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Rock Solid Radiofrequency Identification
by Joseph Vinhais, Vice President Of Regulatory Compliance, Brooks Software Life Sciences
Pfizer Inc. announced last month that it would employ radiofrequency identification (RFID) in an effort to thwart recent counterfeiting problems with one of the best-selling pharmaceutical products on the market – Viagra®. RFID technology can help forward-thinking pharmaceutical manufacturers protect both their copyrights and patient safety, and avert the myriad problems that can occur throughout the supply chain. As more companies move toward electronic systems, it has become increasingly important to ensure that the technologies they rely on are robust. The selection of an RFID system is one that organizations must consider carefully, because solid RFID systems can help organizations trust that when a product with their name on it reaches the pharmacy, it is authentic.
What is RFID?
RFID is a type of dynamic labeling that many organizations are turning to as an alternative to traditional barcodes. The use of RFID has the potential to revolutionize the pharmaceutical industry, ensure product integrity, and improve patient safety. RFID tags – which can be tiny adhesive stickers – emit radio signals via an antenna built into the tag. An RFID reader picks up all of the information stored on a microchip built into the tag.
RFID has several advantages over traditional barcodes. Because RFID tags contain microchips, they are able to store large amounts of data, and they have significant read-write capability. In addition, while barcodes require that a laser line pass directly over the barcode, RFID tags do not require direct line-of-site scanning and RFID readers can obtain information from ultra high frequency tags at a range of up to 3 meters.
Going Paperless
Companies are moving away from paper systems because automation yields efficiencies and a tangible return on investment. For example, execution software, such as a manufacturing execution system (MES) or enterprise resource planning (ERP) software, are direct means to reduced cycle times, increased throughput, and reduced human error during data entry via the use of electronic batch records. RFID readers send signals that excite RFID tags, which then send data back to the reader. Middleware obtains this information from the reader, filters it, and stores this information into a database and then systems like MES or ERP can use the data to make manufacturing decisions, planning decisions, and so on. This permits automatic process verification and helps ensure regulatory compliance because the enterprise system – and anyone retrieving data from it – can report instantaneously where product is within the process at any time.
Barcodes are a decent choice in the path toward dynamic labeling and require far less paper, but still require printed documentation. In a truly paperless environment, there are no hardcopies to rely on, so RFID labels must be dependable and unfailingly correct. As more and more pharmaceutical companies move toward paperless manufacturing systems, organizations that elect to employ dynamic labeling and RFID systems must feel confident that the system they choose is rock solid.
Electronic Pedigrees
A handwritten traveler follows most manufactured drugs through the manufacture and distribution process, typically sent along with or taped upon a pallet containing upwards of 500 cases of product (each with 40-500 packages of 500 pills per package per case). Currently, about 3% of the pharmaceutical market uses barcode technology, meaning that over 97% of patients do not have the protection that barcodes offer. Because it is vital to maintain the integrity of pharmaceutical products and since so few pharmaceutical companies currently use any tracking system, moving toward electronic pedigrees using RFID tags rather than barcodes is the logical next step for most organizations.
An electronic pedigree is a protected record that documents the lifecycle of the drug, including its manufacture and distribution, to ensure that both occur under safe, predetermined conditions. The pedigree can include information, such as the product name, the lot number, the electronic product code (EPC), the national drug code (NDC), and so forth. The electronic pedigree maintains detailed information, accessible from data collected via RFID reads, for each package of product all the way through the supply chain.
In January, Pfizer became the first pharmaceutical company to track a product’s production RFID technology with its popular product Viagra (sildenafil citrate). Pfizer elected to employ RFID technology after a number of Viagra counterfeiting problems. Pfizer uses RFID tags that incorporate the EPC into each package, case, and pallet of Viagra. The EPC can work synchronously with RFID collected data to ensure that drug counterfeiting is not occurring, as organizations can use the data collected from the RFID tag to track every step of the process and ensure that the product that ends up at the pharmacy is the same product that left the plant. While Pfizer is not yet using the full track and trace functionality of RFID, the company is leading the way when it comes to protecting both its product as well as the products intended recipients – patients. In the end, pharmacists can use a simple scanning system to make sure they have received and are distributing authentic product.
While barcodes also help keep track of product, the barcode typically applies only to the 500-case pallet; and barcodes very generally identify the manufacturer and product. Barcodes do not provide the real-time data that pharmaceutical manufacturers need to track their products. In addition, once someone removes the shrink-wrap on a pallet, the barcode for that pallet is lost.
RFID tags allow scanning of the entire pallet at once, down to the individual package level. This means that data frequency increases, even though the data amount is far vaster than what one would get with barcodes. The information is thus timelier and more detailed. Electronic pedigrees maintain that high level of detail for each package – not case or pallet. Then, the end pharmacy does not have to scan lists of barcodes to find the appropriate product. An electronic read identifies the code on the RFID tag, which provides an automatic confirmation of the integrity of the product.
Recall Tracking
RFID functionality allows pharmaceutical manufacturers to track and trace product from manufacture to the patient. Some of this technology already exists in the medical device arena and can apply to drug delivery technologies as well. In medical device manufacturing, the RFID tag would remain on the device throughout its life – from manufacturing to the hospital, and even into the patient (in the case of implantable devices). Thus, if there is a product recall, the EPC could permit manufacturers, hospitals, or physicians to find instantaneously where a defective product has landed, as it can point to the manufacturer, product, and individual item within the product. Using RFID tags for medical devices and drug delivery systems would mean that companies could maintain product information well beyond that supplied by the EPC code if they chose, which would allow for even better tracking through the supply chain.
In the pharmaceutical industry, RFID provides all of the benefits of lifecycle management for shelf-life specific products. For example, most drugs must ship in a certain amount of days to avoid product expiration. RFID tags would prevent shipment of product that is too late in the lifecycle, avoiding costly wasted shipments or product recalls.
RFID is the Final Gatekeeper
RFID is the ultimate gatekeeper when organizations go paperless because there is no hardcopy backup of the information the tags contain. Companies that operate in a truly electronic environment without RFID in place have no real way to track product movement. For example, if an organization uses MES without RFID technology, it is not operating as efficiently as possible because it has to maintain paper travelers. Likewise, if companies employ RFID technology in a paperless environment, they no longer have paper travelers, inspection sheets, and so forth upon which to rely. Thus, if something goes wrong with the systems they have in place, there is no data, which means that the RFID technology they employ must be rock solid.
Rock-Solid RFID
Pharmaceutical organizations moving toward paperless environments should take advantage of RFID technology, but should weigh carefully these decisions when looking at RFID providers. Organizations should look for an RFID provider that has a long history in the industry and the experience to foresee and alleviate potential problems. Such maturity means that the provider has established protocols in place for troubleshooting common problems and already has worked out any system glitches. This is especially important when looking at real-time data. Real-time signals of production activity in a paperless environment can and should provide real-time data. Organizations can look for RFID solutions that already provide real-time reporting. Organizations also should look for a scaleable system that can expand with growth, not only when it comes to collecting data, but also when it comes to reporting and making automatic decisions about the data. For any organization considering new technology, the ability to visualize beyond the short term will help smooth the transition necessary to capitalize on the utilization of newly available data.
An RFID implementation should have the capacity to interface to existing solutions, so that the organization can phase in new processes seamlessly as they evolve. For example, once the data comes from the hardware, organizations that already have MES in place can act on that information and provide real-time reporting functions surrounding the data. If they do not have an MES system, but later add one, the RFID system should be one that can work with that transition via appropriate, time-tested software.
It is equally important that organizations select a system that is mission-critical 24 hours a day, seven days a week, such that if one system goes down, the information it maintained is already in multiple backup systems. A secondary backup system should automatically take over in the event of a primary system failure, such that users do not even see what happened.
The systems should also be capable of automated intelligent decision making for processes, by applying a set of uniform rules to the data such that human intervention is not required. As the real power of going paperless with the new RFID implementation begins to sink into the consciousness of the organization, it will begin to see multiple ways that automated intelligent decision will continue to add value.
Pharmaceutical organizations working toward full electronic functionality can do so with a strong RFID system. RFID provides the checks and balances organizations need to go paperless, and the confidence of being able to see – at the touch of a finger – whether its product is in production, on a truck, sitting in inventory, or distributed to a pharmacy. Such confidence will propel pharmaceutical manufacturers down the road to true electronic efficiency.
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