According to the World Health Organization (WHO), counterfeit drugs are a major risk for patients, resulting in treatment failures, and in some cases, death. They also inflict enormous economic damage. It is estimated that up to 10% of all drugs sold worldwide are counterfeit. In some countries the share is as much as 50 percent. According to the WHO, counterfeit drugs have an estimated market value of approximately $75 billion dollars¹ a year within an overall pharma market of $965 billion².

Drug counterfeiters are increasingly focused on critically needed pharmaceuticals such as antibiotics or cancer treatment. Regulatory authorities and businesses alike want to counter this trend by making medicines traceable from manufacturing and distribution, on through to the pharmacy. The manner in which this can be accomplished is through serialization, which is a process by which the smallest unit of packaging is given a unique identification number.

Until recently, the investment in equipment and know-how for the serialization of drugs was a difficult hurdle for drug manufactures. This was partly attributable to a long-standing uncertainty in the U.S. market and the lack of uniform rules within the U.S. Thus, states like California did not proceed with their own regulations until late last year when Congress adopted the Drug Quality and Safety Act (DQSA) with corresponding requirements for the entire country.

Since then, this issue has been gaining importance among manufacturers and suppliers of drug products. Other countries as well have been focused on the issue of serialization. In many, regulations are already in place, or soon to be introduced in the next few years.

What Challenges Does the Industry Face?
Even if the legislators and authorities of various countries are united towards one goal, their approaches differ. All agree that they want to achieve unique identification and clear verification of the authenticity of products. However, when it comes to monitoring there are two fundamental approaches in the regulations that are followed:

• A point of dispense authentication
• Continuous track and trace solution

In the European Union, the point of dispense authentication is preferred. With this system, when dispensing a drug to the patient, the product can be determined to be exactly what the label says it is. By 2017 manufacturers will be required to print a unique, machine-readable 2D code on all sales packaging. In addition, all cartons must have a tamper evident seal. Before delivery, the codes have to be sent to a central regulatory agency database for recording. When dispensing to the patient, the pharmacist compares the code on the packaging with that in the database. Once dispensed, the status in the database is changed to reflect the status of “dispensed”. Other countries want to go further than that, expecting that in addition to clear verification, one is able to check the products throughout the entire supply chain.

The U.S. is striving to implement an electronic system for track-and-trace of all drugs within the next ten years. The precondition is that manufacturers must implement serialization by the end of 2017. In addition, some countries, such as, Turkey, India and Argentina, have required serialization for drugs for some time. China is currently under implementation. Drug companies that sell their products in more than one market are now facing challenges dealing with the different regulations.

Up Against Varying Requirements
As in other areas, requirements for serialization differ between individual countries, in some cases substantially. Thus, different countries have different requirements relating to:

• Serialization data
• Serial number characteristics
• Tracking requirements
• Reporting requirements

If manufacturers supply several markets, they need flexible serialization solutions in order to respond to these variations and must also provide different formats for serial numbers and codes. They should also be able to offer point of dispense authentication as well as a subsequent integration into a consistent track-and-trace system. Therefore, companies have to establish “parent-child” relationships between the sales unit to shipping case, and shipping case to transport pallet.

Provide Modular Solutions
What then must a serialization solution take into account and provide for? Although there are different approaches and methods, for all systems the following elements are the same:

• Options and formats for different serial numbers
• A defined area for serial numbers on packaging
• IT solutions for the management of serialization data through to aggregation and batch sampling
• Technical systems for requesting, printing, reading and verifying data serialization
• Interfaces for data transfer
• Processes for quality control and assurance

For compliance with regulatory requirements, manufacturers should identify sales packaging with unique serial numbers and identification labeling. This information must be readable for both humans and machines. The basis for this may be 1-D linear codes or 2-D data matrix codes. The labeling follows the GS1 structure and includes GTIN, unique serial number, batch number and expiry date. Each sales unit is first aggregated with the shipping case according to the ‘parent-child’ principle. A 2-D data matrix code provides in addition to the information above, the number of boxes enclosed. Additionally, the pallets can be clearly identified with a 1-D linear barcode and the shipping case aggregated with the pallets according to the”parent-child” principle. For this, a SSCC-18 (Serial Shipping Container Code) is used. Depending on needs, the generation of serial numbers can either follow in a sequential or random order. Moreover, the security codes can be expanded to include additional identification information.

Enabling Data Exchange
Essential components for the successful implementation of a serialization solution involve both an IT software and a technical implementation on the packaging lines. For example, with corresponding IT capabilities on the packaging lines, printing as well as management and exchange of serial numbers are necessary. Integration into the existing IT landscape is absolutely crucial. Thus the solution must be linkable to systems for enterprise application integration and must be able to communicate with them accordingly. A connection to ERP systems is necessary to start orders and to report back with the printing information. Object events need to be recorded for the required reports and documentation. Finally, the production must be controlled locally via an on-site server. Useful applications for process integration as provided by SAP PI are at the heart of such a solution. Thus, in addition to common interfaces (EPCIS), transfer protocols (AS2) and messages based on XML with EPCIS design, other solutions are possible. The dialog across various systems provides a number of options for documentation such as commissioning reports for serial numbers after packaging, decommissioning reports, serialized advanced shipping notifications (sASN), as well as documentation required for future use.  Samples can be implemented in production by default via in-process controls. Linking up with mobile solutions could also allow batch sampling with the appropriate identification labeling to be done in the warehouse.

Clear Benefits for Everyone
In best practice, serialization provides the smallest unit of packaging with a singular labeling via a unique identification number, creating the basis for increased safety and efficiency along the supply chain. Companies can use the system to identify potential for process optimization. With a track-and-trace program, internal and external distribution channels are comprehensive and transparent, which will not only save money but also make counterfeiting more difficult, and support medical personnel and patients alike. One can be sure that the drug you are using is actually the real product. Finally, drug manufacturers also benefit from serialization because counterfeits are more easily recognizable; considerably reducing not just the economic loss but also the damage that might be done to the corporate image. 

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Daniela Guttmann is, Product and Service Manager, Vetter Pharma International GmbH. She has an MBA in International Business Development from the ESB Business School Reutlingen, Germany. She started her career path in the pharmaceutical industry in 2003 contributing to different areas of the business in Latin America and Europe. Daniela joined Vetter in 2011, where she is a product and service manager responsible for secondary packaging, serialization and sterile water for injection services.

References

1. WHO http://www.who.int/bulletin/volumes/88/4/10-020410/en/ 
2. IMS Health http://www.imshealth.com/portal/site/ims/menuitem.d248e29c86589c9c30e81c033208c22a/vgnextoid=96bdd595ae072410VgnVCM10000076192ca2RCRD&vgnextfmt=default