Meeting Ministry of Health Turkey GS1 Healthcare

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Meeting Ministry of Health Turkey GS1
Healthcare
Ankara, 22 January 2008
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What is GS1?

• GS1 is a not-for-profit organisation dedicated to
  the design and implementation of global standards
  to improve the efficiency and visibility of
  supply chains globally and across sectors

• 30 years of experience
• 108 member organisations
• Neutral platform for all supply chain
  stakeholders
• Over a million companies doing business across
  145 countries
• Over 5 billion transactions a day

GS1 is the most widely used supply chain
standards system in the world
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GS1 System of Standards
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Global Healthcare User Group

• GS1 Healthcare is a voluntary, global user
  community bringing together all Healthcare
  stakeholders

Manufacturers ? Wholesalers ? Distributors
Hospitals ? Pharmacies ? Regulatory Bodies ?
Trade Associations ? GS1 Member Organisations
2007 Extended Leadership Team
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Mission Vision
Our Mission
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.
Our Vision
To become the recognised, open and neutral source
for regulatory agencies, trade organisations and
other similar stakeholders seeking input and
direction for global standards in Healthcare for
patient safety, supply chain security
efficiency, traceability and accurate data
synchronisation.
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How GS1 works
GS1 Standards in Healthcare are based
on justified business requirements
Work Teams formed of representatives from
companies across the Healthcare sector meet
regularly to discuss the industrys needs, and
determine how global standards could solve global
problems.
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Progress in standards development

• AIDC Application Standards
• GTIN Allocation Rules for Healthcare ratified
• Business requirements for Auto-ID data content
  and carriers defined
• Serialisation schema defined
• Work team currently finalising first AIDC
  Application Standards
• Traceability in Healthcare
• Develop the Traceability in Healthcare Standard
  by the end of June 2008
• Any resulting change requests will then be
  submitted to GS1 Global Standard Management
  Process (GSMP) for ratification
• To develop a Traceability in Healthcare
  Implementation Guideline and to document Case
  Studies and Best Practices by the end of December
  2008
• Data Synchronisation Product Classification
• GDSN standards gap analysis demonstrates the
  majority of Healthcare needs are supported by the
  current standard
• Global GDSN Proof-of-Concept pilot planned for
  2008

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Roadmap towards global standards
2008
2007
2006
2009
GTIN Allocation
AutoID Data
Packaging/ Direct Marking
Serialisation
Carrier
GS1 Standards Group
AIDC Application Standards
Healthcare Product Traceability
Traceability
Classification
Healthcare Data Synch
Data Synchronisation
Schedule for deliverables to the GS1 GSMP (GS1s
standards development team) Version 1.5 -- August
2007
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Working with authorities around the world

• GS1 Healthcare and GS1 Member Organisations are
  working with authorities around the world
• US FDA - Unique Device Identification
• California Board of Pharmacy (and other US
  States) - e-Pedigree
• US Department of Defense - Data Synchronisation
• Canada Public Health Agency Identification of
  vaccines
• UK Department of Health Coding for Success
  Program in NHS
• Council of Europe Safe medication practices
• New Zealand Ministry of Health Medication
  Safety Project
• Australia NEHTA National Product Catalogue and
  EDI
• Japan, Korea, China, Italy, France, Spain,
  Germany, etc.

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GS1 Standards in Healthcare Recognised by
governments
The Department of Health is recommending that
the GS1 System should be adopted throughout the
Healthcare system in England and presents an
action plan calling for engagement in GS1 global
Healthcare User Group. February 2007 Policy
Guidance Document UK Department of Health
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GS1 Standards in Healthcare Recognised by
governments

• The newly approved Healthcare GTIN Allocation
  Rules international standard provides a global
  reference for consistent, unique medical device
  identification.
• This standard can enhance patient safety by
  providing regulators, device manufacturers,
  Healthcare facilities, and device users with a
  common format for traceability of medical
  devices from production to delivery to the
  patient (point of care).
• Jay Crowley
• Senior Advisor for Patient Safety
• U.S. Food and Drug Administration

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GS1 Standards in Healthcare Recognised by
governments

• NEHTA endorses the adoption of global standards
  on the allocation of GTINs in Healthcare.
• The Healthcare GTIN Allocation Rules developed by
  the GS1 Global Healthcare User Group provide a
  solid basis for ensuring consistent and
  best-practice implementation of GTINs to support
  and uphold standards around ensuring and
  maintaining data integrity in the global
  Healthcare community.
• Ken Nobbs
• Manager Supply Chain
• National E-Health Transition Authority
  (Australia)

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Regulations in Turkey

• Draft Regulation Guidance on the identification
  and bar coding of medicinal products drug
  traceability system
• GS1 Healthcare commends the Ministry of Health in
  Turkey for taking a leadership role in promoting
  standardisation in automatic identification
  traceability
• GS1 Healthcare believes these regulations will
  have a substantial positive impact on patient
  safety
• GS1 Healthcare would like to raise some questions
  and recommendations

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Identification Keys

• Product identification
• GS1 Healthcare welcomes the usage of GTINs as
  foreseen in the Draft Guidance
• Which GTIN should be entered in the Turkish
  database?
• Many manufacturers already use GTINs to identify
  their products, but use different GTINs for the
  same product for its different packaging levels,
  such as sales unit, unit-of-use and case
• Supplier identification
• Which GLN should be provided?
• Is the GLN for the Active Pharmaceutical
  Ingredient (API) also required?
• How do we deal with the often-encountered
  situation when suppliers to our products that do
  not wish to provide a GLN for the API?

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Data Set

• For pharmaceutical products
• Inclusion of expiry date and lot number support
  current business practises
• GS1 Healthcare would encourage the MoH in Turkey
  to set a signal towards a long term strategy with
  GTIN and serial number only as this would allow a
  greater number of products to be marked with
  smaller bar codes. Batch/lot number and
  expiration date can be looked up in the database
• Timelines
• Would Turkish MoH consider potential use of
  item-level and case-level serialisation on High
  and Medium risk Rx drugs, and case-level
  serialisation for Low risk Rx drugs as an
  alternative?

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Data Carrier

• Bar codes
• GS1 Healthcare welcomes the future usage of GS1
  DataMatrix
• The introduction will require production lines to
  be adapted
• Track trace required? If yes, would phased
  approach be acceptable?
• Would GS1 DataMatrix be combined with linear bar
  code on the package?
• Are any linear bar codes, including EAN-13, also
  required on the item level if Data Matrix is
  applied?
• Are the minimum bar code quality requirements
  based on global standards?
• When does the MoH project the Turkish market to
  be ready with camera-based scanning?
• As camera-based scanners can read GS1 DataMatrix,
  GS1-128 and GS1 DataBarTM (formerly RSS) would
  you allow all three as all three are allowed by
  global standards?
• RFID
• Has the MoH considered the potential use of RFID
  as data carrier in the future?

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Other topics

• Turkish Database
• How will serial numbers be entered in the
  database? When will we get the details on
  messaging, data formats and the web based
  interface?
• Will an automated data messaging standard be
  provided? Human entry of every single item to
  their web based interface wont be practical with
  the volume of product.
• What is the process for resolving failed
  authentications or correcting data with errors
  with their central database?
• Existing stock to be relabelled
• Do all products need to be removed from the
  market after the transitioning phase?
• How long is the transitioning phase?
• Import restrictions
• Does a medical product need to comply with the
  regulation when it enters Turkey? Or can it be
  labelled locally?

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Other topics

• Language
• GS1 Healthcare recommends to provide guidelines
  and regulations also in English for
  manufacturer's global headquarters to understand
  and implement the requirements

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Contact details
GS1 Global Office Avenue Louise 326, bte
10 B-1050 Brussels, Belgium T 32 2 788 78 00 F
32 2 788 78 99 W www.gs1.org