This article explains the role of serialisation and the main technological approaches to beat counterfeit drugs. Understanding where the US ePedigree-based approach and a European-style mass serialisation route came from helps to put the differences in perspective
As efforts to prevent counterfeit drugs become more global and co-ordinated, Vince Postill, VP of Business Development, PRISYM ID explains the role of serialisation and the main technological approaches
It is well-recognised 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 quick to react to new opportunities and, in particular, weaknesses in the legitimate production and supply of medicines and devices.
The World Health Organisation (WHO) estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. This figure rises to 10% globally, although in some developing countries an estimated one third of medicines are counterfeit.
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 US$200bn (€156bn) every year and, therefore, can be very attractive to low paid print operators.
While patients may be unaware of the true risk, the pharmaceutical industry can be far from complacent. It is safe to say that, having recognised these risks the industry has developed over many years a variety of anti-counterfeit strategies, both covert and overt. They range from sophisticated pack design and labelling using special inks, holograms, tamper evident seals and on-dose nanoparticles to field agents actively investigating instances of counterfeit product.
So if all this is being done, what has changed and why the 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 the problem of counterfeiting (and illegitimate trade in medicines) they have sought to protect their citizens.
A variety of schemes have been introduced to address the problem
Industry regulators have introduced a variety of schemes to address the problem – from protecting the packaging to securing the supply chain. These involve government-issued devices, such as vignettes and holograms, and 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 a coherent strategy that is so desperately needed either regionally or in a global marketplace.
The WHO created an Impact Taskforce in 2006 to bring all relevant stakeholders together – regulators, enforcement agencies, manufacturers and solution providers – to help quantify the size of the problem and consider how best to address it. As an on-going 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, as is defining global identification standards using organisations such as 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 mentioned above, two technologies have been developed in the bid to beat counterfeit drugs: the US ePedigree-based approach and the European-style mass serialisation route. Understanding where these approaches came from helps put the differences in perspective. More importantly it highlights where these approaches can converge.
The ePedigree approach is based around creating a non-repudiable electronic record surrounding chain of custody and chain of ownership (sale) 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, critically it includes wholesalers who may be responsible for repackaging into other unit levels, e.g. from pallet to case.
The ePedigree records an entire product and supply chain lifecycle
The 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 lifecycle so that any fraudulent activity (such as product diversion) can be more easily identified. A break in or a missing electronic pedigree also raises suspicion about a product’s integrity.
ePedigree approach – based on the EPCglobal Drug Pedigree Messaging Standard: An ePedigree is an electronic record containing information regarding each transaction resulting in a change of ownership of a prescription drug, from sale by the manufacturer, through acquisition and sale by a wholesaler, until final sale to a pharmacy or a person furnishing, administering or dispensing the prescription drug
Mass Serialisation is about allocating a unique serial number to all products at item level –sometimes referred to as a UID (Unique Identification) or SNI (Standardised Numerical Identification). Traditionally, numbers or identifying codes would be sequential, but as part of an anti-counterfeiting initiative this is inadequate. Sequential serial numbers can easily be predicted by counterfeiters and replicated along with batch/lot codes and expiry dates. Therefore a mechanism needs to be in place to allocate random numbers so they are non-predictable.
In the case of pharmaceutical serialisation it is normally on secondary packaging, such as patient pack or retail level (carton). Where appropriate it can be on primary packaging, such as the blister. While creating a system for generating, allocating and encoding products is complex, it brings many advantages for track & traceability. This applies to combating counterfeiting and wider business process improvement within the internal and external supply chain.
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.
The US FDA recommends serialising products at item level
The US FDA has 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 infra-structure required to manage them.
For life science organisations moving towards serialisation, a number of elements are important, including high speed printing, code verification, subsequent storage and retrieval of any of these millions of codes at any point within the lifecycle of a product and beyond.
Organisations need to make sure that they put into practice the correct systems and processes that 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.
Details, such as who, what and when, are all written to a secure location
These types of solution give full peace of mind during the production process. When label printing or marking directly onto products, all print actions need to be automatically recorded in an audit log. Details, such as who, what (batch, lot, GTIN and serialisation code) and when, are all written to a secure location.
Also a system that supports design level integration with vision inspection systems using common standards is key. During the design process, users are able to set up and define which areas on the label format are subject to inspection by the camera systems. As well as defining the areas, it is possible that the user can define the type of inspection that is to take place on that block.
EFPIA Product and Verification System: Product and Data Flow. Source: EFPIA Product Verification Project – Joint final Report April 2010
Possible inspection modes include: optical character recognition, optical character verification and barcode reading. As the inspection mask forms part of the label design it is subject to revision control and approval management, which provides confidence that the inspection is taking place as designated. In the event that the vision inspection reveals a label failure, it is possible to configure automated reprints or line stop conditions to facilitate inspection of the printing devices.
In short, implementing this type of approach creates a highly collaborative coding and labelling environment that increases efficiency in labelling and despatch operations and drops the gavel on counterfeit drugs and devices.
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 there are many elements that 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. It is likely that a multi-layered approach will prove the most successful; however, technology will certainly have been the most important helping hand.