pharmaceuticals track and trace system

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Republic of Turkey Ministry of Health General Directorate of Pharmaceuticals and Pharmacy Pharmaceuticals Track and Trace System (İTS) Taha YAYCI 10.09.2011

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The Turkish “Pharmaceuticals Track and Trace System” (generally abbreviated as ITS) defines the infrastructure constructed to track and trace all units belonging to each pharmaceutical product in Turkey. ITS is an application of the infrastructure that is known as “Track & Trace” in the literature.Datamatrix code is used instead of formerly used barcode to ensure the uniqueness of the units. Every single step and action of the unit in the supply chain is gathered by web services to provide the traceability.

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Page 1: Pharmaceuticals track and trace system

Republic of TurkeyMinistry of Health

General Directorate of Pharmaceuticals and PharmacyPharmaceuticals Track and Trace System (İTS)

Taha YAYCI10.09.2011

Page 2: Pharmaceuticals track and trace system

Content

• What is İTS?• Objectives• Basic Concepts• Time Plan• Workflow Diagram• Web Services• Participants• Statistics• Questions

Page 3: Pharmaceuticals track and trace system

What is İTS?

The Turkish “Pharmaceuticals Track and Trace System” (generally abbreviated as ITS) defines the infrastructure constructed to track and trace all units belonging to each pharmaceutical product in Turkey. ITS is an application of the infrastructure that is known as “Track & Trace” in the literature. Datamatrix code is used instead of formerly used barcode to ensure the uniqueness of the units. Every single step and action of the unit in the supply chain is gathered by web services to provide the traceability.

Page 4: Pharmaceuticals track and trace system

Objective

• Ensure the reliable supply of drugs to patients

• Prevent counterfeiting, fraud, smuggling and illegal sale of drugs

• Prevent barcode scams• Support rational drug use, supply

data to control market

Page 5: Pharmaceuticals track and trace system

Basic Concepts

PRODUCT;• Every single box of a drug. It defines the unique box of a

pharmaceutical tracked by ITS.

GTIN;• Global Trade Item Number.• Ensures the uniqueness of a drug universally. Unique number created

by GS1 for a single trade item.

SN;• Serialization Number printed on the box of a drug. GTIN and SN

ensures the uniqueness of a single box.

PARTICIPANT;• A person, group, organization, or system who is affected by İTS

actions

Page 6: Pharmaceuticals track and trace system

Time Plan

• Project Kick-OffOctober 2007• DemoAugust 2008• Publication of Web ServicesNovember

2008• Pilot ApplicationSeptember

2009• Go LiveJanuary 2010• İTS Portal, İTS PTS, HardwareJanuary 2011

Page 7: Pharmaceuticals track and trace system

Put on the Market? StockpiledStockpiled

Sent to the WholesalerSent to the Wholesaler

İTS

İTS

STOCK

İTS Sell ? StockpiledStockpiled STOCK

Sent to the Hospital/PharmacySent to the Hospital/Pharmacy

İTSHOSPITAL

İTS İTSConsume? Sell ?StockpiledStockpiledSTOCK StockpiledStockpiled STOCK

PATIENT PATIENT

ConsumeConsume

İTS

SellSell

İTS

İTS

İTS

İTS

Menufacture/Import Notification

Sale/Cancel Sale Notification

Consume/Sale Notification

İTS İTS

İTS Query Sale

WHOLESALER

Product is marked with DATAMATRIX after serialized by

GTIN and SN

PHARMACY

REIMBURSMENTCOMPANY or ASSOCIATION

Workflow Diagram

Page 8: Pharmaceuticals track and trace system

Web Services

İTSMANUFACTURER• Manufacture Not.• Sale Not.• Cancel Sale Not.• Deactivation Not.• Export Not.• Product Verification

WHOLESALER• Purchase Not.• Return Not.• Sale Not.• Cancel Sale Not.• Deactivation Not.• Product Verification

HOSPITAL• Purchase Not.• Return Not.• Consume Not.• Deactivation Not.• Product Verification

PHARMACY• Purchase Not.• Return Not.• Sale Not.• Cancel Sale Not.• Deactivation Not.• Product Verification

PAYBACK ORGANIZATION• Query Sale

Page 9: Pharmaceuticals track and trace system

Participants

PATIENT

Manufacturer• 245

Wholesaler• 645

Pharmacy• 25.605

Hospital• 1.525

Payback Organization• 42

Page 10: Pharmaceuticals track and trace system

Statistics

• AVEARAGE RESPONSE TIME0,312 s.

• DEACTIVE DRUGS82.115.990

• SOLD DRUGS1.645.153.038

• SALEABLE DRUGS WITH DATAMATRIX 1.629.246.091

• SALEABLE DRUGS WITH TEMPORARY DATAMATRIX

169.738.458

• TOTAL DRUGS3.444.137.587

Page 11: Pharmaceuticals track and trace system

QUESTIONS