Medication Event Prevention and Error Reduction James D. Newman Human Performance Consultant Kristin C. Klein, PharmD, FPPAG Clinical Associate Professor and Clinical Specialist University of Michigan

The speakers have no actual or potential conflicts of interest in relation to this presentation.

Have you ever been involved in an serious medication error that wasn’t reported? A. Yes B. No

To err is human… 44,000-98,000 deaths/year due to preventable medical errors in the United States Less than cancer and heart disease In the same range as influenza, pneumonia, diabetes, and alzheimer’s IOM estimates that a hospitalized patient is at risk of 1 medication error per day Kohn LT, ed, Corrigan J, ed, Donaldson MS, ed. To Err Is Human. Centers for Disease Control and Prevention. IOM. Preventing medication errors.

Common Principles of Human Performance 1. People are fallible 2. Error-likely situations are predictable 3. Individual behaviors are influenced 4. Operational upsets can be avoided 5. People achieve high levels of performance based encouragement and reinforcement

Human Limitations

Medication Errors Definition: "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer“ “Do no harm”

Human Error Types: Can occur at any point in medication use process Active Errors Change equipment, system or processes that trigger immediate undesired consequences Unsafe act committed directly by a person in contact with the patient or system Latent Errors Result in undetected organization-related weaknesses or equipment flaws that lie dormant Failures within the system that may trigger an event when combined with an active failure Reason J. BMJ 2000;320:

Medication Use Process Prescribing Physician Nurse Practitioner PA Pharmacist Transcribing Physician PA, NP Nurse Unit clerk Pharmacist Dispensing Pharmacist Pharmacy intern Pharmacy technician Administering Nurse Pharmacist Monitoring Physician PA, NP Nurse Pharmacist Adapted from: IOM. Preventing medication errors.

What is Human Performance? An individual… …working within organizational systems… …to meet expectations set by leaders.

What is a Human Performance Improvement Program? A program embedded into the workflow of a system that is designed to prevent, detect, and correct human error When an error happens, this system’s resilience is tested How an error is treated after it is discovered or revealed unveils the culture of the people within the system

Why should I care? What kinds of things do we do to reduce consequence? So what are we afraid of? What motivates us to prevent errors? What motivates you? Threats of sanctions in the real world – medical industry: law suits built into the legal system

Human Performance Definitions Error: An unintentional deviation from an expected behavior Violation: Deliberate, intentional acts to evade a known policy or procedure requirement for personal advantage usually adopted for fun, comfort, expedience, or convenience

Origins of Human Error Slip, trip, or lapse Human Errors Operational Upsets System Induced Errors Equipment Failure Human Error

Human Limitations Stress Avoidance of mental strain Inaccurate mental models Limited working memory Limited attention resources Mind set Difficulty seeing own errors Limited perspective Susceptible to emotion Focus on the goal Fatigue

Hazardous Attitudes Pride: “Don’t insult my intelligence.” Heroic: “Ill get it done, by hook or by crook.” Invulnerable: “That can’t happen to me.” Fatalistic: “What’s the use?” Bald Tire: “Gone 60K miles without a flat yet.” Summit Fever: “We’re almost done.” Pollyanna: “Nothing bad will happen.”

Error Precursors (TWIN) Limited short-term memory Personality conflicts Mental shortcuts (biases) Lack of alternative indication Inaccurate risk perception (Pollyanna) Unexpected equipment conditions Mindset (“tuned” to see) Hidden system response Complacency / Overconfidence Workarounds / OOS instruments Assumptions (inaccurate mental picture) Confusing displays or controls Habit patterns Changes / Departures from routine Stress (limits attention) Distractions / Interruptions Illness / Fatigue Lack of or unclear standards “Hazardous” attitude for critical task Unclear goals, roles, & responsibilities Indistinct problem-solving skills Interpretation requirements Lack of proficiency / Inexperience Irrecoverable acts Imprecise communication habits Repetitive actions, monotonous New technique not used before Simultaneous, multiple tasks Lack of knowledge (mental model) High Workload (memory requirements) Unfamiliarity w/ task / First time Time pressure (in a hurry) Individual Capabilities Task Demands Human NatureWork Environment

View on Human Error Old Human error is a cause of accidents To explain failure, investigations must seek failure They must find people’s inaccurate assessments, wrong decisions and bad judgments New Human error is a symptom of trouble deeper inside a system To explain failure, do not try to find where people went wrong Instead, find how people’s assessments and actions made sense at the time, given the circumstances that surrounded them

Ever see this before?

The Traditional Heisenberg Model Number of errors is relative to the severity of consequences For every major accident there are many errors Leads us to assume that driving down errors will eliminate major accidents

The New View of the model The consequence of error has no relationship to the number of errors It is related to the number and integrity of defenses Any error can lead to a major accident if defenses fail

Commonly Accepted HP Formula Reducing Error AND Managing Defenses leads to Zero Operational Upsets Re + Md → OU

What kind of cultural traits should you be pursuing in your organization? Encourage Reporting: Value errors as leading safety data Create a Just Work Environment: Don’t try and punish errors out of the system Flexibility: Prepare workers to adapt effectively to changing demands Learning: Create opportunities for observation, reflection and feedback Training: Knowledge and attitudes are being adequately transferred to the less experienced workers

System Vulnerabilities People will never perform better than what the organization will allow If a system relies on people doing the right thing every time, it will fail No working system remains in stasis

How leaders influence the system What they pay attention to, measure, and control Their reactions to critical incidents or crises The allocation of resources Their criteria for allocation of rewards and punishment Their criteria for selection, advancement, and termination Their deliberate attempts to coach or model behaviors

Your Human Performance Improvement initiative HPI is not just training It is a way of doing business that includes: Preventing Conduct of operations and work management Simulations and training Use of Human Performance Tools Performance management and assurance Systems development and re-engineering Detecting Meaningful performance indicators Behavioral observation and walk-arounds Correcting Issues reporting, management and corrective actions Event investigation and lessons learned

Which of the following describes your hospital? A. Community hospital B. Regional hospital C. Academic medical center D. Other

PREVENTING MEDICATION ERRORS

Preventing Errors CPOE with clinical decision support Associated with lower error rates New error types Entering order for wrong patient Clinical pharmacists on inpatient units Regular medical reconciliation Especially at transitions of care Automated dispensing cabinets Neuspeil DR, Taylor MM. Health Services Insights 2013;6:47-59

When does medication reconciliation take place at your institution? A. Only at admission B. Only at discharge C. Both at admission and discharge D. Whenever a patient is transferred to a different phase of care

Preventing Errors Staff/trainee education E-training, annual competencies Barcoding Associated with 48% reduction in preventable adverse drug events Standardization Implementing guidelines, preprinted ordersets 80:20 rule Culture change Quality improvement projects Neuspeil DR, Taylor MM. Health Services Insights 2013;6:47-59

Standardized Concentrations ISMP has recommendations for standardized concentrations for neonatal infusions Michigan initiative for standardizing pediatric oral concentrations for compounding ASHP developing national standardized concentrations for IV and oral compounded medications Funding from FDA’s Safe Use Initiative

Human Performance Tools Self-checking (STAR) Verification Practices Peer-checking Concurrent verification Independent verification Three-part communication Job Site Review Pre-job briefing Post-job critique Procedure use & adherence Questioning attitude & Stop when unsure

HPT – Self-Checking (STAR) Self-Checking (STAR) is a Human Performance Tool that helps the individual methodically focus his/her attention on the details of the task at hand. The individual consciously and deliberately reviews the intended action and expected response before performing the task. This includes distinct thoughts and actions designed to enhance an individual’s attention to detail in the moment just before performing the task. STOP THINK ACT REVIEW

HPT – Verification Practices Both peer checking and concurrent verification can prevent errors because they are being performed at the same time as the action Peer checking simply requires checking prior to the manipulation of the component Tech check tech for cart fill; pharmacist checking tech preparing IV compound Concurrent verification requires the verification of the component and expected response before, during and after manipulation of the component 2 separate pharmacists verifying chemo order Independent Verification focuses on confirming the “status” of the system or component Pharmacist verifying physician order, nurse verifying physician order and pharmacy preparation

HPT – Three-part Communication Effective communication ensures all parties involved are on the same page. 1. Sender states the message When practical, the sender and receiver should be face to face The sender ensures that he/she has the receiver’s attention—normally calling the receiver by name or position Sender states the message clearly and concisely 2. Receiver acknowledges the sender The receiver paraphrases back the message in his or her own words Equipment designators and nomenclature are repeated word for word The receiver may ask questions to verify his or her understanding of the message

HPT – Three-part Communication 3. Sender acknowledges the receiver’s reply If the receiver understands the message, then the sender responds with “That is correct” If the receiver does not understand the message, the sender responds with “That is wrong” (or words to that effect) and restates the original message 4. If corrected Receiver acknowledges the corrected message, again paraphrasing the message in his or her own words

HPT – Job Site Review A Job Site Review is simply taking the time to examine your work area to ensure conditions are as you expected them to be It is also a tool to identify potential problem areas at the work location Explore the job site and adjacent surroundings prior to the start of work to ensure you are knowledgeable of conditions such as: Critical parameters or indicators important for task success Error likely situations or conditions, particularly at the critical steps Safety Concerns Correct patient Correct chart Correct drug

HPT – Pre-job Brief Shift turnover and patient updates communicated via discussion with outgoing shift or through chart transcriptions Sign out, iVents, pharmacists’ sticky notes

HPT – Post-job Critique Lessons learned, Near Misses, Good Catches, and any other knowledge that can be transferred to the system to improve it

HPT – Procedure Use and Adherence Why following Procedures is Important Procedures are the primary tool we use to safely and efficiently operate and maintain the medical use process Not properly following procedures is a large contributor to human error and many consequential events Clear guidance covering uncertainty will produce more consistent and error-free performance The way employees use and maintain procedures is a primary indicator of your staff’s safety culture

HPT – Questioning Attitude & Stop When Unsure A Questioning Attitude should exist at all times, causing you to Stop When Unsure over any concern you may have. Many Programs call these out as separate tools, but that is not necessary. A questioning attitude must be constantly present to use the tools deliberately and not just out of habit or by accident. The bang for the buck is in choosing to use a tool purposefully and employing it properly. Thinking about potential consequences and reviewing your physical actions prior to performing the action is how human performance tools are successful in assisting us in our daily life and work Tools should be used after identification of Critical Steps within the work activity. These tools ensure Critical Steps are completed correctly.

Managing Defenses Defenses Means or measures (controls, barriers, and safeguards) taken to prevent human error and to mitigate the consequences of an error Barrier Anything that protects a system or person from a hazard whether physical, administrative, or human in nature

Managing Defenses Defenses are designed to serve one or more of the following functions: Create understanding and awareness of the local risks and hazards Recover from off-normal conditions and restore the system to a safe state Provide clear guidance on how to operate safely Detect and warn about the presence of off-normal conditions or imminent dangers Protect people, equipment, and the environment from injury, damage, and undesired consequences Contain and eliminate the sources of potential injury, damage, or undesired consequence should they escape the barriers intended to contain them Enable the potential victims to escape or be rescued from hazards

What Are Managed Defenses?  Soft Defenses / Administrative Controls  Procedure/process focused defenses that guide programmatic oversight  Require human interaction  EXAMPLES Identification of error-prone work processes Assessments/Benchmarking Post-job reviews Trending Causal analysis Procedure quality and backlog management Training Reduction of fatigue Checklists Error reporting

What Are Managed Defenses?  Hard Defenses / Engineered Controls  Equipment focused defenses  Do not require human interaction  EXAMPLES Elimination of workarounds Labeling Med Dispensing Units Computer programs Physically locked barriers Hand rails Locks placed on components tagged out of service System interlocks Machine guards

DETECTING MEDICATION ERRORS

Error Traps Change in job conditions Distractions First/late shift Mental/emotional stress Multiple tasks Overconfidence Knowledge gap Peer pressure Physical environment Time pressure Vague guidance Room for interpretation Look-alike, sound-alike medications Administration devices

Inpatient Medication Errors Prescribing and administering errors account for ~75% of medication errors Prescribing: errors/1000 orders errors/1000 pediatric patients Dispensing: 2.6 errors/1000 admissions in a tertiary care center 6-12% of all errors IOM. Preventing medication errors. Miller et al. Qual Saf Health Care 2007;16:

Inpatient Medication Errors Administering: Overall rate 0-26% (median=8.3%) % in ICUs Occurs more frequently with IV medications 27% of all pediatric administrations at a teaching hospital Nurses responsible for catching 86% of errors IOM. Preventing medication errors. Miller et al. Qual Saf Health Care 2007;16: Neuspeil, Taylor. Health Services Insights 2013;6:47-59.

Prescribing/Transcribing Errors Wrong drug Wrong dose/wrong route Wrong patient Prescribing medication patient is allergic to/intolerant of Use of unapproved abbreviations E.g., MS for morphine sulfate or magnesium sulfate; U instead of units Inappropriate use/lack of use of zeros “Always lead, never follow”

Dispensing Errors Wrong drug/wrong preparation Look-alike, sound-alike medications Repackaging Wrong dose/wrong concentration Compounding Wrong route Wrong patient Delay in delivery

Why Dispensing Errors Occur Workload/staffing issues Distractions/interruptions Inadequate dosing references Inadequate training Poorly designed work areas Inadequate lighting, inadequate counter space, clutter Inadequate package labeling

Administration Errors Wrong drug/wrong preparation Wrong dose/wrong concentration Wrong rate Wrong time Wrong route Wrong patient

5 Rights of Administration Right drug Right dose Right route Right patient Right time

Monitoring Errors Failure to monitor serum drug levels Failure to monitor signs of toxicity E.g., creatinine, QT interval, LFTs Failure to follow-up on labs E.g., vancomycin level, anti-Xa level, PTT, INR Failure to adjust therapy based on lab values

High-Alert Medications Drug Classes Adrenergic agonists/ antagonists Anesthetics Antiarrhythmics Antithrombotics Cardioplegic solutions Chemo Hypertonic dextrose/saline Dialysis solutions Epidural/intrathecal meds Oral hypoglycemics Insulin Inotropic meds Liposomal meds (and alternatives) Narcotics Moderate sedation agents Especially for children Neuromuscular blockers Parenteral nutrition IV contrast Sterile water for irrigation, injection, inhalation (≥100 mL)

High-Alert Medications Specific Medications Subcutaneous epinephrine IV epoprostenol Insulin U-500 Magnesium sulfate injection Methotrexate oral (non- oncologic use) Opium tincture IV oxytocin Nitroprusside Concentrated potassium chloride injections Potassium phosphate injections IV promethazine Vasopressin

CORRECTING MEDICATION ERRORS

How are medication errors communicated in your department? A. Word of mouth B. Via periodic departmental s C. Via departmental grand rounds or meetings D. On an individual basis E. Not at all

Voluntary Reporting Focus on improving safety Focus on near misses or minimal patient harm Internal or external

Internal Reporting Systems Advantages: Timely advice for management of specific patient Provides a record of the event May prompt immediate review/advice from legal counsel Disadvantages: May miss patterns of behavior Unjust disciplinary action Inaction

External Reporting Systems Development of best practices and standards of case Development of smart technology to reduce errors Identification of error that occurs in rare situations/patient populations Smetzer JL, Cohen MR. In: Medication Errors, 2 nd ed.

External Reporting Systems ISMP Medication Error Reporting System SMP.aspx FDA Medwatch Confidential Can be reported by anyone

Mandatory Reporting Purpose is to hold providers/organizations accountable May be regulated by state agencies Subject to penalties or fines Sentinel events are reportable to Joint Commission

Barriers to Reporting Fear of censure Fear of public disclosure Damage to reputation Leadership not supporting or valuing Nothing to gain Shame

Barriers to Reporting Study of physicians, pharmacists, and nurses to identify barriers to error reporting Incentives to reporting: Patient protection: Overall improvement patient care Specific error that occurred in a patient Provider protection: Fear of censure To avoid legal action Professional compliance: Expectation of reporting set by institution Hartnell N, et al. BMJ Qual Saf 2012;21:361-8.

Barriers to Reporting Burden of reporting Accessibility, time to complete Professional identity Reluctance to report another’s error, fear of appearing incompetent Information gap Lack of awareness of what to report Organizational factors Lack of trust in organization, inaction, no timely follow-up Fear Censure, malpractice suit Hartnell N, et al. BMJ Qual Saf 2012;21:361-8.

Error Reporting Error report should be easily accessible Best reported by an individual involved Report should be factual Should be reported as soon as possible

After an Event Timely reporting of event Timely investigation of cause of event Root cause analysis, failure modes and effects analysis (FMEA) Identification of latent and active failures Creation or revision of processes to prevent error from occurring again Ongoing analysis of processes

What to Report How error occurred Normal workflow/procedure Why error occurred At risk behaviors How to prevent it Smetzer JL, Cohen MR. In: Medication Errors, 2nd ed.

CASES

Betsy Lehman Case 39-year old mother of 2, diagnosed with breast cancer. Admitted November 14 for high-dose cyclophosphomade (phase 1 trial). Protocol: 1000 mg/m 2 /day x4 days. Fellow misread protocol as 4000 mg/m 2 /day x4 days. Betsy died on December 3 as a result of the overdose. Error not discovered until her data was entered into the clinical trial computer 10 weeks later. IOM. Preventing medication errors.

Which of the following error traps may have contributed to Betsy’s overdose? A. Knowledge gap B. Time pressure C. Distractions D. Vague interpretation E. Physical environment

Which of the following human performance tools may help to prevent this type of medication error? A. Peer checking B. Independent verification C. Post-job critique D. Procedure use E. S-T-A-R

Case Full-term infant born to a Spanish-speaking mother with a history of syphilis. Because it was difficult to elicit whether the mother had received adequate therapy for syphilis, the decision was made to treat the infant for congenital syphilis. Through consultation with an ID physician and the health department, a dose of benzathine penicillin G 150,000 units IM was recommended. The hospital physicians, nurses, and pharmacists were unfamiliar with the treatment of congenital syphilis, or the benzathine form of penicillin G. IOM. Preventing medication errors.

Case The pharmacist: Consulted patient’s chart for the dose Consulted a drug information reference for the dose Misread dose as 500,000 units/kg (instead of 50,000 units/kg) Prepared and dispensed 1,500,000 units (2.5 mL) of the drug IOM. Preventing medication errors.

Case The nurse: Questioned the volume (would require 5 injections) Consulted drug information reference to see if medication could be given IV No information specific for benzathine penicillin Aqueous penicillin safe to use IV Missed the manufacturer’s label warning “IM use only” The nurse practitioner: Assumed benzathine penicillin was a brand name for aqueous penicillin Changed order to IV IOM. Preventing medication errors.

Case Nurse administered benzathine penicillin via slow IV push. After 1.8 mL of drug was infused, the baby became unresponsive and could not be resuscitated. Upon autopsy, it was confirmed that the infant did not have congenital syphilis. IOM. Preventing medication errors.

Which of the following represents latent failures that occurred in this case? A. Inadequate drug information resources B. Lack of specialized training for health-care practitioners C. Failure to identify large volume for IM injection D. Lack of means for communicating with patients with language barriers E. Failure to identify 10-fold overdose

Which of the following represents latent failures that occurred in this case? A. Inadequate drug information resources B. Lack of specialized training for health-care practitioners C. Failure to identify large volume for IM injection D. Lack of means for communicating with patients with language barriers E. Failure to identify 10-fold overdose

Which of the following human performance tools may be helpful to reduce the errors identified in this case? A. Independent verification B. S-T-A-R C. Pre-job briefing D. Three way communication E. Concurrent verification

Case A nurse prepares a bag of IV fluids containing potassium phosphate at the nurse’s station for an adult patient, and leaves the bag on the counter while she checks on another patient. Another nurse picks up the bag of IV fluids (with potassium phosphate) thinking it is for her patient, a 7-month old boy. Ten minutes after she hangs the fluids on the baby’s IV pump, he goes into cardiac arrest and cannot be resuscitated.

What are some latent failures which may have contributed to this medication error? What are some active failures which may have contributed to this medication error? What systems does your institution have in place to prevent errors such as this?

Thank you.

Assessment Questions Which of the following is an error trap that may contribute to prescribing errors? A. Inadequate lighting in the clean room B. Working during the day shift C. Use of treatment guidelines D. ER resident completing a rotation in a pediatric ICU

Assessment Questions Which of the following is an error trap that may contribute to prescribing errors? A. Inadequate lighting in the clean room B. Working during the day shift C. Use of treatment guidelines D. ER resident completing a rotation in a pediatric ICU

With which of the following medications would peer checking be most useful during the order entry/verification process? A. Lisinopril based upon a patient's home medication list B. Amoxicillin for a patient with community-acquired pneumonia C. TPN for an oncology patient D. Levetiracetam for seizure prophylaxis

With which of the following medications would peer checking be most useful during the order entry/verification process? A. Lisinopril based upon a patient's home medication list B. Amoxicillin for a patient with community-acquired pneumonia C. TPN for an oncology patient D. Levetiracetam for seizure prophylaxis

Which of the following is a barrier to voluntary reporting of medication errors? A. Fear of retribution B. Incorporation of a just reporting culture C. Administrator expectation of reporting errors D. Electronic submission process

Which of the following is a barrier to voluntary reporting of medication errors? A. Fear of retribution B. Incorporation of a just reporting culture C. Administrator expectation of reporting errors D. Electronic submission process

Which of the following may contribute to dispensing errors? A. Minimizing distractions B. Storing look-alike medications next to each other C. Electronic medication references D. Insuring adequate counter space

Which of the following may contribute to dispensing errors? A. Minimizing distractions B. Storing look-alike medications next to each other C. Electronic medication references D. Insuring adequate counter space

Which of the following is an example of a human performance tool that can help a pharmacy technician prevent medication errors? A. Using automated dispensing cabinets B. Tech checking tech during cart fills C. Insuring appropriate lighting in critical work areas D. Relying on peer opinion of compounding procedure

Which of the following is an example of a human performance tool that can help a pharmacy technician prevent medication errors? A. Using automated dispensing cabinets B. Tech checking tech during cart fills C. Insuring appropriate lighting in critical work areas D. Relying on peer opinion of compounding procedure

How often is a hospitalized patient at risk of a medication error? A. Once per day B. Twice per day C. Once per week D. Twice per week E. Once per month

How often is a hospitalized patient at risk of a medication error? A. Once per day B. Twice per day C. Once per week D. Twice per week E. Once per month