Transcript SCI2003 Template - American Pharmacists Association

Managing Medication Risks
Through a Culture of Safety
Learning Objectives
• Identify characteristics of safety in highreliability 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 Safety
• 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 organization’s culture:
– Incorporates a pattern of shared basic assumptions
• Values:
• Beliefs:
• Behaviors:
What is important
How things work
The way things are done there
– Teaches the workforce in explicit and implicit ways
– Embodies senior leadership philosophies
– Makes life predictable by being able to anticipate how
leaders will likely react to a situation
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 other’s abilities
• Learning culture
– Emphasis on competency and willingness to adapt
Recurring Safety Themes in HROs
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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
organization’s strategic plans
– Medication safety makes good business sense
• Medication safety strategic goals
– Assess internal medication use processes and capabilities
– 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 staff
– 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 workers
• 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
organizations
• HRO preoccupation with system failures
– Encourage and reward error and near-miss reporting
– Support in-depth analyses of errors and near misses
• Instead of seeing a near miss as a success (i.e., the system
worked), seen as nearly having a disaster
– 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 worker’s sign of strength to know one’s 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 outcome
• 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
disciplined
Just Culture in Health Care:
Where We Are Going…
• A just culture emphasizes learning and shared
accountability for outcomes
• Workers know the organization’s safety values and
continually look for risks that pose a threat
• Workers are thoughtful of their behavioral choices
• Managers look for systems designs to enhance worker
performance
• Accountability is not dependent upon outcomes, rather
on behavioral choices under the worker’s control
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 place
• Table 23-3 describes at-risk behaviors in the medication process
• For managing at-risk behaviors, see textbook pages 618–9
– 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
– At-risk behavior
– Reckless behavior
Console
Educate
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
accountable
• 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 cause
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Highly functional teams make fewer errors than individuals
Efficiency, safety, and clinical outcomes are improved
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: www.jointcommission.org/SentinelEvents/Statistics/
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 Center
• Identified aspects of being a team player
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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. 2005;31:185–202.
Barriers to Teamwork in Health Care:
Complexity 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 safety
– Example: airline customers typically don’t 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. 2000;320:745–9.
Recommendations for
Reducing Workplace Intimidation
• 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 intimidation
• 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
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Long working hours
Excessive workloads, unsafe staffing ratios
Distractions
Overreliance on education
Lack of technology and proven principles of error reduction
Lack of redundancies for critical processes
• Have recovery plans to minimize loss after an error
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 Systems:
Designing for Reliability
• Reliability in health care = failure-free care of all patients
• Reliability is measured by a system’s failure rate
• 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 performance
– 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 Systems:
Using 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” nature
• Bundles may change over time as new elements are identified
Error-Defying Systems:
Redundancy
• 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. 1995;274:35–43.
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 institutions
– 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 discussion
– 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 community
– 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 commit
– Educated patients are the safest patients
– Directly involving patients has helped organizations move
toward highly reliable health care
Additional Information on
the Patient’s 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 Culture:
Barriers to Learning in Health Care
• 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 change
– 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 safety:
– 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
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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 information
– Percentage of medication orders with prohibited error-prone
abbreviations
– Time interval between prescribing and administering “stat”
medications
– Number of pharmacy interventions per 100 admissions
• 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 culture
– 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 errors
– 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
– ISMP’s 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
1. 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
2. Search the literature
— Find out what is known about the area targeted for
measurement
3. Establish aims
― Answer the question, “What are we trying to accomplish?”
― Have ambitious aims to show the current system is
inadequate
― Leaders should regularly communicate and reinforce aims
Balancing Measures:
Steps in the Process (continued)
4. 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 collection
5. 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 (continued)
6. 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
7. 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 performance
– 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 process
• 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 importance
• 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
References
Agency for Healthcare Research and Quality. Hospital survey
on patient safety culture. Pub. No. 04-0041. September
2004. Available at: http://www.ahrq.gov/
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.
2005;31:185–202.
Institute for Safe Medication Practices. ISMP trigger alert list.
September 6, 2000. Available at: http://www.ismp.org/
Newsletters/acutecare/articles/20050310_2.asp
References
Joint Commission on Accreditation of Healthcare
Organizations. Root causes of sentinel events.
Available at: http://www.jointcommission.org/
SentinelEvents/Statistics/
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis
of adverse drug events. JAMA. 1995;274:35–43.
Senge P, Kleiner A, Roberts C, et al. The Dance of
Change. New York, NY: Doubleday/Currency; 1999.
Sexton JB, Thomas EJ, Helmreich RL. Error, stress, and
teamwork in medicine and aviation: cross sectional
surveys. BMJ. 2000;320:745–9.