Implementation of a tier system for IVIG indications to address IVIG shortage at a tertiary care pediatric medical center.

BACKGROUND: Drug shortages are a common issue that healthcare systems face and can result in adverse health outcomes for patients requiring inferior alternate treatment. The United States recently experienced a national drug shortage of intravenous immunoglobulin (IVIG). Several reported strategies to address the IVIG and other drug shortages have been proposed; however, there is a lack of evidence-based methods for protocol development and implementation. OBJECTIVE: To evaluate the efficacy of introducing a multidisciplinary task force and tier system of indications and to minimize adverse effects during a shortage of IVIG. METHODS: Faculty members across disciplines with expertise in IVIG use were invited to participate in a task force to address the shortage and ensure adequate supply for emergent indications. A tier system of IVIG indications was established according to the severity of diagnosis, urgency of indication, and quality of supporting evidence. Based on inventory, indications in selected tiers were auto-approved. Orders that could not be automatically approved were escalated for task force review. RESULTS: Overall, there were 342 distinct requests for IVIG during the study period (August 1, 2019 to December 31, 2019). All Tier 1 indications were approved. Of all requests, only 2.6% (9) of requests were denied, none of which resulted in adverse effects based on retrospective chart review. Seven patients who regularly receive IVIG had possible adverse effects due to dose reduction or spacing of treatment; however, each complication was multifactorial and not attributed to the shortage or tier system implementation alone. CONCLUSION: Implementation of a multidisciplinary task force and tier system to appropriately triage high-priority indications for limited pharmaceutical agents should be considered in health institutions faced with a drug shortage.

What a Waste: Perioperative Fentanyl Wastage at a Pediatric Hospital.

The purpose of this study was to quantify the wasted IV fentanyl in the perioperative period at a pediatric hospital. Data collected from electronic charting were used to calculate the amount of wasted medication. We show significant wastage of IV fentanyl during the perioperative period, and propose medication formulations that prevent financial, environmental, and supply-chain complications.

Measuring the impact of an empiric antibiotic algorithm for pulmonary exacerbation in children and young adults with cystic fibrosis.

BACKGROUND: Antimicrobial stewardship is a systematic effort to change prescribing attitudes that can provide benefit in the provision of care to persons with cystic fibrosis (CF). Our objective was to decrease the unwarranted use of broad-spectrum antibiotics and assess the impact of an empiric antibiotic algorithm using quality improvement methodology. METHODS: We assembled a multidisciplinary team with expertise in CF. We assessed baseline antibiotic use for treatment of pulmonary exacerbation (PEx) and developed an algorithm to guide empiric antibiotic therapy. We included persons with CF admitted to Children's National Hospital for treatment of PEx between January 2017 and March 2020. Our primary outcome measure was reducing unnecessary broad-spectrum antibiotic use, measured by use consistent with the empiric antibiotic algorithm. The primary intervention was the initiation of the algorithm. Secondary outcomes included documentation of justification for broad-spectrum antibiotic use and use of infectious disease (ID) consult. RESULTS: Data were collected from 56 persons with CF who had a total of 226 PEx events. The mean age at first PEx was 12 (SD 6.7) years; 55% were female, 80% were white, and 29% were Hispanic. After initiation of the algorithm, the proportion of PEx with antibiotic use consistent with the algorithm increased from 46.2% to 79.5%. Documentation of justification for broad-spectrum antibiotics increased from 56% to 85%. Use of ID consults increased from 17% to 54%. CONCLUSION: Antimicrobial stewardship initiatives are beneficial in standardizing care and fostering positive working relationships between CF pulmonologists, ID physicians, and pharmacists.

Safety and Tolerability of Monoclonal Antibody Therapies for Treatment of COVID-19 in Pediatric Patients.

There is a little data regarding safety or efficacy of monoclonal antibody treatment for mild-to-moderate COVID-19 in pediatric patients despite it being frequently used in adults. This retrospective study of 17 patients with mild-to-moderate COVID-19 who received monoclonal antibody therapy found that the treatment was well tolerated, safe, and may be effective in halting progression to severe disease.

Reducing Vancomycin Use in a Level IV NICU.

BACKGROUND AND OBJECTIVES: Vancomycin remains one of the most commonly prescribed antibiotics in NICUs despite recommendations to limit its use for known resistant infections. Baseline data revealing substantially higher vancomycin use in our NICU compared to peer institutions informed our quality improvement initiative. Our aim was to reduce the vancomycin prescribing rate in neonates hospitalized in our NICU by 50% within 1 year and sustain for 1 year. METHODS: In the 60-bed level IV NICU of an academic referral center, we used a quality improvement framework to develop key drivers and interventions including (1) physician education with benchmarking antibiotic prescribing rates; (2) pharmacy-initiated 48-hour antibiotic time-outs on rounds; (3) development of clinical pathways to standardize empirical antibiotic choices for early-onset sepsis, late-onset sepsis, and necrotizing enterocolitis; coupled with (4) daily prospective audit with feedback from the antimicrobial stewardship program. RESULTS: We used statistical process u-charts to show vancomycin use declined from 112 to 38 days of therapy per 1000 patient-days. After education, pharmacy-initiated 48-hour time-outs, and development of clinical pathways, vancomycin use declined by 29%, and by an additional 52% after implementation of prospective audit with feedback. Vancomycin-associated acute kidney injury also declined from 1.4 to 0.1 events per 1000 patient-days. CONCLUSIONS: Through a sequential implementation approach of education, standardization of care with clinical pathways, pharmacist-initiated 48-hour time-outs, and prospective audit with feedback, vancomycin days of therapy declined by 66% over a 1-year period and has been sustained for 1 year.

Methylene blue for postcardiopulmonary bypass vasoplegic syndrome: A cohort study.

BACKGROUND: Methylene blue (MB) has been used to treat refractory hypotension in a variety of settings. AIMS: We sought to determine whether MB improved blood pressure in postcardiopulmonary bypass (CPB) vasoplegic syndrome (VS) in a complex cardiac surgery population. Furthermore, to determine variables that predicted response to MB. SETTING AND DESIGN: This was conducted in a tertiary care medical center; this study was a retrospective cohort study. MATERIALS AND METHODS: Adult cardiac surgery patients who received MB for post-CPB VS over a 2-year period were studied. Mean arterial blood pressure (MAP) and vasopressor doses were compared before and after MB, and logistic regression was used to model which variables predicted response. RESULTS: Eighty-eight patients received MB for post-CPB VS during the study period. MB administration was associated with an 8 mmHg increase in MAP (P = 0.004), and peak response occurred at 2 h. Variables that were associated with a positive drug response were deep hypothermic circulatory arrest during surgery and higher MAP at the time of drug administration (P = 0.006 and 0.02). A positive response had no correlation with in-hospital mortality (P = 0.09). CONCLUSIONS: MB modestly increases MAP in cardiac surgery patients with VS. Higher MAP at the time of drug administration and surgery with deep hypothermic circulatory arrest predict a greater drug response.

Appropriate Use of Vancomycin in NICU Despite Free-for-All Policy.

OBJECTIVES: Because of increases in antimicrobial resistance, the use of vancomycin in late-onset sepsis has come under scrutiny. The primary outcome of this study was to determine if vancomycin for the treatment of late-onset sepsis in the neonatal intensive care unit (NICU) was being discontinued within 72 hours according to the existing protocol. Secondary outcomes included the appropriateness of therapeutic drug monitoring associated with vancomycin, and renal dysfunction associated with the use of vancomycin in the NICU outside of the 72-hour policy. METHODS: A retrospective chart review was completed for patients in the NICU who received vancomycin for the treatment of late-onset sepsis between the dates of January 1, 2014, and July 1, 2014. RESULTS: There were 125 vancomycin treatment courses, of which 97 were included. Appropriate use of vancomycin, per policy, occurred in a total of 87 of 97 courses (89.6%). Therapeutic drug monitoring was evaluated by the number of appropriate troughs, determined using renal function and previous trough concentrations. There was not a statistically significant difference in the number of inappropriate troughs drawn between those that were continued on vancomycin appropriately (n = 17 courses; 4 of 44 inappropriate troughs) versus inappropriately (n = 10 courses; 1 of 22 inappropriate troughs; p = 0.66), despite the large number of troughs drawn. Adverse renal outcomes were not statistically significant in patients continued inappropriately on vancomycin (p = 1.0). CONCLUSIONS: Vancomycin use in the NICU for late-onset sepsis is appropriate per the existing antibiotic policy. Therapeutic drug monitoring could be improved, and adverse renal outcomes due to inappropriate continuation of vancomycin are rare.