Track & Trace for Pharmaceutical Applications

Copyright Laetus This document may not be translated, copied or reprinted in whole or in part without prior written approval by Laetus. Many thanks to Paul Osborne form Performance PharmaTech Limited, who supported us creating this abstract of the pharmaceutical Track & Trace situation. http://www.pptech.eu/ Many thanks as well to Domino, UK and Hapa AG, Switzerland for supporting with details about the suitable printing technology. http://www.domino-printing.com/ http://www.hapa.ch/ Address We are worldwide available for you. You can find your local Laetus Support on our homepage under Contact....

Author G. Rodeck G. Rodeck G. Rodeck P. Osborne G. Rodeck Track and Trace for Pharmaceutical Applications Comments Initial release Minor corrections Text review Draft for update Review and release of 1.4 update

Track and Trace for Pharmaceutical Applications

Track and Trace for Pharmaceutical Applications

Counterfeiting of pharmaceutical products is not often discussed by manufacturers, for obvious reasons, but currently it is: Increasing at an alarming rate Very lucrative, with low penalties A significant danger to patients worldwide Counterfeiting is difficult to control (and sometimes to detect), and is growing increasingly sophisticated. Counterfeit medicines have four main categories: I. Appropriate amount of active ingredients - the perfect imitation of a preparation with the same active ingredients and identical packaging. From a medical point of view, the risk associated with this is small,...

Figure 2 - Seized pharmaceutical counterfeits by year in EU The seizure of 24m more counterfeit medicines last year coincided with the emergence of China as the primary source of fake drugs. China accounted for two-thirds of counterfeit medicines seized by the EU last year compared to less than five per cent in 2010. Measures to impede the success of counterfeiting of medicines generally comprise of five separate objectives: Add at least one overt and one covert feature to all primary packaging Add overt and covert features to secondary packages where applicable Upgrade covert technologies to...

Track & Trace Basics An Evolving Compliance Landscape The compliance landscape has been evolving for some period now. As governments and legislators have become more aware of the problems of counterfeit drugs, they have sought to protect their citizens by introducing measures to combat the counterfeiters. This has led to a number of different solutions being discussed and implemented. For the purposes of this paper, the focus is on the differences between the US Electronic Pedigree (ePedigree) based approach and the European style Mass Serialization route. Understanding where these approaches...

It would be of great benefit in the fight against pharmaceutical counterfeiting if a full track and trace system could be implemented. However, such an implementation for the very complex supply chain of pharmaceuticals world-wide is a task of daunting magnitude. Two major approaches have emerged for the control of pharmaceutical products; these are the American ePedigree and the European Falsified Medicines Directive (FMD) which is supported by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and securPharm proposals. A system which is dependent on track and trace...

It is fully electronic (i.e. not paper-based) - The law and all of the accompanying discussions by the Board of Pharmacy make it clear that the only acceptable form of a pedigree is electronic. This will make it much more reasonable to implement because supply chain members can make use solely of computers to exchange, store and validate pedigrees, without fear that their trading partners can only handle paper pedigrees Pharmacy returns must be reflected on pedigrees - This was an original requirement of the Florida Pedigree Law too, but it was removed under pressure from lobbyists before the...

In addition, the SNI can be linked to databases containing this and other information. Any addition to this information within the SNI will unnecessarily increase the length of, and introduce complexity into, the SNI. However, if a manufacturer or re-packager chooses to include expiration date and/or lot or batch number with the SNI, it should ensure that the resulting number still permits users to distinguish and make use of the SNI. For example, expiration date and lot or batch number may be incorporated in accordance with the GS1 standards for use of Global Trade Item Numbers (GTIN). In May...

A closer look at the EFPIA code The suggested code is a GS1 Data Matrix code and contains four elements of information, i.e. article number, batch number, expiry date and a randomised serial number. Manufacturer Product Code - GTIN (or Pseudo GTIN e.g. CIP code) ‘Global Trade Item Number’ according to GS1 Standards (14 numeric digits) Unique serial number (randomized – up to 20 alpha-numeric characters) Expiry date (6 digits – YYMMDD) Batch number (up to 20 alpha-numeric characters) Figure 6 – EFPIA Coding The combination of article and serial number provides the pack’s unique identity. The exact...

European Stakeholder Model Serialisation with Random Numbers Upload Number Data Matrix Code : Vvupon Dispense Authenticate Number The key stakeholders all support the Point-of-Disperising verification concept European Stakeholder Model ► Parallel Distributor: mandatory verification + data upload •^r"^^ Manufacturer: data upload + voluntary verification ^^^^ Periodic cross-region update -> Pharmacy: mandatory verification Wholesaler: voluntary verification

Benefits of Track & Trace With unit-of-sale serialisation, the Product code (GTIN), and the batch number, additional USC and expiry date information will need to be included in a barcode in order to be read automatically. This then gives the following advantages: 3.1. Automatic Detection of Expired Products Expired products that are either returned or expire in warehouses are the bane of pharmaceutical distributors. With serialisation, distributors obtain more visibility into their warehouses and potentially into their customers’ inventory management practices. With improved visibility into distributors’...