Counterfeit and diverted drugs account for a staggering €400 billion annually, posing severe risks to patient safety and public health.1 Counterfeit drugs compromise patient care and often fail to provide life-sustaining medication.
Diversion, the unauthorised distribution of legitimate medicine to unintended markets or sellers, further compromises patient health with mishandled or tainted products. Diversion not only degrades quality but also impacts pricing and brand reputation.
E-commerce challenges
Online pharmacies, important players in the e-commerce sector, often operate fraudulently by selling counterfeit, expired or mislabelled products.
Despite efforts such as the transparency programme to safeguard genuine products, counterfeit ones infiltrate the market — even on reputable platforms such as Amazon.
With the convenience and price advantages of e-commerce, consumers are more likely to take risks for a bargain. Although e-commerce offers opportunities for increased access to medications, it also compromises patient safety and public health.
Brands can take different measures to protect themselves, starting with raising awareness and educating staff members regarding counterfeiting and diversion.
Industry response and regulation
The rise in counterfeit drugs in Europe, such as Ozempic for weight loss, underscores the immediate need for industry wide vigilance.2 Progress has been made in terms of tackling counterfeiting with the implementation of the EU Falsified Medicines Directive (FMD).
However, more is required to enhance patient safety and ensure a safe supply chain. Traceability within the supply chain is vital to verify product movements at each stage and is essential to combat counterfeiting.
The power of serialisation
The EU FMD requires all prescription drugs in the EU to be equipped with antitampering devices and unique identifiers that are readable by humans and machines. Serialisation assigns each item a unique code, facilitating traceability from production to end-user.
The unique identifier of a product must consist of a product code, serial number, national reimbursement number (if required), batch number and expiration date, all encoded into a 2D data matrix barcode.
This technique not only helps to detect diverted products but also enables pharmaceutical companies to optimise production and address discrepancies in real-time.
Ensuring supply chain integrity
Maintaining a resilient and transparent pharmaceutical supply chain has become crucial. Advanced track-and-trace technologies allow manufacturers to monitor the journey of drugs, enhancing distribution efficiency and safeguarding consumer safety.
Traceability is instrumental when it comes to managing recalls efficiently, minimising the impact on patients and ensuring that only safe and authentic products are in circulation.
Traceability refers to tracking and documenting the movement of products and materials throughout the supply chain, starting from the initial production stage to the end consumer.
It involves recording relevant information such as the origin, manufacturing processes, transportation, storage conditions and distribution details of each product or supply item at each change of ownership and movement.
By implementing robust traceability systems, stakeholders can monitor and verify the integrity, safety and authenticity of pharmaceutical products.
Digital product authentication
As the supply chain evolves, leveraging digital tools becomes more critical. Modern digital fingerprinting technologies offer covert, non-replicable and non-additive product authentication solutions that integrate seamlessly with existing 1D and 2D barcodes and packaging.
With an easy-to-use smartphone app, these tools enable instant verification of product authenticity throughout the supply chain, enhancing security and providing immediate counterfeit detection.
Looking ahead
The future of the pharmaceutical supply chain includes developing the next-generation AI-powered, artwork-based technologies for defect and anomaly detection.
Through machine learning, a high-resolution model of the brand’s artwork is uploaded into the system where it is trained by AI to detect defects, differences, anomalies, colour, print, dimension, etc.
Once fully trained, a smartphone app can be used to snap a picture of the product to verify its authenticity. This innovation promises to revolutionise how we ensure product safety and authenticity. Stay tuned for more updates on how modern technologies are shaping the future of the pharmaceutical supply chain.
References
- www.cnbc.com/2023/12/11/fraud-in-a-bottle-big-pharma-takes-on-counterfeit-drugs.html.
- www.politico.eu/article/several-people-hospitalised-over-alleged-fake-ozempic-drug-in-austria-diabetes-weight-loss/.