SÉRIALISATION : UN CAS CONCRET DE CODIFICATION EN TURQUIE. Les Rencontres CIP/ACL 29 novembre Maison de l artisanat - Paris 8ème

Transcription

1 SÉRIALISATION : UN CAS CONCRET DE CODIFICATION EN TURQUIE Maison de l artisanat - Paris 8ème

2 LES RENCONTRES CIP/ACL h00 14h30 Sérialisation : un cas concret de codification en Turquie o Doctor Saim KERMAN Head of Medicines and Medical Devices Agency of Turquey o Serap MALCOK ALTUNKAN - Ministry of Health Turkish Track&Trace System o Taha YAYCI - Project Coordinator, Ministry of Health Turkish Track&Trace System o Gunay SAKIROGLU - Janssen Cilag Turquey 2

3 Turkish Pharmaceuticals Track and Trace System (İTS) Turkish Medicines and Medical Device Agency Serap M. Altunkan, Ms.Sc.Pharm 29/11/2012

4 What is İTS? Objectives Basic Concepts Time Plan Workflow Diagram Web Services Stakeholders Statistics Achivements CONTENT

5 WHAT is İTS? The Turkish Pharmaceuticals Track and Trace System defines the infrastructure constructed to track and trace all units belonging to each pharmaceutical product in Turkey İTS 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

6 OBJECTIVE Protecting public health Prevent counterfeiting, fraud, smuggling and illegal sale of drugs Support rational drug use, supply data to control market Ensure the reliable supply of drugs to patients Certify the reliability of drugs Raise the service quality of the participants Prevent barcode scams Create a database for general use

7 BASIC CONCEPTS Product : Every Single box of a drug. It defines the unique box of a pharmaceutical tracked by İTS GTIN : Global Trade Item Number. Ensures the uniqueness of a drug universally. Unique number created by GS1 for a single item number SN : Serialization Number printed on the box of a drug. GTIN and SN ensures the uniqueness of a single box Stakeholder : A person, group, organization or system who is affected by İTS actions GLN: It is a simple tool used to identify a location and can identify locations uniquely where required

8 ( 01 ) GTIN - Global Trade Item Number ( 21 ) SN - Serialization Number ( 17 ) Expiry Date ( 10 ) Batch Number

9 TIME PLAN October 2007 Project Kick Off August 2008 Demo November 2008 Publication of Web Services September 2009 Pilot Application January 2010 Go Live January 2011 İTS Portal, İTS PTS, Hardware January 2012 Phase II 2013 E-prescription and e-report

10 WORKFLOW DIAGRAM

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12 WEB SERVICES Purchase Not. Return Not. Sale Not. Cancel Sale Not. Deactivation Not. Product Verification Purchase Not. Return Not. Consume Not. Deactivation Not. Product Verification Purchase Not. Return Not. Sale Not. Cancel Sale Not. Deactivation Not. Product Verification Manufacture Not. Sale Not. Cancel Sale Not. Deactivation Not. Export Not. Product Verification Query Sale

13 Manufacturers/Importers Wholesalers Pharmacies Hospitals Reimbursment Companies STAKEHOLDERS Manufacturer Unions Wholesaler Associations Turkish Pharmacists Association Hospitals of Turkish Armed Forces Ministry of Finance Family Physicians

14 STATISTICS (Stakeholders) Manufacturer 300 Reimbursement 41 ITS Wholesaler 296 Pharmacy Hospital

15 STATISTICS (Products) Pharmacy/ Hospital Sold Exported Consumed Wholesaler Recalled Manufactured Total Deactive Data: 26 Nov İTS Portal

16 AVERAGE RESPONSE TIME 0.02 sec.

17 ACHIEVEMENTS Protect public health Prevent package and barcode scams Prevent illicit sale of drug Prevent counterfeit drugs Prevent drug theft Support rational drug use Narcotic drugs could be effectively tracked Blackmarket arised especially in the period of epidemi is prevented Clipping barcodes of the packages method to verify the sale is no longer in operation

18 ACHIEVEMENTS Ensure the reliable supply of drugs to patients Recalls Market control Create reports for market control, public health and managerial aspects from the collected data by using data mining Prevent tax fraud Make our participants such as wholesalers, public and private hospitals and pharmacies to be up to some standards and support this workflow by softwares

19 Tracked Product Groups Pharmaceutical Track and Trace System track and traces the products that are defined in "Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use". Excluded products are defined below; Serums (with the exception of peritoneal dialysis solutions, medical foods and enteral nutrition products), Radiopharmaceuticals, The cold-chain products that should be stored below eight degrees celsius Manufactured for private use drugs such as allergy vaccines These products above would be tracked and traced in the following phases.

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