The complexity of the pharmaceutical supply chain and the incidence of counterfeit medicines entering the market have brought real risks to populations and tough challenges for authorities. Several governments have introduced regulations based on the serialisation of medicines to allow for their verification. With a standardised global approach to serialisation being the ultimate goal, what are the advantages and challenges associated with today's varying concepts? In this article, Jean-Marc Bobée, former director industrial anti-counterfeiting strategy at Sanofi and keynote speaker at NEXUS 17 in Barcelona, outlines global and local traceability concepts and explores the 'security to cost' ratios linked to differing approaches.
The global traceability concept
Serialised data matrix codes are fast becoming the global standard for the traceability of medicine packs. Data matrix codes contain a unique identifier for each medicine (product code and serial number), as well as the batch number and expiry date. These codes can be read automatically at the point-of-dispense to highlight any duplication, detect expired products, instigate batch recalls and ultimately ensure that the right product is delivered to the right patient.
Regulations based on the global concept follow two scenarios – "serialisation only" and "serialisation and aggregation."
The serialisation only concept limits serialisation to the unit of sale level and is the approach outlined in the EU Falsified Medicines Directive (FMD). Serialisation in this form requires the application of a data matrix containing the unique identifier, combined with systematic control by pharmacists at the point-of-dispense. The control operation verifies that the serial number exists in the database and that the medicine has not already been sold in another pharmacy. In addition, the system checks that the product is not being recalled.
Serialisation only is a simplified version of full track-and-trace solutions seen in other parts of the globe. The concept requires no aggregation between logistic units and places no additional burden on wholesalers and distribution centres as there is no systematic control required at these points in the supply chain.
The approach, however, does not provide the serial numbers of medicine packs on pallets or cases and requires investment at the pharmacy level for data matrix verification. That being said, the approach offers a high 'security to cost' ratio as the medicine is systematically verified as being safe before reaching the patient, without the need for additional verification steps throughout the supply chain.
Serialisation and aggregation
The second scenario is a serialisation and aggregation method which is the system adopted by several countries such as Turkey and Argentina. It requires serialisation of all logistic units across individual medicine packs, bundles, cases and pallets, and requires systematic control by manufacturers and wholesalers.
The approach represents a complex system that is more challenging to implement than the serialisation only concept, requiring additional equipment on packaging lines and in distribution centres to manage aggregation of all logistic units. As a result, greater involvement is needed from companies throughout the pharmaceutical supply chain such as wholesalers. The approach also requires the development of more complex and sophisticated databases to exchange information safely and securely at different points in the drug product's journey to the patient.
The main advantage of this approach is the high level of product visibility it provides. Aggregation makes it possible to track and locate a specific pack based on distribution history data at multiple points. However, due to the higher costs and greater level of complexity, it represents a lower 'security to cost' ratio when compared to the serialisation only concept outlined in the EU FMD. However, it should be outlined that in many countries, the level of infrastructure (internet network and response time) does not always allow systematic verification at point of dispense and the serialisation and aggregation concept offers, in this case, a good alternative to improve patient safety.
The Mobile Authentication System (MAS)
More localised regulations have been developed to answer the specific problems of some local supply chains.
For example, in Africa, unsecure supply chain infrastructures and limited dispensing points and budgets have contributed to a huge problem related to counterfeit medicines. Nigeria and Ghana's MAS allows patients with mobile phones to self-verify the identity of a medicine. Scratch labels containing codes are applied onto medicine packs. Patients can send the codes via SMS and receive confirmation of a product's identity. This approach is based on serialisation only without any traceability information data, so packs are also unable to be tracked in the supply chain.
The MAS requires significant investment in manufacturing and applying labels, associated activation (link between product batch and pin code and serial number of each label) and transmission of all related information to a database. There are also challenges in motivating patients to control their own medicines with only 5 to 10 per cent currently using the system. Therefore the answer provided by the MAS server to the patient is not 100 per cent secure due to the fact that a low fraction of the population is checking its medicines and the controlled product can still be the first pack of a series of fakes. While the MAS is not an infallible system, it can save patient life when the pack serial number does not exist in the database. It is suited to a non-mature supply chain where the illegal selling of drugs and reliance on street markets is high, giving the patient a tool to potentially verify the safety of their medicines.
However, considering the high cost for the manufacturers and the limited level of control and security for the patients, the MAS system offers a low 'security to cost' ratio and should be considered as a transitory solution before moving to the global concept.
Other local concepts
Other examples of local concepts include the China E code system (linear barcode printed on the pack and containing a serial number), the Bollino system in Italy as well as the specific Vignettes, which are currently used in Belgium and Greece. These will be substituted by the serialised data matrix within the scope of the EU FMD.
Standardisation will provide huge advantages to the global supply chain including significant reductions in cost and interoperability between different countries such as in Europe.
The industry should continue its work with government authorities to deploy a global traceability concept worldwide in association – when possible – with a systematic control at point of dispense. This includes the challenge of replacing the MAS concept by an efficient and affordable solution based on a serialised data matrix.
Another challenge will be to secure the distribution of pharmaceutical products sold via the internet, by developing an efficient solution based on the global traceability concept.
Jean-Marc Bobée will be leading a speaking session on global traceability concepts at Nexus 2017. The event takes place in Barcelona, 7-8 June. For further information, please visit http://nexus-tracelink.com/