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Industry Adoption Roadmap Update

Grant HodgkinsAlcon Laboratories, Inc.

Former Co-Chair, EPCglobal Industry Adoption Task ForceCurrent Co-Chair, GS1 Healthcare AIDC Standards

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Topics

• IATF Roadmap Overview

• GS1 Healthcare Standards Overview

• Where We’re Going

• Questions and Answers

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What is the IATF Roadmap

• IATF – Industry Adoption Task Force (EPCglobal)

• Tasked by EPCglobal HLS leadership team to create the first holistic strategy to meet California and other urgent compliance initiatives

• Cross-functional team of 80+ participants, most representing global healthcare entities, mobilized from Jun-2006 to Oct-2007

• Worked closely with FDA and CA BOP to craft mutually agreeable solutions

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Oct2006

Oct2007

Oct2008

• Around the time the IATF Roadmap was completed, EPCglobal HLS and GS1 HUG merged to form GS1 Healthcare

• The IATF deliverable was used as input to new global standards using newly-created work teams

GS1 HUG Work Groups(AIDC, Traceability, GDSN)

EPCglobal HLSIndustry Adoption Task Force

GS1 Healthcare Work Groups(AIDC, Traceability, GDSN)

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IATF Roadmap

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IATF: Team MembersSupply Chain Partners

•Abbott Laboratories•Ahold N.V.•Albertsons•Alcon Laboratories•Allergan•AmerisourceBergen Corp.•AstraZeneca•Baxter Healthcare Corp.•Bristol Meyers Squibb•Cardinal Health•CVS•Dai Nippon Printing•Genzyme Corporation•GlaxoSmithKline•Johnson & Johnson•Ken Traub Consulting LLC

Supply Chain Partners

• Kimberly-Clark• Matsushita Electric• McKesson Corporation• Merck & Co.• MetaBiz• Motorola Inc.• NEC Corporation• Nestle S.A.• Pfizer Inc.• Proctor & Gamble• Royal Philips

Electronics N.V.• Target• The Dow Chemical

Company• Unisys• Upsher-Smith Labs• Walgreens Company

Trade / Regulatory

• Auto-ID Labs (MIT)• CPhA• EPCglobal HLS

Community• FDA• GS1 HUG Community• HDMA• NACDS• NCPA

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IATF Roadmap: Context

• When this work group began in mid-2006, the world was a much different place…– California regulation set to become effective Jan. 1, 2009– Much confusion and controversy about serialization, pedigree

vs. track / trace, RFID vs. Barcodes, Inference, NDC Masking, etc.

– High sense of urgency for answers, direction, and a plan– Virtually no standards were completed– No practical experience with mass serialization in any industry

• The IATF was charged with bringing some clarity and direction to this confused space

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Overview of the IATF Roadmap

• Serialization

• e-Pedigree

• Implementation and related guidance

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IATF: Serialization• Uniquely Identify – Pallets, Totes, Cases, Items.

• Unique Identification should be based on Serialization.– Use current GS1 and EPCglobal serialization schemes appropriate

for the chosen data carrier.– Synchronize serial numbers when using two or more data carriers:

• SSCC: serial number ranges are the same for both Barcode and RFID.• SGTIN: serial number range for AI(21) when used as backup for SGTIN-96

should be limited to same range as SGTIN-96.

– Avoid encoding of Lot Code and/or Expiry Date as an integral part of the serial number; instead, encode this data into RFID User Memory and/or into barcode Application Identifiers designed for this purpose.

• Include backup human-readable text per GS1 standards.

Answers one specific issue; now resolved

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IATF: Serialization

• Other special-interest serialization topics:

– Serialized Inference Inferring reads when less than 100% of data carriers are read.

– NDC Masking Optional, interim practice to mask the Item Reference portion of

the 10-digit NDC in RFID tags to avoid divulging product number for products with patient privacy concerns.

– Barcode and RFID Co-Existence Synchronizing serial numbers when using two or more data

carriers.

This is NOT recommended and does not meet GS1 Stds

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IATF: e-Pedigree

• There are two Options to provide a Pedigree:– Option 1 – Drug Pedigree Messaging Standard– Option 2 –Track and Trace

• Drug Pedigree Messaging Standard available now.– Software available today with EPCglobal certifications.

• Track and Trace in Requirements phase now.– Standards will follow at a later date.– Then software will be available.

Update:Global Traceability Standard entering standards approval process

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IATF: e-Pedigree

• Rx ASN (modified EDI Transaction Set 856, Advance Ship Notice) does not meet California requirements for pedigree.– Cannot support ‘certification under penalty of perjury’.– Does not exist in an ‘interoperable electronic system widely

used…’– Does not meet requirement for ‘manufacturer-initiated

pedigree’.

• Rx ASN’s could be used to facilitate supply chain transactions (receipts, shipments, etc.).– ASN’s support efficient receiving practices.– Use of ASN’s will not meet pedigree obligations for

jurisdictions requiring the pedigree in an ‘interoperable electronic system’.

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IATF: Implementation GuidanceTypical Activities For All Trading Partners

• Engage with your Industry Trade Associations to ensure you have the most current information regarding policy and positions.

• Work with EPCglobal and GS1 groups to obtain standards, education, and to learn from others.

• Choose Serialization data carriers for every packaging level.

• Choose Pedigree Option and software.

• Develop scale-up and rollout-plans for Serialization and Pedigree (e.g., based on SKU counts or geographical rollout).

• Work with all affected trading partners with sufficient leadtime on Serialization and Pedigree choices and options to facilitate efficient supply chain operations.

• Convert operations to apply, commission and aggregate serial numbers.

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IATF: Implementation GuidanceTypical Activities For All Trading Partners

• Develop, implement, and adhere to effective Privacy standards to ensure appropriate use of these technologies.

• Install capability to transact serial numbers and serialized pedigrees—based on specific local regulatory requirements.

• Test serialized pedigree + serialized product final configurations with trading partners.

• Start shipping serialized and pedigreed products.– Pallet, Tote, Case, Item Serialization.– Transact a manufacturer-initiated pedigree.– With sufficient lead time to load the supply chain with serialized products

supported by a pedigree.• Execute your Scale-Up / Rollout Plans.• Retain Pedigree data according to regulatory data retention requirements.• Respond to requests for verification of Pedigree data.

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GS1 Healthcare:Standards Update

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GS1 Healthcare – Organization

• GS1 Healthcare Leadership Team– Roadmap– Direction and resources for work teams

• Active Teams related to IATF Work– Global AIDC Application Standards Team– Global Traceability Team– Global Data Synchronisation Network (GDSN) Team

• Other Global work teams

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Membership around the world

ManufacturersAbbott LaboratoriesAlcon LabsAmgenAstra ZenecaBaxterB. BraunBoston ScientificCookCovidienEdwards LifescienceGlaxo Smith KlineJohnson & JohnsonKing PharmaceuticalMedtronicMerck & Co.Novartis PharmaPall MedicalPfizerPurdue PharmaSchering PloughSmiths MedicalSakura Seiki

Distributors/Healthcare providers/GPOs/T&LCardinal Health (U.S.)CH Aulnay sous Bois (France)Comparatio Health (Germany)CVS (U.S.)DHL Exel Supply ChainErasmus MC Rotterdam (NL)UNI.HA (representing 17 French university hospitals)Hong Kong Hospital AuthoritiesMcKesson (U.S.)Novation (U.S.)Orthopädisches Spital Speising Wien (Austria)Premier (U.S.)Marienhospital Herne (Germany)UMC Groningen (NL)University Hospital Geneva (CH)University Kentucky Healthcare (U.S.)Wiener Krankenanstaltenverbund (Austria)

Non-voting membersAHRMMCladimedInstituto Brasileiro de Ética Concorrencial – ETCOLIF – Swedish Association of Pharmaceutical ManufacturersPublic Health Agency of CanadaUS DoDUS FDA

Manufacturers3MBayerBecton DickinsonBoehringer IngelheimColoplastDraeger MedicalGenzymeHospiraKimberly-ClarkNovo NordiskPurdue PharmaSt. Jude MedicalStrykerTeva PharmaceuticalsTerumoUCBUpsher-Smith…Distributors/WholesalersAexxdisAmerinetAmerisource BergenCH2DepolaboGalexisGAMMA WholesaleGeodisMcMahonOwens & Minor…

Healthcare providers/RetailersAlfred Hospital (Australia)Ascension Health (U.S.)Capital District Health (Canada)CHU de Québec (Canada)CHU Dijon (France)HUG Geneva (Switzerland)London Drugs (U.K.)Mayo Clinic (U.S.)Sisters of Mercy (U.S.)Sobeys Pharmacy (U.K.)UHCS Augusta VA (U.S.)Walgreens (U.S.)Wal-Mart (U.S.)…AssociationsAHA (U.S.)CIP/ACL (France)CHeS (U.S.)EFPIA (Europe)Eucomed (Europe)FENIN (Spain)GIRP (Europe)HDMA (U.S.)International Hospital FederationJFMDA (Japan)Medical Industry Association of AustraliaNACDS (U.S.)Patient Safety Foundation (U.S.)…

Members global user group Local participation

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GS1 Healthcare – Local Groups

And more being developed…(Belgium, Japan, Mexico, Sweden, Turkey)

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GS1 Healthcare Roadmap

• Phase 1 nearing implementation– Standard: AIDC– Standard: Traceability– Standard: GDSN Healthcare Extensions

• Phase 2 to kickoff shortly

• Work scheduled thru 2009

20© 2008 GS1

Roadmap towards Global Standards

2Version 1.8 – September 2008

Work in progress or planned Work finalised or near closure

200920082007

Packaging/

Direct Marking

Traceability

Data Synchronisation & Classification

Carrier

AIDC Application Standards (Ph1)

AutoID Data

Serialisation

AIDC Application Standards (Ph2)

Review GTS

Implement. Guide

Pilot

Attribute Gap Analysis

Pilot Strategy (GDSN-GPC)

Healthcare Extension

Long Term Classification

GTIN Allocation

Inventory Classif systems

Schedule for deliverables to the GS1 Global Standards Management Process

– approx. 6 months needed for final standard approval

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GS1 AIDC Application Standard

© 2008 GS1

AIDC Application Standards

Objective: developing global standards for the automatic identification and data capture for Healthcare products at all packaging levels

Completed:

•Rules for GTIN Allocation

•Data requirements for Automatic Identification (including Serialization)

•Carrier requirements for Automatic Identification

Next steps:

•Phase 1 (through Q4 ‘08): draft AIDC Application Standards for a majority of product types and packaging levels, with primary emphasis on pharmaceuticals

•Phase 2 (until Q2 ‘09): draft AIDC Application Standards for remaining product types in the “exception” category (e.g., surgical instruments)

•Practical timeframe for adoption

•Expected stakeholder support and business impacts

Scope:

•Healthcare products

•From finished goods at manufacture to the end of treatment at the Healthcare facility

22© 2008 GS1

AIDC Final Deliverable:Updates to GS1 General Specifications

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Human Readable Information Decision Tree

Carrier Decision Tree

Product Marking

GRIDS

Symbol Placement Rules

23© 2008 GS1

Product Marking Grids

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Product

Grouping

Package

Levels

Product Marking Cells

MI

Pharmaceuticals

Distributed and/or Sold Primarily Via

Retail Channels

Medical Devices

Distributed and/or Sold Primarily Via

Retail Channels

Pharmaceuticals

Distributed and/or Sold Primarily Via

Non-Retail Channels

Medical Devices

Distributed and/or Sold Primarily Via

Non-Retail Channels

Medical Devices

Distributed and/or Sold Primarily Via

Retail Channels

Medical Devices

Distributed and/or Sold Primarily Via

Non-Retail Channels

Pharmaceuticals

Distributed and/or Sold ViaRetail and/or

Non-Retail Channels

Medical Devices

Distributed and/or Sold Primarily Via

Non-Retail Channels

Description of the Example Product Hierarchy

DPM: 1 pillPrimary Package: 1 pill in blisterpack of 12 pillsSecondary Package: 3 blisterpacks of 36 pills in one cartonCase: 24 cartons (864 pills)Pallet: 200 cases (172,800 pills)

DPM: 1 consumer bandagePrimary Package: 1 bandage in pouchSecondary Package: 12 pouched bandages in one cartonCase: 12 cartons (144 bandages)Pallet: 200 cases (28,800 bandages)

DPM: 1 pillPrimary Package: 1 pill in blisterpack of 12 pillsSecondary Package: 3 blisterpacks of 36 pills in one cartonCase: 24 cartons (864 pills)Pallet: 200 cases (172,800 pills)

DPM: 1 empty syringePrimary Package: 1 empty syringe in blisterpackSecondary Package: 12 empty blisterpacked syringes in one cartonCase: 12 cartons (144 syringes)Pallet: 200 cases (28,800 syringes)

DPM: 1 contact lensPrimary Package: 1 contact lens in vialSecondary Package: 2 vials of 1 contact lens each in one cartonCase: 12 cartons (24 contact lenses)Pallet: 100 cases (2,400 lenses)

DPM: 1 catheter (temporary)Primary Package: 1 catheter in blisterpackSecondary Package: 6 blisterpacked catheters in one cartonCase: 24 cartons (144 catheters)Pallet: 200 cases (28,800 catheters)

DPM: 1 pillPrimary Package: 1 pill in blisterpack of 12 pillsSecondary Package: 3 blisterpacks of 36 pills in one cartonCase: 24 cartons (864 pills)Pallet: 200 cases (172,800 pills)

DPM: 1 re-usable scalpel handlePrimary Package: 1 re-usable scalpel handle in pouchSecondary Package: 6 pouched re-usable scalpel handles in one cartonCase: 15 cartons (90 scalpel handlesPallet: 200 cases (18,000 handles)

Direct Part Mark(AIDC marked directly onto a single, unpackaged, unlabeled item)

Primary Package(AIDC marked onto the first level of packaging, either on the packaging or on a label affixed to packaging. May consist of 1 single item, or a group of items for a single therapy such as a Kit.)

Secondary Packaging (AIDC marked onto the next level of packaging, containing one or more single items in their Primary Packaging)

Case / Shipper(AIDC marked onto a shipping container. May contain one or more items in their Primary Packaging and/or Secondary Packaging.)

Pallet(AIDC marked onto a pallet. May contain one or more Case / Shippers.)

MINIMUM Level of AIDC Marking (Non-Retail)MINIMUM Level of AIDC Marking (Retail) ENHANCED Level of AIDC Marking HIGHEST Level of AIDC Marking

No Marking No Marking No Marking No Marking No Marking No Marking

GTINSerial No.

-Not for Implants

Hospital:-8003/8004-optional

GTINLotExpirySerial No.Potency (kits)

Hospital:-8003/8004-optional

Trade Item:-GTIN-Lot-Expiry-Serial No.-Potency (kits)

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry-Serial No.

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry-Serial No.

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

GTIN

Hospital:AI(01)+AI(21)+AI(8008)

GTINLotExpiry

[Need 2 marks]

GTINLotExpirySerial No.Potency

Hospital:AI(01)+AI(21)+AI(8008)

No Marking

(mark with GTIN if no Secondary Package)

GTINLotExpiry

GTINGTIN

12 Syringes 6 Catheters

GTINLotExpiry

GTINLotExpiry

GTINLotExpirySerial No.Potency (kits)

Hospital:-8003/8004-optional

No Marking

(mark with GTIN if no Secondary Package)

No Marking

(mark with GTIN if no Secondary Package)

No Marking

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

2 Contact Lens

GTIN

No Marking

(mark with GTIN if no Secondary Package)

Trade Item:-GTIN-Lot-Expiry-Serial No.-Potency

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Trade Item:-GTIN-Lot-Expiry

Logistics:-SSCC

Logistics:-SSCC

Hospital:AI(01)+AI(21)+AI(8008)

GTIN

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ENCODED DATAManufacturerDistributor / Repacker GTIN-12; -13; or -14, + Serial No., or EPC SGTIN (if RFID)-Exception: No marks on Implants

Hospital -AI(8003) or AI(8004)-Optional if SGTIN is not marked on item by Brand Owner

DATA CARRIERManufacturerDistributor / Repacker Data Matrix or RFID

-Exception: No marks on Implants

Hospital Data Matrix or RFID

Medical Devices

Distributed and/or Sold Primarily ViaNon-Retail Channels

DPM: 1 scalpel handlePrimary Package: 1 scalpel handle in pouch

Secondary Package: 6 pouched scalpel handles in one carton

Case: 15 cartons (90 scalpel handlesPallet: 200 cases (18,000 scalpel handles)

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Excerpt of Direct Part Mark Standards

Description of the product packaging

Data Carrier recommendationsData to be encoded

2.1.5 Fixed Measure - Direct Part Marking – Brand Owner Marked

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Preferred AIDC Carrier(s): GS1 DataMatrix

Optional AIDC Carrier: EPCglobal RFID tags (in addition to bar code)

Supported AIDC Carrier: N/A

Preferred AIDC Carrier(s): GS1 DataMatrix

Optional AIDC Carrier: EPCglobal RFID tags (in addition to bar code)

Supported AIDC Carrier: N/A

Identification Level: Highest Identification Level: Highest

GS1 Key: GTIN-12, -13, -14GS1 Key: GTIN-12, -13, -14

GS1 Key Attributes: Serial Number

GS1 Key Attributes: Serial Number

Product Category: Medical Device Product Category: Medical Device

Important Application Standard Notes: Direct part marking (DPM) refers to the process of marking a symbol on an item using an intrusive or non-intrusive method. This does not include parts which are marked using labels or other indirect marking processes. Direct Part Marking is not required for Implantable Medical Devices. If a product that is required to marked at the Direct Part Mark level is contained in a Primary Package and that Primary Package obscures the DPM barcode, then the Primary Package is required to be marked with the required marks in this section. Specific GS1 DataMatrix rules & requirements apply, see GS1 Gen. Spec. for specific details / rules.

Important Application Standard Notes: Direct part marking (DPM) refers to the process of marking a symbol on an item using an intrusive or non-intrusive method. This does not include parts which are marked using labels or other indirect marking processes. Direct Part Marking is not required for Implantable Medical Devices. If a product that is required to marked at the Direct Part Mark level is contained in a Primary Package and that Primary Package obscures the DPM barcode, then the Primary Package is required to be marked with the required marks in this section. Specific GS1 DataMatrix rules & requirements apply, see GS1 Gen. Spec. for specific details / rules.

27© 2008 GS1

Phase 2 –Standards Development

• Very Small Instrument Marking

• Patient Identification

• Dispensing Unit

• Global Standard for plasma Derivatives Products

• Symbol Placement Rules and Illustrations

• Encoding cross-referenced part numbers

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Specific Phase 2 Activities are Being Defined

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GS1 Traceability Standard

© 2008 GS1

Global Traceability in Healthcare

Objective: defining the global solution for traceability in Healthcare toensure that the business needs of the industry are fulfilled, including ensuring global traceability in an efficient, secure and reliable way, addressing restrictive legal requirements, addressing authentication from manufacturer to patient, and achieving cross-industry interoperability

Next steps:

•Phase 2 (until end ‘08): draft Traceability in Healthcare Implementation Guidelines, Case Studies, Best Practices

Completed:

•Phase 1: draft Traceability in Healthcare Standard based on existing GS1 Global Traceability Standard (GTS)

Scope:

•Pharmaceuticals and medical devices

•From finished goods at manufacture to end of product life

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GS1 GDSN Standard

© 2008 GS1

Global Data Synchronisation & Product Classification

Objective: developing a data synchronisation standard, including a classification solution, which will allow the Healthcare industry to use the GS1 GDSN (Global Data Synchronisation Network)

Completed:

•GDSN gap analysis (228 data requirements are supported by the current GDSN standard - 27 new requirements need to be defined and added to the GDSN standard)

•Inventory of classification systems in use across the world (approximately 35 different classification and nomenclature systems in use in various parts of the world)

•Global GDSN pilot

Next steps:

•Publish GDSN pilot Use Case

•Develop long term recommendation for product classification (until June ‘09)

•Create GDSN Extension for Healthcare (until Q2 ‘09): Combine new attributes and the 228 above, add healthcare specific business rules and validations

Just Published

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Summary

• The IATF Roadmap, although no longer completely current, remains a good one-stop source for understanding serialization and pedigree challenges

• Those challenges are now being aggressively addressed at a global level by GS1 Healthcare

• Virtually all key questions raised in the IATF Roadmap have been migrated into one or more GS1 Healthcare groups for resolution and action

• Combining forces has accelerated activities, globalized the solutions, and enabled productive dialogue with regulators across the globe

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Questions?