemic antibiotics before IP antibiotic administration (95%). Vancomycin was the most common antibiotic used for both systemic therapy (100%) and IP irrigation (94%). The median number of IP antibiotic doses received per patient was 5.5 (interquartile range [IQR] 1-9). Recurrence of PPE within 6 months of initial PPE resolution occurred in 28% of patients. Intrapleural antibiotic irrigation was well tolerated in all patients. CONCLUSION: Vancomycin is most commonly used for IP antibiotic irrigation at our institution after patients have undergone a thoracic surgery, which was most commonly an EPP.

High-dose intravenous vancomycin therapy and the risk of nephrotoxicity.

PURPOSE: National guidelines recommend higher serum trough concentrations when using vancomycin to treat certain clinical conditions, but there is concern that higher-dose vancomycin therapy causes nephrotoxicity. We evaluated risk factors associated with nephrotoxicity in patients receiving high-dose intravenous vancomycin. METHODS: This retrospective cohort study evaluated the clinical outcome of 80 hospitalized adult patients with normal baseline renal function who received ≥4 g/d of intravenous vancomycin for ≥48 hours between January 1, 2011, and December 31, 2011. After abstracting clinical risk factors, we used an analysis by methods of best clinical subsets to develop a multivariable model predicting nephrotoxicity in patients receiving high-dose vancomycin. FINDINGS: The overall rate of nephrotoxicity in the study population was 6%. Trough concentrations >20 mg/L were identified in a similar proportion of patients who did and did not develop nephrotoxicity. Patients who developed nephrotoxicity trended toward having a lower body mass index, higher daily dose, longer duration of therapy, and greater exposure to intravenous contrast and nephrotoxic medications. In a multivariable model, the combination of intravenous contrast and nephrotoxic medications was a significant predictor of nephrotoxicity, and duration of high-dose vancomycin was a significant confounder. IMPLICATIONS: Administration of high-dose intravenous vancomycin may have less associated nephrotoxicity than previously reported, although duration of vancomycin therapy may play a role. Concomitant exposure to intravenous contrast and other nephrotoxic medications is a more significant predictor of developing nephrotoxicity than vancomycin dose or trough.