New serialisation methods are among the best ways to combat counterfeit drugs, but their development is a huge source of expense for the pharmaceutical industry.

“Patient safety is still the main driver of the industry,” says Michael Völlinger, from German pharma giant Grünenthal. “Serialisation means an additional measure to ensure patient safety, and to increase supply chain transparency and patient safety.”

It means that, globally, complete tracking and tracing throughout the full supply chain, especially in markets that are more prone to counterfeits due to lack of national controls or regulations, will add additional security.

“This is why [we’re] happy to see the current trend in all markets to serialise,and even track and trace, not just the final products, but the complete supply chain down to the raw materials,” explains Völlinger.

This is typically done together with chemical and microbiological testing of all the raw materials used in the process to clearly identify all products, and to make sure that the final products are always of the same quality and are safe for patients.

Counterfeit operations

Völlinger’s role is as part of the global operations and supply chain development team at Grünenthal. “I’m concerned with building up a strong infrastructure to comply with current and upcoming regulations. I’m also looking to advance and strengthen supply chain processes,” he says.

Grünenthal’s serialisation track and trace programme (STT) has been designed to undertake this. “My job is to ensure the buildup of a global, uniform solution to securely manage and track our serialised products,” Völlinger says. “This is not just a huge effort from a technical point of view, but it also has an impact on all areas of production and logistics for our products.”

This is replicated across the industry as many pharma companies also produce and package products for other companies as a contract manufacturing organisation (CMO).

“We do not just have to comply with national regulations,” Völlinger explains, “but also with many customer-specific requirements and wishes. Our aim was to build a very flexible system with a lot of room for adjustments and customers-pecific enhancements.”

This is important, as the entire industry has to be ready for the February 2019 deadline of the European Falsified Medicine Directive, and Grünenthal must appear to be a reliable and attractive partner to work with.

Serialisation affect

“Acting as marketing authorisation holder and CMO, we are ready to support serialisation requirements around the globe for our patients and customers,” states Völlinger.

He is keen to stress that serialisation is not just a ‘one-man show’ in an organisation, but is a joint effort that involves every department of all pharma companies.

“We have people looking into every market to find and monitor changing serialisation requirements, and we are involved in many working groups on a national and European level to actively contribute and help shape the future of the global supply chain,” says Völlinger. “We have already implemented the first pilot markets and some customer-specific requirements.”

Chemical testing

Chemical testing is one of the most important ways to hinder counterfeiting drugs. There are a variety of chemical and physical standard-detection techniques available to detect fake products, most of which take days or weeks to confirm a result while needing expensive machinery and laboratory equipment. It only makes sense to use those mechanisms if there is already a suspicion that a product is counterfeit, Völlinger explains.

At the same time, there are efforts to develop and simplify physico-chemical testing techniques using testing strips or similar carriers to test for active ingredients or suspicious products. These would allow testing of materials along the supply chain, potentially at border controls, or even with the aid of certified distributors, on a risk basis, or in case of doubt. They will, of course, never give the same certainty or final results, but could be the perfect aid to finding first suspicions followed by extensive physico-chemical testing – even before the product reaches the first patient.

The use of track and trace in the chemical testing of suspect counterfeit drugs is also an important way of detecting fakes. “Combining the different worldwide regulations to serialise and tamper-proof the sales packaging of medicines, with the ability to quickly test and verify the authenticity of a product, will make a great difference in fighting counterfeits,” explains Völlinger.

“If you combine track and trace with the ability to test the product as it moves through the supply chain, you get a quick way of identifying where and how the counterfeit drugs have been introduced into the chain. This will not only enable companies to find and recall counterfeit drugs quickly and precisely but also to identify the maleficent organisations responsible and actively fight their endeavours.”

Serialisation is not just a ‘one-man show’ in an organisation, but is a joint effort that involves every department of all pharma companies.

Patient safeguards

An important part of these processes is making sure that there are safeguards for patients to test for fake drugs in order to determine that patients have not taken medicines that contain harmful ingredients. The best way to ensure that a patient does not ingest a harmful ingredient is to catch and recall the counterfeit product before it reaches them.

“Monitoring the complete supply chain down to the raw material testing with chemical and microbiological methods is the best way to achieve this,” Völlinger says. “The chemical identity of products is verified in addition to tests of packaging integrity, so all the steps up to the final product are monitored. Adding the capabilities of serialisation will help to strengthen Grünenthal’s capability to track and fight counterfeits quickly and effectively.”

One of the ways for this is the chemical testing programme, which should be implemented at different points throughout the supply chain to maintain security.

“On a global level, it would make sense not just to talk about serialisation, but amend tracking and tracing throughout the supply chain, and combine all of this with the ability to test for counterfeits on a risk basis,” Völlinger says. “There is, of course, a significant cost factor involved with all of that, and this is why quick and cost-effective physico-chemical testing techniques – that are easy to use – would be a perfect addition. Then it could even be up to each country to implement something like this with their border controls, for example.”

WHO has released a checklist for the visual inspection of medicines, and this was meant to be a white paper for border controls or freight companies to check the authenticity of products. “The issue is that there are counterfeits that are of a very high forgery standard,” says Völlinger. “It is very difficult to identify them using visual inspections alone, especially for untrained personnel.”

This is why, Völlinger believes, quick and cheap tests to aid in this endeavour would be a great help.

However, all of this means additional costs throughout the supply chain for vendors of raw materials, contract manufacturers and many more. It is therefore important that those standards become national or supranational law in order to ensure that all companies comply.

New developments

“If I look at other market sectors I would assume that, sooner or later, the ecological footprint will become more important for the customer, at least in developed countries with close to unlimited access to medicinal supplies and many brand options,” Völlinger says.

“At the same time, with the increasing ability to gather data, the patients and target market needs will be more identifiable. Last, but not least, the places where healthcare is provided will shift away from big hospitals and might become more communal or be delivered at home.”

This means that pharma companies might see some benefits in simplification, but quantify their supply chain to allow the delivery of smaller batches and the ability to cover more destinations. Perhaps more production within the destination countries, in combination with lower volumes, the need for increasing flexibility and providing a full tracking and tracing service, will help to ensure patient safety.

Some companies use centrally managed IT systems on a global scale to provide services and support for their production sites. This ensures that security standards are met, while they remain close to customers, providing quick product to market times and low transportation costs.

Complete tracking and tracing throughout the full supply chain, especially in markets that are more prone to counterfeits due to lack of national controls or regulations, will add additional security.

STT is a huge task that all pharmaceutical companies have undertaken due to the regulatory uncertainties that prevented many them from making changes or spending a huge amount of money in order to comply with the suspected regulations.

“For companies that act not just for their own product, but also as CMO, it is very important to be ready on time and offer their aid and support to the market,” concludes Völlinger.

“This is not just true for serialisation, but there are even more projects running at the same time, like exact identification of APIs, bulk and products, and the so-called Identification of Medicinal Products Project or the Unique Device Identification for medicinal devices.”

All of these projects are a means to an end for transparency and patient safety.