Serialisation solution for a counterfeit crises

A new serialisation system, which requires each package of medication to be identified via a unique ID code before being given to the customer, is to lead the fight against the problem of medical forgeries, which cost the industry billions of dollars in lost revenue and pose significant health risks for consumers.

Health is such an important asset that we must protect it with everything we have at our disposal. However, the market is flooded with millions of counterfeits as criminals forge the complete product spectrum ranging from lifestyle products such as hair restorers to critical pharmaceuticals such as cancer medications. Of great concern, in addition to incalculable health risks for consumers and billion-dollar losses for the industry, is the fact the forgeries are difficult to detect.

The IT-based serialisation of individual pharmaceutical packages is aimed at putting an end to this situation.

As long as a counterfeit pill is the same size, shape and colour as the original, neither the physician nor the pharmacist – not to mention the consumer – are able to identify it as such. This can only be accomplished with modern analytical methods where the medication is broken down into its components and chemically analysed at great cost. Of course, this is impossible in everyday use.

What is more useful and efficient is to come up with methods that tackle the problem at the beginning of the supply chain, i.e. where the pharmaceuticals are packaged at the manufacturer or contract packager.

Take control
The tagging of pharmaceutical products is already being carried out today, but mostly at the pallet or container level. As a result, it is difficult to clearly determine the source and authenticity of individual packages. At the pharmacy or doctor’s office, all patients, doctors and pharmacists can do is check the printed data such as names, active ingredients and the manufacturer’s label against the prescription – and hope that everything is in order.

According to the latest figures published by European customs authorities, this is a risky undertaking, however. During the first European Union-wide coordinated customs operation, more than 34 million counterfeit pills were confiscated over two months in 2008 alone. In addition to antibiotics, the impounded products included mostly cholesterol reducers, cancer and malaria medications, erectile dysfunction pills and painkillers. The forgeries had either no or diluted active ingredients, or even wrong active ingredients, which means that they could even be deadly in a worst-case scenario.

That’s why governmental and non-governmental institutions demand binding legal guidelines for the clear labelling of pharmaceutical packages as is already required by the United States’ Food and Drug Administration (FDA) and recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The latter is working to design a standardised platform to protect against counterfeit medications by creating a uniform coding and identification solution for the European pharmaceutical industry.

Individual identification
The solution, which is based on information and communication technology from Siemens, has been tested since October 2009 in a pilot project in Sweden. It requires each package of medication to be identified via a unique ID code before being given to the customer. This code consists of a serialised 2-D data matrix code and a serial number. Compared with other methods such as radio frequency identification (RFID) tags, this method is relatively inexpensive, because adding the data matrix imprint with regular ink costs less than one cent. The cheapest RFID tags, on the other hand, cost at least 10 cents. In addition, the code is easy to create and affix as long as the manufacturer has the appropriate equipment. In practice, the solution works like this: the code is read with a scanner and forwarded to a system, where it is checked for authenticity. If a number appears twice, the system issues a warning. In response, the pharmacist or other persons handling the product can immediately withdraw it from circulation.

Identifying forgeries takes more than a code, however.

Monitoring and tracking medication packages across the entire supply and production chain requires an effective and transparent data management system that ranges from the packaging process to the enterprise resource planning (ERP) and (supply chain management) SCM systems.

Needless to say, all of these processes are backed-up by a great deal of technology and a lot of industry expertise. For example, the IT service provider, Siemens IT Solutions and Services, as one of the main suppliers of the EFPIA project contributes not only the links to the pharmacies but is also responsible for the project management and the information interfaces between pharmacies and pharmaceutical companies. Other duties include the operation maintenance of the IT infrastructure, data integration, and system development and security.

Global and local
What makes the serialisation solution from Siemens so special is the fact that it is just as suitable for globally operating pharmaceutical companies as it is for the little pharmacy on the corner. Since the solution is highly adaptable, it meets the needs of today’s production and packaging environments where products for many countries are manufactured on a single line. Different templates meet the requirements of all country-specific regulations and configurations such as those governing expiration dates. In England, for example, the date must be expressed as day-month-year, while the U.S. requires month-date-year.

In addition, different countries have different requirements regarding the generation of serial numbers (European requirements are stricter than those in the U.S.). The European pharmaceutical industry, for example, often uses randomly generated numbers instead of consecutive serial numbers. Plus, many companies use third-party contractors in the production and packaging of pharmaceutical products. These include packaging specialists, who must be included in the comprehensive process across all stations in the supply chain. Another important consideration to be taken into account is the fact that most companies already have a validated system for handling their packaging lines to which the new, separate serialisation systems must be able to link with reasonable effort and cost.

To meet these countless requirements, a particularly important feature of the Siemens AutoID Connector (SAC) comes into play: as can be expected from one of the world’s largest SAP partners, Siemens, the serialisation solution is SAP-certified and can therefore be fully integrated into the SAP environments of most chemical and pharmaceutical companies. The customer ultimately benefits, because this ensures the consistent administration and exchange of serial numbers from logistics partners down to the retail level. The system therefore supports the customer not only by issuing serial numbers on the packaging line, but during subsequent steps such as in distribution centres or when communicating with contract packagers or contract manufacturers.

What sounds nice in theory also works in practice. Together with an international packaging specialist, Siemens recently introduced its serialisation solution in a packaging line and tested the unique identification of products on the article level – at high speed and with great success. This success benefits the company and its customers alike, because product serialisation protects not only the consumer, but makes manufacturers more efficient. Forgeries are prevented from the start, which is good for the bottom line. In addition, the system provides unprecedented transparency across production processes, distribution channels and life cycles, which makes it easier to identify potential savings. And if a batch or an individual package nevertheless turns out to be defective, a recall is quickly and easily accomplished. The serial number makes it easy to find out which packages were manufactured and distributed during a specific period of time, thus limiting potential losses and liability claims.

The best of both worlds
While the introduction of legal guidelines for the standardised marking of pharmaceuticals creates some costs, it also provides companies with opportunities to improve their efficiency and customer relationship management. California is leading the way in the serialisation of electronic pedigrees for drugs, and from 2015 the U.S. state’s law is expected to require every single product to carry a unique number.

Similar policies have already been implemented or are in the process of being introduced in several European countries too. In Turkey, for example, since October 2009 all medical products intended for humans must be individually encoded, and France plans to make coding of the individual packages obligatory as of the beginning of 2011. Outside of Europe, countries such as the U.S. or South Korea are also considering the introduction of such regulations. Brazil is looking to introduce serialisation regulations by January 2011. After all, health is an important asset all over the world.

Company profile

Siemens IT solutions

For further information, visit: www.it-solutions.siemens.com

Email: juergen.manz@siemens.com