provides the most effective method of ensuring product security

Transcription

1 28 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Supports anti-counterfeiting and public health Combats fraud and prevents reimbursement fraud Reduces dispensing errors Gives quality assurance for patients Provides common standards across Europe, allowing inter-operability Offers a cost-effective solution for all parties provides the most effective method of ensuring product security 29 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

2 Traceability enabling technologies Technology epedigree Serialization Authentication RFID Datamatrix or barcode Fast and reliable printing In-line printing controls Invisible taggant Optical Variable Devices DNA- or chemicalbased security tag 31 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 A Univoque and NON-Predictive series of Characters has to be printed on the BOX at the manufacturing site, and verified at the subministration &/or sales point A safe connection to a Unique reference Database verify the correlation between the two numbers, so can authenticate each single box The Pharmacist can check the AUTHENTICITY of each single box connecting the Vendor s DB Manufacturer Distribution Chain Pharmacy Carton 1234 Carton Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 A Univoque and NON-Predictive series of Characters has to be printed on the BOX at the manufacturing site, with a second code in addition (possibly hidden), or any additional safe measure (special inks, etc.) The additional element is not verified at the distribution or at the sales point, but it s used by the vendor or by the distributor as an additional Autenticity confirmation Manufacturer Distribution Chain Pharmacy Carton 1234 Covert Code ABC Carton 1234 Covert Code ABC 33 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

3 Univoque and NON-Predictive series of Characters printed at each Packaging Line The code are related eachother either with specific Generation Procedures and/or either some aggregation/grouping procedures during Production Even if this solution has some validity inside the plant, it could even use by authentication Process by the Pharmacist Manufacturer Carton 1234 Case ABCD Pallet K6J7 Codes are related eachother 34 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 A Unique Code identify the smallest unit of the product, and will be RECORDED at any steps of the supply chain to the distribution/sales point The ELECTRONIC PEDEGREE allows each supply chain component to trace all steps to the manufaturing plant This solution could be implemented together with other Grouping or Identification Tecniques Manufacturer Wholesaler A Wholesaler B Pharmacy Shipment JHKL Shipment JHKL Shipment JHKL Shipment JHKL 35 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Worldwide Initiatives (Analysis Coding & tecniques Recommandations by EFPIA, epedegree, Brazilian Resolution) 36 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

4 GS1 is a leading global not-for-profit organisation dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors Formed in 2005 out of the EAN International and the UCC organizations) The GS1 system of standards is the most widely used supply chain standards system in the world GS1's products and solutions are used across a wide range of industry sectors 37 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 EPCglobal is a joint venture between GS1 (formerly known as EAN International) and GS1 US (formerly the Uniform Code Council) It is an organization set up to achieve worldwide adoption and standardization of Electronic Product Code (EPC) technology The main focus of the group currently is to create both a worldwide standard for RFID and the use of the Internet to share data via the EPC Global Network EPCglobal's board of governors includes representatives from EPCglobal, GS1, Auto-ID Labs, Cisco Systems, DHL/Exel Supply Chain, Haier Group Company, Johnson & Johnson, Kimberly-Clark Corporation, LG Electronics, Lockheed Martin Corporation, METRO AG, Novartis Pharma AG, Office of the Secretary of Defense, Procter & Gamble, Sony Corporation, The Dow Chemical Company and Wal-Mart Stores, Inc. 38 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 EFPIA: European Federation of Pharmaceutical Industries and Associations Represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. 39 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

5 The European Commission is proposing a number of legislative actions to address the problem of the increase of medicinal products detected in the EU which are falsified in relation to their identity, history or source. While broadly speaking EFPIA welcomes the Commission's initiative to propose concrete measures to address these problems, EFPIA does not believe that patient safety would be fully secured through the Commission s current proposals. Efpia Position Paper on European Commission s on Counterfeit Madicinal Products (October, 2009) 40 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

6 43 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Serialization is the process of identifying an object with a unique serial number that can be exchanged universally In the pharmaceutical industry is applied to each item, case, and pallet of a drug to track the flow of product within the supply chains of manufacturers, distributors and wholesalers Pharmaceutical companies that implemented epedigree solutions are now looking at implementing serialization using 2D barcode and RFID technology to transfer product information between trading partners towards gaining compliance 45 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

7 46 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 One cell quiet zone surrounds the matrix Clock pattern off on sequence This cell is always white for ECC200 Clock pattern off on pattern L shape locator pattern Cell size is important inches/0.33mm seems to give best read rates- and is GS-1 recommended 47 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 A Data Matrix code is a two-dimensional matrix barcode consisting of black and white "cells" or modules arranged in either a square or rectangular pattern The information to be encoded can be text or raw data Usual data size is from a few bytes up to 2 kilobytes The length of the encoded data depends on the symbol dimension used Error correction codes are added to increase symbol strength: even if they are partially damaged, they can still be read A Data Matrix symbol can store up to 2,335 alphanumeric characters Data Matrix symbols are rectangular in shape and usually square, they are made of cells: little elements that represent bits Depending on the situation a "light" module is a 0 and a "dark" module is a 1, or vice versa. Every Data Matrix is composed of two solid adjacent borders in an "L" shape (called the "finder pattern") and two other borders consisting of alternating dark and light "cells" or modules (called the "timing pattern"). Within these borders are rows and columns of cells encoding information. The finder pattern is used to locate and orient the symbol while the timing pattern provides a count of the number of rows and columns in the symbol. As more data is encoded in the symbol, the number of cells (rows and columns) will increase. Symbol sizes vary from 8 8 to Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

8 Compared to other barcode types, Data Matrix is approximately 30 times smaller than a Code 39 barcode representing the same data The required Reed-Solomon error correction built into Data Matrix ECC200 is able to reconstruct and verify the data scanned for improved accuracy Linear and 2D Barcode Simbology Evaluation Chart Code 39 without check digit: Code 128 Auto: Data Matrix ECC200 with ASCII encoding mode: Barcode Type Worst Case Accuracy Best Case Accuracy Data Matrix 1 error in 10.5 million 1 error in million Code error in 2.8 million 1 error in 37 million Code 39 1 error in 1.7 million 1 error in 4.5 million 49 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 A pedigree is a document that contains prescription drug information and chain of custody as it moves through the supply chain An epedigree is an electronic record of drug information and drug chain of custody that is authenticated and updated electronically as drugs move through the supply chain Trading partners - exchange epedigrees and have the ability to update them working with common standards (GS1 which provides standards for manufacturers, distributors, wholesalers and retailers for epedigree information epedigree - records with complete and accurate information about each transaction during transfer of ownership, lot number, dosage and expiration date of the drugs, company details (name, address, and license number) 50 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

9 52 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Europe Safe & Secure Supply Chain US (e) - Pedigree ID Verify Physical Verification Track Proactive Track Retrospective Product Security Transactio n Security 54 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

10 55 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 COUNTRY IMPLEMENTATION DEADLINE Australia Current (2007) Belgium Current Brazil 1/14/2012 Canada Current (2008) Chile 2010 China Current France 12/31/2010 Germany 2009 COUNTRY IMPLEMENTATION DEADLINE Greece Current (2005) Ireland Italy Current Current Japan 2009 Korea 2013 New Zealand 2009 Turkey 07/01/2009 Serialization Implementation dates for various countries (As of March 2009) 56 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 EFPIA in collaboration with Apoteket AB conducted a pilot project in order to demonstrate the feasibility of the proposed approach to product verification The pilot was carried out in Sweden during the period of 17 September 2009 to 25 January 2010 in cooperation with the Swedish pharmaceutical manufacturers association ( Läkemedelsindustriföreningen, Lif). 1. Amgen 2. Astra-Zeneca 3. Bayer HealthCare 4. Boehringer Ingelheim 5. GlaxoSmithKline 6. Janssen Cilag 7. Lundbeck 8. Merck Serono 9. Novartis 10. Novo Nordisk 11. Nycomed 12. Pfizer 13. Roche 14. Sanofi Aventis Apoteket selected 25 pharmacies in the greater Stockholm area to participate in the project. The total number of dispensing points in the selected pharmacies is about 180 while the number of dispensing points per pharmacy ranges from 2 to 10. Fourteen pharmaceutical companies provided a total of 25 products for participation in the pilot. It was the goal of EFPIA to have about 100,000 packs verified and dispensed during the duration of the operational phase of the pilot. All participating pharmacies were equipped with scanners capable of reading Data Matrix codes to allow for product verification. Also, the existing Point of Sale (POS) was amended to include the necessary extra functionality. Product verification and dispense operations were fully integrated into the ordinary pharmacy workflow. 57 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev