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Managing Medication Risks Through a Culture of Safety


Managing Medication Risks Through a Culture of Safety Learning Objectives Identify characteristics of safety in high- reliability organizations (HROs) Describe the ... – PowerPoint PPT presentation

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Title: Managing Medication Risks Through a Culture of Safety

Managing Medication Risks Through a Culture of
Learning Objectives
  • Identify characteristics of safety in high-
    reliability organizations (HROs)
  • Describe the application of HROs in health care
    and medication safety
  • Discuss the role of teamwork and
    multidisciplinary teams in transforming
    organizations to a culture of safety

Organizations With a Better Safety Record Than
Health Care
  • High-reliability organizations (HROs)
  • Chemical manufacturing
  • Nuclear power industry
  • Aviation
  • Health care has taken notice and is attempting to
    achieve HRO status
  • We have a long way to go

Managing Medication Risks Through a Culture of
  • Eliminating preventable events requires changing
    mindsets about patient safety and the underlying
    health care culture
  • Health care providers must be ready to embrace a
    change in culture that improves patients safety
  • HROs have laudable safety records stemming from a
    culture that has shared safety goals and values
    at all levels

Defining a Culture of Safety
  • An organizations culture
  • Incorporates a pattern of shared basic
  • Values What is important
  • Beliefs How things work
  • Behaviors The way things are done there
  • Teaches the workforce in explicit and implicit
  • Embodies senior leadership philosophies
  • Makes life predictable by being able to
    anticipate how leaders will likely react to a

Senge P, et al. The Dance of Change. New York,
NY Doubleday/Currency 1999.
Five Safety Subcultures
  • Informed culture
  • Emphasis on collecting, analyzing, and
    communicating information
  • Reporting culture
  • Emphasis on reporting usable data
  • Just culture
  • Emphasis on trust among coworkers
  • Flexible culture
  • Emphasis on respecting each others abilities
  • Learning culture
  • Emphasis on competency and willingness to adapt

Recurring Safety Themes in HROs
  • Strategic emphasis on safety
  • Mindfulness and resilience
  • Just culture
  • Teamwork and localized decision-making
  • Error-defying systems and redundancy
  • Proactive focus and community involvement
  • Learning culture
  • Safety measurement

Strategic Emphasis on Safety
  • Strategic plans in health care
  • Include medication safety objectives in health
    care organizations strategic plans
  • Medication safety makes good business sense
  • Medication safety strategic goals
  • Assess internal medication use processes and
  • Assess external influences on medication safety,
    patient needs, and the health care marketplace
  • Consider the long-term benefits to staff and
    patients in determining safety goals
  • Goals should be brief and clear
  • Review the sample strategic goal shown in the
    textbook (Chapter 23, page 608)

Strategic Emphasis on Safety
  • Leaders are critical in setting and executing
    strategic goals for medication safety and
    maintaining a culture of safety
  • Table 23-1 lists characteristics of senior
    leaders in HROs
  • Leadership roles
  • Hold safety discussions in a visible area,
    question, record comments, summarize, and thank
  • Address issues and provide feedback to staff
  • Send a clear message that safety is important
  • WalkRounds is a tool for encouraging
    communication between senior leadership and
  • See Table 23-2 in textbook for questions to ask
    staff during WalkRounds

Mindfulness and Resilience
  • Workers in HROs pay attention to their work in a
    more mindful way than workers in less reliable
  • HRO preoccupation with system failures
  • Encourage and reward error and near-miss
  • Support in-depth analyses of errors and near
  • Instead of seeing a near miss as a success (i.e.,
    the system worked), seen as nearly having a
  • Avoid complacency, overconfidence, and inertia
  • HRO leadership is aware that success does not
    necessarily breed success

Mindfulness and Resilience
  • Reluctance to simplify interpretations
  • Take nothing for granted
  • Resist oversimplified view of the issue
  • Seek out differing view points and encourage
    healthy skepticism
  • Encourage mutual respect and teamwork
  • Sensitivity to operations
  • HRO workers are likely to be familiar with jobs
    and operations beyond their own
  • Workers provide real-time information helping to
    quickly identify problems
  • Problems get full attention quickly helping to
    prevent large-scale issues

Mindfulness and Resilience
  • Commitment to resilience
  • HROs anticipate system failures and build
    competence of the workforce to respond, contain,
    and recover quickly from failures
  • Resilience requires workers to act while thinking
    about a problem that has already occurred
  • Deference to expertise
  • HROs do not depend on seniority but allow those
    with the expertise to make the decisions
  • A flexible decision-making structure with those
    from all levels is in place based on expertise
  • Consider it a workers sign of strength to know
    ones own limit of expertise and ask for
    assistance from staff

Just Culture in Health Care Where We Were
  • Punitive culture
  • Pre-1990, individual workers were thought to be
    fully accountable for the outcome of patients
    under their care even if the worker did not have
    direct control of the processes to achieve a safe
  • Fear drove errors underground
  • Blame-free culture
  • By 1990s, the shift toward acknowledging that
    even the most experienced, caring, and vigilant
    caregiver could make an honest error
  • Some who recklessly endangered patients were not

Just Culture in Health Care Where We Are Going
  • A just culture emphasizes learning and shared
    accountability for outcomes
  • Workers know the organizations safety values and
    continually look for risks that pose a threat
  • Workers are thoughtful of their behavioral
  • Managers look for systems designs to enhance
    worker performance
  • Accountability is not dependent upon outcomes,
    rather on behavioral choices under the workers

Just Culture in Health Care Where We Are Going
  • A just culture includes a proactive model for
    addressing system and behavioral risks before
    events occur
  • The most important questions following an error
  • How did the error occur and how can it be
    prevented in the future?
  • Not Who did it?
  • Some states (i.e., Minnesota and North Carolina)
    have collaboration between the state department
    of health, licensing boards, and hospitals to
    support a just culture community

Just Culture in Health Care Where We Are Going
  • Three types of behaviors involved in errors
  • Human error weakest link, unpredictable, and
    involving an unintentional behavior
  • At-risk behavior workers drift into unsafe
    behaviors that need to be uncovered and removed
    with stronger incentives for safe behavior put in
  • Table 23-3 describes at-risk behaviors in the
    medication process
  • For managing at-risk behaviors, see textbook
    pages 6189
  • Reckless behavior the worker realizes
    possibility of harm, but does it anyway
  • These behaviors should be managed through
    remedial or disciplinary actions

Just Culture in Health Care Where We Are Going
  • Response to behaviors in a just culture
  • Human error Console
  • At-risk behavior Educate
  • Reckless behavior Punish

Teamwork and Localized Decision-Making
  • Definition of team a distinguishable set of
    two or more committed individuals with specific
    roles and complementary skills who interact to
    achieve goals for which they are mutually
  • In HROs, teams comprising multiple disciplines
    and levels of workers meet regularly to plan,
    deliberate, communicate, and evaluate their work
  • Decision-making is shifted from top leaders to a
    more localized decision-making model in HROs
  • The teams and entire workforce are informed about
    safety, errors, and causal trends because HROs
    have established cross-departmental, meaningful
    feedback systems

Aviation Industry Example
  • Crew resource management
  • Established in 1979 in response to several
    airline accidents
  • Poor communication was found to be the problem in
    70 of accidents reviewed
  • Attitudes of superior pilots
  • Aware of personal limitations
  • Aware of diminished decision-making capacity
    during emergencies
  • Encourage crew members to question decisions
  • Sensitive to the personal problems of crew
  • Recognize the need to verbalize plans
  • Understand the need to train other crew members

Teams in Health Care
  • Statistics confirm that failed communication and
    incongruent teamwork account for a large portion
    of poor clinical outcomes
  • In 2005, 80 of harmful errors reported to The
    Joint Commission had poor communication as a root
  • Highly functional teams make fewer errors than
  • Efficiency, safety, and clinical outcomes are
  • Hospital stays and costs are decreased
  • The challenge to health care not whether to
    deliver care with teams, but how well care can be
    delivered with teams

Joint Commission on Accreditation of Healthcare
Organizations. Root causes of sentinel events.
Available at
Barriers to Teamwork in Health Care Training
  • The need for training competencies is endorsed by
    the Institutes of Medicine (IOM), The Joint
    Commission, and the ECRI Evidence-Based Practice
  • Identified aspects of being a team player
  • Team leadership
  • Mutual performance monitoring
  • Backup behavior
  • Adaptability
  • Team (or collective) orientation
  • Shared mental model
  • Mutual trust
  • Closed-loop communication
  • Table 23-4 in the textbook provides examples of
    behavioral aspects of teamwork

Baker DP, et al. Jt Comm J Qual Saf.
Barriers to Teamwork in Health CareComplexity
and Autonomy
  • Intent of teamwork and collaboration, but result
    is uncoordinated, sequential, and autonomous care
  • Providers perceive their individual patient
    encounter (vertical moment) as efficient, however
    patients may perceive multiple vertical moments
    as chaotic and disjointed
  • A challenge is connecting health care teams to
    each other integrate vertical moments into the
    horizontal continuum of care
  • A reduction in autonomy and a shared concept of
    team members as equivalent actors can improve
  • Example airline customers typically dont know,
    nor do they request by name, their pilot
  • Passengers accept that all pilots are equivalent
    to each other

Barriers to Teamwork in Health Care
Hierarchical Structure
  • Seasoned health care professionals often work
    with and tolerate practitioners who are difficult
    or intimidating
  • Challenging authority is discouraged
  • Difficult to point out safety problems to those
    in authority
  • Those at the top of hierarchy may not see the
    problem or recognize a need for teamwork
  • Survey of surgical staffs and airline crews
    showed 59 of attending surgeons were opposed to
    steep hierarchies and questioning by junior team
    members, while 94 of airline crews preferred
    flat hierarchies and questioning by subordinates

Sexton JB, et al. BMJ. 20003207459.
Recommendations for Reducing Workplace
  • Establish a steering committee to define
    intimidation, develop a mission statement, and
    create an action plan
  • Create a code of conduct
  • Survey staff attitudes about intimidation
  • Have an open dialogue about workplace
  • Establish a standard, assertive communication
    process for health care providers to use for
    conveying important information
  • Establish a conflict resolution process
  • Encourage confidential reporting of behaviors
  • Enforce zero tolerance for intimidating behaviors
  • Provide ongoing education
  • Lead by example
  • Reward outstanding examples of teamwork

Error-Defying Systems and Redundancy
  • Design systems that defy errors
  • Consider factors that relate to unsafe conditions
  • Long working hours
  • Excessive workloads, unsafe staffing ratios
  • Distractions
  • Overreliance on education
  • Lack of technology and proven principles of error
  • Lack of redundancies for critical processes
  • Have recovery plans to minimize loss after an

Error-Defying Systems Unresolved Problems
  • Problems thought to have been resolved can
    reappear later
  • Steps to remedy problem reduce the risk of
    errors, but do not completely prevent errors
  • Example
  • Midazolam syrup bulk bottles were stored on
    pediatric floors
  • After several calculation errors, automated
    dispensing cabinet screen was redesigned to
    display warnings, and dosing conversion charts
    were posted nearby
  • Subsequently, dosing errors still occurred
    because of confusion using conversion charts new
    system was also error prone
  • The efforts of health care providers to reduce
    errors are on the road to error prevention, but
    their efforts are not fully reliable

Error-Defying SystemsDesigning for Reliability
  • Reliability in health care failure-free care of
    all patients
  • Reliability is measured by a systems failure
  • Studies show 10-1 failure rate is the current
    level of performance in most health care
    organizations, while it is 10-6 in aviation
    passenger safety
  • Measures of reliability
  • 10-1 depends on rules, policies, and staff
    education to reduce errors dependent on human
  • 10-2 systems are designed with tools and concepts
    to compensate for human weaknesses
  • 10-3 or better reflect well-designed systems
  • Table 23-5 in the textbook discusses key safety
    principles for designing and redesigning systems

Error-Defying SystemsUsing a Bundle Strategy
  • When care processes are grouped into bundles of
    several interventions, health care practitioners
    are more likely to change work processes and
    implement them
  • Bundle strategy can be applied to medication
    error prevention
  • Bundles should be small
  • Strategies should be based on proven, validated,
    error-prevention principles
  • Bundles should be treated as a cohesive unit
  • All strategies in a bundle must be implemented
  • Institute for Healthcare Improvement says the
    power of bundles lies in their all or none
  • Bundles may change over time as new elements are

Error-Defying SystemsRedundancy
  • Redundancy allows a system to fail benignly
    because extra staff and equipment can detect and
    intercept errors before harm occurs
  • A process that has only a single check before
    reaching the patient lacks redundancy
  • Systems lacking redundancy need to become more
    reliable these processes need to be redesigned
  • An estimated 2 of errors during drug
    administration are captured and corrected
  • 48 of prescribing orders are corrected because
    of system checks
  • Errors should be made visible and easy to reverse
    or irreversible errors should be made difficult
    to commit

Leape LL, et al. JAMA. 19952743543.
Proactive Focus and Community Involvement
  • HROs engage in proactive risk assessment
    activities rather than waiting for an accident
  • Shared knowledge
  • External error reporting systems allow sharing of
    lessons learned, analysis of submitted reports,
    dissemination of alerts, and suggestions for
    error-reduction strategies
  • Medication Errors Reporting System, disseminated
    by Institute for Safe Medication Practices
    (ISMP), is the primary external voluntary
    reporting program for medication safety in the
    United States
  • Knowledge from outside
  • Health care facilities do not routinely seek
    outside information about errors in other
  • HROs search for and welcome outside knowledge

Proactive Focus and Community Involvement
  • Process for proactive change
  • Assign to one or more practitioners to search the
    literature for the latest information
  • Make proactive change a standing agenda item for
  • Create a worksheet prior to each meeting that
    describes published errors and recommendations
  • Review outside information in a systematic way
  • Plan for changes and include an action plan for
    change (e.g., Gantt chart)
  • Test changes on a small scale, make revisions,
    and then introduce the change to the organization

Proactive Focus and Community Involvement
  • ISMP quarterly action agenda
  • Describes problems and gives recommendations for
    reducing risk
  • Recommends sharing the action agenda with staff
    and committees to stimulate discussion
  • Eliminating never events
  • Some events occur infrequently or the strategies
    for preventing them have not been tested,
    therefore little attention given to these errors
  • Practices that most health care providers would
    consider unsafe have been tolerated because of
    infrequent occurrences of errors
  • Complacency about the risk of rare, harmful
    events is indefensible

Proactive Focus and Community Involvement
  • Patient and community involvement
  • Health care providers should educate the public
    about errors, the causes, and the prevention
  • The media is an effective tool practitioners
    should use to respond to and educate the
  • Health care providers should speak at local
    programs or host one
  • Practitioners can show commitment to safety by
    showing how their facility deals with errors and
    takes steps to make errors more difficult to
  • Educated patients are the safest patients
  • Directly involving patients has helped
    organizations move toward highly reliable health

  • Additional Information on
  • the Patients Role in
  • Medication Error Reduction
  • Available in Slide Deck for Chapter 13

Learning Culture
  • HROs value learning as inseparable from everyday
    work and a necessary precursor to change
  • Training
  • Trying to make the workforce perform flawlessly
  • Learning
  • Understanding the constraints that keep the staff
    from flawless work
  • Leaders of HROs know that real change comes from
    commitment, not from management-driven compliance

Learning Culture in Health Care
  • Organizations should create a patient safety
    information system to collect, analyze, and
    disseminate information on errors and risks
  • Lessons learned from the safety information
    system form the nucleus of the learning culture
  • A learning culture depends on these key
    characteristics of a safety culture
  • Just culture how an organization handles blame
    and punishment affects what is reported
  • Resilience how flexible workers are in adapting
    to changes and handling fluctuations
  • Teamwork small teams function best in
    organizational learning
  • Questioning to what degree are questions and
    concerns embraced?

Learning CultureBarriers to Learning in Health
  • Learned helplessness is a barrier to learning in
    health care abandoned effort because former
    attempts were fruitless
  • People grew less willing to speak up
  • Problems may go unnoticed
  • Problems may be reasoned away rather than pursued
  • People see a smaller number of error reports as a
    positive factor
  • It may not mean fewer errors, just less reporting
  • Work-arounds (quick fixes) are the dominant
    response to problems instead of systemic fixes

Learning Culture First-Order and Second-Order
Problem Solving
  • First-order problem solving
  • React to the immediate environment
  • Used by workers to compensate for a problem, but
    not to discover or address underlying causes
  • May allow a problem to reappear
  • Does not communicate problems to those who could
    investigate causes and remedy them
  • Create new problems elsewhere
  • Second-order problem solving
  • Seek to change the underlying systems and
    processes, thus preventing recurrence
  • Address both the unexpected problem and the
    underlying causes

Learning Culture Leadership and Change
  • Learning is meaningless without action that
    brings about change
  • Leaders and workers must be willing and able to
    implement necessary changes
  • Leaders inspire organizational learning and
  • See Table 23-8 in textbook for leadership actions
    that promote organizational learning

Learning Culture Leadership and Change
  • Key change management concepts to improve patient
  • Challenge the status quo effective leaders
    explain concepts that are alternatives to
    business as usual
  • Form a guiding coalition a group of effective
    leaders who can lead the change
  • Communicate vision the guiding coalition forms a
    vision of the future that is easy to communicate
  • Use Plan-Do-Study-Act cycles the guiding
    coalition uses this process to spread the change,
    setting time frames and ensuring that resources
    for the change are in place
  • Multiple tactics target problems at multiple
    levels leaders employing these tactics improve
    the likelihood of successful change
  • Disable the trump acknowledge the problem and
    offer solutions, thus trumping those resisting
    the change

Safety Measurement
  • HROs know their safety climate and their level of
    system performance
  • Devote resources to more accurate ways of
    detecting risk, errors, and harm
  • Tracking outcomes over time gives HROs reliable
    outcome data
  • Measurement is difficult in health care, but
    fundamental to improvement
  • Types of measures
  • Process measures
  • Structural measures
  • Outcome measures
  • Balancing measures

Safety Measurement Process Measures
  • Assesses performance of core processes in
    medication use
  • Task oriented
  • Processes associated with high-alert medications
    should be targeted for measurement such as
  • Number of pharmacy profiles without allergy
  • Percentage of medication orders with prohibited
    error-prone abbreviations
  • Time interval between prescribing and
    administering stat medications
  • Number of pharmacy interventions per 100
  • Improving the process and reducing the risk of
    severity of error should decrease the risk
    priority number over time

Safety Measurement Structural Measures
  • Assesses the organizational structures such as
    culture, values, and leadership
  • Not task oriented
  • Examples of structural measures include
  • Percentage of staff meeting with agency staff
  • Percentage of staff reporting a positive safety
  • Number of error reports received
  • Agency for Healthcare Research and Quality
    designed a survey of hospitals, measuring 10
    dimensions of a safety culture
  • The survey helps to collect information from
    frontline workers that would not otherwise be
    available to organizational leaders

Agency for Healthcare Research and Quality.
Hospital survey on patient safety culture. Pub.
No. 04-0041. September 2004.
Safety Measurement Outcome Measures
  • Assesses the results of processes
  • Determines whether efforts to improve medication
    safety have been successful
  • Example
  • Observing medication dispensing and
    administration are a more accurate measurement
    than collecting data on errors
  • The trained observer documents what was dispensed
    or administered and compares it with the original
    prescription or order
  • Limitations of observational method
  • Cannot be used to detect prescribing errors
  • Staff needs to be committed to the observations

Safety Measurement Outcome Measures
  • Harm may be a more reliable outcome measure than
  • It is clear and direct, encompasses all
    unintended results, and keeps practitioners
    focused on improvement
  • Nonpreventable designation may promote acceptance
    of harm as a property of the medication system
    versus practitioner responsibility
  • Examine patient records to collect data on
    adverse drug events
  • Look for one or more triggers and follow-up as
    needed to confirm whether harm actually occurred
  • ISMPs list of triggers includes
  • Drugs diphenhydramine, vitamin K, flumazenil,
    glucagon, etc.
  • Lab results serum creatinine, low/high blood
    glucose, etc.
  • Effective methods for uncovering triggers have
    been devised

Institute for Safe Medication Practices. ISMP
trigger alert list. September 6, 2000.
Balancing Measures
  • Measures ensure that a change in one part of the
    system is not causing problems in another part of
    the system
  • Selecting measures
  • Measuring medication safety should have the goal
    of learning how to improve, not to punish
  • Measurement systems do not have to be complicated
  • Set up to collect enough information to take the
    next step toward improvement
  • Measurement process should be systematic
  • Ensure that the measures are clear, the purpose
    and goal are as intended, the collection methods
    are adequate and feasible, and the data collected
    are valid, consistent, and reliable

Balancing Measures Steps in the Process
  • Determine the medication safety issue to be
    measured and improved
  • Use external sources of information to identify
    issues that can lead to serious patient harm
  • Use internal sources to narrow the choices
  • Search the literature
  • Find out what is known about the area
    targeted for measurement
  • Establish aims
  • Answer the question, What are we trying to
  • Have ambitious aims to show the current system is
  • Leaders should regularly communicate and
    reinforce aims

Balancing Measures Steps in the Process
  • Construct the measures
  • Measures should have clinical relevance
  • Measures should provide useful information about
    the topic of interest
  • State the measure clearly to avoid errors in data
  • Establish a data collection plan
  • The time commitment must be acceptable to all
    those involved with the process
  • The plan should describe areas such as when and
    how often the data should be collected, the
    setting for data collection, etc.

Balancing Measures Steps in the Process
  • Test and use the measures
  • Test on a small scale for clarity, adequacy,
    utility, feasibility, and appropriateness for the
    intended purpose
  • If the measure is acceptable, data collection,
    analysis, and communication of the findings
    should proceed
  • Communicate the findings
  • The data should be disseminated after analysis
  • Findings can be distributed through memos,
    posters, storyboards, and oral presentations
  • Findings should be supported with graphic
    displays such as histograms, pie charts, Pareto
    charts, line graphs, or control charts

Balancing Measures Benchmarking
  • Definition of benchmarking a process of
    identifying practices that yield optimal results
    and implementing those best practices to improve
    organizational performance
  • Effective benchmarking includes both benchmarks
    and enablers
  • Benchmarks are measures of comparative
  • Enablers are specific practices that lead to
    exemplary performance
  • Error rate is not usually a valid benchmark
  • Reported errors are more likely to reflect the
    rigor of the error identification and reporting
  • Many errors remain undetected or unreported

Balancing Measures Benchmarking
  • Little effort is directed toward identifying
    enablers of safe medication use
  • Focusing on low error rates gives the errors,
    rather than their correction, disproportionate
  • Low error rates may give a false sense of
    security and acceptance of preventable errors
  • Benchmarking will be effective, as applied to the
    medication-use process, only if objective
    measurement is used to identify best practices
  • Success is more likely if benchmarking is focused
    on specific areas of drug therapy

  • Agency for Healthcare Research and Quality.
    Hospital survey on patient safety culture. Pub.
    No. 04-0041. September 2004. Available at
    http// qual/hospculture/hospcult.pdf
  • Baker DP, Salas E, King H, et al. The role of
    teamwork in professional education of physicians
    current status and assessment recommendations. Jt
    Comm J Qual Saf. 200531185202.
  • Institute for Safe Medication Practices. ISMP
    trigger alert list. September 6, 2000. Available
    at http// Newsletters/acutecare/art

  • Joint Commission on Accreditation of Healthcare
    Organizations. Root causes of sentinel events.
    Available at http//
  • Leape LL, Bates DW, Cullen DJ, et al. Systems
    analysis of adverse drug events. JAMA.
  • Senge P, Kleiner A, Roberts C, et al. The Dance
    of Change. New York, NY Doubleday/Currency
  • Sexton JB, Thomas EJ, Helmreich RL. Error,
    stress, and teamwork in medicine and aviation
    cross sectional surveys. BMJ. 20003207459.