The purpose of all global serialisation initiatives is to clearly label each individual medicine pack sold in order to prevent counterfeit pharmaceuticals from finding their way into the legitimate supply chain.
In response to the demand from the United States that every pack sold should be provided with an adhesive RFID label, the EFPIA (European Federation of Pharmaceutical Industries and Associations) proposed a system of coding and serialisation using a 2D matrix code applied to the folding cardboard boxes in common use. The main aim was to avoid the enormous cost of producing adhesive RFID labels.
Apart from ensuring that each folding cardboard box is clearly coded and the individual packs can be verified when dispensed to the patient in the pharmacy, the EFPIA initiative also enables the data on the precise date and time of the sale to be used for the logistical planning of the entire supply chain. This also encourages the sale of medicines through retail pharmacists.
Unlike the bar codes customarily used for pharmaceuticals (e.g. PZN in Germany), the 2D matrix code comprises a chessboard-like pattern of white and black squares with 2 solid adjacent borders in an L-shape
The chief advantages of this type of code are its minimal space requirements and the large volume of information it carries. The 2D matrix code shown here contains the GTIN (Global Trade Identification Number), the batch number, the expiry date and the 14-digit randomized security number.
When written out in full, the code provides the following information:
Aspects that need to be discussed are the use of the GTIN, which is not applied to pharmaceuticals in all European countries, and the incorporation of the batch number and the expiry date.
In most cases, the use of data relating to the packaging order, such as the batch number and the expiry date, compels pharmaceutical manufacturers to print the 2D matrix code during or immediately after the packaging step. Since this information always has to be printed legibly on the outer packaging as well, and there is a guaranteed link to the article number and the security number in the data base, this requirement needs to be reconsidered, particularly given the fact that manufacturers of folding cardboard boxes and/or adhesive labels can print the 2D matrix code to a far higher quality and much more economically.
Overview of serialisation schemes that have already been implemented
For some years now all medicine packs in Belgium have had to be provided with a simple adhesive label printed with a serial number and a bar code that is verified by the pharmacist at the time of sale. In addition, useful information on the product is displayed on the pharmacist’s computer screen. This scheme is operated by the Aegate company in collaboration with Belgian pharmacists. Their participation is voluntary, and market acceptance is very good.
According to Aegate, this scheme is also operated in Italy and Greece in combination with the adhesive labels that are already in use there. Aegate claim that market acceptance is very good in these countries too.
In Turkey the main principles of the EFPIA scheme were initially adopted and introduced as a legal requirement for the entire supply chain. This action was taken to put a stop to widespread validation fraud, which involved taking the receipt used when billing the pharmaceuticals (which was generally printed on a flap of the folding cardboard box) and then returning the pharmaceuticals to the supply chain in a new, counterfeit folding box. In order to overcome any problems caused by pharmacists being resistant to the scheme, or lacking the technology to participate, the EFPIA scheme was modified in such a way that the content of the code had to be printed in human-readable text next to the 2D matrix code. As a result the 2D matrix code takes up much more space.
In very many cases it is then no longer possible to print the legally required variable data and the appropriate prefix together with the 2D matrix code on the flap of a folding cardboard box. So in such cases both sealing flaps of the folding box are used, or the 2D matrix code is applied subsequently outside the packaging plant.
Turkish law also requires all the logistic units used within the supply chain to be labelled so as to ensure monitoring throughout the entire supply chain. For the same reason bundles, corrugated board folding boxes and pallets are also labelled with 2D matrix codes. The progress of every medicine pack can now be tracked along the entire length of the supply chain by reading the 2D matrix code.
The initial problems in Turkey show that this scheme is very complex and difficult to implement for all those concerned. It is questionable whether the huge effort involved solves the actual problem of fraud, because although the packaging is tracked along the supply chain, the whereabouts and use of the medicines cannot be controlled.
Preparations for the implementation of the EFPIA scheme are well advanced in France and Korea. In both countries the 2D matrix code is currently being used without a security number. It remains to be seen whether the adhesive label additionally used in France can be discontinued, because, as in Italy, it is transferred to the prescription as proof of sale.
A control scheme for the medicines traditionally produced in China was first introduced in the People’s Republic as long ago as 2007. Foreign manufactured products were first affected some years ago, and the scheme now also covers products packed outside China. By 2015 all medicines sold in China will be labelled in this way.
In contrast to the EFPIA system, the bar code used in the People’s Republic of China consists of a seven-digit article number and a thirteen-digit randomised security number. As in Turkey, all the logistic units (bundles, corrugated board folding boxes and pallets) are labelled and tracked along the supply chain. The illustration below shows a Chinese bar code with an encrypted serial number. The quality of the offset-printed Chinese characters is just as good as the elements of the code that are produced by UV-inkjet printing.
The dispensed pack is verified not by the pharmacist, but by the customer, who either reads the code using the camera in his cell phone or by entering the twenty-digit number in an internet “app”. In this way, in addition to information about the pharmacy where he or she purchased the product, the patient can access a wealth of other data, such as the expiry date and the batch number of the medication.
Since the Chinese authorities are the owners of the system, they can intervene immediately in the event of irregularities and deal with any problems. The chief advantage of this system is that the barcode is pre-printed by the manufacturer of the folding cardboard boxes. They currently use their own UV-inkjet printing machines, which apply the barcode to a very high quality standard (generally Grade A!!) to the print sheet before or after the folding cardboard boxes themselves are printed. Depending on the type of printing machine and the folding cardboard boxes used, up to 150,000 boxes per hour can be printed.
Developments such as integrating the UV printing step into the offset printing machines, using the folding cardboard box manufacturer’s gluing machine to print the UV-bar code, or switching to 2D matrix codes are also conceivable.
Compared with the scheme used in Turkey, the People’s Republic of China has succeeded in implementing a monitoring system covering the entire distribution chain that sets new standards in terms of both simplicity and costs.
The problem of counterfeiting within the Chinese pharmaceuticals market is likely to be significantly reduced as a result.
A number of companies based in Germany took part in a pilot project in Sweden initiated by the EFPIA. Although the project demonstrated the fundamental practicability of the idea, it was not suitable as a rigorous application test because of its limited scope, and is therefore to be repeated on a much broader scale in Germany. To this end the Bundesvereinigung der Deutschen Apothekerverbände (ABDA – National Federation of German Pharmacists’ Associations), the Pharmaceutical Industry Associations (BAH, BPI, VfA), the Wholesale Pharmaceutical Traders’ Association (Phagro), the Information Office for Pharmaceutical Specialities (IFA) and the Advertising and Sales Company of German Pharmacists have formed a partnership and established securPharm, a company whose remit is to set up and carry out a pilot project in Germany on a much larger scale with a view to implementing the system required by European legislation. According to securPharm, pharmaceuticals manufacturers have already begun labelling selected products with the 2D matrix code. Packs with the 2D matrix code are to be tested in a countrywide pilot project due to be launched in January 2013.
Given this background, it is clear that a uniform verification system is unlikely to become established in Europe, and certainly not worldwide. Countries such as Italy and probably also Belgium will not alter their tried-and-tested systems, and other countries will doubtless take the same attitude.
The system used in the People’s Republic of China has advantages in terms of both cost and simplicity, and enables patients to verify the packs they have received/purchased. This will persuade countries that are in a similar situation – mainly in Asia, Latin America and Africa – to follow suit.
It would be relatively simple to guide the EFPIA scheme in a similarly favourable direction – by omitting the variable data.
It is now up to the decision-makers to draw the correct conclusions and make the right decisions before it is too late. It should also be remembered that the labelling and verifying of pharmaceutical packs with serial numbers in code form is but one component of a safety concept. Proof of originality and anti-counterfeiting measures provide further safeguards.