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A Bar Code Case Study Steve Braun Today’s Presentation • • • • • • 2 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 3 ― 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. 4 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. 5 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. 6 Customer Direction • Group purchasing organizations – Contractual commitments • Wholesalers/distributors • Leading providers – St. Alexius – VA Hospital Systems 7 Formed the Bar Code Team Manufacturing Plants Regulatory Affairs Graphic Studio Materials Management Label Control Technical Operations Engineering 8 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 • • • • 9 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 10 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 11 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 12 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 13 FDA proposed regulation announced March 13, 2003 Hospira initiative completed March 27, 2003 Manufacturing With Bar Codes 14 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? 15 Electronic Catalog • Accessible from the corporate web site 16 Product Identification • Updated daily • May be downloaded into spread sheet 17 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 18 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 19 Keys to Success • Champion(s) • Team approach • Executive management support • FDA engaged • Network of knowledgeable experts • Listen to customers • Frequent reviews 20 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 21 Hospira Advancing Wellness… Through the right people and the right products