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Will new serialisation legislation redraw the lines in the battle against pharmaceutical counterfeiting?

The challenge of counterfeiting in the pharmaceutical industry is an ever present and constantly evolving power struggle between the pharmaceutical companies and criminal organisations who seek to profit by selling cheap, ineffective and often lethal copies of products, either through existing supply chains or over the internet.

Historically, pharma companies’ anti-counterfeiting measures have been kept secret, even within their own organisations. The less people who know the techniques being employed, the less opportunity there are for leaks. Both overt and covert approaches are used and before looking to the future, they are worth reviewing.

Overt anti-counterfeiting techniques are clearly visible on the packaging. Similar to techniques employed in the banking industry, components are designed to include graphical patterns and elements, including holographic images and colour shift inks, that are difficult to replicate at low cost.

Covert measures are in the main invisible to casual viewers and are a key method of identification of counterfeit product. Techniques employed include UV varnishes with known subtle changes to their repeating patterns, micro-text (very small text, invisible to the naked eye and only reproducible by specialist printing), reactive inks and chemical tagging agents, all allowing the legitimacy of a pack to be validated by the dispenser or investigating authority. Implementation costs for all these methods vary, as do their success rates, but each endeavour to make the counterfeiter’s task a little harder.

These approaches have been employed individually by companies, each organisation seeking to find a solution that protected their products and their patients, largely in isolation. In 2006 however a World Health Organisation coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce) was established, seeking to make a step change in anti-counterfeiting measures and drug security. This coalition sought to identify standards and initiatives that could be implemented across borders to address the pernicious rise in counterfeiting globally. For the first time, realistic, holistic approaches could be envisaged, exploiting innovative technological solutions that could make the tracking and tracing of product possible from manufacture through to dispensing.

To give some context to the potential size of the problem, US figures suggested that if 1% of the 3.4 billion prescriptions issued in the US in 2006 were dispensed with counterfeit product, then 34 million prescriptions could be affected. In other countries the problem is thought to be much higher, affecting perhaps 30% of all prescriptions.

The state of California attempted to take the legislative lead back in 2004, with portions of their anti-counterfeiting and anti-diversion legislation requiring implementation in 2005/06. The electronic pedigree elements first came into effect in 2009, requiring full traceability of product from manufacture to pharmacy, at ‘immediate container’ level, though the implementation deadline has now been pushed back to 2015. Serialisation of the saleable unit remains the primary requirement, requiring electronic systems to track, trace and document all transactions.

inpharm datamatrix

Elsewhere, India has recently announced mandatory serialisation requirements for all exported products from July 2011, through the use of 1D and 2D barcode implementation on primary, secondary and tertiary packaging. The European Parliament, following a successful trial in Sweden, have recently (Feb 16 2011) progressed a directive that will require all companies manufacturing and handling medicines within the EU to address anti-counterfeiting in their distribution chains. Amongst the measures (which include the compulsory use of tamper evident labels) will be the adoption of mandatory, pan-European pack serialisation, most likely through the use of 2D barcodes, allowing pharmacists to instantly know if a pack has been dispensed with the same serialisation code. This builds on the recent implementation in France of Data matrix codes containing product identification number, batch number and expiry date information on each pack. Following final approval by the Council of Europe, national governments will then implement serialisation legislation locally, with a possible European-wide deadline for completion.

So, the clock is counting down towards a major milestone in anti-counterfeiting. Technology partners have the solutions to manage these new and complex data requirements. Systems are available to allocate, print, check and manage serialisation data and share it across the supply chain and pharmacist network, both at national and international levels, integrating with existing manufacturing, shipping and receiving transactional systems. As a by-product this has the potential to deliver greater visibility to supply chains of real-time sales data, making for more effective demand management – companies can manufacture product against real sales as opposed to forecasts and thereby realise efficiency benefits.

What is undeniable is the significant increase in costs for the whole pharmaceutical sector, in manufacturing, warehousing and dispensing, that will be required to meet the directives. Good consultancy advice will therefore be paramount in implementing the most appropriate and cost effective solutions for pharmaceutical businesses.  

Pinnaculum and other specialist industry consultants stand ready to assist companies, delivering both patient safety and improved revenue by reducing counterfeiting opportunities to an absolute minimum. The arms race of counterfeiters versus legislators, pharma companies and solution providers will continue long into the future but new technologies and initiatives can give reason for optimism.

Mark Wilkinson is managing director of Pinnaculum, a specialist graphics and packaging management consultancy to the pharmaceutical and life sciences sectors, who support their clients through outsourcing, technology, consultancy and creative services. www.pinnaculum.co.uk

This article appeared in the April 2011 edition of Pharmafocus

Posted by Mark Wilkinson

Filed in Anti-counterfeiting,

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