The counterfeit drug problem continues to grow and it has received recent media attention with stories highlighting Avastin patients and unraveling the wrong-doings of Ranbaxy. The issue of counterfeit pharmaceuticals was previously contained to lifestyle medicines, such as ED medications or diet pills. However, the counterfeit market has expanded and impacts patients with chronic disease conditions, such as diabetes and heart disease, as well as life threatening conditions, such as cancer, HIV and conditions requiring antibiotics or anti-virals.
Counterfeits pose a significant threat to patients, their communities and global public health – by driving antibiotic and antiviral resistance. For example, a substandard dose of a medication is potentially more dangerous than a dose with no active ingredient because it could spur a disease mutation and resistance to a drug. The entire community would be affected. Further, this drug resistance, spurred from counterfeits, could contribute to the inability to eradicate or control infections like malaria and TB in developing countries.
Additionally, counterfeits impact drug supply/shortages. This includes access to approved drugs, drugs needed for clinical trials and products needed for discovery in the lab. Yet another reminder of the widespread and complex impact counterfeits have on inventory levels/drug shortages, as well as, public health, patient safety and brand erosion and consumer trust.
To eliminate the risk of counterfeits and mitigate the subsequent impact of counterfeits, global regulatory intervention and enforcement, as well as, the use of scalable, robust and flexible track and technology are fundamental.
Eliminating Risks of Counterfeits: Global Regulations
In response to the significant threat counterfeits have to patient's safety, health officials and manufacturers have sought to mandate track and trace and serialization as part of global regulations and guidelines. For example, EU Serialization will be introduced in 2014, followed by the FDA/California Serialization standard in 2015 and further down the road a federal mandate. Additionally, WHO has established the IMPACT (International Medical Products Anti-Counterfeiting Taskforce) initiative, involving a range of stakeholders in collaborative efforts to protect consumers from buying and using counterfeit products. International institutions such as Interpol, the World Customs Organization (WCO) and The European Directorate for the Quality of Medicines (EDQM) are working closely with governments and companies to create a global security system and strengthen regulations.
At present, while global regulations and guidelines evolve, regional and local regulations vary. To address this, stakeholders seek to harmonize coding with GS1 standards, as well as unique identifiers such as GTINs. Manufacturers are also implementing serialization systems to implement product authentication and through track and trace create product pedigree.
Requirements for serialization and subsequent accountability and chain of custody has spanned across the globe and has been fueled by countries demanding serialization from their import/export trading partners. For example, in order to continue to comply with regulatory mandates in European and future US markets, India and China have begun implementing serialization and chain of custody requirements into manufacturing processes and practices.
Eliminating Risks of Counterfeits: Track and Trace Technology
Given the complex and fragmented nature of global pharmaceutical production and consumption, track and trace technology, solutions and services are fundamental to safeguarding patient safety and protect product integrity.
Track and trace technology is a simple and effective way to leverage basic serialization and item level identifiers and protect patients and consumers against counterfeiting and substandard medicines. Its advantage is that it enables the serial number also known as a Unique Identifier Number (UIN) to be recorded at various points throughout the supply chain on a central server or on the product itself; facilitating the discovery of where counterfeit products have entered the supply chain – end-to-end. Additionally, serialization of each unit provides companies visibility into their supply chain down to the unit level of every event, as well as providing visibility for optimal inventory forecasting. The visibility translates into chain of custody and ultimately the accountability required to safeguard patient health and safety, as well as ensuring access to medicine via inventory management.
Track and trace goes below the surface of medicines alone, and safeguards the active and inactive/bulk ingredients. Hence, supporting the adage it is only as good as what goes into it. Track and trace also provides for full traceability of products globally as well as regionally.
The prevalence of counterfeits continue to grow. Counterfeit drugs effect safety, public health, drug supply of approved drugs and drugs needed for development, and pose a serious threat to manufacturers who seek to protect their brands and continue innovating. Counterfeiting erodes the trust we have in our healthcare providers, regulators and the legitimacy of research, scientific development and medical treatment.