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 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: What is important• Beliefs: How things work• Behaviors: 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

• 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


• 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


• 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


• 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 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

• 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– 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– 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


• 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


• 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


• 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– 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.

managing medication risks through a culture of safety

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