Medication Safety - PDF

Medication Safety and Quality Improvement Donald McKaig, RPh Lifespan Pharmacy Director Medication Safety, Quality, and Information Technology Objectives Understand the Swiss Cheese Model of error causation. Describe the concepts of continuous quality improvement...

Medication Safety and Quality Improvement Donald McKaig, RPh Lifespan Pharmacy Director Medication Safety, Quality, and Information Technology Objectives Understand the Swiss Cheese Model of error causation. Describe the concepts of continuous quality improvement (CQI) and examples of methodologies (e.g., Lean, Six Sigma, PDCA cycles). Identify the characteristics of high reliability organizations (HRO) that can help reduce the risk of errors and patient harm. Describe how these HRO characteristics are critical for organizations to be able to respond to evolving threats. Apply specific strategies from HROs to identify opportunities for improvement and implement effective safeguards to reduce the risk of errors and patient harm. Explore concepts of Just Culture and importance in establishing a safe and reliable culture. Evaluate case reports to explain ways in which system and human factors can lead to failure and patient harm.  The Swiss Cheese Model Reason J. Human error: models and management. West J Med. 2000;172(6):393-396.  Medication Safety Closed Loop Lifespan Inpatient Hospitals Prescribing ✓ Clinical Decision Support Order Review ✓ Electronic order sets ✓ Clinical Decision Support ✓ Electronic CPOE interface ✓ Lab results interface ✓ Alerts; max dose, drug-specific, CPOE drug-lab Pharmacy Medication System Administration barcode scanning Smart pumps with ✓ Right Patient ✓ Right Form interoperability ✓ Right Drug ✓ Right Time ✓ Right Dose ✓ Right Rate Electronic Charting Automated Dispensing Dispensing ✓ Interface with Pharmacy ✓ Restricted override Transcription ✓ Guiding light technology ✓ Barcode verification ✓ Med admin profile populates directly from Pharmacy ✓Automatic charting of admin when drug scanned Swiss Cheese Holes: Look-Alike/Sound-Alike Medications  Swiss Cheese Holes: Distractions and interruptions Studies indicate frequent interruptions in healthcare Distractions or interruptions as frequently as every 2 minutes†. Interruptions increase risk of medication errors‡. Interruptions for nursing during medication preparation and administration associated with ~12% increase in procedural failures and clinical errors. Higher severity errors associated with number of interruptions. Strategies to reduce distractions/interruptions Define critical tasks, create “no interruption zones” if possible. Limit alarms, alerts, noise, disruptions from phone calls. Establish process for electronic messaging or asynchronous communication for non- urgent matters. Encourage reporting and mitigate factors leading to distraction/interruption. †https://psnet.ahrq.gov/perspective/interruptions-and-distractions-health-care-improved-safety-mindfulness. (Accessed 4/15/24) ‡Westbrook JI, Woods A, Rob MI, Dunsmuir WTM, Day RO. Association of Interruptions With an Increased Risk and Severity of Medication Administration Errors. Arch Intern Med. 2010;170(8):683–690. doi:10.1001/archinternmed.2010.65  Emerging threats to safe medication systems Pandemic disrupted learning Administering a medication even Healthcare workforce crisis impact opportunities though the barcode will not scan Burnout, anxiety, and depression Reduced mindfulness around culture of Retroactively charting after a Workplace violence increasing safety medication is administered (back- Supply chain vulnerabilities and Healthcare workforce crisis charting) drug shortages continuing – Shortage of trainers and training Scanning barcodes from sources programs other than the medication itself – Experiential knowledge-pool (i.e., proxy scanning) draining Not understanding a BCMA system – Burnout alert (e.g., wrong time, medication not on patient profile), yet still administering the medication https://www.nbcbayarea.com/investigations/number-of-ca-pharmacy-error-investigations-spiked-during-covid/2849130/ (accessed 3/21/23) Image from https://khn.org/news/home-health-agencies-often-miss-medication-errors-endangering-patients/ Key event details 66 year-old woman being discharged from hospital. Nurse from hospital calls local pharmacy with discharge prescriptions including one for metolazone 2.5 mg. Pharmacy technician receives and transcribes telephone orders. Technician unfamiliar with medication being called in and uses pharmacy system to reference drug names, types “MET 2.5” Technician chooses entry for “methotrexate 2.5 mg” and enters with a frequency of “take one tablet daily”. Pharmacist fails to identify the error during prescription check process. During pickup, patient husband offered counseling, declines. Home care nursing fails to pick up on the error during home visit. Patient takes methotrexate daily for two weeks, brought to hospital with mouth sores, abnormal bleeding—dies after short hospitalization. The Aftermath Wrongful death suit filed by family. Seeking compensatory damages and additional damages for “aggravating circumstances”. $2 million awarded for compensatory damages, but court did not allow for damages for aggravating circumstances. Appeal filed by family—decision reversed on appeal and damages for aggravating circumstances allowed, citing: Pharmacist failure to review prescription. Technician receiving phone prescriptions (in violation of company policy). Failure to counsel for high-risk medication. Conclusion that pharmacy had made “no meaningful changes to its procedures as a result of [the patient’s] death”.  Pharmacy manager statements from court documentation when asked about changes made following this event: Acknowledged that while [pharmacist’s] failure to review [patient’s] prescriptions was “a breakdown in the system”, they also testified that “she was unaware of any way in which [the organization] could have prevented the outcome in this case”. Noted that in response to the error pharmacists “have had in-depth conversation about being more conscientious than we already were, you know, just trying to be more safe in everything that we do.” Continuous Quality Improvement (CQI) “Continuous quality improvement” is a structured process to identify and document quality related events (QREs) and to identify and address root causes of error to improve patient care. A “quality-related event (QRE)” is an error, adverse incident, near miss, or unsafe condition that occurs in the review, preparation, dispensing or administration of medications by pharmacy staff. Why CQI? Improved patient safety Improved employee satisfaction and engagement Required by state boards of pharmacy as part of pharmacy practice standards  Continuous Quality Improvement (CQI) Methodologies Lean Six Sigma 6-σ PDSA Cycle “Voice of the customer” Eliminate variation in process Sustained, measured improvement Identify and eliminate waste  Lean and Six Sigma PERFORMANCE IMPROVEMENT Lean Six Sigma Eliminates Waste Eliminates Variation 6  = 3.4 defects/million opportunities Toyota Motorola Consistent; Faster; Attain High More Efficient Reliability Achieves Simplicity Achieves Stability  7 Principles of Lean Management Respect people—Gemba walk Eliminate waste Ensure quality through testing Create and encourage knowledge Keep options open Deliver fast Optimize  Six Sigma Methodology D M A I C Define Measure Analyze Improve Control 30 Day 60 Day 90 Day Project Closure Rapid Cycle Testing Using Lean Concepts Hardwiring using Control Plans  Sound Familiar? DMAIC (Process) SOAP (Patient) DEFINE SUBJECTVE MEASURE OBJECTIVE ANALYZE ASSESSMENT IMPROVE PLAN CONTROL Adjust plan, monitor patient Plan, Do, Study, Act Plan the test, including data collection strategy Do the test, running on a small scale Study the results, analyzing and comparing to expectations Act on what you learned, planning for the next step and cycle Adapt and modify your approach Adopt what worked on larger scale Abandon if did not add value High Reliability Organizations (HROs)  High Reliability Organization Background High Reliability Organizations (HROs) are organizations that operate in complex, high hazard domains for extended periods without serious accidents or catastrophic failures. ✓Goal is NOT zero errors or hazards. ✓Goes beyond just standardization. ✓Condition of persistent mindfulness of hazards. ✓Safety prioritized over time pressures. ✓Staff have authority and responsibility to maintain safety. Weick KE; Sutcliffe KM. San Francisco, CA: Jossey-Bass; 2015. ISBN-13: 9781118862414. A few organizations get outstanding results with average people working in brilliant systems, but most organizations get mediocre results by hiring brilliant people to fight their way through broken systems* *Graban (2009) Lean Hospitals: Improving Quality, Patient Safety, and Employee Satisfaction.  High Reliability Organization Characteristics Reluctance to simplify. Preoccupation with failure. Sensitivity to operations. Deference to expertise. Commitment to resilience. Weick KE; Sutcliffe KM. San Francisco, CA: Jossey-Bass; 2015. ISBN-13: 9781118862414. Reluctance to Simplify. Resist simplifying the understanding of work processes and how and why things fail and succeed. Acknowledge systems are complex and dynamic. Seek underlying rather than surface explanations. Recognize value of standardization to workflows to reduce variation. Appreciate the complexity in the number of teams, processes, and relationships involved in conducting daily operations. Preoccupation With Failure. The team is actively aware of and thinking about potential failure. Acknowledge that new threats emerge unexpectedly. Pay close attention to weak signals of potential problems. Absence of errors does not create complacency, but increased vigilance. Near misses are viewed as learning opportunity and not evidence of safety. Preoccupation With Failure—Taking Action! Talk about safety as part of daily work. Promote use of internal medication error reporting systems. Actual and prevented errors Process for documenting and analyzing trends in errors Review and assess external information on medication errors. FDA Alerts Institute for Safe Medication Practices (ISMP) Medication Safety Alerts and Self- Assessments Failure Mode Effect Analysis (FMEA) Performed proactively on a process Identify all steps in the process What could go wrong at each step and…why? What would be the consequence of failure? How effective are our current safeguards? Implement improved or additional safeguards to reduce risk of error FMEA in Focus: Insulin multi-dose change High levels of insulin waste and related costs. Rework and wasted resources dispensing and re-dispensing insulin vials. In 2023 YTD (all hospitals): >13,000 med messages sent by nursing requesting lispro/glargine (~42 per day) Delays in patient care waiting for insulin to be sent to patient units. Risk of “sharing” vials while waiting for new vial to be sent—infection risk Regulatory and safety risks of unsecured insulin vials, vials left behind in patient boxes in rooms where used. Standard practice at most health systems.  Multi-Use Insulin High Level Process Insulin vial added Nurse removes Nurse prepares to Omnicell as vial of insulin from insulin dose, labels “standard stock” the Omnicell syringe at Omnicell Nurse Two RN check Nurse returns administers and signoff in insulin vial to insulin to patient LifeChart Omnicell 7/29/2024 Prepared by Pharmacy Services  Failure Mode and Effects Analysis (FMEA) Risk Priority Scoring Rubric 7/29/2024 Prepared by Pharmacy Services  Failure Mode and Effects Analysis (FMEA) Example—Nursing prepares/labels syringe 7/29/2024 Prepared by Pharmacy Services FMEA Results—Top 20 causes of process failure FMEA Analysis—Mitigated Risk of Failure Process with added Risk Priority Number Process w/ current mitigation strategies in (RPN) controls place 400 or higher 5 0 300-399 6 4 100-299 8 10 Less than 100 11 16 To Err is Human Understanding Root Causes of Failure and a Just Culture Approach to Responding to Medication Errors Commitment to Resilience—Root Cause Analysis Form a team Include all stakeholders Determine what happened Ask “5 whys” Flowchart workflows Identify root causes of failure Document specific causes of failure Be specific, cause and effect Develop action plan and measures “Why Ask the Five Whys”? The Washington Monument is Disintegrating… Why? #1 The chemicals used to clean it are too harsh. Why? #2 There are a lot of bird droppings on the monument. Birds like to eat spiders and there are a LOT of spiders on the Why? #3 monument. Spiders like to eat gnats and there are a LOT of gnats around Why? #4 the monument. Gnats are attracted to lights at dusk and there are a LOT of Why? #5 lights illuminating the monument at dusk. Root Cause? Lights turned on at dusk attract a large number of gnats. Solution! Turn lights on at the monument at a later time Developing an Effective Action Plan Sensitivity to Operations. Strive to maintain a high awareness of operational conditions. Promote “big picture understanding” or “situational awareness”. Understand the context of the current state of their work in relation to the entire unit. Awareness for staff of what is going on around them. Understand how the current state might support or threaten safety. Sensitivity to Operations—Taking Action! Leadership engagement in day-to-day operations. Huddles and touchbases. Measure things that matter. Identify and address patterns of “normalization of deviance”. Institutionalization New staff shown at-risk behaviors as part of the norm Socialization Rewards and punishments based on willingness of person to adopt at-risk behavior Rationalization At-risk behavior promoted as acceptable and even necessary to “get the job done” Bus Horiz. 2010 ; 53(2): 139. doi:10.1016/j.bushor.2009.10.006  Data reviewed to monitor medication use systems ✓Staff reported safety events ✓Barcode scanning for meds ✓Omnicell overrides ✓Smart pump library compliance ✓Temperature excursions ✓Pharmacist interventions ✓Dashboards and scorecards ✓Staff engagement survey Deference to Expertise. Appreciate that people closest to the work are the most knowledgeable. Understand that person with the greatest knowledge might not be the person with the highest status and seniority. Create a spirit of curiosity and learning by de-emphasizing hierarchy. Organizational climate is such that all staff members are comfortable speaking up about potential safety problems.  Deference to Expertise—Taking Action! Establish and promote open lines of communication with staff Staff huddles Reward and recognition for safe practices, reporting Establish an environment of “psychological safety” Focus on what’s right, not who’s right. Increases likelihood of reporting errors Commitment to Resilience. Recognize errors will happen, commit to ensuring that errors do not lead to harm or disable the system. Develop fundamental understanding of unpredictable nature of system failures. “I’ve never seen this fire before”. Everyone practices performing rapid assessments of and responses to challenging situations. Identify potential safety threats quickly and respond before safety problems cause harm to mitigate the seriousness of the event. Utilize tools to help investigate errors to gain deeper understanding of potential causes of failure  Just Culture “Just culture refers to a values-supportive model of shared accountability. It's a culture that holds organizations accountable for the systems they design and for how they respond to staff behaviors fairly and justly. In turn, staff members are accountable for the quality of their choices and for reporting both their errors and system vulnerabilities.” Boysen PG 2nd. Just culture: a foundation for balanced accountability and patient safety. Ochsner J. 2013;13(3):400-406. Just Culture in the News… Behaviors That Can Be Expected in a Just Culture Human Error At-Risk Behavior Reckless Behavior Human Error Inevitable, unpredictable, unintentional failure Not related to a behavioral choice Failures of execution Skill-based mistake: “Slips or lapses” Confusing two look-alike/sound-alike medications Forgetting to order a laboratory test for vancomycin Failures of planning Rule-based: Not correctly programming a Smart Pump Knowledge based: Prescribing a drug based on incorrect body weight Institute for Safe Medication Practices (ISMP). The Differences Between Human Error, At-Risk Behavior, and Reckless Behavior Are Key to a Just Culture; 2020. Human Error When human error has occurred, ensure the individual should be consoled Potential severity of the error outcome should play no role in how individuals are treated (avoid “severity bias”). All individuals are treated fairly when they report their mistakes. Institute for Safe Medication Practices (ISMP). The Differences Between Human Error, At-Risk Behavior, and Reckless Behavior Are Key to a Just Culture; 2020. At-Risk Behavior Behavioral choices that are made when individuals have lost the perception of risk associated with the choice or mistakenly believe the risk to be insignificant or justified Institute for Safe Medication Practices (ISMP). The Differences Between Human Error, At-Risk Behavior, and Reckless Behavior Are Key to a Just Culture; 2020. At-Risk Behavior If at-risk behavior is identified, coaching is needed Productive conversation that helps the individual to see the risk associated with their behavioral choice Meant to raise awareness of the situation and help to identify reasons why it occurred and ways to fix the system Institute for Safe Medication Practices (ISMP). The Differences Between Human Error, At-Risk Behavior, and Reckless Behavior Are Key to a Just Culture; 2020. Reckless Behavior Conscious disregard of a substantial and unjustifiable risk The risk they are taking is substantial Others are not engaging in this behavior Recognition of the substantial and unjustifiable risk If reckless behavior is identified, discipline is needed. Swift action required System redesign may be helpful to protect against future behavior Institute for Safe Medication Practices (ISMP). The Differences Between Human Error, At-Risk Behavior, and Reckless Behavior Are Key to a Just Culture; 2020. Substitution Test “Could someone else on the team with the same experience and level of training have done the same thing?” Prevents an unreasonable standard of evaluating behavior, such as: “Would an expert given days or weeks to analyze a situation knowing the outcome of your choice and having information you could not know have done the same thing?”  “The Gray Area” “The quickest way to get you killed on a manned space flight is to not follow standard operating procedure”. “The second quickest way to get you killed is to always follow standard operating procedure”. Karol Joseph "Bo" Bobko, Space Shuttle Pilot on 3 missions Wrap Up and Key Points Continuous quality improvement (CQI) is a structured processes that improves patient safety and is a critical component of safe and reliable healthcare delivery models. Medication errors that cause harm are usually due to multiple points of failure due to human and system-related factors. A Just Culture is critical to establishing shared accountability for organizations and staff and to ensure appropriate response when an error occurs. Implementing strategies used by High Reliability Organizations (HRO) can help identify ways to proactively reduce risk of error and to quickly respond to emerging threats, such as a worldwide pandemic. Want to read more on Just Culture and High Reliability? Let’s Chat!