Geo Focus: Turkey – Implementing Effective Serialization Under Regulation

Murat Mendi06.11.2014

• Brief Introduction

• Turkish Track and Trace Overview

• System Implemented at Nobel Pharma

• Benefits of the System

• Lessons Learned

Agenda

About Me?• Born in Turkey in 1972• Got my Bachelor’s Degree in

Management in 1995 from Boğaziçi University, İstanbul

• Got my MBA in 1998 from CSULA• Has been working in the IT field

since 1998• Joined Nobel in 2006 as CIO• Became GM in 2012• Currently Serving as

Executive Board Member

About Nobel

• Established in 1964

• HQ in İstanbul , multinational generics manufacturer operating over 17 countries with more than 2000 employees worldwide

• 3 Contract Manufacturing Sites (Turkey, Uzbekistan, Kazakhstan)

• API Manufacturing site and R&D in Turkey

• With over 200M$ Net Sales ranked among top 20 Pharmaceutical Companies in Turkey

• Brief Introduction

• Turkish Track and Trace Overview

• System Implemented at Nobel Pharma

• Benefits of the System

• Lessons Learned

Agenda

Project History

October 2007 • Project Phase 1 Kick-Off

August 2008 • Demo

November 2008 • Publication of Web Services

September 2009 • Pilot Application

January 2010 • Project Phase 1 Go Live

January 2012 • Project Phase 2 Go Live İTS Portal, İTS PTS

ParticipantsPATIENT

Manufacturer• 245

Wholesaler• 645

Pharmacy• 25.605

Hospital• 1.525

Payback Organization• 42

Number of Units Sold: 3 Billion/Annualy• Manufactured and Imported

Number of Prescriptions: 1 Billion/Annualy

3 Million Prescriptions handled per day (6 Million for peak times)

What Do We Track?The information which the DataMatrix contains is stated below:• Barcode Number –GTIN (Global Trade Item Number): The maximum

14 digit number which serializes products worldwide.• Serial Number –SN: The unique registration number defined by the

manufacturers for each unit/package on the basis of products.• Expiration Date –XD: The last date that the product can safely be

used.• Batch Number –BN: Is the registration number that distinguishes a

batch from another during its manufacturing.

How the System OperatesPut 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

İTS

HOSPITAL

İTS İTSConsume? Sell ?StockpiledStockpiledSTOCK StockpiledStockpiled STOCK

PATIENT PATIENT

ConsumeConsume

İTS

SellSell

İ TS

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

About the Data• Every single action taken on drugs pass through to İTS as

web service notifications. • Notifications consist: Manufacture, export, purchase,

return, sale, cancel sale and deactivation.• It is estimated that every single drug box will have an

average of 14 actions in its lifecycle. Estimating that annually 3 billion boxes are sold, it can be calculated that totally 42 billion actions are stored in the system. By adding reverse logistics movements and verification services it can go up to about 50 billion annually.

About Apps

Web Services

İTS

MANUFACTURER• 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

Web Services

PTS

MANUFACTURER• Sale Not.• Cancel Sale Not.

WHOLESALER• Purchase Not.• Return Not.• Sale Not.• Cancel Sale Not.

HOSPITAL• Purchase Not.• Return Not.

PHARMACY• Purchase Not.• Return Not.• Sale Not.• Cancel Sale Not.

• Brief Introduction

• Turkish Track and Trace Overview

• System Implemented at Nobel Pharma

• Benefits of the System

• Lessons Learned

Agenda

Our Vendors

NOBEL İTS Locations

İnternet

İnternet

İnternet

Veritabanı

Seri Numarası Üretim

Uygulaması

Sağlık Bakanlığı

Sunucular

Sunucular

Nobel Manufacturing Site

Nobel Sales Org.

Manufacturing (Nobel + CM), and Deactivation Not. to MoH

Nobel Wharehouse

Not. of Sales, Revision and Shipment orders to wharehouse,Wharehouse not. of completed shipments to HQ + Not. of Returns from Wholesalers and Contract Man. Products to HQ + Barcoding of Imported Products

İnternet

İnternet

Not . of Manufacturing and Revision Ordersto Man. Site. + Manufacturing, Deactivation and Shipment Not. To Nobel HQ and Wharehouse Sales and

Deactivation Not. to MoH

Database Replikasyonu (Yedekleme) Wholesalers

Veritabanı

Seri Numarası Üretim

Uygulaması

...Line 1 Line 2 Line 7

Production Not. from lines to database

Returns

İade Hattı (Sadece Okuma)

Revizyon Hattı (Okuma ve Yazma)

Contract Man. Cust.

CM Prod. Shipment

İnternet

Cont. Man. Not. to MoH

Contract Manufacturing Not.

Revizyon Hattı (Okuma ve Yazma)

Imported Products

İTS

Sales

İTS Modules

İTS

Production Management

Module AuthorizationModule

Notification Service Module

Packet Transport System

Synchronization Module

Warehouse management

ModuleReturn and

Deactivation Module

Shipping Module

Business Rules Management

Module

Printer Management Module

Fault Recording System

Business Continuity Module

Reporting Module

Sample Workflow for Returns

2D Barcoding @ Manufacturing Site

Sample Video

İTS Main Processes - 1

• Manufacturing• Production Order Manufacturing• Revision Order Manufacturing

• Product Shipment• Contract Manufacturing Shipment• Shipment to Nobel Warehouse

• Warehouse Product Acceptance• Acceptance from Nobel Manufacturing Site• Acceptance from other Contract Manufacturing Sites• Acceptance of Returns from Wholesalers• Acceptance of Products with no 2D Barcodes (Import Products)

• Wharehouse Product Shipment• Shipment to Wholesalers

İTS Main Processes - 2

• Wharehouse Operations• Transfer Orders• Label Printing• Queries of Products• Stock Counting• Creating New Pallet/Case/Shrink information due to partial shipments• Suspend/Quarantine Products

• Notifications• İTS Notifications• PTS Notifications

Nobel System Architecture

Advantages of Our System

• NET Development enabled us to develop and customize the

system according to our needs at a much cheaper price

• Used Terminal Servises Architecture to prevent device specific

deployments

• Disaster Recovery

• Each Location has Failover Clustering

• Merge Replication set between factory and HQ for online

data backup

• Brief Introduction• Turkish Track and Trace Overview• System Implemented at Nobel Pharma• Benefits of the System• Lessons Learned

Agenda

Benefits for the Government

• Prevent package and barcode scams (approx. 50 million USD),

• Prevent illicit sale of drug (approx. 10 million USD),• Prevent quack remedy (approx. 20 million USD),• Prevent drug theft (approx. 15 million USD),• Support rational drug use,• Clipping barcodes of the packages method to verify the sale

is no longer in operation,• Prevention of the drugs become unusable by falling or

breaking due to clipping of the barcode (App. 4%),

Benefits for the Government

• Narcotic drugs could be effectively tracked,• Immediate and absolute actions can be taken on callbacks

after side effects are found,• Market control can be done more effectively and more

accurately,• Create reports for market control, public health and

managerial aspects from the collected data by using data mining,

• Prevent tax fraud by reports created using stock and sale data of the participants.

Benefits for Nobel

• Better Stock Management• Better Shipment Management• Better Recall Management• Reduced disputes with wholesalers regarding the

shipments• Verify returns to make sure that they are not already sold at

the pharmacies (Prevent Scams)• Track Parallel Trade (Especially to Balkan Countries) to its

resource

• Brief Introduction

• Turkish Track and Trace Overview

• System Implemented at Nobel Pharma

• Benefits of the System

• Lessons Learned

Agenda

Lessons Learned• Do not divide the implementation into two phases as we

did in Turkey• Wholesalers should be in the system from the beginning• Wasted a lot of time and energy to implement the second phase

• Do not try to track the products existing in the market before the go live date• We were asked to label products in the pharmacies with temporary

2D barcode labels. This was a huge failure in the implementation and cost the government a lot

• Spend more time on the pilot• 3 Months of pilot period was not enough to resolve all the issues in

the system. We had several blackouts in the initial stages of the implementation

Any Questions I Can Answer?