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A Bar Code Case Study
Steve Braun
Today’s Presentation
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Why Hospira Implemented Bar Coding
Program Management
Customer Communications
From Bar Codes to RFID
Keys to Success
Lessons Learned
Hospira
Advancing Wellness Through Innovation
― Plum® Infusion System
with positive valving
― PCA Infusion System
― LifeShield® needle
protection systems
introduced
― Omni-Flow® IV Medication
Management System
― Plum® Infusion System
added RS232 dataport
1980s
― ADD-Vantage®
System
― FirstChoice® Premix solutions
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― National Hospital
Pharmacy Quality Awards
― LifeShield® CLAVE®
Connector
― Carpuject® syringe
technology acquired
― Q2™ Monitoring System
― Remote communication
1990s
― Oximetrix® 3
Monitoring System
― SAFESET™ Blood
Sampling System
― Continuing education
courses for MD,
RPh, RN
― Label enhancements
― Nutritional containers
bar-coded
― ASHP medication
error reduction
grants
― Bar-coded IV and injectable
products introduced
― Needlestick Prevention
Systems web site launched
― Ansyr®
― All unit-of-use
injectables and
IV solutions
bar-coded
TODAY
syringe
― Q2™ Plus Monitor
― Plum A+®
Infusion System
― LifeCare® PCA3 Medication
Management System
Introduced with bar code ID
of drug concentration
― Plum A+® Infusion System with
enhanced safety portfolio
The Need to Improve
Hospital Patient Safety
7,000 deaths per year1
Potential
ADEs 5.5%
ADEs 6.5%
1.8% are
preventable2
12% of Patients Exposed to
an Adverse Drug Event (ADE)
or Potential ADE2
1. Phillips et al, Lancet. 1998.
2. Bates et al. JAMA. 1995.
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Patients Not
Exposed
Medication Errors in the Hospital
• 51% of hospital errors occur during administration1
Leading Administration Errors2
Error Type
Incidence
Adverse Drug Events by Drug Class3
Drug Class
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).
1. Leape LL, et al. JAMA. 1995. 2. Leape LL, et al. JAMA. 1995. 3. Bates DW, et al. JAMA. 1995.
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ADEs
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
Manufacturing
Plants
Regulatory
Affairs
Graphic
Studio
Materials
Management
Label
Control
Technical
Operations
Engineering
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Quality
Assurance
Hospira Bar Code
Implementation Team
Marketing
Program Plan
• Over 5,800 packages: 1,200+ drugs
• Committed to a standard; UCC.EAN-128
• Began with corrugate
– Low technical hurdles
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Prioritized based on customer needs
Incorporated with any other label changes
5 manufacturing plants
No financial justification
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 labeled
with bar codes at the unit of use
Ten-Unit Pack
Five-Unit Pack
Single Unit
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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
announced
July 2002
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FDA proposed regulation
announced
March 13, 2003
Hospira initiative
completed
March 27, 2003
Manufacturing With Bar Codes
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Moving Beyond Manufacturing
• How do you know if a product has a bar code
on the label?
• Where is the database of UPN numbers and
corresponding NDC numbers maintained?
Is this a validated system?
• What product identifier does your customer
use to order product?
• How are they linking the product identifier
for 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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Radio Frequency Identification (RFID)
• Track and trace technology
vs. simple identification
• Opportunity for:
– Patient identification
– Pump or other equipment locator
– Drug or other expensive supply locator
Narcotics pose challenge
to track and trace (control) today
Host
System
RFID Reader
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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
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Hospira
Advancing Wellness…
Through the right people and the right products