Click on the links below to read articles of interest about counterfeit medicines and the EAASM.
Information sheet: European Alliance for Access to Safe Medicines. This information sheet details the mission, objectives and strategy of the Alliance. (March 2007)
Information sheet: European Alliance for Access to Safe Medicines – Become Part of the Solution. This information sheet highlights the growing problem of counterfeit medicines and identifies the role of the Alliance in addressing the issue. (March 2007)
28 July 2010
Whilst patients may be unaware about the true risk of drug counterfeiting, the pharmaceutical industry is far from complacent. It is safe to say that, in recognising these risks, the industry has developed over many years a variety of anti-counterfeiting 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 products.
If all of 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. 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 to 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.
This article looks at two technologies – the ePedigree approach and mass serialisation – and provides advice for companies wanting to implement serialisation for their products.
The World Health Organization created the International Medical Products Anti-Counterfeiting Taskforce (IMPACT)1 in 2006 to bring all relevant stakeholders together, including regulators, enforcement agencies, manufacturers and solution providers, to help quantify the size of the counterfeiting problem – and how to best address it. It has become obvious since then 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) has been 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 for beating counterfeit drugs – the US ePedigree-based approach and a European-style mass serialisation route, as proposed by European pharmaceutical industry federation EFPIA2. Understanding where these approaches came from helps put the differences in perspective. More critically, 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 wholesaling process, it critically includes wholesalers that may be responsible for repackaging into other unit levels, eg from pallet to case.
An ePedigree system 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.
Mass serialisation is about allocating a unique serial number to all products at item level – sometimes referred to as 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, the number is normally placed on secondary packaging such as the patient pack or the retail level (carton). Where appropriate, it can be on primary packaging, such as blister packs. Whilst creating a system for generating, allocating and encoding products is complex, it brings many advantages for tracking and traceability. This applies to combating counterfeiting as well as wider business process improvement within the internal and external supply chain.
Once a product has been securely identified with a unique random serial number and the product has entered the supply chain, this information is passed to a central checking database that can then be accessed to either confirm the authenticity of a package or record that the package has been dispensed or otherwise removed from the supply chain.
This process obviously relies upon the generation of serial numbers that cannot be predicted, upon the numbers being kept secure until the product is released and most importantly upon the integrity or security of the package to which the serial number is applied.
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, one does not have full visibility of exactly what has been moved.
In April, the US Food and Drug Administration put forward a recommendation in the form of a final guidance document to serialise products at item level3. This item level data can be linked to the initially larger aggregated packages that 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.
For life sciences 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 life-cycle of a product and beyond. Organisations need to make sure that they put into practice the correct systems and process 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 built-in serialisation capabilities, which can provide very high volumes of unique, secured and "intelligent" serial numbers, for this process would, therefore, seem vital. These types of solutions 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.
Another key component of implementation is having a system that supports design level integration with vision inspection systems using common standards. 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. 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, by implementing this type of approach, a company can create a highly collaborative coding and labelling environment that increases efficiency in labelling and despatch operations, and drops the gavel on counterfeit drugs and devices.
It is important for regulators and manufacturers alike to recognise that there are many elements that are critical to the long-term success of an anti-counterfeiting and patient safety strategy. All players involved in the supply chain need to be ready to act and adapt, and it is likely that a multi-layered approach will prove the most successful. However, technology will certainly be the most important helping hand.
1. WHO IMPACT web page
2. EFPIA anti-counterfeiting pilot success could see industry recognise parallel traders as part of supply chain, RAJ Pharma online, 19 April 2010
3. US FDA issues guidance on standardised numerical identifiers, RAJ Pharma online, 8 April 2010
This article is based on a white paper published by PRISYMID entitled Time to Act – Has Judgment Day Arrived for Counterfeit Drugs?, which can be downloaded here.
Vince Postill is development director at PRISYM ID, a UK-based company that delivers labelling and identification solutions for organisations that need complete product auto-identification and life-cycle traceability. Email:firstname.lastname@example.org.
Ian Banks (EAASM Board Member): Chip off the old block (PM Live)
Defending the patient: The EAASM has courted controversy with proposals to protect consumers from counterfeits. Jim Thomson
The 'click' of death? Operation PANGEA - the name given to the worldwide clampdown on internet sites selling counterfeit medicines, has brought this extremely serious problem fully into the spotlight (Irish Pharmacy News, January 2009)
British Medical Association Internet Medicines Press Release. A warning to patients about the dangers of buying prescription drugs via the internet has been released by the British Medical Association. (29 November 2007)
Parallel Trade is an Unacceptable Risk to Patient Safety. Jim Thomson launches a brutal and controversial assault on parallel trade. (August 2007)
How effective is the Medicines and Healthcare products Regulatory Agency in protecting patients? Jim Thomson, EAASM Chair, critically examines the protocols in place which are supposed to keep UK patients protected against substandard and counterfeit medicines (Pharma Marketletter, 29 October 2007)
Are Your Pills Fake? As counterfeit medicines reach local chemists, are YOU at risk? (Daily Mail, 23 October 2007)