Track 'n' trace: securing the drug supply chain: Dutta Sujovit, from Cognizant's RFID Center of Excellence, discusses the drug supply chain.
The US prescription drug supply chain has been considered to be the safest in the world for a long time, but a continuous rise in the number of counterfeit drugs (WHO estimates that more than 10% of the world drug market is counterfeit (1)) and the overall rise in the number of counterfeit drug cases booked by the FDA has raised serious concerns. (2) A WHO survey estimated that as much as 40% of the global counterfeit drug trade happens in industrialized countries. A big part of this number is bound to be in the US, which comprises close to 50% of the world pharmaceutical market. Drug supply chain security is a critical issue as it directly affects the health of patients. An estimated 25-50% of the medicines consumed in developing countries are thought to be fakes. The data show that there is a tremendous increase in the number of counterfeit medicines seized by European customs services, with more than 4 million articles representing an increase of 51% compared with 2006. (3) Figure 1 depicts the counterfeiting cases in the US. (4) Apart from counterfeiting, there are other serious concerns, such as tax evasion and profiteering from the diversion and reimportation of expired drugs or drugs meant for the poor. Securing the drug supply chain will ensure that the drugs received by patients are the unexpired, original drugs sent out by the manufacturer. This would also provide tangential benefits to the manufacturer by preventing unnecessary, costly drug recalls or market withdrawals and the associated erosion of brand equity.
Securing the Drug Supply Chain
Although the need to secure the drug supply chain has been established, the next question to consider is how to secure it. There are two objectives here: patient safety, to ensure that the drugs reaching patients are original and unexpired, and preventing the illegal diversion and reimportation of drugs. While the first objective of drug safety can be achieved by manual or automated authentication mechanisms at the point of dispensing or tracking and tracing, the second problem can only be solved by tracking and tracing the movement of each drug through the entire supply chain. Tracking and tracing drugs by paper (pedigree) at each stage of the drug supply chain is expensive and logistically impossible to manage for the hundreds of drugs that each player in the supply chain handles. Electronically tracking and tracing (ePedigree) each drug in the supply chain has the tangential benefits of optimizing the supply chain, inventory tracking and reduction and allows better handling of reverse logistics for expired drugs or drug recalls. Lost sales owing to out of stock situations or the misplacement of drugs can be nearly eliminated using this approach.
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Based on available standards and best practices, the pharmaceutical industry is currently following two different approaches to address track 'n' trace requirements
ePedigree Workflow: Each transaction in the drug supply chain needs to be recorded, which will eventually provide the pedigree of a drug. (5) This electronic pedigree gets transmitted to the drug-receiving unit before the actual shipment. This electronic pedigree or 'ePedigree' is a chain of ownership document that is assembled from an initial ("base") pedigree containing considerable product information and, also, information about the first owner, who is also the originator of the document. Each new ownership transfer record needs a signature relating to the new information added (seller and buyer information) to the existing chain of ownership document. The seller may need to add additional information to reflect changes made (repackaging or subpackaging) to the product described in the original product information (or by previous repackaging/subpackaging information items). In some cases, an electronic signature from the buyer will be required that includes information about who and when the product was "accepted" by the buyer (Figure 2).
Pedigree Document Format: The components in an actual pedigree depend on the specific business situation in which it is used (pedigree initiated by manufacturer, pedigree initiated by wholesaler, pedigree for repackaged item, etc.). The basic components of a pedigree initiated by manufacturer are shown in Figure 3. The unit that receives the pedigree, which might be a wholesaler, records the receiving information and appends it to the pedigree. After the receiving information gets appended to the pedigree by the wholesaler, the wholesaler signs the pedigree and sends it to the next receiving unit. The pedigree format at the wholesaler end looks like Figure 4. The ePedigree solution would maintain 'cradle to grave' integrity for a drug and, thus, would provide verification of drug shipment integrity from manufacturer to retailer. The ePedigree solution, based on cutting-edge technologies and backed by a foolproof security mechanism, will simplify the online tracking and tracing of drugs through the drug supply chain.
Pedigree Envelope Format
The pedigree envelope format is an electronic wrapper used to transmit a collection of pedigrees associated with an outbound customer shipment. The pedigree envelope may also contain information about the association of pedigrees to quantities of products in specific cases in the shipment to facilitate product-to-pedigree matching for non-serialized items. The matching of products received to their corresponding pedigrees is a requirement of the pedigree process (Figure 5).
Track 'n' Trace Workflow
In a Manufacturer [right arrow] Distributor [right arrow] Pharmacy flow, current pedigree flow allows one pharmacy to check the details of all the products that have been received by the distributor from the manufacturer. Even though the pharmacy receives only a part of the shipment, the existing standard allows the pharmacy to know the full details of the entire shipment, from manufacturer to wholesaler. This could be a potential threat for the security of the rest of the shipment. To avoid this, a central repository based track 'n' trace solution is becoming increasingly popular and market-leading IT product companies have started offering the products that can be used to build such track 'n' trace solutions. This will help in on-demand pedigree generation that will enable supply chain participants to generate ePedigree documents on the fly for the specific products that the receiver-supply chain node has got from the sender supply chain node. The central repository, referred to as Electronic Product Code Information Services (EPCIS), comprises a data scan repository, a capture interface to get the scanned data and a query interface to expose the stored information to any external applications. The goal of EPC Information Services (EPCIS) is to enable disparate applications to leverage Electronic Product Code (EPC) data via EPC-related data sharing, both within and across enterprises. Ultimately, this sharing is aimed at enabling participants in the EPC Network to gain a shared view of the disposition of EPC-bearing objects within a relevant business context.
Enabling Technology for ePedigree and Track 'n' Trace
The two major anticounterfeiting solutions that the industry is currently using are RFID (Radio Frequency Identification) and barcodes. Although the FDA doesn't mandate the use of RFID in securing the drug supply chain, it has recommended its use for several years now. (6) FDA continues to believe that RFID is the most promising technology for anticounterfeiting solution implementation, although some analysts have said that RFID technology will take more time to mature. Both the technologies support automatic identification methodologies but, because of its non-line-of-sight feature, RFID will yield better operational efficiencies. RFID also has the added advantage of more data storage; but, 2D barcodes can help to address that requirement too. Being less costly, pharmaceutical companies currently prefer barcodes ... but have a longer-term vision of migrating to RFID.
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Directive of the European Parliament to minimize falsified medicinal products: The European Commission released its "pharmaceutical package," which strongly proposes the use of "security devices" to trace pharmaceutical products. The security devices could be a barcode or RFID and the products need to carry this mandatory safety device. These can be replaceable under strict conditions. (7)
New regulation from Turkey MoH: The Ministry of Health in Turkey has introduced new regulations that include the requirement to serialize (using a data matrix 2D barcode) all products, including promotional samples, hospital packaged products, prescription and non-prescription drugs, intermediate products and formulas for medical purposes. The Ministry of Health has mandated the use of the 2D barcodes on all pharmaceutical and nutritional products manufactured on or after 1 January 2009. Products made prior to this date may continue to be distributed ("grandfathered") without a 2D barcode until 31 December 2009.
Broad-based solution for enterprise rollout: Cognizant is working with different hardware and software vendors to come up with a broad-based anticounterfeiting solution. Key aspects of the technology development in broad-based solution are as follows:
* Coarse-grained and truly interoperable services
* Integration with a robust Product Information Management tool to rationalize the product data
* Distributed device monitoring and management
* Authentication of each owner of a drug product from current owner back to the original manufacturer shipment
* Validation that electronic data matches the physical product received
* Association of pedigree information to outbound shipments
* Confirmation that shipped products have complete and accurate pedigrees
* Real-time modelling of a large-scale pharmaceutical supply chain using RFID to help in feasibility study and cost, benefit and operational challenge visualization in multiple areas.
The package addresses the growing business application around a common RFID infrastructure, such as regulatory compliance, product security, patient safety, theft/shrink management, shipping and receiving accuracy, lot and batch tracking, expiration date management, returns management, recall management and cold supply chain.
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Cognizant believes that properly deployed barcoding, RFID and related technologies can pave the way to the real-time tracking and tracing of drugs across the entire supply chain, thus making it much safer than it is today. The track 'n' trace and pedigree solution would help to achieve accelerated returns on technology investments as customers would be able to meet compliance requirements, quickly and cost effectively, to gain immediate business advantages and gain powerful supply chain analytical tools that use data generated by RFID/barcodes to make profitable decisions in real-time, including dwell time metrics and inventory turn data.
(1.) World Health Organization, "Substandard and Counterfeit Medicines," WHO Fact sheet N[degrees] 275 (www.who.int/mediacentre/factsheets/2003/fs275/en), 1 June 2007.
(2.) R. Lutter, "FDA's Recent Experience Fighting Counterfeit Drugs," presented at RFID World Conference, Dallas, Texas, USA (1 March 2006).
(3) http://ec.europa.eu/taxation_customs/resources/documents/customs/ customs_controls/counterfeit_piracy/statistics2007.pdf.
(4.) http://meetings.nacds.org/RFID/2008/Presentations/ Monday_Jeffrey_Shuren.pdf.
(5.) EPCglobal, "Pedigree Ratified Standard," Version 1.0 (5 January 2007).
(6.) US Food and Drug Administration, "Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update," www.fda.gov/oc/initiatives/counterfeit/update2005.html (1 June 2007).
(7.) http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/ pharmpack_12_2008/counterfeit-directive_en.pdf.
1. M. Bartel, et al., "XML-Signature Syntax and Processing," www.w3.org/TR/xmldsig-core (1 June 2007).
For more information
Senior Architect, Global Technology Office
Figure 1: Counterfeiting cases in the US. 1997 9 1998 5 1999 11 2000 6 2001 21 2002 27 2003 30 2004 58 2005 32 2006 54 2007 31 2008 56 Note: Table made from bar graph.
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|Title Annotation:||supply chain management|
|Date:||Jul 1, 2009|
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