Track and Trace
By Lloyd Mager
What to Expect from Contract Partners to Protect Your Drug Supply Chain
Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. Some countries have required static coding since the 1990s, while others began requiring variable coding (to include serialization, expiry and lot number) in the 2000s, and the U.S. and Canada have until (insert date here)to comply with guidelines for unique product identification.
As global guidelines take full effect, it is worth understanding how contract manufacturing organizations are preparing themselves to comply to meet the needs of their customers.
First, Some Background
The idea to “track and trace” drug products from the source of manufacture to the patient in the pharmacy (or other dispensary) stems from a need to protect patients from “suspect” drugs — those that could be counterfeit, stolen, or contaminated.
While the U.S. FDA says approximately one percent of prescription drugs in developed countries are known to be counterfeit, it does acknowledge that the complexity, not to mention the size, of the global supply chain has left patients open to some harmful incidents. In a 2013 speech before Congress, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, testified that $20 million in illegally imported and counterfeit Lipitor was distributed in the U.S. in 2003, and that as recently as 2012, more than 500 U.S. medical practices had been informed they had purchased unapproved drugs. Also in 2012, counterfeit versions of Adderall and Vicodin ES were reported to the FDA. The FDA lists on its website more than a dozen announcements warning of counterfeit drugs, from Botox and Viagra to cancer drugs, since 2010.
A global surveillance and monitoring system implemented in 2013 by the World Health Organization has discovered more than 920 medical products that meet its criteria as substandard, spurious, falsely labelled, falsified, and counterfeit (SSFFC).
Products are being labeled with identifiers at the individual salable unit level, as well as case and pallet levels. As FDA describes it, a package of six pre-filled syringes sold as a single unit would need a unique identifier from the manufacturer/packager. But if they are separated and sold individually, each syringe would then require a new ID from the reseller.
FDA recommends using the National Drug Code and product serial number to ID salable units, saying such a system is robust enough to uniquely identify the billions of prescription drugs sold. The global organization GS1 offers a standard that includes elements such as a product ID number, a lot number, expiry information, and serial number. The information is printed as a 2D matrix barcode (or RFID chip), as well as, in some cases, in “human readable” format, on the packaging.
Digital identification helps to determine that the medical or pharmaceutical product is genuine and that its chain of custody is intact. This refers to its traceability, that one can track where the unit is and where it’s headed, and trace where it has been, both in terms of location and custodian.
This benefits many participants in the supply chain, from the manufacturers and their CMOs, to logistics providers, distributors and repackagers, customs and regulators, and dispensers such as pharmacies, clinics, and hospitals.
While finding and impeding counterfeiting is the main driver behind track and trace, it bestows additional benefits beyond patient safety. The move to serialize at the unit level and engage the digital supply chain improves overall visibility of the supply chain. It helps businesses with product protection, recall processes, more accurate and efficient returns and shipping, and more efficient reimbursement. Not only can it assure a manufacturer continuity of supply to it markets, but it leverages technology to add business value. Serialization can even be used to track patient compliance with dosing.
As pharmaceutical manufacturers well know, external partners can be essential for services that assist with everything from the product pipeline to packaging. When it comes to selecting a contract manufacturer to manufacture, package, and distribute pharmaceutical products, what should one ask relative to track and trace?
What is the CMO’s experience and expertise with track and trace? Has the organization embraced this as a paradigm shift, or just an exercise in product labeling? Contract manufacturers should display strong supply chain management skills and invest in the technologies to support track and trace requirements.
Look for a CMO that can scale with your needs for high volume packaging. In order to print serialized data and the 2D barcode, has your CMO’s packaging line been updated with additional equipment and software? Have traceability processes been created within the distribution operations and throughout the supply chain to capture and transact such traceability events as product shipped, received, returned, or even recalled?
Can the CMO meet the requirements of multiple markets across geographies, with packaging lines and distribution points that enable you to reach your target markets?
Can your CMO handle aggregation, which is the hierarchy of labeling and identification from salable unit within a case within a pallet? While regulation and guidance on this is not settled or well defined, it is an area to prepare for.
Does the CMO offer package design expertise? Can they assist in finding ways to get all required information into a well-designed package or package insert?
Just as physical product goes through a supply chain process, so too must all the associated digital data. No product can be dispersed without associated data, making the data as important a link as any other in the supply chain.
Adherence to track and track guidelines helps ensure the safety of the drug supply chain, while delivering business benefits that can add value to pharmaceutical companies, their contract partners, and others involved in the supply chain. Though serialization or identification efforts were initiated in different markets across the globe over the past decade, some organizations are more prepared than others to face the challenges and leverage the opportunities presented by track and trace.
Find a CMO partner that provides high quality products and services, the flexibility to meet your needs and reliability to deliver, as well as the expertise in packaging and ongoing guidelines relative to track and trace. Importantly, look for a CMO with a culture of engagement — both with your organization and one that embraces change and works with global regulators to understand, comply, and benefit from changing rules and recommendations.
Thre's no margin of error when it comes to the security of your pharmaceutical supply chain. Contact us to get started.