A Bar Code Case Study

Steve Braun

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Today’s Presentation

• Why Hospira Implemented Bar Coding• Program Management• Customer Communications• From Bar Codes to RFID• Keys to Success• Lessons Learned

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Hospira

Advancing Wellness Through Innovation

1980s 1990s TODAY

― Plum® Infusion System with positive valving

― PCA Infusion System

― Omni-Flow® IV Medication Management System

― ADD-Vantage® System

― FirstChoice® Premix solutions

― LifeShield® needleprotection systemsintroduced

― Plum® Infusion System added RS232 dataport

― Oximetrix® 3 Monitoring System

― Continuing educationcourses for MD,RPh, RN

― National Hospital Pharmacy Quality Awards

― LifeShield® CLAVE® Connector

― Q2™ Monitoring System

― SAFESET™ Blood Sampling System

― Label enhancements

― Nutritional containers bar-coded

― Carpuject® syringe technology acquired

― Remote communication

― ASHP medication error reductiongrants

― Ansyr® syringe

― Q2™ Plus Monitor

― Plum A+® Infusion System

― Bar-coded IV and injectable products introduced

― Needlestick Prevention Systems web site launched

― All unit-of-useinjectables andIV solutionsbar-coded

― LifeCare® PCA3 Medication Management SystemIntroduced with bar code IDof drug concentration

― Plum A+® Infusion System with enhanced safety portfolio

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The Need to ImproveHospital Patient Safety

1. Phillips et al, Lancet. 1998. 2. Bates et al. JAMA. 1995.

12% of Patients Exposed to an Adverse Drug Event (ADE) or Potential ADE2

Potential ADEs 5.5%

ADEs 6.5%

1.8% are preventable2

Patients Not Exposed

7,000 deaths per year1

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Medication Errors in the Hospital

• 51% of hospital errors occur during administration1

1. Leape LL, et al. JAMA. 1995. 2. Leape LL, et al. JAMA. 1995. 3. Bates DW, et al. JAMA. 1995.

Leading Administration Errors2 Adverse Drug Events by Drug Class3

Error Type Incidence Drug Class ADEs

Wrong Dose 27% Analgesics (Narcotics) 30%

Wrong Drug 12% Antibiotics 24%

Missed Dose 8% Sedatives 8%

Wrong Time 7% Antineoplastic 7%

Known Allergy 6% Cardiovascular 4%

Wrong Choice 4% Anticoagulants 3%

Wrong Frequency 2%

Adapted from a system analysis of a prospective cohort study of medication error reports on admissions from 11 medical and surgical units in two tertiary care hospitals over a 6-month period (N=4,031 nonobstetrical adult admissions).

Results from a prospective cohort study of medication error reports on admissions from 11 medical and surgical units in two tertiary care hospitals over a 6-month period (N=4,031 nonobstetrical adult admissions).

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The Promise of Bar Codes

• Bar code-enabled systems have been shown to reduce medication errors

by 64.5% (at VA facility)1

by 71% (at North Colorado Medical Center)2

1. Malcolm et al. 2000 Annual HIMSS Conference. 2. Pucket F. Am J Health-Syst Pharm. 1995.

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Customer Direction

• Group purchasing organizations– Contractual commitments

• Wholesalers/distributors• Leading providers

– St. Alexius– VA Hospital Systems

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Formed the Bar Code Team

Hospira Bar Code Implementation Team

Technical Operations

Engineering

Label Control

Graphic Studio

Manufacturing Plants

Regulatory Affairs

Materials Management

Quality Assurance

Marketing

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Program Plan

• Over 5,800 packages: 1,200+ drugs• Committed to a standard; UCC.EAN-128• Began with corrugate

– Low technical hurdles

• Prioritized based on customer needs• Incorporated with any other label changes• 5 manufacturing plants• No financial justification

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Challenges

• Linear bar codes too large– 300 items too small for UCC.EAN-128

• Including some of the most critical drugs

• What standard would industry adopt?• Price increases unacceptable to customers• Unexpected issues (RSS)

– Verifiers– Software– Packaging levels

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RSS Technology

• UCC owned technology• Hospira is the first health care

company to use Reduced-Space Symbology (RSS) to bar-code injectables and I.V. solution products

• RSS allows all information to fit in an area as small as a pen cap

• Trial run made in 2001 at St. Alexius proved readability

• Expands opportunity for additional information

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Hospira Bar Code Initiative

• All injectables and I.V. solutions labeledwith bar codes at the unit of use

Single Unit

Five-Unit Pack

Ten-Unit Pack

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Hospira Bar Code Initiative

• Encompasses more than 1,200 drug and I.V. products• Critical mass for POC Medication Management

System• Outstanding customer support and appreciation

Initiative announcedJuly 2002

FDA proposed regulation announced

March 13, 2003

Hospira initiative completed

March 27, 2003

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Manufacturing With Bar Codes

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Moving Beyond Manufacturing

• How do you know if a product has a bar codeon the label?

• Where is the database of UPN numbers and corresponding NDC numbers maintained?Is this a validated system?

• What product identifier does your customeruse to order product?

• How are they linking the product identifierfor ordering with the UPN?

• How do you make all product identifiers known to customers? How do you update them on changes?

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Electronic Catalog

• Accessible from the corporate web site

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Product Identification

• Updated daily• May be downloaded

into spread sheet

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RFID Reader

HostSystem

Radio Frequency Identification (RFID)

• Track and trace technologyvs. simple identification

• Opportunity for:– Patient identification– Pump or other equipment locator– Drug or other expensive supply locator

Narcotics pose challengeto track and trace (control) today

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From Bar Codes to RFID

• Supply channel value initial goal • Customer and the FDA will define

implementation timeline• Will have need for both technologies• EPC implementation required • Similar project approach• Shared/accessible electronic files required

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Keys to Success

• Champion(s)• Team approach• Executive management

support• FDA engaged• Network of

knowledgeable experts

• Listen to customers• Frequent reviews

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Lessons Learned

• Education is important• Risk versus reward• Work with standards organization

– Voice equals change– Build alliances

• RSS software (new technology) may delay• Understand the market• Leadership brings rewards

Hospira

Advancing Wellness…

Through the right people and the right products