Presentation
Multiple Indications, Multiple Dosing Instructions, One Packaging Solution: A Human Factors Approach to Reducing the Risk of Tenecteplase Dosing Errors Across a Multi-Site Healthcare System
SessionApplied Methods (HE9)
DescriptionThis presentation will describe the challenges presented by off-label use of a medication and how the application of human factors methods and principles were used to reduce the risks associated with this hazard.
Tenecteplase (TNK) is a thrombolytic that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute myocardial infarction (MI). This is the only FDA-approved indication for TNK. However, TNK has widely become the preferred drug for acute ischemic stroke across many healthcare systems due to the ease of administration at the bedside. Time to administration has a significant impact on the effectiveness of early stroke intervention. When compared to alternate thrombolytics used for acute ischemic stroke (i.e., Alteplase), TNK is comparable in clinical effectiveness and substantially faster to prepare and administer (Wang et al., 2024), with reconstitution taking only one minute and administration being completed with a single bolus.
Although beneficial, there is a medication safety risk associated with the off-label use of TNK because the dosing varies based on the indication it is being used for. The maximum dose for stroke is only half of the maximum dose for MI, which may result in a potentially serious adverse event for a patient if the incorrect dosing is used. The manufacturer’s packaging can only include dosing information for the FDA-approved indication of MI. This increases the risk of dosing errors since the labeling being referred to at the bedside excludes the dosing for stroke. If the MI dosing on the manufacturer’s label is referred to and accidentally used, a stroke patient will have received double the intended dose, ultimately increasing their risk of bleeding.
At MedStar Health, a large healthcare system in the Baltimore-Washington metropolitan area with nine acute care hospitals, TNK for stroke was adopted on a rolling basis, with each hospital employing their own strategies for addressing this risk. Strategies included placing stickers over the MI information on the manufacture’s box or training users not to use the box for stroke dosing information. Inconsistencies in the execution of these strategies left gaps that contributed to confusion and near miss events. The system pharmacy team identified the need for a systemwide solution to reduce the likelihood of dosing errors across MedStar Health.
Developing a solution that accommodated the complexities and variability of TNK usage across multiple hospitals was a project well suited for the application of human factors and safety science principles. MedStar Health’s system pharmacy and patient safety teams collaborated to conduct a proactive risk assessment on potential mitigation strategies in order to create one standardized solution for the system. Representatives from various disciplines and hospitals were interviewed to fully understand current state and obtain feedback from those who would be directly impacted by any changes.
While gathering information in interviews and observations, team members asked interviewees about their perceived risks, challenges, and pain points associated with several potential options for a repackaging solution. These options included the following:
1. Separate packages for different indications
2. One package with dosing instructions for all indications
3. One package with no dosing instructions, requiring users to locate the information elsewhere (e.g., the electronic order or dosing cards located outside of the packaging).
Key risks factors that were identified included the following:
• Managing the workflow for repackaging locally at each hospital was a heavy lift for pharmacy staff. Low staffing numbers and turnover had contributed to packaging and stocking errors at some entities.
• TNK usage varied widely across the system. The vast majority of TNK usage is for stroke, with most hospitals having only ever used it for this indication. However, two hospitals had used it for MI, and one had used it for massive pulmonary embolism (PE; another off-label usage of TNK with the same dosing as MI). Additionally, usage of TNK for MI and massive PE may increase across the system in the future.
• Some hospitals have designated stroke response teams who would be responsible for the vast majority of TNK administration, while other hospitals do not. Targeted TNK training is more difficult at hospitals without stroke response teams.
• While it is expected that the electronic order will always be used as the source of truth for dosing information, there are scenarios in which this does not occur (e.g., an order has not been placed at the time of administration). This gap between “work-as-imaged” and “work-as-done” contributed to apprehension around removal of dosing instructions from the packaging across disciplines.
• Employing separate packaging strategies for each indication would introduce complex repackaging and informatics workflows to ensure proper coding, billing, stocking, and barcode scanning. The required workflow for this potential strategy presented many significant opportunities for error.
Proactively evaluating the risks associated with the potential solutions, it was determined that a single package with all dosing instructions carried the least amount of uncontrollable risk. Items from the manufacturer’s package are now removed from the box and placed in a heat-sealed plastic bag with a single dosing card that clearly distinguishes the different dosing instructions. The design of this card employs human factors design principles, such as the use of color to separate the instructions and graphics to guide the user to the correct location on the card. For example, brain, heart, and lung icons are used as visual cues within the stroke, MI, and PE instruction sections, respectively. Additionally, to further reduce the chance of using the incorrect dosing instructions, all information has been arranged onto a single-sided piece of paper. This raises awareness that there are different dosing instructions without a user having to reference multiple sheets or sides of paper. This TNK repackaging solution gives the care teams the information they need, at the time they need it, in a clear and usable format – regardless of the indication or hospital.
It was also evident that a single, centrally managed workflow for repackaging presented fewer opportunities for error. Furthermore, shifting this responsibility from the hospitals to the system pharmacy team would have a positive impact on the workload of hospital-based teams. Repackaged TNK is now ordered and distributed to each hospital via the centralized medication distribution process.
This presentation will describe the complexities of creating a single solution for a multi-hospital system and share details on the final solution that was implemented. While the specific project described in this presentation applies to a single medication, the methods, challenges, and learnings are applicable to many safety improvement opportunities within complex healthcare systems. Additionally, this work highlights the importance of partnerships between human factors practitioners, patient safety teams, and clinical leadership to increase the effectiveness of safety improvement work.
Tenecteplase (TNK) is a thrombolytic that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute myocardial infarction (MI). This is the only FDA-approved indication for TNK. However, TNK has widely become the preferred drug for acute ischemic stroke across many healthcare systems due to the ease of administration at the bedside. Time to administration has a significant impact on the effectiveness of early stroke intervention. When compared to alternate thrombolytics used for acute ischemic stroke (i.e., Alteplase), TNK is comparable in clinical effectiveness and substantially faster to prepare and administer (Wang et al., 2024), with reconstitution taking only one minute and administration being completed with a single bolus.
Although beneficial, there is a medication safety risk associated with the off-label use of TNK because the dosing varies based on the indication it is being used for. The maximum dose for stroke is only half of the maximum dose for MI, which may result in a potentially serious adverse event for a patient if the incorrect dosing is used. The manufacturer’s packaging can only include dosing information for the FDA-approved indication of MI. This increases the risk of dosing errors since the labeling being referred to at the bedside excludes the dosing for stroke. If the MI dosing on the manufacturer’s label is referred to and accidentally used, a stroke patient will have received double the intended dose, ultimately increasing their risk of bleeding.
At MedStar Health, a large healthcare system in the Baltimore-Washington metropolitan area with nine acute care hospitals, TNK for stroke was adopted on a rolling basis, with each hospital employing their own strategies for addressing this risk. Strategies included placing stickers over the MI information on the manufacture’s box or training users not to use the box for stroke dosing information. Inconsistencies in the execution of these strategies left gaps that contributed to confusion and near miss events. The system pharmacy team identified the need for a systemwide solution to reduce the likelihood of dosing errors across MedStar Health.
Developing a solution that accommodated the complexities and variability of TNK usage across multiple hospitals was a project well suited for the application of human factors and safety science principles. MedStar Health’s system pharmacy and patient safety teams collaborated to conduct a proactive risk assessment on potential mitigation strategies in order to create one standardized solution for the system. Representatives from various disciplines and hospitals were interviewed to fully understand current state and obtain feedback from those who would be directly impacted by any changes.
While gathering information in interviews and observations, team members asked interviewees about their perceived risks, challenges, and pain points associated with several potential options for a repackaging solution. These options included the following:
1. Separate packages for different indications
2. One package with dosing instructions for all indications
3. One package with no dosing instructions, requiring users to locate the information elsewhere (e.g., the electronic order or dosing cards located outside of the packaging).
Key risks factors that were identified included the following:
• Managing the workflow for repackaging locally at each hospital was a heavy lift for pharmacy staff. Low staffing numbers and turnover had contributed to packaging and stocking errors at some entities.
• TNK usage varied widely across the system. The vast majority of TNK usage is for stroke, with most hospitals having only ever used it for this indication. However, two hospitals had used it for MI, and one had used it for massive pulmonary embolism (PE; another off-label usage of TNK with the same dosing as MI). Additionally, usage of TNK for MI and massive PE may increase across the system in the future.
• Some hospitals have designated stroke response teams who would be responsible for the vast majority of TNK administration, while other hospitals do not. Targeted TNK training is more difficult at hospitals without stroke response teams.
• While it is expected that the electronic order will always be used as the source of truth for dosing information, there are scenarios in which this does not occur (e.g., an order has not been placed at the time of administration). This gap between “work-as-imaged” and “work-as-done” contributed to apprehension around removal of dosing instructions from the packaging across disciplines.
• Employing separate packaging strategies for each indication would introduce complex repackaging and informatics workflows to ensure proper coding, billing, stocking, and barcode scanning. The required workflow for this potential strategy presented many significant opportunities for error.
Proactively evaluating the risks associated with the potential solutions, it was determined that a single package with all dosing instructions carried the least amount of uncontrollable risk. Items from the manufacturer’s package are now removed from the box and placed in a heat-sealed plastic bag with a single dosing card that clearly distinguishes the different dosing instructions. The design of this card employs human factors design principles, such as the use of color to separate the instructions and graphics to guide the user to the correct location on the card. For example, brain, heart, and lung icons are used as visual cues within the stroke, MI, and PE instruction sections, respectively. Additionally, to further reduce the chance of using the incorrect dosing instructions, all information has been arranged onto a single-sided piece of paper. This raises awareness that there are different dosing instructions without a user having to reference multiple sheets or sides of paper. This TNK repackaging solution gives the care teams the information they need, at the time they need it, in a clear and usable format – regardless of the indication or hospital.
It was also evident that a single, centrally managed workflow for repackaging presented fewer opportunities for error. Furthermore, shifting this responsibility from the hospitals to the system pharmacy team would have a positive impact on the workload of hospital-based teams. Repackaged TNK is now ordered and distributed to each hospital via the centralized medication distribution process.
This presentation will describe the complexities of creating a single solution for a multi-hospital system and share details on the final solution that was implemented. While the specific project described in this presentation applies to a single medication, the methods, challenges, and learnings are applicable to many safety improvement opportunities within complex healthcare systems. Additionally, this work highlights the importance of partnerships between human factors practitioners, patient safety teams, and clinical leadership to increase the effectiveness of safety improvement work.
Authors
Event Type
Oral Presentations
TimeWednesday, April 211:37am - 12:00pm EDT
LocationHarbour C
Hospital Environments (HE)