A Bar Code Case Study Steve Braun

Today’s Presentation 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 Omni-Flow® IV Medication Management System ADD-Vantage® System FirstChoice® Premix solutions LifeShield® needle protection systems introduced Plum® Infusion System added RS232 dataport Oximetrix® 3 Monitoring System Continuing education courses 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 reduction grants 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-use injectables and IV solutions bar-coded LifeCare® PCA3 Medication Management System Introduced with bar code ID of drug concentration Plum A+® Infusion System with enhanced safety portfolio 1980s 1990s TODAY

The Need to Improve Hospital Patient Safety 7,000 deaths per year1 Potential ADEs 5.5% ADEs 6.5% 1.8% are preventable2 Patients Not Exposed 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.

Medication Errors in the Hospital 51% of hospital errors occur during administration1 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 Wrong Time 7% Antineoplastic Known Allergy 6% Cardiovascular 4% Wrong Choice 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.

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.

Customer Direction Group purchasing organizations Contractual commitments Wholesalers/distributors Leading providers St. Alexius VA Hospital Systems

Formed the Bar Code Team Technical Operations Engineering Label Control Graphic Studio Manufacturing Plants Regulatory Affairs Materials Management Quality Assurance Marketing Hospira Bar Code Implementation Team 10

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

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

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

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

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 FDA proposed regulation announced March 13, 2003 Hospira initiative completed March 27, 2003

Manufacturing With Bar Codes

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?

Electronic Catalog Accessible from the corporate web site

Product Identification Updated daily May be downloaded into spread sheet

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

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

Keys to Success Champion(s) Team approach Executive management support FDA engaged Network of knowledgeable experts Listen to customers Frequent reviews

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