Last month, it was predicted that the global trade in counterfeit goods, including medicines, is set to rise to nearly $1 trillion in 2009. In the UK alone, an estimated 8 million counterfeit drugs found their way to NHS patients in 2008. As a result, counterfeiting is still high on the agenda for pharmaceutical companies.
When it comes to the supply chain, packaging is often seen as the least important part of the cycle. However, it is vital when dealing with the problem of counterfeiting. Tracking technologies can be used in conjunction with packaging to allow manufacturers to trace legitimate products from commissioning event through to decommissioning and provide the manufacturer with peace of mind.
Radio Frequency Identification (RFID) is one such technology that is somewhat re- emerging as a contender in the pharmaceutical supply chain arena. A tag can be placed on any traceable unit (e.g. bottle, case, pallet), so RFID can be seen as a viable alternative to linear bar codes. Recent studies show that RFID label applications allow lines to run at speed while 2-dimensional label applications require the production line to work below optimum speed. This is breathing some new life in to RFID as an option for unit level labelling. However, 2-dimensional remains the front runner for unit level labelling.
As an anti-counterfeit measure, either allows unique identification of a product in seconds. The need to purchase large quantities in a field survey and subject every unit to rigorous lengthy testing in the lab is redundant. Information is captured during manufacture and tracked throughout the product lifecycle. When the package label is scanned, this information can be pulled directly from the central repository providing details of whether the serial number is still valid, what and where the product should be. If the location where you bought a product is not in sync with the receiving event, a red flag is raised. RFID tags have the additional benefit of not requiring line-of-sight scanning, unlike 2-dimensional bar codes. This can make it easier for covert field studies to detect counterfeits or diversion. RFID is also the favoured technology by logistics providers as they can scan hundreds of products in seconds as it moves through the supply chain.
Raising the red flag for counterfeit products is not limited to these sporadic field studies. Business applications that sit on top of the central data repository for RFID data can also be used to identify misdemeanours in the supply chain. For example, we provide counterfeit detection and diversion detection applications to a number of our clients in the pharmaceutical industry. These technologies flag unexpected or impossible events such as duplicated serial numbers as well as help manage the huge amount of RFID data in any supply chain. In fact, a data management system is crucial to prevent inundation from the vast amount of tag information. Although tags and the network are key parts of overall solution, there is no value to implement such a system without the right services to handle the information.
As pharmaceutical packaging continues to evolve, larger organisations are looking to expand tracking technology on a global scale. A pharmaceuticals final destination is decided increasingly later in the product lifecycle so the ability to track products across oceans allows companies to keep track of their merchandise wherever it lands.
As a result, many pharmaceutical companies are now looking to implement a central organisational structure. The ability to centralise brand protection and monitoring activities in a single department means an international strategy can be designed for implementation at a local level. Product visibility is aggregated and put in a central repository that can be accessed by both internal users and external partners worldwide. After all, visibility is paramount for secure, cost-effective and efficient operations between the manufacturer and its trading partners. In addition to this, standards, like EPCIS (used for exchanging electronic product code information), ensure that visibility in an organisation is optimised through ensuring that all data users can find the information that they need.
In addition, this central organisational structure can also help meet the increasing number of compliance requirements in specific regions and at an international level. A number of European countries have individual compliance legislation which will shortly be expanded across the EU. Manufacturers must be able to keep up with changing legislations as they happen without needing to revamp company strategy at every turn. After all, if a company is not legislation compliant it cannot trade. A central organisational structure simplifies this process while still allowing a degree of flexibility between local offices.
Although manufacturing and distributing pharmaceuticals appears a straightforward process, complications arise when looking to protect medical products from the counterfeit community. For many pharmaceutical manufacturers, part of the solution to this problem can be found in logistics-based IT. Tracking solutions such as RFID allow organisations to cross-reference every unit from their output instantaneously whilst being able to comply with todays legislation heavy marketplace. This is a complex problem to solve but with a single effective track and trace solution and the likelihood of an organisations offerings appearing on the black market can be reduced.