As markets become more global it is harder to ensure that the drugs received by paying customers are genuine. Cognizant reviews the developing role of IT and other new technologies in making the supply chain more secure
Counterfeiting and diversion are two serious problems that affect global trade and deprive customers of products they have paid for. When the product in question is an intravenous drug, a counterfeit could be life threatening.
Counterfeits mean huge, illegal profits for unscrupulous middlemen. Manufacturers are trying to exercise greater control over the supply chain and cut the number of intermediaries for the benefit of end users. IT also has a role to play in improving the security of the supply chain.
The World Health Organisation (WHO) estimates that more than 10% of the world drug market is counterfeit1 and the overall rise in the number of counterfeit drug cases logged by the Food and Drug Administration (FDA) has raised serious concerns.2 A WHO survey estimated that as much as 40% of the global counterfeit drug trade happens in industrialised countries.
Drug supply chain security is a critical issue as it directly affects the health of patients. Data shows that there is a tremendous increase in the number of counterfeit medicines seized by European customs services; more than 4 million articles were seized in 2007, an increase of 51% over 2006.3
In addition to counterfeiting, there are other concerns of tax evasion and profiteering from diversion and re-importation of either 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 prevent unnecessary, costly drug recalls or market withdrawals and the associated erosion of brand equity.
The question is how to secure the drug supply chain to:
- Provide patient safety – i.e. ensure that the drugs reaching patients are original and unexpired and
- Prevent illegal diversion and re-importation 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 be solved only by tracking and tracing the movement of each drug through the entire supply chain.
Track and trace of drugs by paper (pedigree) at each stage of the supply chain is expensive and logistically unmanageable for the hundreds of drugs each player in the supply chain handles. Electronic tracking and tracing (e-pedigree) of each drug in the supply chain has tangential benefits of optimising the supply chain, inventory tracking and reduction and allows better handling of reverse logistics for expired drugs or drug recalls. Lost sales due to out of stock or misplacement of drugs can be virtually eliminated with this approach.
Based on the available standards and best practices, the industry is currently following two different approaches to address track and trace requirements.
Using electronic pedigree workflow,4 each transaction in the drug supply chain needs to be recorded. The resulting e-pedigree will be transmitted to the drug-receiving unit before the actual shipment. It 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 that is over the new seller and buyer information added to the existing chain of ownership document.
The seller may need to append additional information to reflect changes (repackaging or sub-packaging) of the product described in the original product information (or by previous repackaging/sub-packaging information items). In some cases there will be a requirement for electronic signatures from the buyer that include information about when the product was accepted and by whom (see figure 2).
The components in an actual pedigree document depend on the specific business situation in which it is used (for example, a pedigree initiated by the manufacturer, by a wholesaler, for a repackaged item, etc). The basic components of a pedigree initiated by a manufacturer are shown in figure 3.
The unit that receives the pedigree, such as a wholesaler, records the receiving information and appends it to the pedigree. After the receiving information gets appended to the pedigree, the wholesaler signs the pedigree and sends it to the next receiving unit. The pedigree format at the wholesaler end looks like that shown in figure 4.
The e-pedigree solution would maintain ‘cradle to grave’ integrity for a drug and thus would provide verification of drug shipment integrity from manufacturer to retailer. The e-pedigree solution, based on cutting-edge technologies and backed by a foolproof security mechanism, will simplify online tracking and tracing of drugs through the drug supply chain.
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-serialised items. The matching of products received to their corresponding pedigrees is a requirement of the pedigree process.
In a manufacturing – distributor – 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 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 counter this threat, a central repository-based track and trace solution is becoming popular and market-leading IT product companies have started offering products that can be used to build such a solution. This will help in on-demand pedigree generation, which will enable supply chain participants to generate e-pedigree 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 is being referred to as Electronic Product Code Information Services (EPCIS) and will consist of a data scan repository, a capture interface to get the scanned data and a query interface to expose the stored information for any external applications.
The goal of using 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.
The industry is currently leveraging two major technologies for anti-counterfeiting solutions:
- RFID (Radio Frequency Identification)
- Barcodes
While the FDA doesn’t mandate the use of RFID in securing the drug supply chain, it has recommended its use for several years now.5 The FDA continues to believe that RFID is the most promising technology for anticounterfeiting solution implementation, although some analysts have said RFID technology will take more time to mature.
Though both the technologies support automatic identification methodologies, barcodes require a line of sight to the code in order to read it, where RFID does not. RFID will therefore yield better operational efficiency. It will also have the advantages of more data storage. Two-dimensional barcodes can help to address that requirement too. As the least-costly option, pharma companies are currently favouring barcodes, but with a future vision of migrating to RFID.
A recent directive from the European Parliament requires companies to minimise falsified medicinal products.6 The European Commission also recently released its ‘Pharmaceutical Package’ that proposes the use of ‘security devices’ for traceability of pharmaceuticals products. Products need to carry this mandatory safety device, which could be based on barcodes or RFID. These can be replaced but only under strict conditions.
The Ministry of Health in Turkey has introduced new regulations that include the requirement to serialise (using a two-dimensional barcode in the form of data matrix) all products, including promotional samples, hospital packaged products, prescription and non-prescription drugs, intermediate products and formulas for medical purposes.
It 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 without a two-dimensional barcode until 31 December, 2009.
Cognizant is working with a number of hardware and software vendors to come up with a broad based anti-counterfeiting solution. Key aspects of the technology development in this broad-based solution are:
- Coarse grained and truly interoperable services
- Integration with a robust Product Information Management tool to rationalise 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 visualisation of cost, benefits and operational challenges in multiple areas
- The package addresses growing business application around a common RFID infrastructure like 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.
Cognizant believes that barcodes, RFID and related technologies deployed properly in an enterprising fashion can pave the way for real-time tracking and tracing of drugs across the entire supply chain, thus making it much safer than it is today. The track and trace and pedigree solution would help achieve accelerated returns on technology investment as customers would be able to:
- Meet compliance requirements quickly and cost effectively to gain immediate business advantages
- Gain powerful supply chain analytical tools that use data generated by RFID/barcoding to help make real-time profitable decisions including dwell time metrics and inventory turn data.