Transcript Slide 1

Reducing Emergency Department
Visits due to Adverse Events from
Medications
USPHS Scientific & Training Symposium
May 25, 2010
Daniel Budnitz MD, MPH, CDR USPHS
Division of Healthcare Quality Promotion
Disclaimer
“The findings and conclusions in this
presentation are those of the author and do
not necessarily represent the official position
of the Centers for Disease Control and
Prevention”
Overview
1. An injury-based approach to medication safety
–
Errors vs. harm
2. Population-based harm data for priority setting
–
Frequency, severity, preventability
3. Patient-centered interventions
–
Opportunities, collaboration & injury prevention
1. An Injury-based Approach
Bank Robber
1901 - 1980
http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm
William Sutton
Gentleman, Innovator, &… Bank Robber
1901 - 1980
http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm
“Slick Willie” Sutton
Gentleman, Innovator, &… Bank Robber
“Why do you rob banks?”
“Because, that’s where the
money is.”
1901 - 1980
http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm
Sutton’s Law & Drug Safety
“Where the highest costs are incurred,
therein lies the highest potential for over-all
cost reduction”
-- Sutton’s Law applied to management accounting
Sutton’s Law & Drug Safety
“Where the highest costs are incurred,
therein lies the highest potential for over-all
cost reduction”
-- Sutton’s Law applied to management accounting
“Where the highest number of adverse drug
events (ADEs) occur, therein lies the highest
potential for over-all harm reduction”
-- Sutton’s Law applied to drug safety
Mediation Safety in 2000s:
Decade of Errors
2000
2006
A Focus on Error Reduction…
Errors
Errors = Preventable events that may lead to
inappropriate medication use or patient harm
... Rather Than Harm Reduction
ADEs
ADE = Injury (harm) caused by a drug
Some Errors ∩ Harm
Errors
Stable
Patient
ADEs
Injured
Patient
Why Not Start with Harms?
Errors
ADEs
(Harms)
Injured
Patient
Focus on Harms that are…
Errors
Serious,
Common,
Preventable
Injured
Patient
Public Health Approach
Evaluate
Impact
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
Population Surveillance
Data Drive the Public
Health Approach
Public Health Approach
Little national
data on harms
Evaluate
Impact
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
Population Surveillance
Data Drive the Public
Health Approach
January, 2000
Evaluate
Impact
“…the data on emergency
department visits and
hospital admissions are
insufficient for estimating
overall ADE frequency”
Identify the
Harm
2. Population-based Harm Data
for Priority Setting
Frequency, severity,
preventability
Why Emergency Visits &
Hospitalizations?

Medication use 1
–
–
1.
82% adults take at least 1 medicine
18% adults >64 take 10 or more
1. Slone Epidemiology Center at Boston University, 2008
Why Emergency Visits &
Hospitalizations?

Medication use 1
–
–

1.
2.
82% adults take at least 1 medicine
18% adults >64 take 10 or more
Medication costs 2
Hospitals
Clinics
Community
$27B
$33B
$227B
1. Slone Epidemiology Center at Boston University, 2008
2. Hoffman et al. Am J Health Syst Pharm 2009;66:237-57
Serious, Acute Harms:
Emergency Departments (EDs)
Community
Setting
ED visit
NEISS-CADES:
Population Representative Surveillance

Stratified probability sample of 24-hour EDs
-

63 hospitals
4 strata by hospital size / 1 stratum for pediatric
Cases weighted by inverse probability of selection
Case Definition (ADEs)
Injury from the use of a drug:
•
Emergency department (ED) visit
•
Treating physician explicitly attributed
•
To a drug*
•
Intended for therapeutic use
*Drugs include: Rx, OTC, Supplements, Vaccines
Budnitz DS et al. JAMA 2006;296:1858-1866
Estimated Annual Impact of
Ambulatory Adverse Drug Events
2004-2005
Deaths
Hospitalizations
Emergency visits
Office visits
?
>117,000
0.4 per 1,000
>700,000
2.4 per 1,000
> 3.6 million
14.3 per 1,000
Budnitz DS et al. JAMA 2006;296:1858-66
Zhan C et al. Jt Comm J Qual Patient Saf 2005;7:372-8
ED Visits for ADEs by Event Type,
United States, 2004-2005

Similar numbers of ED visit for allergic reactions,
non-allergic adverse effects, and unintentional
overdoses
Budnitz, D. S. et al. JAMA 2006;296:1858-1866.
Budnitz DS et al. JAMA 2006;296:1858-1866
Hospitalizations for ADEs by Event Type,
United States, 2004-2005

Most hospitalizations due to unintended overdoses
 66% due to warfarin, antidiabetic agents, or other
narrow-therapeutic index drugs
►
Budnitz, D. S. et al. JAMA 2006;296:1858-1866.
Budnitz DS et al. JAMA 2006;296:1858-1866
Drugs Implicated in ED Visits for ADEs
United States, 2004-2005
►
►
Budnitz DS et al. JAMA 2006;296:1858-1866
ADEs Treated in EDs by Patient Age,
United States, 2004-2005
Budnitz DS et al. JAMA 2006;296:1858-1866
Public Health Approach for
Medication Safety, 2008
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
Older Adults
~ 1 out of 150 per year
~ 7x hospitalization rate
~ 927,000 ED visits, 2008
Public Health Approach for
Medication Safety
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
“Potentially
Inappropriate”
Medications
??
Older Adults
~ 1 out of 150 per year
~ 7x hospitalization rate
~ 927,000 ED visits, 2008
“Potentially Inappropriate” Medicines
Adapted from Fick DM et al. Arch Intern Med 2003;163:2716-25
Budnitz, DS et al. Ann Intern Med 2007;147:755-765
“Potentially Inappropriate” Prescribing
Impacts Interventions

National Quality Measures
–
–

CMS
–
–
–

HEDIS / National Quality Forum measure
AHRQ annual Healthcare Quality Report
Monitoring of nursing home prescribing
Part D payment for Medication Therapy Management
9th Scope of Work for quality improvement
Computerized clinical decision support
–
“Meaningful Use”
Frequency of ED Visits for ADEs,
Persons ≥65 Years
►
Budnitz DS et al. Ann Intern Med 2007;147:755-765
Frequency of ED Visits for ADEs,
Persons ≥65 Years
►
►
►
►
Budnitz DS et al. Ann Intern Med 2007;147:755-765
Frequency of ED Visits for ADEs,
Persons ≥65 Years
Budnitz DS et al. Ann Intern Med 2007;147:755-765
Risk of ED Visits for ADEs,
Persons ≥65 Years
Budnitz DS et al. Ann Intern Med 2007;147:755-765
Based on Harm: Focus on Older
Adults & Certain Medicines

Frequency:
–
1 in 150 older adults / year

Severity: 7x more likely to be hospitalized

Preventability: Dosing and monitoring
–
3 drugs (insulin, warfarin, and digoxin)
–
33% of estimated ADEs treated in EDs
Public Health Approach for
Medication Safety
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
“Potentially
Inappropriate”
Medications
Older Adults
~ 1 out of 150 per year
~ 7x hospitalization rate
~ 927,000 ED visits, 2008
Public Health Approach for
Medication Safety
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
Anticoagulants
Insulins
NTI Medicines
Older Adults
~ 1 out of 150 per year
~ 7x hospitalization rate
~ 927,000 ED visits, 2008
Public Health Approach
Evaluate
Impact
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
Anticoagulants
Insulins
NTI Medicines
 4 proposed Sub-objectives
http://www.healthypeople.gov/HP2020/Objectives/
3. Patient-centered Prevention
Partnerships
ADEs Treated in EDs by Patient Age,
United States, 2004-2005
Budnitz DS et al. JAMA 2006;296:1858-1866
Unintentional Overdoses Cause Most
Emergency Visits in Children <5 Years Old
Type
1,022
7,911
Percent
Unintentional
Overdoses
58%
Allergic Reactions
28%
Side Effects
5%
Vaccine Reactions
8%
Secondary Effects
1%
5,022
56,416
27,500
Cohen AL, et al. J Pediatr 2008;152: 416-421
Rates of Emergency Department Visits for
Unintentional Overdoses, 2004-2005
Schillie SF et al. Am J Prev Med 2009;37:181-7
Rates of Emergency Department Visits for
Unintentional Overdoses, 2004-2005
1 out of every 180
two-year-olds
each year
Schillie SF et al. Am J Prev Med 2009;37:181-7
Underlying Causes of Emergency
Department Visits for Child Overdoses,
2004-2005
Schillie SF, et al. Am J Prev Med 2009;37:181-7
Underlying Causes of Emergency
Department Visits for Child Overdoses,
2004-2005
Schillie SF, et al. Am J Prev Med 2009;37:181-7
Underlying Causes of Emergency
Department Visits for Child Overdoses,
2004-2005
Schillie SF, et al. Am J Prev Med 2009;37:181-7
PROTECT Partnership

Preventing Overdoses & Treatment Errors
in Children Taskforce

Federal agencies, manufacturers (OTC),
professional organizations, safety experts

Innovative safety packaging (↓ ingestions)

Standardize dosing units and abbreviations
for liquid medicines (↓ errors)
Packaging Innovations to Reduce
Pediatric Ingestions
Active
Passive
Principles of Standardization &
Health Literacy
http://www.chpa-info.org/scienceregulatory/Voluntary_Codes.aspx
Tamiflu Suspension
Medication-safety efforts in ambulatory
settings must recognize the central role of
patients and lay caregivers in medication
management. Instructions and labeling
should be clear, concise, consistent, and
designed for the way prescriptions are
written and used. As highlighted by Parker
et al., dispensing liquid medications with
dosing devices with markings that match
the units used in the instructions on the
pharmacy label is one necessary step
toward safer medication use.
Public Health Approach for
Medication Safety
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Harm
Improving
packaging,
labeling
- 1 in 180 two-year olds
- Unsupervised ingestions
98,000 ED visits/year for
children <=5 years old
 4th proposed Sub-objective
http://www.healthypeople.gov/HP2020/Objectives/
Summary
1. Injury-based approach to medication safety
–
Identify the harms
2. Population-based harm data for priority setting
–
Identify common, serious, preventable harms
3. Patient-centered interventions
–
Use opportunities, collaboration & lessons of
injury prevention
Acknowledgements
Division of Healthcare
Quality Promotion, CDC
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Nadine Shehab
Kelly Weidenbach
Victor Johnson
Melissa Schaefer
Maribeth Lovegrove
Michael Jhung
Daniel Pollock
Sarah Schillie
Chesley Richards
Center for Drug Evaluation and
Research, FDA
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Karen Weiss
Solomon Iyasu
Gerald Dalpan
Judy Staffa
Pamela Scott
Mary Willie
Margie Goulding
Charles Ganley
Sue Johnson
US Consumer Product Safety
Commission
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Tom Schroeder
Joel Freidman
Cathleen Irish
TM
Additional Slides
Implications for Antibiotic Use
• Antibiotics
– 7 of the top 14 drugs implicated
in ED visits for ADEs
– 142,000 ED visits/year
– ~ 80% are allergic reactions
• Risks of adverse events from
antibiotics incorporated into
national campaign to promote
judicious antibiotic use
– CDC Get Smart
Budnitz DS, et al. JAMA 2006;296:1858-66.
Shehab N, et al. Clin Infect Dis 2008;47:735-43.
OTC Medicines are Commonly Involved
in Emergency Visits for Overdoses
.
.
.
.
.
Schillie SF, et al. Am J Prev Med 2009;37:181-7
Example: Innovations to Reduce
Needlesticks
Active
Passive
Drug Management by Setting
Hospital
Who prescribes?
MD
Who administers?
RN
Who stores?
PharmD
Who monitors?
MD, RN, PharmD, Lab
Support systems?
Extensive
ADE monitoring?
Incident reporting
Basis for safety
interventions?
Systems engineering
Industrial quality control
Budnitz DS and Layde PM. Pharmacoepidemiol Drug Saf. 2007;16:160-5
Drug Management by Setting
Hospital
Ambulatory
Who prescribes?
MD
MD & Layperson
Who administers?
RN
Layperson
Who stores?
PharmD
Layperson
Who monitors?
MD, RN, PharmD, Lab
Layperson & MD
Support systems?
Extensive
Minimal
ADE monitoring?
Incident reporting
Public health surveillance
Basis for safety
interventions?
Systems engineering
Industrial quality control
Injury Prevention Strategies
Budnitz DS and Layde PM. Pharmacoepidemiol Drug Saf. 2007;16:160-5
NEISS-CADES:
Data Collection
 Ongoing surveillance based on chart abstraction
Limitations

Setting: only ED visits
–

Underestimates
–
–

No inpatient follow-up or mortality
Relies on caregiver recognition, physician
documentation, and accurate abstraction
High PPV, lower sensitivity
Selection biases
–
–
Acute onset ADEs
ADEs which can be diagnosed in ED
Identifying ADE Cases
START
STOP
Do not report
ADE
1. Look in Diagnosis Section of chart:
Do diagnoses include key words?
•
•
•
•
•
•
•
Allergic reaction
Adverse effect
Side-effect (s/e)
Secondary to (2°to, due to, related to)
Ingestion (poisoning)
Toxicity (overdose, supra-therapeutic level)
Medication error
NO
YES
2. Is a Drug involved?
Drugs include: prescription meds,
over-the-counter meds, vaccines,
vitamins, & dietary supplements.
4. Fill out ADE Screen:
YES
• Record ED chart DIAGNOSIS
word for word
Or suspicious symptoms?
•
•
•
•
Angioedema (face/lip/throat swelling)
Anaphylaxis (severe allergy)
Rash (urticaria, dermatitis)
Bleeding (GI Bleed, hematemesis, epistaxis,
3. Is there evidence of:
• Suicide attempt?
• Intentional overdose?
• Abuse / Recreational use?
hypocoaguability, high INR/PT)
• Hypoglycemia (low blood sugar)
NO
YES
STOP
Do not report
ADE
NO
• Record drug name(s)
• If available, record dose, route,
frequency, and duration
• Record reason for visit, testing,
and treatments
• Record any other information
(e.g., discharge instructions or
medication error information)
FINISH
Recording Case Data
• Drug data
– Name of implicated medication(s)
– Dose, frequency, duration, route
– Concomitant drugs
• Patient demographics
• Testing and treatments in ED
• Physician diagnoses
• Patient disposition
• Narrative description of event
Public Health Approach for
Medication Safety
Insulin,
Warfarin
Design
Intervention
Identify Risk
& Protective
Factors
Identify the
Problem
Older Adults
- 2x rate ED visits
- 7x hospitalization rate
256,000 ED visits in 2008
Identify Plausible Interventions
Phase-Factor Matrix
Factor
Phase
Pre-event
Event
Post-event
Host
(Patient)
Agent
(Drug)
Environment
Preventing Adverse Events from Warfarin
Budnitz DS and Layde PL Pharmacoepidemiol Drug Saf 2007;16:160-5