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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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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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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