Evolving World of Pharma: Fighting falsified medicines

Since November 2018 in the USA, and February 2019 in Europe, all pharmaceuticals have needed to be serialized. Beyond manufacturing, there has been a gradual implementation for serialization, aggregation and exchanging transaction information all the way along the supply chain. Last November, for example, distributors faced a serialization deadline, and later this year (November 2020) dispensers will need to ensure that they have the necessary equipment, staff and processes in place to ensure the verification of all medicines. By November 2023, the whole pharma supply chain will be required to provide complete unit level traceability. Such authentication for risk-based verification of each product, recalls, resales and returns should ensure that only safe and authentic medicines ever reach patients.

However, despite the great steps taken so far, falsified medicines remain a lucrative business for criminals. They may contain ingredients of low quality or in the wrong doses, be deliberately and fraudulently mislabelled with respect to their identity or source, or they may have fake packaging, the wrong ingredients, or low levels of the active ingredients. According to the European Medicines Agency (EMA), the phenomenon of falsified medicines is still on the increase, including expensive anticancer products, and those in high demand such as antivirals.

Clearly, the serialization of packaging is intended to help stop this illegal trade. In addition, according to the Schreiner Group – a German company offering customized products, solutions and services for the pharma industry – there are numerous security features that manufacturers can use to make their medicine packaging tamper-proof.

“The serialization of packaging, complemented by anti-counterfeiting labels, helps stop this illegal trade,” declares Andrea Richter, Project Manager for Product Communications at Schreiner Group, in the company’s blog. Richter goes on to list no fewer than twelve selected security features that manufacturers can use to make their medicine packaging tamper-proof. These include anti-counterfeiting labels, multi-tear closure labels, NFC-labels for digital tamper evidence, luminescent verification features, covert hologram seals, label-integrated thermochromatic inks and other packaging technologies – all of which can offer the efficient authentication of medicines.

Another solution is the use of microparticles – physical, chemical identifiers (PCIDs) – within the products themselves. For example, the newly-developed fields of DNA barcoding and DNA-specific formulation chemistry have enabled the development of one such solution by Applied DNA Sciences, a leading provider of molecular technologies that enables supply chain security, anti-counterfeiting and anti-theft technology.

“With breakthroughs in nanotechnology, forensic science and material sciences, it has now become possible to formulate DNA into materials that are non-biological: to generate DNA-containing plastics, fabrics, inks, pharmaceutical coatings, oils, emulsifiers and detergents,” said Dr Michael Hogan, Vice President – Life Sciences at Applied DNA Sciences, in an article last year in Chemicals Knowledge. The advent of such DNA-marking technology provides a potential weapon against the counterfeiting of pharmaceuticals.

Although synthesized from standard DNA building blocks, the PCIDs have been designed to have no biological function. By fabricating DNA as very small fragments, the DNA-based PCID becomes highly stable with respect to extreme heat, UV light and dryness. They have the capacity to convey a large amount of information and, as a result, permit the tracking of a product through the supply chain.

Similarly, last month, Nature Communications published an article about another type of new tiny edible PCID that could help fight counterfeit drugs. Created by researchers at Purdue University (Indiana, USA), the PCID uses a technique called ‘physical unclonable functions,’ or PUF, that was originally developed for authentication in information and hardware security. The PCID acts as a digital fingerprint, generating a different response each time it is scanned under a compatible LED light. The microparticles emit cyan, green, yellow or red fluorescent colors. Digital bits can then be extracted from an image of those patterns to produce a security key, which a pharmacy or patient can use to confirm the drug’s authenticity.

“Our concept is to use a smartphone to shine an LED light on the tag and take a picture of it,” said Jung Woo Leem, a Biomedical Engineering Postdoctoral Associate at Purdue, in a statement to the press. “The app then identifies if the medicine is genuine or fake.”

As we have said before, the key to success lies in the digitalization of the industry. From the application of a unique identification code, through aggregation and exchanging transaction information all the way along the supply chain, and now with the development of PCIDs that can be ‘read’ with a dispenser’s smart phone, there can surely be no doubt left that we are working in an age of digitized pharma. And – in my opinion – there can be no doubt that pharma is a better place for it.

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and has more recently taken up the role of Editorial Director at Chemicals Knowledge. She continues to also provide independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

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