Addressing counterfeit pharmaceuticals.
Counterfeit medicines are not a new phenomenon with warnings dating back to the 4th century BC. A recent TIME magazine[1] article suggests we have a long journey ahead. It featured a story exposing the societal risks when counterfeit medicines enter the market. Unscrupulous criminals and organized crime will stop at nothing to take advantage of lax market controls and poor consumer and patient awareness. The startling graphic below highlights the extent of the health and safety risks as highly toxic ingredients and contaminants are discovered in counterfeit prescription medicines and common over-the-counter (OTC) drugs. The article further suggests the counterfeit medicines has grown to USD 75 billion annually. Moreover, the World Health Organization (WHO) notes that all countries are touched by the issue while several reports suggest annual death tolls could exceed 1 million. Governments are acting with revised regulations such as the EU’s Falsified Medicines Directive and the US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA). In these examples, GS1 supply chain standards are accepted as part of the supply chain controls.
Figure 1: Poisons found in medicines
Empirical research on fake pharmaceuticals
A recent peer-reviewed publication[2] highlighted the alarming growth in the number of counterfeit medicines reported, noting it’s the “top of the iceberg”. They further note that while organized crime benefits, issues include lax or non-existent regulations and controls, corruption, bribery, illicit trade and the intricacy of distribution networks.
Figure 2: Global increase in medicine counterfeiting ‑ Source: Pharmaceutical Security Institute (PSI)
Importantly, the researchers suggest the “pharmaceutical industry must defend itself by building protective features into its products and perfecting techniques of counterfeit analysis that will provide the authorities with the forensic intelligence that could identify and destroy the counterfeit networks. The vast literature further highlights that effective anti-counterfeit measures must include the identity of all parties handling, processing, (re)packing, distributing etc. in the supply chain. This notion aligns with the concepts of transparency and digital chain-of-custody.
INEXTO solutions enables digital chain-of-custody
INEXTO’s depth of experience enabling digital chain-of-custody solutions helps clients gain much-needed visibility and transparency in their supply chains. Clients can verify the location and legal custody of in-transit shipments and individual serialized products along the entire global supply chain, satisfying regulatory requirements and mitigating the risk of counterfeit and illicit trade.
INEXTO: How does it work?
The pharmaceutical sector is starting to benefit from INEXTO’s experience in mass serialization alongside covert/overt and forensic tools to protect brands, consumers and patients. INEXTO’s years of experience in solving these problems and deploying scalable and secure solutions for serialization, aggregation, tracking, tracing, recall as well as covert/overt and forensic anti-counterfeit measures is vital to ensure industry compliance and reduce the social burden. The INEXTOR serialization module is a highly scalable solution and currently assigns and manages 50+ billion secure unique serialized identifiers annually for clients. The subsequent traceability data is captured as EPCIS events in the INEXTRACK module which currently scales to multi-billions of EPCIS supply chain events annually. Furthermore, the traceability data in INEXTRACK can be queried using the INEXTRACE smartphone application which provides consumers and market surveillance authorities with the capability to query and verify a product’s traceability, its safety and whether on recall. In addition, INEXTRACE facilitates access to relevant company details, validation of product attributes and provides an invaluable tool to authenticate the product.
INEXTO SUITE
INEXTO is a proven leader in providing GS1 centric solutions in multi-party supply chains. Today, the INEXTO SUITE of solutions are implemented in 1000+ manufacturing lines and 1500+ locations worldwide. INEXTO’s proven scalability and thought leadership is helping organizations today to bridge the information asymmetry gap, comply with regulation, improve competitive advantage and enhance transparency and consumer trust.
[1] http://time.com/2826641/poison-pills/
[2] Dégardin et al (2013) Understanding and fighting the medicine counterfeit market