To achieve this, a more sophisticated labelling system than the European Article Number (EAN) barcode — the current retail labelling standard — is needed in the pharmaceutical sector. Although conventional barcodes have revolutionized labelling during the last 30 years, by today's standards they offer limited capacity for data handling in some applications; for example, with thousands of individual product packs carrying the same barcode, it is impossible to check if a barcode has been copied and used on counterfeit goods, or if products are destined for different markets. Furthermore, EAN barcodes provide no capacity for batch or shipmentspecific data.
A report by the FDA in 2004 included a number of widereaching guidelines for drugs manufacturers to help protect consumers from counterfeit products.1 These recommendations included stricter licensing requirements, tougher penalties, increased education and collaboration in the supply chain, and the use of new labelling technologies. While most manufacturers can see the benefits of implementing more effective labelling systems, however, many are unsure of how to continue. With sometimes conflicting information offered by the providers of competing systems, finding the right labelling solution can be difficult.
New labelling technologies
Today's drug manufacturers can choose from a wide selection of automatic identification and data capture (AIDC) technologies; these have been developed to enable detailed productspecific data to be stored on labels, identified and communicated around the world. Solutions range from printed barcodes to radio frequency identification (RFID) tags, but all essentially fulfil the same purpose: a smarter, more versatile way of storing and sharing data.
For instance, using AIDC technologies, manufacturers can include product or batchspecific data in individual product labels. In the pharma industry, this could enable suppliers and retailers to verify a product quickly and accurately — in most cases using standard technology. Just as importantly, additional data can be encoded in the product labels as they pass through the supply chain, providing detailed information on the journey a product has taken from manufacturer to consumer; therefore, considerably improving traceability.
Perhaps the most publicized, and controversial, of these new labelling technologies is RFID. RFID tags can be read without the need for close contact or a direct line of sight, and offer read/write functionality, which makes them ideal for tracking products and monitoring processes. However, many decisionmakers remain confused about the capability of RFID, and the relatively high cost and complexity of implementing the technology has prevented its progress in many areas, including the pharma industry. The issue of compatibility has also been a stumbling block as manufacturers are hesitant to label products with tags that other organizations throughout the supply chain may not have the technology or expertise to read or update.
These issues have contributed to the growing popularity of the 2D barcode in pharmaceutical applications. The 2D barcode is a development on the now ubiquitous EAN (1D) barcode, offering a more sophisticated level of data handling, while being considerably cheaper and easier to implement than completely new technologies.
2D barcodes can hold considerably more information than standard barcodes (usually up to approximately 1000 characters of information on a single label, depending on the level of encryption) making them better suited to meet the requirements of today's manufacturers. This increased level of information can be held on a label the same size or smaller than a conventional barcode label, and the codes can, in most cases, be printed using the same technology, helping to minimize the cost of upgrading. Furthermore, as well as allowing product information to be accessible from a central database, 2D barcodes can also function as a database themselves, providing a portable information source on the labelled product.
Currently, there are two types of 2D barcode available: stacked and matrix. Stacked barcodes are essentially multiple rows of small standard barcodes stacked vertically above one another, which allows more information to be stored on a single label. Matrix barcodes, specifically 'DataMatrix' codes, have so far been more popular in the pharmaceutical sector, partly because of their ease of integration and compatibility. These matrix codes provide greater data capacity than the stacked type, and can usually be scanned vertically or horizontally to make them easy to read.
While DataMatrix codes work in a similar way to conventional barcodes, they look quite different. The codes comprise a pattern of black and white cells, typically in a square format. This makes them extremely spaceefficient and scaleable depending on the amount of information to be stored.
Following years of development, DataMatrix codes are now a viable labelling solution for pharma manufacturers. This is partly thanks to error detection and correction techniques that can be incorporated into the barcode to improve reliability and scan success rates; for example, data can be duplicated several times to provide backups if part of the label is damaged.