Tracking and tracing pharmaceutical products is more than just an exercise in inventory management. It is a life-saving practice that is mandated by law. In 2012, the Centers for Disease Control (CDC) and local health authorities tracked a multistate outbreak of fungal meningitis back to a compounding center in Massachusetts. The compounding center was illegally manufacturing steroids that had become contaminated with common environmental fungi. These steroids were used to treat spinal inflammation and pain, and when injected caused a variety of ailments including inflammation of the brain (meningitis). The outbreak, which ultimately killed 64 people and sickened over 700 others, made clear how little information was being retained concerning the origins and storage of pharmaceuticals.
In response, the U.S. Congress passed the Drug Supply Chain Security Act (DSCSA) in 2013 to better protect the public from counterfeit or contaminated pharmaceuticals and to speed up recalls of unsafe medicines. Its provisions began going into effect in 2014 and requirements will continue to be phased in through 2023. In 2024, the Food and Drug Administration expects to be able to track and trace a package of pharmaceuticals all the way back to its origin point. In order to meet that goal and comply with the law, pharmaceutical manufacturers and distributors must enable better tracking and tracing of pharmaceutical products.
How Pharmaceutical Track and Trace Works
The FDA mandates what is called serialization for pharmaceutical products. This involves assigning each pharmaceutical a unique identification number that is associated with data that can be read across supply chains. This creates a transparent record of any transactions a product has undergone (transactions refers to a change in ownership rather than a change in custody).
With the right equipment, whole truckloads of RFID-equipped products can be read and recorded in a single pass through an RFID reader.
Unique identification codes are nothing new to most supply chains. One type of identifier is already clearly identifiable on most consumer packaged goods in the form of barcodes. These can be encoded with any number of already existing identification standards. The challenge barcodes pose is the time required to manually scan codes one-by-one. Expanding this tedious task to every pharmaceutical product and transaction it undergoes translates to a lot of man-hours—and associated costs—spent solely on tracking. There are, however, technologies that can speed this up.
Passive radio frequency identification (RFID) chips broadcast an identifier in response to radio waves. These RFID chips can be used to swiftly record serialized identifiers, as they don’t require the scanner to be aimed directly at a barcode. This makes them friendly to automated processes like Automated Storage and Retrieval Systems or palletizers, reducing time costs still further. With the right equipment, whole truckloads of RFID-equipped products can be read and recorded in a single pass through an RFID reader. However, at a cost of approximately fifty cents per chip, the expense of using RFID tracking on every carton adds up quickly. Using RFID chips to track at the pallet level instead can reduce the numbers of RFID tags needed, lowering the costs of RFID tracking overall.
Tracking and Tracing of Pharmaceuticals Through Pallets
The DSCSA currently requires pharmaceutical manufacturers and distributors to provide a serialized identifier down to the lot level. Eventually, the law will require that pharmaceuticals have identifiers at the case level associated with a complete transactional history of that case. It is in recording this transaction history and making it available at both ends of the supply chain that pallet-level identification can help. Pallet-level tracking has the following benefits:
- Case-level serialized identifiers can be associated with pallet serial numbers in a database, which can be shared through warehouse management systems.
- Instead of scanning each pharmaceutical identification number during every transaction, the pallet-level identifier can be recorded and the identifiers of the pharmaceuticals associated with it recorded.
- Pharmaceuticals only need to be scanned when they are first palletized and when they are depalletized.
While this system offers a great deal of promise, it is heavily dependent on the reliability and durability of the RFID-enabled pallets used.
How Plastic Pallets Enable Pharmaceutical Track and Trace
The products loaded onto a pallet are already recorded on a pallet license, which is simply a printed sheet of paper with an identifier, the inventory of the products on the pallet, and a machine-readable code of some type. However, it is common for a pallet license to be lost or misplaced during product transportation. One of the challenges in implementing track and trace is that procedures tend to assume that at least some of these identifications will be lost during shipping. The quantity of products received is simply verified against what was ordered and unique identification numbers aren’t checked unless a reason arises to do so. This causes issues during recalls, as it means there is no ready mechanism to trace products back through the supply chain to their origins. This issue isn’t exclusive to tracking and tracing pharmaceuticals, either. Food supply chain traceability has been subject to similar issues.
One way to prevent the loss of serialized identification numbers is to make them a permanent and unremovable part of the shipping platform. That isn’t possible with traditional wood pallets, which often break and have boards replaced. Indeed, getting the maximum life out of a wood pallet inevitably requires replacing deck boards, stringers, or blocks, meaning that any identification number or RFID chip is only temporary.
The ability to permanently embed serialized identifiers in plastic pallets makes associating case-level identification with load unit (pallet) level identification more reliable.
However, the same is not true of plastic pallets. Plastic pallets, unlike wood pallets, are simply much better suited to tracking at the pallet-level using technology such as RFID tagging. Plastic pallets:
- Have a durable unitized construction, rather than being composed of individual boards fastened together.
- Are easily embedded with RFID tags, which become a permanent part of the pallet.
- Don’t splinter or crack and lose large pieces of material.
The ability to permanently embed serialized identifiers in plastic pallets makes associating case-level identification with load unit (pallet) level identification more reliable. It also enables tracking and tracing of pharmaceutical products through transactions in the supply chain without having to manually scan every case at every transaction point—and without the expense of equipping every case and transaction point with RFID equipment. Plastic pallets offer a reliable method of developing the track and trace procedures and methodologies that are mandated by law.
iGPS plastic pallets are equipped with embedded RFID tags for tracking and tracing pharmaceutical products. Improve traceability in pharmaceuticals by giving our team a call at 1-800-884-0225, emailing a specialist at [email protected], or visiting our contact page.