While there is no perfect solution to guarantee the integrity of the supply chain or to eradicate counterfeits, traceability technology can play an important role in checking security and integrity of products
The problem of counterfeit medicines is not new; it is widely known that many countries in the developing world have been plagued by this criminal activity for years. In some developing markets, counterfeits are estimated to account for between 25% and 50% of all drugs.
There is no doubt that countries with inappropriate product registration and supply legislation or weak law enforcement are the most vulnerable to counterfeiters. Combination of lenient penalties for drug counterfeiting along with the comparatively low risk of being caught has made this an increasingly attractive activity.
Yet nowadays, this is no longer just a problem of the developing world. The European Commission is now taking the matter seriously enough to address the issue at a legislative level. So what has changed? Some have claimed that this merely the result of heavy lobbying by industry seeking to pursue an aggressive intellectual property rights agenda. The truth is, counterfeit medicines are a problem all over the world. The perpetrators are getting smarter, and new, easily available technologies for making accurate copies of labels and packaging have made it simpler to copy packaging and leaflets. This has both enabled and encouraged counterfeiters to target high-value markets. The increasing rate of counterfeit drug seizures by EU customs is alarming, but what has really provoked a political response is the growing presence of counterfeit drugs entering the legitimate supply chain.
While the absolute numbers of counterfeits remain low in comparison with the numbers available through unofficial and unregulated channels such as the internet, the security and integrity of the existing supply arrangements have been shown to have a number of Achilles’ heels. In the UK, the government’s Medicines and Healthcare products Regulatory Agency (MHRA) has presided over nine batch recalls of counterfeit medicines since 2004, with products including
Casodex, Lipitor, Plavix and Zyprexa penetrating the legitimate supply chain. Europe is not the only region affected; more than 50 cases of counterfeit medical products were investigated by the US Food and Drug Administration (FDA) in 2006 alone.
For a long time, initiatives have existed to increase international collaboration between authorities involved in guaranteeing product security, including customs and other regulatory bodies. However, the most ambitious of recent initiatives has come from the EU, with the European Commission issuing a set of legislative proposals to stop “falsified medicines” (ie, counterfeit medicines) entering the legal supply chain in Europe.
One key element of the Commission’s proposal focuses on the need to guarantee the integrity (ie, security and reliability) of product packs along the supply chain. The proposal introduces the need to apply safety features such as overt, covert or forensic devices on packaging. This would mean that the package could be checked to make sure that the product within is genuine. However, these features are useless unless they are combined with tamper-evident features to guarantee the integrity of the product itself. These would serve to indicate whether a pack has been opened or tampered with, thus ensuring the reliability of any product identification applied by the original manufacturer all along the supply chain.
While tamper-evident features and the use of authentication technologies present a primary layer of security, it must be noted that they can still be copied, and therefore on their own do not offer an insurmountable barrier to counterfeits. It has become increasingly clear that more sophisticated traceability systems must eventually form the cornerstone of any comprehensive anti-counterfeiting strategy.
At the moment, product traceability is ensured only at batch level and does not allow for the identification of individual packs. In the best-case scenario, a linear barcode – including the product code – is scanned with a barcode reader in the pharmacy, although this is not the case in all countries. The batch number and expiry date (variable information) are written in on the secondary and primary packaging and are currently controlled visually by the pharmacist.
But the general identification of medicines in Europe currently varies depending on the country, with each using its own national product codes, such as Italy’s Bollini, Germany’s PZN and France’s CIP code. Several governments are now taking steps to introduce a country-specific traceability system, based on mass serialisation (unique pack identification). Belgium, Italy and Greece already request that each pack has a uniquely identified serial number in addition to the national product code. The governments of Spain, Turkey and Serbia are meanwhile working on new legislation to make the use of a serial number mandatory.
The European Commission has recognised the need to improve traceability of products but has not proposed any specific way to address this. The proposal restricts itself to the need for pharmacies to “identify individual packs”, therefore requiring manufacturers to serialise their products.
This has led the European research-based pharmaceutical industry, through EFPIA, to put forward a recommendation to develop a harmonised system for the coding of each individual pharmaceutical product pack, based on the Data Matrix code (ECC 200), which contains a randomised serial number to enable the unique identification of each unit of sale. The code would also include the existing product code (identifying the product and its manufacturer), the expiry date of the product and the batch number.
Following a detailed analysis of the various traceability solutions available, EFPIA considers that to effectively minimise the risk of substandard or counterfeit products reaching the patient, there is only one point at which it is necessary to know that the product is safe: that is, at the final stage of the supply chain (when it is dispensed to the end user at the pharmacy or hospital), before the product reaches the patient.
EFPIA recommends a control of the serial number of each medicine (prescription drug) at the dispensing point (pharmacy or hospital), using a web service to access manufacturers’ databases. This, however, supposes that all medicines reach the patient in the original pack, making it possible to guarantee that the serial number printed on the packaging of the medicine has not been modified.
In order to do this, EFPIA is developing an end-toend product verification system allowing a systematic control of each pack’s serial numbers at the point of dispensing.
By scanning each pack, the pharmacist will be able to check the product “status” through a web link system, accessing a central manufacturer’s database (according to an IS architecture currently in design) to verify the authenticity of each dispensing unit before it reaches the patient. It is important to note that, unlike an electronic system to allow tracking and tracing of each product along the supply chain, the end-to-end product verification system does not guarantee the genuine nature of the product contained within the coded product pack.
Instead, what it does do is to provide a mechanism whereby product information such as expiry date and batch codes can be verified, and any errors can be detected prior to widespread proliferation of a problem, such as counterfeiting or tampering. This “serialised data matrix” is currently the only traceability technology that could be implemented quickly (within 3-4 years) for all products, at an acceptable cost. Critical requirements of the system are a secure database and a quick pharmacist response time (ideally less than one second from the time of scanning).
Eventually, the system would be integrated into pharmacy software. The process of product authentication could be undertaken by the pharmacy during the initial stock check-in process. By undertaking the verification check at the point where new stock is introduced to the pharmacy, most potential errors can be detected before the pack is dispensed to a patient.
The verification process would allow pharmacy staff to check the legitimacy and validity of stock. The data gathered from the verification process can be fed directly into pharmacy stock handling systems, which rely on the product article code or product local drug code to operate. The process of product verification would also make it easier to check product expiry
dates and batch codes, permitting more effective and efficient products recalls.
It is clear there is no perfect solution to guarantee the integrity of the supply chain or to eradicate counterfeits. However, traceability technology can play an important role in checking the security and integrity of products available in pharmacies. It would improve the safety of product dispensation, as well as allow more effective and efficient products recalls and the automatic detection of expired products. It can be said that such a solution, if combined with online e-prescription systems, would significantly reduce dispensing errors, helping to deliver the right product to the right patient at the right time – with the right outcome.