2017 pharmacy education - proces3.proce.com/res/pdf/chs2017oct18handout.pdf · 2017 pharmacy...

Improving Patient Safety: Preventing Medication Errors Through Event AnalysisCHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2017 Pharmacy Education Series

October 18, 2017Improving Patient Safety:

Preventing Medication Errors Through Event Analysis

Featured Speaker:

Christina Michalek, BS, RPh, FASHPMedication Safety SpecialistInstitute for Safe Medication Practices

Submission of an online post‐test and evaluation is the only way to obtain CE credit for this webinar

Go to www.ProCE.com/CHSRx Webinar attendees will also receive an email with a direct link to the web page Print your CE statement of completion online

– Credit for live or enduring (not both) Deadline: November 17, 2017 CPE Monitor (applicable to pharmacists and pharmacy technicians)

– CE credit automatically uploaded to NABP/CPE Monitor upon completion of post‐test and evaluation (user must complete the “claim credit” step)

CE Broker ‐ this CE activity is approved for State of Florida Medication Safety CE credit. Pharmacists and pharmacy technicians licensed in the State of Florida must provide their license number to info@proce.com for completed CE credit to be posted to CE Broker.

Online Evaluation, Self-Assessmentand CE Credit

Attendance Code

Code will be provided at the end of today’s activity 2

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2016 Pharmacy Education Series

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Ms. Michalek does not have any relevant commercial and/or financial relationships to disclose.

Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

October 18, 2017Improving Patient Safety:

Preventing Medication Errors Through Event Analysis

Featured Speaker:

Christina Michalek, BS, RPh, FASHPMedication Safety SpecialistInstitute for Safe Medication Practices

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Pharmacy Technician CE)

– 2.0 contact hours

Funding:This activity is self‐funded through CHSPSC.

This CE activity is approved for State of Florida Medication Safety CE credit.

Improving Patient Safety: Preventing Medication Errors

Through Event Analysis

CHS Medication Safety Webinar

October 18, 2017

Presented by: Christina Michalek BS, FASHP

Disclosure

Christina Michalek declares no conflicts of interest, real or apparent, and no financial

interests in any company, product, or service mentioned in this program, including grants,

employment, gifts, stock holdings, and honoraria.

Objectives• Explain system‐based causes of error and how to use this information to ensure patient safety through the prevention of medication errors

• Recognize the difference between prospective and retrospective risk identification and the difference between active and latent failures

• Outline strategies to identify multiple root causes of a medication error

• Discuss how human behavior, practice environment, and performance shaping strategies may be used in error reduction and prevention

My Goals for You

• Use what you already know added to what is discussed today to help you to be more proactive in identifying risk and preventing medication events

• Empower you to use system thinking in your daily work

• Facilitate analysis and identification of the root causes of errors

• Leave you with ideas and strategies to help prevent medication errors

Outline

• Risk identification: How do we identify risk?

• System thinking: How do we analyze events?

• Error prevention and reduction

• Root cause analysis: Identifying causal factors in an event

Finding errors: Risk Identification

Risk Identification

The detection of an actual or potential problem associated with patient care

Recognizing variations in process or expected outcomes which may or may not involve patient harm

Raise a concern before it contributes to an adverse effect/error

Error reporting ≠ Risk identification

Risk is Everywhere

• Risk is not inherently bad

• Healthcare can be “safe” but not “risk‐free”

• Which risks are worth taking?

Image courtesy of moggara12 at FreeDigitalPhotos.net14

Identification Methodology

• Prospective/Proactive – Risk

– Condition or state of being

– Hazardous condition or behavior

• Retrospective – Error

– May or may not have reached the patient

– May or may not have resulted in harm

The Tip of the Iceberg

Lot use: Voluntary event reports

BUT…. beware of

what’s hiding below

Analyzing risk using error reporting alone may cause us to believe we don’t have any medication safety

issues; “we’re safe”

Question

Based on studies, what percentage of adverse drug events are reported?

a. 80%

b. 50%

c. 20%

Voluntary Reporting

• Studies of medical services suggest that only 1.5% of all adverse events result in an incident report.

O.Neil A., Ann Intern Med 1993; 119:370‐376

• Less than 4% of all adverse drug events involving use of rescue drugs were reported

Schade, Am J Med Qual 2006 Sep‐Oct;21(5):335‐41

Voluntary Reporting

• Engages frontline staff‐ this is good

• May be difficult for busy frontline staff to initiate reports

• Can be an indicator of organizational culture

– Low volume may indicate fear of punishment

• Consistency in information collected can be a challenge

• Retrospective (error has occurred)

Cultural Factors and Reporting

• Concern about medication error rates

• Analysis of errors by discipline (silos)

– That’s pharmacy’s problem

• Nothing changes

• That can’t happen here

Enhancing Reporting

• Make it a goal

• Emphasize reporting of close calls/near misses

– Easier to talk about events that did not reach a patient

• Give feedback

• Good Catch Award Program

Other Sources of Information

• Technology data (retrospective)• Rapid response team reports (retrospective)• Focused medication reviews (prospective)• Chart review ‐ coding, triggers (retrospective)• FMEAs (prospective)• RCAs (retrospective)• Self Assessments (prospective)• Safety or executive walk‐rounds (prospective)• Safety briefings/staff meetings (prospective)

FMEA: failure mode and effects analysisRCA: root cause analysis

Concurrent Risk Assessment

• Pharmacy interventions

• Nursing interventions

• Triggers and markers (also could be retrospective)

• Active surveillance – change over time

• Clinical decision support

• Observation

Specific Risk Identification Methods

Self Assessments

Failure Mode and Effects Analysis (FMEA)

• A proactive process to identify potential errors and determine possible effects

• Team‐based, systematic, proactive approach• Identify the ways that a process or design

– Can fail– Why it might fail– What will happen if it fails– How it can be made safer

• Veterans Affairs National Center for Patient Safety– www.patientsafety.va.gov

• Failure modes

– Detectability

– Probability

– Severity

– Risk priority number

Healthcare (HFMEA)

Consider the Process Flow

• Who purchases?

• Where stored?

• Who prescribes?

• How is it ordered?

• Where is it used?

• How does it arrive?

• Who administers it?

• How/who monitors?

• Who adjusts therapy?

• How is administration documented?

• How is it reordered?

• What COULD happen?

External Data

• Joint Commission Sentinel Event Alerts

• FDA MedWatch email notifications

• ISMP publications

• National Alert Network (NAN) Alerts

• The Joint Commission Journal on Quality and Patient Safety

• Media – what your administrator and board are following

External Data

Triggers

• An easily identifiable, focused item representing an opportunity (or clue) that may lead to an adverse event

• Medications, laboratory tests, patient conditions

• Something went wrong

• Effective method for measuring harm

Pharmacist Interventions

• During order entry or verification

– Dose adjustments, drug selection recommendations

• Customized screening alerts

– Patient information, lab information, drug database warnings

• Active surveillance triggers

Observation

• Requires a direct observer

• Compared observation of what was administered to original order

• 2002 study

– Found almost 1 in 5 (19%) of the doses were in error

– 7% were rated potentially harmful

Observation

• Take this further than medication administration

– Processes (verbal orders, compounding, programming infusion pumps, workflow)

– Storage conditions

– Communication dynamics

Technology Data

• Information systems– Alerts– Overrides– Missing patient information

• Barcode medication administration– Wrong medications, wrong patient, wrong time

• Automated Dispensing Cabinets– Overrides

• Infusion pumps– Hard maximum limit triggers– Soft low and maximum limit triggers

Question

Test your knowledge….

Which of the following methods can be used to identify risk?

a. Technology decision support alerts that trigger during use

b. Shift‐to‐shift briefings

c. Reviewing ADC reports

d. All of the above

System thinking: How to analyze events

Systems Thinking

• A system is a group of interacting, interrelated, and interdependent components that form a complex and unified whole

• A way of understanding the relationship among a system’s parts, rather than the parts themselves

To Err is Human• No one is immune

• Human error is not a behavioral choice

• Least manageable link in error

• Manage causes and consequences of errors through system design

Blame Paradox

• Practitioners are human

• They will never be error‐free…even when they are “very careful…”

• Errors can always be tied to system‐base caused or latent failures in the system which “set‐up” the practitioner for error

We All Drift

• Drifting = at‐risk behaviors

• Primary reasons

– Desire to accomplish more

– Fading perceptions of risk

– Unknowingly create unjustifiable risk

– Convince one’s self they are in a safe place

– Everyone’s doing it that way

Drift • Behavioral choice that increases risk where risk is not recognized, or is mistakenly believed to be justified

• Driven by perception of consequences

‐ Immediate and certain consequences are strong

‐ Delayed and uncertain consequences are weak

• System‐based causes; culture tolerant of risk

‐ “It’s never happened here” syndrome

Everyday Risk ‐ ‘Choices’ ‐ Drift

• Wearing seat belts in cars

• Using a mobile phone while driving

• Texting while driving

• Driving over the speed limit

• Right turn on red without stopping

Everyday Risk at Work ‐ ‘Choices’ ‐ Drift

• Perform time‐outs

• Correct double‐check when needed or required

• Labeling of all syringes and bowls

• Read back or repeat back of verbal/telephone orders

• Reuse of single dose vials

• Using bar code scanning systems

• Responding to computer alerts

• Have the medication administration record (MAR) at the bedside

Assume That Errors Will Occur

• Assume that errors are inevitable

• Many factors, latent (blunt end) and active (sharp end), must be present and in proper alignment for error to occur

• Emphasis on redesign of system to make it more difficult to err

Latent (System) Failures

• Incomplete information about a patient

• Unclear communication of a drug order

• Lack of computer warnings (interactions, allergies, dosages, etc.)

• Ambiguous drug references

• Drug storage (look alike/sound alike medications, hazardous chemicals)

• Unclear policies/procedures

• Failed checking processes

Limitations on Human Performance

• Limited ability to multi‐task

• Interruptions and distractions

• Fatigue and psychological factors

• Environnemental factors (light, noise, temperature)

• Human Factors– Confirmation bias

– Dependence on heuristics during times of stress

– Normalization of deviance

Different Things That are Too Similar

The Power of the Human Mind

Aoccdrnig to rscheearch at CmabrigdeUinervtisy, it deosn’t mttaer in haht oredr the ltteers in a wrod are, the olny iprmoent tihng is that the frist and lsat ltteer be at the rghit pclae. The rset can be a tatol mses and you can sitllraed it wouthit a porbelm.

This is bcuseae the huamn mnid deos not raedervey lteter by istlef, but the wrod as a wlohe.

Amzanig huh?

Key Elements of the Medication Use System

1. Patient information

2. Drug information

3. Communication of drug information

4. Labeling, packaging, and nomenclature

5. Drug storage, stock, standardization, and distribution

6. Device acquisition, use, and monitoring

7. Environmental factors

8. Staff competency and education

9. Patient education

10. Quality, culture, and risk management issues

ISMP Assess‐ERR™

Medication System Worksheet

Investigation and Analysis of

Errors

Error Reduction Strategies

Primary Principles for Error Reduction

• Reduce or eliminate the possibility of error

• Make errors visible

• Minimize the consequence of errors

• Report and analyze internal errors

• Report errors externally and use external information

Error Reduction Strategies

Strategy– Fail‐safes and constraints

– Forcing functions

– Automation and computerization

– Standardization

– Redundancies

– Reminders and checklists

– Rules and policies

– Education and information

– Suggestions to “be more vigilant”

Power (Leverage)

– High (“Blunt end”)

– Medium

– Low (“Sharp end”)

Car won’t start if alcohol is detected

on breath

Reminder signs and

checkpoints

Rule/Law: It’s illegal to drive over the allowable alcohol

Maximize Access to Information Necessary information at the appropriate time

Use Constraints to Limit Access

• Reduce access to dangerous items

– Prohibit pharmacy access by non‐pharmacists

– Limit number of choices/concentrations

• Move problem products out of reach

– Concentrated electrolytes

– Neuromuscular blocking agents

Forcing Functions

• Ensures that parts from different systems are not interchangeable

• Forces proper methods of use

• Makes errors immediately visible

– Preprinted order forms or computer options that “force” selection (limited list of medications or available dosages)

– Oral syringe should not be able to fit onto an intravenous line

Forcing Functions: Prevent from happening

Limit AccessRestrict use

• Hazardous chemicals

• Neuromuscular blocking agents

Simplify Reduce the number of options

Available Heparin Concentrations

• 10 units/mL

• 100 units/mL

– 1 mL vial

– 10 mL vial

• 1,000 units/mL

– 1 mL vial

– 2 mL vial

– 10 mL vial

– 30 mL vial

• 5,000 units/mL– 1 mL vial– 10 mL vial

• 10,000 units/mL– 1 mL vial– 4 mL vial– 5 mL vial– 10 mL vial

• 20,000 units/mL– 1 mL vial– 5 mL vial

SimplifyReduce the number of options

ExternalizeTransfer error‐prone tasks

• Use commercially‐available products

• Outsource low volume solutions

• Prepare chemotherapy in a centralized location with specialized staff

RedundancyMultiple pathways

• No single failure can cause an event

• Second pathway prevents failure

Question

According to studies, what percentage of errors can be identified by an independent double‐check?

a. 20%

b. 60%

c. 75%

d. 95%

RedundancyDouble checks

• Can be an important safety strategy

• Takes extra time

• Some believe may lead to more mistakes as staff may rely upon the checker to catch the mistake

• Work best when independent

– No cues from the person who carried out the work

RedundancyDouble checks

• Identify a high rate of errors

• Study of prescriptions awaiting pick up– 5,700 prescriptions

– 240 filled in error (2.1% considered potentially harmful)

• Studies where artificial errors were introduced – 93‐97% were identified by an independent double check

• Hard to find your own mistakes (confirmation bias)

Situational AwarenessEnhance understanding to reduce drifting into unsafe behaviors

• Simulation– Clinical scenarios

– Real‐life conditions

– Initial and ongoing training

– Used in pharmacy school education (and other medical disciplines)

– Available in many hospitals

Positive Performance ShapingImprove human performance

• Environment

– Temperature

– Lighting

– Noise

– Distractions

• Workload

– Shift length

– Importance of breaks

– Multi‐tasking

– Mixed messages

– Rewarding risky behavior

Checklists/RemindersAssist with remembering

• Reminders

– Order sets (e.g., management of hypoglycemia)

– Auxiliary labeling (e.g., “For Intravenous Use ONLY – FATAL IF GIVEN BY OTHER ROUTES”)

• Checklists

– IV Compounder set up

– Adding a new drug to a database

– Complex validation processes (e.g., chemotherapy preparation)

Summing UpError Reduction Strategies

• Error prevention strategies are not mutually exclusive

• The fastest and easiest solution may not always be the best… and may introduce new sources of error

• People cannot be expected to compensate for work systems

Root Cause Analysis (RCA)

Definitions

• Root Cause: Most fundamental reason an event has occurred

• Contributing Factor: Additional reasons, not necessarily the most basic reason that an event has occurred

Characteristics of RCA• Retrospective process for identifying the most

basic, causal factors that underlie variation/event

• Identifies behavioral risk points and their potential contribution to the event• Human error• At-risk or reckless behavior

• Identifies system risk points as analysis digs deeper by repeatedly asking “Why?” and “How?”• System failures

• Identification of risk-reduction strategies, action plan, measures

Why is RCA Important?

• Preventable adverse events will happen and are destined to repeat

• Provides understanding of conditions that lead or can lead to patient harm

• Jumping prematurely to solutions may miss the target and not fix the problem

• Opportunity for shared accountability and learning– All members of RCA team crucial to success

Root Cause(s) Analysis

A retrospective process for identifying the most basic or causal factors that underlie variation in performance, including the occurrence, or possible occurrence of a sentinel event

TJC Glossary of Terms

Root Cause(s) Analysis

Effective and lasting change can occur only when the root causes of variation in performance are discovered and remedied

TJC Glossary of Terms

The Goals of RCA/Event Investigation

What happened?

What does procedure require?

How were we managing it?

Increasingvalue

What normally happens?

Why did it happen?

Goals of an RCA• Create a detailed chronological sequence of the

event • Next move from an event-oriented explanation to a

system-oriented explanation of the event• Identify all the human errors and behavioral

choices that led to the event• Human error is not a behavioral choice

• Identify the underlying causes of each human error and incorrect behavioral choice• Breech of policy, not following procedure, cutting a

corner• Determine how we were managing the risk before

the event

Why, why, why, why…

Why Did It Happen?• What are the individual’s performance shaping

factors?o Information?o Equipment/Tools?o Job/Task?o Qualifications/Skills?o Individual Factors?o Environment/Facilities?o Organizational Environment?o Supervision?o Communication?

Why Did It Happen?• What are the system-based causes?

o Lack of patient information?o Lack of drug Information?o Failure to communicate?o Labeling, packaging, nomenclature problems?o Drug storage and standardization issue?o Medical device problem?o Lack of patient education?o Lack of staff education/orientation/supervision?o Environmental or staffing issues?o Culture of safety?

Why Did It Happen

• Explain at-risk behaviorso Why was the decision made?

• Incentives to cut the corner?• Perceptions of risk?

o How prevalent is the behavior?• Individual?• Group?

The Basics of Event Investigation• How was the organization (manager) managing

the risk?o Employee to manage?o High skill/competency?o Performance shaping factors (system, individual)?o Maintain high perception of risk?o Strategies?

o Barriers, forcing functions, fail safes? o Redundancy?o Recovery?

When is RCA Necessary?

• Not every adverse event • Organizations should specify/define

“require RCA?” or “investigate through cases reviews or investigative techniques?”

8 Deadly Sins1) Focus on individuals2) Hindsight bias3) Reacting to emotional component of patient

harm4) Failure to move beyond proximate causes5) Believing there is a single root cause6) Response confused with proactive risk

management7) Tunnel vision (both causes and actions)8) Weak error reduction strategies

Kellogg KM, et al. BMJ Qual Saf 2017;26:381‐387

Summary of RCA Process• Appoint a team• Train the team on the RCA process• Create an initial sequence/timeline of the event• Gather information

– Interviews/observations/simulations/literature

• Synthesize information • Identify root causes and contributing factors• Develop an action plan• Communicate the action plan• Implement the action plan• Measure effectiveness

“Nurse administered 51 g of magnesium sulfate, which resulted in a patient death”

Failure model of complex system failuremodified from James Reason, 1991

Ambiguous order

No pharmacy review; No protocols Floor Stock;

5 vials of Mag Sulfate

Inadequate practitioner orientation

CommunicationSystem

Drug InfoSystem

Drug Storage System

Staff Education and Competency

Risk management

No Independent Double Check

Question

Test your knowledge……

Which of the following is considered a high‐leverage safety strategy?

a. Providing a lecture on a new drug

b. Performing a FMEA for a new infusion pump

c. Applying “high‐alert” labels to medications

Question

Test your knowledge….

All of the following are examples of safety strategies except:

a. Maximizing use of premixed solutions

b. Educating staff about high‐alert medications

c. Simultaneously performing double‐checks

d. Utilizing allergy bracelets for patients

Conclusion

• Risk identification must go beyond just voluntary error reporting

• It is best to utilize prospective, retrospective, and concurrent methods of risk identification

• Error prevention requires emphasis on performance shaping strategies

• During a RCA, avoid focus on a specific individual; instead, focus on the system‐based causes of the error

ISMP National Medication Errors Reporting Program and Vaccine Errors

Reporting Program

ISMP is a federally certified patient safety organization (PSO)

Jerry H. Reed, MS, RPh, FASCP, FASHP

Senior Director, Pharmacy Services

Community Health Systems

Update on Current Pharmacy Initiatives and Strategies

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