Fighting Fakes With Technology

Packaging serialization and coding technology has been central to winning the pharmaceutical counterfeiting battle, keeping sensitive and high-value products safe in supply chains, preserving authenticity and improving consumer safety. © sofiko14 – stock.adobe.com.

Five Core Questions Every Pharma Business Must Ask

By David Gonzalez, Global Technical Account Manager at MM Packaging

The global war on counterfeit pharmaceuticals is a mounting challenge, but the pharma sector has made many important advances in this field. Packaging innovation has been central to winning the pharmaceutical counterfeiting battle and, as the primary touchpoint for users, has a highly protective role to play not just in keeping sensitive and high-value products safe in supply chains, but also in preserving authenticity and safety.

The world over, packaging is all too often an ‘unsung hero’, but in the pharmaceutical sector in particular, new technologies are taking center stage and taking the fight to illicit or fake pharma products. Proving to be one of the most effective routes to achieving this is package coding and serialization, the process of printing unique, unit-by-unit, identifiers onto packaging.

Printed directly onto packaging or applied through labels, coding gives each pack a Unique Serial Code (USC) that is stored and tracked within a central database. This USC is unique to that individual pack, cannot easily be duplicated, and is machine-readable and scannable. What this does is turn each separate product into a data point that can be read like a barcode, tracked and verified. This coding can be checked throughout the supply chain, and if the code isn’t present in the central database, the product can be held or rejected. In turn, this protects the authenticity of pharmaceutical and medical products.

The concept of coding isn’t new, but for today’s pharma businesses, it’s never been more accessible. As print technology advances, packaging converters that operate in the health and pharma fields can accomplish more from their printing processes through the application of the latest serialization and coding techniques.

Whether driven by regulatory compliance or enhancement of pack security, businesses seeking more protective measures through coding have five key questions to consider.

Why is coding still so high on the pharma packaging agenda?

There’s no margin for error when it comes to pharmaceutical authenticity and user safety, and the risks are high. Data from the Pharmaceutical Security Institute shows that reported pharmaceutical crime incidents rose to more than 6,500 cases in 2022, and the World Health Organization (WHO) reports that in some regions around the world, around 10% of pharma and medical products in circulation are falsified.

Of course, there is no ‘magic bullet’ to solving the counterfeit conundrum, but the continued rise of pharmaceutical fraud and counterfeiting puts pressure on the packaging industry to respond and innovate. With new printing and digitalization technologies in widespread use, the focus has dramatically shifted to coding technology, in addition to other covert and overt security measures.

As part of a serialization approach, coding technology has emerged as a pivotal tool in combating pharmaceutical counterfeiting and ensuring the integrity of the healthcare supply chain. While there are currently potential process weaknesses in the monitoring of serialized codes from production to patient, growing regulation that mandates the use of serialization has arrived on the pharmaceutical market. This is further putting focus on serialization technologies, and how pharmaceutical businesses can integrate this into their packaging supply chains.

Why are counterfeit pharmaceuticals such a dangerous long-term problem?

The rising challenge of counterfeit pharmaceuticals harms not only the reputation of pharma businesses and the industry at large, but the users that rely on medication. Public health is put at significant risk, as counterfeit pharmaceuticals are not regulated, and often not scientifically qualified or verified.

Adding to the problem, today’s pharmaceutical technology is highly sophisticated, and can support patient health in more ways. For example, the pharma sector is developing next-gen solutions that result in high value drugs, therapies and treatments. In turn, these have a higher price point, making counterfeit alternatives more profitable. Examples include the rise of pharma products that target obesity and fertility. These complex drugs have higher price points and high demand brings scarcity, which makes the sale of counterfeit illicit products highly lucrative and attractive to counterfeiters.

The prevalence of counterfeit products then harms public trust in the wider pharmaceutical field, so it’s vital that businesses are taking action. The packaging security technology available today serves as a deterrent to counterfeiters, providing a means for rapid identification and rejection of fraudulent products within the supply chain. Coding, as part of a wider security strategy, gives users added confidence in the authenticity of the products they use.

Where does coding sit within regulatory frameworks?

In various localities around the world, coding and serialization are now part of pharmaceutical regulations, and even packaging and printing businesses that don’t operate in the pharma sector will find it useful to understand these requirements.

Well known examples legislation addressing coding and serialization needs include the European Union’s Falsified Medicines Directive (FMD), which mandates the use of serialization on prescription medicine packaging. Similarly in the United States, the Drug Supply Chain Security Act (DSCSA) also requires the implementation of serialized product identifiers as of November 2023, and similar forces are found in China’s Drug Administration Law (DAL) and South Korea’s Drug Track and Trace system.

For total international supply chain compliance, it’s vital that businesses remain up to date on these regulatory demands, particularly as the pharma sector continues to be more connected and globalized.

What considerations should be made when choosing a coding technology?

Today, coding can be integrated simply into packaging and print production workflows. However, the coding system selected has to do more. For example, logistics can be highly complex for pharma businesses that operate internationally, so scuff resistance and image adherence to keep the code clear and legible is vital. In addition, the code should not degrade in heat, humidity and cryogenic environments, which can be a significant challenge as cold chain pharma becomes more common.

Further, for flexibility, the ideal coding system should be compatible with a very wide range of substrates, reflecting the innovation seen today in packaging materials, as well as be high speed in application, to not create a bottleneck in the packing and filling process.

As the pharma sector moves ahead into 2024 and beyond, the choice of coding technology is pivotal in addressing the escalating challenge of counterfeit drugs, and it falls to packaging partners to make it happen. Thoughtful consideration of coding technology is essential for ensuring the safety, authenticity, and efficiency of pharmaceutical supply chains.

About the Author

David Gonzalez is a Global Technical Account Manager at MM Packaging. MM Packaging is a secondary pharmaceutical packaging specialist, and the developer of Clear Code® a serialization system that uses CO2 fiber or UV laser alongside proprietary color change technology to provide superior quality coding.The business offers bespoke pre-serialization services to reduce supply chain complexity and help pharmaceutical businesses control costs. To learn more about MM Packaging and its activities, please visit www.mm-packaging.com.

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