An approach to deploy mass product serialization using EPC and carrier technologies like 2D barcodes and RFID, outlining an option to implement a solution that meets the ePedigree requirement and leverages industry standards.

At industrial manufacturing and packaging level, a major focus is on patient safety and in the recent past, in the pharmaceutical industry has been facing several challenges in this regard. These challenges are in addition to other challenges, such as the continuous increase in the cost of bringing drugs to market and shrinking revenues because of factors such as patent expiry, thin pipeline, penetration of generics, declining R&D productivity, reducing healthcare spending among others.

Some of the key challenges related to the drug supply chain are the management of drug expiration, drug returns/recalls and counterfeit drugs. One of the main reasons for drug return is the drug’s expiration prior to dispensing. Also as per the current system, the drug recall process (using the batch number) is complex and expensive, where all to-be-recalled products must be tracked and then shipped back. Hence managing the administration of the drug recall is crucial both from the angle of patient safety as well as from the perspective of cost effectiveness of the whole process. In the pharmaceutical industry, drug counterfeiting poses a serious threat and challenge to patient safety. Drug counterfeiting severely impacts the cost of the drug, as well as the revenues, profitability and brand of the drug manufacturer.

Counterfeit drugs include drugs that have expired or have been adulterated or those that fake the brand name of pharmaceutical companies. To combat drug counterfeiting, the secure distribution of drugs must be ensured and the pedigree of drugs must be captured. Secured distribution is ensured by using mass serialization, where each product is assigned a unique identifier such as an Electronic Product Code (EPC). The use of 2D barcode and Radio Frequency Identifier (RFID) addresses the challenge of serialization. Mass serialization also enables the traceability of products using the track-and- trace process. This process traces the entire lifecycle of the product in the supply chain market. The EPC Information Service (EPCIS) addresses the challenge of capturing information such as location, time, disposition, business transaction and other details of the product in the supply chain.

Counter measures

To address the challenge of counterfeit drugs in the market, pharmaceutical companies, governments, regulatory agencies and non-government organizations are taking several steps. These steps include measures such as new regulations, better control on the drug distribution network, adopting new technological solutions, bringing awareness along with the better collaboration across agencies, governments and other stakeholders.

To tackle this, different countries are adopting different approaches and roadmaps – for example, in Europe some countries have already adopted the Serialization program and the European Union (EU) is working on developing standards for its member countries. The European Federation of Pharmaceutical Industries and Associations (EFPIA) supports the principle of mass serialization. This serialization assigns unique product identification codes on the secondary packaging of all pharmaceutical products sold in the EU. The EFPIA proposes this system to verify the product while dispensing medicine to ensure the authenticity of the dispensed product. A common controlled data source called Pharmaceutical Interchange Logistic Link (PILL) verifies the dispensing product.

Mass serialization with RFID and 2D barcodes

Mass serialization may be accomplished by assigning unique identifiers such as EPC for products. EPC is a globally recognized unique serial number that identifies an item in the supply chain. The 2D barcode and RFID are two carrier technologies that implement the unique serial numbers (as per the EPC coding scheme) for the products. The table below highlights the key differences in adopting the 2D barcodes and RFID technology.  2D barcode is most commonly used technology as it is easy to implement, with a lower cost of deployment. However, there are a few constraints with this technology, such as the requirement of line-of-sight to capture product details as well as the capturing each product detail individually. Hence in case product-level tracking is required, each product package/case must be dismantled and brought individually in line-of-sight of the bar code readers. This requires time and effort, and hence is more expensive.

The line-of-sight constraint of the bar code technology may be circumvented by using RFID technology. RFID allows the reading of multiple product tags at the same time without dismantling the product. The RFID tag also allows the capture of more data as compared to bar code tags, and provides the option to use more advanced tags (such as writeable tags, tags with sensors) that help perform various complex business operations (like temperature monitoring, alerts). The tag used in RFID technology can be hidden in the product packaging, which further helps improve product security. RFID is relatively a newer technology than bar codes, and is slowly maturing over time. At present, this technology has been deployed in a few industries and business scenarios to improve efficiency and compliance requirements.

However, there are some known challenges with RFID-based solutions for electronic track-and-trace, which slows down its adoption. These are the high cost of tags/infrastructure, potential reliability issues of (UHF – Ultrahigh Frequency) tags with liquids/metals, evolving regulations and standards and patient privacy. For ePedigree requirements, the RFID solution is an effective solution. The FDA also recommends RFID as a promising technology to achieve ePedigree. EFPIA recommends 2D barcodes because it is easy to implement and it is cost effective. However, a solution that not only supports the existing technology (Bar code, paper tracking and a framework for RFID) but is also extendable to provide support for other potential technical options and requirements in the future is the mandate.

ePedigree with DPMS and EPCIS

For capturing and sharing information across trading partners, EPCglobal standard EPCIS may be used. EPCIS captures key information regarding various business events such as location, time, disposition and business transactions in the life of the product movement along the supply chain. Thus, EPCIS provides new opportunities (such as optimized inventory management, expiry date, and on-shelf availability management) to improve efficiency, transparency and security. EPCIS is a standard that defines interfaces for representation and exchange of data between various entities. This framework is designed to work with serialized objects and includes data model, capture interface and query interface. To meet the ePedigree regulatory requirements for the security and authenticity of drugs or medical products, EPCglobal has developed the Drug Pedigree Message Standard (DPMS). DPMS captures data when the ownership of the product changes across the supply chain and allows the partners to exchange the pedigree data in an interoperable and secure manner.

Thus, it provides a standard uniform data format which may be exchanged between partners and also provides the varying data requirements at different state levels. At present, no law demands any specific data format to be adopted for this purpose; however, California law requires a uniform standardized nonproprietary data format to be used across the supply chain partners.

Staggered deployment

To create a secure supply chain, one of the key requirements is the implementation of serialization. This helps trace, validate and verify the authenticity of the drug at any stage of the supply chain. Hence the new regulations (Serialization, Pedigree and others) in countries like the USA, Belgium, Turkey and China have been introduced and technologies like EPC, RFID and/or 2-D Barcodes have evolved to support these. In the near future, because of the staggered deployment approach, the combination of both paper and ePedigree will exist and will largely use technologies like RFID and 2D barcodes. Though these technologies have not been enforced, these two carrier technologies along with EPC will help the industry implement the required ePedigree regulations. Because of the ease of implementation and the low cost, it is expected that 2D barcodes will be more popular in Europe, but in the USA it is expected that a hybrid approach will be adopted (for example, using RFID at a case level and the 2D barcode at an item level) and a combination of technologies will be used.

Extract of a white paper by TataConsultancy