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Pharmaceutical Manufacturing and Packing Sourcer

Time to Act

Despite extensive measures to halt their spread, counterfeit drugs are becoming more and more prominent in the global market. Vince Postill of PRISYM ID explains how serialisation provides companies with an effective weapon in the fight against fakes

THE SCALE OF THE THREAT

It is well understood that counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety. It is a global issue that affects all of us. It does not recognise borders or trade agreements, and its supply chain is fast to react to new opportunities and, in particular, weaknesses in the legitimate production and supply of medicines and devices.

The World Health Organization estimates that up to one per cent of medicines available in the developed world are likely to be counterfeit. This figure rises to 10 per cent globally, although in some developing countries it estimates that one third of medicines are not genuine.

Counterfeit drugs not only have an impact on legitimate businesses, but they also promote drug resistant strains of disease and can worsen medical conditions and even kill patients. The counterfeit industry is worth $38 billion every year and can therefore seem a very attractive market to enter for the unscrupulous.

While patients may be unaware of the true risk from counterfeiting, the pharmaceutical industry must avoid complacency. It is safe to say that, having recognised these risks, over many years the industry has developed a variety of anti-counterfeiting strategies, both covert and overt. These range from sophisticated pack design and labelling using special inks, holograms, tamper-evident seals and on-dose nano particles to field agents actively investigating instances of counterfeit product.

GLOBAL ACTION

So, if all this is being done, what has changed and why the new level of urgency? In short, the landscape has been evolving for some time. As governments and legislators have become more aware of the issues surrounding counterfeiting and the illegitimate trade of medicines, so they have sought to protect their citizens.

Industry regulators have introduced a variety of schemes to address the problem, from protecting packaging to securing the supply chain. These involve government-issued devices such as vignettes and holograms as well as the more topical information technology-based ePedigree and mass serialisation solutions, where an authentication and data trail is created.

Unfortunately, it has become clear that a country-by-country approach creates a multitude of compliance variables and potential supply chain and packaging conflicts. This does little to help create the coherent strategy that is so desperately needed either regionally or in a global market place.

TURNING TO TECHNOLOGY

In 2006, the World Health Organization created an Impact Taskforce to bring all relevant stakeholders together. These included regulators, enforcement agencies, manufacturers and solution providers, tasked with helping quantify the size of the problem and how best to address it.

As an ongoing project, it has become obvious that implementing a one-size fits all solution is almost certainly unachievable. However, it is agreed that track-and-trace technology is vital, alongside defining global identification standards using organisations such as the not-for-profit supply chain standards organisation GS1 to put in place a workable framework.

Specifically, GS1’s Global Trade Item Number (GTIN) was identified as a global standard for item and object identification that works with manufacturers, distributors, retailers and others within the drug supply chain. It can uniquely identify pharmaceutical products at a package level throughout the supply chain and, according to GS1, has already been adopted by 65 countries. As a result, it makes a good building block to help track the progress and authenticity of products.

CONVERGING APPROACHES

Beyond GTIN, two technologies have emerged as forerunners in the bid for beating counterfeit drugs – the US ePedigree-based approach and a European-style mass serialisation route. Understanding where these approaches came from helps put their differences in perspective. More critically, it highlights where these approaches can converge.

ePEDIGREE

ePedigree is based around creating a non-repudiable electronic record surrounding chain of custody and chain of ownership of prescription medicines and medical devices within the supply chain. It contains information on all transactions, from the time a pack or logistics unit leaves the manufacturer, to the point it enters a pharmacy or someone dispenses the drug. Encompassing the entire shipping and wholesale process, it critically includes wholesalers who may be responsible for repackaging into other unit levels, for example from pallet to case.

ePedigree aims to create a highly secure supply chain within which trusted and identified parties buy, sell, receive and dispatch goods. Each transaction is sealed using digital signature technology to protect the document. It records an entire product and supply chain life cycle so that any fraudulent activity (such as product diversion) can be more easily identified. A break in the chain or a missing electronic pedigree also raises suspicion about a product’s integrity.

MASS SERIALISATION

Mass serialisation allocates a unique serial number to all products at item level, sometimes referred to as a unique identification (UID) or standardised numerical identification (SNI). Traditionally, numbers or identifying codes would be sequential, but when forming an anti-counterfeiting initiative, this measure is inadequate. Sequential serial numbers can easily be predicted by counterfeiters and replicated along with batch or lot codes and expiry dates. Therefore, a mechanism needs to be put in place to allocate random numbers so that they are not predictable.

In the case of pharmaceutical serialisation, the serial number itself normally appears on secondary packaging, such as patient packs or retail boxes. Where appropriate, it can also appear on primary packaging, such as blisters. While creating a system for generating, allocating and encoding products is complex, it brings many advantages for tracking and traceability. This applies to combating counterfeiting and wider business process improvement within the internal and external supply chain.

MAKING THE LINK BETWEEN ePEDIGREE & SERIALISATION

Pressure is building on ePedigree to carry data about serialised product and packaging as part of the transaction record. It is not hard to see why, when without it you do not have full visibility of exactly what has been moved.

Only in the last month, the FDA in the US has now put forward a recommendation to serialise products at item level. This item level data can be linked to the initially larger aggregated packages which carry their own unique identity. As packs get split or de-aggregated and moved onto other supply chain ePedigree records, the serial numbers and their initial pedigree can be linked and traced back to their origin. Thus there is a convergence between the two approaches and the technology and infrastructure required to manage them.

IMPLEMENTATION

For life sciences organisations moving towards serialisation, a number of elements are important, including highspeed printing to get the codes onto products in a timely manner, code verification, subsequent storage and the retrieval of any of these millions of codes at any point within the life cycle of a product and beyond. Organisations need to make sure that they put into practice the correct systems and processes which can support them in meeting global standards and country specific requirements now and in the future.

Implementing a fit-for-purpose validated labelling solution with in-built serialisation capabilities which can provide very high volumes of unique, secured and ‘intelligent’ serial numbers for this process would therefore seem vital.

 These solutions give peace of mind during the production process. When label printing or marking directly onto products, all print actions need to be recorded automatically in an audit log. Details such as who, what (batch, lot, GTIN and serialisation code) and when are all written to a secure location.

A system that supports design level integration with increasingly more prevalent vision inspection systems using common standards, such as optical character recognition, optical character verification, and barcode reading, is key. During the design process, users must be able to set up and define which areas on the label format are subject to inspection by these camera systems. As well as defining the areas, it is possible that the user could define the type of inspection which is to take place on that block. As the inspection mask forms part of the label design, it is subject to revision control and approval management, providing confidence that any inspection will take place as designated.

In summary, by implementing this type of approach, organisations can create a highly collaborative coding and labelling environment which increases efficiency in labelling and dispatch operations, and slams the door on counterfeit drugs and devices.

A SAFER FUTURE

From both a personal and business level we all want to minimise the counterfeit threat and it is important for regulators and manufacturers alike to recognise that there are many elements which are critical to the long-term success of an anti-counterfeit and patient safety strategy. We all need to be ready to act and adapt, and it is likely a multi-layered approach will prove the most successful.


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Vince Postill is the Development Director at PRISYM ID and is responsible for the development and professional services teams. He has considerable experience in software development, 18 years of which has been gained within the Auto-ID market. Previously Vince worked for a number of different software companies, including Racal Radar Defence Systems. His roles have varied from Commercial Sales, Product Development to Managing Director. With his considerable experience in business development, Vince is also responsible for the company’s strategic partnerships.
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