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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).
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
Serialization and Track & Trace The Balancing Act
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
Serialization and Track & Trace The Balancing Act
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
Serialization and Track & Trace The Balancing Act
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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© GS1 US 2011 31
2015 Readiness Pilots Get involved & Learn from others
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
www.GS1US.org
Connect with the GS1 US community on
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