An Important Dot Understanding and Improving Medication Safety in - - PowerPoint PPT Presentation

An Important “Dot” Understanding and Improving Medication Safety in Pediatrics

Paul Sharek, MD, MPH

Assistant Professor of Pediatrics, Stanford University Medical Director of Quality Management Chief Clinical Patient Safety Officer Vice President of Quality, Safety, and Outcomes Management Lucile Packard Children’s Hospital

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The Basics

Learning objectives

• Unique challenges to ensuring medication safety in children
• Burden of medication harm in children
• Review Best Practices in pediatric medication safety
• Introduce “next generation” strategies (high reliability constructs) for

pediatric medication safety

Take home messages

• Harm (including medication related harm) occurs at high frequency in

children’s hospitals

• Numerous best practices to improve medication safety.
• Taking it the next level: Translating high reliability concepts into health

care is the next generation of medication safety

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How we will spend the next 30 minutes…

• Introduction
• Epidemiology of harm (medication related) in children
• Best practices in medication safety
• Institute for Healthcare Improvement
• NICHQ
• Others
• The next generation of patient safety interventions (high

reliability science)

• Summary

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• I. Uniqueness of Children

Special issues for children- relevant to medication safety

1. Weight based dosing (and weights change frequently) 2. Organ system development is variable, affecting metabolizing and excretion 3. Meds mixed by pharmacists or nurses at time of use 4. Pediatric meds often need to be diluted from adult formulations 5. Many pediatric medications come in multiple formulations 6. Children less likely to recognize/communicate an error or harm

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• II. The Burden of Harm in Children

Adverse Drug Event (ADE) Adverse Drug Event (ADE) - An injury, large or small, caused by the use (including non-use) of a drug. This may be as harmless as a drug rash or as serious as death.

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• II. The Burden of Harm in Children

Medication Error (ME)

• Definition: Any error in the process of:
• Ordering
• Transcribing
• Dispensing
• Administering
• Monitoring a medication
• Caveats
• Medication errors are not defined by outcome
• May not result in an actual adverse drug event

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• II. The Burden of Harm in Children

Harm vs. Error (IHI)

• “Error”: concept of preventability, process-focused
• “Adverse event”: harm, outcome focused
• Relationship between errors and adverse events

Errors Adverse Events

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• II. The Burden of Harm in Children

Medication errors and ADEs in Children

Kaushal et al, JAMA, 2001;285:2114-2120

• *p value <0.005

*

Total ADE rate 2.3 per 100 admissions

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• II. The Burden of Harm in Children

Age Specific Error Rates (per 100 admissions)

Kaushal et al, JAMA, 2001;285:2114-2120

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• II. The Burden of Harm in Children

Unit Specific Error Rates (per 100 orders)

Kaushal et al, JAMA, 2001;285:2114-2120

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• II. The Burden of Harm in Children

ADE Rates with Trigger Tool

Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008

960 Pediatric Inpatients; 11.1 ADEs per 100 admissions; 22x more ADEs than incident reports

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• II. The Burden of Harm in Children

ADE Rates with Trigger Tool

Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008

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• II. The Burden of Harm in Children

Pediatrics: ADE Rates with Trigger Tool

Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008

10 20 30 40 50 60 70 80 90 100 E F G H I

Percent NCC MERP severity level

ADE Severity Level

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Severity Rating of Adverse Events*

Category E: contributed to or resulted in temporary harm to the patient and required intervention Category F: contributed to or resulted in temporary harm to the patients and required initial or prolonged hospitalization Category G: contributed to or resulted in permanent patient harm Category H: required intervention to sustain life Category I: contributed to or resulted in the patient’s death *Source: National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

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• II. The Burden of Harm in Children

ADE Rates with Trigger Tool

Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008

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• II. The Burden of Harm in Children

ADE Rates with Trigger Tool

Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008

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• II. The Burden of Harm in Children

PICU Trigger Tool Trial: In Press

Total Patient Count: 734 Total Triggers: 2,816 Total # AEs identified: 1,488 Total Number of Patients with Adverse Events: 455 (62%) 91% of patients with an AE Identified with a Trigger (=416/455) Number of patients with multiple (> 1) Unique AEs: 245 (33%) Average LOS: 7.1 Days Average AEs over all Patients: 2.03/patient Average AEs in patients with adverse events: 3.27 / patient Overall # AEs per 100 pt. Days= 28.6 Average AEs per Trigger (Positive Predictive Value of any given trigger): 0.444 Average Triggers per Patient: 3.84 Mean Time for Chart Reviews: 24.7 minutes (per reviewer)

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• Prolon

g hosp.

• Interv.

to sustain life

• Perm.

harm

• 256 (17.20%) AEs were classified as ADEs
• No ADEs contributed to patient death
• II. The Burden of Harm in Children

PICU Trigger Tool Trial: In Press

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• II. The Burden of Medication Harm in Children

PICU Trigger Tool Trial: In Press

Statically significant risk factors:

• Surgical patients (preventable ADEs)
• Intubated patients (preventable ADEs)
• >18 yo patients (preventable ADEs)
• 13-18 yo and >18 yo patients (total ADEs)

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• II. The Burden of Harm in Children

Where the Adverse Drug Events Occur vs. Errors

(David Classen)

• Formulary,

purchasing decisions

• Inventory

management

• Dispense/
• distribute

medication

• Obtain

Medication-related History

• Document

Medication History

• Diagnostic/

Therapeutic Decisions Made

• Medication

Ordered

• Evaluate order
• Select

medication

• Educate patient
• regarding
• medication
• Order verified

and submitted

• Prepare

medication

• Educate staff

regarding medications

• History-Taking
• Ordering
• Pharmacy Management
• Education
• Select the
• correct drug for
• the correct
• patient
• Administer
• according to
• order and
• standards for
• drug
• Document
• administration
• and associated
• information
• Assess and

document

• patient response
• to medication
• according to
• defined

parameters

• Intervene as
• indicated for
• adverse
• reaction/error
• Administer Medication
• Monitor/Evaluate Response
• Document
• Medication Inventory Management
• Administration Management
• Incident/adverse

event surveillance and reporting

• Surveillance

*

ADEs = 11%

Transcription Errors = 12%

ADEs = 26%

Admin errors = 38%

ADEs =14%

Dispensing Errors = 11%

ADEs = 49%

Prescribing errors 39%

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• II. The Burden of Harm in Children

Summary findings

1. Overall: 11.1 ADEs per 100 admissions 2. Opiates 51% of all ADEs in children 3. Vast majority of medication related harm is temporary 1. Hospital wide 2. PICU setting 4. Most harm occurs at ordering and administration stages 5. 17% of all harm in PICU setting is drug related 6. Preventable ADEs in PICU: Risk factors 1. Surgical patient 2. Intubated patient 3. Increasing age

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• III. Best practices for Medication Safety-overview
• Institute for Healthcare Improvement (IHI)
• National Initiative for Child Health Quality (NICHQ)
• Harvard group (Bates/Kaushal/etc) recommendations
• American Academy of Pediatrics (AAP)

recommendations

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• III. Best Practices

IHI 100,000 Lives Campaign (12.2004)

• 1. Deploy Rapid Response Teams…at the first sign of

patient decline

• 2. Deliver Reliable, Evidence-Based Care for Acute

Myocardial Infarction…to prevent deaths from heart attack

• 3. Prevent Adverse Drug Events (ADEs)

…by implementing medication reconciliation

• 4. Prevent Central Line Infections…by implementing a

series of interdependent, scientifically grounded steps

• 5. Prevent Surgical Site Infections…by reliably delivering

the correct perioperative antibiotics at the proper time

• 6. Prevent Ventilator-Associated Pneumonia…by

implementing a series of interdependent, scientifically grounded steps

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• III. Best Practices

IHI Generation 2: The 5 Million Lives Campaign

100,000 lives campaign interventions PLUS New interventions targeted at harm:

• Prevent Pressure Ulcers...
• Reduce Methicillin-Resistant Staphylococcus aureus (MRSA)

Infection…

• Reduce Surgical Complications...
• Deliver Reliable, Evidence-Based Care for Congestive Heart

Failure…

• Get Boards on Board….
• Prevent Harm from High-Alert Medications... starting with a focus on

anticoagulants, sedatives, narcotics, and insulin

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• III. Best Practices

IHI Recommended strategies to decrease ADEs (F Federico. JQPS. 2007;13(9):537-542)

• I. Design systems that prevent errors and harm

1. Orders sets 2. Pre-printed order forms 3. Clinical pathways/protocols (standardize approach to similar med/diseases) 4. Reminders /information about monitoring parameters in the order sets 5. Standardize concentrations/dose strengths

• II. Identify errors before they reach the patient

1. Pharmacist review of orders 2. Double checks (where appropriate) 3. Critical lab information at the point of care

• III. Construct systems that quickly mitigate error/harm once it

reaches the patient

1. Antidotes available at bedside 2. Protocols that allow RNs to administer antidotes

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• III. Best Practices

NICHQ* recommended additional tactics: Pediatrics

• Use Trigger tools to detect and track harm
• Appropriate use of standardization
• Standardize doses
• Standardize concentrations
• Standardize order sets
• Reconcile medications
• Establish accurate home medication lists (include herbs/remedies)
• Maintain current medication lists
• Documents allergies
• Avoid allergens

* National Initiative for Children's Healthcare Quality

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• 1. Ward based Clinical Pharmacists: 82% reduction in

medication errors (88% potential ADEs)

• 2. CPOE with Decision Support: 73% reduction in

medication errors (75% of potential ADEs)

• 3. Improved communication: between physicians,

nurses, and pharmacists 65% reduction in medical errors (86% of potential ADEs)

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Conclusion: “…together these 3 interventions…could potentially prevent up to 98.5% of all medication errors…(96.7% potential ADEs)”

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Minimal effect with

• Bar coding
• Smart pumps
• Robots

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Smart Pumps and Bar Coding… the jury is still out

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Smart Pumps and Bar Coding… the jury is still out

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• III. Best Practices: American Academy of Pediatrics

Policy Statement on preventing medication errors

Pediatrics.2003;112(2):431-436

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• III. Best Practices: American Academy of Pediatrics Policy Statement
• n preventing medication errors (2003)

Categories of Recommendations (n=8)

• 1. Hospital systems actions and guidelines
• 2. Prescriber actions and guidelines
• 3. Prescriber education and communications
• 4. Pharmacy actions and guidelines
• 5. Pharmacy education and communication
• 6. Nursing actions and guidelines
• 7. Nursing Education and Communication
• 8. Patients and families

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• III. Best Practices:

Strategies to Address Adverse Drug Events

• Practical-Target top offenders
• Rational and Logical
• I contend that this is like being on call, putting out fires…
• Will get you to 10-2 or 10-3 level of reliability
• Stretch your mind…To really address pt safety, to make a huge

impact on patient safety

• …shift in philosophy
• …paradigm shift
• Look to other complex high risk industries who have done this well

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• IV. The Next Generation of Medication Safety:

High Reliability Organization Theory

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Are we better off 5 years after IOM???

• JAMA. 2005 May 18;293:2384-90

“…Although these efforts are affecting safety at the margin, their overall impact is hard to see in national statistics”

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What About Now???

Charles Vincent, BMJ November 2008;337:1205-1207

Considerable efforts have been made to improve patient safety and it is natural to ask…are patients any safer? The answer to this simple question is curiously elusive…we believe that the lack of reliable information on safety and quality

• f care is hindering improvement in

safety across the world.

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Average Rate Per Exposure of Catastrophes and Associated Deaths Per Activity (“Reliability”)

Amalberti, et al. Ann Intern Med.2005;142:756-764

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Highly Reliable Organizations Characteristics (Attributes)

Karl E. Weick, PhD Organizational Psychologist University of Michigan

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Attributes of High Reliability Organizations*: Weick

• 1. Preoccupation with failure
• 2. Reluctance to simplify interpretations
• 3. Sensitivity to operations
• 4. Commitment to resilience
• 5. Deference to expertise

Weick, et al. Research in Organizational Behavior. 1999;21:81-123 Weick, Managing the Unexpected: Assuring High Performance in an Age of Complexity, Jossey Bass 2001

*Think about processes with “Catastrophic consequences” (ex. K infusion, anesthesia, ECMO, etc)

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Attributes of High Reliability Organizations: Weick

• 1. Preoccupation with failure
• Small failures are as important as large failures
• Example: wrong breast milk
• Worry about normalization of unexpected events
• Avoid complacency:
• Success breeds confidence in a single way of doing

things and generates complacency

• Ex. “My patient has never had a Potassium
• verdose, so why should I change?”
• Success narrows perceptions

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Attributes of High Reliability Organizations: Weick

• 2. Reluctance to simplify interpretations
• Closer attention to context leads to more

differentiation of worldviews and mindsets

• Look for the root cause, not the obvious cause
• Ex. …Dumb resident wrote a 10-fold
• verdose…
• Root Cause: “dumb” resident was up all

night, in ED with seizing kid, called by RN for verbal order, …

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Attributes of High Reliability Organizations: Weick

• 3. Sensitivity to operations (“situational awareness”)
• Attentive to the front line where the real work gets done
• Ex. RNs in NICU noticed pump programming confusing with

Intralipids when on same pump as TPN

• Authority moves toward expertise:
• Role of RNs
• Role of Clinical MDs, PNPs
• Role of Parents
• Make continuous adjustments that prevent errors from accumulating

and enlarging based upon reporting from operations, not the “master plan”

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Attributes of High Reliability Organizations: Weick

• 4. Commitment to resilience
• Develop capabilities to detect, contain, and

bounce back from those inevitable errors that are part of an indeterminate world

• Ex. Trigger tools (and automation)
• A focus on intelligent reaction, improvisation
• Correct errors before they worsen and cause

more serious harm

• Ex. “stop the line”

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Attributes of High Reliability Organizations: Weick

• 5. Deference to expertise
• Decisions are made on the front line, and authority migrates to the

people with the most expertise, regardless of their rank

• Ex. RNs (not contracting, or IT) choose new smart pumps after

extensive simulations

• Avoidance of the structure of deference to the powerful, coercive, or

senior

• Make knowledge about the system transparent and widely known
• The „important‟ decision maker changes depending on the decision

maker‟s specialty

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• IV. Next Generation Medication Safety

Paul’s Practical Solutions to Move Toward High Reliability

Leadership

“Patient first” mantra

Organizational clarity

Mission statement Goals/incentives aligned

Human factors integration

Fatigue, staffing ratios, labels

Culture

“patients first”, collegiality, communication, reporting

Simulation

Prepare in advance for high risk situations

Zero defect philosophy

Defects in care not accepted as inevitable

Stop the line

Responsibility to stop dangerous processes and fix

Systems thinking

Systems and processes drive outcomes

Standardization

Checklists, boarding passes, order sets

Data driven

Data driven and evidenced based decision making

Technology: Tools for supporting ideal

processes

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Conclusions

• Adverse Drug Events in hospitals occur frequently
• Multiple specific evidence based interventions to

improve medication safety in children

• The next generation of medication safety
• Use tenets of reliability science
• Integrate attributes of highly reliable organization
• And remember…