traceability in the global supply chain masterclass gdp séverine dewerpe, healthcare manager, gs1...

Traceability in the global supply chain

Masterclass GDP

Séverine Dewerpe, Healthcare Manager, GS1 Belgilux

March 5th, 2015

© GS1 Belgium & Luxembourg 2015

Agenda

• Why global standards?

• Developments on traceability across the world

• Global regulatory developments

• Benefits of traceability in the vaccines supply chain

• Q&A


Why global standards?

3



Lack of standards in daily life is inefficient and annoying …

4



5

… in healthcare it is dangerous and inefficient !

• Multiple bar codes on one package – which one to scan?

• Different types of bar codes – inconsistency; incompatibility

• No bar code – need to bar code; re-package; re-label

Photo Here


Re-bar coding by the hospital (or 3rd party provider)

The need for global standards in healthcare

6

© 2013 GS1

Re-bar coding by the hospital (or a 3rd party provider)

The Need for Global standards in Healthcare

© 2013 GS1



© 2013 GS1



© 2013 GS1




Speak one language

Reduce complexity

7


An international standard organisation

GS1

8

Not-for-profit111 Member Organisations

Over one million user companies(from SME to global companies)

Member driven150 countries served; 20 different domains

2,500 people helping usOver 6 billion transactions a day


A voluntary, global Healthcare User Group

GS1 Healthcare

To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies.

9


GS1 Healthcare Global User Group


GS1 Healthcare around the World

Manufacturers• 3M• Abbott Laboratories/Abbvie• Actavis Pharma, Inc• Actelion Pharmaceuticals Ltd• Alcon Labs• AMAG Pharmaceuticals, Inc• Amgen• Astra Zeneca• B. Braun• Baxter• Bayer• Becton Dickenson• Cook Medical• Covidien• Edwards Lifescience• Eli Lilly and Company• F. Hoffmann-La Roche Ltd• Fresenius• GE Healthcare• Genzyme• Gilead• GlaxoSmithKline• Johnson & Johnson• Medtronic• Merck & Co.• Novartis• Pall Medical• Pfizer• Purdue Pharma• Smiths Medical• Takeda• Teleflex• TEVA• ZimmerSolution provider• 1WorldSync, Inc.• Advanco• Axway• Blue Sphere Health Ltd.• Dirk Rodgers Consulting, LLC• Excellis Health• GHX

• Marsh Consulting Ltd. • OCS Checkweighers GmbH• Oracle• Seidenader• TracelinkDistributors/Healthcare providers/GPOs/T&L• AmerisourceBergen (US)• Cardinal Health (US)• CH Aulnay sous Bois (France)• Comparatio Health (Germany)• DHL Exel Supply Chain (UK)• Erasmus MC Rotterdam (NL)• Filip Vtori (Macedonia)• Hong Kong Hospital Authority• HUG Geneva (Switzerland)• King FAISAL Specialist Hospital & Research

Center (Saudi Arabia)• McKesson • Novation (US)• Premier (US)• St. James Hospital (Ireland)• UMC Groningen (NL)• UNI.H.A (representing 17 French university

hospitals)• UPS • Wiener Krankenanstaltenverbund (Austria)Non-voting members• AHRMM• Cladimed• EDQM – Council of Europe• FDA USA• Instituto Brasileiro de Ética Concorrencial –

ETCO• Public Health Agency of Canada• US DoD

Manufacturers• 3M• Bayer• Becton Dickinson• Boehringer Ingelheim• Coloplast• Draeger Medical• Genzyme• Hospira• Kimberly-Clark• Novo Nordisk• Pierre Fabre• Purdue Pharma• Sanofi Aventis• Smith and Nephew • St. Jude Medical• Stryker • Terumo• Teva Pharmaceuticals• UCB• Upsher-SmithDistributors/Wholesalers• Aexxdis• Alliance Unichem (Netherlands)• Amerinet• AmerisourceBergen• Brocacef (Netherlands)• CH2• Depolabo• Galexis• GAMMA Wholesale• Geodis• McMahon• Mediq (Netherlands)• Owens & MinorHealthcare providers/Retailers• AMC Amsterdam (Netherlands)• Antonius Ziekenhuis Nieuwegein

(Netherlands)• Ascension Health (US)• Bernhoven Ziekenhuis Uden

(Netherlands)• Capital District Health (Canada)• CH René Dubos Pontoise (France)

• CHI Robert Ballanger (France)• CHRU Strasbourg (France)• CHU de Québec (Canada)• CHU DIJON (France)• Deventer Ziekenhuis (Netherlands)• Erasmus Medical Center (Netherlands)• HealthShare NSW Health• HUG Geneva (Switzerland)• London Drugs (UK)• Maxima Medisch Centrum (Netherlands)• Mayo Clinic (US)• Sisters of Mercy (US)• Sobeys Pharmacy (UK)• UHBS (Switzerland)• UHCS Augusta VA (US)• UMC Nijmegen (Netherlands)• UMC Utrecht (Netherlands)• VU medical center (Netherlands)• Walgreens (US)• Walmart (US)Associations• AHA (US)• CHeS (US)• CNOP (France)• EFPIA (Europe)• Eucomed (Europe)• FENIN (Spain)• GIRP (Europe)• HDMA (US)• International Hospital Federation• JFMDA (Japan)• LEEM (France)• NACDS (US)• Patient Safety Foundation (US)• SNITEM (France)Others• GCS UNI H A (France)• NEHTA (Australia)• RESA IDF (France)

Members global user group Local participation

… And many more …

© GS1 Belgium & Luxembourg 2015 12

GS1 in Healthcare: global system of standards to ensure visibility


GS1 Identification Keys

• Unique

• Non-significant

• International

• Secure

• Foundational

13

Item identifier =

Logistics unit identifier =

Location identifier =

And more …

GTIN

SSCC

GLN

Global Trade Item Number

Serial Shipping Container Code

Global Location Number


Some data carriers can carry more detailed information about that specific unit

14

Capturing the identification key … and beyond

Item identifier Expiry date

Batch number

Serial number(21)123


0901234567001

ER

P E

ntr

ies

GTIN: 0901234567001EXPIRATION: 21.Mai 201

BATCH/LOT: 123456

SERIAL: 12345

NHRN:

Scanning & AIs in action...

01108576740020171714112010NYFUL0121192837713A1B2C3D4E5F6G ?21192837

NYFUL01 192837

713A1B2C3D4E5F6A1B2C3D4E5F6

01108576740020171714112010NYFUL01

20 Nov 201410857674002017


DataMatrix on pharmaceuticals

country requires DataMatrixcountry 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)

South Korea: Pharma regulatory requirement (2012)

Spain: Pilot

Serbia: Pilot

Switzerland: SmartLog Pilot

Turkey: Regulatory requirement (2010)

Canada: Vaccines

Austria: Cytostatics

India: Regulatory requirement for drug exports 2013

Argentina: Traceability regulation

US:Traceability Regulation (2017)

Colombia: Pilot of INVIMA on traceability

Jordan: Pharma regulatory requirement (2015)

Algeria: Pharma regulatory requirement (2014)

Saudi Arabia: Pharma regulatory requirement (2015)

Ukraine: Pharma regulatory requirement (2013)

© Copyright GS1 AISBL, 2012. All Rights Reserved.


Traceability

Building blocks for traceability

Unique Identification- Products- Logistics units- Location & Legal entities

Data Capture- Barcodes- EPC/RFID

Data Communication- Share data- Retrieve data

Links Management- Physical flow- Information flow

Traceability


Regulations emerge worldwide Supply Chain costs increase

Electronic Health RecordsMedication errors

CounterfeitingBrand

Protection

BUT•Traceability is complex, multi-sectorial and cross border, but it is not always recognized as such

•Traceability is becoming a necessity, but one that is addressed by an endless number of isolated solutions

•GS1 Standards can help…

Key Drivers for traceability


Physical Event Data - Recall

• What

what physical objects were involved (e.g. sGTIN in a GS1 Carrier)

e.g. (01)10222222333334(21)12344(10)A1345B

• When

when the event took place (timestamp)

e.g. 110922 (22nd September 2011)

• Where

where the event took place (e.g. GLN)

e.g. 1234567890128 (Goods In, General Hospital)

• Why

what business process step was being carried out

(e.g. receiving, shipping…)

The 4 W’s


Global standards enable …

Compliance with regulations,effective and efficient implementation of traceability systems in

Healthcare

Such as:

Track & Trace, Authentication, UDI

= Visibility

*Visibility = What, When, Where & Why

20


EU Commission proposal

• The composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date.

• Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level.

• The repository containing the unique identifiers will be set up and managed by stakeholders. National competent authorities will be able to access and supervise the database.

21


The move towards harmonisation and GS1 standards in Europe

© Copyright GS1 AISBL, 2012. All Rights Reserved.


• A pan-European end-to-end system enabling medicines to be verified at point of dispensing

• Developed by the stakeholders who will use it on a day-to-day basis• Run on a non-profit basis; costs to be borne by Manufacturing Authorisation

Holders• Pilot in Germany - SecurPharm

Pharma – Different emerging models…

23

Driver:To address counterfeiting (falsified medicines), prevent them reaching the patient

EFPIA /GIRP/PGEU/ EAEPC European Stakeholder Model (ESM)

Source ESM presentations


Pharma – Different emerging models…

24

Driver:To address counterfeiting (falsified medicines), prevent them reaching the patient

European Directorate for the Quality of Medicines & HealthCare (EDQM) eTACT

Part of the Council of Europe; EDQM members 37 European countries, bigger than EU

Traceability from manufacture to the patient, ultimately give also patients access to authenticate product MoU with Ukraine


US Federal Drug Quality and Security Act (DQSA)

25

…as part of U.S> Drug Quality and Security Act H.R. 3204

• Preempts all state laws – including California

• New programme on securing the identity of parties in the supply chain, specially new license program for wholesalers

• Migration path: First phase lot bases, serialisation (SNI) after four years (2017), full track & trace after 10 years (2023)

• Instead of “pedigree” now “transaction” – until 2017 either paper or electronic:

1. Transaction Information (TI)2. Transaction History (TH)3. Transaction Statement (TS)


Major deadlines/requirements

26

2015• For each change of ownership all three transaction information (TI, TH and TS) need

to be provided

• Request for info by FDA needs to be fulfilled in 48 hours

• Authorized trading partners

• Lot-based information flow

2017• Serialisation added on package and case

• 2D DataMatrix on package, linear or 2D on case

• Transaction information in electronic format

• Information on product ID plus serial number in 24 hours

2023• Interoperable electronic tracing and exchange of transactions

• Traceability on item level (secondary package level)

Still a lot of open questions – recent request for comments by FDA until 21st April


WHO VPPAG recommendations for vaccines

27

• VPPAG* Recommendations on use of bar codes on vaccine packaging to be included in the next WHO Generic Preferred Product Profile (gPPP)

• Project in Tanzania proving the benefits of bar coding for vaccines will be launched this year

*Vaccine Presentation and Packaging Advisory Group http://www.who.int/immunization/policy/committees/vppag/en/index2.html

http://www.who.int/immunization/policy/committees/vppag/en/index2.html


Proof of principle in Tanzania

28

• Tracking vaccines from manufacturer to recipient

• Reduce wastage and spoilage by improved inventory management and logistics information

• Tracking down to the district level

• Final objective – link the vaccine to the child


Pilot in the US

29

National Childhood Vaccine Injury Act (NCVIA) requires documentation of manufacturer and lot number of vaccines

• Project from Sept 2011 to Aug 2013

• Participants:• 2 Vaccine Manufacturers• 8 vaccines• 217 Immunizers• 10 Immunization Information

Systems• Products with GTIN, Lot and

expiration date


Results

30

• Preliminary results confirm a positive effect on vaccine data accuracy and completeness

• Providers have positive perceptions regarding impact of 2D barcoding on efficiency and accuracy

• Providers are willing to adopt practices to incorporate 2D barcode vaccine use but not until the majority of vaccines are 2D barcoded

• Detailed information at http://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/

http://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/




Report quantifies supply chain issues in Healthcare

New McKinsey & Company

31

New McKinsey report “Strength in unity: The promise of 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 or

http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf

Source: http://www.mckinsey.com

http://www.gs1.org/healthcare/mckinsey



http://www.mckinsey.com/


•“Implementing global standards across the entire healthcare supply chain could save 22,000-43,000 lives and avert 0.7 million to 1.4 million patient disabilities”

•“Rolling out such standards-based systems globally could prevent tens of millions of dollars’ worth of counterfeit drugs from entering the legitimate supply chain”

•[We] “estimate that healthcare cost could be reduced by $40 billion-$100 billion globally” from the implementation of global standards

•“Adopting a single set of global standards will cost significantly less than two” (between 10-25% less cost to stakeholders)

Huge cost savings and patient safety benefits when adopting a single global standard in healthcare

32

New McKinsey & Company

SOURCE: McKinsey report, “Strength in unity: The promise of global standards in healthcare”, October 2012


Country-by-country solutions are not sufficient nor effective

Global standards

33

The need for global standards

• Healthcare is local Healthcare providers are

local Regulations are local

• Healthcare is global- Healthcare supply chains

often cross borders


Save the date: 9 March, Brussels, Tour & Taxis

Please join us! You will learn…

• How GS1 global standards get implemented worldwide and help to improve patient safety and supply chain efficiency

• About new regulations on traceability and UDI (Unique Device Identification) across the world

• Use cases and implementation at manufacturers, wholesalers and hospitals

GS1 Belgilux Healthcare Day


Imagine a world …


GS1, One language, one voice

Global GS1 standards will make this a reality –

get engaged and support the ongoing efforts!

36

IMPROVE PATIENT SAFETY


Contact

37

Séverine DewerpeHealthcare & Barcodes ManagerGS1 Belgium & Luxembourg

E [email protected] +32 2 290 57 73W www.gs1belu.org

mailto:[email protected]

http://www.gs1belu.org/


Questions?

38

traceability in the global supply chain masterclass gdp séverine dewerpe, healthcare manager, gs1...

Documents