Securing the Supply Chain to Combat Counterfeit Medicines

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Pharma IQ
09/07/2010

Counterfeit medicines present a serious challenge for the pharmaceutical industry. As well as the dangers to public health presented by such drugs, the presence of counterfeit medicines serves to reduce confidence within the pharmaceutical industry as a whole.

Ensuring that their supply chain is secure is just one way in which companies can reduce the risk of counterfeit drugs entering the industry. The problem is not just confined to the developing world, but is increasingly been seen within the European Union (EU) market as well.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) highlights that current regulations allow products to be "re-boxed, relabelled or over-stickered" , which can lead to the damage of identification numbers, make it difficult to identify counterfeit drugs.

Verification measures

EFPIA carried out successful tests earlier this year, which established that using a two-dimensional data matrix could be effective as an anti-counterfeit measure for the pharmaceutical industry.

Some 25 pharmacies in Stockholm, Sweden and 14 manufacturers participated in the project which involved the scanning and verification of 100,000 packs. Pharmaceutical distributors Tamro and KD Pharma and the Swedish pharmaceutical manufacturer's organisational, LIF, also supported the project.

The organisation said that the results of the tests show that the EFPIA's system is "viable, proportionate, secure and cost-effective", and also provides a method through which to locate expired drugs and recalled products.

However, if such a system was to be put in place for the pharmaceutical industry the EFPIA said that all packs should feature just one barcode, as users where sometimes confused when there were multiples.

Stefan Carlsson, chief executive officer of Apoteket, the pharmacy chain involved in the trials, added: "We were very pleased with the experience; the system integrated seamlessly into our existing point of sale system and normal workflow; this made it easy to use. Our experience of the data matrix suggests it will be valuable for preventing counterfeits and for other management functions in the pharmacies."

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Track and trace in the pharmaceutical industry

Improvements to track and trace technology is one way in which the pharmaceutical industry is looking to clamp down on the trade of counterfeit medicines.

Innomech, a company based in Cambridge, UK, has created a system using a two dimensional codemark which can be as small as 2 mm by 2 mm, enabling it to be printed on the surface of capsules or coated tablets.

The code, which can contain as many as 10 billion numbers, when scanned links to a database containing detailed information on the raw materials used and the time of manufacture. This database could be accessed online to verify the information and in many cases the codes can be read using a picture from a camera phone.

Steve Robertson, managing director of Innomech, said that the company is now "working with several clients to help adjust their manufacturing processes to incorporate this powerful new approach and enable products to be much more easily marked than has previously been possible."

The International Authentication Association (IAA) also believes that current track and trace technology doesn't go far enough. It claimed that the United States Joint Strategic Plan on IP Enforcement did not go far enough to combat the counterfeiting of drugs by simply establishing a mandatory requirement for track and trace in the pharmaceutical industry.

Jim Rittenburg, chairman of the IAA, said: "The national plan to fight counterfeiting should include references and guidance on the means of authentication, because detecting fakes is a key part of any anti-counterfeiting strategy."

He added: "This is also highlighted in the approach that governments take to protect their money. Although banknotes are all serialised for tracking purposes, they also contain a multitude of overt and covert authentication features such as security threads, holographics, watermarks, microtext, security inks, invisible taggants, etc."