Up to 15 percent of all medicinal products in the world are counterfeit, according to estimates from the World Health Organization. Unlike substandard drugs, which are occasionally produced by established manufacturers as result of errors in the manufacturing process, counterfeit drugs are produced with the intention to mislead consumers. As a result, these drugs often lack essential active ingredients, or contain dangerous contents, which can result in treatment failure or even death.

The problem of counterfeit drugs is a growing one. The global sale of counterfeit drugs will reach $75 billion in 2010 – a 92 percent increase in five years, according to estimates from the U.S.-based Center for Medicines in the Public Interest. As drug counterfeiting becomes an increasingly dangerous and costly worldwide problem, pharmaceutical companies are working in conjunction with standards organizations to develop a system for tracking and tracing medicines globally.

However, because there are more than 25,000 pharmaceutical packaging lines worldwide requiring modification, effectively implementing industry-wide track and trace standards presents substantial challenges to both manufacturers and machine builders. It’s critical that manufacturers find ways to overcome these challenges.

Countries around the world have already implemented track and trace legislation, and because most pharmaceutical manufactures operate globally, they must still comply with these rules. In addition to regulatory concerns, pharmaceutical companies that take a leading role in implementing track and trace technologies will have the opportunity to realize significant financial gains. These solutions provide manufacturers with an increased ability to manage product expirations, decrease the impact of product recalls, and minimize the counterfeiting losses that have become an epidemic in the industry.

The Current State of Standards

Today, global standards for track and trace vary enormously. In the U.S., multiple states have enacted e-pedigree regulations requiring serialization, which is the process of marking individual items with a unique identifying code by applying an RFID tag or printed barcode directly to the product so it can be traced through the supply chain.

In Europe, a number of countries also are demanding varying types of serialization solutions within supply chain processes. Many other countries are expected to follow suit. For example, as of December 2009, all pharmaceutical industry products distributed in Turkey were mandated to have the ECC200 Data Matrix barcode made up of Global Trade Item Number (GTIN), serial number, expiry date, batch number and human readable text. A similar standard without serialization is being implementing via French CIP 13 legislation, which has a deadline date of December 31, 2010.

Unfortunately, because systems implemented by different countries track information in different ways, there is not a standard system for tracking and tracing medicines across the whole of Europe. To help remedy the situation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has proposed implementation of a standardized identification solution for all pharmaceutical products across Europe.

The EFPIA solution calls for an end-to-end product verification process that ends at the point of dispense when pharmacists verify a unique serial number listed on a 2D data matrix barcode generated by the manufacturer. A scan of the data matrix will reveal any duplication of data on packs, triggering the system to alert that pharmacist to the possibility of a counterfeit product, according to the EFPIA.

Driving Toward a Global Standard

Unified track and trace processes across Europe certainly will help reduce production of counterfeit drugs; however, a global solution is necessary in order to truly eliminate the problem. To help achieve this goal, GS1 (formerly known as EAN International) and GS1 US (formerly Uniform Code Council, Inc.) have established EPCglobal to set up and achieve global adoption and standardization of Electronic Product Code (EPC) technology.

EPC Information Services (EPCIS) is an EPC global standard that offers a data model to record product movement throughout the supply chain. EPCIS standards are both industry and application neutral. In addition, the standards are user extensible, which allows each participating country to maintain and govern its own database of information to meet unique requirements.

The standards also allow for secure information exchange leveraging established security mechanisms – all participants control their own data and share it only with those entities they choose. Using this capability, some countries are choosing to create data vaults and databases to store serialization information for the entire country. It should be noted that EPCIS standards are not intended to replace existing enterprise systems, rather, supplement and complement the systems that are already in place.

Key Elements of Track and Trace

An effective track and trace solution requires implementing three levels of functionality – print and verify, serialization and track and trace. With this functionality, manufacturers can systematically print and verify marking numbers on all products (lot number, check digit, product classification, etc.), mark each product with a unique serial number, and create a central database of this information. The central database allows manufacturers to track and store the location and status of each product as it travels through the supply chain until it is sold to the customer. 

Serialization data can be extracted from four layers of supply chain operations, following the path an individual medicine from manufacturing through final delivery. The process begins on the shop floor, where serialization data first is created. Here, each individual drug manufactured is marked with a unique identifying code either using an RFID tag or printed barcode. Any hierarchy-level information, such as blisters, folder cartons, bundles, cartons, packages, or containers also is recorded at the shop floor layer.

Since production of pharmaceuticals in a single plant can involve several process stages, serialization information from each process stage is next collected and administered on a plant-wide layer. After that, serialization information is collected at the internal supply chain (enterprise) layer where data on product shipments between plants for further distribution is recorded. Last, the process of delivering drugs to distributors, wholesalers, pharmacists and hospitals is recorded at the external supply chain layer. This multi-layered approach allows for an end-to-end product verification process at the point of dispense.

Serialization solutions can be especially effective when quality requirements are high, when the product has an impact on consumer health and safety, when there is a threat of counterfeit products or when there is need for a full product history.

Beyond these considerations, serialization solutions can offer drug manufacturers and regulatory authorities deep insight into the supply chain, which can be used to gain a number of business advantages. In a 2009 AMR Research survey on supply chain integration, executives cited the following expected business benefits from item-level serialization:

·        Greater inventory visibility

·        Improvement in the returns process

·        Improved ability to detect and eliminate counterfeiting

·        Improved ability to detect and reduce “gray market” activity

·        Access to more timely and accurate sales data

The Challenges of Serialization

Implementing global standards such as EPCIS standards will present a number of challenges for manufacturers, especially when it comes to serialization:

·        Guaranteeing the uniqueness of serial data. To achieve this, the industry must provide a global schema that allows each manufacturer to apply a unique worldwide number. Ideally, there also would be a way to randomize these identifying numbers to help prevent counterfeiters from falsely replicating the system. 

·        Implementing a process and securing the proper equipment to efficiently apply and read barcodes

·        Overcoming physical product limitations that may make it difficult to label products

·        Printing and verification in the high-speed pharmaceutical manufacturing environment. Data matrix printing alone will present a major roadblock - it is forecast that up to 80 percent of installed coding and verification devices within the pharmaceutical and healthcare sector will not be able to print and verify at the speed and quality levels required by industry standards.

Today, many smaller system providers are implementing serialization solutions that offer cameras, scanner and software solutions focused on vision inspection. Because vision inspection is only one piece of the serialization puzzle, manufacturers implementing these solutions may have more difficultly fully addressing all of the challenges associated with serialization. Considering a modular, scalable serialization solution based on a layered model, such as the FactoryTalk PharmaSuite serialization solution from Rockwell Automation, may prove more effective and supports the flexibility needed to address changing country regulations in the long-run.

A scalable serialization model helps address the challenges on the shop floor and the plant layer, while connecting up through the enterprise layer as well. The solution can be easily integrated into existing packaging lines or used with new packaging lines. To cater to varying legislation, end markets and cost profiles, the solution can be implemented step-by-step. The typical process involves three stages, starting with print and verify, moving to product serialization and finally reaching complete product traceability.

The Rockwell Automation serialization solution, for example, is specifically designed for mass data handling required in pharmaceutical manufacturing. The system provides for the generation, randomization, aggregation, synchronization and management of serial numbers on all product packaging levels. It’s compliant with EPCIS standards and supports the transaction of serialization data to third-party systems such as SAP, IBM and contractor systems. It also supports transactions to global hosted serialized data vaults and databases from authorities and government organizations.

In order to help ensure that data is stored consistently and reliably and that it is visible for users, it’s important that a serialization solution includes a central server, site database and client application with HMI. A number of other features also help make the solution more effective:

·        A dedicated Ethernet control network architecture integrating a PLC controller for streamlined data communication across the plant

·        Integration of high-speed coding and verification capabilities required by industry standards including EPCIS

·        Device independent integration of printers, vision inspection camera systems, handhelds, RFID equipment with control of all serialization components of the line from one single cabinet. This add-on capability helps ensure minimal interruption of production and minimal validation burden.

·        A flexible workflow-based serialization application supports a consistent solution that considers local-area specific needs.

Industry leading pharmaceutical manufacturers are taking a proactive approach to serialization. Regardless of the status of regulatory requirements, savvy manufacturers realize that the stakes are extremely high when it comes to track and trace and that they have a lot to lose financially by postponing implementation. And in this intensely competitive industry, serialization solutions can provide a powerful way to negate some of the largest challenges the industry is facing – and offer new and exciting business opportunities.