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European Pharmaceutical Contractor

False Move

The European Falsified Medicines Directive (FMD), ratified in 2011, is arguably the most significant landmark to date in the war on fake drugs. The law will require a traceable safety feature or unique identifier, and a tamper-evident closure on almost all prescription medical products sold in the EU.

This legal initiative and others worldwide – for example, in the US, Argentina, Brazil, China, India and elsewhere – have tended to focus on digital issues: codes, readers and databases that will be needed for product traceability. Less attention has been paid to the physical authentication of the package and product. However, a successful anti-counterfeiting strategy should incorporate both coding and physical verification in an integrated approach that is appropriate to the specific risk profile, manufacturing environment, budget and legal obligations.

Strategy Planning

Anti-counterfeiting should always be a planned and ongoing activity driven by top executives, not a reactive tactical response by operational managers to each reported incident. By treating counterfeiting like any other systemic corporate risk and taking appropriate mitigating precautions, best-in-class corporations are reducing their liability and minimising their total cost of ownership of product security technologies.

Modifications to manufacturing equipment and production processes – necessary for the serialisation and e-pedigree processes described here – are complex and time-consuming.

These activities need the collaboration of many disparate stakeholders and departments. Mistakes can be very costly, so detailed planning is vital. The team should also have the remit to seek and capture positive benefits.

Technology is often invoked as the solution to counterfeit medicines, but there is a lot of hyperbole. There are many excellent vendors out there, but none of their products are a solution to counterfeiting on their own. Developing a single, unbreakable and future-proof authentication technology is probably not even possible. That does not mean that developing an effective and solid defence against counterfeits is a futile pursuit, but it cannot be done well without a clear strategy that addresses the rest of the business.

Digital Traceability

Much of the recent focus on combating fake drugs has involved serialisation, track-and-trace or e-pedigree discussions. Traceability technologies, involving unique codes and data carriers that can be verified throughout the supply chain, are valuable and have a definite role to play in reducing the opportunity for criminals to enter the legitimate supply chain on a large scale.

Although they share common characteristics, digital traceability systems come in a variety of types, each striking a different trade-off between practicality and security. Manufacturers with international supply chains need systems that are flexible enough to address such local challenges.

Uniquely coded packs are a central component of many national and regional security systems for pharmaceuticals and healthcare products. The format, generation, storage and querying of unique identifiers forms a central component of the FMD and will be equally vital in the US supply chain for both pharmaceuticals and medical devices.

The theory is that by identifying and tracing each pack in the supply chain, we remove the opportunity for counterfeiters to insert large quantities of illicit goods undetected into the legitimate commercial channels, since the improperly coded products will be rapidly detected. The data format that has been chosen for most of these systems is the globally compatible GS1 numbering system. Interoperability between different systems is the key to the effectiveness of serialisation, so common standards are critical, and this aim now seems to have been achieved – albeit with a few significant exceptions such as China.

Practical Considerations

Creating and printing a unique number for each of the billions of individual packs of medicines which circulate in the global supply chain creates practical challenges. To avoid timeconsuming and error-prone manual input, machine-readable codes are strongly preferred. However, the linear bar codes familiar from retail environments are not suited to the task as they need to be impracticably large to encode the necessary information. Many packs simply do not have sufficient space.

The most cost-effective carrier is the Data Matrix, a two-dimensional code with a much higher data capacity per unit area than a standard linear barcode. These are cheap and relatively easy to print (the technical challenges of line implementation notwithstanding). However, many existing laser-based barcode scanners cannot read Data Matrix codes. Some pharmacies will therefore need to upgrade their point-of-sale equipment to camera-based readers which can handle both linear and two-dimensional codes.

Coding and verifying every drug pack will be complex and certainly add some costs, although these have frequently been exaggerated. Traceability on its own will not prevent counterfeiting, but it will be a large step towards a more secure supply chain. It also brings clear potential for improving patient safety and commercial efficiency as a potential upside of pack coding.

Network Security

In the EU and US, there are new business models to be explored around service delivery via codes and mobile phone scanners. In some developing countries, such as Nigeria and India, simple SMSbased verification systems already in use require much less complexity. They use random numeric or alphanumeric codes applied during manufacture, either by labelling or direct printing, which are then verified by the customer or pharmacist at the point-of-sale using simple mobile phones.

Although there are potential security issues in this approach, it appears that the network security effect of aggregating millions of patient-level transactions means that attempts to clone or spoof the system can be quickly spotted and dealt with. Patients also like the opportunity for direct interaction, and there are a number of new models which are exploiting this enthusiasm by offering other opt-in services after the verification step.

We can expect Data Matrix codes, backed by global standards and exploiting the rising prevalence of smart phones, to revolutionise the interaction between manufacturer and patient. Drug companies will require new innovations in service that should provide plenty of opportunities for contractors and external providers.

Tamper-Evident Closures

Another key security enhancement proposed by the FMD is the requirement for sealed packs, to discourage removal or replacement of the product on its journey from manufacturer to patient. Authorised repackagers, such as international distributors, must replace the original packaging with an equivalent, securely closed box or container.

In the European supply chain, where unit-of-use formats such as blister packs are more common, this relatively simple action of sealing packs is an effective deterrent. In some other countries, most notably the US, this measure may not be as useful because medicines are typically manufactured and transported in bulk and then dispensed into smaller containers by the pharmacist.

The types of secure closure commonly used include glued and perforated end flaps, adhesive seals, shrink wrap and tear tape. Vials and bottles can be protected with snap-off caps, induction seals, and so on. All of these technologies are designed to be single use (tamper-evident) rather than impregnable (tamperproof ) so that they are easy to remove yet hard to replace. In the rush to serialisation, the challenges and therefore business opportunities should not be neglected.

Other Physical Authentications

Anti-counterfeiting technologies which give a yes-no answer to the question: “Is this pack genuine or not?” are still very useful. These may be visible features such as colourshift inks and holograms, or covert features such as micro and nano structures, chemical markers and taggants. Serial numbers and codes – the key components of digital traceability – are easily duplicated, so having another authentication feature which is difficult to copy is a wise safeguard. These features can even be incorporated into the code printing step to give each code a second ‘fingerprint’ that is near-impossible to copy.

There are many challenges in putting security features on packs: finding available space on the artwork, disseminating the tools needed for verification, and so on. In Europe, where repackaging is common and legal, a carefully-designed feature on an outer box may even be discarded during legitimate parallel trade.

The closer the authentication feature is to the active ingredient, the less likely it is to become dissociated from the product during transit through the supply chain – although features that are not visible on the outside surface of the saleable unit are harder to check during a normal transaction.

When designing security layers, it is useful to ask: “How could a criminal break my product security?” rather than just: “Could they reproduce this technology?” Remember that criminals have entropy on their side. They only need to cause disorder and confusion in order to soften up the market for their fakes, so their approach does not need to be elegant. Taking an analytical approach to every process impacted by product security (remember to include reverse logistics as well as forward product flow) often results in major security improvements or opportunities for technology intervention at minimal cost.

Removing Vulnerabilities

Anti-counterfeiting features are not ‘fire and forget’ weapons. Rather, the fight to protect genuine goods is an unceasing arms race requiring constant vigilance through market surveillance and re-evaluation of tactics when necessary. Brand owners must be ready to implement alternative technologies at short notice when security is breached. This may mean pre-qualifying technologies that are kept in reserve, but the time will have been well spent when rapid action is needed after a high-profile counterfeiting incident.

Many companies have focused largely on technology approaches to their anti-counterfeiting needs. The improvement or elimination of insecure processes across the whole supply chain should not be overlooked because security is only as strong as the weakest link.

Putting a padlock on a gate is ineffective if the burglar can easily climb over the fence. Instead, look for data disconnects and local ‘workarounds’. Often, local managers solve local problems without realising that they may be introducing system vulnerabilities. Gap analysis projects for large companies have discovered some surprising vulnerabilities in their handling of sensitive traceability and anticounterfeiting information.

Future Approach

Anti-counterfeiting is an ongoing process, not a discrete project. Individual elements or territories have compliance deadlines, but the overall mindset needs to be one of continuous vigilance. By addressing strategy, processes, physical security and digital traceability in a planned and integrated way, drug companies can reap genuine business benefits from new legal obligations, as well as playing their part in keeping patients safe.

On the benefits side, some companies have devised ways of making consumer verification a profit centre by adopting and embracing the opportunity for a dialogue with patients (1). Simple but powerful interventions can lead to better adherence, improved clinical outcomes and easier reporting of adverse events.

It may transpire that in a few years the verification process will be an automatic part of a much bigger patient engagement programme. Perhaps in 10 years, pharma business models might look more like Amazon or Apple than the blockbuster-based, boxshifting focus of the recent past.

Reference
1. Davison M, Challenges and opportunities from worldwide serialisation initiatives, Journal for Patient Compliance, pp40-42, 2013


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Mark Davison is a leading global expert on fake drugs and an author. He is Chief Executive Officer of Blue Sphere Health Ltd, acting Chief Business Officer of PharmaSecure Inc, and has held senior roles in the pharmaceutical industry and with security system vendors and contract research organisations.
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