best practices in the field of serialization and safe supply chain
TRANSCRIPT
Best Practices in the Field of
Serialization and Safe Supply Chain
Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office
26 November 2015
© GS1 2015
Agenda
• GS1 – and global standards
• ABC – Argentina, Brasil, China and other
countries – what is the world doing beyond
Europe?
• Serialisation – how and when?
• Visibility in the supply chain – reality or myth
• Patient Safety and the “Level below the Each”
© GS1 2015
What is GS1?
GS1 is a neutral, not-for-profit standards
organisation that helps companies do business
across the world
112 Member Organisations around the world
Developing standards for over 1 million companies
worldwide
25 industries served across 150 countries
Barcodes scanned more than 5 billion times a day
globally
© GS1 2015
GS1: global system of standards to ensure visibility
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© GS1 2015
GS1 Healthcare - voluntary, global User Group
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.
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GS1 Healthcare: an expanding, committed community of globally engaged stakeholders…
…and there are many more companies working with GS1 at a local level
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…as well as with leading healthcare providers to implement…
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Developments across the world
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Regulatory bodies need to address Public Health
Hospitals look for improvement in patient care and cost reduction
Deviations from a global harmonised approach
make implementation costly and complex
© GS1 2015
GS1 Healthcare - Public Policy Database
• 40 countries • 64 dossiers • 233 documents
GS1 Healthcare
Public Policy database
Welcome! This database provides the latest relevant regulatory requirements, stakeholder agreements and user requests related to
Healthcare product identification, product catalogues and traceability at national, regional and local levels.
community, and governmental bodies and regulators involved in the Healthcare sector.
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This information is only accessible for global GS1 Healthcare members and GS1 Member Organisations. Each registration application will require approval by GS1. • Register here to access the GS1 Healthcare
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© GS1 2015
GS1 Healthcare - Public Policy Database
It provides information's on: • the latest relevant regulatory requirements, • stakeholder requirements related to Healthcare product identification, product catalogues and traceability at national, regional and local levels.
Only accessible for global GS1 Healthcare members – For a list of members and information on membership please see at http://www.gs1.org/healthcare/membership
© GS1 2015
European Federation of Pharmaceutical Industries and Associations (EFPIA): Recommendation for Coding of
Pharmaceutical Products in Europe
Data Matrix – Coding proposal derived from GS1 standards (EAN 128 syntax with Application Identifiers; DataMatrix ECC200)
Manufacturer Product Code (GTIN or NTIN): 14 digits
Unique Serial Number (randomized): up to 20 alpha-numeric characters
Expiry Date: 6 digits (YYMMDD)
Batch Number: up to 20 alpha-numeric characters
+ minimum requirements on quality of randomisation
Specifications provided in EFPIA’s: “European Pack Coding Guidelines”
Example:
GTIN: (01) 07046261398572
Batch: (10) TEST5632
Expiry: (17) 130331
S/N: (21) 19067811811
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© GS1 2015 13
Identification and barcoding: The desired future direction globally
Product Identifier (GTIN)
Serial Number
Expiry date
Batch/Lot number
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APEC Roadmap for Global Medical Product Integrity and Supply Chain Security
• 5-year project sponsored by the APEC LSIF (Life Science and Innovation Forum) and the APEC RHSC (Regulatory Harmonization Steering Committee) launched in 2013
• 10 work groups covering the scope – e.g. Single Point of Contact, Distribution and Manufacturing practices, Importing and Exporting practices, Detection technologies, Internet sales, Product Identification, Track and trace systems – Conduct of a gap assessment between APEC member economies – Development of guidelines covering best practices – Development and initiation of a training program
• Track and Trace Work Group – facilitated by GS1 –
has been provided a 2 days training during the APEC SOM 3 in Cebu on 27-28 August 2015
• ABAC pilot will use GS1 standards incl EPCIS
Three Recommendations
• Define clear objectives
• Collaborate with all stakeholders
• Use Global Data Standards
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X
“Unique” product ID for Traceability
• Even though the word “unique” generally means “being
the only one of its kind; unlike anything else”… with
practical traceability operations various levels of
“uniqueness” may exist or be defined.
• A global standardized system is needed for “unique”
identification numbers to ensure world-wide supply
chain compatibility.
• The result: gain efficiency, have the right product in the
right place at the right time, more effective recalls,
improve patient safety, prevent counterfeit drugs entering
the market, and so on…
• BUT – everybody in the Supply Chain needs to implement
to achieve…
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© 2014 GS1 US ALL RIGHTS RESERVED
Visibility
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© GS1 2015
GS1 Standards help save €5 million worth of stock at St. James’s Hospital, Ireland (2010)
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Issue(s)
• Infected medication remained in the supply chain after recall in 2001- leading to subsequent infection and over 80 deaths
• Lack of standardised bar codes on haemophilia medication and ineffecitve traceability
Solution
• Deployment of multi-location Electronic Patient Record system • Deployment of medication delivery traceability system • Implementation of GS1 Standards, including GTIN, GLN, GS1
DataMatrix
Results
Over € 5 million worth of medication stock has been removed from the supply chain • Product wastage reduced from €90,216 to zero in the year post
service implementation • Documentation errors reduced from 12 to zero in the year post service
implementation Mock recall identified location of all (100%) medication within 10 minutes
St James’s Hospital, Dublin (Ireland) – manages the National Centre for Hereditary Coagulation Disorders (NCHCD)
© GS1 2015
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NOTE: Data carriers shown are for illustration purposes only!
Note: Images shown are for illustration example only, refer to local regulations and/or the latest version of the GS1 General Specification for more detail.
All packaging levels
© GS1 2015
Some new 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.
• 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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Thanks to EAHP and other global experts
© GS1 2015
Standard = Agreement
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• Single unit – allocation is responsibility of brand owner, not
expected to be marked in AIDC format
• Single unit package = primary package = GTIN, other data
attribute like lot/batch number, expiry date, serial number are
voluntary
• Secondary package = GTIN and attribute data (expiry date and/or
lot/batch number and/or serial number)
© GS1 2015
To improve patient safety
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For the primary purpose of reducing medication errors and protecting patient safety, EAHP’s statement calls for each single
dose of medicine used within hospitals and supplied to the hospital by manufacturers or wholesalers to include an individual barcode in
GS1 DataMatrix format.
http://www.eahp.eu/practice-and-policy/bar-coding-medicines-to-the-single-unit#
© GS1 2015
Huge cost savings and patient safety benefits when adopting a single global standard in healthcare
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“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 billions 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)
SOURCE: McKinsey report, “Strength in unity: The promise of global standards in healthcare”, October 2012
© GS1 2015
29th Global GS1 Healthcare Conference 18 to 20 April 2016, Dubai, UAE
• Traceability, Unique Device Identification (UDI) and global
regulatory developments
• Use cases and implementations from hospitals, wholesalers
and hospitals – what are the experiences, the benefits
• Patient safety and quality of care – how to improve those
• Global standards for the supply chain in developing countries
© GS1 2015
THANK YOU
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© GS1 2015
Contact Details
Ulrike Kreysa
Vice President Healthcare
GS1 Global Office
W www.gs1.org/healthcare
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