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.

10,000 Good Catches: Increasing Safety Event Reporting In A Pediatric Health Care System.

BACKGROUND: In 2014, Children's National Health System's executive leadership team challenged the organization to double the number of voluntary safety event reports submitted over a 3-year period; the intent was to increase reliability and promote our safety culture by hardwiring employee event reporting. METHODS: Following a Donabedian quality improvement framework of structure, process, and outcomes, a multidisciplinary team was formed and areas for improvement were identified. The multidisciplinary team focused on 3 major areas: the perceived ease of reporting (ie, how difficult is it to report an event?); the perceived safety of reporting (ie, will I get in trouble for reporting?); and the perceived impact of reporting (ie, does my report make a difference?) technology, making it safe to report, and how reporting makes a difference. The team developed a key driver diagram and implemented interventions designed to impact the key drivers and to increase reporting. RESULTS: Children's National increased the number of safety event reports from 4,668 in fiscal year 2014 to 10,971 safety event reports in fiscal year 2017. Median event report submission time was decreased by nearly 30%, anonymous reporting decreased by 69%, the number of submitting departments increased by 94%, and the number of reports submitted as "other" decreased from a baseline of 6% to 2%. CONCLUSIONS: Children's National Health System's focus on increasing safety event reporting resulted in increased organizational engagement and attention. This initiative served as a tangible step to improve organizational reliability and the culture of safety and is readily generalizable to other hospitals.