Chandan Pat, Business Development Manager, Essentra, says that the key to implementation of a successful serialisation system is information management and the control of data integrity
In just over one year’s time, the EU Falsified Medicines Directive (FMD) has come into effect. The new legislation will apply to a number of medicinal products for human use and will consist of two key elements of safety feature; first, track and trace serialisation solutions and secondly, tamper verification solutions.
This legislation supports efforts to counter the rising issue of falsified medicines. As the illicit trade is becoming ever more sophisticated, the risk of these fake products reaching patients increases and can be extremely dangerous. Counterfeiters in some parts of Asia have been known to pay patients leaving pharmacies to obtain their genuine packaging in order to then fill them with false products.
As a leading global provider of healthcare packaging and authentication solutions, Essentra advocates the implementation of multiple measures to provide enhanced security, including serialisation, tamper verification and authentication solutions.
The FMD states that healthcare packaging must be a ‘unique identifier’ – which is most often done via serialisation; the system of tracking, tracing and verifying products via unique identification codes. These codes reveal the complete history of a drug, and take the form of a linear barcode, 2D barcode or a combination of numbers. The code will express key information about the drug contained in the box, allowing for the confirmation of the authenticity of the medicine and help to ensure that patients take the correct drugs.
However, there are still a number of challenges for pharmaceuticals to overcome in order to implement an efficient serialisation system. Firstly, a uniform mechanism must be put in place that meets the requirements at each level of the supply chain. This may require existing suppliers within the supply chain to invest in new IT systems, databases and business structures, which can be both expensive and administratively challenging. In addition, the creation of the required serial codes themselves is costly, particularly when additional elements are included. The more complex the structure of the serial codes, the more difficult standardisation will be across all companies within the supply chain.
With so many different codes and suppliers to manage, Essentra believes that the key to the implementation of a successful serialisation system is information 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 large amount of data. Each individual unit will have a unique identification code and, once printed, this code must be recorded and tracked through the drug’s journey from supplier to consumer. The monitoring and organisation of this vast amount of information can be demanding, so companies and governments must work together to create an effective data management system.
In addition to the unique identifier, the FMD also states that packaging should also contain an ‘anti-tampering device’. These devices are vital as they instantly allow the consumer to identify if the product they are about to use has been previously opened or interfered with, providing a first layer of security. Some examples of these solutions could be a label that is irreversible after opening, a label that leaves a void message or a carton that has glued locks.
Additionally, authentication features can provide a further layer of protection. They are often classed into three categories; overt, covert and forensic. Overt technologies enable instant authentication through visual inspection, such as holographic devices and colour-shift inks. Covert solutions – for example, microtext and microscopic tagging – rely on technologies such as infra-red and ultra-violet inks, and are difficult to detect without specialist equipment. Finally, forensic features, which include molecular markers and biological tracers, offer a further layer of authentication and can only be identified with laboratory equipment.
It is therefore clear that pharmaceutical companies and governments must act now to protect consumers from the threat of counterfeiters. With just a year until the FMD deadline, many companies are either at implementation stage or have already created new security and serialisation systems in-house. Meanwhile, those companies with hand-packed goods are tending to outsource to specialist secondary packaging companies, such as Essentra. Though introducing these solutions may be costly, the benefits to patients will be significant – and ultimately, that is who the pharma industry aims to protect.