Reducing Emergency Department Visits due to Adverse Events from

Medications

Daniel Budnitz MD, MPH, CDR USPHSDivision of Healthcare Quality Promotion

USPHS Scientific & Training Symposium

May 25, 2010

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”

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

Overview

1. An Injury-based Approach

Bank Robber

http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm

1901 - 1980

William SuttonGentleman, Innovator, &… Bank Robber

http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm

1901 - 1980

“Slick Willie” SuttonGentleman, Innovator, &… Bank Robber

“Why do you rob banks?”

“Because, that’s where the money is.”

http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm

1901 - 1980

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

2000 2006

Mediation Safety in 2000s:

Decade of Errors

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

Stable Patient

ADEsErrors

Injured Patient

Why Not Start with Harms?

Errors

(Harms)

ADEs

Injured Patient

Focus on Harms that are…

Errors

Injured Patient

Serious,Common,

Preventable

Design Intervention

Evaluate Impact

Identify Risk & Protective

Factors

Identify the Harm

Population Surveillance

Data Drive the Public

Health Approach

Public Health Approach

Design Intervention

Evaluate Impact

Identify Risk & Protective

Factors

Identify the Harm

Public Health Approach

Little national data on harms

Population Surveillance

Data Drive the Public

Health Approach

Evaluate Impact

Identify the Harm

January, 2000

“…the data on emergency department visits and hospital admissions are insufficient for estimating overall ADE frequency”

2. Population-based Harm Data for Priority Setting

Frequency, severity, preventability

Why Emergency Visits & Hospitalizations?

Medication use 1

– 82% adults take at least 1 medicine– 18% adults >64 take 10 or more

1. 1. Slone Epidemiology Center at Boston University, 2008

Why Emergency Visits & Hospitalizations?

Medication use 1

– 82% adults take at least 1 medicine– 18% adults >64 take 10 or more

Medication costs 2

1. 1. Slone Epidemiology Center at Boston University, 20082. 2. Hoffman et al. Am J Health Syst Pharm 2009;66:237-57

Hospitals Clinics Community

$27B $33B $227B

Serious, Acute Harms: Emergency Departments (EDs)

Community Setting

ED visit

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

NEISS-CADES:Population Representative Surveillance

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

2004-2005Deaths

Hospitalizations

Emergency visits

Office visits

>700,000

>117,000

> 3.6 million

?

14.3 per 1,000

2.4 per 1,000

0.4 per 1,000

Zhan C et al. Jt Comm J Qual Patient Saf 2005;7:372-8

Budnitz DS et al. JAMA 2006;296:1858-66

ED Visits for ADEs by Event Type, United States, 2004-2005

Budnitz, D. S. et al. JAMA 2006;296:1858-1866.Budnitz DS et al. JAMA 2006;296:1858-1866

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

►

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

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, 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

“Potentially Inappropriate” Medications ?

?

Budnitz, DS et al. Ann Intern Med 2007;147:755-765

“Potentially Inappropriate” Medicines

Adapted from Fick DM et al. Arch Intern Med 2003;163:2716-25

“Potentially Inappropriate” Prescribing Impacts Interventions

National Quality Measures– HEDIS / National Quality Forum measure– AHRQ annual Healthcare Quality Report

CMS– 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

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

“Potentially Inappropriate” Medications

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

AnticoagulantsInsulins

NTI Medicines

Design Intervention

Identify Risk & Protective

Factors

Identify the Harm

Public Health Approach

Evaluate Impact

AnticoagulantsInsulins

NTI Medicines

http://www.healthypeople.gov/HP2020/Objectives/

4 proposed Sub-objectives

3. Patient-centered Prevention Partnerships

Budnitz DS et al. JAMA 2006;296:1858-1866

ADEs Treated in EDs by Patient Age, United States, 2004-2005

Unintentional Overdoses Cause Most Emergency Visits in Children <5 Years Old

1,022

5,022

7,911

56,41627,500

Type Percent

Unintentional Overdoses

58%

Allergic Reactions 28%

Side Effects 5%

Vaccine Reactions 8%

Secondary Effects 1%

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

Schillie SF et al. Am J Prev Med 2009;37:181-7

1 out of every 180 two-year-olds each year

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.

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

Public Health Approach for Medication Safety

http://www.healthypeople.gov/HP2020/Objectives/

4th proposed Sub-objective

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

Summary

Acknowledgements

Division of Healthcare Quality Promotion, CDC

• 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

• Karen Weiss• Solomon Iyasu• Gerald Dalpan• Judy Staffa• Pamela Scott• Mary Willie• Margie Goulding• Charles Ganley• Sue Johnson

US Consumer Product Safety Commission

• Tom Schroeder• Joel Freidman• Cathleen Irish

TM

Additional Slides

• 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

Implications for Antibiotic Use

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

Ongoing surveillance based on chart abstraction

NEISS-CADES:Data Collection

Setting: only ED visits– No inpatient follow-up or mortality

Underestimates– 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

Limitations

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

Or suspicious symptoms?• Angioedema (face/lip/throat swelling)• Anaphylaxis (severe allergy)• Rash (urticaria, dermatitis)• Bleeding (GI Bleed, hematemesis, epistaxis,

hypocoaguability, high INR/PT)• Hypoglycemia (low blood sugar)

2. Is a Drug involved?Drugs include: prescription meds,

over-the-counter meds, vaccines, vitamins, & dietary supplements.

Identifying ADE Cases

YES

NO

NO3. Is there evidence of:• Suicide attempt?• Intentional overdose?• Abuse / Recreational use?

YES

4. Fill out ADE Screen:

• Record ED chart DIAGNOSISword for word

• 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)

YES

NO

STOPDo not report

ADE

STOPDo not report

ADE

START

FINISH

• 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

Recording Case Data

Design Intervention

Identify Risk & Protective

Factors

Identify the Problem

Insulin, Warfarin

Older Adults- 2x rate ED visits- 7x hospitalization rate

256,000 ED visits in 2008

Public Health Approach for Medication Safety

Identify Plausible InterventionsPhase-Factor Matrix

FactorPhase

Host (Patient)

Agent (Drug) Environment

Pre-event

Event

Post-event

Preventing Adverse Events from Warfarin

Budnitz DS and Layde PL Pharmacoepidemiol Drug Saf 2007;16:160-5