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Pharmaceutical Manufacturing and Packing Sourcer

Counterfeit Combat

Counterfeit Combat Measures are being taken to tackle the sale of counterfeit drugs around the globe. However, with the rise of ecommerce and the increasing complexity of supply chains, more needs to be done to protect companies and consumers

Counterfeiting remains a persistent threat to consumers within the healthcare and pharmaceutical industries. Data released by the US FDA states that approximately 10% of all drugs sold globally are counterfeit. While counterfeiters are active around the world, not all markets suffer equally. Developed nations have the lowest instance of counterfeit pharmaceuticals, with an estimated 1% penetration rate in Europe and the US, while developing nations show particularly high penetration rates. For example, it is estimated that up to 30% of all medicines in Africa and the Far East are falsified. In 2011, the WHO reported that 64% of all antimalarial drugs in Nigeria were counterfeit, further demonstrating the severity of the epidemic.

Counterfeiting continues to expand, propelled by more complex supply chains, increasing sophistication of criminals, a lack of enforcement capacity and the expansion of ecommerce; up to 50% of drugs available online are fake, with estimates reaching up to 70% in some African and Eastern European countries.

Incoming Legislation

To address this ever-growing threat, various anti-counterfeiting measures have been identified by pharma companies and governments alike, and are now being implemented around the globe. The challenge of this task should not be underestimated as there is currently no global standard being set, which in turn makes implementation complicated and inconsistent. As such, both governments and companies must continue to work together in order to continuously improve. One success in the legislative arena was in 2011, when the European Parliament and Council of the European Union formally recognised the public health threat posed by counterfeit pharmaceutical products and agreed upon actions that should be put into place to combat it through the Falsified Medicines Directive (FMD). The Directive has not only publicly raised the issue of counterfeiting in the pharma industry, but has also prescribed some specific solutions – such as serialisation and tamper verification – that will require changes from data management throughout the supply chain to packaging.

Available Options

The solutions proposed for combatting counterfeiting generally fall into one or more of the following categories:

The solutions proposed for combatting counterfeiting generally fall into one or more of the following categories:

● Track and trace/serialisation
● Tamper verification
● Authentication systems

However, it is important to realise that implementing multiple measures will provide the most enhanced level of security.

Track and Trace

Serialisation is the system of tracking, tracing and verifying products via unique identification codes. These codes reveal a complete history of the drug and can take the form of a linear barcode, a 2D barcode or a combination of numbers. Technologies for more advanced solutions are currently being developed, but the format of the unique code differs from country to country.

However, irrespective of format, the code will convey key information about the drug contained in the box: for example, the EU FMD states that manufacturers are required to print the drug’s product code and serial code of the unique identifier on the packaging in human-readable format. Furthermore, if requested by the member state where the product is intended to be placed on the market, the outer packaging must state the national number identifying the drug. These data elements confirm the integrity of the medicine and help to ensure that patients are taking the correct reliable product.

There still remain a number of challenges that the pharma industry needs to overcome when implementing an efficient serialisation solution. Firstly, a uniform system must be put in place that meets the requirements at each level of the supply chain. This may obligate existing suppliers and companies to integrate new IT systems, databases and business structures, which could prove financially and administratively onerous.

The creation of the serial codes themselves will call for significant expenditure, particularly when additional elements are included. The more complex the structure of the serial codes, the more challenging standardisation will be across all companies throughout the supply chain. According to some estimates, the majority of the coding solutions currently used in the pharma and healthcare industries could be rendered obsolete by the FMD.

The key to the implementation of a successful serialisation system, which all companies must take into consideration, is data management and the control of data integrity. The process of track and trace will mean that every point within the manufacturing chain will have to carry out a stop-check, resulting in the collection of a large amount of data.

Each individual unit will have a unique identifying code which, once printed, must be recorded and tracked throughout its entire journey from supplier to consumer. If a box is accidentally damaged, inventory must be notified and the code must be recorded as inactive. The monitoring and organisation of this vast amount of data will prove challenging, so companies and governments must work together to create an effective means by which it can be managed.

One country that is currently running a comprehensive track and trace infrastructure is Turkey. This was initially implemented as a means of combatting insurance fraud, and is now capable of tracking and tracing all products within and entering the country. Their system utilises unique GS1 GTIN serial numbers through both human- and machine-readable formats. As goods progress through the supply chain they are recorded, and when the goods finally reach the consumer, the unique information is cross-referenced with the master database to confirm that the product originated from the manufacturer. Without this confirmation, there is no way for reimbursement through Turkey’s health system. This provides both track and trace and an economic disincentive for people to use ‘out-of-system’ medication.

Tamper Verification
However, while serialisation provides unit-level track and trace, counterfeiters can easily collect used authentic packaging and refill it with fake product, reclosing the original packaging and passing the product off as genuine. This is in fact occurring in countries such as China, where counterfeiters pay patients leaving pharmacies for their drug boxes. This demonstrates the need for a multilayered security approach, to provide protection for both the packaging and the contents inside.

Tamper verification is one of the more straightforward solutions that allows the consumer to identify immediately if the product has been opened or otherwise interfered with. Accordingly, it provides the end user with confidence, allowing them to personally confirm that the product they are opening is genuine.

As stated in the FMD, tamper verification features must be applied to packaging of certain medicinal products as required. There are now nine categories of tamper verification features included in the European Standard:

● Flaps of folding boxes closed with glue, labels or tapes
● Specially constructed folding boxes
● Sealing labels and tapes
● Film wrappers
● Sleeves
● Breakaway or tear-away closure
● Display blister pack
● Blow-fill-seal containers
● New and emerging technologies

Beginning with folding boxes, tamper evidence can be built into the design of cartons via the use of glued locks, such as dagger locks. The side-walled glued skillet with scored top opening and the standard sidewall glue skillet with zip-tear opening provide additional solutions. All of these built-in features entail the destruction of the original carton. In these cases, it should be noted that providing consumers with features that allow for easy opening of the pack, such as those with scored opening, help to eliminate frustrating experiences that could put the consumer off a particular brand or product.

Additionally in the case of sealing labels, tamper verification can be provided with varying levels of sophistication. At entry level, simple labels with high adhesive provide a clear visual indicator that the pack has been opened, as the removal of the label will also remove part of the packaging.

For brands that require a more consumer-friendly experience, labels which leave behind a visual cue on the original packaging upon removal can be utilised. One such example is a void release label that leaves behind text on the original packaging to indicate it has been opened. Another option is a frangible label that essentially falls apart on opening.

Overwrap with tear tape is a further possibility that protects against tampering and allows layers of security to be cost-effectively added via the tear tape itself. This solution is particularly elegant from a consumer standpoint as it does not impact the branding found on the original packaging or destroy the experience of the original pack.

Authentication systems allow products or packaging to be verified as genuine. Such solutions range from overt (obvious to the naked eye) – for example, tamper evidence and security print features – through to more covert (requiring specialist equipment to identify their presence or not) or forensic features, such as product marking with ultraviolet, infrared or taggant inks.

Invest in Safety

The optimal approach to protect against counterfeiting will include layers of security to combine both overt and covert technologies, track and trace systems, and tamper verification, thus making it as difficult as possible for counterfeiters and illicit trading to succeed. Such layers should, wherever possible, be intrinsic to the item or packaging to ensure that the item itself, rather than the security feature alone, is authenticated.

It is clear that pharma companies must react to the threat posed by counterfeiters, not only to protect their own brand integrity, but also, more importantly, to ensure that patients are consuming the genuine medicine they require. Implementing various levels of solutions, from track and trace serialisation to tamper evidence, is the only way that companies can guarantee that their products are authentic and have not been altered by counterfeiters. With the increase of parallel trading, the online sale of drugs, black market trade and the complexity of supply chains, pharma – alongside governments – must continue to invest in the appropriate materials and infrastructure.

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