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Trend Report No. 12: Anti-Counterfeiting for Pharmaceutical Packaging / June 2015
Against enemy Infiltration in pharma packages
- The number of counterfeit pharmaceutical products continues to increase. This has an unsettling effect on markets and a detrimental impact on producers.
- Various guidelines have been issued to help provide positive identification for drugs. However, the differences in marking regulations between markets cause problems for pharmaceutical makers.
- One thing is certain: a combination of security features offers the best protection.
One out of every two drugs sold online is thought to be a counterfeit. Besides the immediate economic impact on manufacturers, counterfeit products undermine consumer confidence and tarnish the image of pharmaceutical producers, causing long-term harm to the industry. To come to grips with the problem of counterfeit drugs, manufacturers use visible and hidden marking to make things more difficult for counterfeiters, and they also work with the customs authorities. Track & Trace solutions support product traceability and make it possible to verify that the product is genuine at the point of sale or at home by the end customer, e.g. using a smartphone. For a product protection technology to be truly useful, it must meet four minimum criteria: quick and simple identification, absolute certainty by the average user that the product is genuine, anti-counterfeit protection and affordable cost. Protection techniques cannot normally fulfil all of these criteria to the same degree.
Insular solutions and cross-border strategies
To a large extent, legislators across the world have long been aware of the dangers posed by counterfeit drugs and they have formulated anti-counterfeiting regulations for pharmaceutical packaging, some of which have already come into force. One of the first was Turkey with the ITS system which is based on serialization and data matrix codes. In the US, the FDA is working on introduction of an e-pedigree system which supports cradle-to-grave traceability. Marking regulations were introduced in China in March 2013. After that date, manufacturers may only sell pharmaceutical products that have an EDMC (Electronic Drug Monitoring Code). However, insular national initiatives in a globalized world are likely to miss the mark. That is the thinking behind EU Directive 2011/62/EU. As things now stand, starting in 2018 the Directive will be binding on all EU member states and will require a combination of serialization marking and tamper evidence (indicating if a product has been previously opened).
Effective in combination
Manufacturers have to combine various anti-counterfeit features to ensure the best possible protection for end users - and for themselves. Tamper evidence, for example, is an integrated feature of carton design. When a consumer opens the outer packaging, perforation tears open indicating that the carton is being opened for the first time. Labels with a void effect are another option. When the label is applied and later removed, it exposes marking on the back as an unmistakable indication of manipulation, for example a barcode. The void effect gives the user the assurance that the code which he or she is exposing has not been seen before by an unauthorized third party. Consequently, it is not possible for a product counterfeiter to copy the code prior to the sale of the original product and put a counterfeit product into circulation with a code which is stored in the manufacturer's database. In addition, pharmaceutical companies can apply hologram printing, transparent sealing on the flap or surfaces that reflect UV light to the secondary packaging. The idea behind these features is to make it perfectly obvious at all times whether highly effective drugs are genuine or counterfeit. Export and subsequent reimport of pharmaceuticals is not unusual in a highly globalized market environment. This obviously does not make security particularly easy in the logistics chain. To combat the problems, closer cooperation is needed between countries and companies. The answer is the collaborative supply chain.
Serialization for cradle-to-grade tracking
As is the case with other market players, many companies that supply labelling applications make use of the cloud. The marking systems are based on unique data matrix codes which producers print onto their pharmaceutical products and secondary packaging. Data which corresponds to the specific code is stored on a server and includes information such as shelf life, batch and product number and a serialization number. All legitimate parties in the logistics chain have access to this data, giving them a cradle-to-grave traceability tool which makes it easier to distinguish between genuine products and counterfeits. When a pharmacist scans in a code at the sales counter, the system immediately issues a warning if there is no entry in the database which corresponds to the data which has been entered. Securpharm has set out on a mission to introduce this approach on a widespread basis. An alliance of pharmaceutical producers, pharmacists and wholesalers was formed in March 2012 to roll out an end-to-end tracking system. A pilot project was launched in January 2013. Press Spokesperson Joachim Odenbach was able to report some initial good news immediately after the launch of the pilot phase: “It works!” Initial full-load scanning at wholesalers was so successful that the transition to normal operations began right away. Since then, the movement of pharmaceutical products can be traced by accessing the data matrix code affixed to the product.
Wireless counterfeit protection
In addition to the barcodes and data matrix codes which are already well established in the market, another option is available to pharmaceutical producers which makes it possible to positively identify the packaging in the logistics chain. RFID is nothing new in the logistics industry. RFID (Radio Frequency Identification) tags use electromagnetic waves for product identification. The big advantage of this approach is that in contrast to data matrix codes, rather than containing (only) a reference to the data in some remote database, they can actually store the information. They provide better anti-counterfeit protection because in contrast to data matrix codes, drug counterfeiters cannot simply copy the codes to create the impression that the product is genuine. One further advantage is the fact that dealers can even read information from the transponders through metal walls depending on the frequency used. This makes RFID a powerful auto ID technology for traceability and product protection. It presupposes, however, that the logistics processes are understood throughout the entire logistics chain. This is primarily due to the fact that changeover to RFID requires a relatively high up-front investment which has to generate a payback. Also, the ongoing cost of the transponders is higher compared to printed data matrix codes. As a result, this technology is more suitable for expensive drugs used for cancer therapy or blood samples than for high-volume antibiotics.
Combining colors and pigments
Micro color codes can be used to provide additional security protection to supplement the data matrix codes without the need for RFID tags and electronics. The color matrix can be stored in a pharmaceutical company or pharmacy database to positively identify various pharmaceutical products. The color marking is invisible to the naked eye. A pen microscope is needed to identify the product. The system has been on the market for many years and is still regarded as secure, and it is accepted as evidence in court. This is particularly important for pharmaceutical makers because in case of doubt they must be able to prove that an ineffective or harmful item is a counterfeit copy of their product. Special pigments called taggants which producers can add to any color are another option. These markers, which are also invisible to the naked eye, react to light from a laser pointer, reflecting the light at a particular wavelength (and hence color). Using the right laboratory equipment, it is possible to identify the pigments under a microscope. This technique has the advantage that they are not visible under ordinary conditions, and cutting and lamination do not degrade them.
Proof of authenticity and consumer information combined
Anti-counterfeit protection using printable data memory can be taken right down to the molecular level. The storage medium is a special ink which can be applied by manufacturers using conventional techniques and which acts as a visible, hidden or forensic security feature. The storage density is several MB per cm2, surpassing the density of RFID technology which is in the KB range. The data images are polymer based and the technology can be used to align the molecules. The technique creates a virtually endless number of possible combinations, providing reliable anti-counterfeit protection comparable to biometric identification. The customer can also encrypt the data or store different information on the packaging for different recipients. That could include for example usage instructions for consumers and batch numbers to provide end-to-end traceability in the distribution chain.
Summary
There is no lack of techniques for providing effective anti-counterfeit protection. It is important to keep in mind however that a combination of tamper proofing and track & trace as required by EU Directive 2011/62/EU (currently) offers the best level of consumer protection. As a general rule, the more security features that are used, the better the protection. There must also be a reasonable cost/benefit ratio. Things will get more interesting when all of the marking requirements in worldwide markets come into force. Until that happens, global players will have to integrate highly flexible solutions into their production line. If they fail to do that, they will lock themselves out of the markets.
At ACHEMA 2015, exhibitors in pharma, packaging and logistics in Hall 3, the Forum and the Agora-Pavilion present how they address the challenge of counterfeit protection.
ACHEMA Trend Reports are compiled by specialized international journalists. DECHEMA is not liable for incomplete or inaccurate information. ACHEMA Trend Reports can be used for editorial purposes free of charge; the source has to be named (more details on
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