In response to globalization and heightened competition, very complex supply chain ecosystems have emerged across the pharmaceutical industry. As a result, the number of raw materials suppliers, manufacturers, distributors, third-party logistics partners, and dispensers involved in getting a drug from the production line and into a patient’s hand is higher than ever before.
As supply chains grow infinitely more complex, counterfeiting, diversion, and importation of unapproved or substandard drugs will continue to threaten the integrity of the supply chain and pose a tremendous risk to patient safety.
The World Health Organization estimates that counterfeit drugs make up 10% of the drug market worldwide.
In the United States, several high-profile counterfeit drug cases served to shed light on the importance of supply chain integrity and its role in protecting patient safety:
- 2002 - Counterfeit Epogen, purchased from a large retail pharmacy chain in New York, results in severe health issues for a young liver transplant patient. In addition to the manufacturer and the major distributor, the counterfeit Epogen had been handled by 3 different wholesalers, 2 pharmacies, 4 unlicensed go-betweens, and 1 suspected counterfeiter1
- 2008 - Contaminated heparin imported from China enters the U.S. supply chain posing as pure heparin, resulting in an estimated 81 deaths and a large number of adverse events in the U.S. alone3
- 2012 - Counterfeit versions of Avastin, a cancer medication, penetrate the U.S. supply chain through a network of foreign and online distributors. The counterfeit Avastin, which was sold to an estimated 72 doctors in 22 states contained cornstarch, acetone and other chemicals, but no active ingredient to fight cancer – posing a huge risk to patient safety and potentially causing patients who received the counterfeit meds to lose several months of their lives, due to ineffective treatment2
In 2013, in an effort to combat counterfeit prescription drugs and protect patient safety, the DSCSA (Drug Supply Chain Security Act) was passed in the U.S. The DSCSA requires companies across the pharma supply chain to implement track-and-trace technology and processes to allow a specific drug’s movement to be followed from the manufacturer to the pharmacy, and ultimately, the patient. DSCSA implementation has been spread out over several phases, with unit-level traceability enforcement currently planned for 2023.
The U.S. is certainly not alone in this push toward better supply chain visibility and product traceability. Countries around the world have implemented pharmaceutical product serialization and track-and-trace regulations, each with their own unique set of requirements and enforcement timelines.
For many pharma companies, faced with the daunting task of managing huge volumes of serialized product data and harmonizing information exchange across massive supply chain partner networks, the need to comply with DSCSA and other global product traceability regulations served as an impetus for digitizing supply chain operations. Digitization enables more integrated, efficient and secure pharma supply chain networks that not only improve product quality and patient safety, but also help generate significant business value from serialization data…
- With unprecedented visibility into where their products have been, and where they end up, pharma companies gain actionable insights they can use to be more adaptive and responsive to customer and partner demands
- In addition to discovering product diversions and potential counterfeiting, massive data repositories can be analyzed to detect anomalies in manufacturing, prevent product shortages, and optimize supply chain operations
- By extending access to product information and authentications tools for physicians, pharmacists, and patients via mobile apps, pharma companies can improve customer engagement and help ensure product quality and safety at the point of care
It is clear that for pharma companies, the benefits of digitization extend far beyond meeting immediate regulatory compliance milestones. Digital disruption is shaking up every industry. How will pharma companies need to evolve to stay in the game? Stay tuned as we continue to explore this topic in future blog posts…
For over a decade Axway has worked with leading pharma companies to reduce the cost and complexity of compliance with global product serialization and traceability regulations. Axway Track & Trace provides organizations with visibility to the data they need to secure the integrity of their supply chain ecosystem to deliver improved quality and patient outcomes.
Watch this video to see how Pharma Packaging Solutions leverages Axway Track & Trace to provide a complete end-to-end serialization solution and secure the integrity of the pharmaceutical supply chain
- The Health and Economic Effects of Counterfeit Drugs, Am Health Drug Benefits, 2014 June
- US House of Representatives, Committee on Energy and Commerce. Hearing on counterfeit drugs. Memorandum. February 25, 2014
- How Fake Cancer Drugs Entered U.S., Wall Street Journal, July 20, 2012