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Pedigree Update. California Society of Health-System Pharmacists October 20, 2007 Bob Celeste, Director, Healthcare – EPCglobal North America. Pedigree Update Standards and Adoption. Pedigree Terms How we got here Future Choices What you need to do Auto-ID in the Hospital.
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Pedigree Update California Society of Health-System PharmacistsOctober 20, 2007Bob Celeste, Director, Healthcare – EPCglobal North America
Pedigree UpdateStandards and Adoption • Pedigree Terms • How we got here • Future Choices • What you need to do • Auto-ID in the Hospital
The Global Language of Business GS1 US FamilyStandards Adoption and support OVERALL BENEFITS: Improving efficiency & visibility in supply and demand chains Global standards for automatic identification RAPID AND ACCURATE ITEM, ASSET OR LOCATION IDENTIFICATION Global standards for electronic business Messaging RAPID, EFFICIENT & ACCURATE BUSINESS DATA EXCHANGE Global Standards for data Synchronisation STANDARDISED, RELIABLE DATA FOR EFFECTIVE BUSINESS TRANSACTIONS Global Standards for RFID-based Identification MORE ACCURATE, IMMEDIATE AND COST EFFICIENT VISIBLITY OF INFORMATION
GS1 around the world Countries with a GS1 Member Organization Countries served on a direct basis from GS1 Global Office 104Member Organizations. 145 Countries served. Local services, global reach.
About GS1 US • Formerly known as the UCC • Established 1973 (think U.P.C.) • Implements the GS1 System in the U.S. • 23 industries, 280,000 members in U.S. • 1 million global members, 155 Countries • 18,000 identified healthcare members in U.S. • Uniquely identify products, assets and locations • Bar codes, EPC, e-Commerce, UNSPSC • Voluntary, not-for-profit, member driven
Early Market Adopters Healthcare & Life Sciences Electronics & High Tech Logistics & Transport Consumer Goods Food & Beverage Retail
Emerging New Industries Aerospace & Defense Footwear & Apparel Chemical Industrial Automotive
Industry Pharmaceutical Manufacturers Medical Device Manufacturers Distributors Retail Pharmacies Hospitals GPOs Regulatory FDA (Pharma, Med Devices) State Boards of Pharmacy DEA, EPA, FCC Associations AHA BIO CSHP HDMA HIMSS NACDS PhRMA Universities MIT – Auto-ID Labs Drexel University Stanford University University of Wisconsin University of Einhoven University of Arkansas Healthcarewho we are working with …
Pedigree IssuesStandards and Adoption • Serialization • Marking/Tagging • Information Sharing • Validation • Authentication • Authorization
Definitions Pedigree, Serialization, EPC, RFID • Pedigree: The document, electronic or paper, which communicates the custody history for a particular medication. • Serialization: A unique number assigned and affixed to a particular unit of item. Used to identify the particular bottle. • EPC: Electronic Product Code – A globally and multi-industry acceptable identifier standardized by EPCglobal used to serialize items in many supply chains around the world. • RFID: The technology that can carry an EPC. Made up of a tag (computer chip), antennae and substrate.
Pedigree: • Today: One Standard • Tomorrow: Choices
PedigreeOne Standard today … future choices • Why choices? • Standards Availability • Hardware and Software Availability • Regulations (FDA, 50 States) • Trading Partner Capability • Internal Architecture Maturity
Map of State Pedigree Legislation/Regulations As of July 27, 2007 WA ME ND MT MN OR NH ID WI SD NY VT MI WY MA IA PA NE NV RI OH IL UT IN CA CT CO WV VA KS MO NJ KY NC DE TN AZ OK NM AR MD SC GA AL MS TX LA HI FL AK Enacted Legislation, rules pending. Final Rules Adopted Legislation Vetoed No Legislation or Regulations Enacted Legislation Proposed Legislation 15 9 13 6 6 1
PedigreeOne Standard today … future choices • Standardized today: • Pedigree Messaging Standard • EPCIS based Pedigrees • EPCIS + Discovery Service • EPCIS + Discovery Service + Global Data Synchronization (GDSN) • Emerging: • Near Future:
PedigreeOne Standard today … future choices • What are the differences? • verbosenessnoun • an expressive style that uses excessive words [ant: terseness] … WordNet® 3.0, © 2006 by Princeton University.
Pedigree – One Standard today …. Future choicesHow do they compare? Actionable Intelligence → Verboseness → EPCIS + Discovery EPCIS based Pedigree Pedigree Messaging Standard EPCIS + Discovery + Data Sync
PedigreeOne Standard today … future choices • Standardized today: • Pedigree Messaging Standard • EPCIS based Pedigrees • EPCIS + Discovery Service • EPCIS + Discovery Service + Global Data Synchronization (GDSN) • Emerging: • Near Future:
Pedigree – One Standard todayHow do they work? – Pedigree Messaging Standard • Development timeline: • Start: August 2005 • Ratified: January 2007 • Certified Software: June 2007 • What we knew then: • Florida – June 2006 • FDA – July 2006 • California – January 2007 • EPCIS was almost 2 years away • Discovery was 3+ years away • Principals: • Develop based on Florida and FDA, with knowledge of California, Nevada, global + future modes (EPCIS, etc.) • Trace Capability only
Pedigree – One Standard todayHow do they work? – Pedigree Messaging Standard Signed manufacturer pedigree (initiated by manufacturer, after the wholesale distribution, signed by both manufacturer and wholesaler)
Pedigree – One Standard todayHow do they work? – Pedigree Messaging Standard Signed manufacturer pedigree (initiated by manufacturer, after the wholesale distribution, signed by both manufacturer and wholesaler) Pedigree with return transaction (initiated by manufacturer, received and signed inbound by wholesaler, return transaction applied by wholesaler for manufacturer return and signed outbound, received and signed inbound by manufacturer) Pedigree Flow for a Manufacturer-initiated Drop Ship The pedigree flow is described for a drop ship transaction brokered by wholesaler, where pharmacy purchases the product from the wholesaler, but the manufacturer ships the product directly to the pharmacy. In this scenario, the manufacturer initiates the start of the drop ship pedigree documenting the sales transaction from the manufacturer to the wholesaler with the shipping information indicating the direct shipment to the pharmacy. The wholesaler adds only the second part of the drop ship transaction to the pedigree documenting the sales transaction from the wholesaler to the pharmacy. Partial Receipt of Products against Pedigree The partial receipt of product against pedigree is described for a sale from a manufacturer to a wholesaler, when the manufacturer initiates the pedigree. The wholesaler receives the products in two partial shipments and updates each partial receipt against the original pedigree, resulting in a new received pedigree for each partial receipt.
Pedigree – One Standard todayHow do they work? – Pedigree Messaging Standard Manufacturer Wholesaler Repackager Provider
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PedigreeOne Standard today … future choices • Standardized today: • Pedigree Messaging Standard • EPCIS based Pedigrees • EPCIS + Discovery Service • EPCIS + Discovery Service + Global Data Synchronization (GDSN) • Emerging: • Near Future:
Pedigree – EmergingHow do they work? – EPCIS based Pedigrees • Development timeline: • EPCIS Ratified April 2007 • EPCIS Certified Software: August 2007 • What we knew then: • Florida – June 2006 • FDA – December 2006 - U.S. District Court enjoins FDA from implementing sections of final PDMA rule • California – January 2009 • Discovery -1+ years away • Principals: • Leverage EPCIS framework as architecture for future benefits (ePOD, Returns, Diversion/Theft detection) • Trace Capability only
Pedigree – EmergingWhat is EPCIS? • Cross-Industry Standard EPCIS events answer 5 questions … • Who • What • Where • When • Why Used by companies to ask internal questions and externally to communicate with Trading Partners In the near future, you may use EPCIS in the form of … • Hospital and Pharmacy applications • Cell Phones
External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data Pedigree – EmergingHow do they work? – EPCIS based Pedigrees Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC
Pedigree – EmergingHow do they work? – EPCIS based Pedigrees External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data
PedigreeOne Standard today … future choices • Standardized today: • Pedigree Messaging Standard • EPCIS based Pedigrees • EPCIS + Discovery Service • EPCIS + Discovery Service + Global Data Synchronization (GDSN) • Emerging: • Near Future:
Pedigree – Near FutureHow do they work? – EPCIS + Discovery Services • Development timeline: • Start: January 2007 • EPCIS Ratified April 2007 • EPCIS Certified Software: August 2007 • What we knew then: • Florida – June 2006 • FDA – December 2006 - U.S. District Court enjoins FDA from implementing sections of final PDMA rule • California – January 2009 • Discovery -1+ years away • Principals: • Support for Mult-Tier Supply Chains such as Healthcare • True Track and Trace Capability
External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data Pedigree – Near FutureHow do they work? – EPCIS + Discovery Services Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC
Access Control Services • Access Rules ONS Authentication Services • Authentication Certificates • EPC Manager # Pedigree – Near FutureHow do they work? – EPCIS + Discovery Services Discovery Services Network Data • EPC Registered Events External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data
Access Control Services • Access Rules ONS Authentication Services • Authentication Certificates • EPC Manager # Pedigree – Near FutureHow do they work? – EPCIS + Discovery Services Discovery Services Network Data • EPC Registered Events External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data
Access Control Services • Access Rules ONS Authentication Services • Authentication Certificates • EPC Manager # Pedigree – Near FutureHow do they work? – EPCIS + Discovery Services Where has this Item been? Query Discovery Services Network Data • EPC Registered Events I.P. Address External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data
PedigreeOne Standard today … future choices • Standardized today: • Pedigree Messaging Standard • EPCIS based Pedigrees • EPCIS + Discovery Service • EPCIS + Discovery Service + Global Data Synchronization (GDSN) • Emerging: • Near Future:
Pedigree – Near FutureHow do they work? – EPCIS + Discovery + GDSN • Development timeline: • Start: January 2007 • EPCIS Ratified April 2007 • EPCIS Certified Software: August 2007 • What we knew then: • Florida – June 2006 • FDA – December 2006 - U.S. District Court enjoins FDA from implementing sections of final PDMA rule • California – January 2009 • Discovery -1+ years away • Principals: • Support for Multi-Tier Supply Chains such as Healthcare • True Track and Trace Capability + Product, Location Data efficiencies
External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data Pedigree – Near FutureHow do they work? – EPCIS based Pedigrees Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC
Access Control Services • Access Rules ONS Authentication Services • Authentication Certificates • EPC Manager # Pedigree – Near FutureHow do they work? – EPCIS based Pedigrees Discovery Services Network Data • EPC Registered Events External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data
Access Control Services • Access Rules ONS Authentication Services Product and Location data is shared and validated Prior to Supply Chain use. Result: Smaller, more reliable EPCIS transactions • Authentication Certificates • EPC Manager # Pedigree – Near FutureHow do they work? – EPCIS based Pedigrees Discovery Services Network Data • EPC Registered Events External Available Data • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events • Observe Events Wholesaler Repackaging DC Manufacturer DC Wholesaler DC Retail / Hospital Pharmacy Manufacturer Retailer DC • Production • Packaging • Staging • Shipping • Returns / Recalls • Supply & Production Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Pick • Re-Pack • Storage • Pick & Pack • Ship • Capacity Planning • Receipt • Put Away • Storage • Pick & Pack • Ship • Returns/Recalls • Capacity Planning • Receipt • Put Away • Storage • Breakdown Routing • Case Breakdown • Shelf Restocking • Returns/Recalls • Demand & Fulfillment Planning Internal Processes • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • ------------------------ • Receive Event • Stock Event • Item/Location • Ship Event • Read Events • --------------------- • Stock Event • Item/Location • Ship Event Internal Data
Pedigree & SerializationWhat your hospital needs to do • Get Educated • Decide to act • Short term strategy • Long term strategy • Get Involved • GS1 Healthcare • GS1 Healthcare US • Associations • CSHP • Trials and Pilots • Your Distributor
Hospital use of Auto-Id (RFID, Bar Code)What’s coming to your Hospital? Locations Medical Devices Assets The growth of disconnected point solutions signals the need for standardization within the hospital setting Pharmaceuticals / Biologics Patients Blood & Blood Products
GS1 Healthcare USHospital Forum • Foster dialog among stakeholders • Provide ongoing opportunity to discuss and confront issues of mutual interest and concern • Neutral venue for broad ranging discussions that will serve to facilitate cooperation between Hospitals and their trading partner community in the area of standards based solutions • Provide a catalyst for voluntary collaboration on topics that may drive standards development efforts
Questions Bob CelesteDirector, Healthcare, EPCglobal North Americarceleste@epcglobalna.org(609) 620-4512