Serialization and Traceability GS1 Standards: A Manufacturer’s Perspective

Mike Rose

Johnson & Johnson Health Care Systems Inc.

Vice President, Supply Chain Visibility

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 2

Topics

• Protecting patients and consumers

• What is serialization and track & trace?

• Importance of GS1 standards

• Public-Private Partnerships

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 3

Helping Patients and Consumers Receive Genuine Products

People

Policy

Process

Information

Technology

Enforcement

Requires a

multi-layered approach

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 4

Detecting Counterfeit Products The Role of Serialization and Bar Codes

Provides an additional identification

feature to more accurately identify a

package

Must use the GS1® Standards

Enables authentication of the package

However, does not ensure the contents

are genuine

Must use with additional processes,

security features and measures

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 5

Serialization and Track & Trace Manufacturer Implications

• Developing public-private partnerships, e.g.,

APEC, ESM, PDSA

• Responding to different regulatory

requirements

• Building new, agile, cost effective capabilities

for serialization and traceability

• Standardizing identifiers for all products (i.e.,

GS1 standards)

• Modifying existing processes, procedures and

IT systems while conforming to GMPs and

GDPs

• Maintaining operational efficiency in

manufacturing as well as distribution

• Integrating with external manufacturers,

customers and regulatory systems

© 2014 GS1

Pharma – World (including Europe) coding & serialisation requirements

2010 2011 2012 2013 2014 2015 2016 2017

Regulated requirement

Tender requirement

Important development

Emerging Regulatory req.

… 2018

Libya: serialisation – timeline to be defined

South Africa: traceability – timeline to be defined

Turkey 2010

Track & Trace

Serbia 2010

Traceability regulation

Cyprus 2010

Product Code

USA 2010

FDA SNI guidance

Denmark 2011

Product Code

France 2011

Batch Variable

Europe 2011

European Legislation

India 2011

Serialisation

for export – 3rd level

Argentina 2011

1st product group

Canada 2012

Vx Batch Variable

India 2012

Identification for

tender

requirements

Korea 2012

Batch Variable

Specified drugs

Argentina 2012

Serialisation 2nd

product group

Japan 2012

Revised MHLW

Barcode Guidelines

Korea 2013

Batch Variable

Ethical drugs

India Jan. 2013

Serialisation for

export - 2nd level

Nigeria 2013

MAS all

anti-malarial /

MAS all

antibiotics

Chile 2013

Identification

& traceability

Argentina 2013

Serialisation 3rd

product group

Europe Q4 2014

Delegated acts

finalised

Denmark 2014

AMGROS: DataMatrix

or bar code

England/NHS

2014

GTIN, GLN

and product

data

Mexico 2014

Draft Regulation

on traceability

Singapore 2014

Barcoding on

injectable

Korea

2015

Serialisation

Phase 1

China 2015

Serialisation

Phase III (all

products)

Taiwan

2015/2016

Draft Regulation

Barcode req. -

Saudi Arabia 2015

DataMatrix

Japan 2015

Barcoding

primary level

USA 2015

DSCSA -

Product Tracing

Requirements

(lot/batch/exp)

Brazil 2016

ANVISA Track &

Trace regulation

(all pharmaceuticals)

Saudi Arabia 2017

Serialisation

Ukraine 2016

Serialisation

(manf. & wholesal.)

Jordan 2017

Serialisation

USA 2017

DSCSA - Serialised

product identifiers

Europe 2017

Compliance to FMD

USA 2023

DSCSA - Pkg (item-level)

traceability

Brazil 2015

ANVISA Track & Trace

regulation (3 batches of

product) China 2013

Serialisation

Phase II

China 2012

Serialisation

Phase I

Algeria: serialisation – timeline to be defined

Philippines

30 June

2015 - GTIN

© Copyright GS1 AISBL, 2012-2014. All Rights Reserved.

Kenya 2014

KEMSA

Barcoding

Ukraine 2017

Serialisation

(retailers)

India 2015

Serialisation for export

Mono-carton

Korea Oct,2014

Serialisation plan

Korea

2015

Serialisation

Phase 2 (end)

Korea 2016

Aggregation

(optional)

Slovenia 2017

DataMatrix

Cannot be distributed without consent from GS1 AISBL

GS1® STANDARDS IN HEALTHCARE

7

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 8

Pharmaceutical Item Level Product Serialization

Changes the way we handle our products

A unique serial identification number is assigned to each item identifying it with a product number and associated serial number.

It’s applied at every package level (bottle, case, and pallet).

These unique numbers are uploaded into a database and can provide timely product intelligence

from manufacturing to the patient.

PREZISTA® 600mg serialized label with 2D data matrix

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 9

12 serialized & aggregated

Prezista bottles in a case

261 cases to a pallet. Each case

has the parent serial number

Pallet is shipped

(truck, boat, or

airplane) to DC

DC where

individual cases

get pulled from

the pallet ,

scanned and

shipped to

Customer

Wholesaler

Customer

receive products,

scans every case

and ships to

pharmacies,

hospitals, etc.

Wholesaler

ships product

to pharmacies,

hospitals, etc.

They scan bar code

with serial number

Rx

Pharmaceutical Supply Chain Future with Serialization and Traceability

Regulatory mandates are

demanding visibility of products

from point of packaging to

point of dispense.

• These mandates demand improved

supply chain visibility

• Products are identified, serialized,

authenticated, tracked & traced

• What product? Where has it been?

Where is it going? How long has it

been there?

• Using data captured as product

moves through the supply chain,

answers questions as to the

disposition of inventory

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 10

Using GS1 compliant barcodes (UCC-EAN13)

Each product SKU has one relative barcode (UCC-EAN13)

Download E-code from website client.

Every E-code is unique

However, every carton has their different, unique E-code though they have the same UCC- EAN13

China Electronic Tracking Code (E-Code) • E-code code (serial number) according to code 128C standard

• The electronic tracking code doesn’t follow the GS1 standard – that is, E-code is not

GTIN, SSCC, GLN etc.

• The E-code is given by E-code website client managed by 21th century, Acquired by Alibaba which was on IPO in US

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 11

Public-Private Partnerships Needed for Success

APEC Business Advisory Council – Regulations,

Standards and Track & Trace

European Stakeholder Model (ESM) – European

Medicine Verification System for EU Falsified Medicines

Directive

Pharmaceutical Distribution Security Alliance (PDSA) –

US Drug Supply Chain Security Act Consortium

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 12

Industry

Consumer

Government

Public-Private-Consumer Partnerships

Enabling Environment

Enforcement & Prosecution

Zero Tolerance

Awareness Campaigns

International Cooperation

Global Standards

Awareness

Verification

Reporting

Monitoring & Reporting

Awareness Programs for

Consumers & Professionals

Implementation

Global Standards

21 countries

APEC Business Advisory Council Global Data Standards: Supply Chain Integrity for Pharmaceutical Products

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 14

APEC Business Advisory Council (ABAC) Global Standards: Serialization and Track & Trace Pilot

Several pharmaceutical manufacturer participants

Facilitated by University of Tennessee Health Science

Center and Memphis University with involvement from

GS1 Global

Phase I - Assessed status of need for global healthcare

standards (report drafted…finalize in next 1-2 months)

Phase II – Developing serialization and track & trace

pilot

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 15

ABAC – Phase II Project Planning

The goal of Phase II is to develop a pilot for the

utilization of an appropriate standard

o GS1 Healthcare Standards

The project objective is to demonstrate visibility across

the pharmaceutical supply chain from manufacturer to

patient

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 16

ABAC – Phase II Project Planning

Phase II Project Roadmap

o Identification of products with GS1 Standards

o Include automatic identification and data capture (AIDC)

technologies and business-to-business electronic messaging

(eCom)

o Identification of pharmaceutical companies (multinational/local) as

voluntary participants in the large-scale pilot project

o Identification of specific products

o Identification of at least two APEC countries and destination cities

within those countries for participation in the project

o Identification of wholesalers/distributors and their respective

drugstores and/or healthcare provider institutions for participation

o Determination of period of execution of the project

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 17

ABAC – Phase II Project Planning

Identification of success indicators including:

o Effectiveness of receipt process and forwarding of information to a

traceability web platform for

– Manufacturers

– Wholesalers/Distributors

– Pharmacies

– Healthcare providers

o Capabilities to trace medications by supply channel, commercial

and institutional

o Query capabilities for inspection, oversight, and Control process

o Product recall simulation results

European Stakeholder Model European Medicines Verification System

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 19

EU Falsified Medicines Directive

Requires serialization by manufacturers, and verification

at the point of dispense by pharmacists

Tamper evident features must be applied by

manufacturers

Mandates manufacturers to fund the medicines

verification system

Information can be used by competent authorities for

other purposes – e.g., reimbursement,

pharmacoepidemiology studies

In response, EFPIA formed the European Stakeholder Model (ESM)

bringing together all the relevant stakeholders to be proactive in securing the legal

supply chain and to protect patients

ESM STAKEHOLDERS HAVE A COMMON VISION OF MEDICINES VERIFICATION

Protect patients

Secure the legal supply chain

Be proactive as market partners

Set up a stakeholder-governed model that is

Functioning

Harmonised

Cost-effective

Inter-operable

20

FUNDAMENTAL PRINCIPLES FOR MEDICINES VERIFICATION IN THE EU

•Unique identifier with randomised serial number + tamper evident packaging

•Check of pack’s authenticity at point of dispense

SAFETY FEATURES

•Transactional data belongs to stakeholder that generated it, e.g. pharmacists for dispensing data

•No access to data of other stakeholders except for verification purposes DATA

•Systems governed by independent non-profit organisations, established and managed by relevant stakeholders

•Systems supervised by EU and/or national authorities

•Data accessible for competent authorities for reimbursement, pharmacovigilance & pharmaco-epidemiology purposes

GOVERNANCE

•Coding system harmonised across Europe based on ISO-standards allowing integration of existing national codes

•Flexible to implement national solutions within an EU technical framework

•Interoperable between different national systems through European Hub

SYSTEM DESIGN

21

COMMON BASIC CONCEPT: UNIQUE IDENTIFIER

Data-Matrix code, developed to ISO-standards

Supports GS1 standards

Key data elements:

Product code (GTIN/NTIN)

Randomised unique serial number

Expiry date

Batch number

National health number (where necessary)

Product #: 09876543210982

Batch: A1C2E3G4I5

Expiry: 140531

S/N: 12345AZRQF1234567890 Expected to be required by Delegated Act

22

COMMON BASIC CONCEPT: “POINT OF DISPENSE VERIFICATION”

Expected to be required by

Delegated Act

23

European Medicines Verification System Design for Interoperability and Efficiency

Germany

National

System

Pharmacy Wholesaler

Pharmaceutical

Manufacturer

Parallel

Distributor

National

System

European

Hub

24

National Blueprint

System

National Blueprint

System

National Blueprint

System

National Blueprint

System

Blueprint template to reduce cost of national

systems and to ensure interoperability

GOVERNANCE STRUCTURE ALLOWS FOR EFFECTIVE MANAGEMENT OF VERIFICATION

SYSTEM

GENERAL PRINCIPLE System management and governance by not-for-profit organisation under supervision of relevant competent authority

EU level and national level organisations cooperate on the basis of service level agreements

NATIONAL LEVEL National Medicines Verification Organisations (NMVO), e.g. in Germany: securPharm e.V.

EU LEVEL European Medicines Verification Organisation (EMVO, to be founded)

25

EMVO-MEMBERS ARE ALLOCATED TO A CONSTITUENCY

Membership open to other stakeholder

associations

26

Summary

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 28

Summary • Growing awareness and

support from regulators for

GS1 standards

• Benefits include: • Improves patient safety

• Helps fight against counterfeit

products

• Improves supply chain integrity

• Accurately identifies product for

evidence-based medicine,

adverse event reporting

• Helps ensure the 5 R’s, e.g.,

right product, right dosage,

right patient, right route, right

time

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

Confidential | 29

7 Billion Reasons to Care

Serialization and Traceability Will Benefit

Patients and Consumers Around the Globe

29