Transcript FDA Circular 2014-011 - Philippine Association of Pharmacists

Philippines
FDA Circular No. 2014-011
José A. Albert
President & CEO
GS1 Philippines
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Philippines
Introduction
© 2011 GS1
FDA Circular No. 2014-011
Philippines
• The use of Global Data Standard
• Scope: All products and establishment requiring FDA
Registration
• Global Product Identification & Global Establishment
Identification
• Date for full compliance: June 30, 2015
© 2011 GS1
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Philippines
Guidelines
Application Requirements
1. Each application for authorization of an establishment must
indicate in the application form the unique establishment
identification number.
2. Each application for authorization of a product must indicate
in the application form the Global Trade Item Number.
3. No documents are required to be provided in support of the
identification number as part of the authorization process.
4. The Agency can verify the identification numbers provided
through a network that can synchronize global data.
5. Failure to provide a verifiable Global Trade Item Number by
itself is sufficient ground for denial of application.
© 2011 GS1
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Philippines
Global Data Standard
• Unique global product identification code and data
structure
• Identification code expressed in a machine readable
manner (Barcode or RFID Tag) so as to enable
automatic data capture or AIDC (Automatic Identification
and Data Capture) techniques
• Identification of each package level of a product
• Key to unlock information about the product such as
where the raw materials came from, who the suppliers
were, and where the product was manufactured
• Example: GS1 GTIN (Global Trade Item Number)
© 2011 GS1
Philippines
© 2011 GS1
AIDC Technique –
Barcode Scanning
Philippines
Host
© 2011 GS1
AIDC Technique – RFID
(Radio Frequency
Identification)
Reader
Module
Antenna
Tag
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Global Product Data Standard
Philippines
• Proposed framework for implementation of industry wide
global product data standards to
• Improve efficiency in cross border procedures
• To increase supply chain visibility in trade
• Initial improvement through capacity building/pilot
projects
• End goal the broad adoption of global product data
standards throughout the supply chain in APEC member
economies
• Supports the APEC supply chain improvement goal to
lower supply chain cost in APEC by 10% by 2015
© 2011 GS1
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APEC Statements
Qingdao, China, May 2014
Philippines
• We reaffirm the positive contribution global data standards
can make to enhancing supply chain efficiency and we
welcome recent initiatives to share information and
experiences on global data standards. We support further
efforts to advance cooperation in this area. - APEC Ministers
Responsible for Trade
• APEC members promote the use and benefits of global data
standards for cross-border control and supply chain
management - Committee on Trade and Investment
• APEC member economies are moving ahead with a joint
multi-year initiative to improve the integrity of medical product
manufacturing and security of distribution chains across
borders to combat fraud in the world’s largest consumer
market. - APEC Life Sciences Innovation Forum
© 2011 GS1
Philippines
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Advantages of Global
Standard Data
Automation
Supply Chain (end-to-end) Visibility
Assists with product traceability
Facilitates Product Recall
Enables to trace the Chain of Ownership
of a Product
• Facilitates identification of products
entering the jurisdiction of a country
© 2011 GS1
Philippines
End-to-End Visibility
Interoperability
Collaboration
© 2011 GS1
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Philippines
Traceability
• The ability to trace the history, application, or location of
that which is under consideration (ISO 9001:2000)
• The ability to chronologically interrelate uniquely
identifiable entities in a way that is verifiable
• An end-to-end supply chain process where different
companies collaborate to optimize the interfaces
determined by its different directions, areas and subprocesses
• The ability to track forward the movement through
specified stage(s) of the extended supply chain and
trace backward the history, application or location of that
which is under consideration
© 2011 GS1
Philippines
Recall/ Withdrawal
• Withdrawal: “any measure aimed at preventing the
distribution, display and offer of a product dangerous to
the consumer (2001/95/EC)".
• Recall: " any measure aimed at achieving the return of
a dangerous product that has already been supplied or
made available to consumers by the producer or
distributor (2001/95/EC)".
• Difference: Withdrawal happens when products are not
available at the Point of Sales while Recall happens
when products are available at the Point of Sales
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Product Recall: Functional View
Philippines
Retailer Receives Recall
Notification Immediately
Manufacturer Initiates
Recall
- Manufacturer completes
recall notification form
(including attachments)
- All other internal recall
and risk management
processes remain in place
-GS1 ProductRecall
enables the real-time
communication of recall
information to retail
partners
© 2011 GS1
Complements and enhances existing
product recall processes by providing
users;
- An application developed by industry,
for industry
- Real-time information exchange
- A single trusted source for product
recall data
- Retailer receives the recall
notification – including detailed
product information and
images, attachments, and
disposal instructions – instantly
and accurately.
- Retailer uses recall
information to drive more
effective/efficient internal
processes – including the
removal, disposal, and return
of a recalled product.
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Philippines
© 2011 GS1
GS1 Recall Notification
Process
Philippines
Chain of Ownership
(Pedigree)
• The ability to trace the history of an individual item or
product
• A record, in electronic form, containing information
regarding each transaction resulting in a change of
ownership of a given product (drug), from sale by a
manufacturer, through acquisition(s) and sale(s) by one
or more wholesalers, manufacturers, or pharmacies,
until final sale to a pharmacy or other person furnishing,
administering or dispensing the drug.
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Philippines
Facilitates Cross-Border
Trade
Common
Product
Identifier
IMPORTER
© 2011 GS1
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Philippines
GTIN (Global Trade Item
Number)
• A trade item is any item (product or service) upon which
there is a need to retrieve pre-defined information and
that may be priced, or ordered, or invoiced at any point
in any supply chain. This includes individual items as
well as all their different configurations in different types
of packaging.
• The Global Trade Item Number™ (GTIN™) is used for
the unique identification of trade items worldwide. GTINs
may be 8, 12, 13 or 14-digits in length. Their data
structures require up to 14-digit fields, and all GTIN
processing software should allow for 14 digits.
© 2011 GS1
Philippines
GS1 and the Healthcare Sector
© 2011 GS1
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Philippines
Healthcare Timeline
• 1995 – GS1 expanded the use of the GS1 Standards in the
Healthcare Sector with the first Healthcare Collaboration
Project
• 2005 – Healthcare Sector came to GS1 asking for help
• 2005 – Healthcare becomes a GS1 Focus Priority
• 2005 – Healthcare User Group (HUG) Established
• 2006 – 1st HUG Conference
• 2007 – 1st GS1 Healthcare Conference
• 2009 – 1st Publication of GS1 Healthcare Reference Book
• 2010 – GS1 joins the Joint Initiative Council on Global Health
Informatics
• 2012 – McKinsey Healthcare Report
© 2011 GS1
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HUG Global Voting Members
(Manufacturers)
Philippines
•
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© 2011 GS1
Abbott Laboratories
AstraZeneca
Baxter
Bayer
B. Braun
Bristol Myers Squibb
Glaxo Smith Kline
Johnson & Johnson
Merck
Novartis
• Pfizer Inc.
• Takeda Pharmaceuticals
International GMBH
• Alcon Laboratories
• 3M
• Amgen
• Cook
• Covidien
• Medtronic
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Joint Initiative Council (JIC) on
Global Health Informatics
Philippines
International
Organisation for
Standardization
European
Committee for
Standardization
Health Level 7
international
International
Health
Terminology SDO
Clinical Data
Interchange Standards
Consortium
Integrating the
Healthcare
Enterprise
To enable common, timely informatics standards by
addressing and resolving issues of gaps, overlaps and
counterproductive standardization efforts
GS1 Supply and Demand Chain Standards Specialist
© 2011 GS1
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New McKinsey & Company
Philippines
Report
New McKinsey report “Strength
in unity: The promise of global
standards in healthcare”
Benefits of a Single Global
Standards in healthcare
Highlights the cost savings and
patient safety benefits of
adopting a single global supply
chain standard in healthcare
Available at:
http://www.gs1.org/healthcare/mckinsey
© 2011 GS1
Philippines
Key Messages
• Healthcare is at a crossroads
• Global standards could help save thousands of lives and
billions of dollars every year
• Every part of the healthcare value chain could benefit
• Multiple standards would diminish benefits
• Senior leaders would have to collaborate
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Barcoding in the Philippine
Healthcare Sector
Philippines
• Pharmaceutical Products have been barcoded for the
retail sector (Point-of-Sales) for the last 20 years
• Dialogue between GS1 Philippines and Hospitals
currently on going
• Two hospitals are currently engaged to pilot or
implement barcoding to reduce error in medication –
tracking pharmaceutical from manufacturer to patient
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Philippines
Did you know . . .
Medication at CJW Medical Center
(January through March 2007)
• 720,197 doses administered
• 91% doses scanned (655,379)
• 123,813 warnings (17.2% administered) (18.89%
scanned)
•
•
•
•
© 2011 GS1
1.9% not on patient’s MAR (2,352)
1.4% doses exceeds ordered amount (1,733)
108 allergy warnings
33 expired medication warnings
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Philippines
GS1 System and the
Healthcare Sector
© 2011 GS1
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GS1 System of Standards
Philippines
• The GS1 System of Standards is designed to
enable visibility to identify, capture and share
information about products, between
business partners and more - make it
possible for companies to speak the same
language, connect with other and move
their business forward.
Identify
© 2011 GS1
Capture
Share
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Philippines
IDENTIFY
GS1 Identification Keys
Product
• Global Trade Item Number
(GTIN)
• Serialized Global Trade Item
Number (SGTIN)
Companies
• GS1 Company Prefix
• Global Location Number
(GLN)
• Electronic Product Code
(EPC) Manager Number
Location
• Global Location Number
(GLN)
• Serialized Global Location
Number (SGLN)
© 2011 GS1
Pack, Case, Pallet
• Global Trade Item Number
(GTIN)
• Serialized Global Trade Item
Number (SGTIN)
• Serial Shipping Container Code
(SSCC)
Multiple Logistic Units
• Global Shipping Identification
Number (GSIN)
• Global Identification Number for
Consignment (GINC)
Assets
• Global Individual Asset Identifier
(GIAI)
• Global Returnable Asset Identifier
(GRAI)
Services
• Global Service Relation
Number (GSRN)
• Global Document Type
Identifier (GDTI)
• Global Coupon Number
(GCN)
Product Attributes
• Dates, e.g. Best before
Date
• Batch Number
• Serial Number
• Logistic Measures
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CAPTURE
GS1 Automatic Data Capture Tools
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SHARE
Philippines
GS1 Share Tools
Interoperbility
Physical Flow of Goods
Data Type
GS1 Standard
Type of Supply Chain Information
Master Data
Global Data Synchronization
Network (GDSN)
e.g. Product Description. Dimensions,
Brand Owner, Product Classification
Transaction Data
eCom (EDI): EANCOM. GS1 XML,
Business Message
e.g. Purchase Order, Despatch Advice,
Invoice, Payment
Event Data
Electronic Product Code
Information Service (EPCIS)
What, Where, When, Why – e.g. product
Received, Shipped, Picked & Packed
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Improving Patient Care and Supply
Philippines
Chain Efficiency
Patient Safety
Supply Chain Efficiency
IDENTIFY &
CAPTURE
Barcode
RFID
e-COMMERCE
EDI/XML
Transactions
ELECTRONIC
MANAGEMENT
TRANSACTIONS
e-Records
e-Prescriptions
TRACEABILITY
COMPLIANCE
DOH & FDA
Regulations
e-pedigree
Recall
Asset & Equipment
Tracking
STANDARDIZED PRODUCT DEFINITION (GDSN)
STANDARDIZED LOCATION IDENTIFICATION (GLN)
STANDARDIZED PRODUCT IDENTIFICATION (GTIN)
STANDARDIZATION
© 2011 GS1
INTEROPERABILITY
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Pallet
Packaging levels
Case /
Shipper
Secondary
package
Primary
package
Unit-ofuse
Different packaging levels require different
GTIN’s
© 2011 GS1
Case/Shipper and Pallet
Philippines
These packaging configurations that may be used either as
trade units or logistic units. Case/Shipper may contain one
or more trade items in their primary packaging or their
secondary packaging. Pallets may contain one or more
cases/shippers.
Example: Case/Shipper
Example: Pallet
Note: Only fixed configuration pallets and shippers may be identified
with a GTIN.
© 2011 GS1
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Philippines
Healthcare Secondary
Package
• A level of packaging marked with an AIDC
carrier that may contain one or more primary
packages or a group of primary packages
containing a single item.
© 2011 GS1
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Philippines
Healthcare Primary
Package
• Healthcare Primary Packaging trade items are
pharmaceutical and medical products or their
packages presented to support the Point-ofCare (direct consumption based on right
product, dose, and route of administration.
• If an item is a Regulated Healthcare Retail
Consumer Trade Item and also a Non-Retail
Trade Item then the bar code marking for
Regulated Healthcare Retail Consumer Trade
Items is required at a minimum.
© 2011 GS1
Healthcare Configurations
& Packaging Levels
Philippines
Primary Packaging - The first level of packaging in direct
contact with the product and marked with an AIDC data
carrier either on the packaging or on a label affixed to the
packaging. For packaging configurations that include a retail
consumer trade item, primary packaging is a packaging level
below the retail consumer trade item.
Secondary Packaging: A
level of packaging marked
with an AIDC carrier that
may contain one or more
primary packages or a
group of primary packages
containing a single item
© 2011 GS1
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Definitions
• Single unit = Single item of
medicine/Medical device
without any package, for
example the single tablet in a
blister or bottle, the syringe as
such.
© 2011 GS1
• Single unit package (GS1
primary package) is the one
that contains one discrete
pharmaceutical dosage form.
i.e. a tablet, a certain volume
of a liquid or that is the
immediate package for a
medical device like a syringe
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Philippines
Definitions
• Multiple unit package
(can also be GS1 primary
package) – Immediate
package for a medicine
with more than one single
unit
• Unit dose (unit dose is
the prescribed dose for a
patient while single unit
relates to the product)
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© 2011 GS1
Philippines
Product Identification
• A GTIN is the generic identification of the different
configurations in different types of packaging of a
specific product
• A GTIN can be narrowed down by adding specific
attributes
• Expiry Date (AI 17)
• Lot/Batch Number (AI 10)
• Serial Number (AI 21)
• A GTIN + Serial Number (AI 21) identifies a unique
individual product
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Data Carrier Usage…
Philippines
…translation
“UDI and pharmaceuticals to GS1”…
Data Carriers
Example “UDI Applicable” GS1 bar code Data Carriers potentially seen at:
…the Warehouse
GS1-128 “Concatenated” data
…the Hospital
GS1-128 “Non-concatenated” data
(01)10857674002
(01)10857674002(17)141120(10)1234AB
(17)141120(10)1234AB
GS1-128 “Non-concatenated” data
GS1 DataMatrix
(01)10857674002
(17)141120(10)1234AB
(01) 10857674002017
(17) 141120
(10) 1234AB
GS1-128 “Concatenated” data
ITF-14
(01)10857674002(17)141120(10)1234AB
NOTE:  Examples only, not to scale and not necessarily the only options.

Manufacturer determines symbology choice, see the GS1 General Specifications for all options & details.
Data may be carried in a single “concatenated” GS1-128 (best practice) or in two GS1-128s (allowed alternate).
 GS1 DataMatrix is particularly suited to small spaces and Direct Part Marking (DPM).

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Data Carrier Usage…
Philippines
…translation
“UDI and pharmaceuticals to GS1”…
Data Carriers
Example “UDI Applicable” GS1 bar code Data Carriers potentially seen at:
…the Point of Care
…the Retail POS
EAN 13
GS1-128 “Concatenated” data
UPC-A
UPC-A
(01)10857674002(17)141120(10)1234AB
GS1 DataMatrix
ITF-14
(01) 10857674002017
(17) 141120
(10) 1234AB
NOTE:  Examples only, not to scale and not necessarily the only options.

Manufacturer determines symbology choice, see the GS1 General Specifications for all options & details.
UPC-A, EAN-13 and ITF-14 do not encode “Production Identifiers” (Application Identifiers)
 Data may be carried in a single “concatenated” GS1-128 (best practice) or in two GS1-128s (allowed alternate).
 GS1 DataMatrix is particularly suited to small spaces and Direct Part Marking (DPM).

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Date Attribute Identification
Philippines
GTIN – 4800204028727
Expiry Date.Coded – 161215
GTIN – 4800204028727
Expiry Date – Dec. 15, 2016
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Lot/Batch Number Attribute
Identification
Philippines
GTIN – 4800204028727
Lot No. – 207 IWB
GTIN – 4800204028727
Lot No. – 207 IWB
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Lot/Batch Number Attribute
Identification
Philippines
GTIN – 4800204028727
GTIN – 4800204028727
Expiry Date. – 161215
Lot Number 207 IWB
GTIN – 4800204028727
Lot Number 842678AB
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Philippines
Serialized GTIN
GTIN – 4800204028727
Lot No. – 207 IWB
Serial Number 842678AB
GTIN – 4800204028727
Serial Number 842678AB
Serialized GTIN: GTIN +
Serial Number
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Philippines
Use of Different
Attributes
• Lot/Batch Number – Recall/Withdrawal
• Serial Number – Chain of Ownership
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Capturing the Identification
Key
Philippines
Some data carriers can carry more detailed
information about that specific unit
Item identifier
Expiry date
Batch number
Serial number
(21)123
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© 2011 GS1
Philippines
Global Establishment
Identification
• A establishment is any entity (physical
location or legal entity) within the supply
chain
• Global Location Number (GLN) is the GS1
identification key used to identify physical
locations or legal entities where there is a
need to retrieve pre-defined information to
improve the efficiency of communication
within the supply chain
© 2011 GS1
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GLN Implementation in Company
Philippines
Structure
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GLN Use
Philippines
Application Identifier
GS1 AI
Definition (Identification of Type of Location)
414
Identification of Physical Location
410
Ship to – Deliver to
411
Bill to – Invoice to
412
Purchased from
413
Ship for – deliver for – Forward to
415
Invoicing Party
• Encoding a GLN with AI (414)
(414) 4809876543217
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Philippines
A model for Global Standards Harmonization in
Healthcare
UDI (Unique Device
Identification)
© 2011 GS1
Philippines
Global Harmonization
• The world is flat
• World trade has made the free flow of goods
• Goods have to be tracked and trace most
particlarly where consumer (patient) safety is
concerned
• The regulators from across the world realized
the need for a common set of rules that would
make this possible
• The first area chosen was Unique Device
Identification (UDI)
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Philippines
•
•
•
•
© 2011 GS1
Global Harmonization
Global Harmonization Task Force (GHTF) waws conceived in 1992 in
order to obtain greater uniformity between national medical device
regulatory systems for the purpose of enhancing patient safety and
increase access to safe, effective an clinically benefinial technologies
A partnership between regulators and te regulated for the purpose to
encourage convergence in regulatory practices related to ensuring the
safety, effectuveness/performance and quality of medical devives.
Promote technological innovation and facilating international trade.
This was primarily accomplished through publication and dissemination
of harmonized guidance documents on basic regulatory practices.
In February 2011, nternational Medical Device Regulators from around
the world conceived of a forum to discuss future directions in medicall
device regulatory harmonization
A voluntary group was came together to build on the strong
foundational work of the Global Harmonization Task Force on Medical
Device (GHTF), and to accelarate international medical device
regulatory harmonization and convergence
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Philippines
Composition of IMDRF
Members
Observer
•
•
•
•
•
•
•
• World Health Organization
(WHO)
© 2011 GS1
Australia
Brazil
Canada
European Union
Japan
United States
Pending Membership
• China
• Russia
• Affiliate Organization
• Asian Harmonization
Working Party (AHWP)
• APEC LSIF Regulatory
Harmonization Steering
Committee
Philippines
UDI: Scope
All products placed on
the market that fall
within the definition of a
medical device in both
the GHTF and IMDRF
documents
http://www.gs1.org/sites/default/files/do
cs/healthcare/ghtf-sg1-n071-2012definition-of-terms-120516.pdf
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Philippines
UDI: Purpose
A common, worldwide
system for product
identification to
eliminate differences
between jurisdictions
and offer significant
benefits to
manufacturers, users
and/or patients, and
Regulatory Authorities.
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Benefits for Patient Safety
Philippines
• Improved recall procedure and adverse event reporting
• Documentation of product/patient relationship – in electronic
health records (EHR) and registries
• Visibility of inventory – availability of devices
• Reduction of medical errors
• Supply chain security/anti-counterfeiting
© 2011 GS1
UDI system… overall System at a glance
UDI/UDID - System
UDID
UDI
(database)
Static Data
Elements
• DI
(static data)
• DI = primary access
key
• PI
(dynamic data)
•…
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
DI = Device Identifier
PI = Production Identifiers
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© 2011 GS1
Philippines
UDI number
• Develop UDI number based on ISO 15459 : US FDA will accredit
issuing agencies (e.g. GS1, HIBCC, ICCBBA)
• Created and maintained by the manufacturer
• Device Identifier (DI) Static : manufacturer, make, model,
catalogue number
• Production Identifier (PI) Dynamic : serial number, lot number,
expiration/manufacturing date
• Phase out national numbering system (NDC/NHRIC)
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UDI in the GS1 system of standards
…UDI
Philippines
© 2011 GS1
in GS1 terms…
Philippines
GUDID population using
GDSN
• GDSN is a single point of entry for publishing an item’s
master data
• Supply Chain and Market data to GPOs and Providers
• GUDID data to the FDA and other similar UDIDs globally
• Benefits to the approach
• Single entry platform
• Population of data one to many
• Providers and other customers receive public GUDID
data elements
GPO
HOSPITAL/PROVIDER
GDSN
MANUFACTURER
FDA UDID
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European Commission & UDI
Philippines
Sept. 2012
EC
proposals
on MD & on
IVD
Regulations
Sept. 2013
EP vote in
Committee
on draft MD
Regulation
Discussions in
EP and Council
© 2011 GS1
Oct. 2013
EP vote in
Plenary on
draft MD
Regulation
Q2 2014
Final MD
Regulation
adopted
EC, EP, Council
meetings to reach
political agreement
Q3-4
2014
EC
starts
drafting
DA on
UDI
…
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EC:European Commission; EP:European Parliament; DA:Delegated Acts: implementing measures of regulatory requirements
Philippines
Track and Trace Work Group
APEC Roadmap for Global Medical
Product
Integrity and Supply Chain
Security
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Global Medical Product Integrity and
Philippines
Supply Chain Security
A 5 year project is sponsored by the APEC
Committee on Trade and Investment (CTI). The
proponent economy is the US and the cosponsoring economies are Canada, Korea,
China, Taiwan, Singapore, Mexico, Thailand,
Japan, Peru, Russia and Malaysia. The targeted
audience is national regulatory authorities,
industries regulated by national regulatory
authorities, and other stakeholders concerned with
quality, safety and efficacy of medical products
moving in international commerce
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Did you know . . .
Philippines
• In 2012, there was a 13% increase in the number of
incidents of counterfeit drugs entering the Legitimate
Supply Chain
Pharmaceutical Security Institute (PSI)
• A fake cancer drug was purchased by 19 hospitals and
medical centers in the United States
• The number of counterfeit drugs uncovered at EU
borders in 2005 was 560,598 and that it increased to
4,081,056 in 2007
• 34,000,000 fake tablets sized on the continent borders
in just 2 months – Gunter Verheugen VP European
Commission (end 2009)
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Philippines
Track and Trace Work
Group (TTWG)
• Led by GS1
• GS1 is a neutral facilitator of the WG
• Scope: pharmaceuticals
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Philippines
Philippine Status
• Philippines has been listed under APEC economies that
decision making and/or not yet adopted requirements on
pharmaceuticals traceability
• The Philippines has endorsed and signified willingness
to participate in the pilot (e-mail June 1, 2014 – DirectorGeneral Kenneth Hartigan-Go)
© 2011 GS1
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Philippines
Requirements
• Identify: refers to the data attributes assigned to a
product
• Capture: refers to the type of data carrier (bar code or
RFID tag) that the identifier is held in
• Share: refers to data that is capture and can be shared
between parties within and outside of organisations
across the supply chain. There are three types:
• Master, Transactional and Event data
NOTE: The Philippines has satisfied the Identify requirement with FDA
Circular No. 2014-011. Besides the Product ID, lot/batch number is
required.
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Philippines
Methods Agreed
1. identify countries of relevance of the primary analysis
covering APEC economies and non-APEC economies
with singular local situations
2. carry out a primary analysis of the situation in those
countries covering regulatory requirements and industry
practices
3. identify best practices based on the primary analysis
4. weight those best practices
5. develop recommendations and training material
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Philippines
Purpose of Pilot
• International adoption of electronic standards for serializing
and tracking-and-tracing goods moving in international
commerce not only will mitigate compliance costs for
companies, but will also facilitate trade, efficiencies in the
movement of goods, and better communication between
responsible governmental authorities having jurisdiction over
a set of goods.
• In the case of the pharmaceutical sector, additional benefits
can be reaped in the area of national drug safety, health care
costs, and global public health. In this Proposal, the
pharmaceutical sector is ready to participate in demonstrating
the twin pillars of cost reduction and greater certainty of
acceptance of products offered for import due to the
enhanced security of the supply chain.
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Philippines
Anti-Counterfeit
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ISO 16678:2014 (1)
Philippines
SO 16678:2014 describes framework for identification and
authentication systems. It provides recommendations and best
practice guidance that include:
• consequences and guidance of
• management and verification of identifiers,
• physical expression of identifiers, and
• participants' due diligence;
• vetting of all participants within the system;
• relationship between the unique identifier and possible
authentication elements related to it;
• questions that deal with the identification of the inspector and
any authorized access to privileged information about the
object; and
• inspector access history (logs).
© 2011 GS1
ISO 16678:2014 (2)
Philippines
Accordingly, ISO 16678:2014 establishes a framework and
outlines functional units used to achieve trustworthiness
and interoperability of such systems.
It does not specify any specific technical solutions, but
instead describes processes, functions, and functional
units using a generic model to illustrate what solutions
have in common.
Object identification systems can incorporate other
functions and features such as supply chain traceability,
quality traceability, marketing activities, and others, but
these aspects are out of scope of ISO 16678:2014.
© 2011 GS1
Philippines
Solution to Counterfeit
Drugs
• Supply Chain Visibility
• Documenting each transaction of the
product
• Pedigree (Universal and Uniform or
Electronic) – Chain of Ownership
• Track and Trace
• Harmonized Coding and Identification
System for Drugs
© 2011 GS1
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Philippines
Authentication and
Pedigree
Safe & Secure Supply Chain
Is the object genuine?
Is the chain of ownership intact?
Pedigree
Authentication
Object Identity
Object Authentication
Is the object
identified valid?
Does the Object have the
expected covert and/or
overt security features?
© 2011 GS1
Track
Where is the
Object and
where is it
heading?
Trace
Where was
the Object?
(Location &
Owner or
Custodian)
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Philippines
Authentication
Object Identity
Object Authentication
• Physical and visual
inspection (e. g. specific
material, unique
construction features.
stitching)
• Integrity of the outer
packaging
• Presence of the brand
insignia, label including a
GS1 barcode
• Sensory Tools
© 2011 GS1
• Overt (open)
• Covert (hidden)
• Forensic (analytic)
• Digital Tools
• Object Serialization
• Object Identification
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Philippines
•
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© 2011 GS1
Chain of Ownership
e-Pedigree
A record, in electronic form, containing information regarding each
transaction resulting in a change of ownership of a given drug, from
sale by a manufacturer, through acquisition and sale by one or more
wholesalers, manufacturers, or pharmacies, until final sale to a
pharmacy or other person furnishing, administering
A single pedigree shall include every change of ownership of a given
drug from its initial manufacture through to its final transaction to a
pharmacy or other person for furnishing, administering, or dispensing
the drug
A pedigree shall track each drug at the smallest package or immediate
container distributed by the manufacturer, received and distributed by
the wholesaler, and received by the pharmacy or another person
furnishing, administering, or dispensing the drug
Any return of a drug to a wholesaler or manufacturer shall be
documented on the same pedigree as the transaction that resulted in
the receipt of the drug by the party returning it.
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Information in a Pedigree
Record
Philippines
• The source of the dangerous drug, including the name, the federal
manufacturer's registration number or a state license number as
determined by the board, and principal address of the source
• The trade or generic name of the drug, the quantity of the
dangerous drug, its dosage form and strength, the date of the
transaction, the sales invoice number, the container size, the
number of containers, the expiration dates, the lot numbers, and
serial number (if provided)
• The business name, address, and the federal manufacturer's
registration number of each owner of the drug, and the drug
shipping information, including the name and address of each
person certifying delivery or receipt of the dangerous drug
• A certification under penalty of perjury from a responsible party of
the source of the dangerous drug that the information contained in
the pedigree is true and accurate
© 2011 GS1
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© 2011 GS1
Anti-Counterfeit
Measures Adopted
Turkey
Argentina
Saudi
State of California (superceded by Federal Law – Drug
Supply Chain Security Act)
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Philippines
Laws/Projects to be
Implemented
•
•
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•
EU – eTACT Project
EU – Falsified Drug
USA – Drug Supply Chain Security Act
South Korea – Drug Distribution Management Policy
APEC – Global Medical Product Integrity and Supply
Chain Security
• ESM (A Medicine Verification for Europe)
© 2011 GS1
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© 2011 GS1
Common Features
Tamper-free Packaging
Track and Trace
Unique Medicine Identification
Verification Hub
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Philippines
Models of Verification Hubs
© 2011 GS1
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Philippines
Turkey: ITS Web
Services
1,520
Purchase Notice.
Return Notice
Sale Notice
Cancel Sale Not.
Deactivation Not.
Product Verification
642
Manufacture Not.
Sale Notice
Cancel Sale Not.
Deactivation Not.
Export Notice
Product Verification
Purchase Notice
Return Notice
Consume Notice
Deactivation Not.
Product Verification
Purchase Notice
Return Notice
Sale Notice
Cancel Sale Not.
Deactivation Not.
Product Verification
25,518
Query
254
© 2011 GS1
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Philippines
Argentinean Solution
CENTRAL
DATABASE
(ANMAT)
Lab
DB
Distrb
DB
Drug
St DB
Drug
St DB
Lab
Distri
Drug St
Drug St
© 2011 GS1
Pharm
DB
Pharm
Pat
Verification model EFPIA
supports
Philippines
Product- and Data-Flow End-to-End
Pharma
Manufacturer
Distributor
Wholesaler
Pharmacist/
Hospital
Patient
Product Flow
Unique
Serialisation
Verification
Dispensing
Verification
?
Data Transfer
Product
Serialisation
Database
European Federation of Pharmaceutical
Industries & Associations
© 2011 GS1
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Authentication Process for Viagra™
Philippines
EPC data in matrix barcode.
RFID Tags have been
introduced in the most
counterfeited product
at Pfizer: Viagra™.
© 2011 GS1
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Pedigree Process for Viagra™
Philippines
© 2011 GS1
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Philippines
U.S. Traceability: the
Drug Supply Chain Security Act
© 2011 GS1
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Philippines
The Drug Supply Chain
Security Act
• Outlines critical steps to build an electronic, interoperable system to
identify and trace certain prescription drugs as they are distributed
in the United States.
• Ten years after enactment, the system will facilitate the exchange of
information at the individual package level about where a drug has
been in the supply chain. The new system will:
• enable verification of the legitimacy of the drug product identifier
down to the package level;
• enhance detection and notification of illegitimate products in the
drug supply chain; and
• facilitate more efficient recalls of drug products.
© 2011 GS1
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© 2011 GS1
Key Provisions
Product identification: Manufacturers and repackagers to put a unique
product identifier on certain prescription drug packages, for example, using
a bar code that can be easily read electronically.
Product tracing: Manufacturers, wholesaler drug distributors, repackagers,
and many dispensers (primarily pharmacies) in the drug supply chain to
provide information about a drug and who handled it each time it is sold in
the U.S. market.
Product verification: Manufacturers, wholesaler drug distributors,
repackagers, and many dispensers (primarily pharmacies) to establish
systems and processes to be able to verify the product identifier on certain
prescription drug packages.
Detection and response: Manufacturers, wholesaler drug distributors,
repackagers, and many dispensers (primarily pharmacies) to quarantine
and promptly investigate a drug that has been identified as suspect,
meaning that it may be counterfeit, unapproved, or potentially dangerous.
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Philippines
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© 2011 GS1
Key Provisions (2)
Notification: Manufacturers, wholesaler drug distributors, repackagers,
and many dispensers (primarily pharmacies) to establish systems and
processes to notify FDA and other stakeholders if an illegitimate drug is
found.
Wholesaler licensing: Wholesale drug distributors to report their licensing
status and contact information to FDA. This information will then be made
available in a public database.
Third-party logistics provider licensing: Third-party logistic providers,
those who provide storage and logistical operations related to drug
distribution, to obtain a state or federal license.
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Contact Details
Philippines
GS1 Philippines, Inc.
#20 San Rafael St.,
Bo. Kapitolyo, Pasig City
PHILIPPINES
T +63 2 637 08 97 to 98
W www.gs1ph.org