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Health Care/Pharmaceutical

GS1 Standards for Serialization and Visibility Within the

U.S. Pharmaceutical Supply Chain

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• Health Care/Pharmaceutical: GS1 Standards for Serialization and Visibility Within the U.S. Pharmaceutical Supply Chain GS1 Healthcare US is driving the adoption and implementation of GS1's standards to improve patient safety and supply chain efficiency. Members from across the pharmaceutical supply chain are building an industry reference model to enable efficient product serialization and visibility. The program provides a unique opportunity to gain insights into the benefits of supply chain visibility, and to prepare for serialization requirements. Speaker: Bob Celeste, Director of Healthcare, GS1 US Takeaways: • Introducing the GS1 US Implementation Guideline, "Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes (To Support Serialization, Pedigree and Track & Trace)" • Utilizing a simulated supply chain to test exception processes for minimizing implementation surprises, increasing pilot effectiveness •How to resolve the majority of issues prior to implementation with trading partners, thus reducing implementation costs

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110+ member service organizations

serving business around the world

About GS1

GS1 brings together stakeholders across an industry

to develop, adopt, and use information standards that

revolutionize the way they do business.

• GS1 Standards make it possible for companies to

leverage the power of information by identifying,

capturing, and sharing data about products, locations,

and more.

• GS1 is a global, not-for-profit organization with more than

110 member organizations (MOs) serving business

around the world.

• GS1 is neutral, user-driven, and user-governed.

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ABOUT GS1 US

GS1 US serves more than 250,000 businesses across

25 industries in the United States.

• Leading industry initiatives in Apparel / General

Merchandise, Consumer Packaged Goods / Grocery,

Foodservice, Fresh Foods, and Healthcare

• Administrating the GS1 System of standards

• Providing support services, tools, education, and training

• Connecting communities through events and online forums

GS1 US is the pioneer of the Universal Product Code (U.P.C.)

and the Electronic Product Code™ (EPC®).

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GS1 By the numbers

• 2 million companies around the world

use GS1 Standards

• more than 5 billion GS1 barcodes

are scanned every day

• 5 million products are assigned U.P.C.s

in the GS1 Data Driver® item management tool

• 5 million products are registered by brand

owners in the 1SYNC Data Pool

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GS1 Standards in Healthcare

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Why Global Standards?

The package has:

• 6 machine readable codes (5 bar codes, 1

data matrix).

• 17 flags (UK, Ireland, Malta, Netherlands,

Belgium, Germany, Austria, France, Spain,

Portugal, Greece, Cyprus, Norway, Sweden,

Denmark, Iceland, Finland) (not Italy)

• 12 different language texts (English, French

and German are used in more than one

country).

healthcare

PROGRAMS / INITIATIVES

• GS1 Healthcare US

– Driving the adoption and implementation of GS1 Standards to improve

patient safety and supply chain efficiency since 2008

– Bringing together members from all segments of the U.S. healthcare

industry to address the most pressing supply chain issues

• 2010 and 2012 Sunrise Dates

To accelerate wide-scale adoption of GS1 Standards, "sunrise" dates were

established by the industry:

– 2010 for location identification (Global Location Number – GLN)

– 2012 for product identification (Global Trade Item Number –

GTIN)

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healthcare

PROGRAMS / INITIATIVES (CONT.)

• 2015 Readiness and FDA Track and Trace Initiatives

GS1 Healthcare US works with members of the U.S. pharmaceutical industry

to help prepare companies for product serialization, 2015 state drug pedigree

requirements, and FDA track and trace initiatives using GS1 Standards.

• FDA Unique Device Identification (UDI) for Medical Devices

– The proposed FDA UDI regulation aims to transform disparate medical

identification methods into a standardized system.

– The GS1 GTIN provides the foundation for companies to meet these

requirements.

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Global implications

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Why Serialization and Visibility?

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Counterfeit

Diversion

Theft

What are the issues?

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Will the solution cost more than problem?

Protect the supply chain without stopping the supply chain!

Provide visibility without also providing unfair business advantage.

This amounts to an order of magnitude change in accuracy.

Better the devil you know than the devil you don’t.

Pharmaceuticals New coding & serialisation requirements

Denmark - 2011 Product Code

France - 2011 Batch Variable

Denmark - 2012 Product Code

Canada - 2012 Vx Batch Variable

Korea - 2013 Batch Variable

Turkey - 2010 Track & Trace

Europe – Q2 2011 European Legislation

Brazil - 2011 Track & Trace

Europe - 2016 European Compliance to

Pharma Directive

California - 1st Jan 2015 50% Mfg Product

California - 1st Jul 2016 Wholesalers

California - 1st Jan 2016 100% Mfg Product

California - 1st Jul 2017 Retail/Hosp/Pharmacies

USA - Q2 2010 FDA SNI guidance

Serbia - Q4 2010 Traceability regulation

2010 2011 2012 2013 2014 2015 2016 2017

Regulated requirement

Tender requirement

Important development

Cyprus - 2010 Product Code

Korea - 2015 Serialisation

Netherlands - 2012 NVZ Product code

China - 2011 Track & Trace

Europe - 2013 Delegated acts

finalised

India 2011 Batch Variable

India 2012 Serialisation

India 2011 Serialisation for export

Argentina 2012 Serialisation for traceability

England/NHS - 2012 Product Code

Identification of pharmaceuticals

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= country accepts GTIN

= country requires NTIN

= country requires national ID #

= no input available

Serialisation of pharmaceuticals

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= country requires serial number

= country developing requirement for serial number

DataMatrix on pharmaceuticals

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= country requires DataMatrix

= country using DataMatrix in pilots and/or developing requirement for DataMatrix

Belgium: Pilot project unit dose marking

Brazil: Traceability pilot successfully completed – ANVISA regulation

France: AFSSAPS regulation (2011)

Korea: pharma regulatory requirement (2011)

Spain: Pilot

Serbia: Pilot

Switzerland: SmartLog Pilot

Turkey: Regulatory requirement (2010)

Canada: Vaccines

Austria: Cytostatics

India: Tender requirement for October 2011

Argentina: Traceability regulation

Pedigree, Track & Trace, Visibility

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Visibility, Traceability, Track and Trace, Pedigree Terms

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Visibility

Track and Trace / Traceability

Pedigree

Visibility: All of Track & Trace / Traceability. Can also provide status or disposition of item. May include other attributes that provide insight as to whether the item is fit for use. Leverages separate Master Data management.

Traceability / Track and Trace: Interchangeable terms. GS1 uses Traceability while others (FDA) use Track & Trace). Provides ability to track forward to determine where the item currently is or trace back where it had been. Can leverage separate Master Data management.

Pedigree: Usually defined by U.S. State or Federal law. Information to “trace” the distribution history of an item. May include Chain of Custody and/or Chain of ownership.

Fit for use

Additional Status data

(Temp Profiles?)

Proof of Delivery Inventory

Levels

The Balancing Act

THINGS TO CONSIDER, PERCEPTION ISSUES

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Serialization and Track & Trace The Balancing Act

Decommissioning Track & Trace

On Arrival Multi-Architectures

Inference 1 Up, 1 Down On Demand

Single Architecture Models

Decisions, Decisions, Decisions


Manufacturer Wholesaler Pharmacy

Contract Manufacturer Solid Dose Manufacturing

Biological Products Generic Drug Manufacturer

National Wholesaler Regional Wholesaler Specialty Wholesaler

3PL Returns Processor

Repackager Kitter

Hospital Pharmacy Chain Pharmacy

Independent Pharmacy

Overly Simplistic View of the

Supply Chain


Normal Processes Basic Forward Logistics

Drop Shipments Kitting

Repackaging Recalls Returns

Withdrawals Refusals

Exception Processes Visible Overage Visible Shortage

Pedigree Serial # Discrepancy Pedigree Lot Discrepancy

Product Inference Problem Concealed Discrepancy

Physical Inventory - Visible Overage Physical Inventory - Concealed Overage

Physical Inventory - Pure Shortage Physical Inventory - Concealed Shortage

Pedigree Data Error Pedigree Data Not Received

Undelivered Shipment Lost Shipment

Unidentified Sender Pedigree Security Error

Damaged Bar Code or RFID Damaged Product

Damaged Shipment Product Damaged after Receipt

Unauthorized Return

Perception of the amount of

Processes Impacted or

Created


Responding to Emergencies

Returning to Normal flow of

Operations

Frequency of Disaster

Planning and Recovery

Standards Activities in the U.S.

IMPLEMENTATION SUPPORT

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Standards activities within the U.S. Implementation Support

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Inference

Architectural Model

Security / Governance

Pilots

Secure Supply Chain Task Force

Implementation Guide Update

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Contents of the guideline:

• Identifying Trade Units (Products, Cases, and Kits): • Identifying Logistics Units (Cases, Pallets, and

Totes) • Identifying Parties & Locations

Encoding GS1 Data Carriers • Translating Captured Data • Master Data Management (product and location

data) • Applying GS1 Standards for Event Data • Supply Chain Events to be Captured for Pedigree • Additional Supply Chain Events for Track & Trace • Exceptions Processing • Pilot learnings / best practices • Forward Logistics Examples • Reverse Logistics Examples • Potential Architectural Models

Standards activities within the U.S. Implementation Support - Statistical Sampling Model

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http://www.stanford.edu/

http://www.gs1us.org/

2015 Readiness Pilots Sample Pilot Tracker

Manufacturer X

Barcode Quality Pharmacy Z

X X

Extended Trading Partners

Manufacturer X

Wholesaler Y

Pharmacy Z

X

X

X

X

X X

Traceability Pilots Task Force

Pilot Panel Calls

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Date Agenda Topics

2/29/2012 Main Topic: Serialization on packaging lines (encoding,)

3/14/2012 Main Topic: Interoperability and exchange between partners

3/28/2012 Main Topic: Pilot Planning

4/11/2012 Main Topic: Managing traceability information and implementation across the enterprise (scaling, avoiding competing implementations inside your co)

4/25/2012 Main Topic: Labeling (AI (30), Item Count), labeling practices you might encounter

5/9/2012 Main Topic: Packaging level indicators

5/16/2012 Main Topic: Pharmacy/Clinic roundtable

5/30/2012 Main Topic: Master Data Management

Contact Information

CORPORATE HEADQUARTERS

Princeton Pike Corporate Center

1009 Lenox Drive, Suite 202

Lawrenceville, NJ 08648 USA

T +1 609.947.2720

E [email protected]

www.GS1US.org

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