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News February 22, 2011

Global compliance issues influence pharmaceutical traceability

Impending global legislation is set to bring wide-ranging changes to the coding and marking operations of pharmaceutical manufacturers.

More challenges facing the healthcare industry today than at any time in the previous 30 years. Pressure on patents, massive growth in the incidence of counterfeit products, a spotlight on manufacturing efficiency, and the increased complexity of developing and releasing new medicines are all causing major upheaval within the industry.

In addition, an increasing number of fiscal recovery and legislative compliance programs continue to oblige manufacturers to allocate considerable investment and undertake modifications to existing production lines. Any company supplying to the market in question needs to demonstrate compliance, so that in effect, it's an issue for virtually the entire global pharmaceutical community. Many manufacturers assume that by implementing a track-and-trace system, they will resolve all or many of the current issues, but that's not necessarily the case.

It is also worth noting that “track” refers to the identification of the product location in real time as it moves forward through the distribution chain, whereas “trace” defines the historical understanding of where a product has been, looking backwards through the distribution chain. It is therefore entirely possible to implement a track or trace system, which are not interdependent.

Any assumption that track-and-trace is the sole solution to all problems brings to mind the debate in the not too distant past over the potential of RFID. You will no doubt recall there being a tremendous amount of excitement generated around RFID and how this “silver bullet” would hold the answer to fulfilling the authentication requirements of the entire supply chain.

Rumors of RFID's death have been greatly exaggerated. Indeed, RFID is still alive, well, and active in the business of asset tracking, particularly for high-value goods. What is also true is that other coding strategies, namely one- and increasingly two-dimensional codes, have their place and offer their own particular benefits as data carriers.

Those sectors in which RFID has made inroads, have in some cases, actually seen the technology become a driver for change. In particular, and perhaps because of the imperative of legislative compliance, this includes the pharmaceutical sector, which has to a large extent proven a test-bed for RFID technology. That said, its use within this sector is far from universal; an acknowledged lack of robustness makes it unsuitable for 100% verification at unit-of-sale level on packaging lines, for example.

That's because the lower read rates compared to conventional codes increase the likelihood for error and hence the potential to undermine the entire audit trail. However, RFID is establishing itself as a data carrier at pallet level, where a simple manual re-scan in the event of a read-failure, reduces such an eventuality.

Fundamentally, the much-vaunted potential of RFID as a data carrier has actually prompted both debate and action on the establishment of an infrastructure for mass serialization. Where the original premise of such systems was that RFID would be the data carrier from packaging line to dispensary, experience shows that a mix of technologies is the most practical solution. At unit-of-sale level, therefore, best practice--as recommended by regulators such as the U.S. Food and Drug Administration and industry bodies including EFPIA--is currently a line-of-sight bar code, such as 2D data matrix. The key difference is that where formerly RFID was perceived to be the solution, the focus now is on the management of captured data, with the choice of data carrier being less significant.

Mass serialization, vignettes, and increased use of 2D data-matrix codes

With mass serialization schemes scheduled for implementation in various European markets over the next four to five years, there are a number of reasons for the continued prevalence of machine-readable codes like 2D data matrix within the pharmaceutical industry. The benefits of mass serialization have also given rise to a move away from covert layers with more secure overt layers and, longer term, the increased potential for online digital tax/duty/vignette labels.

Indeed, a number of legislatures are also proposing schemes based on coded vignette labels, to provide physical as well as electronic records of reimbursement. Irrespective of whether codes are marked directly onto the product or onto a vignette, it is likely that the data carrier will be ECC200 2D data matrix.

Data Matrix ECC200 is the most common format due to its small size, is extremely robust as a data carrier and boasts a large information capacity; it can also be read omni-directionally at low contrasts. ECC200 codes incorporate advanced Reed Solomon encoding error checking and correction, which allows bar codes that are up to 60% damaged to still be recognized.

Since 2004, this type of code has also been part of the GS1 (EAN/UCC) family of standards; the ISO-recognized set of data structures that remain the most commonly used.

Global legislation and its ensuing challenges

The development of technologies capable of printing and reading 2D data matrix codes online has allowed the healthcare industry to realize some of the aspirations in patient safety, through authentication, the prevention of reimbursement fraud, and the combat of illicit trade.

That has given rise to various legislative drivers that are further influencing the move towards machine-readable codes like the ECC200 data matrix. A growing area of interest is mass serialization and a number of countries are changing their packaging requirements through increased traceability legislation. As well as the utilization of 2D bar codes, this is set to involve a greater use of serialized numbers and increased levels of human-readable information.

Among this legislation is France's CIP13, which, requires every pharmaceutical item produced to incorporate a 2D data-matrix bar code comprising product code/batch number/expiry date.

Other countries also have similar proposals in place to adopt the same legislation, which will mean that manufacturing companies will be obliged to add new print and verify capabilities to their existing lines. Indeed, from a general technology point of view, it is estimated that up to 80% of installed coding devices within the pharmaceutical and healthcare sector required to print this information will be redundant at the speed and quality levels required.

Although it may look like a vastly different set of requirements there are two common themes of either vignette labeling or the addition of machine-readable directly on packaging. For the implementation of machine-readable code printing, excellent coding and good handling is a necessity, while vision and data management might be an additional requirement. The need to add RFID could also be possible, although this is unlikely to be implemented below pallet level. Thermal ink-jet printers, thermal-transfer, print-and-apply labeling, drop-on-demand and piezo ink-jet printingwhich can all be suitable depending upon the particular application needs.


Commercial confidentiality frequently precludes those involved in implementing traceability projects to share their experiences. That was one of the reasons that Pera launched its Securetrace Project. Pera, a U.K. not-for-profit technology centre, received funding for a track-and-trace pilot through the U.K. technology strategy board and subsequently formed a consortium of 10 leading technology partners.

The process begins when pharmaceuticals are imprinted with unique and secure 2D bar codes featuring authenticating markers in the ink. A unique natural fingerprint is also generated using laser surface authentication. Pack data is aggregated to cartons and pallets, bar codes and RFID labels are applied to cartons, and all information is stored in a master database. Once the pharmaceuticals leave the packaging facility, field readers provide authentication and verification of the product as it travels through the supply chain to its point of dispensation.

There are a number challenges associated with printing machine-readable codes--namely that the code formats are much larger. Data-matrix codes need better mechanical handling and process control than normal and the printing technologies depend on several variables.

The choice of vision system is also critical (standards/algorithms/connectivity) and the data management and security is of paramount importance. What is fundamental is the need to have a holistic project approach, as any system is only as good as its worst part.

Implementation issues

It should not be forgotten that, even upon successful application of the appropriate data carrier, problems can still arise further down the supply chain. Like France's CIP13, Turkey's ITS (Ilac Takip Sistemi) scheme aims to incorporate the compulsory use of the same 2D code in order to allow full tracking of healthcare products. This includes prescription and over-the-counter medicines and dietary supplement products from their importation or production in the country through to the point of dispensing in the pharmacy.

Despite having the label as one of the world's foremost distribution hubs for counterfeit medicines, the project was initially designed to combat widespread reimbursement fraud in the country, which is estimated to cost the state around $150m a year. Securing the supply chain from counterfeit, substandard, and diverted medicines is an added benefit.

Implementation of the ITS scheme has suffered ongoing problems; having only just gone live after much delay, ITS illustrates the logistical obstacles that impact upon the rollout of such projects. Most of the opposition to the Turkish system has arisen from smaller pharmacies, which are against the cost of purchasing and implementing the scanner system for the scheme, estimated to cost around $150, and any related equipment such as an updated IT system. This has led many to predict that the date for mandatory implementation may slide even further, if such issues cannot be overcome.

In addition to the EFPIA pan-European proposal and defined implementations in Turkey and France, other countries that are proposing increased product identification and authentication within the healthcare sector include Brazil, China, Serbia, South Korea, Spain, and Greece.

However, there is no one solution that will fit all legislative requirements or customer requests. The best approach is to be clear which markets are being supplied by which lines and therefore determine the minimum requirements for product compliance. Many companies then decide which approach they wish to adopt, if any, above the basic requirements of legislative compliance at a corporate, geographic, or site level.

It is therefore essential that manufacturers and packaging companies sit down with key suppliers and leading industry experts to agree the best approach for a phased, long-term, cost-effective, and sustainable program to suit their needs. After all, there is no universal technology and different packages will work best with different circumstances.

In addition, the irksome and protracted instigation of the Turkish scheme demonstrates one of the fundamental aspects of implementing such systems: regardless of whether it's an RFID label, 2D data-matrix code, or another form of data carrier, it is how the information is handled and what happens to it after it has been applied that is most important. This will be influenced by a number of cost, logistical, technological, and infrastructural issues, to name a few. Also evident is that the chances of success for any traceability scheme depend on buy-in from the entire supply chain community.

Once these issues are successfully addressed, managing the data correctly will uphold the requirement for supply chain visibility from point of manufacture to point of sale and ensure the fundamental objectives of any identification strategy--irrespective of the type of data carrier--are met.

--Article supplied by Craig Stobie, Healthcare Sector Manager at Domino

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