Tampered evidence and serialization

Data released by the United States Food and Drug Administration (USFDA) states that approximately 10% of all pharmaceuticals sold globally are counterfeit. Whilst counterfeiters are active around the world, not all markets suffer equally. Developed nations have the lowest amount of counterfeit pharmaceutical goods with an estimated 1% penetration rate in Europe and the USA, whilst developing nations show particularly severe levels. For example, it is estimated that up to 30% of all medicines in Africa and the Far East are fake. In 2011 the World Health Organization (WHO) reported that 64% of all antimalarial drugs in Nigeria were counterfeit.

These figures continue to grow due to increasingly complex supply chains, the increased sophistication of counterfeiters, a lack of enforcement capacity and the expansion of ecommerce. According to the WHO up to 50% of drugs available online are fake – with estimates reaching up to 70% in some African and Eastern European countries.

In light of this, various anti-counterfeiting efforts have been developed by pharmaceutical companies and various legislation is being implemented by governments around the world. For example, in China all healthcare packaging currently includes a 20-digit Electronic Drug Monitoring Code (EDMC), so packs can be tracked and tested for authenticity throughout the supply chain. However, the China Food & Drug Administration (CFDA) issued a notice in July last year stating that amendments to the drug system requirements were in progress, following criticism of the existing system. The key issue that the industry faced was the fact that the EDMC coding format did not correspond with other traceability systems around the world, with many countries – including South Korea, India and Turkey – using the Global Trade Item Number (GTIN) format.

It is clear that the current global anti-counterfeiting systems and methods need to be reviewed – and in some cases need to be imposed, with countries such as Japan having no agreed deadlines for action – in order to be successful. Although legislation does vary, all proposed regulation covers either or both systems of serialisation and tamper verification. As a leading global provider of packaging and authentication solutions, Essentra advocates implementing several of these measures to provide enhanced security through a multi-layer approach.

Serialisation

Serialisation is the system of tracking, tracing and verifying products via unique identification codes. These unique identifiers reveal a complete history of the drug; from the supplier to consumer, for the duration of the drug in the marketplace and any additional time necessary for returning and disposing of the pack after it has expired. The codes are commonly presented as a linear barcode, 2D barcode or a combination of numbers, conveying key data elements such as the drug’s product code, national reimbursement and identification number, batch number and expiry date. These data elements should also be printed on the packaging in a legible format in case the barcode is unreadable. In addition to confirming the integrity of the medicine and helping to ensure that patients are taking the correct reliable medicine, these data elements also facilitate withdrawal and return procedures should a recall be necessary.

When implementing a serialisation system, pharmaceuticals have various issues to keep in mind. Firstly, a uniform system must be put in place that meets the requirements at each level of the supply chain. This may require existing suppliers and companies within the supply chain to integrate new IT systems, databases and business structures, which could prove both financially and administratively challenging. In addition, the creation of the required serial codes themselves will call for significant expenditure. The more complex the structure of the serial codes, the more challenging standardisation will be across all companies in the supply chain.

The key to the implementation of a successful serialisation system is the ability to run a functioning repository system that allows for precise data management and the control of data integrity. The process of track and trace will mean that every point within the manufacturing chain will have to carry out a stop-check, resulting in the collection of a significant quantity of data. Each individual unit will have a unique identifying code and, once printed and supplied to the public, must be decommissioned in the system so any other pack that has the same code cannot be verified. If under unforeseen circumstances a box is accidentally damaged and made unusable, the code must be recorded as inactive. The organisation of this vast network of data will prove challenging, so companies and governments must work together to create a successful way of managing it effectively.

Tamper verification

Indeed, while serialisation verifies the authenticity of the pack of medicine, counterfeiters can easily collect used genuine materials and refill them with fake drugs, reclosing the original packaging and passing the product off as genuine. This has been seen in China, where counterfeiters obtain genuine boxes from patients leaving pharmacies. This reinforces the need for a multi-layered security approach, to provide protection for both the packaging and the contents inside.

Tamper verification shows whether the packaging has been opened or altered since it left the manufacturer, ensuring that the content of the packaging is authentic. It provides the end user with confidence, allowing them to personally judge that the product they are opening is genuine and originates from the legitimate manufacturer. This can be done in several different ways, for example through glued cartons, tapes or specialist labels.

Essentra has developed three types of tamper evidence labels – fibre-tear, void and frangible – all of which can be applied to pharmaceutical cartons. Fibre-tear labels irreversibly damage the carton board on to which they are affixed, void-release labels leave a void message when removed, and frangible film labels use a specially engineered substrate that disintegrates when removed.

Summary

The optimal approach to protect against counterfeiting will include both serialisation and tamper verification solutions, thus making it as difficult as possible for counterfeiters and the illicit trade to succeed. It is clear that the pharmaceutical industry must react to the threat posed by counterfeiters not only to protect the integrity of brand owners but also, more importantly, to ensure that patients are consuming the genuine medicine they require.