Serialisation: the winding road to implementation

The need for pharmaceutical serialisation is universally acknowledged but has led to a proliferation of national schemes with no global standardisation; Essentra Packaging looks at why serialisation is only part of the solution to counterfeiting challenges

The healthcare and pharmaceutical industry is becoming increasingly prone to substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. It is clear that the globalisation of the market has played its role in exacerbating this challenge, but the growing sophistication of counterfeiters, the expansion of e-commerce and a lack of an enforcement capacity have been fundamental drivers.

To give an idea of the scale of this problem, the World Health Organisation has estimated that up to 15% of all pharmaceutical drugs globally are counterfeited. While this translates to around 1% of drugs in developed countries within Europe and North America, the issue is more severe in developing countries in Africa and the Far East where the figure can rise to 30%. Furthermore the World Health Organisation reported that in 2011, 64% of all antimalarial drugs in Nigeria were counterfeit, a situation that could prove fatal for those suffering with the disease.

In response to this continued threat, government leaders, politicians and executives from major pharmaceutical providers are coming together to increase efforts to protect citizens from SSFFC medical products, currently through track and trace serialisation and tamper verification features. As a leading global provider of packaging and authentication solutions, Essentra advocates the implementation of both serialisation and tamper verification features, to increase patient safety.

Serialisation enables the tracking, tracing and authentication of products through the use of unique identification codes. Each code – presented as a linear barcode, 2D barcode or number combination – reveals a complete transactional history of the drug, through the supply chain to the consumer. Additionally, the code will provide key information such as the product’s name, the pack quantity and expiration date. Each unit-level serial number connects to a larger network of numbers that identify the medication within a bulk container, case or carton.

Although the advantages of drug serialisation are widely known in the pharmaceutical industry, the importance of mandatory serialisation has not been widely appreciated. While serialisation helps to protect the reputation of pharmaceutical companies, it ultimately aims to protect patients by making sure that they are taking the intended medicine.

The reality is that for serialisation to truly serve its purpose, a uniform system must be put in place, bringing together chemists, manufacturers, packaging companies and pharmacies. But implementing a system that is sufficiently robust creates a variety of challenges.

First, the process of creating a complex structure for serial codes is cost intensive, and as additional elements are included in the codes, the more difficult it will be to standardise across the supply chain. These costs will have to be absorbed within the supply chain.

There are also several technological and infrastructure challenges to be considered with the implementation of a uniform allocation of serial numbers. Procedures must accommodate the data management required at every step of the process from manufacture and distribution of the individual product unit through the supply chain, but also the return, rework and other potential loopholes.

If a new system has to be created to accommodate this, it will require existing suppliers and companies to integrate the new procedures into their IT systems, databases and business structures, again increasing costs. Therefore packaging suppliers and pharmaceutical companies must be agile, flexible and be able to manage several different serial numbers and formats.

Overall, to implement a successful serialisation system, packaging and pharmaceutical companies must have a strong control of data management and data integrity. Carrying out track and trace serialisation will mean that every point within the manufacturing chain will be required to perform a stop-check, resulting in the collection of a large volume of data. Each individual unit will be registered under a unique identifying code and, once printed, must be recorded and tracked throughout the drug’s transactional journey. Therefore, if a box is accidentally damaged in the manufacturing process, the code must be recorded as inactive and passed back through the relevant systems.

Perhaps one of the greatest outstanding questions is related to the challenge of legislation. Despite the fact that significant laws did come into effect as early as 2006, there are still many issues to be resolved, such as whether existing national law will need to be changed, if serialisation is required by all countries and if a global standard should be employed.

As there is no global standard at present, different governments worldwide have varying legislations, leading to significant loopholes. Not only do the details of their legislation differ but also, under some national laws, serialisation requirements are applied to varying types of medicines. The following cases highlight the challenge in hand:

  • The EU will have its own serialisation requirements in 2018, as laid out in the EU Directive on Falsified Medicines, three years after the Delegated Act was published in the first half of 2015.
  • The Drug Quality and Security Act (DQSA - H.R. 3204), which was signed by President Obama in November 2013, has pre-empted any state laws including California ePedigree and the existing Florida legislation. Item level serialisation will be pushed to 2017.
  • Turkey is running a comprehensive track and trace infrastructure. Initially meant to combat insurance fraud, it is now capable of completely tracking and tracing all products entering Turkey. The track and trace system currently in place in Turkey is probably the most comprehensive system globally.
  • China has active legislation and manufacturers have to request serial numbers for products to be produced in – or to be imported into – China, and then report the actual serial numbers to the China FDA once they have been produced or imported.
  • India has established legislation for all exported products. There are currently no requirements for government reporting, but manufacturers have to keep the serialised data to be able to verify single packages on request.
  • South Korean legislation for serialisation became effective in 2015 and does not include government reporting in the first step, which will become mandatory in 2016. No details have been published yet on how this will work.
  • In Argentina, legislation is effective but limited to certain products, although that number is rapidly growing. ANMAT published a detailed specification of the central Argentina database in January 2014.
  • Brazil has not executed the country’s proposed legislation. New guidance was published at the end of 2013 which will become effective in 2016. A ‘Normative Instruction’ was published in August 2014 that details the requirements to a large extent, and the English translation of the Message Specifications was published in a draft version recently. The regulation requires serialisation and government reporting, both into a central database as well as along the supply chain. The current interpretation makes the manufacturer responsible for the entire supply chain.

Furthermore, there are also a number of countries that are still preparing their respective legislation, such as Saudi Arabia, Jordan, Ukraine, Columbia and Mexico, all of which will only finalise this by mid-2016 or in 2017.

Addressing these challenges requires a common legislation to be adopted. Both local and global issues need to be considered, as companies now have supply chains that extend across many countries. Across the board, legislations must run in harmony with one another, and countries will need to invest heavily in making sure that this system succeeds.

Another consideration is the importance of establishing long-term relationships with strong partners who are able to help manage costs and minimise risks. These partners must be well-informed about the current regulatory requirements to ensure these are appropriately managed and also to proactively propose improvements that will support implementation of future initiatives in the most efficient way possible. Flexibility will be vital as partners incorporate new features as technology and requirements evolve.

It is clear that much of the complexity in creating and managing serialisation programmes stems from the complexity of the pharmaceutical supply chain itself. Prescription drugs are distributed to every corner of the world – they are produced, distributed, repacked and sold by hundreds of thousands of organisations working together to provide patients with the drugs that they need. Serialisation clearly helps to protect consumers, but currently must adhere to a wide variety of legislative needs and cannot just be used in isolation to provide full protection from SSFFC medical products.

Serialisation does provide unit-level track and trace and verification of the packaging, but counterfeiters can easily collect used authentic packaging, refill it with fake product, reclose the original packaging and attempt to pass off the product as genuine. If consumers are using less controlled distribution channels such as the internet, it will be difficult to identify these fakes.

This is a trend that is happening in countries such as China, where sophisticated counterfeiters offer money to patients leaving pharmacies for their authentic drug boxes. This threat demonstrates why a multi-layered security approach should be applied, (serialisation and tamper verification features), providing protection for both the packaging and the contents inside.

Tamper verification is a very simple and easy way for consumers to identify whether the original packaging of their products has been opened or otherwise tampered with. As stated in the aforementioned EU Directive on Falsified Medicines, tamper verification features must be applied to packaging of certain medicinal products as required, and must demonstrate visible and irreversible damage to packaging. This allows consumers to easily see if their packaging has been previously opened, and empowers them to seek confirmation about the authenticity of their particular product. The European Standard now includes nine categories of tamper verification, including sealing labels, tapes, sleeves and specially constructed folding boxes.

The increase of counterfeit drugs, black market trade, the online sale of drugs and the complexity of supply chains has resulted in a number of additional challenges for pharmaceutical companies and governments. It is paramount that they continue to invest in the appropriate materials and infrastructure. Ultimately, the implementation of various layers of solutions, including serialisation and tamper verification features, is the only way that companies can increase their confidence that their products are authentic and have not been altered by counterfeiters.

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