Turkish National Data Bank Project for Pharmaceutics

1
Turkish National Data Bank Project for
Pharmaceutics Medical Devices

• Ulrike Kreysa, GS1 Global Office
• Mark Hoyle, Covidien
• Eucomed MedTech Forum
• Brussels, 14 October 2008

2
Healthcare Projects in Turkey

• Two important projects concerning healthcare
  sector
• Turkish Pharmaceuticals Medical Devices
  National Data Bank (e-catalogue)
• Drug Tracking System

3
Healthcare system in Turkey
Social Security Institution REIMBURSEMENT
MoH Supervision Regulation
Private Hospitals
Public Hospitals
Pharmacies
4
Official objective of the project

• The primary goal of the National Data Bank
  Project for Pharmaceutics Medical Devices is to
  create a common language, to share data
  electronically between all relevant parties like
  Manufacturers, Exclusive Dealers, Distributors,
  Purchasers, Users, Surveillance Authority and
  Reimbursement Agency.
• This project is sponsored by the MoHealth,
  MoLabor Social Insurance MoFinance of Turkish
  Republic with a signed legislation dated July 14,
  2004.

5
Initial Situation
Hospitals (Procurement, Stock Control, Internal
Consumption)
Party
Exclusive Dealer
Party
Reimbursement Agency (SIA)
Turkish Manufacturer
Party
Surveillance Authority (MoH)
Distributer
Party
Medical Doctors, Patients
Party
Vendors
All kind of communications methods between
relevant Parties to share product data
Party
Forwarding Companies
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Problems Difficulties

• Communication did not match to a standard model.
• Phone, fax, internet, e-mail, paper, etc...
• Sometimes an exclusive dealer gives input for
  requested data
• Sometimes this data came from a third party
• Requires plenty of communication traffic.
• Different parties have different datas for the
  same product specifications no harmonisation
• Each party has its own way of data recording
  model - no synchronisation
• No classification - products can not be grouped

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New Model
Hospitals (Procurement, Stock Control, Internal
Consumption)
Party
Exclusive Dealer
Party
Reimbursement Agency (SIA)
National Data Bank
Party
Surveillance Authority (MoH)
Turkish Manufacturer
Party
Medical Doctors, Patients
Distributor
Party
Vendors
Party
Forwarding Companies
8
Data Model
Company
Law Data
Basic Data Set (PRICAT)
Clinical Data
Formula of Drug
Price
Mandatory Data Set for Data Synchronization
Everyone uses PRICAT document for his data.
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Most Important Data Fields

• GS1 Global Trade Item Number (GTIN) or
• HIBC Universal Product Number (UPN) as unique
  product identifier
• Product number needed of sales unit

UPN or GTIN number is on the item as well as in
the Data Bank Acceptable barcode types are
GTIN-12, GTIN-13, GS1-128
GTIN in linear barcode

• Latest versions of UNSPSC (United Nations
  Services and Products Standard Codes) GMDN
  (Global Medical Device Nomenclature) are used for
  medical equipment classification

10
Databank

• Works fully in an electronic environment.
  (www.huap.org/ubb)
• All product data entries are submitted via web
  only by accreditated users acknowledged by the
  Companies.
• The uploaded data are inspected and approved by
  authorized staff of MoH SIA
• Detailed registrations of all procedures are
  stored with different message numbers.

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Statistics in February 2008

• 2432 Accreditated Company
• Appr. 590.000 each of registered Medical Devices
• 588.263 Medical Device controlled approved by
  SIA (Social Insurance Association)

12
Deadlines for Medical Devices

• Deadline for registration of product numbers is
  01.01.2009
• Deadline for printed barcodes on products is now
  the same date!
• Otherwise NO reimbursement for products!

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For Pharmaceuticals only!

• GS1 Application Identifiers will be used
• Bar code type will be GS1 DataMatrix
• DataMatrix barcode will contain
• GTIN
• Serial number
• Expiry date
• Batch number (optional)

14
A SKU including Turkey
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Remember the Use Case
16
(No Transcript)
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PRICAT Database for Turkey Make Only One GTIN
Available for the Product
PRICAT - Conversion
?
10694393123452
10694393123452
5
0694393123455
?
20694393123459
20694393123459
18

• GTIN Allocation is the responsibility of the
  Brand Owner
• GTIN is an Umbrella term for all data structures
  (GTIN-8, 12, 13 14)
• All database applications handling GTIN must be
  constructed using 14 digits
• Brand Owner to choose symbology based on Use
  Case
• Use Case dictates data structure
• Conversion of GTIN-14 to GTIN-13 is not possible
• GTIN country of origin dictates retail symbology
  (EAN or UPC) both usable globally.

GS1-Healthcare Application Standard will
determine the above therefore let the brand owner
follow the Standard and apply it without
prescriptive language.
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• GTIN country of origin dictates retail symbology
  (EAN or UPC) both usable globally.

UPC-A
EAN-13
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Role of GS1 in the Projects

• GS1 Turkey works collaboratively with related
  institutions
• GS1 Healthcare User Group has strong interest in
  these projects
• GS1 Healthcare authorities visited Ministry of
  Health and Social Security Institute
• Projects authorities attended GS1 Healthcare
  conferences in England and Spain
• Next steps
• Create a local Healthcare User Group in Turkey
• Seek again meeting with MoH to discuss issues

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Contact Details

• GS1 Global Office
• Avenue Louise 326, bte 10
• B-1050 Brussels, Belgium
• T 32 2 788 78 00
• W www.gs1.org
• ulrike.kreysa_at_gs1.org
• mark.hoyle_at_covidien.com