Forthcoming legislation is set to bring wide-ranging changes to the coding and marking of pharmaceuticals. But as Craig Stobie, healthcare sector manager at Domino, explains, even with the application of the right data carrier, there are many other issues to overcome
Cast your mind back to the not too distant past and you might recall a tremendous amount of excitement being generated around RFID and how this "silver bullet" would hold the answer to fulfilling the track and trace requirements of the entire supply chain.
You are probably wondering why the hubbub around this supposedly revolutionising technology has since quietened. To borrow a famous quote, the truth is that rumours 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 proved to be 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. This is because the lower read rates compared with 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 serialisation. 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 FDA and industry bodies including EFPIA - is currently a line-of-sight barcode, 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 serialisation
With mass serialisation schemes likely to be implemented in a number of European markets over the next four to five years, there are a number of reasons for the continued prevalence of machine readable codes such as 2D data matrix within the pharmaceutical industry. Data Matrix ECC200 is the most common format; small in size, it is an extremely robust data carrier that boasts a large information capacity and can be read omnidirectionally at low contrasts.
What is more, ECC200 codes incorporate advanced Reed Solomon encoding error checking and correction; this allows barcodes that are up to 60% damaged still to be recognised. Since 2004, this type of code has also been part of the GS1 (EAN/UCC) family of standards; the ISO recognised set of data structures remains the most commonly used.
The development of technologies capable of printing and reading 2D data matrix codes on-line has finally allowed the healthcare industry to realise some of the aspirations in patient safety, through authentication, the prevention of reimbursement fraud and the combat of illicit trade.
This has given rise to various legislative drivers that - thanks to the array of benefits delivered - are further influencing the move towards machine readable codes such as the ECC200 data matrix. As mentioned, a growing area of interest is mass serialisation and a number of countries are currently changing their packaging requirements through increased traceability legislation. As well as the utilisation of 2D barcodes, this is set to involve a greater use of serialised numbers and increased levels of human readable information.
Within this legislation is France's CIP13; when it comes into effect on 1 January 2011, this will require every pharmaceutical item produced to incorporate a 2D data matrix barcode comprising product code/batch number/expiry date.
Other countries have similar proposals in place to adopt the same legislation, which will mean that manufacturing companies will be obliged to add new print and verification capabilities to their existing lines. 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.
It was partly as a result of such measures that Domino introduced its G-Series of thermal inkjet printers, the attributes of which afford specific advantages to manufacturers seeking to fulfil new track and trace legislation by printing 2D bar codes and other machine readable formats. Already making a difference to the coding and marking operations of manufacturers, the G-Series has proved to be a formidable asset in combating counterfeiting and protecting brand value.
Even upon successful application of the appropriate data carrier, problems can still arise further down the supply chain. In common with France's CIP13, Turkey's ITS (Ilac Takip Sistemi) scheme aims to incorporate the compulsory use of the same 2D code 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 inglorious label as one of the world's foremost distribution hubs for counterfeit medicines, the project was initially designed to combat widespread re-imbursement fraud in the country, estimated to cost around US$150m (b102m) a year. Securing the supply chain from counterfeit, substandard and diverted medicines is an added benefit.
However, implementation of the ITS scheme was delayed (at the time of writing it was scheduled to go live on 1 October), demonstrating the enormous logistical obstacles that affect the roll-out of such projects. Most of the opposition to the Turkish system has come from smaller pharmacies, which are against the cost of purchasing and implementing the scanner system for the scheme, estimated at around $150(b102), 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.
The irksome and protracted instigation of the Turkish scheme demonstrates one of the fundamental aspects of implementing such systems: regardless of whether it is 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 but 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.
New counterfeit pack detection technology
Researchers at Leicester University, UK have combined crime research and space physics in a project that could lead to the quick detection of counterfeit pharmaceuticals.
Born out of collaboration between Perpetuity Research and Consultancy International (PRCI) âEuro a spin out of the University ââ"šÂ¬ and the Universityââ"šÂ¬Ã¢"žÂ¢s Space Research Centre, the technique relies on detecting the differences between the characteristics of light reflected from printed packaging.
The unique light source incorporated within the system and the selection of the critical points on the packaging at which the tests are conducted provides a degree of randomness that is not known to the counterfeiter and restricts the ability for it to be replicated.
The technology has been developed from a spectrograph originally designed for astronomical research and trials so far have resulted in a 100% success rate in identifying counterfeit products where the differences could not be detected with the naked eye.
www.le.ac.uk