Medication Safety in Ambulatory Care Thursday, February 15, 2007 12:00 – 1:00 p.m. Eastern Time.

Medication Safety in Ambulatory Care

Thursday, February 15, 200712:00 – 1:00 p.m. Eastern Time

Moderator: Karen Frush, MD, FAAPChief Patient Safety OfficerDuke University Health SystemDurham, North Carolina

This activity was funded through an educational grant from the Physicians’

Foundation for Health Systems Excellence.

Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities Grid

The AAP CME program aims to develop, maintain, and increase the competency, skills, and professional performance of pediatric healthcare professionals by providing high quality, relevant, accessible and cost-effective educational experiences. The AAP CME program provides activities to meet the participants’ identified education needs and to support their lifelong learning towards a goal of improving care for children and families (AAP CME Program Mission Statement, August 2004).

The AAP recognizes that there are a variety of financial relationships between individuals and commercial interests that require review to identify possible conflicts of interest in a CME activity. The “AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities” is designed to ensure quality, objective, balanced, and scientifically rigorous AAP CME activities by identifying and resolving all potential conflicts of interest prior to the confirmation of service of those in a position to influence and/or control CME content. The AAP has taken steps to resolve any potential conflicts of interest.

All AAP CME activities will strictly adhere to the 2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. In accordance with these Standards, the following decisions will be made free of the control of a commercial interest: identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the CME activity.

The purpose of this policy is to ensure all potential conflicts of interest are identified and mechanisms to resolve them prior to the CME activity are implemented in ways that are consistent with the public good. The AAP is committed to providing learners with commercially unbiased CME activities.

DISCLOSURESActivity Title: Safer Health Care for Kids - Webinar Medication Safety in Ambulatory Care Activity Date: February 15, 2007

DISCLOSURE OF FINANCIAL RELATIONSHIPS All individuals in a position to influence and/or control the content of AAP CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider of commercial services discussed in CME activities.

Name Name of Commercial Interest(s)*

(*Entity producing

health care goods

or services)

Nature of Relevant Financial

Relationship(s) (If yes, please list: Research Grant,

Speaker’s Bureau, Stock/Bonds

excluding mutual funds, Consultant,

Other - identify)

CME Content Will Include

Discussion/ Reference to Commercial

Products/Services

Disclosure of Off-Label (Unapproved)/Investigational Uses of Products

AAP CME faculty are required to disclose to the AAP and to learners when they plan to discuss or

demonstrate pharmaceuticals and/or medical devices that are not approved

Heather McPhillips, MD, MPH, FAAP

No No No No

Karen P. Zimmer, MD, MPH, FAAP

No No No No

DISCLOSURESSAFER HEALTH CARE FOR KIDS - PROJECT ADVISORY COMMITTEE AND STAFF DISCLOSURE OF FINANCIAL RELATIONSHIPS All individuals in a position to influence and/or control the content of AAP CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider of commercial services discussed in CME activities.


(*Entity producing health care goods

or services)

Nature of Relevant Financial Relationship(s)

(If yes, please list: Research Grant, Speaker’s

Bureau, Stock/Bonds excluding mutual funds,

Consultant, Other - identify)

CME Content Will Include Discussion/

Reference to Commercial Products/Services

Disclosure of Off-Label (Unapproved)/Investigational Uses

of Products AAP CME faculty are required to

disclose to the AAP and to learners when they plan to discuss or


Karen Frush, MD, FAAP (PAC Member)

No No No No

Uma Kotagal, MD, MBBS, MSc, FAAP (PAC Member)

No No No No

Christopher Landrigan, MD, MPH, FAAP (PAC Member)

No No No No

Marlene R. Miller, MD, MSc, FAAP (PAC Chair)

No No No No

Paul Sharek, MD, MPH. FAAP (PAC Member)

No No No No

Erin Stucky, MD, FAAP (PAC Member)

No No Not sure No

Nancy Nelson (AAP Staff) No No No No

Melissa Singleton, MEd (Project Manager – AAP Consultant)

No No No No

Junelle Speller (AAP Staff) No No No No

Linda Walsh, MAB (AAP Staff)

No No No No

DISCLOSURESAAP COMMITTEE ON CONTINUING MEDICAL EDUCATION (COCME) DISCLOSURE OF FINANCIAL RELATIONSHIPS All individuals in a position to influence and/or control the content of AAP CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider of commercial services discussed in CME activities.


(*Entity producing health care goods

or services)

Nature of Relevant Financial Relationship(s)

(If yes, please list: Research Grant, Speaker’s

Bureau, Stock/Bonds excluding mutual funds,

Consultant, Other - identify)

CME Content Will Include Discussion/

Reference to Commercial Products/Services

Disclosure of Off-Label (Unapproved)/Investigational Uses

of Products AAP CME faculty are required to

disclose to the AAP and to learners when they plan to discuss or


Ellen Buerk, MD, FAAP

No No No No

Meg Fisher, MD, FAAP

No No No No

Robert A. Wiebe, MD, FAAP

No No Not sure No

Jack Dolcourt, MD, FAAP

No No No No

Thomas W. Pendergrass, MD, FAAP

No No No No

Beverly P. Wood, MD, FAAP No No No No

CME CREDIT

The American Academy of Pediatrics (AAP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The AAP designates this educational activity for a

maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

This activity is acceptable for up to 1.0 AAP credit. This credit can be applied toward the AAP CME/CPD Award available to Fellows and Candidate Fellows of the American Academy of Pediatrics.

OTHER CREDIT

This webinar is approved by the National Association of Pediatric Nurse Practitioners (NAPNAP) for 1.2 NAPNAP contact hours of which 1.0 contain pharmacology (Rx) content. The AAP is designated as Agency #17. Upon completion of the program, each participant desiring NAPNAP contact hours should send a completed certificate of attendance, along with the required recording fee ($10 for NAPNAP members, $15 for nonmembers), to the NAPNAP National Office at 20 Brace Road, Suite 200, Cherry Hill, NJ 08034-2633.

The American Academy of Physician Assistants accepts

AMA PRA Category 1 Credit(s)TM from organizations accredited by the ACCME .

Heather McPhillips, MD, MPH, FAAPAssistant Professor and Associate Residency DirectorDept. of Pediatrics, University of WashingtonChildren’s Hospital and Regional Medical CenterSeattle, Washington

Medication Safety in Ambulatory Pediatrics

Heather McPhillips, MD, MPH

University of Washington, Department of Pediatrics

Funding Source:

Agency for Healthcare Quality and Research

Collaborators:

Robert Davis, Christopher Stille, Marlene Miller, Rainu Kaushal, Dave Smith, John Pearson, John Stull, Susan Andrade, Jerry

Gurwitz &

The HMO Research Network CERT

Objectives

• Epidemiology of medication errors in ambulatory care What do we know about medication errors in children

specifically in the outpatient setting?

• Known risk factors for medication errors What are barriers to error-free prescribing to children? Which children are at highest risk for errors?

• Strategies to reduce or eliminate medication errors in ambulatory settings What is known and where does future work need to focus?

Medication Safety in Children

• Children are seen by physicians often and receive medication in up to 60% of these visits.

• Medication errors are common and can occur at any step in the process Prescribing errors (dose, drug, allergy) Dispensing errors (formulation, instructions) Administration errors (dose, timing, others)

Objective #1





Medication Errors in the ED

Kozer et al (Pediatrics, 2002)

• Retrospective review of medication errors in charts during 12 randomly selected days in emergency department

• Prescribing errors in 10% of charts Only counted errors 20% or more outside of dosing range Analgesics, antibiotics, antihistamines, asthma drugs most

likely involved Highest risk in trainees at beginning of year and seriously ill

patients

Sedation Errors

Cote et al (Pediatrics, 2000)

• Examined 95 adverse sedation events (ASEs) 2/3 resulted in death or permanent injury

• Sedation for dental procedures accounted for 32 ASEs

• Medication overdoses, multiple sedatives, improper administration and inadequate monitoring contributed to serious errors

• Nearly ½ ASEs occurred outside the hospital setting (home, dental office, clinic, car)

Administration Errors

• Errors in administration of medications to children by their caregivers are common As few as 30% of parents correctly administer proper dose

of acetaminophen to their child Even when parents provided with correct dosing information

and child’s weight, correct dose given 40% of the time

• Frush et al (Archives of Pediatrics, 2004): Significantly less error associated with simplified color-coded information sheet and color-coded dosing syringe 50% conventional vs 92% color-coded given correct dose

Outpatient Chemotherapy for ALL

Taylor et al (Cancer, 2006)

• Reviewed chemotherapy at clinic visit over two-month period for 69 patients prescribed 172 drugs

• Identified 17 medication errors in 13 children (19%)

• Administration errors were most common, followed by prescribing errors

Potential Ambulatory Dosing Errors

McPhillips et al (Journal of Pediatrics, 2005)

• Examined potential dosing errors in new outpatient prescriptions for 22 common medications at 3 HMOs

• Potential dosing errors occurred in 280 of 1,933 (15%) of prescriptions 8% potentially overdosed 7% potentially underdosed

Dosing Variation Mg/Kg/Day(Children < 35kg, N = 1,050 Dispensings)

Class of Drug %RDD %< MinRDD %>MaxRDD

Total 67 21 12

Analgesics 79 3 18

Asthma/Allergy 57 26 17

Behavioral 59 25 16

Antibiotics 81 16 4

Anti-epileptics 70 27 3

McPhillips et al, Journal of Pediatrics, 2005

Objective #2





Challenges in Pediatric Prescribing

1. Pediatric prescribing is complex

2. Off-label medication use is common

3. Lack of standardization of recommended doses

4. Lack of guidelines regarding use of adult dosing regimens

Prescribing is Complex

(1) An accurate weight must be obtained and correctly transcribed (pounds or kilograms)

(2) In the course of a brief visit, the prescriber then must:• convert pounds to kilograms• make rapid weight-based calculations to determine daily

dose • divide daily dose into multiple doses to obtain the

appropriate frequency for the medication• choose the correct preparation and concentration (liquid,

chewables, tablets) of the medicine• Determine the amount of liquid/tablet to be taken for

individual dose

Prescribing is Complex

(3) Communication with the parent or caregiver often will

occur without the medication present

(4) The prescription must be legible and correctly interpreted

by the pharmacist

(5) The pharmacist must dispense the appropriate

medication in its appropriate formulation labeled with the

appropriate dose and frequency.

Off-label Prescribing is Common

• Top 100 drugs dispensed to 2 million HMO members (HMO Research Network CERT) 40 have no labeling for children 32 have some labeling restrictions

• Study examining prevalence of off-label use (1999-2001) 13% of children <17 years dispensed off-label medication 25% of children <2 years dispensed off-label medication

• Off-label medications increase risk of Adverse Drug Events (ADEs)

• Less information available about appropriate doses—less standardization

Recommended Doses Can Differ

Source Recommended pediatric dose for oxycodone

Harriet Lane Handbook 0.2 to 0.9 mg/kg/day q 4-6 hours

HMO Formulary No weight-based dose provided.

Children’s Hospital Formulary

0.2 to 1.6 mg/kg/day q 3-4 hours

No Clear Rules about Adult Dosing

• No standard for when to switch from weight-based dosing (pediatric) to daily dosing (adult)

• Some medications provide both weight-based and age-based dosing (how do you choose?)

• Difficult to determine potential errors

• Unclear if clinically relevant

For example: amoxicillin

6 year-old 40kg male with otitis failed conservative therapy

Dr. Smart would like to treat with 90 mg/kg/day divided bid

Appropriate pediatric dose:

3600 mg/day (1800mg bid)

Appropriate adult dose:

2000 mg/day (1000 bid)

Potential overdose?? Potential underdose??

Risky Situations

Medications Prone to Error(N = 2,028 Dispensings)

Class of DrugClass of Drug % RDD% RDD % UD % UD % OD% OD

Total 87 6 7

Analgesics 86 prn 14

Asthma/Allergy 89 prn 11

Behavioral 88 5 7

Antibiotics 86 12 2

Anti-epileptics 80 20 1


Children at Risk for Potential OD

Characteristic Odds Ratio (95 CI)*

Age 0 to 3 years 1.6 (1.1 to 2.5)

Male 1.7 (1.1 to 2.4)

1 to 4 additional meds 1.4 (1.0 to 2.0)

5 or more additional meds 3.4 (1.4 to 8.0)

No clinic visit 1.8 (1.3 to 2.6)

*Adjusted for HMO, class of drug


Objective #3





Computerized Prescribing for Children: Will it reduce error?

• CPOE may prevent substantial errors in children in inpatient settings (ICU), but most systems are currently home-grown

• Little is known about effectiveness in ambulatory settings

• Few commercial systems have “standard” pediatric decision support

% Within

RDD % UD % OD

% Potential Error

HMO with CPOE

(N= 1,033) 88 4 8 12

HMOs with hand-written prescriptions

(N=994)

86 8 6 14

Can CPOE Prevent Errors?


Conclusions

• Medication errors are common in ambulatory pediatrics and dispensing and prescribing errors are most common.

• Higher risk prescribing situations include young children children who have not been seen in clinic multiple medications at one time “prn” medications (analgesics, asthma meds)

• CPOE without decision support may not reduce medication dosing errors in children.

Implications/Future Studies

• Electronic prescribing is a potentially successful strategy but NOT without pediatric decision support Evidence in inpatient settings that CPOE reduces

medication dosing errors

• Complexity of pediatric prescribing leads to complexity in designing electronic systems

• Simplified dosing regimens and standardization of medication doses is needed

ReferencesKozer E, Scolnik D, Macpherson A, Keays T, Shi K, Luk T, Koren

G. Variables associated with medication errors in pediatric emergency medicine. Pediatrics. 2002 Oct;110(4):737-42.

Kozer E, Scolnik D, MacPherson A, Rauchwerger D, Koren G. Using a preprinted order sheet to reduce prescription errors in a pediatric emergency department: a randomized, controlled trial. Pediatrics. 2005 Dec;116(6):1299-302.

Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000 Oct;106(4):633-44.

Li SF, Lacher B, Crain EF. Acetaminophen and ibuprofen dosing by parents. Pediatr Emerg Care. 2000 Dec;16(6):394-7.

References

Simon HK, Weinkle DA. Over-the-counter medications. Do parents give what they intend to give? Arch Pediatr Adolesc Med. 1997 Jul;151(7):654-6.

Frush KS, Luo X, Hutchinson P, Higgins JN. Evaluation of a method to reduce over-the-counter medication dosing error. Arch Pediatr Adolesc Med. 2004 Jul;158(7):620-4.

Taylor JA, Winter L, Geyer LJ, Hawkins DS. Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia. Cancer. 2006 Sep 15;107(6):1400-1406.

References

McPhillips HA, Stille CJ, Smith D, Hecht J, Pearson J, Stull J, Debellis K, Andrade S, Miller M, Kaushal R, Gurwitz J, Davis RL. Potential medication dosing errors in outpatient pediatrics. J Pediatr. 2005 Dec;147(6):761-7.

Gandhi TK, Weingart SN, Seger AC, Borus J, Burdick E, Poon EG, Leape LL, Bates DW. Outpatient prescribing errors and the impact of computerized prescribing. J Gen Intern Med. 2005 Sep;20(9):837-41.

Karen P. Zimmer, MD, MPH, FAAPAssistant ProfessorJohns Hopkins UniversityBaltimore, Maryland

Epidemiology and Intervention for Pediatric Ambulatory

Medication Errors Karen P. Zimmer, MD, MPH

Marlene R. Miller, MD, MSc

February 15, 2007

Safer Health Care for Kids Webinar

“Medication Safety in Ambulatory Care”

Goals

• Background• Epidemiology

Example: Analysis of a National Voluntary Database (MEDMARX Database)

• Suggestions for Addressing Medication Errors• Process Improvement

Example: Narcotic Prescription Writer

Background on Medication Errors

• Most common adverse eventIOM, 2000; Bates 1995

• Most error prone step is prescribingLesar TS, 2002; Errors DB, 1999

• Most errors occur as a result of both individual and system failures

Leape LL et al. 1995; Reason J, 2000

• Competent staff make mistakes

National Reporting System: United States Pharmacopeia MEDMARX

• United States Pharmacopeia (USP) A practitioner-based organization that sets standards for

identity, strength, quality, purity, packaging, labeling, and storage of therapeutic products.

• MEDMARX Database National, voluntary, internet-accessible error reporting

system Consists of 616 subscribing hospitals since January, 2005 All are US hospitals All 50 states are represented

Study on Epidemiology

• Objective: To characterize and understand medication errors in the outpatient clinic settings What types of medication errors occur? Where in the process do errors occur? What harm occurs?

MEDMARX

• Error reporting System Standardized Provides information on prescriptions as well as

medications in all types of ambulatory clinics• Error timing• Unit location• Phase of care in which error occurred• Error category• Cause of error• Medication Involved

MEDMARX Analysis• Inclusion Criteria

Queried database for all error reports from 2003 and 2004

Involving patients < 19 years of age In all outpatient clinics (general and specialty clinics) Error category limited to harm scores of Category C-I

(medical errors that reached the patient).

Results: All Errors

• Medication error reports (N=566) Involved 636 products (medications)

• Number of participating institutions 154 (2003) and 162 (2004)

• Clinic-Type Distribution General Community Hospital Affiliate (52%) Stand alone Outpatient Clinic (28%) University Hospital Affiliate (11%)

• Age distribution Greatest for ages 1-3 (25.1%) and 12-18 (24.7%)

Results: All Errors

• Harm Score Over 2/3 of errors reached the patient but did not

cause harm (Category C) 4% harmed the patient (Category E-I) Family/Patient discovered medication errors

almost 20% of the time.

Results: All Errors

• Error Node Definition: the phase of the medication process

where the error occurs• Administering (42%) • Prescribing phases (41%)• Dispensing (12%)• Transcribing/Documenting (4%)• Monitoring (1%)

Distribution of Error Types for All Medications

17%

14%

11% 10%

9%

7%

4% 4%3%

22%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

Imp

rop

er

do

se

/qu

an

tity

Pre

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ing

Err

or

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d/w

ron

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Fo

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are

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y

Ex

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or

Wro

ng

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Wro

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ati

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Results: Medications Involved

0

5

10

15

20

25

30

35

40

45Immunologic(vaccines)

Antimicrobials

CNS meds (sedatives)

Respiratory Tract(bronchodilators)

Dermatologic Agents

Hormones (Insulin)

Antihistamines

Gastrointestinal

Musculoskeletal

Therapeutic Nutrients

Ophthalmic

Otic agents

Percent

Age Distribution for Vaccines Errors

0-1 years1-3 years4-6 years7-11 years12-18 years

25.1%

24.7%

18.7%

17.0%

14.5%

Error Distribution:Top 5 Vaccines

7

9

9

10

12

0 2 4 6 8 10 12 14

Pneumococcal Conjugate Vaccine

Diphtheria, Tetanus Toxoids, Acellular PertussisAdsorbed, Hepatitis B (Recombinant), and

Inactivated Poliovirus Vaccine

Varicella Virus Vaccine Live

Influenza Virus Vaccine

Hepatitis B Vaccine, Recombinant

Vaccines: Types of Errors

8

141717

27

0

5

10

15

20

25

30

Per

cen

ts

Age Distribution for Antimicrobials Errors

0-1 years1-3 years4-6 years7-11 years12-18 years

22.7%

18.6%

24.7%

20.6%

13.4%

Antimicrobials: Distribution

7

10

12

28

0 5 10 15 20 25 30

Amoxicillin andClavulanate

Ceftriaxone

Azithromycin

Amoxicillin

Percents

Antimicrobials: Error Types

21

18

1312 12

2

17 17

8

27

11

14

0

5

10

15

20

25

30

Pe

rce

nts

Antimicrobials

Vaccines

Suggestions for Addressing Medication Errors

• Error Prevention An evaluation framework in place Error-resistant systems are better than continuous education Providing redundant checks (increasing pharmacist

availability, different methods and persons at the various stages of the medication process, 2 person, or using software and a person)

• Leveraging Technology• Standardized Practice

Lehmann CU and Kim GR, Clin Perintal 2005

Standardized Practice Preprinted order sheet in a pediatric ED reduced errors

(OR 0.55, CI 0.34-0.90)Kozer et al, Pediatrics 2005

• A modified outpatient prescription form was used to reduce prescription errors in an adult populationKenety and Littentber, Joint Commission on Accreditation of Healthcare Organizations

• Electronic prescribing in an adult, ambulatory practice improved throughput and increased patient satisfactionPapshev,et al. Am J Manag Care 2007; Adubofour K, etl al. J of National Med Assoc 2004

A Successful Intervention: Example

Methods• Method/Design

Retrospective study December 2005 to October 2006 Program implemented over several months Inpatient and outpatient settings

• Eligibility: General pediatric services and all surgical services Residents, fellows, nurse practitioners

• Narcotic prescriptions for all discharged patients from 0-18 years of age

• Users: 266 prescribers General pediatric (112, 42%) Orthopedic (38, 14%) Surgery (33, 12%

Distribution of Medications

0.1% 0.2% 0.4% 1.0% 1.4% 2.3% 2.3% 2.8% 6.0% 6.2% 7.3% 7.3%

62.7%

0.0%

20.0%

40.0%

60.0%

80.0%

Avi

nza

MS

Con

tin

Kad

ian

Per

coce

t(A

ceta

min

ophe

nw

ith O

xyco

done

Tylo

x(A

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min

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nw

ith O

xyco

done

)

Oxy

Con

tin

Ace

tam

inop

hen

with

Cod

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Tabl

et

Mor

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e

Met

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Dia

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m(V

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Hyd

rom

orph

one

Ace

tam

inop

hen

with

Cod

eine

Elix

ir

Oxy

codo

ne

Outcome of Prescription Attempts

4,995 Attempts

713 Attempts With Alerts

4,282 Attempts Without Alerts

2,942 Prescriptions1,340 Incomplete 416 Incomplete297 Overridden

3,239 Total Prescriptions

Results

• A prescription attempt with an alert was abandoned 58% of the time compared to 31% of the time if no alert were generated (p<0.001).

• Alerts resulted in statistically significant increase in

abandoned prescription attempts.

Conclusion

• Identify vulnerabilities based on commonly used medication types, age of patients and practice environment

• Support systems that highlight potential errors can alter behavior and prevent errors from being completed

Take Home Points

• Dosing errors are common in ambulatory pediatrics• Administering and prescribing are key error-prone

stages• Narcotic analgesics pose high risk of harm• Decision support is a crucial part of electronic

prescription writing systems.

Medication Safety in Ambulatory Care Thursday, February 15, 2007 12:00 – 1:00 p.m. Eastern Time.

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