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Medication Safety for Medical Directors: Building Better Systems


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Title: Medication Safety for Medical Directors: Building Better Systems

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

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.

ISMP Canada Services
  • Voluntary Error Reporting Program report via
  • 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
  • Education bulletins, presentations, interactive
    workshops, student lectures

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

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
  • 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.

  • Reporting incidents is important

Ignorance is not bliss!
Reported errors (3-6)
British Airways Incident Reports
Goal is harm reduction
  • High alert medications
  • Vulnerable populations
  • Gaps in medication use processes

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

High-Alert Medications
  • For example
  • Opioids
  • Insulin
  • Anticoagulants
  • Chemotherapy agents

Incident Analysis (Root Cause Analysis)
  • Three questions
  • What happened?
  • Why did it happen?
  • What can be done to reduce the likelihood of a

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.

Canadian RCA Framework
Available from http//www.patientsafetyinstitute.
  • Structured individual incident analysis offers
    more information to generate better solutions

Case 1 - Morphine
  • An elderly resident living in a LTC home was
  • palliative care, which included morphine 1 to 2
  • 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.

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

Morphine CalculationAvailable concentration 15
  • 1 mg 0.15 mL
  • 1 mg 0.1 mL
  • 1 mg 0.07 mL
  • 1 mg 0.7 mL

Morphine 15 mg/mL
  • Correct calculation
  • 1 mg 0.07 mL
  • 2 mg 0.13 mL
  • Incorrect calculation
  • 10 mg 0.7 mL

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

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
  • Stat INR ordered results so high they were
  • Resident transferred to hospital by ambulance.
  • Resident died later that evening due to internal

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Case 2 - Warfarin - Timeline
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

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

Task Select Causes / Contributory Factors
  • Discuss in pairs
  • (2 minutes)

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
  • Stat INR ordered results so high they were
  • Resident transferred to hospital by ambulance.
  • Resident died later that evening due to internal

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

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

Sharp End vs. Blunt End

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

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
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

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
  • 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.

How many adverse drug events occur annually in
the US in the LTC setting?
  • 3,500
  • 35,000
  • 350,000
  • 3,500,000

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

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

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

Adverse Drug Events (ADEs) in LTC
  • 9 month study ADE rate 9.8 per 100 resident
  • 42 ADEs deemed preventable
  • Errors associated with preventable events
    occurred most often at the stages of ordering and
  • 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

Adverse Events in Community Pharmacy
  • Observational study in 50 pharmacies in 6 US
  • Overall dispensing accuracy 98.3
  • 77 errors in 4481 prescriptions 5 clinically
  • 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.)

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

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
  • Responding to individual incident reports

Need to change the way we think about errors
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
  • ? Blame and Shame

  • 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.

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

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

The Systems Approach
  • though we cannot change the human condition, we
    can change the conditions under which humans
  • Reason J. (2000). Human error models and
  • BMJ, 320(7237) 768-770. Retrieved from

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

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
  • 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).

  • Why do incidents occur

Reality of Health Care Environments
  • Cognitive overload
  • Workloads
  • Multitasking
  • Interruptions
  • Difficult technology
  • Look-alike packaging and labelling
  • Sound-alike medication names

Potter et al. 2004. Advances in Patient
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

Examples of At-Risk Behavioursin the Medication
Use Process
  • Not verifying patient allergies before
    prescribing / dispensing / administering
  • Writing incomplete orders or orders with
    hazardous abbreviations
  • Not questioning unusual or incomplete orders
  • Not welcoming/supporting clarification of unclear
  • ISMP Medication Safety Alert! October 7, 2004

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
  • (2005)

  • Humans have limitations that impact on

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

Everyday Human Factors Engineering Problems

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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.

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

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

  • Manufacturer
  • Labelling and packaging changes
  • Pharmacy
  • Systematic process for checking DIN numbers
  • 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

  • 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
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Actions to support memory
  • Limit interruptions
  • Minimize reliance on memory
  • Minimize travel

Attention hasinherent human limitations
  • Basketball video

How many passes?
  • 15
  • 16
  • 17
  • 18
  • 19
  • 20

Anything else?
Inattentional Blindness
  • Failing to see what should have been plainly
  • 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

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

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

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

Hierarchy of Effectiveness(Summary)
  • Highest
  • Lowest
  • Forcing functions and constraints
  • Automation / computerization
  • Simplification / standardization
  • Reminders, checklists, double checks
  • Rules and policies
  • Education and information

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
  • Examples
  • Gas line fittings in operating rooms
  • Automobile design reverse gear
  • On-line forms

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

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

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

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

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
  • e.g. drug or drug class, age category, care

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

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

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

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

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

  • ISMP Canada Medication Safety InitiativesRelevan
    t to LTC

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)

Medication Safety Self-Assessment (MSSA) for LTC
  • Selected National Results

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

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
Essential resident information available when
prescribing, dispensing, and administering
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
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
  • 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)

  • Role of the Medical Director and the Professional
    Advisory Committee

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

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,
  • Support for staff
  • Disclosure to resident/family who is the key
    organizational contact for family follow up
  • Reporting form readily available

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

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

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
  • Educational tool widely share de-identified
    details for learning purposes

How is the PAC involved in in your own settings?
  • Review of incident reports by PAC (not just
  • Participation in MSSA
  • Development of standardized protocols
  • All of the above
  • None of the above

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

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

ISMP Canada Safety Bulletins
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
  • ? 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

  • 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

  • Report a medication incident
  • through the ISMP Canada website
  • 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)
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