What is the recommended or acceptable soft limit override rate during pump programing?

What is the recommended or acceptable soft limit override rate during pump programing?

Comment by InpharmD Researcher

There is a lack of data to determine whether an acceptable soft limit override rate during pump programming exists, as rationale for overrides may include patient presentation, administered drug, provider discretion, or an amalgamation of reasons. Published studies in different clinical scenarios report a wide range of soft limit override rates, with one study reporting only 4-6% of alerts resulting in edits. Notably, high override rates may increase risk of error and reduce effectiveness of smart infusion pumps.

Background

While the 2017 Clinical Practice Guideline on Safe Medication Use in the ICU did not specify a single acceptable soft-limit override rate, it noted that excessive alert overrides and drug library bypasses can limit the effectiveness of smart infusion pumps. Available evidence suggests that smart pumps may reduce medication errors and adverse drug events related to incorrect infusion rates; however, studies have shown that high override rates may diminish these benefits. As a result, the guideline does not recommend a specific override-rate threshold and instead supports institution-specific monitoring and optimization of drug library alerts and override limits through a multidisciplinary approach to promote safe medication administration. [1]

A 2014 systematic review analyzed the benefits and risks associated with the use of smart infusion pumps in healthcare settings, focusing on their impact on medication error rates. It was mentioned that smart pumps were associated with reductions in programming errors, particularly wrong-dose, wrong-rate, and pump-setting errors; however, they did not eliminate medication errors. The review identified low compliance with drug library use, bypassing of safety features, and frequent overrides of soft alerts as important limitations. The authors noted that hard limits were generally more effective than soft limits because soft alerts could be overridden and emphasized the importance of optimizing drug libraries, minimizing unnecessary alerts, and using continuous quality improvement processes to maximize the safety benefits of smart pump technology. [2]

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

What is the recommended or acceptable soft limit override rate during pump programing?

Level of evidence

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Please see Tables 1-2 for your response.

Smart pumps improve medication safety but increase alert burden in neonatal care
Design	Retrospective study using smart pump records N= 370,000 infusion starts
Objective	To assess whether smart pumps are effective at reducing medication errors in the neonatal population and determine whether they are a source of alert burden and alert fatigue in an intensive care environment
Study Groups	All infusion starts (N= 370,000)
Inclusion Criteria	Neonates and infants hospitalized in a level IV NICU from 2014 to 2016
Exclusion Criteria	Not specified
Methods	Using smart pump records, over 370,000 infusion starts for continuously infused medications were evaluated. Attempts to exceed preset soft and hard maximum limits, percent variance from those limits, and pump alert frequency, patterns, and salience were evaluated. Data were analyzed for alert frequency, compliance with drug library, user response to alerts, and alert burden by time and medication.
Duration	January 2014 to December 2016
Outcome Measures	Primary: Prevention of medication errors by smart pumps Secondary: Alert burden and alert fatigue, compliance with dose error reduction software, alert salience
Baseline Characteristics		All patients (N= 370,000 infusion starts)
	Average gestational age, weeks	35
	Average length of stay, days	23
Results		All infusion starts (N= 370,000)	p-value
	Infusion starts with alerts, %	4.3%	<0.0001
	Alerts overridden, %	73.6%	<0.0001
	Alerts cancelled, %	23.3%	<0.0001
	Alerts reprogrammed, %	3.1%	<0.0001
Study Author Conclusions	Smart pumps have the ability to improve neonatal medication safety when compliance with dose error reducing software is high. Numerous attempts to administer high doses were intercepted by dosing alerts. Clustered alerts may generate a high alert burden and limit safety benefit by desensitizing providers to alerts. Future efforts should address ways to improve alert salience.
Critique	The study provides valuable insights into the effectiveness of smart pumps in reducing medication errors in neonates. However, the retrospective design and focus on a single NICU may limit the generalizability of the findings. The study highlights the issue of alert fatigue, but does not provide solutions to mitigate this problem. Additionally, the exclusion criteria were not specified, which may affect the interpretation of the results.

References:
[1] [1] Melton KR, Timmons K, Walsh KE, Meinzen-Derr JK, Kirkendall E. Smart pumps improve medication safety but increase alert burden in neonatal care. BMC Med Inform Decis Mak. 2019;19(1):213. Published 2019 Nov 7. doi:10.1186/s12911-019-0945-2

Continuous quality improvement using intelligent infusion pump data analysis
Design	Practice report in a community teaching hospital
Objective	To describe the use of continuous quality-improvement processes in the implementation of intelligent infusion pumps in a community teaching hospital
Study Groups	Not applicable
Inclusion Criteria	Not applicable
Exclusion Criteria	Not applicable
Methods	Implementation of intelligent infusion pumps with server-based safety software, creation of drug libraries, and continuous quality improvement (CQI) processes to refine safety limits and improve compliance. Data analysis from infusion practices to identify CQI initiatives
Duration	Implementation began May 2, 2006, with data collection and analysis from June 2007 to December 2009
Outcome Measures	Compliance rates with safety software use
Baseline Characteristics	Not applicable
Results	Date (mm/yy)	Compliance Rate (%)
	November 2006	33%
	February 2007	39%
	November 2007	59%
	November 2008	97%
	December 2009	98%
	Infusion edits, defined as reprogramming done in response to alerts, remained relatively stable, ranging from 0.4% to 1.2% throughout the study period. In contrast, overrides—instances where initial infusion rates were not adhered to despite alerts—showed a rising trend until March or April 2008 before declining, except for a temporary increase between August and November 2008. Four major revisions to drug libraries were made during this time, possibly influencing these trends. As libraries became more refined and user-friendly, a decrease in overrides was expected. Only 4–6% of soft limit alerts resulted in edits (data presented in a figure).
Adverse Events	Not applicable
Study Author Conclusions	Compliance rates for use of infusion pump safety software varied among CCAs over time. Education, auditing, and refinement of drug libraries led to improved compliance in most CCAs.
Critique	The study highlights the successful implementation of intelligent infusion pumps and the importance of continuous education and CQI processes. However, the lack of a control group and the focus on a single institution may limit the generalizability of the findings. The study also does not provide detailed quantitative data on the reduction of adverse drug events.

References:
[1] [1] Breland BD. Continuous quality improvement using intelligent infusion pump data analysis. Am J Health Syst Pharm. 2010;67(17):1446-1455. doi:10.2146/ajhp090588