The War Continues - The European Union's Falsified Medicines directive, ratified in 2011, was arguably the most significant landmark to date in the war on fake drugs.

The law will require (from around 2016) a traceable safety feature and tamper evident closure on almost all prescription medical products sold in the EU. Mark Davison, CEO of Blue Sphere Health, examines some of the approaches his customers are using to comply with the directive and other legal obligations around the world.

The Big Picture: Safe and Authentic Medicines

Discussion of the impact of new legal initiatives in the EU, U.S., Argentina, Brazil, China, India and elsewhere has tended to focus on digital issues: the codes, readers and databases that will be needed for traceability. Less attention has been paid to the physical authentication of the package and product. A successful anti-counterfeiting strategy should incorporate both coding and physical verification in an integrated approach.

Blue Sphere Health spends a lot of time helping drug and medical device companies to develop product security approaches that are appropriate to their specific risk profile, manufacturing environment, budget and legal obligations.

Strategy

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

Modifications to manufacturing equipment and production processes - necessary for serialization and ePedigree - are complex and time-consuming. These activities need the collaboration of many departments. Mistakes can be very costly so planning is vital - as the old carpenter's saying goes, "measure twice and cut once."
Digital Traceability

Uniquely coded (serialized) packs are a central component of many national and regional security systems for pharmaceuticals and healthcare products. 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 serialization, so common standards are critical. After a few false starts, this seems now to have been achieved.
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 time-consuming 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 barcode. These are cheap and relatively easy to print (although initial technical issues need to be solved) but many existing laser-based bar code 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 2D codes.

Coding and verifying every drug pack will be complex and will certainly add some costs, although these have frequently been exaggerated. Traceability on its own it will not prevent counterfeiting but it will be a large step towards a more secure supply chain.

Tamper-Evident Closure

Another key security enhancement proposed by the directive is the requirement for sealed packs, to discourage removal or replacement of the product on its journey from manufacturer to patient. Authorized 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 U.S., this measure may not be as useful as 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 etc. All of these technologies are designed to be single use (tamper-evident) rather than impregnable (tamper-proof) so that they are easy to remove but hard to replace.

Physical Authentication

Anti-counterfeiting technologies that give a yes-no answer to the question "Is this pack genuine or not?" are very useful. These may be visible features such as colorshift 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 a "one-pass" solution with multiple layers of security.

Processes

Many companies have focused on technology "solutions" to their anti-counterfeiting needs, but the improvement or elimination of insecure processes should not be overlooked. Security is only as strong as the weakest link.

Look for data disconnects and local "workarounds." Often, local managers solve local problems without realizing that they may be introducing system vulnerabilities. Gap analysis projects for large companies have uncovered some surprising vulnerabilities in their handling of sensitive traceability and anti-counterfeiting information.

Conclusions

Anti-counterfeiting is an ongoing process, not a discrete project. Individual elements 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.

We are all customers for the pharmaceutical industry at some time in our lives, so we owe it to ourselves to ensure that medicines continue to be genuine and safe.


Win a Copy of Mark Davison's Book!
"Pharmaceutical Anti-Counterfeiting" covers the key concepts and explains the available options in pharmaceutical anti-counterfeiting including a mix of policy, strategy, tactics and practical implementation tips. A must-read for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries.

To register to win a free copy, send an email with your business mailing address to CHEManager-Europe@gitverlag.com by Monday, Feb. 27!

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