7/6/2016 1 MEDICATION ERRORS: A SYSTEMATIC APPROACH TO EVALUATION AND PREVENTION PREPARED BY: JOSEPHINE JEAN-POSTELL, PHARM.D., BCPS COORDINATOR – MEDICATION SAFETY AND QUALITY, MRHS IRA SCHATTEN, PHARM.D., BCPS, CPPS COORDINATOR – MEDICATION SAFETY AND QUALITY, MHP 2016 ANNUAL MEETING DISCLOSURE • Josephine Jean-Postell has a vested interest in or affiliation with the following company who may have offered financial support or grant monies for this continuing education activity • Merck • Ira Schatten has no actual or potential conflict of interest in relation to this continuing education activity 2016 ANNUAL MEETING PHARMACIST OBJECTIVES • By the end of this discussion the participants will be able to: 1. Define the relationship between medication errors and adverse drug events 2. Describe the impact medication errors have on patient safety and health care systems 3. Categorize medication errors by common causes and severity 4. Compare and contrast how Continuous Quality Improvement, Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA) impact medication errors 5. Identify strategies and technologies to enhance patient safety and prevent medication errors in pharmacy practice 6. Apply ‘Just Culture’ principles to evaluate systems, people, and behavioral motives involved in a medication error 2016 ANNUAL MEETING TECHNICIAN OBJECTIVES • By the end of this discussion the participants will be able to: 1. Define the relationship between medication errors and adverse drug events 2. Describe the impact medication errors have on patient safety and health care systems 3. Recognize common causes and types of medication errors 4. Explain how Continuous Quality Improvement, Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA) impact medication errors 5. Identify strategies and technologies to enhance patient safety and prevent medication errors in pharmacy practice 6. Understand the ‘Just Culture’ principles and how they are used to evaluate systems, people, and behavioral motives involved in a medication error 2016 ANNUAL MEETING THE IMPACT OF MEDICATION ERRORS • Medical error is now the third leading cause of death • Approximately 251,000 deaths per year • National Patient Safety Foundation • 1/3 of Americans have been affected by a serious medication mistake • 28% of these are related to a medication error 2016 ANNUAL MEETING THE IMPACT OF MEDICATION ERRORS 2016 ANNUAL MEETING
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MEDICATION ERRORS: A SYSTEMATIC APPROACH TO EVALUATION AND PREVENTIONPREPARED BY:JOSEPHINE JEAN-POSTELL, PHARM.D., BCPS COORDINATOR – MEDICATION SAFETY AND QUALITY, MRHS
IRA SCHATTEN, PHARM.D., BCPS, CPPS COORDINATOR – MEDICATION SAFETY AND QUALITY, MHP
2016 ANNUAL MEETING
DISCLOSURE
• Josephine Jean-Postell has a vested interest in or affiliation with the following company who may have offered financial support or grant monies for this continuing education activity • Merck
• Ira Schatten has no actual or potential conflict of interest in relation to this continuing education activity
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PHARMACIST OBJECTIVES• By the end of this discussion the participants will be able to:
1. Define the relationship between medication errors and adverse drug events
2. Describe the impact medication errors have on patient safety and health care systems
3. Categorize medication errors by common causes and severity
4. Compare and contrast how Continuous Quality Improvement, Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA) impact medication errors
5. Identify strategies and technologies to enhance patient safety and prevent medication errors in pharmacy practice
6. Apply ‘Just Culture’ principles to evaluate systems, people, and behavioral motives involved in a medication error
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TECHNICIAN OBJECTIVES• By the end of this discussion the participants will be able to:
1. Define the relationship between medication errors and adverse drug events
2. Describe the impact medication errors have on patient safety and health care systems
3. Recognize common causes and types of medication errors
4. Explain how Continuous Quality Improvement, Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA) impact medication errors
5. Identify strategies and technologies to enhance patient safety and prevent medication errors in pharmacy practice
6. Understand the ‘Just Culture’ principles and how they are used to evaluate systems, people, and behavioral motives involved in a medication error
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THE IMPACT OF MEDICATION ERRORS
• Medical error is now the third leading cause of death
• Approximately 251,000 deaths per year
• National Patient Safety Foundation
• 1/3 of Americans have been affected by a serious medication mistake
• 28% of these are related to a medication error
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THE IMPACT OF MEDICATION ERRORS
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WHAT IS A MEDICATION ERROR?
• Medication error: • Any preventable event that may cause or lead to
inappropriate medication use or patient harm while the medication is in the control of:
• Health care professional
• Patient
• Consumer
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WHAT IS A MEDICATION ERROR?
• Medication error: • May be related to professional practice, health care
products, procedures, and systems
• May include • Prescribing• Order communication• Product labeling• Packaging and nomenclature• Compounding• Dispensing• Distribution• Administration• Education• Monitoring• Use
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A medication error is “any error occurring in the medication use process.”(Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. 1995. Relationship between medication errors and adverse drug events. Journal of General Internal Medicine 10(4): 100–205.)
MEDICATION USE PROCESS• SODAM
• Selection• Ordering• Dispensing• Administering• Monitoring
• Errors can occur at any point in the Medication Use Process
• They occur most frequently in the Ordering (56%) and Administration (34%) phase JAMA.1995; 274:29-34
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CATEGORIZATION OF MEDICATION ERRORS
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NCC MERP INDEX FOR CATEGORIZING MEDICATION ERRORS
• Category H• An error occurred that required
intervention necessary to sustain life
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DEFINITIONS
• Adverse Drug Event (ADE): An injury resulting from medical intervention related to a drug
• Source: Institute of Medicine (IOM)
• Adverse Drug Reaction (ADR): Any response to a drug which is:• noxious and unintended
• occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function• Source: World Health Organization (WHO)
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NCC MERP Fact Sheet 2015-02 v91
DEFINITIONS• “Preventable ADE”: harm caused by the use of a
drug as a result of an error• Patient given a normal dose of drug but the drug was
contraindicated in this patient
• These events warrant examination by the provider to determine why it happened
• “Non-Preventable ADE”: drug-induced harm occurring with appropriate use of medication • Anaphylaxis from penicillin in a patient with no previous
history of an allergic reaction
• While these are currently non-preventable, future studies may reveal ways in which they can be prevented
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NCC MERP Fact Sheet 2015-02 v91
MEDICATION ERRORS VS. ADE
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Medication Errors
No Harm
ADE
Non-preventable Harm
Preventable Harm ADR
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THE 7 RIGHTS OF MEDICATION ADMINISTRATION
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Right Drug Diltiazem CD vs. SR or Metoprolol daily product vs. BID product
Right Dose Giving Metoprolol 25mg instead of ordered ½ tab of the 25mg for 12.5mg
Right Patient Medication given to Smith, John instead of Smith, Jane
Right Route Rectal suppository inserted vaginally - Dulcolax / Anusol HC
Right Time Pt took Warfarin at home before admission and scheduled for same day of admission
Right Technique
Not using spacer for inhalation, breathing in too rapidly/slowly
Right Documentation
Medication patch applied to one area but documented as another, 2 tabs indicated and given but documented as 1 tab given (i.e. Percocet)
http://quizlet.com/12819290/7-rights-of-drug-administration-flash-cards/ - Accessed 3/12/2015
COMMON CAUSES OF MEDICATION ERRORS
• Wrong time error
• The failure to administer a medication within a predefined time
• Unauthorized drug error
• Administration of a medication not authorized by a prescriber for the patient
• Deteriorated drug error
• Administration of a drug that has expired
• The physical or chemical dose-form integrity has been compromised
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http://www.ashp.org/s_ashp/index.asp
COMMON CAUSES OF MEDICATION ERRORS
• Improper dose error
• Administration of a higher/lower dose than or ordered by prescriber
• Administration of duplicate doses
• Wrong-dosage-form error
• Administration of a drug product in a different dosage form than ordered by prescriber
• Wrong-drug-preparation error
• Drug product incorrectly formulated or manipulated before administration
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http://www.ashp.org/s_ashp/index.asp
PROCESSES/PROCEDURES WHERE ERRORS MAY OCCUR
• Order Entry
• Medication Selection
• Drug Delivery
• Drug Preparation/Prepacking
• Pyxis Fills
• Outpatient Prescriptions
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RIGHT DRUG
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• A DIAGNOSIS, CONDITION, OR INDICATION FOR USE EXISTS FOR EACH MEDICATION ORDERED
CONTINUOUS QUALITY IMPROVEMENT
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QUALITY IMPROVEMENT PROCESSES
• The way to prevent errors is to redesign the systems and processes that lead to errors rather than focus on correcting the individuals who make errors
• Effective strategies for reducing errors include making it difficult for staff to make an error and promoting the detection and correction of errors before they reach a patient and cause harm
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Institute for Safe Medication Practices. Accessed at: http://www.ismp.org/faq.asp#Question_5
SWISS CHEESE EFFECTLAYERS OF SAFETY
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WHY SYSTEMS ARE IMPORTANT
• Decrease likelihood of making errors
• Increase efficiency
• Create order• Step by Step Instruction – IV queue technology
• Standardization • Protocols
• Order Forms
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PLAN, DO, CHECK, ACT (PDCA)
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DEFINITIONS• Failure Mode and Effects Analysis (FMEA):
• Ongoing quality improvement process that is carried out in healthcare organizations by a multidisciplinary team
• Conducted before any error actually happens.
• Root Cause Analysis (RCA):
• A reactive process
• Employed after an error occurs, to identify its underlying causes.
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RCA VS. FMEA
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Root Cause Analysis (RCA) Failure Modes and Effects Analysis (FMEA)
Timeframe Retrospective Prospective
Focus Individual case Process
TJC Requirements On all sentinel event cases Annually on a high‐risk process
Advantages Asks what happened and why Broad impact on entire system, doesn’t require an event prior to study. Prevents adverse events before they happen.
Limitations Hindsight bias, findings may apply only to a specific case and may or may not have broader implications for the entire system, labor intensive
Labor intensive
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FMEA – PEANUT BUTTER & JELLY
Necessity
“Process Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to Prevent
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FMEA – PEANUT BUTTER & JELLY
Necessity
“Process Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to Prevent
Obtain Bread
No Bread No Sandwich
5/5 Out of Stock
Moldy
3/5 15 CheckPantry
Inspect Bread
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FMEA – PEANUT BUTTER & JELLY
Necessity
“Process Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to Prevent
Obtain Bread
No Bread No Sandwich
5/5 Out of Stock
Moldy
3/5 15 CheckPantry
Inspect Bread
Put PB on Bread
No PB Jelly Sandwich
3/5 Out of Stock
Past Expiration
2/5 6 Check Pantry
Check Expiration
Date
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FMEA – PEANUT BUTTER & JELLY
Necessity
“Process Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to Prevent
Obtain Bread
No Bread No Sandwich
5/5 Out of Stock
Moldy
3/5 15 CheckPantry
Inspect Bread
Put PB on Bread
No PB Jelly Sandwich
3/5 Out of Stock
Past Expiration
2/5 6 Check Pantry
Check Expiration
Date
Spread PB&J with
Knife
No Knife PlainBread
4/5 Dishes Not
Cleaned
5/5 20 Clean Dishes
RCA – THE TITANIC
1) Define the problem
2) Analyze the causes
3) Select the best solutions
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RCA – THE TITANIC
1) Define the problem
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Source: http://www.thinkreliability.com
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RCA – THE TITANIC
2) Analyze the causes
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Source: http://www.thinkreliability.com
RCA – THE TITANIC
2) Analyze the causes
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Source: http://www.thinkreliability.com
RCA – THE TITANIC
2) Analyze the causes
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Source: http://www.thinkreliability.com
RCA – THE TITANIC
2) Analyze the causes
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Source: http://www.thinkreliability.com
RCA – THE TITANIC
3) Select the best solutions
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Source: http://www.thinkreliability.com
STEPS TO PREVENT ERRORS
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NATIONAL PATIENT SAFETY GOALS
• Identify patients correctly• NPSG.01.01.01: Use at least two
ways to identify patients • For example, use the patient’s name and
date of birth
• This is done to make sure that each patient gets the correct medicine and treatment
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http://www.jointcommission.org/standards_information/npsgs.aspx Accessed 3/12/15
NATIONAL PATIENT SAFETY GOALS
• Use medicines safely• NPSG.03.05.01: Take extra care with patients who
take medicines to thin their blood
• NPSG.03.06.01: Record and pass along correct information about a patient’s medicines • Find out what medicines the patient is taking
• Compare those medicines to new medicines given to the patient
• Make sure the patient knows which medicines to take when they are at home
• Tell the patient it is important to bring their up-to-date list of medicines every time they visit a doctor
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http://www.jointcommission.org/standards_information/npsgs.aspx Accessed 3/12/15
AHRQ PATIENT SAFETY TIPS
• Re-engineer hospital discharges• Reduce potentially preventable readmissions by:
• Assigning a staff member to reconcile medications• Schedule necessary follow-up medical appointments
• Create a simple, easy-to-understand discharge plan for each patient that contains:• A medication schedule• A record of all upcoming medical appointments• Names and phone numbers of whom to call if a problem
arises
• AHRQ-funded research shows that taking these steps can help reduce potentially preventable readmissions by 30 percent
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http://www.ahrq.gov/patients-consumers/diagnosis-treatment/hospitals-clinics/10-tips/index.html
AHRQ PATIENT SAFETY TIPS
• Educate patients about using blood thinners safely • Patients who have had surgery often leave the hospital
with a new prescription for a blood thinner
• If used incorrectly, blood thinners: • Can cause uncontrollable bleeding • Are among the top causes of adverse drug events
• A free 10-minute patient education video and companion 24-page booklet, both in English and Spanish, help patients understand what to expect when taking these medicines
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http://www.ahrq.gov/patients-consumers/diagnosis-treatment/hospitals-clinics/10-tips/index.html
ROLE OF TECHNOLOGY
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THE ROLE OF TECHNOLOGY
• Dipensing Technologies – Automated Dispensing Cabinets (ADCs)
• Pyxis®, Omnicell®, Baker CellTM
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THE ROLE OF TECHNOLOGY
• Computerized Physician Order Entry (CPOE)
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THE ROLE OF TECHNOLOGY
• Electronic Medical Record (EMR)
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THE ROLE OF TECHNOLOGY
• Barcode Medication Administration (BCMA)
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THE ROLE OF TECHNOLOGY• IV Preparation Software
• DoseEdge®, ScriptPro Telepharmacy®
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THE ROLE OF TECHNOLOGY• Carousel Technology
• Pharmogistics®, Talyst®
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THE ROLE OF TECHNOLOGY• RFID/Crash Cart Tray Software
• Kit Check®, Tray Safe®
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THE ROLE OF TECHNOLOGY• Simulation
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HIGH ALERT MEDICATIONS
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HIGH ALERT MEDICATIONS
• High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error
• Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients
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http://ismp.org/Tools/highAlertMedicationLists.asp Accessed 3/12/15
HIGH ALERT MEDICATIONS
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http://ismp.org/Tools/highAlertMedicationLists.asp Accessed 3/12/15
Classes
• Insulins
• Opiates/ Narcotics
• Cancer Chemotherapy
• Oral hypoglycemics
• Anticoagulants
Medications
• Warfarin
• U-500 insulin
HIGH ALERT MEDICATIONS - STRATEGIES• Improving access to information about these drugs
• Limiting access to high-alert medications
• Using auxiliary labels
• Using automated alerts
• Standardizing the ordering, storage, preparation, and administration of these products
• Employing redundancies
• Automated or independent double-checks when necessary
• Note: manual independent double-checks are not always the optimal error-reduction strategy and may not be practical for all of the medications on the list
• Providing mandatory patient education
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http://ismp.org/Tools/highAlertMedicationLists.asp Accessed 3/12/15
HIGH ALERT MEDICATIONS
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LOOK-ALIKE/SOUND-ALIKE MEDICATIONS
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LOOK-ALIKE/SOUND-ALIKE MEDICATIONS
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LOOK-ALIKE/SOUND-ALIKE MEDICATIONS
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LOOK-ALIKE/SOUND-ALIKE MEDICATIONS
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Which CarpujectTM does NOT belong?
LOOK-ALIKE/SOUND-ALIKE STRATEGIES• Tall man lettering descriptions in pharmacy computer
system, Pyxis formulary, and unit dose packaging system database (e.g., hydrOXYzine, hydrALAzine)
• Brand/generic names on medication administration records and automated dispensing cabinet computer screen
• Storage of products with look or sound-alike names in different locations of the pharmacy and automated dispensing cabinets
• Report Errors related to LASA drugs
• Give consideration to name confusion when adding new products to the formulary
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LOOK-ALIKE?
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PRODUCT CHANGE
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ERROR IN MEDICINE
• Much of mental functioning is automatic, rapid and effortless
– Leape, L.L.
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INATTENTIONAL BLINDNESS• Brain has limited resources when it comes to
attentiveness
• Our senses receive much more information than can possibly be processed at one time
• The brain allows a lot of information in, peeling off just a few pieces of selected information for a closer look
• The brain fills in the gaps
• Accidents happen when attention mistakenly filters away important information and the brain fills in the gaps with incorrect information
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INATTENTIONAL BLINDNESS
• More likely to occur if attention is diverted to secondary tasks• More complicated tasks require our full
attention
• Low workload, Carrying out highly practiced tasks• Boredom and decreased mental attention
• Expectation – Confirmation Bias
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SYSTEM DESIGN STRATEGIES
• Make no mistake
• Information
• Knowledge/Skill
• Perception of High Risk
• Barriers, Forcing Functions, Fail-safes
• Redundancy
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Low Reliability
High Reliability
SYSTEM REDUNDANCY
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1:1,000,000,000 Odds of both pilotshaving a heart attack and autopilot failure
1:1,000 Odds of one pilothaving a heart attack
1:1,000,000 Odds of both pilotshaving a heart attack
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ERROR PREVENTION STEPS
• Do not bypass safety features
• Speak up when there is doubt about a situation
• Request training when indicated
• Visually review each item selected for Pyxis fill/carousel refill• Ensure correct expiration date is recorded
• Report errors/dangerous practices
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ERROR PREVENTION STEPS• Steps to prevent Medication Errors
• Use available technology
• Follow steps for LA/SA Drugs
• Do not use dangerous/unapproved abbreviations
• Confirm the prescriber’s orders if unclear
• Stay focused, alert, and collected at all times
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http://www.jointcommission.org/
PHYSICAL ENVIRONMENT
• Inadequate lighting
• Disorderly, cluttered workspace
• Inadequate storage space
• Layout
• Workflow – poor traffic patterns
• Distractions
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WORKLOAD
• Long shifts
• Lack of breaks
• No backup plan for staffing shortage
• Agency staff
• Added clinical programs not communicated to staff
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JUST CULTURE
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JUST CULTURE
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JUST CULTUREAn evolution from Punitive to No Blame to Just Culture
• Punitive: work carefully, counseling, discipline, procedural violations unacceptable
• Blame Free: response to shortcomings of a punitive culture, workers who made honest errors were not truly blameworthy
• Just Culture: emphasis on learning and shared accountability, workers continually look for risk and are thoughtful about behavioral choices, managers look for system design features that are reliable
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JUST CULTURE
• Good system design + good behavioral choices of staff = good results
• Accountability is not dependent on outcome but behavioral choices under worker’s control
• Shared accountability
• Four areas of focus: • learning/reporting culture• open/fair culture• design of safe systems• management of behavioral choices
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BEHAVIORS
• Human error: inadvertent action; inadvertently doing other than what should have been done; slip, lapse, mistake
• At-risk behavior: behavioral choice that increases risk where risk is not recognized, or is mistakenly believed to be justified
• Reckless behavior: behavioral choice to consciously disregard a substantial and unjustifiable risk
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JUST CULTURE ALGORITHM
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JUST CULTURE ALGORITHM
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With System With Employee
Human Error (HE)
Modify system performance shaping factors
Console employee
Remedial action
At-Risk Behavior (ARB)
Modify system performance shaping factors
Coach employee
Remedial action
Reckless Behavior (RB)
Punitive action
Remedial action
MAKE A DIFFERENCE
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CONCLUSIONS• By the end of this discussion the participants will be able to:
1. Define the relationship between medication errors and adverse drug events
2. Describe the impact medication errors have on patient safety and health care systems
3. Categorize medication errors by common causes and severity
4. Compare and contrast how Continuous Quality Improvement, Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA) impact medication errors
5. Identify strategies and technologies to enhance patient safety and prevent medication errors in pharmacy practice
6. Apply ‘Just Culture’ principles to evaluate systems, people, and behavioral motives involved in a medication error
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QUESTIONS?
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REFERENCES1) Preventing Medication Errors, Quality Chasm Series, IOM2) National Coordinating Council for Medication Error Reporting and Prevention. Web. 15 Sept. 2011.
<http://www.nccmerp.org/aboutMedErrors.html>.3) Grissinger, Matthew. System Elements of Medication Use. Proc. of ISMP Medication Safety
Intensive, Orlando, FL. 2010. Print.4) Smetzer, Judy. Just Culture. Proc. of ISMP Medication Safety Intensive, Orlando, FL. 2010. Print.5) Smetzer, Judy. Human Factors in Medication Safety. Proc. of ISMP Medication Safety Intensive,
Orlando, FL. 2010. Print.6) "ISMP's List of High Alert Medications.” www.ismp.org. 2008. Web. 16 Sept. 2011.
<http://www.ismp.org/tools/highalertmedications.pdf>.7) http://www.nccmerp.org/aboutMedErrors.html8) https://www.ismp.org/faq.asp#Question_39) http://www.ashp.org/s_ashp/index.asp10) https://www.ismp.org/Tools/institutionalhighAlert.asp11) http://www.nccmerp.org/council/council1999-03-19.html12) http://www.jointcommission.org13) ISMP Medication Safety Alert, Volume 21, Issue 9 - May 5, 201614) ISMP Medication Safety Alert, Volume 13, Issue 23, November 20, 200815) IOM 1999 To Err is Human Report16) JAMA.1995;274:29-3417) ISMP Medication Safety Alert, What’s in a name? Ways to Prevent Dispensing Errors Linked to
Name Confusion, June 12, 200218) http://www.uspharmacist.com/content/d/pharmacy%20law/c/16572/
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