track & trace geneva 2014
TRANSCRIPT
• 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.
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
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
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
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