Health Care/Pharmaceutical. GS1 Standards for Serialization and Visibility Within the U.S. Pharmaceutical Supply Chain

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Neal Briggs
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2 Health Care/Pharmaceutical GS1 Standards for Serialization and Visibility Within the U.S. Pharmaceutical Supply Chain 2

3 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 3

4 110+ member service organizations serving business around the world 4

5 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. 5

6 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 ). 6

7 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 7

8 GS1 Standards in Healthcare 8

9 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). Why Global Standards?

Norway, Sweden, Denmark, Iceland, Finland) (not Italy) 12

10 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). Why Global Standards?

11 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) 11

12 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. 12

13 Global implications 13

14 Why Serialization and Visibility? Counterfeit Diversion Theft 14

15 What are the issues? This amounts to an order of magnitude change in accuracy. Will the solution cost more than problem? Protect the supply chain without stopping the supply chain! Provide visibility without also providing unfair business advantage. Better the devil you know than the devil you don t. 15

16 Cyprus Product Code Denmark Product Code India 2011 Batch Variable France Batch Variable Pharmaceuticals New coding & serialisation requirements Denmark Product Code Canada Vx Batch Variable England/NHS Product Code Korea Batch Variable Korea Serialisation Europe European Compliance to Pharma Directive Turkey Track & Trace Brazil Track & Trace India 2012 Serialisation Europe Delegated acts finalised California - 1st Jan % Mfg Product California - 1st Jul 2017 Retail/Hosp/Pharmacies USA - Q FDA SNI guidance China Track & Trace Europe Q European Legislation Netherlands NVZ Product code California - 1st Jan % Mfg Product California - 1st Jul 2016 Wholesalers Serbia - Q Traceability regulation India 2011 Serialisation for export Argentina 2012 Serialisation for traceability Regulated requirement Tender requirement Important development

17 Identification of pharmaceuticals = country accepts GTIN = country requires NTIN = country requires national ID # = no input available 17

18 Serialisation of pharmaceuticals = country requires serial number = country developing requirement for serial number 18

19 Canada: Vaccines DataMatrix on pharmaceuticals Switzerland: SmartLog Pilot Spain: Pilot France: AFSSAPS regulation (2011) Belgium: Pilot project unit dose marking Austria: Cytostatics Serbia: Pilot Turkey: Regulatory requirement (2010) Korea: pharma regulatory requirement (2011) Brazil: Traceability pilot successfully completed ANVISA regulation Argentina: Traceability regulation India: Tender requirement = country requires DataMatrix for October 2011 = country using DataMatrix in pilots and/or developing requirement for DataMatrix 19

20 Pedigree, Track & Trace, Visibility 20

Visibility, Traceability, Track and Trace, Pedigree Terms Proof of Delivery Fit for use Visibility Track and Trace / Traceability Additional Status data (Temp Profiles?

21 Visibility, Traceability, Track and Trace, Pedigree Terms Proof of Delivery Fit for use Visibility Track and Trace / Traceability Additional Status data (Temp Profiles?) Inventory Levels 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 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. 21

22 The Balancing Act THINGS TO CONSIDER, PERCEPTION ISSUES 22

23 Serialization and Track & Trace The Balancing Act Inference 1 Up, 1 Down On Demand Single Architecture Models Decisions, Decisions, Decisions Decommissioning Track & Trace On Arrival Multi-Architectures

Simplistic View of the Supply Chain Contract

Biological Products Generic Drug Manufacturer

Specialty Wholesaler 3PL Returns Processor

24 Serialization and Track & Trace The Balancing Act Manufacturer Wholesaler Pharmacy Overly Simplistic View of the Supply Chain 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

Serialization and Track & Trace Normal Processes Basic Forward Logistics Drop Shipments Kitting Repackaging Recalls Returns

Overage Visible Shortage Pedigree Serial # Discrepancy Pedigree Lot Discrepancy Product Inference Problem Concealed

Physical Inventory - Concealed Shortage Pedigree Data Error Pedigree Data Not Received Undelivered Shipment Lost Shipment

25 Serialization and Track & Trace Normal Processes Basic Forward Logistics Drop Shipments Kitting Repackaging Recalls Returns Withdrawals Refusals The Balancing Act Perception of the amount of Processes Impacted or Created 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

26 Serialization and Track & Trace The Balancing Act Responding to Emergencies Frequency of Disaster Planning and Recovery Returning to Normal flow of Operations

27 Standards Activities in the U.S. IMPLEMENTATION SUPPORT 27

28 Standards activities within the U.S. Implementation Support Architectural Model Security / Governance Inference Pilots 28

Secure Supply Chain Task Force Implementation Guide Update Contents of the guideline: Identifying Trade Units (Products, Cases, and Kits): Identifying Logistics Units (Cases, Pallets, and Totes)

29 Secure Supply Chain Task Force Implementation Guide Update 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 29

30 Standards activities within the U.S. Implementation Support - Statistical Sampling Model 30

31 2015 Readiness Pilots Get involved & Learn from others GS1 US

32 2015 Readiness Pilots Sample Pilot Tracker Barcode Quality Manufacturer X Pharmacy Z X X Extended Trading Partners Manufacturer X Wholesaler Y Pharmacy Z X X X X X X

33 Date Traceability Pilots Task Force Pilot Panel Calls 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 33

34 Contact Information CORPORATE HEADQUARTERS Princeton Pike Corporate Center 1009 Lenox Drive, Suite 202 Lawrenceville, NJ USA T E rceleste@gs1us.org Connect with the GS1 US community on

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Healthcare. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA

Healthcare. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA Healthcare Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA Release 1.0, May 23 2017 Table of Contents 1 Introduction... 7 2 IDENTIFY: Questions about GS1