Chapter 68: Providing a Framework for Ensuring Medication Use Safety

To Err is Human: Building a Safer - the first report of the Institute of Medicine (TOM) Committee on Quality.
Health System - This bench-mark report reframed medical error as a chronic threat to public health and galvanized media
attention to the issue.
Crossing the Quality Chasm: A New - Second – even more comprehensive report
Health System for the 21st Century - which called for nothing less than a redesign of the US healthcare system.
Chasm - painted a graphic and detailed picture of how and where the healthcare system fails to meet the needs and
expectations of the patients it serves.
Err - offered a similar conclusion relative to safety: flaws are unacceptable and common.
Six Aims for Improvement, 1. safe
establishing what should be
attainable: ÷
2. effective
3. timely
4. patient-centered
SETPEE 5. efficient

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6. equitable
-

•
Chasm called for change at four levels: 1. Experiences of patients and communities
2. Microsystems of care
3. Healthcare organizations (macrosystems)
4. Healthcare environment
Quality Chasm Series - Continues to build the body of evidence, understanding, and necessary action steps to keep patients safe
- Highlight the breath e- .
a-
Priority Areas for National Action - Clearly identified 20 priority areas that collectively address preventive measures care coordination, patient self-
Transforming Healthcare Quality management, and health literacy issues that cross acute, chronic, and palliative care domains.
Fostering Rapid Advances in - Identified the need for primary care redesign, improved information and technology infrastructures, insurance
HealthCare: Learning from System coverage changes, and malpractice reform strategies necessary to make care patient-centered and safety
Demonstrations focused.
Leadership by Example: Coordinating - multi-pronged approach to care improvement by suggesting that the federal government take advantage of the
Government Roles in Improving influence it has to set the standards for national healthcare quality.
Healthcare Quality
Patient Safety: Achieving a New - outlines the IOM recommendations for enhancing knowledge, developing tools, disseminating results in order
Standard for Care to build the necessary health data interchange and work plan to develop data standards applicable to the
collection, coding, and classification of patient safety information.
Health Professions Education: A - provides a mix of approaches to improve training environments, research, public reporting and leadership
Bridge to Quality - recommended an overarching vision for the education and competency base needed for health professionals
to be successful in a commitment to redesigning the healthcare system:
Keeping Patients Safe: Transforming - identifies necessary safeguards for safe and effective care
the Work Environment of Nurses
Changes that could impact all care 1. effective leadership
professionals and patients safety
efforts:
I
2. adequate staffing
3. organizational support for ongoing learning
4. interdisciplinary collaboration
I
5. appropriate work design
6. organizational support through governance and culture that supports safety as a priority
Preventing Medication Errors - This book set an agenda for improving the safety of medication use, by providing an overview of the system for
drug development. regulation, distribution, and use.
Will benefit from this guide to reducing 1. Patients
medication errors: 2. Primary healthcare providers
3. Healthcare organization
4. Purchasers of group healthcare
5. Legislators
6. Those affiliated w/ providing medications
Quality Chasm Series - highlight the breath and diversity of issues that must be addressed to improve local as well as natural
healthcare quality
Safety - an implied minimum standard in providing healthcare
- can only be achieved by learning how system component interact
Adverse Event - an injury caused by medical treatment. not necessarily due to an error.
AE Adverse Drug Event
-
- An injury, large or small, caused by the use (including nonuse) of a drug.
-

Two types of ADEs 1. Those caused by errors

2. Those that occurs despite proper use of medication
Preventable ADE - injury due to an error in the use of a drug (including failure to use).
Potential Adverse Drug Event - ADE is a medication error that has the potential to cause an ADE but did not, either by luck or because it was
PAPE intercepted
Adverse Drug Reaction - injuries caused when drugs are used in the - usual accepted fashion.
- By definition, then, an ADR does not result from an error.
Swiss Cheese Metaphor - Has been utilized by Reason and others to represent a dynamic, moving picture of defensive layers
Examples of latent conditions: 1. Lack of adequate patient information

Meredores, Ken Charles M. BSPh-3A

 2. Lack of appropriate communication 1. lack of adequate patient information
lack of appropriate communication
2.

3. Lack of or ambiguous drug information lack of

3-
ambigvos Any information
or

4. Lack adequate medication labeling 4. lack of medication labeling

5. lack of orientation and staff education
5. Lack of adequate orientation and staff education or resources on a topic area 6. lack of computer warnings
6. Lack of computer warnings of Improper
medication storage
g. Unclean procedures / policies
7. Improper storage of medications
8. Unclear policies/procedures
The design of many care systems for 1. Interruptions
patients have built-in features that 2. Workload
increase latent error potential: -
3. Work schedules
4. At risk behaviors or workarounds
System inequities - can be unforeseen and create quality and reliability problems at some point within the process.
Latent conditions - are seeded within the infrastructure of the organization and are often related to production or service design,
contracting, regulatory, or governmental mandates.
Latent error - demonstrates a new way of thinking for healthcare systems
Error theories in other industries focus 1. Errors are common
on the following concepts 2. Errors are a result aif complex cognitive mechanism
3. Psychologists, human factors specialties, and engineers are critical to the investigation of error and
development of error prevention strategies

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4. Man-machine interfaces need investigations for error potential
5. Defining complex systems and their component interactions are crucial
6. Work environment redesign, including ergonomic factors must be incuded
Medication-use System - This system is a complex group of related processes that includes prescribing, processing, dispensing, staff
and patient education, administration, and monitoring the effects of medications.
Medication errors - A property of MUS as a whole rather that purely the result of the acts or omissions of the people who interact
with the system
Contributing factors led to that 1. Poor order communication
individual’s perceived failures 2. Dangerous medication storage practices
includes: 3. Look-alike packaging an labeling
Latent failures - Are weaknesses in organizational structures that support the medication process
- Subtle and may not appear to directly cause an error

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“Key elements” of the medication 1. Patient information
system: 2. Drug information
3. Communication of Drug Orders and Other Drug Information
4. Drug Labeling and Packaging
5. Drug Standardization, Storage, and Distribution
6. Use of Devices
7. Environmental Factors
8. Staff Competency and Education
9.
Examples of latent failures: 1. Incomplete information about a patient
2. Unclear communication of a drug order

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4. Lack of computer warnings
5. Ambiguous drug references
6. Drug storage
7. Unclear policies/procedures
8. Lack of staff education
Drug information must be readily 1. Drug reference texts
accessible to all practitioners through 2. Drug information center
a variety of sources including: 3. Internet
Pharmacy order entry systems - Should screen for food and drug interactions, allergies, dose limits, and duplication of therapy, and these
DOES features should be tested for this capability
Confirmation bias - Something we experience from time to time
- You are more likely to believe information that supports your view rather than information that does not
Medications and drug supplies may be 1. Sample medications
stored and dispensed in a 2. Potentially hazardous drugs
manner that increases the likelihood of 3. Chemotherapeutic agents
an error, includes: 4. Oral hypoglycemic agents
5. Chemicals used in compounding
6. Non-drug supplies
Floor stock - There are a number of items that are stored in patient care areas
Joint Commission - established a medication management standard that requires that accredited facilities limit after-hours, non-
pharmacist access to supplies of medication to a secure location or a night/weekend cabinet outside the
pharmacy,

Meredores, Ken Charles M. BSPh-3A

 Specific safety procedures relating to 1. ensuring that medication labels face forward
organizing drug inventory would 2. adequate space for separate storage of each medication and strength
include: -
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3. ensuring that critical information on manufacturer’s label is not obscured
4. separating products that are for external or internal use
-

Environmental factors: 1. poor lighting

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2. temperature
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3. cluttered workspaces
-

4. noise
5. interruptions

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6. staffing pattern deficiencies
7. variation in workloads
Burnout - "A state of emotional exhaustion in which service providers view recipients impersonally and their own
general / mental fatigue feelings of
-

wearin ed performance disparagingly.”

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Cognitive Fatigue Hypothesis - Suggests that- prolonged stress reduces attention capacity because disproportionate resources are devoted to
the stressor, reducing the capacity left for performance
Frustration mood theory - Suggest that building frustration resulting from stress establishes irritation and anger, which diminish ability to
perform and affect interpersonal relationship
Chronic mental fatigue - The result of excessive cognitive work over weeks or months, coupled with cumulative stress, and is not
relieved by rest.
-
Existing competencies - become the base for transformational learning, and new capability evolves when new information is provided
to learners about the impact of their own actions and those of others.
Team training - an essential investment to establish an important building block for safety improvement
- focus of all team initiatives should be from the perspective of hazard avoidance
Pichert and Hickson suggest the 1. Identify patient preferences tor information
following framework for 2. Evaluate patient and family's desired decision-making role
• communications with patients: 3. Provide assessment and response to patient ideas, concerns, and expectation
4. Discuss clinical issue
5. Identify all alternatives
6. Present and evaluate evidence available\
7. Discuss pros and cons
Fatigue from intensive irk 8. Identify concerns
and excessive cognitive 9. Determine methods to resolve conflicts
lived 10. Agree on action plan and a follow up plan
17 short
11. Document the discussion and plan
Recommendations for initiating these 1. seek counsel from the healthcare organization's risk manager
difficult 2. Select a setting that will preserve dignity and confidential:
conversations include: 3. Deliver a clear message
4. Discuss support options
5. Wait silently for a reaction from patient and/or family
6. Deal with the reaction
7. Express empathy
8. Conclude interaction
9. Document the discussion Consider a follow-up meeting
10. Share findings with necessary organizational personnel.
12 questions to ensure safe 1. What are the brand and generic names of the medication?
medication use: 2. What is the purpose of the medication?
3. What is the strength and dosage?
4. What are the possible side effects, and what should be done if they occur?

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5. Are there medications that should be avoided while using this product?
-

6. How long should this medication be used? What outcomes are expected?
7. When is the best time to take this medication? .

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8. How should this medication be stored?
9. What should be done it a dose is missed?
10. What foods should be avoided while taking this medication?
11. Does this medication replace another medication currently prescribed? 0
12. What written information is available to explain this medication? ,
Aviation Safety and Reporting System - to collect and respond to voluntary submitted aviation safety reports, and incorporated a systems-approach
(ASRS) regarding error analysis and prevention.
American Society for Anesthesia (ASA) - have continued this effort by developing and establishing practice/treatment guidelines, as well as supporting
continued research in the areas of workload analysis/ fatigue.
- Additionally, ASA efforts focus on a team approach to care as well as providing for checks and balances in
anesthesia activities.
Systemness - How the elements function together
System - A group of interdependent people, items, processes, products, and services with a common aim.
IOMs Chasm offers four 1. Establish a national focus on patient safety
recommendations for a 2. Identify and learn from errors
tiered strategy: 3. Raise standards and expectations for improvement in safety
Meredores, Ken Charles M. BSPh-3A
 EIRC 4. Create a safety system inside healthcare organizations
-

Medical safety research - has focused on identification. quantification, and exploration of causal pathways of error, as well as the
,

concept of safety culture and the structure that supports a safety culture.
Quinn’s theory - smallest replicable unit, stemming from research of highly successful organizations that continually engineered
-

the frontline interface relationship that connected the organization's core competency with customer need
Microsystem - small, organized groups of providers and staff caring for defined populations of patients.
Mindfulness - demonstrated by a virtual preoccupation with failure and its consequences as a potential event.
Presentness - a connection to the actual demands of the moment and current situation, coupled with a chronic unease that
catastrophe might actually occur at any time.
② 10 success characterisitcs
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1. Leadership
2. Organizational support
> leadership
3. Staff focus ①
potato 4. Education and training
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5. Interdependence
> staff

6. Patient focus

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7. Community and market focus >
Patient
8. Performance results
9. Process improvement >
performance

10. Information and information technology

-Medication use process 1. Selection/storage
2. Prescribing/transcribing
SPDAMO 3. Dispensing
4. Administering
5. Monitoring
6. Outcome

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High-alert medications - drugs that bear a heightened risk of cautiion significant patient harm when they are used in error.
Improve medication use safety 1. systems-based approach
2. identifies possible causes and contributing factors to errors
SIE 3. employs risk reduction strategies

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Examples of systems failure 1. Deficiencies in medication knowledge 6.
2. Poor communication
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papatmaaramkahini 3. Poor information transfer
4. Failure to note down medication allergies Emp q
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5. Inaccessibility of patient information 10 '

Many recommendations have been 1. Recommended for storage and selection

provided in the literature for 2. Recommendation for prescribing improvements
consideration to improve medication 3. Recommendation for dispensing
use safety. 4. Recommendation for administration
5. Recommendations for monitoring and outcomes
Closed-loop system - A system that allows integration of prescribing information, medication information, realtime clinical screening,
intervention, and medication administration activities
Suggested methods to improve 1. Reducing label clutter on packaging
medication labeling process 2. Use of color differentiation
3. Distinctive background patterns or borders 0
4. Two-sided labeling
5. Contrasting important medication information on packaging a
Formularies - can be used as instructional and quality tools to assure that only agents that are safe, effective, and necessary
for use are provided for patients under care.
Organized formulary process - comprises a systematic peer review of medications for use and monitoring within a health system.

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Complete order 1. Patient name

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2. Patient-specific data Cage weight height )
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3. Generic and brand name

4. Medication strength
5. Dosage form
6. Amount to be dispensed
7. Complete direction for use
The type of healthcare information that 1. General information storage
is best suited for computerization 2. Repetitive functions
Includes: 3. Complex processes that depend on reproducible results
✗ 4. Items where legibility is essential
5. Items that require timely attention
6. Items where accuracy is vital

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Prevention of dispensing errors will 1. Work environment
require a comprehensive approach 2. Inventory management

①
including evaluation of: 3. Information resources Ah
4. Performance evaluation pertamu%Ea.in
5. Patient involvement

Meredores, Ken Charles M. BSPh-3A

The administration phase serves as a 1. Assuring appropriate indication for use
last final check on processing the 2. Identification of patient
entire medication order itself and 3. Proper use of medication devices
includes: 4. Patient education
niyan na daw ini 5. Monitoring of patients
Leadership - begins with vision, a full and in-depth understanding of the organization, its challenges in clinical quality and
satisfaction, and the ability to create a culture that sustains quality and excellence in delivering healthcare to
patients.
Culture - begins with a commitment to lifelong learning, process redesign, and a belief that no one can ever know it all.
Safety culture - leaders support and sustain the belief that performance and outcomes must be continually measured and

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evaluated, that collaboration and teamwork must be the norm and are valued, and that organizational
expectations demand care coordination and anticipated patient need to provide consistent and predictably high
levels of care.
Schein characterizes culture as 1. shared basic assumptions
defined by six properties 2. that are invented, discovered, or developed by a group as it
3. learns to cope with its problem of external adaptation and internal integration in ways that
4. have worked well enough to be considered valid and, therefore,
5. can be taught to new group members as the
6. correct way to perceive, think, and feel in relation to the problems.
Safety culture - creates a perspective focused on minimizing exposure to danger or injury.
- Safety cultures are characterized by communications that are founded on mutual trust and shared perceptions
of safety's importance, and by confidence in efforts to ensure it is a high priority.
4 subcultures that underpin a safety 1. Reporting culture
culture 2. Just culture
3. Flexible culture
RJFL 4. Learning culture
Reporting culture - focuses on what gets reported when errors or near misses occur since safety cultures depend heavily on what
can be learned from mistakes and near misses.
Just culture - characterized by a trusting environment that en-courages, and even rewards, reporting of safety information.
- A just culture also has a clear line of demarcation between acceptable behavior, which offers learning
opportunity and does not deserve disciplinary action, and unacceptable behavior.
Flexible culture - Adapt to changing demands
- information and decision-making tend to flow to technical expertise; hence, they are less hierarchical.
Learning culture - evolve when information is generated by knowledgeable people and that information is widely shared.
Organizations should identify method 1. Employ risk reduction activities within the work environment
of evaluating the staff's ability to: 2. Assess patient risk and selection for treatments
3. Monitor effects of care
4. Identify ADEs
5. Respond to ADEs when identified.
Root cause analysis - technique utilized to identify the fundamental reason for system failure, focuses on systems and processes

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rather than on individuals involved in the system.
- helps identify clear factors or causes that result in, at best, performance variation and, at worst, adverse events
or errors within a system.
Root cause - a single element that is directly attributed to starting a cause and effect chain
- the most fundamental reason that a failure, or a situation in which performance does not meet expectation, has
occurred
Cause - does not imply or assign blame as part of the definition
- refers to a relationship or potential relationship between factors that enable a failure or error to occur.
Close call - an event that almost occurred
Failure Mode and Effect Analysis - a proactive, prospective technique used to prevent process, system, or product problems before they occur.
- This activity can provide a safety next to identify problems that could occur and provide prediction of failure
severity and the healthcare system's ability to detect potential failures before they occur.
Failure - When a system, process, or service performs in a way that is not intended or desirable.
Mode - The manner or method in which something, like a failure, can occur.
- The term failure mode is then the manner in which something can fail.
Effects - The results or consequences of a failure mode
Analysis - An examination of the elements or structure of a process or service
Criticality Analysis - A method used to identify relative measures of importance for a failure mode,
-

Rank 1. Severity
2. Probability of occurrence
3. detectability
Agency for Healthcare Research and - lead federal agency on quality of care research.
Quality (AHRQ) - Its mission is to support, conduct, and disseminate research that improves access to care and the outcomes,
quality, cost, and utilization of healthcare services.
- Overall focus is: safety and quality, effectiveness, efficiency
Anesthesia Patient Safety Foundation - to assure that no patient shall he harmed by the effects of anesthesia
(APSF) - instrumental in the dramatic improvements in anesthesia safety
Meredores, Ken Charles M. BSPh-3A
 Institute for Healthcare Improvement - independent nonprofit organization
(IHI) - foster systematic improvements in healthcare
- leading force in promoting and facilitating teamwork and collaborative care in a variety of healthcare reform
initiatives. Its mantra is that people and organizations who share a common goal can achieve more by working
- -

together than by working separately.

Institute for Safe Medication Practices - the nation's only nonprofit organization devoted entirely to medication error prevention and safe medication
use.
HMP - known and respected worldwide as the premier resource for impartial, timely, accurate medication safety
information, ISMP's mission is to advance patient safety worldwide by empowering the healthcare community
Joint Commission - has put into place address a number of significant patient safety issues, including the implementation of patient
safety programs, the responsibility of organization leadership to create a culture of safety, the prevention of

OA
sa pinas medical errors through the prospective analysis, redesign of vulnerable patient systems, and the hospital’s
responsibility to tell a patient if he or she has been harmed by the care provided
- is in the process of standardizing and implementing similar patient safety standards throughout its
accreditation programs across the care continuum
National Academy for State Health - the forefront of examining how states monitor and respond to quality and patient safety issues.
Policy (NASHP) - Areas of focus have included the state government's role in patient safety, actions the states have taken to
improve patient safety, and other steps states are taking to improve quality of care.
National Committee for Quality - a private, nonprofit organization dedicated to improvement of healthcare quality, with its primary focus being on
Assurance (NCQA) managed care organizations.
-

- Activities performed by the NCQA include oversight of healthcare quality, conducting quality improvement
initiatives, and recognition of providers that demonstrate excellence in healthcare.
Health Plan Employer and Data - a body of standardized performance measures designed to insure that purchasers and consumers have the
Information Set (HEDIS) information they need to reliantly compare the performance of managed care plans.
National Patient Safety Foundation - mission to help healthcare systems achieve measurable improvements in patient safety.
(NPSF) - It seeks to identify, create, and facilitate the application of a core body of knowledge about patient safety; to
foster a culture of receptivity to patient safety initiatives; and to raise public awareness about patient safety.
National Quality Forum (NQF) - a private, not-for-profit membership organization created to develop and implement a national strategy for
healthcare quality measurement and reporting.
National Coordinating Council for - The mission of the NCC MERP is to maximize the safe use of medications and to increase awareness of
Medication Error Reporting and medication errors through open communication, increased reporting, and promotion of medication error

reviews
Prevention (NCC MERP) prevention strategies.
-

1. Re eetive
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3. Overt mechanical faith

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Cycle Of Error 3 channels
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12 important steps in building and support the development of safety
IN otiu everything
2. Track down bad news
3.CI/arily the onus of
proof
4.TN atch for unusual events and patterns
miss
517 etine the near

holistic view
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7# re eats strategy for lunch

changes when feedback is available
Herning occurs and behavior
Put individuals out there
to actively stand for a safety culture
of culture
IX. Feelings are the engine
IT keep valves simple
think safety first /
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W F- Meredores, Ken Charles M. BSPh-3A
D K

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 Institute for Healthcare Improvement - independent nonprofit organization
(IHI) - foster systematic improvements in healthcare
- leading force in promoting and facilitating teamwork and collaborative care in a variety of healthcare reform
initiatives. Its mantra is that people and organizations who share a common goal can achieve more by working
together than by working separately.
Institute for Safe Medication Practices - the nation's only nonprofit organization devoted entirely to medication error prevention and safe medication
use.
- known and respected worldwide as the premier resource for impartial, timely, accurate medication safety
information, ISMP's mission is to advance patient safety worldwide by empowering the healthcare community
Joint Commission - has put into place address a number of significant patient safety issues, including the implementation of patient
safety programs, the responsibility of organization leadership to create a culture of safety, the prevention of
medical errors through the prospective analysis, redesign of vulnerable patient systems, and the hospital’s
responsibility to tell a patient if he or she has been harmed by the care provided
- is in the process of standardizing and implementing similar patient safety standards throughout its
accreditation programs across the care continuum
National Academy for State Health - the forefront of examining how states monitor and respond to quality and patient safety issues.
Policy (NASHP) - Areas of focus have included the state government's role in patient safety, actions the states have taken to
improve patient safety, and other steps states are taking to improve quality of care.
National Committee for Quality - a private, nonprofit organization dedicated to improvement of healthcare quality, with its primary focus being on
Assurance (NCQA) managed care organizations.
- Activities performed by the NCQA include oversight of healthcare quality, conducting quality improvement
initiatives, and recognition of providers that demonstrate excellence in healthcare.
Health Plan Employer and Data - a body of standardized performance measures designed to insure that purchasers and consumers have the
Information Set (HEDIS) information they need to reliantly compare the performance of managed care plans.
National Patient Safety Foundation - mission to help healthcare systems achieve measurable improvements in patient safety.
(NPSF) - It seeks to identify, create, and facilitate the application of a core body of knowledge about patient safety; to
foster a culture of receptivity to patient safety initiatives; and to raise public awareness about patient safety.
National Quality Forum (NQF) - a private, not-for-profit membership organization created to develop and implement a national strategy for
healthcare quality measurement and reporting.
National Coordinating Council for - The mission of the NCC MERP is to maximize the safe use of medications and to increase awareness of
Medication Error Reporting and medication errors through open communication, increased reporting, and promotion of medication error
Prevention (NCC MERP) prevention strategies.

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Meredores, Ken Charles M. BSPh-3A