Medication Safety for Medical Directors: Building Better Systems

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Medication Safety for Medical Directors Building
Better Systems

• Kris Wichman, RPh, BScPhm, FCSHP
• Julie Greenall, RPh, BScPhm, MHSc, FISMPC
• Project Leaders, ISMP Canada
• November 7, 2009

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ISMP Canada

• ISMP Canada is an independent not-for-profit
  organization dedicated to reducing preventable
  harm from medications.
• Our goal is the creation of safe and reliable
  systems for managing medications in all
  healthcare environments.
• www.ismp-canada.org

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ISMP Canada Services

• Voluntary Error Reporting Program report via
  website
• Error Reporting Software (Analyze-ERR)
  provides electronic database of medication events
  for storage, retrieval, follow up and analysis
• Medication Safety Self Assessment (MSSA)
  Hospital, Community Pharmacy, Complex Continuing
  Care, LTC, Operating Room
• Projects/ Service Contracts - e.g, Ontario
  Medication Safety Support Service
• Consulting Root Cause Analysis, Failure Mode
  and Effects Analysis, Medication System Safety
  Reviews
• Education bulletins, presentations, interactive
  workshops, student lectures

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Where are you from?

• Eastern provinces (NS, NF, NB, PE)
• Central (ON,QC)
• Western provinces (MB, SK, AB, BC)
• Territories (YK, NT, NU)

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Educational Objectives

• At the end of this workshop, participants will
  have gained knowledge and understanding of
• the importance of incident reporting
• the value of individual and aggregate incident
  reviews
• how system factors and human factors engineering
  principles contribute to error potential and
  system improvement in healthcare environments
• system safeguards to reduce the risk of
  preventable harm from medications.

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• Reporting incidents is important

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Ignorance is not bliss!
Reported errors (3-6)
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British Airways Incident Reports
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Goal is harm reduction

• High alert medications
• Vulnerable populations
• Gaps in medication use processes

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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.
• ISMPs List of High-Alert Medications. Available
  at www.ismp.org/Tools/highalertmedications.pdf.

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High-Alert Medications

• For example
• Opioids
• Insulin
• Anticoagulants
• Chemotherapy agents

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Incident Analysis (Root Cause Analysis)

• Three questions
• What happened?
• Why did it happen?
• What can be done to reduce the likelihood of a
  recurrence?

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Why is there a need for RCA?

• Accidents result from a sequence of events and
  tend to fall in recurrent patterns regardless of
  the personnel involved.
• All staff, even the most experienced and
  dedicated professionals can be involved in
  preventable adverse events.

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Canadian RCA Framework
Available from http//www.patientsafetyinstitute.
ca/English/toolsResources/rca/Documents/March2020
0620RCA20Workbook.pdf
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• Structured individual incident analysis offers
  more information to generate better solutions

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Case 1 - Morphine

• An elderly resident living in a LTC home was
  receiving
• palliative care, which included morphine 1 to 2
  mg
• subcutaneously q3-4h prn for analgesia.
• 10 mg morphine was administered instead of 1
  mg by a nurse at the LTC home.
• The attending physician and the residents
  family were notified of the incident. The
  resident subsequently died.

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Accountability???

• Nurse
• LTC Home
• Provincial Government
• 1, 2, 3
• 2 and 3
• None of the above

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Morphine CalculationAvailable concentration 15
mg/mL

• 1 mg 0.15 mL
• 1 mg 0.1 mL
• 1 mg 0.07 mL
• 1 mg 0.7 mL

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Morphine 15 mg/mL

• Correct calculation
• 1 mg 0.07 mL
• 2 mg 0.13 mL
• Incorrect calculation
• 10 mg 0.7 mL

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Which syringe was used?
0.07 mL (1 mg) or 0.13 mL (2 mg)
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• Have you changed your mind about accountability?

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Case 2 Warfarin

• 78-year old with bilateral leg ischemia, severe
  CHF, dementia and a left lung mass
• 2 week hospitalization - unsuccessful right
  bifemoral artery bypass followed by above-knee
  amputation of right leg
• Discharged Aug 19 Rx warfarin 3 mg daily
• Sept 25 - RN discovered INR results not
  available because not ordered on readmission to
  Home
• Stat INR ordered results so high they were
  unreadable
• Resident transferred to hospital by ambulance.
• Resident died later that evening due to internal
  bleeding

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Case 2 - Warfarin - Timeline
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Incident Analysis (RCA)

• What happened (went wrong)?
• Described in incident report and investigation
  results reflected in timeline documentation
• Why did it happen?
• Root cause analysis examines what led to or
  contributed to the incident occurring

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Contributing Factors Root Causes

• Cause refers to a relationship or potential
  relationship between certain factors that enabled
  an event to occur
• Cause does not imply blame
• True root causes are the earliest points where
  action could have been taken to enhance the
  support system to prevent the event or mitigate
  the harm from the event

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Task Select Causes / Contributory Factors

• Discuss in pairs
• (2 minutes)

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Case 1 Warfarin

• 78-year old with bilateral leg ischemia, severe
  CHF, dementia and a left lung mass
• 2 week hospitalization - unsuccessful right
  bifemoral artery bypass followed by above-knee
  amputation of right leg
• Discharged Aug 19 Rx warfarin 3 mg daily
• Sept 25 - RN discovered INR results not
  available because not ordered on readmission to
  Home
• Stat INR ordered results so high they were
  unreadable
• Resident transferred to hospital by ambulance.
• Resident died later that evening due to internal
  bleeding

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Causal or Contributory FactorsSelect your choice

• Prescriber forgetfulness
• General lack of monitoring effects of drugs
• Lack of knowledge of nurses
• Expectation that resident would deteriorate
  rapidly based on medical condition
• No clinical assessment during month
• All of the above
• None of the above

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What underlying causes exist?

• Ask a series of why questions until you have
  worked well away from the sharp end (the
  outcome of the incident) of the event to the
  blunt end
• Usually not just one cause many factors
• Sometimes called the five levels of why

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Sharp End vs. Blunt End

Adapted from the NHS Report Doing Less Harm,
2001
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Types of Cause and Effect Diagrams Tree Diagram
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Use of Diagrams

• Avoids hindsight bias
• things that were not seen or understood at the
  time of the accident seem obvious in retrospect.
• Institute of Medicine. Linda T. Kohn.(2000).
  To Err is Human. Washington, D.C. National
  Academy Press. p. 53.
• Assists in identifying what are the best leverage
  points for action

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Is this a root cause?

• Bottom line question
• If this factor were eliminated or corrected,
  would it have prevented the outcome or mitigated
  the harm?
• ? Would there be a real chance to prevent a
  similar event from happening?

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Causal Statements

• The lack of a standardized protocol for warfarin
  management with an embedded cuing mechanism,
  increased the likelihood that an order for INR
  testing would be omitted, leading to continued
  administration of warfarin without dose
  adjustment, with resulting internal hemorrhage
  and death.
• The lack of an established standardized protocol
  to complete a full assessment and update the
  resident treatment plan post-hospitalization
  decreased the likelihood that omission of an
  order for INR monitoring would be detected,
  leading to failure to adjust warfarin therapy,
  resulting in internal hemorrhage and death.

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Why improvement is important(Do we have a
problem?)
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Institute of Medicine Quality Chasm Series

• To Err Is Human, 1999
• Hospital medical errors kill 44,000-98,000 people
  per year
• Crossing the Quality Chasm, 2001
• A vision for how the health care system must be
  radically transformed to close the chasm between
  current reality and good quality care
• Preventing Medication Errors, 2006
• Medications harm too many at least 1.5 million
  people per year

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Adverse Events in Acute Care in Canada

• 3,745 charts reviewed
• 7.5 of hospital admissions involved in an
  adverse event 37 of adverse events preventable
• Extrapolation
• Of 2.5 million hospital admissions in Canada
  in 2000
• 185,000 experienced 1 or more adverse events
• 70,000 of the 185,000 were determined to be
  preventable
• between 9,000 and 24,000 deaths due to adverse
  events could have been prevented
• Baker GR, Norton P et al. CMAJ, May 25, 2004.

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How many adverse drug events occur annually in
the US in the LTC setting?

• 3,500
• 35,000
• 350,000
• 3,500,000

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How many adverse drug events occur annually in
the US in the LTC setting?

• a) 3,500
• b) 35,000
• c) 350,000
• d) 3,500,000

• Gurwitz JH, Field TS, Avorn J et al. Incidence
  and preventability of
• adverse drug events in nursing homes. Am J Med
  2000 109 87-94

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What is the total annual cost of drug-related
morbidity in the US in the LTC setting?

• 7.6 million
• 76 million
• 760 million
• 7.6 billion

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What is the total annual cost of drug-related
morbidity in the US in the LTC setting?

• a) 7.6 million
• b) 76 million
• c) 760 million
• d) 7.6 billion

• Bootman JL, Harrison D, Cox E, The healthcare
  cost of drug-related morbidity and mortality in
  nursing facilities, Arch Intern Med 1997157
  2089-96

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Adverse Drug Events (ADEs) in LTC

• 9 month study ADE rate 9.8 per 100 resident
  months
• 42 ADEs deemed preventable
• Errors associated with preventable events
  occurred most often at the stages of ordering and
  monitoring
• Residents at increased risk of a preventable ADE
  if taking warfarin, atypical antipsychotic
  agents, loop diuretics, opioids
• Increasing number of medications increases risk
  of ADE
• Gurwitz JH et al. The incidence of adverse drug
  events in two large academic long term care
  facilities. Am J Med 2005 118(3) 251-258

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Adverse Events in Community Pharmacy

• Observational study in 50 pharmacies in 6 US
  cities
• Overall dispensing accuracy 98.3
• 77 errors in 4481 prescriptions 5 clinically
  important
• Extrapolation
• Approximately 4 errors per day if pharmacy fills
  250 Rx
• 51.5 million errors in the US annually (3 billion
  Rx filled annually
• Flynn EA et al.J Am Pharm Assoc (Wash.)
  200343191-200

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Adverse Events in the Community

• Forster AJ et al. Ottawa Hospital Patient Safety
  Study incidence and timing of adverse events in
  patients admitted to a Canadian teaching hospital
  CMAJ 2004 170(8) 1235
• Forster AJ et al. Adverse events among medical
  patients after discharge from hospital. CMAJ
  2004 170(3) 345

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Sources of Harm
Prescribing (39 of errors 28 cause harm)

48 intercepted
Data from Leape et al. JAMA 1995 Gurwitz et
al (2000, 2005) Prescribing and monitoring are
most common
Transcribing (12 of errors 11 cause harm)
Monitoring n/a
33 intercepted
Only 2 intercepted!
Dispensing (11 of errors 10 cause harm)
Administering (38 of errors 51 cause harm)
34 intercepted
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• Responding to individual incident reports

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Need to change the way we think about errors
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The Person Approach

• The person approach focuses on the errors of
  individuals, blaming them for forgetfulness,
  inattention, or moral weakness.
• J. Reason, March 18, 2000, BMJ
• Historically focused on individual performance
  and not system issues
• Fear of reprisals drives important information
  underground
• ? Blame and Shame

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• As healthcare professionals we are taught to
  maintain competence, practice due diligence and
  take care to avoid mistakes.
• Systems theory states that although this is
  necessary, it is not enough.
• ?The way to prevent mistakes or mitigate harm
  from mistakes is to redesign systems with
  integrated safeguards, in addition to practicing
  due care.

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Systems Approach

• Focus is on improving the processes, systems, and
  environment in which people work, rather than
  attempting only to improve individual skills and
  performance

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The Systems Approach

• Recognizes that
• Humans are incapable of perfect performance
• Accidents are caused by flaws in the working
  environment (system) and human errors that are an
  expected part of any working environment
• Accidents can be prevented by building a system
  that is resilient to expected human errors

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The Systems Approach

• though we cannot change the human condition, we
  can change the conditions under which humans
  work.
• Reason J. (2000). Human error models and
  management.
• BMJ, 320(7237) 768-770. Retrieved from
  http//www.bmj.com/cgi/content/full/320/7237/768

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What about professional accountability?

• Does non-punitive mean blame-free?
• Does a system approach mean that individual
  practitioners are not accountable for their
  actions?

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Shared AccountabilityJust Culture

• it is about creating a reporting environment
  where staff can raise their hand when they have
  seen a risk or made a mistake..where risks are
  openly discussed between managers and staff.
• while we as humans are fallible, we do
  generally have control of our behavioural
  choices.
• good system design and good behavioural choices
  of staff together produce good results. It has to
  be both.
• Marx D, Comden SC, Sexhus Z (2005). Our inaugural
  issue In recognition of a growing community.
  The Just Culture Community News and Views, 1(1).

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• Why do incidents occur

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Reality of Health Care Environments

• Cognitive overload
• Workloads
• Multitasking
• Interruptions
• Difficult technology
• Look-alike packaging and labelling
• Sound-alike medication names

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Potter et al. 2004. Advances in Patient
Safety139-51.
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Workarounds At-Risk Behaviours

• Natural tendency to take shortcuts to make
  completion of tasks easier or increase efficiency
  
• Workarounds occur when a procedure or action does
  not fit with the workflow

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Examples of At-Risk Behavioursin the Medication
Use Process

• Not verifying patient allergies before
  prescribing / dispensing / administering
  medications
• Writing incomplete orders or orders with
  hazardous abbreviations
• Not questioning unusual or incomplete orders
• Not welcoming/supporting clarification of unclear
  orders
• ISMP Medication Safety Alert! October 7, 2004

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Workaround Research

• 84 percent of physicians and 62 percent of
  nurses/other clinical-care providers have seen
  co-workers taking shortcuts that could be
  dangerous to patients.
• Fewer than 10 percent of physicians, nurses and
  other clinical staff directly confront their
  colleagues about their concerns, and 1 in 5
  physicians said they have seen harm come to
  patients as a result.
• The 10 of healthcare workers who raise these
  crucial concerns observe better patient outcomes,
  are more satisfied and are more committed to
  staying in their jobs.
• American Association of Critical Care Nurses
• www.silencekills.com (2005)

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• Humans have limitations that impact on
  performance

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What is Human Factors?

• A discipline concerned with design of systems,
  tools, processes, machines that takes into
  account human capabilities, limitations, and
  characteristics
• Human factors engineers work to make the
  environment function in a way that seems natural
  to people

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Everyday Human Factors Engineering Problems

• www.baddesigns.com

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Why does design matter?

• Some designs cause problems that are inconvenient
• Some designs cause problems that are unsafe

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Confirmation Bias / Cognitive Tunnel Vision

• Leads one to see information that confirms our
  expectations, rather than information that
  contradicts our expectations.

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Look-alike Labelling Leads to Tragedy

• 80 year old nursing home resident received 7
  doses (27 grams) of chloral hydrate instead of
  potassium chloride liquid as intended
• ISMP Canada Bulletin 2005
• Vol 5 Issue 7

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Key Findings

• Similar packaging and labelling
• No barcode verification at the vendor level
• Lack of systematic check of drug identification
  number in the pharmacy
• ? Fragmented medication review process
• Resident had received a very high dose of KCl
  (200 mEq daily) to manage furosemide-induced
  hypokalemia for more than one year
• Alternative management strategies for CHF not
  considered

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Recommendations

• Manufacturer
• Labelling and packaging changes
• Pharmacy
• Systematic process for checking DIN numbers
  barcoding
• Adequate space for filling and checking
• Wholesaler
• Barcode verification
• Special attention to high alert medications
  (i.e., segregation, additional safeguards)
• Home
• ? Interdisciplinary medication review at least
  every 6 months
• Staff education re pharmacology, signs of adverse
  drug events, principles of medication system
  safety

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• Healthcare system design relies heavily on memory
  

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Memoryhas inherent human limitations (how long
and how much)

• Limited memory span 7 /- 2 pieces of
  information can be held in short term memory
  when attention is full
• Factors affecting memory
• Stress
• Fatigue and other physiological factors
• Repetition of behaviour

Miller GA (1956). The magical number seven,
plus or minus two some limits on our capacity
for processing information. Psychological
Review, 63(2) 81-97. Retrieved from
http//psychclassics.yorku.ca/Miller/
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Actions to support memory

• Limit interruptions
• Minimize reliance on memory
• Minimize travel

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Attention hasinherent human limitations

• Basketball video

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How many passes?

• 15
• 16
• 17
• 18
• 19
• 20

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Anything else?
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Inattentional Blindness

• Failing to see what should have been plainly
  visible
• Because attention is not focused on it
• Most of our perceptual processing occurs outside
  of conscious awareness
• Attentional resources are finite
• Amount of attention required is affected by
  practice and task difficulty

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Aids to Maintaining Attention

• Be conscious of how many tasks you are trying to
  accomplish at once
• Work to avoid interruptions

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• Given that there are problems in our systems
  leading to increased risk of errors, how can
  understanding human factors help us to make
  changes?

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Safety Strategies

• Eliminate
• Remove the hazard
• Control
• Provide safeguards
• Accept
• Not an option if a serious hazard is
  identified, the minimum safety strategy is a
  control measure

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Hierarchy of Effectiveness(Summary)

• Highest
• Lowest

• Forcing functions and constraints
• Automation / computerization
• Simplification / standardization
• Reminders, checklists, double checks
• Rules and policies
• Education and information

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Forcing Function

• Cohen defines a forcing function as a design
• feature that makes it impossible to perform a
• specific erroneous act.
• Cohen, M.R. (1999). Medication Errors.
  Washington, D.C. American Pharmaceutical
  Association.
• Examples
• Gas line fittings in operating rooms
• Automobile design reverse gear
• On-line forms

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Insulin Safety Needle

• Forcing function
• needle automatically covered by sleeve after
  injection
• Needle can only be used once
• Visible reminder red indicator when used
• NovoFine Autocover

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Using Technology to Re-engineer Medication
Management
Physician Order Entry/Pharmacist Clinical Order
Screening
Electronic MAR and To Do List
Just-In-Time Inventory
Or, automated med/supply depot door or drawer
opens
Scan Patients Wristband
Scan Medication
Smart Drawer Opens
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Simplification / Standardization

• For example, standardized protocols for high
  alert drugs that are integrated into work flow
  via pre-printed order forms or electronic CPOE)
• e.g., for anticoagulants
• Define the roles of each team member, scope of
  INRs results requiring MD attention, required
  monitoring, etc.

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Human Factors Guiding Principle

• Fit the task or tool to the human, not the other
  way around

• Vicente, Kim. (2004). The Human Factor
  Revolutionizing the way people live with
  technology. Vintage Canada

93

• Earlier case examples were used to illustrate
  individual incident analysis.
• Aggregate analysis allows for analysis of
  multiple reports

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Aggregate Analysis

• A process by which analysis is conducted on a
  cluster of reports involving common factors that
  are pre-defined for achieving a specific
  objective
• e.g. drug or drug class, age category, care
  setting

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ISMP Canada LTC Incident Review

• 1066 incidents reviewed
• 25 caused harm
• Warfarin, fentanyl patch and hypoglycemics most
  commonly associated with errors resulting in harm

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ISMP Canada Analysis of LTC Incident Reports

• Opioids
• 1. Order misinterpretation
• Contributing factors Dosing unit mix-ups
  dangerous abbreviations
• 2. Dose omissions
• Contributing factors Interruptions order not
  transcribed to MAR medications not available
  from pharmacy
• Fentanyl patch errors
• Contributing factors resident ordered fentanyl
  patches possibly not a suitable candidate old
  patch not removed every 72 hour schedule leading
  to dose omissions

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LTC Incident Analysis (Contd)

• Insulins
• 1. Mix-ups between different types of insulin
• Contributing factors Look-alike / sound-alike
  close proximity in storage
• 2. Incorrect dose
• Contributing factor Dose requirement changes
  depending on various resident factors (e.g. blood
  glucose level, dietary intake...etc.)
• 3. Incorrect time of administration
• Contributing factors Time dependent nature of
  insulin administration resident not available at
  time of administration order entry /
  transcription error

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LTC Incident Analysis (Contd)

• Anticoagulants
• 1. Drug monitoring errors related to warfarin
• Contributing factor The linkage of the various
  steps of the warfarin administration and
  monitoring process

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Conclusion

• Reports ? Analysis ? Solutions development ?
  Dissemination
• Quality of analysis greatly depends on the
  quantity / quality of incidents received
• Reports rich in detail ? High quality solutions

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• ISMP Canada Medication Safety InitiativesRelevan
  t to LTC

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ISMP Canada Medication Safety Initiatives

• Medication Safety Self-Assessment programs
• Home reviews in Ontario as part of provincial
  task force on medication management in LTC
• Development of medication safety indicators
• Development of a barcoding standard
• Training on incident analysis and best possible
  medication history (BPMH)

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Medication Safety Self-Assessment (MSSA) for LTC

• Selected National Results

103
Provincial Users

• British Columbia (Interior Health Authority)
• Alberta
• Manitoba
• Ontario

104
I Resident Information II Drug
Information III Communication of Drug Orders IV
Drug Labelling/Packaging V Drug
Standardization, Storage
VI Medication Devices VII- Environmental
Factors VIII Staff Competence/Education IX -
Resident Education X Quality/Risk Management
105
Essential resident information available when
prescribing, dispensing, and administering
medications
1- MD, RN, Phm can access lab values in own
locations 4 - allergy information on order
forms or alerted during ordering 9 - bar coding
during administration 14 - drug history current,
complete on admission
106
Opportunities for Improvement Identified from
MSSA Results

• Communication of Drug Orders and Other Drug
  Information (Key Element III)
• Including clinical indication in drug orders
• Avoiding dangerous abbreviations

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Improvement Opportunities Identified from Home
Medication System Reviews

• Enhancement of medication incident detection,
  reporting and analysis processes
• Definition of high alert medications for LTC
  setting to guide implementation of appropriate
  safeguards
• Development of standardized protocols for high
  alert medications and related care processes
• Implementation of medication reconciliation
• Drug use evaluation to improve medication use in
  the home (e.g., avoidance of medications on
  Beers list)

109

• Role of the Medical Director and the Professional
  Advisory Committee

110
Role of Medical Director and Professional
Advisory Committee (PAC)

• Set the tone for the Home
• Help sell the culture
• Communicate expectations e.g.,
• Incident management
• Improvement approach
• Clinical and organizational best practices

111
Role of Medical Director and PAC

• Participate in ensuring that a formal incident
  response framework is established and understood
  by all staff
• Immediate action to be taken by staff re care of
  resident and prevention of imminent recurrence,
  quarantine of articles/securing health record,
  notifications
• Support for staff
• Disclosure to resident/family who is the key
  organizational contact for family follow up
• Reporting form readily available

112
Role of Medical Director and PAC

• Review internal and external reports of
  medication incidents
• Review drug utilization reports
• Participate in MSSA, review results, and guide
  improvement action
• Work to develop standardized protocols, e.g.,
  pre-printed orders
• Develop expectations for medication reconciliation

113
Medication Reconciliation

• Essence is making sense of patients medications
  and resolving conflicts between different sources
  of information to minimize harm and maximize
  therapeutic effects

114
Medication Incident Management

• How to use incident reports
• As part of notification process for incidents
  that have occurred
• Trend analysis within a home or organization
• Monitoring tool for effectiveness of
  interventions
• Educational tool widely share de-identified
  details for learning purposes

115
How is the PAC involved in in your own settings?

• Review of incident reports by PAC (not just
  summaries)
• Participation in MSSA
• Development of standardized protocols
• All of the above
• None of the above

116
Medication Incident Management

• How not to use incident reports
• As an indicator of individual employee competence
  or for disciplinary purposes
• As part of statistical calculation of incident
  rates

117
Communication of Results

• Consider communicating the information learned
  from incident analysis in a generic way to those
  who could also benefit from the information
• Within the home
• Within the corporation, if applicable
• Outside the organization

118
ISMP Canada Safety Bulletins
119
Goal a culture of safety

• Non-punitive response to incident reports
• ? blame culture to just culture
• Analysis of incidents using a system view
• ? individual responsibility to resolution of
  system issues
• Use human factors principles in systems
  improvement
• ? consider hierarchy of effectiveness
• Learning and sharing from incident reports
• ? secrecy to disclosure
• ? Safety is everyones responsibility
• Cassano-Piche A. Human Factors Impact on
  Medication Safety.
• ISMP Canada Conference May 8, 2008

120

• A smart person learns from his or her own
  experiences.a wise person learns from the
  experiences of others.
• Captain Chesley Sully Sullenberger
• US Airways
• Miracle on the Hudson

121

• Report a medication incident
• through the ISMP Canada website
• www.ismp-canada.org
• or by telephone
• 416-733-3131
• 1-866-544-7672
• (1-866-54 ISMPC)
• ISMP Canada is a key partner in the Canadian
  Medication Incident Reporting and Prevention
  System (CMIRPS)