Supply chain security and the ability to authenticate drugs at the point of sale or at dispensation are an essential part of the battle against counterfeit drugs. Siemens and Atos offer a comprehensive serialisation solution, whether the customer needs an individual element or an end-to-end remedy.
An estimated 5% of all drugs sold worldwide are counterfeits, and products worth $40bn are ‘lost in the supply chain’ every year – and the numbers keep rising. In light of these facts, ensuring the safety of their products and protecting their brands plays an increasingly important role for pharmaceutical companies. As well as harming the health of unsuspecting users, forged pharmaceuticals can also cause damage worth millions to the image and reputation of legitimate manufacturers.
In response, pharmaceutical manufacturers have to start adapting their packaging lines and distribution centres in order to be able to deliver uniquely serialised drugs. In addition, countries or, better still, the stakeholders in the drug distribution chain have to start to run pilot projects to test real-time authentication at the point of sale or point of care.
A challenge for global pharma
Authorities around the world have started to issue regulations to enforce drug tracking and tracing based on serialisation. Despite the global character of today’s pharmaceutical supply chains, these laws and regulations continue to be very inconsistent and differ from country to country. While their implementation has been announced, it has also been delayed several times in countries including India and Brazil.
The degree of serialisation also differs. While some regions require the kind of serialisation that involves nothing more than a unique number on each individual package, others also call for an ‘aggregation’ approach, which means that hierarchical information must be linked and stored when articles are boxed up, bundled and palletised. This affects the technical requirements both in terms of data processing and the networking of individual packaging steps.
But all approaches have one thing in common: to protect consumers and the industry against counterfeits, it must be possible to clearly identify, track and trace pharmaceutical products. Item-level serialisation will become a standard requirement around the world. Moreover, pharmaceutical companies have globally spread manufacturing sites with different line equipment and IT infrastructure set-ups, each producing for different markets and different regulatory requirements.
"In light of all these variable and unknown factors, it becomes all the more important to determine the total cost of ownership in a comprehensive manner and to manage it with centralised governance and global standards," says Dr Markus Fuchslocher, head of pharmaceutical industry at Atos. "Local stand-alone solutions offered by small system integrators may look affordable at first, but implementation costs, and primarily maintenance and upgrade costs as well as training costs can be value-destroying in terms of the enterprise as a whole."
When selecting an external partner, close attention should be paid to its financial stability, and its packaging line equipment expertise and know-how with regard to complex IT projects. Consequently, pharmaceutical companies should define their global standards clearly and cover as many of their requirements as possible by adapting preconfigured serialisation-use cases. Serialisation of every single drug package is a complex process for a pharmaceutical company.
"Seamless integration into existing packaging lines with bidirectional communication [to and from the lines] is crucial to managing and controlling drug serialisation without impacting line performance and productivity," says Hans Bijl, who is responsible for serialisation in pharma from Siemens.
Billions of serial numbers have to be generated and printed on drug packages, and the history of billions of drugs has to be electronically stored while meeting the highest requirements in terms of security and availability.
Comprehensive system architecture
Most manufacturers have validated systems for their packaging lines. What is left is to connect independent serialisation systems to these lines without having to revalidate everything.
Another problem is that in many cases the enterprise resource planning (ERP) system continues to be linked to the production systems by manually entering ERP print-outs at the production site. To link both of these worlds through IT, a global architecture must be created on all levels that is able to reconcile data and transmit it via interfaces. This is a huge challenge for IT systems both at site and line level. Companies can use this data hub to quickly exchange data within the enterprise and with their global trading partners. The site-level system supports the manufacturer in implementing serialisation at the packaging line, the warehouse and the distribution centre. This site control layer is an important link between the ERP world and the various line-level systems. It also allows the manufacturer to integrate all partners worldwide into the overall process, whether they be in-house distribution centres or external logistics partners.
All serialisation data are securely stored in this system. It generates randomised serial numbers from the number ranges provided by the ERP system and transmits them to the packaging lines. The site-level software should include defined standard templates, because most manufacturers produce and package at one line for several countries. Therefore, an important feature is the recipe management that meets country-specific serialisation requirements and allows the manufacturer to use different configurations at the line. Site-level standard software comprises:
- serialisation and aggregation (multiple lines)
- serial number generation and/or handling
- packaging hierarchy
- parent/child control
- rework and decommissioning.
The line control system executes the serialisation process by transferring the parent-child hierarchies (package, bundle, case and pallet) to the specific line equipment. Ideally, both printers and camera systems should be connected to a programmable logic controller at the automation level with a special software solution that transmits the data. This reduces the system’s impact at the line to a minimum. The software must be validated in order to meet the pharmaceutical industry’s strict compliance requirements. The line-level system comprises:
- controlling the connected devices (printers, cameras and ejectors)
- gathering the information from the connected devices
- allocating coding information to the different printers
- detecting and handling of failures
- serial number upload, download, administration and distribution at line level
- serial number aggregation for the packaging hierarchies
- applying in-line coding information.
Power line carrier systems feed the data for an entire production batch, which may consist of up to 500,000 individual packages, into an IT system that manages the data for the production site. This system processes the data and stores it locally before forwarding it to the central corporate database when the production run is complete.
Holistic approach to distribution and authentication
Although the country-specific implementation of the EU legislation has just begun, a very promising pilot project initiated by the European Federation of Pharmaceutical Industries and Associations (EFPIA) was run in Sweden. In this project, the EFPIA, in cooperation with Swedish pharmacy chain Apoteket and local wholesalers Tamro and KD Pharma, spent four months testing an encoding and identification solution for which Siemens IT Solutions and Services supplied the information and communication technology. The acquisition of Siemens IT Solutions and Services by Atos Origin in July 2011 resulted in Atos becoming the largest European IT service provider. The company is the European market leader in transaction-based solutions for very high data volumes and security requirements (such as credit card clearing, brokerage and payment processing).
The project involved 25 pharmacies in the Stockholm area, with 14 pharmaceutical companies providing 100,000 packages with 25 different products. The goal was to demonstrate the feasibility of a standardised national coding and authentication system.
In April 2010, the EFPIA published the results of the pilot project, which was highly successful, according to the association. It demonstrated that the model worked in a real-life application and enjoyed a high degree of acceptance among users. The system not only makes it possible to effectively identify counterfeit drugs and expired medications, it is also easy to use, according to over 90% of pharmacists. The response times were highly satisfactory: over 99% of all transactions could be processed in less than a second.
Under live conditions, the pilot project proved that tracking and tracing down to pharmacy level is possible with a high level of performance. It can be assumed that future authentication processes in pharmacies will run just as seamlessly as credit and debit card checks and the use of customer loyalty cards at supermarket cash registers.
"The authentication will be transaction-based for each drug package," says Fuchslocher. "Even the allocation of the costs for each package to the individual stakeholders from manufacturer to wholesaler, to pharmacy and even insurance companies and patients is technically possible."
Ready for serialisation
Pharmaceutical manufacturers should pick the serialisation architecture that works best for them based on its total cost of ownership. The solution should also be globally standardised and locally adaptable.
As far as the country-specific implementation of authentication guidelines at the point of sale is concerned, there is no longer any reason to wait. The technology is available and mature.